Resources & Education

Hypoactive sexual desire disorder: How do you identify it and treat it?

Approximately 1 in 10 women has distressing low sex drive, otherwise known as hypoactive sexual desire disorder (HSDD). How do healthcare providers determine whether a given patient has HSDD? And how should they treat it? The authors address these challenges in this article.

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2018 NPWH Women’s Health Nurse Practitioner Workforce Demographics and Compensation Survey: Highlights Report

The National Association of Nurse Practitioners in Women’s Health (NPWH), in collaboration with the National Certification Corporation (NCC), completed its Women’s Health Nurse Practitioner (WHNP) Workforce Demographics and Compensation Survey in fall 2018. Major objectives of the survey were (1) to obtain detailed demographic information to understand who today’s WHNPs are, where they work, what they do, and which populations they serve, (2) to identify trends in employment compensation specific to WHNPs, (3) to ascertain associations among WHNP education, experience, practice characteristics, and compensation, (4) to identify associations among experience, practice characteristics, and employment/role satisfaction, and (5) to explore trends and attitudes regarding the preceptor role.

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Addressing women’s healthcare needs in the U.S. military

Greetings to all our readers from the Policy Chair and Treasurer-Elect of the NPWH Board of Directors. Before you read my first Policy & practice points column, in which I aim to provide insight into policies affecting women who serve in the military from the perspective of a woman serving in the military, I want to introduce myself. I am a women’s health nurse practitioner (WHNP) and a Lieutenant Colonel in the United States Air Force (USAF). I have 13 years’ experience serving in the military as a WHNP. I have served in multiple locations, including highly operational positions where I have supported military women worldwide. I now serve in the largest research organization in the USAF, where I am developing solutions to better incorporate women into the armed services. Continue reading »

Brain Health is Womenʼs Health

The National Association of Nurse Practitioners in Women’s Health (NPWH) supports collaborative action to establish brain health as a crucial aspect of women’s healthcare. A comprehensive approach includes promoting brain health, detecting cognitive impairment (CI) to facilitate accurate diagnosis and early intervention, and identifying and addressing the needs of individuals who are caregivers for loved ones with CI.

NPWH believes a need exists for extensive research to better understand modifiable factors that influence brain health, improve one’s ability to make an early diagnosis of CI, establish effective therapies to prevent and treat CI, and support families and caregivers of individuals with CI. NPWH endorses federal and state policies that devote resources to finance the needed research and that ensur e access to needed diagnostic, care, and treatment resources for individuals with CI, caregivers, families, and healthcare providers.

Background

Cognitive function refers to memory, speech, language, judgment, reasoning, and planning and thinking abilities.1 Brain health is a term commonly used to describe healthy cognitive function.2,3 Changes in these functions may indicate CI. These changes may range in their level of severity, may be progressive, and may have treatable causes.

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition’s (DSM-5’s) diagnostic categories of minor and major neurocognitive disorders (NCDs) reflect the range in CI severity. Minor NCD is a condition in which the individual has mild but measurable changes in cognitive function that are noticeable to the person affected and to family members and friends but do not affect the individual’s ability to carry out activities of daily living (ADLs).1 Minor NCD may be progressive. Approximately 15%-20% of persons aged 65 years or older have minor NCD.4 Major NCD is impairment characterized by decline in at least two cognitive domains (e.g., memory, attention, language, visuospatial function, executive function) severe enough to affect a person’s ability to perform ADLs; the individual also may exhibit behavioral and psychological symptoms.1 Dementia is a commonly used term for major NCD.

Alzheimer’s disease (AD), a progressive degenerative brain disease, is the most common cause of dementia.1 Most statistics on dementia reflect data related to AD. As of 2018, about 5.7 million adults in the United States have AD, with 5.5 million of them being aged 65 years or older. As the size and proportion of this older U.S. population grows, it is projected that 7.1 million persons aged 65 or older will have dementia, primarily AD, by 2025.1 The annual number of new cases of AD and other dementias will likely double by 2050 unless research discovers the key to prevention.1

These statistics do not reflect pre-clinical AD. Current thinking is that Alzheimer’s-related brain changes may begin 20 or more years before symptoms occur.1 No proven strategies are available to prevent AD. However, recognized risk factors for cognitive decline and AD, some modifiable, do exist.5,6 Increasing evidence suggests that lifestyle interventions may have a long-term impact on preserving brain health. The Alzheimer’s Association published a report in 2015 summarizing existing evidence related to risk factors and risk reduction (Box 1).5

All nurse practitioners (NPs) who care for midlife and older adults play a critical role in early recognition of CI. Early signs and symptoms include problems with memory or language, noted deficits in personal or instrumental ADLs, and concerns reported by the individual or a family member or caregiver.7-9 Assessment to detect CI is a required component of the annual wellness visit established in 2011 for Medicare recipients under the Patient Protection and Affordable Care Act.7

The Alzheimer’s Association has published guidance on detection of CI during the annual wellness visit. This guidance includes an algorithm for health risk assessment, patient observation, unstructured questioning, and structured assessment.7 Use of a structured cognitive assessment instrument can improve detection of CI in primary care settings by identifying individuals who may need further evaluation. Validated brief cognitive assessment tools that can be administered in 5 minutes or less in the primary care setting are available. Individuals whose assessment findings indicate possible CI should be evaluated further or referred to a specialist.7 Several initiatives have provided lists of these assessment tools, as well as recommendations and strategies NPs can use to address brain health and CI (Box 2).10-12

Early detection of CI and diagnosis of dementia are integral to individual and family counseling, advance care planning, and consideration of supportive therapies.13-15 The years from diagnosis to end-of-life may be fraught with poor health and disability, resulting in loss of independence and, over time, a substantially lowered quality of life. When interprofessional team members work together with the individual, family members, and caregivers, the changes that occur throughout the course of the disease process can be anticipated and the best care provided.

The impact of this disease on quality of life extends to the more than 16 million adults in the U.S. who provide unpaid care for loved ones with dementia.1 Approximately two-thirds of these informal caregivers—that is, 10.7 million of them—are women, and more than one-third of these women are the daughters of the individuals with dementia.1 The average age of caregivers is 49 years, although about one-third of them are aged 65 years or older.1,16 One-fourth of caregivers belong to a sandwich generation—that is, they are caring not only for an aging parent but also for children younger than age 18.1

Caregiving tasks include helping with instrumental ADLs (e.g., shopping, providing transportation, managing finances) and personal ADLs (e.g., bathing, dressing, feeding). In addition, caregivers may coordinate healthcare and support services. As dementia progresses, caregivers often must manage behavioral symptoms of the disease (e.g., aggressive behavior, wandering).1 Such tasks can take an emotional and physical toll on caregivers, as well as affect their financial status if they must modify or terminate paid employment and pay for healthcare services for themselves and their care recipient.1,16 In many cases, their own needs go unrecognized and unattended.15

A call to action has arisen to transform policies and practices affecting the role of informal caregivers as a major source of care for a growing population of older adults with dementia. A strategic national-level action plan will be required to address the needs of these caregivers. Policies to create evidence-based training for informal caregivers specific to the care of individuals with dementia, provide support such as expanded family leave and job protection for working caregivers, and fund evidence-based caregiver services are critical. Policies must recognize the needs and values of a diverse population of caregivers and the individuals under their care.15,17,18 Box 3 lists resources devoted to caring for caregivers themselves.

Implications for women’s healthcare and NP practice

Nurse practitioners who provide healthcare to women of all ages have the opportunity to address brain health during annual well-woman visits and/or during other visits if concern about patients’ cognitive function arises. In addition, NPs are likely to see, on a regular basis, a large portion of the roughly 10.7 million informal caregivers who are female. NPs are in an excellent position to identify women who are in the caregiver role and address their physical and mental health needs, including their brain health needs.

Recommendations

Nurse practitioners who provide healthcare for mid-life and older women, as well as women of any age who may be caregivers for loved ones with dementia, should:

  • raise the topic of brain health as part of women’s health during routine healthcare visits;
  • address risk factors for cognitive decline that may be reduced with lifestyle changes (e.g., improved nutrition, regular physical activity, cognitive training, smoking cessation);
  • include a question about memory or cognition on health risk questionnaires;
  • observe for signs and symptoms of CI;
  • use an evidence-based protocol for screening and diagnostic evaluation of patients’ brain health and referral for further evaluation if indicated;
  • include a question about any caregiving responsibilities in health assessment;
  • offer additional screening for caregivers to assess preparedness for caregiving and caregiver strain;19,20
  • develop health system partnerships to connect individuals with dementia and their caregivers with community agencies to identify needs and access help;
  • collaborate with affected individuals, caregivers, and an interprofessional team to facilitate decision making and planning (e.g., living arrangements, advance care planning, end-of-life care) that addresses changing needs over time and across care settings; and advocate for policies at local, state, and national levels that address the needs and values of individual with dementia and their caregivers.

NPWH will provide leadership to ensure that:

  • continuing education programs and other evidence-based resources are available for NPs to learn and update knowledge regarding brain health, dementia, and caregiver needs;
  • ongoing collaborative engagement occurs with a variety of stakeholders to address brain health and caregiving issues as important components of an older women’s health agenda;
  • research moves forward in all aspects of brain health to prevent dementia, treat existing CI, help those with CI maintain function and quality of life, and support caregivers; and
  • policies strongly support individuals and families in coping with the physical, emotional, and financial burden of dementia.

 

References

  1. Alzheimer’s Association. 2018 Alzheimer’s Disease Facts and Figures. alz.org/alzheimers-dementia/facts-figures
  2. Alzheimer’s Association. Brain Health. 2018. alz.org/help-support/brain_health
  3. National Institute on Aging. What is Brain Health? 2018. brainhealth.nia.nih.gov/
  4. Roberts R, Knopman DS. Classification and epidemiology of MCI. Clin Geriatr Med. 2013;29(4):753-772.
  5. Baumgart M, Snyder HM, Carrillo MC, et al. Summary of the evidence on modifiable risk factors for cognitive decline and dementia: a population-based perspective. Alzheimers Dement. 2015;11(6):718-726.
  6. Moga D, Roberts M, Jicha G. Dementia for the primary care provider. Prim Care Clin Office Pract. 2017;44(3):439-456.
  7. Cordell CB, Borson S, Boustani M, et al. Alzheimer’s Association recommendations for operationalizing the detection of cognitive impairment during the Medicare Annual Wellness Visit in a primary care setting. Alzheimers Dement. 2013;9(2):141-150.
  8. Falk N, Cole A, Meredith TJ. Evaluation of suspected dementia. Am Fam Physician. 2018;97(6):398-405.
  9. Scott J, Mayo A. Instruments for detection and screening of cognitive impairment for older adults in primary care settings: a review. Geriatr Nurs. 2018;39(3):323-329.
  10. Alzheimer’s Association. Cognitive Assessment Toolkit. 2013. alz.org/professionals/healthcare-professionals/cognitive-assessment

 

Position Statement | Eliminating Preventable Maternal Deaths

The National Association of Nurse Practitioners in Women’s Health (NPWH) supports coordinated and collaborative efforts at federal, state, local, and professional organization levels to eliminate preventable maternal deaths. For 2011-2015, the pregnancy-related mortality ratio (PRMR) in the United States was 17.2 deaths per 100,000 live births.1 This statistic translates to an average of 700 women dying of pregnancy-related complications each year, a rate that remains higher than that of any other resource-rich country.1 The CDC estimates that 3 in 5 pregnancy-related deaths in the U.S. are preventable.1

NPWH advocates for legislation, policies, and initiatives that promote access to care, establishment and implementation of evidence-based healthcare practices to improve maternal outcomes, and ongoing research into the contributing factors to maternal mortality and effective preventive strategies.

Reducing racial and ethnic disparities in maternal mortality must be a priority. The most recent data have shown that, compared with non-Hispanic white women, non-Hispanic black women had PRMRs that were 3.3 times higher and American Indian/Alaska Native women had PRMRs that were 2.5 times higher.1 NPWH supports action at all levels that address socioeconomic factors, barriers to access to quality healthcare, and implicit bias on the part of healthcare providers (HCPs), all of which contribute to disparities in healthcare services and health outcomes.

Women’s health nurse practitioners (WHNPs) who provide care for women before, during, and in between pregnancies are uniquely qualified to address the known contributing factors for preventable maternal mortality and to optimize health outcomes. WHNPs who specialize in high-risk antepartum and postpartum care are particularly well suited to enhance health outcomes for women with identified maternal morbidity and mortality risks.

Background

In the U.S., a pregnancy-related death is defined as one that occurs during pregnancy or within 12 months of the end of a pregnancy that is causally related to the pregnancy. This causality refers to deaths related to a pregnancy complication, a chain of events initiated by pregnancy, or the aggravation of an unrelated condition by the physiologic effects of pregnancy.1 A death is considered preventable if it is determined that a chance existed that the death could have been averted by one or more changes to community, health facility, patient, provider, and/or systems-level factors.2

Data from the 2011-2015 CDC’s national Pregnancy Mortality Surveillance System (PMSS) report indicated that cardiovascular (CV) conditions led to more than 33% of the pregnancy-related deaths during this time period.1 For the purpose of this data collection, CV conditions included cardiomyopathy, other cardiovascular conditions, and cerebrovascular accidents. Other leading causes of pregnancy-related death were non-CV health conditions, infection, obstetric hemorrhage, amniotic fluid embolism, and hypertensive disorders of pregnancy. Deaths attributable to suicide, drug overdose, homicide, or unintentional injury were not included in this analysis. Causes of death varied with timing during the pregnancy-through-postpartum continuum. Box 1 lists leading causes of death by time relative to this continuum.

Role of maternal mortality review committees
Beyond gathering data on causes of maternal mortality, a concerted effort to understand contributing factors and the potential for prevention of maternal deaths is critical. State-level multidisciplinary maternal mortality review committees (MMRCs) are expanding across the nation, with the goal to identify and analyze maternal deaths using a standardized, systematic process. For each death, the committees make six key decisions: Was the death pregnancy related? What was the cause of death? Was the death preventable? What were the critical contributing factors to the death? What are the recommendations and actions that address the contributing factors? What is the anticipated impact of these actions, if implemented?3

In a recent collaborative report, 13 state MMRCs identified 251 pregnancy-related deaths that occurred between 2013 and 2017.1 The committees were able to make a determination on preventability for 232 (92.4%) of the 251 deaths. Among these 232 deaths, 139 (60.0%) were determined to be preventable.1 The MMRCs categorized contributing factors for these preventable pregnancy-related deaths into five levels: community factors, health facility factors, patient factors, provider factors, and systems-level factors. Preventive strategies were identified for each level, with recognition that most deaths had more than one contributing factor and required more than one preventive strategy (Table).1,3

The comprehensive, multidisciplinary approach of MMRCs facilitates recognition of mental health conditions, including substance use disorders (SUDs), as a leading contributor to maternal deaths (these mental health-related deaths occur primarily in the first year postpartum). In identified cases, a mental health condition was associated with the majority of deaths from unintentional injury, accidental drug overdose, or suicide.3-5 Standardized MMRC data collection and decision forms have been expanded to include specific components regarding mental health and SUDs in order to help MMRC members better understand the role of mental health conditions in terms of pregnancy-related deaths.3

The U.S. Department of Health and Human Services is authorized through the 2018 Preventing Maternal Deaths Act to provide funding to states to establish and sustain MMRCs, disseminate findings, implement recommendations, and develop plans for ongoing HCP education in order to improve the quality of maternal care.6 Shared information from MMRCs can inform policymakers and other stakeholders in their efforts to prioritize recommendations and provide resources to translate them into action. More than 40 states now have an active MMRC in place or in development. Information about which states have or are planning to have MMRCs is available hereA.

Translation of evidence into action
Translation of recommendations from MMRCs and other evidence-based sources into action, along with the study of outcomes, is crucial to eliminate preventable maternal deaths. The Alliance for Innovation on Maternal Health (AIM)—a national partnership of HCPs, public health professionals, and advocacy organizations under the auspices of the Council on Patient Safety in Women’s Health Care— provides resources for this purpose with the creation of safety bundles focused on high-risk maternal conditions.7,8 Safety bundles are evidence-based practices that, when consistently acted upon by the healthcare team, have been shown to improve patient outcomes.9 Each AIM safety bundle has four domains: readiness, recognition, response, and reporting/systems learning. AIM provides support and technical assistance at state and healthcare system levels to implement the bundles. Other resources for translating evidence into action include the American College of Obstetricians and Gynecologists, the California Maternal Quality Care Collaborative, the Center for Reproductive Rights and Black Mamas Matter Alliance, and the Society for Maternal-Fetal Medicine. A list of resources is provided in Box 2.10-26

Legislation and policies are needed to facilitate action that promotes maternal health and reduces maternal morbidity and mortality. Federal and state legislation has expanded support for MMRCs, the work of the Council on Patient Safety in Women’s Health Care, and other maternal health initiatives. Federal-level bills have been introduced to extend Medicaid coverage eligibility to include 1 year of postpartum care. This coverage is particularly important because the 2011-2015 PMSS data indicated that 51.7% of pregnancy-related deaths occurred in the postpartum period, with 18.6% occurring 1-6 days postpartum, 21.4% occurring 7-42 days postpartum, and 11.7% occurring 43-365 days postpartum.1 Extended Medicaid coverage could change postpartum care to an ongoing process tailored to each woman’s own needs rather than a single encounter. The American College of Obstetricians and Gynecologists’ recommendations for a first postpartum visit at 3 weeks and a second visit no later than 12 weeks postpartum would be facilitated.18 A first visit earlier than the traditional 6 weeks, with follow-up at 12 weeks, would allow for better monitoring of risk factors and signs/symptoms of maternal complications, including mental health concerns. HCPs would have more opportunity to provide education, counseling, and any needed referrals, as well as a coordinated transition to well-woman care in the first year postpartum.

Importance of reducing racial/ethnic outcome disparities and implicit racial/ethnic bias
Preventive strategies that address community, health facility, patient, provider, and systems-level factors must give utmost priority to reducing the racial and ethnic disparities in pregnancy-related mortality that have persisted over time. Although the overall PRMR in the U.S. in 2011-2015 was 17.2 deaths per 100,000 live births, racial/ ethnic comparisons revealed significant differences. Non-Hispanic black women and American Indian/Alaska Native women had PRMRs of 42.8 and 32.5 deaths per 100,000 live births, respectively, as compared with 13.0 deaths per 100,000 live births for non-Hispanic white women.1 Causes of these disparities in maternal mortality are not fully understood and are likely multifactorial. Data have indicated that racial and ethnic minority women, compared with non-Hispanic white women, are less likely to (1) receive early and regular prenatal care, (2) have access to maternal-fetal medicine specialists, (3) give birth in higher-quality hospitals, and (4) attend a postpartum visit.27,28 Compared with non-Hispanic white women, non-Hispanic black women are more likely to have health conditions that place them at risk for maternal morbidity and mortality and they have twice the rate of unplanned pregnancies.28

Substantial evidence indicates that implicit racial/ethnic bias exists among HCPs—as it does in the general population—and that this bias can affect patient–HCP interactions, treatment decisions, treatment adherence, and patient outcomes.29,30 (Implicit biases are unconscious attitudes that can influence affect, behavior, and cognitive processes.) More research is needed to fully understand how implicit bias affects patient care and outcomes and whether certain intervention strategies can help address this bias within healthcare.

Implications for women’s healthcare and WHNP practice

WHNPs provide healthcare for women before, during, and in between pregnancies in a variety of settings. The care they provide before and in between pregnancies places them at the forefront to assess for and address known risk factors for maternal complications prior to pregnancy. Box 3 highlights risk factors that can be identified prior to a pregnancy and mitigated by care tailored to each woman’s needs. WHNPs provide essential routine and high-risk pregnancy and postpartum care that includes identification of factors that may place a woman at an increased risk for maternal complications, implementation of care to mitigate risks, and collaboration within the healthcare team when complications occur to foster the best patient outcomes.

With the recognition that up to one-half of pregnancy-related deaths occur in the first year postpartum, the role of WHNPs in the transition from postpartum to well-woman care is crucial to continue to monitor risks and provide appropriate care, including attention to mental health. A concerted effort at community, health facility, patient, provider, and systems levels is critical to make progress in the goal to eliminate preventable pregnancy-related deaths.

Recommendations

NPWH recommends that WHNPs who provide healthcare for women before, during, and in between pregnancies should:
• be aware of their state’s status regarding existence of or plans for an MMRC and monitor data reports.
• seek active involvement in planning and implementing evidence-based maternal mortality preventive strategies at community, provider, patient, health facility, and systems levels to address MMRC-identified causes and contributing factors.
• engage in self-reflection regarding potential for implicit bias and seek educational activities that increase awareness and enhance patient–provider interactions.
• participate in research to more fully understand contributing factors to preventable maternal mortality.
• participate in maternal health quality improvement projects that facilitate translation of evidence to practice with outcomes evaluation
• advocate for local, state, and federal policies and legislation that address known contributing factors, including racial/ethnic disparities related to maternal mortality.

NPWH will provide leadership to ensure that:
• continuing education(CE)programs and other evidence-based resources are available for NPs to learn and update knowledge regarding causes, contributing factors, and strategies to eliminate preventable maternal mortality.
• CE programs and other evidence-based resources on strategies for NPs to recognize and address racial/ethnic biases in themselves and at their healthcare facilities are available.
• collaborative engagement with other professional organizations continues to advance the development, implementation, and evaluation of multidisciplinary best practices that will eliminate the preventable maternal mortality.
• polices at all levels support access to quality care for women throughout the reproductive-age continuum.
• research moves forward in all aspects of prevention of maternal mortality.

References

1. Petersen EE, Davis NL, Goodman D, et al. Vital signs: pregnancy-related deaths, United States, 2011-2015, and strategies for prevention, 13 States, 2013-2017. MMWR. 2019;68(18):423-429. cdc.gov/mmwr/volumes/68/wr/mm6818e1.htm

2. Metz TD. Eliminating preventable maternal deaths in the United States: progress made and next steps. Obstet Gynecol. 2018;132(4):1040-1045.

3. Building U.S. Capacity to Review and Prevent Maternal Deaths. Report from nine maternal mortality review committees. 2018. reviewtoaction.org/Report_from_Nine_MMRCs

4. Metz TD, Rovner P, Hoffman MC, et al. Maternal deaths from suicide and overdose in Colorado, 2004-2012. Obstet Gynecol. 2016;128(6):1233-1240.

5. Smid MC, Stone NM, Baksh LP, et al. Pregnancy-associated death in Utah: contribution of drug-induced deaths. Obstet Gynecol. 2019;133(6):1131-1140.

6. 115th Congress. H.R. 1318 – Preventing Maternal Deaths Act of 2018. congress.gov/bill/115th-congress/house-bill/1318.

7. Mahoney J. The Alliance of Innovation in Maternal Health Care: a way forward. Clin Obstet Gynecol. 2018;61(2):400-410.

8. Council on Patient Safety in Women’s Health Care website. 2019. safehealthcareforeverywoman.org/

9. Resar R, Griffin FA, Haraden C, et al. Using Care Bundles to Improve Health Care Quality. IHI Innovation Series White Paper. Cambridge, MA: Institute for Healthcare Improvement; 2012.

10. Council on Patient Safety in Women’s Health Care. Patient Safety Bundles. 2019. safehealthcareforeverywoman.org/patient-safety-bundles/

11. California Maternal Quality Care Collaborative. Maternal Quality Improvement Toolkits. cmqcc.org/resources-tool-kits/toolkits

12. ACOG. Postpartum Toolkit. Racial Disparities in Maternal Mortality in the United States: The Postpartum Period Is a Missed Opportunity for Action. 2018. http://acog.org/-/media/Departments/Toolkits-for-Health-Care-Providers/Postpartum-Toolkit/ppt-racial.pdf?dmc=1&ts=20190613T1434044080

13. Black Mamas Matter Alliance. Advancing the Human Right to Safe and Respectful Maternal Health Care. Center for Reproductive Rights. 2018. blackmamasmatter.org/wp-content/uploads/2018/05/USPA_BMMA_Toolkit_Booklet-Final-Update_Web-Pages-1.pdf

14. ACOG. Practice Bulletin No. 212: Pregnancy and Heart Disease. Obstet Gynecol. 2019;133(5):e320-e356.

15. ACOG. Practice Bulletin No. 203: Chronic Hypertension in Pregnancy. Obstet Gynecol. 2019;133(1):e26-e50.

16. ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019;133(1):e1-e25.

17. ACOG. Committee Opinion No. 762: Prepregnancy Counseling. Obstet Gynecol. 2019;133(1):e78-e89.

18. ACOG. Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018;131(5):e140-e150.

Statin treatment considerations for cardiovascular disease prevention

Current evidence-based guidelines support the use of statin drugs for primary prevention of cardiovascular (CV) events based on individual CV risk profiles rather than on target cholesterol levels. The purpose of this article is to increase awareness of the impact of CV disease in women and to discuss evidence-based guidelines for the use of statin drugs to decrease CV events in this population. Continue reading »

Clinical management of dilemmas in contraception

In most cases, prescribing contraceptives and managing the care of women using them is straightforward. But sometimes, because of a woman’s health history or changing health status or because of the occurrence of an unforeseen event, a management dilemma arises. The author discusses three dilemmas in contraception and options for managing them. In addition, he provides background information about the evidence-based guidelines that should inform healthcare providers’ decisions about which contraceptives should or should not be prescribed for individual women and discusses contraceptive options that are newly available or on the horizon.

The provision of high-quality contraceptive services is supported by three benchmark, evidence-based clinical practice guidelines developed by the CDC. The U.S. Medical Eligibility Criteria for Contraceptive Use, 2016B, known as the USMEC, provides recommendations on contraceptive safety, particularly for women with chronic diseases.1  The USMEC provides a safety rating for more than 60 conditions in categories of contraceptives such as combined hormonal contraceptives (CHCs), which include combined oral contraceptives (COCs), the contraceptive patch, and the contraceptive vaginal ring; progestin-only contraceptives (POCs), which include depot medroxyprogesterone acetate (DMPA), progestin-only implants, and progestin-only pills (POPs); and intrauterine devices (IUDs) such as the levonorgestrel intrauterine system (LNG-IUS) and the copper IUD (Cu-IUD). In addition, safety information is provided for emergency contraceptives (ECs), barrier methods, fertility awareness-based methods (FABMs), lactational amenorrhea, withdrawal, and sterilization. The safety categories are numbered 1 through 4 as follows:
1. No restriction for the use of a given contraceptive method; the method can be used safely.
2. Advantages of using the method generally outweigh the theoretical or proven risks; the method can generally be used safely, but more than the usual follow-up is needed.
3. Theoretical or proven risks usually outweigh the advantages of using the method; clinical judgment should determine whether the given method can be used safely in a particular woman. In these cases, use of the contraceptive method, particularly one that is highly effective, will be safer than an unintended pregnancy
4. Unacceptable health risk if the contraceptive method is used; do not use the method.

The second guideline, the U.S. Selected Practice Recommendations for Contraceptive UseC, known as the SPR, offers information and recommendations that focus on contraceptive efficacy, rules for use, and management of side effects.2 Of note, the CDC has created an app that combines all the recommendations in both the USMEC and the SPR. The easy-to-use app is downloadable for free at the Apple Store or the Google Play Store by typing CDC Contraception in the search box. All healthcare providers (HCPs) who provide contraceptive services are strongly encouraged to download the app, become familiar with its use, and use it frequently when making contraceptive decisions.

The third guideline, Providing Quality Family Planning Services, 2014D, known as the QFP, which was developed jointly by the U.S. Office of Population Affairs and the CDC, is a resource that fills in the gaps on family planning topics not included in the USMEC or SPR.3 These topics include contraceptive counseling, pregnancy testing and options counseling, achieving pregnancy, basic infertility, preconception health, and preventive health screening for women and men.

Two of the three aforementioned guidelines, the USMEC and the SPR, were updates to the 2012 versions. The updates in these 2016 publications were based on the publication of important new studies, as well as on changes to the World Health Organization (WHO) MEC and SPR recommendations. In the USMEC, safety categories were lowered or raised for several conditions, especially the use of CHCs in women with migraine headaches and the use of POCs in lactating women. Several conditions were included for the first time (e.g., cystic fibrosis, multiple sclerosis) and certain drug–drug interactions were updated (e.g., selective serotonin reuptake inhibitors and St. John’s wort; hormonal methods in women using antiretrovirals for HIV infection). The most important modification to the USMEC was the inclusion of ulipristal acetate (UPA) in the EC section.1 An important update to the SPR is advising a woman to start or resume hormonal contraception no sooner than 5 days after use of UPA.2

Dilemma #1: Use of hormonal contraceptives and breastfeeding

Judy is a 30-year-old woman who experienced an uncomplicated vaginal birth at 37 weeks. Her newborn daughter weighed 2,704 g and is healthy. Judy plans to fully breastfeed her infant and requests a prescription for contraception before discharge on postpartum day 2. She is not interested in an IUD at this time. Which hormonal methods are safe for her to use? When can she safely start using the method chosen?

Combined hormonal contraceptives
Judy and her HCP discuss the pros and cons of CHCs, which include the pill, the patch, and the ring.

Effect on lactation

Among CHCs, COCs have been studied the most with respect to safety of use in lactating mothers and their infants. COCs have been found to have no effect on the quality (content) of breast milk in terms of its amounts of protein, fat, iron, and copper. In terms of the quantity of breast milk, studies conducted in the 1960s and 1970s showed that women who initiated COCs containing high-dose estrogen before the establishment of lactation had a reduced quantity of breast milk.4 By contrast, more recent studies have shown that women who initiated COCs containing low-dose estrogen after lactation was established had minimal, if any, changes in breast milk quantity.5 Nevertheless, concern about the adverse effect of CHCs on breast milk supply still exists—especially in the context of women having difficulty with breastfeeding their newborn for a variety of reasons.

Use of COCs appears to influence the duration of breastfeeding. One early study showed that COC users breastfed for an average of 3.7 months, versus an average of 4.6 months for women who did not use COCs.6 However, a 2016 updated systematic review of 15 RCTs and cohort studies showed an inconsistent impact of COCs on breastfeeding duration and success.7

Neonatal risk
Research has shown that the ethinyl estradiol dose reaching newborns via COC users’ breast milk is similar to the amount they would receive from the mother’s daily ovarian estradiol production. Furthermore, studies have shown no effect of COCs on breastfed infants’ development, including neurologic development and growth rates.7

Maternal risk
Changes in maternal clotting factors persist for up to 6 weeks after childbirth, resulting in an increased risk for venous thromboembolism (VTE) over this time period. Use of CHCs in this setting of increased hypercoagulability could potentially increase VTE risk even more. Given the fact that lactating women rarely ovulate in the first 6 weeks after delivery, the risk of using a CHC far outweighs the benefit because the likelihood of ovulation is so low. As a consequence, the USMEC risk categories are 4 for women <21 days postpartum; 3 for those 21-29 days postpartum, with or without other VTE risk factors* or 30 42 days postpartum with other VTE risk factors*; 2 for those 30-42 days postpartum with no other VTE risk factors; and 1 for those >42 days postpartum.1

Progestin-only contraceptives
Unlike CHCs, POCs have no effect on the quality or quantity of breast milk.8,9 Greater VTE risks are not expected with POCs because they do not affect Packages of oral contraceptivesclotting factors.10 The CDC commissioned a systematic review of 47 studies to assess the effects of POCs when used by lactating women.11 The evidence failed to demonstrate adverse breastfeeding outcomes or health outcomes in infants whose mothers took POCs. USMEC risk categories for lactating women who use POPs (those available in the United States contain norethindrone), DMPA, or the etonogestrel implant are 2 during postpartum days 1-29 and 1 for postpartum day 30 onward.1

General comments
Discussions about contraceptive use by lactating women should consider each woman’s desire to breastfeed, her risk for breastfeeding difficulties, and her risk for unintended pregnancy.1 The following clarification was added to the 2016 USMEC regarding progestin-only methods: “Certain women might be at risk for breastfeeding difficulties, such as women with previous breastfeeding difficulties, certain medical conditions, and certain perinatal complications and those who deliver preterm. For these women, as for all women, discussions about contraception for breastfeeding women should include information about risks, benefits, and alternatives.”

The Academy of Breast-Feeding Medicine has a different take on the use of hormonal contraceptives in breastfeeding women. According to Clinical Protocol #13, HCPs should inform women that CHCs may decrease milk supply, especially in the early postpartum period.12 Hormonal methods should be discouraged in any of these settings: existing low milk supply or history of lactation failure, history of breast surgery, multiple births, preterm birth, or compromised health of mother and/or infant.

Because Judy chooses to breastfeed exclusively, she is highly unlikely to become pregnant in the first 6 weeks postpartum. She wants the many health benefits of long-term breastfeeding that will accrue to both her infant and herself. During this time, she is at significantly increased risk for VTE and should avoid any of the CHCs. If she is fully breastfeeding (no additional nutrition for her newborn), she can rely on lactational amenorrhea as her contraceptive method for at least 12 weeks postpartum, and even longer (but no more than 6 months) if she remains amenorrheic. If she insists on starting a method before leaving the hospital, POPs, DMPA, or a contraceptive implant are all good options—as long as she is reminded to return for advice on another method if she has difficulties with breastfeeding.

*VTE risk factors include age ≥35 years, previous VTE, thrombophilia, immobility, transfusion at delivery, body mass index >30 kg/m2, postpartum hemorrhage, post-caesarean delivery, and pre-eclampsia or smoking.

Dilemma #2: Initiation of hormonal contraceptives after use of ulipristalacetate

Mary Ann is a 25-year-old woman presenting with a request for an EC. She had unprotected intercourse (UPI) with a new partner 4 days ago, on day 10 of her usual 30-day cycle. In addition, she wants to start a method of contraception as soon as possible. Weighing 200 pounds and standing 5 feet, 4 inches, she has a BMI of 34 kg/ m2, placing her in the obese category. What should be done for Mary Ann in terms of her immediate need for an EC and her long-term need for birth control?

Emergency contraceptives available
The single-dose levonorgestrel (LNG) tablet (1.5 mg) is labeled for use within 72 hours of UPI. Its efficacy in preventing pregnancy is good when taken 0-72 hours following UPI and moderate when taken 72-120 hours following UPI. LNG-containing EC products available in the U.S. include Plan B One-Step® and multiple generic one-dose tablets. No physical assessment is required prior to use; in fact, single-dose LNG is widely available without a prescription in pharmacies across the country.

The next option is ulipristal acetate or UPA (Ella®), which prevents ovulation, even with follicles up to 18-20 mm. UPA is taken orally in a single 30-mg dose and is labeled for use up to 5 days after the last UPI. In a meta-analysis of the efficacy of UPA versus LNG, given 0-72 hours following the last UPI, 22 pregnancies occurred in 1,617 women in the UPA group (1.4%) versus 35 pregnancies in 1,625 women in the LNG group (2.2%) (odds ratio, 0.58, 0.33-0.99; P = 0.046).13

The third option—of note, this use is off label—is the copper intrauterine device, which has an EC failure rate of 0.1%.14 This device can be inserted within 5 days after UPI. Women in whom the Cu-IUD is used as an EC can continue using it as a regular contraceptive. A study of Chinese women by Wu et al.15 showed the 12-month post-insertion continuation rate was 94.0 per 100 woman-years. Sanders et al.16 found that the 1-year continuation rate for the Cu-IUD, when initiated as EC, was 60%. The LNG-IUS is still being studied as an EC and cannot yet be recommended for this indication.

Efficacy of ECs in overweight/ obese women
The aforementioned meta-analysis comparing the effects of LNG and UPA as ECs showed that, relative to women of normal weight (BMI <25), overweight women (BMI, 25-30) and obese women (BMI ≥30) had pregnancy rates that were 1.5 times greater and >3 times greater, respectively.16,17 For obese women, the risk was significantly greater for those taking LNG than for those taking UPA. Two studies have shown that absorption of the hormones used in COCs is slower in obese women than it is in women of normal weight.18,19 With ECs, immediate absorption is important; this delay could explain the lower efficacy in obese women.20

In terms of Mary Ann’s immediate need for an EC, she is advised that the Cu-IUD would be much more effective in preventing pregnancy than either oral EC product. Mary Ann decides to have the Cu-IUD inserted right away and keeps it as her birth-control method. Had she not chosen the Cu-IUD, it would have been reasonable to offer her UPA because its efficacy in women in this weight category is better than using no method of EC. In her case, using oral LNG EC would have been no better than using a placebo.

Starting hormonal contraception after receiving ulipristal
For women who are better candidates than Mary Ann for UPA, the following information is important to know. UPA is a selective progesterone-receptor (PR) modulator that blocks the effect of progesterone at many sites. Despite the proven efficacy of this EC method, there was concern that starting a progestin-containing contraceptive immediately after taking UPA would displace UPA from PRs, thereby reducing UPA’s effectiveness. Sure enough, a small pharmacodynamic study showed that initiating a desogestrel (DSG)-containing POP the day after UPA administration significantly reduced the ovulation-delaying effect of UPA.21 In this study, whereas ovulation occurred in only 1 (3%) of 29 UPA-only cycles in the first 5 days, it occurred in 13 (45%) of 29 UPA+DSG cycles. These results prompted a change in the product labeling for Ella22: After using this product, if a woman wants to use hormonal contraception, she should do so no sooner than 5 days after UPA administration. If she has sexual intercourse, she should use a reliable barrier method until her next menstrual period.

Dilemma #3: Management of a lost intrauterine device string

Rosa is a 45-year-old G3P3 who had an IUD inserted 8 years previously. She remembers that it had a T shape but is unsure which type of IUD it is. She reports that she has been unable to feel the string for the past 2 months; before that time, she checked for it sporadically. A speculum examination confirms that no string is present at the external cervical os.

Whenever an HCP encounters a patient with a “missing” IUD string, four possibilities should come to mind: (1) The IUD is in situ, with the string coiled in the cervical canal or endometrial cavity or simply cut short, broken, or severed; (2) The woman has an intrauterine pregnancy, with the IUD string pulled up into the expanding uterine cavity; (3) Asymptomatic expulsion has occurred; or (4) In the unlikely event that the uterus was perforated when the IUD was placed, the string may not be visible because the IUD is embedded in the myometrium or translocated through the uterine wall and into the abdominal cavity.

Recommended steps in management
Before performing any intervention, the first step in management of a lost string is to perform an office pregnancy test. If the result is positive, the pregnancy must be located and dated (see subsection on Pregnancy in next section). If the result is negative, the HCP can probe the cervical canal with an endocervical brush, using a spinning motion to catch the string. (This step is taken next because it is assumed, albeit not yet confirmed, that the IUD is in situ and that the HCP wants to position the string so that the woman can find it the next time she checks for it.) If this maneuver is not effective, the HCP can ask the woman whether she wants to keep the IUD—if it is found to be in the correct position—or if she prefers to have it removed.

If the woman wants to keep using the IUD, and it has not expired, the next step is performance of a pelvic ultrasound, either in the office or in a diagnostic imaging center. If the IUD is identified as being in situ, it can remain in place until the expiration date or until the woman has problems with it or wants to become pregnant. If the IUD is not identified in the uterine cavity, the next step is performance of a kidney/ureter/bladder x-ray (KUB) to determine whether it is outside the uterus but in the abdominal cavity. If so, a translocation is diagnosed. If an IUD is not seen on the pelvic ultrasound or the KUB, then expulsion is diagnosed. These steps can be performed in a single visit by ordering a pelvic ultrasound first and authorizing an immediate KUB if the IUD is not identified.

If the patient wants the IUD removed, extraction can be attempted in the office, but only by an HCP experienced in performing intrauterine procedures. A plastic IUD thread retriever is now available in the U.S.; its use is relatively noninvasive. As an alternative, an alligator forceps can be used to search within the uterine cavity—using a tenaculum to stabilize the uterus before intrauterine manipulation.23 Simultaneous real-time abdominal ultrasound, if available, is helpful in guiding the tip of the instrument used for extraction to the location of the IUD within the endometrial cavity; one study with this technique showed a 97% success rate.24

If an IUD frame or string cannot be grasped or otherwise detected by feel in the cavity, a combination of pelvic ultrasound and a KUB, as described earlier, should be ordered. In this case, the likelihood of asymptomatic expulsion is high, but deep embedment or translocation is possible. If the IUD is grasped but cannot be removed, it likely is embedded, in which case 3D ultrasound or computed tomography (CT) of the pelvis can suggest whether a hysteroscopic or laparoscopic approach is more likely to be successful. Under ideal circumstances, these imaging tests are ordered by the OB/GYN physician who will perform the extraction in the surgical center or operating room, depending on preference, in order to avoid duplication of an expensive imaging procedure.

More information about “missing” string possibilities 2, 3, and 4 Pregnancy with IUD
If the woman’s office pregnancy test result is positive, pelvic ultrasound is used to determine the site of the pregnancy. If it is ectopic, the woman should be referred immediately to an OB/GYN physician for medical or surgical treatment of the ectopic pregnancy. If it is intrauterine and viable, the woman needs to know that the risks of adverse pregnancy outcomes are greater in the setting of IUD retention than if it were to be removed.25 Removal is recommended when the strings are visible or when the device can be removed safely from the cervical canal. If pregnancy termination is planned, then the IUD can be removed during a surgical abortion or before a medication abortion.

If the woman decides to continue an intrauterine pregnancy and the IUD strings are not visible, the HCP should not attempt removal. Instead the HCP should counsel the woman regarding the increased risks of spontaneous abortion, septic abortion, chorioamnionitis, and preterm delivery. The woman should undergo increased surveillance during antenatal care. Because the IUD is outside the amniotic sac, the fetus is not at greater risk for birth defects. Insufficient evidence exists regarding adverse fetal effects of small exposure to LNG during gestation.25

Expulsion of IUD
Expulsion of the IUD occurs in 2% of insertions within the first year. Risk of expulsion is related to the HCP’s skill at fundal placement; the woman’s age, parity, and uterine configuration; time since insertion (increased risk within the first 6 months), and timing of insertion (menses, postpartum, post-abortion); for example the risk is greater if the device is inserted within 48 hours of childbirth.26 A woman with an unnoticed expulsion may present with pregnancy. A woman with a partial expulsion may present with pelvic pain, cramps, or intermenstrual bleeding or she may mention that the IUD string is longer than she previously perceived.26

Perforation leading to translocation or embedment
The overall incidence of uterine perforation as a result of IUD insertion is about 0.1%,27 although the rate is significantly higher— 0.6%—in postpartum women. Depending on how the IUD is positioned and where it has translocated, it is removed via hysteroscopy or laparoscopy. Because the Cu-IUD, compared with the LNG-IUS, can cause greater inflammation and more adhesions, it must be extracted promptly via laparoscopy. The LNG-IUS is less reactive, but most experts recommend laparoscopic removal as well. If advanced imaging such as 3D ultrasound or CT of the pelvis shows that the IUD is embedded in the myometrium, it usually can be removed hysteroscopically. However, if imaging shows that none of the IUD frame is accessible in the endometrium and most of the device protrudes through the myometrium and into the abdominal cavity, laparoscopic removal is indicated.

A pelvic ultrasound shows that Rosa’s IUD is properly situated in the uterine cavity. Because the device is identified as an LNG-IUS that was inserted 8 years earlier, she and her HCP decide that it should be removed and replaced. The first procedure is accomplished in the office with an alligator forceps with simultaneous ultrasound and the old device is replaced by a new one.

Newly approved contraceptives
The FDA approved two new contraceptive products in 2018.

AnnoveraTM CVR (contraceptive vaginal ring) This ring containing segesterone acetate and ethinyl estradiol prevents ovulation for 1 year (13 cycles). The woman inserts it into the vagina herself, leaves it in place for 21 days, and then removes it for 7 days to allow a withdrawal bleed. The ring can be removed over the 21-day period for intercourse and cleaning, but not for longer than 2 hours. This product is like NuvaRing® with respect to the amount of progestin and estrogen released and the diameter, but Annovera is twice as thick (8.4 mm vs. 4 mm) because each ring is used for 13 cycles, not 1 cycle. According to the manufacturer, Annovera CVR is the “first woman-controlled, procedure-free, long-acting, reversible birth control product.” It is longer acting than other methods, but because it does need to be removed and tended periodically, unlike the IUD and implant, which are “forgettable,” it does not qualify as being a true long-acting reversible contraceptive method.

Natural Cycles® app This FABM is the first and only fertility monitoring app with FDA approval to be marketed as a contraceptive. It can be used for either contraception or timing intercourse to become pregnant. With respect to its mechanism of action, it relies on cycle pattern and basal body temperature, not cervical mucus. Use of the app requires the use of a special basal body temperature thermometer that signals the smartphone with the temperature reading. The app factors in current basal body temperature and a woman’s past menstrual and monitoring history in predicting future ovulatory events so that she knows when she can engage in, or avoid, intercourse. Compared with other FABMs, this app has these advantages: It has withstood FDA scrutiny, it integrates objective data about prior ovulation patterns, it requires minimal user intervention, and it has a clear user interface. However, relative to other FABMs, its failure rate is similar and it requires disciplined use by both partners. To minimize contraceptive failure, this app is best used with a barrier method on “red” days.

On the horizon

For decades, contraceptives have been prescribed by HCPs and furnished by clinics or pharmacies. Newer alternatives include having registered nurses or pharmacists prescribe and furnish CHCs via standing orders. But the “delivery system” of the future—and, by the way, the future is here—involves provision of CHCs via telehealth or apps, including NurxE, PRJKT RUBYF, MavenG, virtuwell.comH, pandia healthI, Pill ClubJ, and LemonaidK. The lattermost five apps offer a Skype-like interaction with a nurse practitioner or other clinician. The app Planned Parenthood DirectL is usable in about half the states in the U.S.

One day soon, in a strange counterpoint to storks delivering babies, drones may be delivering pills, patches, and rings to whoever orders them.

References

1. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-103. cdc.gov/mmwr/ volumes/65/rr/pdfs/rr6503.pdf
2. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(4):1-66. cdc.gov/mmwr/ volumes/65/rr/pdfs/rr6504.pdf
3. Gavin L, Moskosky S, Carter M, et al. Providing Quality Family Planning Services: Recommendations of CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014;63(4):1-54. cdc.gov/mmwr/pdf/rr/rr6304.pdf
4. Effects of hormonal contraceptives on breast milk composition and infant growth. World Health Organization (WHO) Task Force on Oral Contraceptives. Stud Fam Plann. 1988;19(6 pt 1):361-369.
5. Espey E, Ogburn T, Leeman L, et al. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012;119(1):5-13.
6. Nilsson S, Nygren KG, Johansson ED. d-Norgestrel concentrations in maternal plasma, milk, and child plasma during administration of oral contraceptives to nursing women. Am J Obstet Gynecol. 1977;129(2):178-184.
7. Tepper NK, Phillips SJ, Kapp N. et al. Combined hormonal contraceptive use among breastfeeding women: an updated systematic review. Contraception. 2016;94(3):262-274.
8. Truitt ST, Fraser AB, Grimes DA, et al. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev. 2003;(2):CD003988.
9. Lopez LM1, Grey TW, Stuebe AM, et al. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev. 2015;(3):CD003988.
10. Sitruk-Ware R. Hormonal contraception and thrombosis. Fertil Steril. 2016;106(6):1289-1294.
11. Phillips SJ, Tepper NK, Kapp N, et al. Progestogen-only contraceptive use among breastfeeding women: a systematic review. Contraception. 2016;94(3):226-252.
12 Berens P, Labbok M; Academy of Breastfeeding Medicine. ABM Clinical Protocol #13: Contraception During Breastfeeding, Revised 2015. Breastfeed Med. 2015;10(1):3-12. abm.memberclicks.net/assets/DOCUMENTS/ PROTOCOLS/13-contraception-and-breastfeeding-protocol-english.pdf
13. Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010;375(9714):555-562.
14. Cleland K, Haoping Z, Goldstuck N, et al. The efficacy of intrauterine devices for emergency contraception: a systemic review of 35 years of experience. Hum Reprod. 2012;27(7):1994-2000.
15. Wu S, Godfrey EM, Wojdyla D, et al. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. BJOG. 2010;117(10):1205-1210.
16. Sanders JN, Turok DK, Royer PA, et al. One-year continuation of copper or levonorgestrel intrauterine devices initiated at the time of emergency contraception. Contraception. 2017;96(2):99-105.
17. Glasier A, Cameron ST, Blithe D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84(4):363-367.
18. Edelman AB, Cherala G, Stanczyk FZ. Metabolism and pharmacokinetics of contraceptive steroids in obese women: a review. Contraception. 2010;82(4):314-323.
19. Westhoff CT, Torgal AL, Mayeda ER, et al. Ovarian suppression in normal-weight and obese women during oral contraceptive use. Obstet Gynecol. 2010;116(2 pt 2):275-283.
20. Rapkin RB, Creinin MD. Update: When it comes to the morning-after pill, physicians need a wake-up call. OBG Manage. 2011;23(8):16-24.
21. Brache V, Cochon L, Duijkers IJ, et al. A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception. Hum Reprod. 2015;30(12):2785-2793.
22. Ella prescribing information. Last updated June 2018. dailymed.nlm.nih.gov/dailymed/ drugInfo.cfm?setid=052bfe45c485-49e5-8fc4-51990b2efba4#LINK_94c46528-93c6-49a5aef1-3597044978d2
23. Prabhakaran S, Chuang A. In-office retrieval of intrauterine contraceptive devices with missing strings. Contraception. 2011;83(2):102-106.
24. Kottmann C, Troncoso M, Valenzuela I, et al. Ultrasound-guided extraction of intrauterine devices with nonvisible threads: 254 consecutive cases: an effective, noninvasive technique. J Ultrasound Med. 2019 Mar 18. Epub ahead of print.
25. Brahmi D, Steenland MW, Renner RM, et al. Pregnancy outcomes with an IUD in situ: a systematic review. Contraception. 2012;85(2):131-139.
26. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 2nd ed. Geneva, Switzerland: WHO; 2000.
27. Rowlands S, Oloto E, Horwell DH.Intrauterine devices and risk of uterine perforation: current perspectives. Open Access J Contracept. 2016;7:19-32. ncbi.nlm.nih. gov/pmc/articles/PMC5683155/

We are Title X

As providers of women’s healthcare and sexual and reproductive health (SRH) services, we must stay up to date and vigilant about the ongoing attacks that are eroding access and rights to essential healthcare services. Policy changes at the federal and state levels are threatening the very core of the comprehensive, evidence-based reproductive health and family planning services delivered through the Title X program in the United States. At the same time, severe restriction of abortion services has rendered the procedure virtually inaccessible in many states. The consequences of these trends are particularly dire for individuals who are most vulnerable, including those who are low income, uninsured/underinsured, and/or adolescents. Historically, Title X-funded clinics have also been a key source of training and employment for women’s health nurse practitioners (WHNPs). Reducing funding for this program not only threatens our livelihood and the pipeline for preparing future providers of women’s healthcare and SRH care but also, in our view, undermines the health of our patients. Continue reading »

Position Statement: Expanding Access to Hormonal Contraception

The National Association of Nurse Practitioners in Women’s Health (NPWH) affirms the right of each individual or couple who desire to use contraception to be able to do so. Barriers to obtaining and successfully using contraception must be eliminated, particularly for the most vulnerable individuals and populations. NPWH advocates for federal- and state-level policies that remove barriers and increase access to affordable, safe, and effective contraceptive methods for all reproductive-aged individuals. Multiple strategies involving legislation, regulations, consumer education, and innovation are necessary. Over-the-counter (OTC) access to hormonal contraceptives (HCs) and pharmacist-provided HCs are two specific strategies that can lower barriers to obtaining safe, effective contraception.

NPWH will provide leadership through policy advocacy, consumer and healthcare provider (HCP) education, and support of research on outcomes related to innovative strategies to expand access to HCs. NPWH supports the right of all individuals to access comprehensive sexual and reproductive health services and to make choices that meet their own needs. Continue reading »

Continuing Education: Insomnia across the lifespan

Healthcare providers (HCPs) caring for women of any age will find that a substantial proportion of them have difficulty falling and/or staying asleep. When insomnia interferes with their daily life and causes distress, they may seek professional help. This article provides background information about sleep, and offers HCPs useful and up-to-date information regarding the evaluation of patients presenting with sleep problems and the wide variety of treatments that are available.

Continue reading »

My career as a nurse advocate

When I was 6 years old, I knew I wanted to be a nurse. I followed through on this aspiration and pursued nursing throughout my adult career. At the same time, I’ve always considered myself artsy. I collect art—there are no bare walls in my house—and I have done a lot of needlework and have even won some awards. But my mission, my passion, which I developed early in my nursing career, is patient advocacy and access to care for women and newborns. Continue reading »

Mycoplasma genitalium-related infection: An STI not quite ready for prime time

Mycoplasma genitalium has been designated by the CDC as an emerging concern among sexually transmitted pathogenic bacteria. Although M. genitalium-related infections are becoming more prevalent worldwide, and more is being learned about them, many questions about the pathogenesis and management of these infections remain unanswered. Until clear clinical guidelines are established, what should healthcare providers know about M. genitalium-related infections? Continue reading »

Male Sexual and Reproductive Health: The Role of Womenʼs Health Nurse Practitioners

The National Association of Nurse Practitioners in Women’s Health (NPWH) affirms the right of all individuals to quality, evidence-based sexual and reproductive health (SRH) care that is non-judgmental, respectful, and culturally appropriate. SRH is an important component in individuals’ overall physical, emotional, and social well-being. SRH encompasses sexuality, sexual relationships, and all matters related to the function and processes of the reproductive system.1 The SRH of one individual often intertwines with that of another individual or individuals. Continue reading »

Treatment of decreased sexual desire in women

About a third of women in the United States experience decreased sexual desire (DSD), a symptom that may be part of a more complex diagnosis. The author discusses DSD with respect to background information, screening, and diagnosis, and then focuses on treatment of this common, oftentimes perplexing, problem. Continue reading »

Men with breast conditions: The role of the WHNP specializing in breast care

The National Association of Nurse Practitioners in Women’s Health (NPWH) affirms the role of the women’s health nurse practitioner (WHNP), as a member of a multidisciplinary breast care specialty team, in providing specialized breast care for women and men. Furthermore, NPWH supports the removal of any restrictions to the provision of male breast care that are based on the WHNP credential. Continue reading »

The ABCDs of bacterial vaginosis: Abnormal flora, Bothersome symptoms, Chronicity, and Differential diagnosis

Faculty:

Alisa Pascale, DNP, WHNP-BC, is a women’s health nurse practitioner at the Vulvovaginal Disorders Program & Gynecology at Massachusetts General Hospital and Clinical Instructor at MGH Institute of Health Professions, both in Boston, Massachusetts.

Intended audience: This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners who provide care for women of any age.

CE approval period: Now through December 31, 2019

Estimated time to complete this activity: 1 hour CE approval hours: 1.0 contact hours, including 0.5 contact hours of pharmacology credit (NCC code 2A)

Goal statement: To understand the abnormal vaginal ecosystem in women prone to bacterial vaginosis (BV) and to use current evidence and guidelines in treating single episodes of BV and in reducing chronic/recurrent episodes of BV. Continue reading »

Educational interventions to increase Tdap vaccination rates among pregnant women

The highly contagious respiratory infection pertussis remains a public health problem for the United States.1 Infants have the highest morbidity and mortality rates from pertussis because of a lack of immunity at birth and an immature immune system. In 2015, a total of 20,762 cases of pertussis were reported in the U.S., with infants accounting for 1,960 cases (9.5% of the total cases).2 Continue reading »

Health policy and the female caregiver: The impact on women’s health

As healthcare providers (HCPs), we are aware of the demographic shift and increased longevity that have resulted in a rise of the aging population in the United States and in many other countries around the world.These changes have increased the need for “informal” caregivers, usually partners or relatives, to provide assistance to individuals at varying levels of healthcare need. Unpaid caregiving by partners, family members, or even friends remains the main source of long-term care for older persons worldwide.This caregiving, usually provided by women, can have an adverse impact on caregivers’ health, quality of life, economic stability, and longevity.2,3 Continue reading »

Managing women’s health issues across a lifespan: NPWH 2017-2018 regional meetings

Before reading the article, click here to take the pretest.

Over the past year, NPWH sponsored four regional meetings highlighting updates on the management of women’s health issues across a lifespan. The meetings were presented to live audiences using an interactive learning strategy, with several clinical scenarios illustrating issues within four topic areas: contraception, bacterial vaginosis, hypoactive sexual desire disorder, and postmenopausal osteoporosis. The author of this article has chosen one scenario for each topic to demonstrate how this learning strategy can cover important health areas in a way that intrigues and challenges, in this case, our readers. Continue reading »

Position Statement: Cervical Cancer Screening

The National Association of Nurse Practitioners in Women’s Health (NPWH) supports a concerted effort to continue to improve cervical cancer screening rates and timely, appropriate follow-up and treatment when screening results are abnormal. The goal is to reduce cervical cancer incidence, morbidity, and mortality. NPWH supports ongoing research to ensure that screening guidelines are based on the best evidence available. Furthermore, NPWH supports policies at the local, state, and federal levels that ensure access to cervical cancer screening services and follow-up as needed. Continue reading »

Managing postmenopausal dyspareunia: An update

Faculty:

Susan Hoffstetter, PhD, WHNP-BC, FAANP, is a professor at Saint Louis University School of Medicine, Department of Obstetrics, Gynecology & Women’s Health, Division of Uro-Gynecology, in St. Louis, Missouri.

Intended audience: This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners who provide care for menopausal and postmenopausal women. Continue reading »

Cultivating your inner Wonder Woman: Policy advocacy

By Diana M. Drake, DNP, MSN, APRN, WHNP-BC

The movie Wonder Woman is said to be, in essence, two solid hours of female empowerment. At the start of 2018, while flying to Salvador, Brazil, to lead a practicum entitled Women’s Health in the Context of Environment, Race, Culture and Policy, I was able to watch this blockbuster film. While doing so, I realized that, in the Brazil practicum, I would be asking my NP students to find their own inner Wonder Woman and become powerful advocates and ambassadors for change within an international context. Continue reading »

Digital assessment of the pelvic floor muscles: A neglected technique

By Helen A. Carcio, MS, MEd, ANP-BC

Clinical evaluation of the pelvic floor muscles (PFMs) should be an integral part of a comprehensive well-woman examination because it can aid in identifying bladder dysfunction and pelvic organ prolapse. Digital assessment of the PFMs, a simple but neglected technique that should be part of every clinical evaluation of the pelvic musculature, is described in detail in this article. Continue reading »

Healthcare for Transgender and Gender Non-Conforming Individuals

The National Association of Nurse Practitioners in Women’s Health (NPWH) affirms each individual’s right to quality, evidence-based sexual and reproductive healthcare and encourages each individual to strive for a healthy self-concept of sexuality and gender identity. Although NPWH has historically focused on the care of cisgender women, we recognize the importance of providing quality sexual and reproductive healthcare to all individuals, regardless of gender identity. Table 1 provides gender identity-related terminology and definitions.1  Continue reading »

Dense breasts: Cancer risk and supplemental imaging modalities

By Mary Ellen Egger, APN, WHNP, CBPN and Diana L. Lam, MD

Faculty:

Mary Ellen Egger, APN, WHNP, CBPN, is a nurse practitioner in the Breast Center at Vanderbilt University in Nashville, Tennessee.

Diana L. Lam, MD, is an Assistant Professor in the Department of Radiology specializing in Breast Imaging at the University of Washington, Seattle Cancer Care Alliance, in Seattle, Washington.

Intended audience: This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners who provide care for women in any age bracket. Continue reading »

Policy and preventive healthcare services: Women living longer, living well

By Diana M. Drake, DNP, MSN, APRN, WHNP-BC

From the perspective of women’s healthcare providers (HCPs) in the United States, one of the major shifts in their field over the past decade has been a female patient population that is growing older, with an increasing mix of midlife and senior-life patients. Continue reading »

New evidence-based guideline for accurate HPV testing in head and neck cancers

The College of American Pathologists has released its newest evidence-based practice guideline, “Human Papillomavirus Testing in Head and Neck Carcinomas,” now available in Archives of Pathology and Laboratory Medicine. The guideline recommends accurate assessments of a patient’s high-risk HPV status, directly or by surrogate markers. Read more.

Genetic testing for hereditary cancer syndromes in women

What is a hereditary cancer syndrome?

Cancer can be sporadic, familial, or hereditary. A sporadic cancer happens at random, maybe because of a mistake that occurred when cells in the body were dividing or because a person was exposed to toxins (poisons) in their environment—for example, cigarette smoke—over a long period of time. A familial cancer occurs in members of the same family and is likely caused by a combination of genetic and toxic environmental factors. A hereditary cancer syndrome is caused by a specific mutation (change) in a certain gene that can be passed down from parent to child. Continue reading »

BRCA and beyond: The contribution of genetics to breast and gynecologic cancers (Part 2)

Faculty

Kate McReynolds, APRN, MSc, MSN, ANP-BC, AGN-BC, is a Genetic Nurse Practitioner at Vanderbilt University Medical Center in Nashville, Tennessee.

Intended audience

This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners who provide care for women in any age bracket.

CE approval period

Now through November 30, 2018

Estimated time to complete this activity

1 hour

CE approval hours

1.0 contact hour of CE credit

Needs assessment

This two-part article focuses on hereditary cancer syndromes associated with breast and gynecologic cancers. In part 1, the author provided background information about hereditary cancer, detailed several specific hereditary breast and gynecologic cancer syndromes (HBGCSs), and explained the gene alterations involved in these syndromes. In part 2, the author describes ways that healthcare providers can identify women who may have one of the two most common syndromes and who could therefore benefit from genetic risk assessment, counseling, and testing—processes she also discusses. The author also explains how to interpret genetic test results and provides management recommendations for the two most common HBGCSs. Continue reading »

Position Statement: Human Papillomavirus Vaccination

The National Association of Nurse Practitioners in Women’s Health (NPWH) supports an intentional and concerted effort to improve human papillomavirus (HPV) vaccination rates—with the goal of ending cancers caused by HPV. All nurse practitioners (NPs) who provide healthcare for adolescents and young adults are crucial to the success of this effort, and are encouraged to take these steps in their clinical practices: Continue reading »

Professional Development: Creating an Award-WInning Poster

first place nurse practioner posterBy Beth Kelsey, EdD, APRN, WHNP-BC, FAANP

Have you recently completed your research study or quality improvement (QI) project, submitted an abstract for conference presentation consideration, and been accepted for a poster presentation? If so, congratulations! Presenting a poster is an excellent venue for disseminating your research and project outcomes to colleagues. Poster presentations, more so than podium presentations, provide an opportunity to interact with individual viewers and with small groups of conference participants. If you are new to presenting, poster format can be less intimidating than standing in front of a large audience. In addition, the one-on-one contacts you can make with a poster presentation are a great way to network with others interested in your topic and to explore possible next steps in your scholarly and professional endeavors. Continue reading »

BRCA and beyond: The contribution of genetics to breast and gynecologic cancers (Part 1) 

BRCA and beyond: The contribution of genetics to breast and gynecologic cancers (Part 1)Faculty
Kate McReynolds, APRN, MSc, MSN, ANP-BC, AGN-BC, is a Genetic Nurse Practitioner at Vanderbilt University Medical Center in Nashville, Tennessee.

Intended audience
This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners who provide care for women in any age bracket.

CE approval period
Now through September 30, 2018 Continue reading »

A PCP’s Guide to Managing Patients at Genetic Risk of Breast Cancer

Hereditary syndromes that increase the risk of breast cancer are not common, but it is critical to recognize and manage them appropriately. This paper reviews the management of patients with the most common hereditary breast cancer syndromes, ie, hereditary breast and ovarian cancer syndrome, hereditary diffuse gastric cancer, Cowden syndrome (PTEN hamartoma tumor syndrome), Peutz-Jeghers syndrome, and Li-Fraumeni syndrome. Continue reading »

The pelvic health and wellness program: A niche clinical entity

In today’s healthcare climate, women’s health nurse practitioners (WHNPs) and other NPs providing healthcare for women are in a unique position, as front-line providers, to develop and implement a comprehensive, conservative, community-based pelvic health and wellness program (PHWP) within their chosen practice settings. The PHWP provides screening, assessment, and management of pelvic floor disorders (Table 1). These disorders include urinary incontinence (UI), overactive bladder (OAB), pelvic organ prolapse, chronic pelvic pain, and sexual dysfunction.1 The PHWP, an innovative, nontraditional, niche offering, can provide a much-needed clinical service in the community, broaden and enhance an NP’s own practice potential, and create a sound business venture to increase practice revenue. This program is a win-win situation because, with proper diagnosis and treatment, more than 90% of women with bladder or pelvic disorders can experience great improvement or a remission of their symptoms.

The healthcare landscape

The time is right; the need is now! Demographic trends are changing the nature of the healthcare landscape. Although overtaken by the Millennials in population, the number of Baby Boomers (persons born between 1946 and 1964) who are entering the 65+ age group is still increasing; the nation’s 65-and-older population grew from 44.7 million in 2013 to 46.2 million in 2014.2 Although people are living longer than ever before, many of them spend the extra years coping with the burden of chronic conditions such as diabetes and UI.3 However, many active women of today will not settle for wearing diapers or pads as the solution to their bladder problems, and will proactively seek help.4 And many Millennials want to make sure that they won’t suffer the consequences of poor pelvic health that their mothers and grandmothers endured. Prenatal and postpartum programs to restore the pelvic floor muscles (PFMs) are both part of the larger PHWP.

Although many women seek professional care for bladder and pelvic problems, others are too afraid, ashamed, or embarrassed to do so. They feel that they have no place to go, and no one to turn to for help. Instead, they sit at home wearing diapers or pads. They fear that the only treatment is surgery and are unaware that conservative measures are available. But if their healthcare provider’s office offered a PHWP, they could avail themselves of the evaluation and treatment they need. That’s where you come into the picture.

Two models: Intrapreneur and entrepreneur

A PHWP can be developed via an intrapreneurial or an entrepreneurial approach. Intrapreneurial NPs, on their own initiative, approach the physicians/partners in the practice with the idea of establishing a PHWP and outline a plan that would transform the idea into a worthy and profitable undertaking. If the physicians/partners approve the plan, then they take responsibility for providing financial and administrative support for the program’s implementation.5 In these situations, the NPs become the program’s managers and take full responsibility  for implementing all facets of it.

This packaging of existing services into a focused  PHWP enhances overall care. Because of the downstream effect of the presence of the PWHP, the general patient base of the practice will likely increase. The woman with UI who is sitting at home with a pad will see that she is not alone, that she has a place to go, and that she has a provider who can address her  problem. Another plus for the practice is that the PWHP provides an internal surgical referral base for patients who prefer the option of surgery over more conservative approaches. Establishment of a PHWP enables the practice to promote the new program, burnishing the favorable image of the practice and increasing its visibility within the community. As I said, it’s a win-win for everyone.

Entrepreneurs, in contrast to intrapreneurs, not only conceive the innovative ideas surrounding the development and establishment of a PWHP, but they also organize, operate, finance, and assume the ris for the new business venture on their own, working outside an existing organizational structure.6 Entrepreneurship is hard work, but well worth the effort, for individuals with an adventurous spirit and the personal and professional resources to support it. An entrepreneurial independent practice requires more financial resources and time and has more potential risks than does the intrapreneurial model, but it also offers greater potential rewards.

Engaging in an intrapreneurial or entrepreneurial enterprise is not for everyone. As with any business venture, NPs must perform the necessary analysis to determine whether this pursuit is right for them. Table 2 lists potential reimbursements from women who progress through the PHWP, as well as costs associated with setting up a PHWP. The start-up costs are relatively low compared with the dramatically higher practice revenue.7 Understanding the basics of coding is essential to both models.8 Medicare and most insurance companies reimburse for assessments, treatments, and procedures done in a PHWP. ICD-10 changes have had little effect on these billing practices. However, NPs need to learn how to get reimbursed and how to maximize those reimbursements, as well as learn what it takes to operate a business and write grants for startup costs. And they will need to develop and establish a patient base and referral sources—the keys to success.

A PHWP can be established in settings other than offices and clinics. For example, intrapreneurial NPs who work in nursing homes or extended-care facilities can pursuethis goal as well.

Strategic enhancements

Whether NPs choose an intrapreneurial or an entrepreneurial approach, they will find that a PHWP can:

Dramatically increase practice revenue. For example, the program can generate $1,000-$2,500 for each patient who progresses through the program (6-8 visits) and gross $100,000-$250,000 a year per 100 patients (not including advanced procedures/testing such as pessary insertion or urodynamic testing);

Recapture monies lost from Medicare cutbacks by offering a program that is procedurally base with a history of proven reimbursement from Medicare;

Provide a lucrative service line to meet the pelvic health needs of women throughout the lifespan, but particularly of the emerging Baby Boomer generation;

Be current and competitive by offering a PHWP;

Package resources and enhance and merge existing

service lines to create a structured, step-bystep program of pelvic healthcare;

Increase utilization of existing resources such as ultrasonography, bladder scans, and laboratory services;

Provide a portal to other services that the practice may offer;

Establish a niche as the premier source of conservative pelvic healthcare in your area;

Increase the practice’s surgical referral base by recruiting women through the conservative arm who decide on a surgical alternative;

Enhance quality of life for women experiencing pelvic dysfunction; and

Enhance marketing opportunities and increase visibility and viability of your practice by offering an exciting new program that can be promoted in the community.7

Timing

Timing is everything. The Affordable Care Act provides two billable opportunities for the integration of pelvic health assessment into a pelvic health practice in the form of preventive teaching and a comprehensive screen. These opportunities are the annual wellness visit under Medicare and the well-woman visit for all other women.

For the first time, two major physician organizations have recommended that first-line therapies for UI and OAB be conservative rather than surgical. The American College of Physicians recommends education, pelvic floor exercises, timed voiding, and fluid managment for UI.9 The American Urological Association offers similar guidelines for OAB.10 These recommendations are well within the scope of practice for NPs.

Financials

At the Health & Continence Institute (HCI), gross revenue is $1,000-$2,500 as each woman progresses through the program. This revenue range does not include fees for pessary insertion. An important aspect is that NPs would be recruiting patients not for just a single visit but, rather, for entry into the PHWP, where they would remain for a series of 6-8 visits over 3-4 months. Startup costs are covered after 4-6 patients complete the program.

When you consider the return on investment, startup costs are strikingly low. These costs depend on the type of model you pursue. Intrapreneurs can easily insert their program into the daily routine of their home office. Only one room is needed for 2-3 days a week. Entrepreneurs have the added challenge of setting up a new office and purchasing equipment and supplies.11 Grants for this purpose are available from organizations such as The Simon Foundation for Continence and The National Associationfor Incontinence. Adding only two new patients a week to the program can lead to gross revenue of $100,000-$250,000. But the best news is that the conservative measures implemented in a PHWP greatly enhance quality of life for women who previously had few options.

Conclusion

The number of women who have pelvic health problems will only increase as Baby Boomers age.12 Pelvic health conditions have been neglected for years, even though they comprise 2 of the 10 most common chronic conditions in U.S. women—OAB and UI.13 These two conditions affect a higher percentage of persons of all age groups than do hypertension, depression, and diabetes.13WHNPs and other NPs caring for women are well positioned to champion, initiate, and implement a PHWP within a practice setting as intrapreneurs or entrepreneurs. An NP entrepreneur is no longer an oxymoron! In fact, it is somewhat surprising that there has not been a groundswell of practitioners wanting to provide this niche clinical service. A large part of the problem may be that practitioners have nowhere to turn to for practical advice or training for themselves!

On a more personal level, many NPs have reached out to the HCI to share that, at this point in their careers, they are seeking new challenges and causes to champion. Many of them are also looking for potential opportunities and ways to meet the needs of women with pelvic health concerns who do not know where to turn. Even more NPs are looking for ways to provide a niche service that is also financially advantageous for them.

Whether readers want to proceed as intrapreneurs or entrepreneurs, they are about to embark on an exciting, rewarding, and lucrative career opportunity. Good luck! =

Helen A. Carcio is founder and director of the Health & Continence Institute, where she independently manages her pelvic health center in Deerfield, Massachusetts. Readers can contact her at the HCI website. She was an Associate Professor at the University of Massachusetts at Amherst in the nurse practitioner program. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn.

Formation of a peer review group for advanced practice nurses: Learning from and with colleagues

In 1996, Dr. Els Borst, former Minister of Health of the Netherlands, proposed that specially trained master’s-prepared nurses assume certain tasks of physicians in order to help meet the growing need for healthcare in the midst of a physician shortage. In light of the increased number of elderly and chronically ill patients today, this need is even more pressing.1  The consequence of Dr. Borst’s proposal was the inauguration of the first Master’s in Advanced Nursing Practice (MANP) program in Groningen, the Netherlands, at the Hanze University of Applied Sciences in 1997.

Since that time, the training and the work accountability of advanced practice nurses (APNs) in the Netherlands have been extended. A major change occurred in March 2009, when Dutch APNs were granted official registration numbers and legal title protection. Nurses can be registered as APNs only after earning a master’s degree from a certified university and undergoing training on the job at a certified healthcare institute with a certified medical and nursing trainer.

Dutch APNs can be registered in one of five nursing specialties: (1) acute care in somatic disorders, (2) intensive care in somatic disorders, (3) chronic care in somatic disorders, (4) preventive care in somatic disorders and (5) mental health. Like physicians, APNs must attend conferences offering staff development workshops and be actively employed for at least 24 hours a week. In 2014, more than 2,500 APNs were registered in the Netherlands.2

After initial registration, APNs must re-register every 5 years to maintain an active license. Since 2010, one of the requisites for re-registration has been participation in peer review (PR). Guidelines of the Dutch Nursing Specialty Registration Board (DNSRB) require APNs to participate in a PR group (PRG) for at least 40 hours per 5-year period.3 In addition, to ensure competence and continuous professional development, periodic self-appraisal and peer feedback must be in place for all levels of nursing.4 

Defining peer review

Peer review is a systematic process by which one assesses, monitors, and makes judgments about the quality of care provided to patients by others, as measured against established standards of practice. 5,6 Nursing PR is an evaluation of one’s professional nursing practice, including identification of opportunities to improve care, by persons with the appropriate expertise to perform the evaluation.7 Because they undergo PR, APNs are a group of healthcare providers (HCPs) whose personal competencies in various nursing specialties are compared— with those of other APNs and with objective criteria—with the aim of improving daily practice.3  PR, recognized as a measure of accountability and a means to evaluate and improve practice,4  enhances development of the APN profession and improves the quality of patient care.

Peer review has multiple benefits for APNs. It facilitates an open and safe learning environment. It provides APNs with an opportunity to reflect on questions and problems together. Because of the interactive setting, APNs invariably learn something new.8PR even offers APNs a break in an otherwise hectic workday. PR can help APNs evaluate the quality of care they have delivered, and gain insight into their greatest strengths and weaknesses as HCPs. With feedback and recommendations from the group, APNs can gain new knowledge and improve their skills.

Creating and working as a PRG

Because the APN profession is relatively new in the Netherlands, the nursing education department of the Erasmus Medical Center Rotterdam had no experience in starting or structuring a PRG. Five years ago, five pioneering APNs working on an internal medicine unit decided to create such a PRG. These APNs found several examples of PRGs in the literature and took the initiative in creating a framework, based on non-empirical research, that took into account the criteria requisites of the DNSRB.

To initiate an effective PRG, some basic steps are essential. The first step is to form a group of 3-5 APNs in the same specialty who have similar interests within their specialty. The next step is to elect a chair to serve a 1-year term. The chair then makes a yearly schedule so that members can plan to attend all PRG meetings. To meet the criterion of spending 40 hours in the PRG over 5 years, the group must meet for about 2 hours every 3 months.

At each meeting, members take turns serving as the contributor, who presents a case related to her work field. One week before the meeting, the contributor sends a recap of the case—along with corresponding literature, protocols, and guidelines—to PRG members so that they can read background material and analyze the case. Each case submitted for PR must have these elements:

• The patient’s presenting complaint, personal and family health history, and physical examination findings;

• An analysis of the case, with corresponding literature or guidelines to clarify or substantiate the diagnosis or the problem;

• A list of dilemmas that can occur or that did occur with the presented case, as well as learning points, and

• Learning objectives extracted from the presented case for discussion.

At the meeting, the contributor uses PowerPoint to present the case and then leads the discussion regarding dilemmas and learning goals. A member who is appointed secretary for each meeting takes notes and creates a report of the thoughts an views exchanged during the meeting. The report includes a summary of the case, the learning goals of the contributor, and feedback/recommendations from the group. After the meeting, the report is sent to the PRG members. Reports of PRG meetings are saved in a digital portfolio.

At the next PRG meeting, notes of the previous meeting are discussed. The chair asks the previous contributor whether she used feedback from the last PRG meeting and applied it to her practice. The process gives the contributor an opportunity to reflect on her own goals and improve the quality of her work.

Choosing the best method to present a case

Within the first year of the PRG’s existence, all five members had submitted a case. The group then met to determine the best format for presenting a case. The PRG considered three options: the testing method, the Balint method, and the research method. These methods were evaluated in terms of whether they enhanced the professionalism  the APN through the sharing of knowledge, expertise, and thoughts. The group was most satisfied with the testing method, which is particularly suitable for case study discussion and for evaluation of clinical guidelines and protocols. With this method, the group works together, sharing ideas and coming to an agreement on how practice can be improved. One downside of the testing method is that the personal learning goals of the APN are not included.

Gaining competencies

In the Netherlands, the focus of learning is to gain competencies. A framework used for the competency- based approach is that of the Canadian Medical Education Directives for Specialists (CanMEDS) (Figure).9 The CanMEDS framework describes seven different roles of an HCP: professional, communicator, collaborator, manager, health advocate, scholar, and, in the center, medical expert. APNs who have gained the first six competencies can become medical experts (the center of the honeycomb), but they cannot become medical experts if they fail to gain one of the six competencies surrounding the central competency. APNs need to enhance themselves in all seven competencies in order to become better HCPs.

Achieving the best practice

A combined framework using both the testing method and the CanMEDS framework was determined to be the best practice. This combined framework was deemed to be the best way to prepare a case for discussion and to give the PRG and the contributor the clearest insight into the question and learning issues provided by the case. The testing method is an ideal way to discuss problems or questions regarding certain procedures and guidelines within the safe confines of a group. In addition, each group member can impart information and share expertise via the group discussions, which can then be absorbed by the other members and translated into their own practices.

Discussion

The PRG found that, over a 4-year period, a combined approach—the testing method and the CanMEDS framework—constituted the best practice for structuring a case for discussion and determining the contributor’s own learning issues. The DNSRB also recommends use of CanMEDS competencies in this regard. If the combined framework does not work well for a given PRG, it may be related to poor group dynamics, lack of a safe environment, or a tendency for members discussing a case to highlight their feelings rather than their own practice. Some PRG members indicated that they sometimes felt vulnerable. It take courage to learn from colleagues. According to Karas-Irwin and Hoffmann,4 a caring environment imbued with genuine respect enhances PRG interactions. By participating in a PRG, APNs in the Netherlands not only meet the needs and criteria of the DNSRB, but also enhance their professional skills and build their knowledge base.

Implications for APNs in the United States

Although there is no specific requirement to participate in PR as part of APN licensure in the United States, PR is recognized as an important component of practice and professional responsibility. 10,11 The opportunity to come together as a small group of APNs with similar clinical practices and interests on a regular basis to review challenging cases provides a collegial environment for learning from each other. Peer assessments can play an important role in enhancing quality of care for complex patients with multiple interrelated chronic conditions, especially as seen in the U.S. with its aging population and the increasing prevalence of obesity and its co-morbidities. =

Simone J. van der Linden is an APN in the Department of Hematology, Cancer Institute; Leni van Doorn is an APN in the Department of Medical Oncology, Cancer Institute; Judith P. van Eck is an APN in the Department of Medicine, Section of Endocrinology; Wanda Geilvoet is an APN in the Department of Medicine, Section of Endocrinology; and Greta Mulders is an APN in the Department of Hematology, all at Erasmus Medical Centre, Rotterdam, The Netherlands. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

Acknowledgment

The authors thank L. Maas, RN, MS, Rotterdam University, Master’s in Advanced Nursing Practice Program, Rotterdam, the Netherlands.

References

  1. Statistics Netherlands. Dutch population expected to reach 17.5 million in 2038. cbs.nl/en-GB/menu/themas/bevolking/publicaties/artikelen/archief/2008/2008-085-pb.htm
  2. Dutch Nursing Association.  2013. venvnvs.nl/files/2014/09/Jaarverslag-VVN-VS-okt13-okt14-def.pdf
  3.  Dutch Nursing Specialty Registration Board. Intercollegiale Toetsing Verpleegkundig Specialisten. 2010. verpleegkundigspecialismen.nl/Portals/45/20100203%20Intercollegiale%20Toetsing%20Verpleegkundig%20Specialisten%20_3.pdf

  4. Karas-Irwin BS, Hoffmann RL. Facing the facts: in-person peer review. Nurs Manage. 2014;45(11):14-17.
  5.  Sherwood GD, Brown M, Fay V, Wardell D. Defining nurse practitioner scope of practice: expanding primary care services. Internet J Adv Nurs Pract. 1997;1(2). geide.org/uploads/6/4/8/8/6488798/definingscope.pdf

  6. Smith MA, Atherly AJ, Kane RL, Pacala JT. Peer review of the quality of care. Reliability and sources of variability for outcome and process assessments. JAMA. 1997;278(19):1573-1578.

  7.  Spiva LA, Jarrell N, Baio P. The power of nursing peer review. J Nurs Adm. 2014;44(11):586-590.

  8. de Haan E. Leren met Collega’s.  Uitgeverij Van Gorcum;2009.
  9.  Frank JR, Jabbour M, Fréchette D, et al. Report of the CanMEDS Phase IV Working Groups. Ottawa, Canada:The Royal College of Physicians and Surgeons of Canada;2005.
  10. National Organization of Nurse Practitioner Faculties. Nurse Practitioner Core Competencies. 2012. c.ymcdn.com/sites/www.nonpf.org/resource/resmgr/competencies/npcorecompetenciesfinal2012.pdf

  11. National Association of Nurse Practitioners in Women’s Health/Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.

     

From practice to policy: The WHNP as advocate

As most of our readers know, the National Association of Nurse Practitioners in Women’s Health (NPWH) and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) released the 7th edition of the Women’s Health Nurse Practitioner: Guidelines for Practice and Education in December 2014. Many women’s health nurse practitioners (WHNPs) use this document to outline their clinical competencies, and faculty use it as a framework in developing WHNP program curricula. But the guidelines go beyond describing clinical practice components and educational requirements; they also include policy and advocacy competencies. In particular, the guidelines enumerate participating in legislative/policy-making activities that influence women’s health and serving as “a consultant and trusted source of information on women’s health for healthcare systems and policy-makers” as key WHNP leadership competencies.1

As core WHNP competencies, policy and advocacy align well with NPWH’s mission and values. NPWH’s mission is to “ensure the provision of quality primary and specialty healthcare to women of all ages by women’s health and women’s health-focused nurse practitioners.” This mission includes protecting and promoting a woman’s right to make her own choices regarding her health within the context of her personal, religious, cultural, and family beliefs. As a professional membership organization, NPWH strives to continuously improve access and quality of healthcare for women through excellence and innovation in continuing education and professional development; to demonstrate leadership in policy, practice, and research; and to provide support and services for our members. These policy-related values are key to achieving our mission:

  • To advocate for healthcare policies that support women and advanced practice registered nurses (APRNs) who care for them; and,
  • To collaborate with strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.2

How do these competencies affect clinical practice?

So, what does all of this mean in the real world of clinical practice? As most of our readers witness every day, policy decisions related to everything from reimbursement for healthcare service delivery to state-based APRN scope of practice regulations to decisions regarding availability of services, medications, or new technologies can affect women’s health—and the realization of NPWH’s mission. The following discussion provides just a few examples.

The Patient Protection and Affordable Care Act seeks to increase access to affordable health insurance, with the ultimate goal of increasing access to healthcare. One way that it does this is by providing a mechanism for federally supported Medicaid expansion to cover most low-income adults (i.e., those earning up to 138% of the federal poverty level). Yet, to date, approximately 20 states have not expanded Medicaid to this level of coverage.3 Most states provide Medicaid coverage during pregnancy; however, in non–Medicaid-expansion states, this coverage stops shortly after delivery. Although coverage of prenatal care facilitates a favorable pregnancy outcome, lack of coverage for care needed before and between pregnancies can have devastating effects on women and their children.

Consider the reproductive-aged woman with type 1 diabetes mellitus (T1DM). Diabetes in pregnancy can adversely affect both maternal and infant outcomes. Women with T1DM have higher rates of maternal mortality and morbidity, including increased rates of pre-eclampsia and cesarean section. Likewise, maternal T1DM increases the risks for fetal and neonatal loss, congenital anomalies, macrosomia, and a host of other neonatal complications. A patient with T1DM who qualifies for Medicaid during pregnancy but loses coverage soon after delivery will not have access to care for her chronic disease prior to her next pregnancy. This gap in care can allow her T1DM to spiral out of control, contributing to increased maternal and infant health problems or even death during subsequent pregnancies.4

In June 2015, the House Labor, Health and Human Services (LHHS) Subcommittee marked up its fiscal year 2016 spending bill, which contained a complete elimination of Title X. The following week, the Senate released a funding bill proposing $257.8 million for Title X, a decrease from the prior year’s $286.5 million budget.5 By the time this article goes to press, we should know how the Title X program fares in the 2016 budget. It is estimated that publicly funded healthcare providers, such as those funded through Title X, met an estimated 42% of the need for publicly supported contraceptive services and supplies in 2013.6 Cuts to, or elimination of, the Title X program would effectively bar many of these women from accessing similar services in the future. In the case of the patient with T1DM discussed earlier who has already lost access to care for her chronic disease, she will also lose family planning services, which may contribute to a shortened pregnancy interval and may increase the potential for a poor pregnancy outcome. Furthermore, because Title X clinics are staffed primarily by NPs, cuts to Title X could decrease women’s access to quality care by WHNPs and other NPs who provide family planning services.

Professional competencies plus organizational values in action

Although many of our readers in clinical practice may have little time to “participate in legislative and policy-making activities that influence women’s health” in the traditional sense, they are our greatest asset in terms of bringing women’s stories to the forefront. NPWH staff keep our fingers on the pulses of policy-makers with power to make decisions about how, where, and from whom each woman can access care that is “within the context of her personal, religious, cultural, and family beliefs,” but our organization’s members provide the stories that give life to the policy. It is through our organization’s members that we at NPWH learn about the challenges that women face in accessing woman-centric care to meet their needs, as well as the barriers faced by WHNPs in attempting to provide that care.

Conclusion

In keeping with the NPWH/AWHONN guidelines, WHNPs possess the leadership competencies to serve as trusted sources of information on women’s health. As NPWH Policy Director, I invite all of our readers to collaborate with NPWH as “strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.” Please contact me at skendig@npwh.org to share your stories about policy issues affecting your practice and your patient population at the local, state, or national level. In this way, we can work together to become a collective voice for the women we serve in moving the policy needle to a place that supports women’s full access to the care that they need delivered by the providers they choose.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH).

References

  1. National Association of Nurse Practitioners in Women’s Health/Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.
  2. NPWH. Mission, Vision, and Values. Mission. 2015. https://www.npwh.org/pages/about
  3. Kaiser Family Foundation. Current Status of State Medicaid Expansion Decisions. July 20, 2015. http://kff.org/health-reform/slide/current-status-of-the-medicaid-expansion-decision/
  4. Negrato CA, Mattar R, Gomes MB. Adverse pregnancy outcomes in women with diabetes. Diabetol Metab Syndr. 2012;4(1):41.
  5. National Family Planning & Reproductive Health Association. Title X: Budget & Appropriations. http://www.nationalfamilyplanning.org/title-x_budget-appropriations
  6. Frost JJ, Frohwirth L, Zolna MR. Contraceptive Needs and Services, 2013 Update. Washington, DC: Guttmacher Institute; July 2015. www.guttmacher.org/pubs/win/contraceptive-needs-2013.pdf

Lung cancer screening*

Tests are used to screen for different types of cancer.

Some screening tests are used because they have been shown to be helpful both in finding cancers early and in decreasing the chance of dying from these cancers. Other tests are used because they have been shown to find cancer in certain people; however, it has not been proven in clinical trials that use of these tests will decrease the risk of dying from cancer.

Scientists study screening tests to find those with the fewest risks and most benefits. Cancer screening trials also are meant to show whether early detection (finding cancer before it causes symptoms) decreases a person’s chance of dying from the disease. For some types of cancer, finding and treating the disease at an early stage may result in a better chance of recovery. Clinical trials that study cancer screening methods are taking place in many parts of the country. Information about ongoing clinical trials is available from the National Cancer Institute website.

Three screening tests have been studied to see if they decrease the risk of dying from lung cancer.

Low-dose spiral CT scan (LDCT scan): A procedure that uses low-dose radiation to make a series of very detailed pictures of areas inside the body. It uses an x-ray machine that scans the body in a spiral path. The pictures are made by a computer linked to the x-ray machine. This procedure is also called a low-dose helical CT scan.

Chest x-ray: An x-ray of the organs and bones inside the chest. An x-ray is a type of energy beam that can go through the body and onto film, making a picture of areas inside the body.

Sputum cytology: Sputum cytology is a procedure in which a sample of sputum (mucus that is coughed up from the lungs) is viewed under a microscope to check for cancer cells.

Screening with low-dose spiral CT scans has been shown to decrease the risk of dying from lung cancer in heavy smokers.

The National Lung Screening Trial studied people aged 55 years to 74 years who had smoked at least 1 pack of cigarettes per day for 30 years or more. Heavy smokers who had quit smoking within the past 15 years were also studied. The trial used chest x-rays or LDCT scans to check for signs of lung cancer.

The scientists found that LDCT scans were better than chest x-rays at finding early-stage lung cancer.  Screening with LDCT also decreased the risk of dying from lung cancer in current and former heavy smokers. A Guide is available for patients and healthcare providers to learn more about the benefits and harms of LDCT screening for lung cancer.

Screening with chest x-rays and/or sputum cytology does not decrease the risk of dying from lung cancer.

Chest x-ray and sputum cytology are two screening  tests that have been used to check for signs of lung cancer. Screening with chest x-ray, sputum cytology,  or both of these tests does not decrease the risk of dying from lung cancer.

  • National Cancer Institute. Updated April 27, 2015. Readers are invited to photocopy Patient education pages in the journal and distribute them to their patients.

 

 

 

PrEP for prevention: Practice update

According to the Centers for Disease Control and Prevention (CDC), about 1.2 million persons are living with HIV in the United States, and about 20% of them are unaware of it.1 Lack of awareness of HIV status contributes to viral transmission. Healthcare providers (HCPs) play a vital role in the screening, diagnosis, and treatment of HIV infection, but they can also play an important role in HIV prevention. This article focuses on pre-exposure prophylaxis (PrEP), a safe and effective intervention that is rapidly becoming a major tool in HIV transmission prevention. The article also provides an overview of the assessment and management of patients prior to and during the use of PrEP.

The CDC estimates that 50,000 persons in the United States are newly infected with HIV every year.1 Most of the new cases involve men who have sex with men (MSM) (n = 30,689), but African-American women represent a disproportionate number of new infections (n = 5,300) when compared with white non-Hispanic women (n = 1,300) and Hispanic/Latina women (1,200).2

The birth rate among HIV-infected women has increased from 6,000-7,000 live births in 2000 to 8,700 live births in 2006, the last year reported.3 This increase in births may be related to the increased availability and use of antiretroviral medications, which significantly decrease mother-to-child transmission risk. Other factors are also in play. Study data suggest that women who are HIV positive and desire children, including those who disclose their seropositive status to their partners, may not be using condoms consistently.4,5 Little is known about birth rates in women who are HIV negative, desire children, and are in a relationship with an HIV-positive partner.

Pre exposure prophylaxis is the most recent intervention in the effort to fight the HIV epidemic. PrEP is a combination of two antiretrovirals, tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine (FTC) 200 mg, taken once daily. This treatment has been shown to reduce transmission risk by upwards of 92%.6 PrEP is available to adult men and women who are HIV negative but have an increased risk of exposure to HIV through sexual and/or injection drug use. PrEP is not approved for use in children or adolescents. Guidelines for PrEP were released in 2014 by the U.S. Public Health Service.<sup.6

Assessment

Health history
To identify and reduce their patients’ risk for contracting HIV infection, HCPs need to take a sexual history as part of primary care and specialty care services. Studies have shown that many HCPs do not ask about risky sexual behaviors and many patients do not disclose them.4,5,7 Assessment of patients’ sexual behaviors and their potential contribution to HIV risk should be part of every healthcare encounter. The 5 P’s of sexual health—partners, practices, protection from sexually transmitted infections (STIs), past history of STIs, and prevention of pregnancy—provide a framework to assess each patient.8

Many patients are not comfortable talking about their sexual practices, partners, and history. HCPs can facilitate this discussion by informing patients that they routinely take a sexual history so that they can provide appropriate sexual health care, and that all information provided is confidential. HCPs can begin by asking these questions, as recommended in the 2014 PrEP guidelines.6 In the past 6 months:

  • Have you had sex with men, women, or both?
  • How many men/women have you had sex with?
  • How many times did you have vaginal or anal sex when neither you nor your partner wore a condom?
  • How many of your sex partners were HIV-positive?
  • If you did have sex with HIV-positive partners, how many times did you have vaginal or anal sex without a condom?
  • Do you have sex with partners who do not know their HIV status?

Next, HCPs need to inquire about any past history of STIs, treatment, past or current symptoms, their partner(s)’ history of STIs, and whether they would like to be tested for HIV during this healthcare encounter. In addition, HCPs can ask patients if they have ever injected drugs not prescribed by their HCP. If the answer is yes, patients are asked whether they have shared injection or drug preparation equipment or been in a drug treatment program in the past 6 months.

If this assessment suggests that a given patient is at high risk for HIV infection, the HCP initiates a discussion about PrEP. Adult MSM who do not have acute or established HIV infection and are not in a monogamous relationship with a recently tested HIV-negative man are potential candidates if they have had anal sex with a male (receptive or insertive) without a condom and/or have had an STI diagnosed in the past 6 months. Adult men and women who are heterosexually or bisexually active who do not have acute or established HIV infection and are not in a monogamous relationship with a recently tested HIV-negative partner are potential candidates if they infrequently use condoms during sex with partner(s) of unknown HIV status who are at substantial risk for HIV infection. Any individual who is HIV negative and in an ongoing sexual relationship with an HIV-positive partner is a potential candidate. In addition, individuals who have used illicit injection drugs in the past 6 months that included sharing injection and drug preparation equipment or who have been in a drug treatment program in the past 6 months are potential candidates. If a patient found to be a potential candidate is interested in PrEP, then further evaluation is needed to determine whether this intervention is appropriate for him or her.

Physical examination and lab screening/testing
No specific physical examination is required prior to initiation of PrEP. However, HCPs should recognize and further investigate fever, rash, and cervical adenopathy as potential clinical signs of acute HIV infection. These findings are especially relevant if a patient reports having experienced viral infection symptoms such as fatigue, myalgia, headache, night sweats, and diarrhea in the prior 4 weeks.

Laboratory tests for prospective PrEP recipients include HIV testing, hepatitis B virus (HBV) screening, and renal function tests. HIV testing is done within 1 week of initiating PrEP. If the test result is positive, PrEP is not initiated because it does not provide adequate therapy for HIV; in addition, there is some concern about the development of drug resistance. If the test result is indeterminate, PrEP initiation is postponed until further testing determines HIV status.

Both TDF and FTC suppress replication of HBV as well as HIV, so the PrEP intervention may offer an additional benefit if a patient has active HBV infection. Reactivation of HBV infection may occur if PrEP is discontinued or taken inconsistently. If screening indicates that a patient is not infected by HBV or immune to it, HBV vaccination is recommended. Patients who have significantly reduced renal function should not take PrEP.

Pregnancy testing is done if indicated. Although data regarding the use of TDF/FTC in terms of fetal health and growth are limited, the FDA has approved PrEP use during pregnancy. No evidence exists of harm to fetuses exposed to TDF or FTC when used for treatment of HIV during pregnancy.6

Management

PrEP must be taken on a consistent basis for maximum prevention benefit. PrEP is safe and effective but may cause a loss of appetite, mild gastric upset, or mild headaches initially. HCPs need to counsel patients about these side effects and inform them about over-the-counter drugs that may lessen these effects. Patients are asked to contact their HCP if the side effects do not subside. PrEP reaches maximum intracellular concentrations in about 20 days; therefore, patients should be advised that effectiveness is not immediate.

All other medications that patients are taking should be reviewed. Drug interaction data are available for TDF, but not for FTC. TDF has no significant effect on oral contraceptive hormone levels. Serum concentrations of some drugs (e.g., acyclovir, valacyclovir, aminoglycosides) or of TDF may be increased when these agents are combined.6

Regardless of whether or not a patient decides to take PrEP, HCPs and patients need to discuss other ways to reduce HIV infection risk (e.g., limiting the number of sexual partners, always using a condom). For some individuals, multi-session behavioral counseling may be required. Women who have the potential to become pregnant should receive counseling and provision of contraception if they do not want to become pregnant, and pre-conception counseling if they are considering a pregnancy. Patients who report substance abuse should receive referrals for appropriate treatment.

Patients should receive information on the signs and symptoms of acute HIV infection and should be advised to contact their HCP if these occur. In addition, those patients who are taking PrEP need to know that they should not discontinue the regimen without first discussing it with their HCP.

Patients taking PrEP are seen for follow-up at least every 3 months. At these visits, HCPs need to assess them for side effects, medication adherence, and HIV risk behaviors, as well as for signs and symptoms of acute HIV infection. HIV testing is repeated at each follow-up visit. A pregnancy test is performed for women who could become pregnant, and STI tests are done as indicated. Renal function tests are conducted every 6 months.

These follow-up visits provide an important opportunity to reinforce the need for consistent medication use and to support HIV risk-reduction behaviors. Discussion about continuing PrEP should take into account personal preference, change in risk profile, and ability to adhere to the daily dosing regimen. PrEP must be discontinued if a patient’s HIV test result is positive or if renal function is significantly impaired.

Conclusion

PrEP is a safe and effective pharmacologic intervention for women and men at high risk for HIV infection. HCPs have the opportunity to improve the lives of their patients and provide preventive care in the fight against HIV.

Lorraine Byrnes is Associate Professor at Hunter Bellevue School of Nursing, Hunter College, City University of New York, in New York City. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

Resources

White space

References
1. Centers for Disease Control and Prevention. CDC Vital Signs: New Hope for Stopping HIV. 2011. cdc.gov/vitalsigns/HIVtesting/index.html

2. Centers for Disease Control and Prevention. Fact Sheets: HIV/AIDS. 2013. cdc.gov/hiv/library/factsheets/index.html

3. Centers for Disease Control and Prevention. HIV among Pregnant Women, Infants, and Children. 2015. cdc.gov/hiv/
group/gender/pregnantwomen/index.html

4. Sanders LB. Sexual behaviors and practices of women living with HIV in relation to pregnancy. J Assoc Nurses AIDS Care. 2009;20(1):62-68.

5. Sullivan K, Voss J, Li D. Female disclosure of HIV-positive serostatus to sex partners: a two-city study. Womens Health. 2010;50(6):506-526.

6. Centers for Disease Control and Prevention. Pre-Exposure Prophylaxis (PrEP). 2015. cdc.gov/hiv/prevention/
research/prep

7. Bernstein KT, Liu KL, Begier EM, et al. Same sex attraction disclosure to health care providers among New York City men who have sex with men: implications for HIV testing approaches. Arch Intern Med. 2008;168(13):1458-1464.

8. Centers for Disease Control and Prevention. A Guide to Taking a Sexual History. cdc.gov/STD/treatment/
SexualHistory.pdf

Not your mother’s WHNP guidelines

In the past, and even continuing into the present day, low-income women and children have encountered barriers in accessing healthcare. Fifty years ago, to help overcome these barriers, Loretta Ford, RN, and Henry Silver, MD, created the first nurse practitioner (NP) program at the University of Colorado; it was there, in 1965, that the NP role first emerged. This certificate education program, which built on the knowledge and skills of the public health nurse, prepared pediatric NPs (PNPs) to work in collaboration with physicians to care for underserved low-income pediatric populations.1

Inspired by the success of the PNP role, innovative nurses and physicians expanded the registered nurse role to include provision of care to underserved pregnant women. The evolution of the obstetric/gynecologic (OB/GYN) nurse’s role from maternity care to women’s healthcare throughout the lifespan, in what would become an advanced practice role, drove the need for uniform standards for education and practice.

To serve this need, the first guidelines, Obstetric-Gynecologic Women’s Health Nurse Practitioner: Role Definition, Role Description, and Guidelines for Educational Development, were published in 1979. These guidelines, updated in 1984 and 1990, remained in effect until 1996. Reflecting the spirit of cooperation inherent in women’s healthcare, the National Association of Nurse Practitioners in Women’s Health (NPWH) and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) collaborated to develop and publish Women’s Health Nurse Practitioner: Guidelines for Practice and Education (hereafter called the Guidelines) in 1996. This 4th edition and two subsequent editions have delineated the emerging skills and competencies necessary for WHNPs to meet women’s healthcare needs.

The 7th edition of the Guidelines

The evolving national healthcare scene, the changing policies/guidelines affecting NP education and practice, and multiple emerging population health concerns have driven the need for periodic comprehensive reviews and revisions of the Guidelines. The 7th edition of the Guidelines provides a clarification of the WHNP role, without expanding the role.1 This edition articulates and differentiates the women’s health population focus by:

• Strengthening language regarding the WHNP’s role in primary care, and;
• Describing key areas of specialty practice consistent with WHNP education and identified competencies, including high-risk pregnancy, infertility, urogynecology, gynecologic oncology, menopause, and gynecologic office-based procedures.

The revision process for the Guidelines

In April 2013, a joint NPWH/AWHONN task force of WHNPs, with equal representation from the two associations, was convened to revise the Guidelines under the leadership of a chairperson with dual NPWH/AWHONN membership. Task force members were selected for their knowledge and experience in women’s health, nursing education, and clinical practice. In addition, the National Certification Corporation (NCC), the only nationally recognized certifying body for WHNPs, was invited to name a representative to participate on the task force.

Over the course of 18 months, the task force took steps to ensure that the updated document would reflect not only current WHNP practice but also the an­ticipated WHNP role of the future. First, the task force reviewed key documents guiding NP practice and education, as well as women’s healthcare, to ensure alignment. Upon completion of the draft document, key WHNP stakeholders were asked to review the document and provide comments to strengthen it. Following this review, NPs in other population foci, along with representatives from the American Association of Nurse Practitioners, the Gerontological Advanced Practice Nurses Association, the National Association of Pediatric Nurse Practitioners, and the National Organization of Nurse Practitioner Faculties (NONPF), participated in a second review. The second review hinged on these questions:

• Do these Guidelines align with key NP guidance documents regarding NP practice and education?
• When, and for what services, would you refer to a WHNP?
• Is the reason that you would refer to a WHNP adequately reflected in the Guidelines document?

All comments were reviewed by the task force and incorporated into the document.

During development of the Guidelines, all NCC-certified WHNPs were invited to complete a survey regarding their current practice, including work setting, skills utilized in practice, content learned in WHNP programs, and content and skill building in the workplace. Survey results indicated that approximately 82% of WHNPs practice in primary care settings, including OB/GYN and family practice offices, family planning clinics, governmental health departments, college health departments, sexually transmitted disease clinics, and prenatal care clinics.2 The other respondents reported working in specialty and sub­specialty practices such as gynecologic oncology, urogynecology, infertility, and maternal–fetal medicine. The survey results, combined with input from non-WHNP colleagues, underscored the broad reach of WHNP practice.

Revisions include alignment with Licensure, Accreditation, Certification & Education (LACE), NONPF NP Core Competencies, American Association of Colleges of Nursing MSN and DNP Essentials, other NP population focus guidelines, and the Institute of Medicine’s (IOM’s) The Future of Nursing: Leading Change, Advancing Health, as well as key documents pertaining to women’s health.

Key differences from prior editions

The 7th edition of the Guidelines represents a comprehensive view of WHNP practice today, emphasizing a lifespan approach to care extending from menarche through senescence. Written within the framework of the LACE consensus model for advanced practice nursing and consistent with the IOM’s groundbreaking report on the future of nursing, the Guidelines, compared with earlier editions, reflect a broader description of WHNP assessment, diagnostic, and treatment activities within the context of general competencies, gynecology, male sexual and reproductive healthcare (SRH), nongynecologic primary care, and obstetrics. WHNP education concepts reflect the practice competencies necessary to partner with women to meet their healthcare needs. The Guidelines elaborate on the WHNP role in male SRH, take a gender-focused approach to women’s health concerns, and recognize WHNPs’ expertise in performing selected office-based procedures. In further clarifying the components of WHNP practice, the Guidelines reflect WHNPs’ expertise and value as care providers, leaders, and consultants in the areas of women’s health and male SRH.

Conclusion

The writing team and reviewers for the Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition spent countless hours bringing this final document to fruition. Guideline development and publication by NPWH and AWHONN included a review of interdisciplinary documents and input from family NP, adult-gerontology NP, PNP, and faculty colleagues in addition to a team of WHNPs. This multifaceted approach exemplifies the collaborative nature of women’s healthcare providers as partners with their female patients in promoting health, preventing disease, and optimizing health outcomes.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at skendig@npwh.org.

References
1. National Association of Nurse Practitioners in Women’s Health/ Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.

2. Kelsey B and the National Association of Nurse Practitioners in Women’s Health. NPWH Women’s Health NP Role and Competencies Survey. 2013. Unpublished data.

Practical strategies for the diagnosis and management of binge eating disorder

Binge eating disorder (BED), now included in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),1 is defined as follows:

  • Recurrent and persistent episodes of binge eating
  • Binge eating episodes that are associated with three (or more) of the following:
    • Eating much more rapidly than normal
    • Eating until feeling uncomfortably full
    • Eating large amounts of food when not feeling physically hungry
    • Eating alone because of being embarrassed by how much one is eating
    • Feeling disgusted with oneself, depressed, or very guilty after overeating
  • Marked distress regarding binge eating
  • Absence of regular compensatory behaviors (such as purging)

Particularly common among females (See Cases 1, 2, and 3) and associated with obesity, BED poses physical, psychological, and social challenges that decrease health-
related quality of life (HRQOL) and increase disease burden.

Etiology

The etiology of BED is multifactorial and complex. Although associated with hedonic hunger, BED is linked less to pleasure and more to an attempt to suppress negative feelings through bingeing without purging.2 Motivation to binge likely also arises from homeostatic hunger.

Risk factors

Risk factors for BED include genetics, female gender, Caucasian ethnicity, weight concern, negative body image, childhood problems, low self-esteem and self-efficacy, low family cohesion, psychiatric morbidity, and stressful events.3,4 In addition, a community-based case–control study demonstrated that patients with BED, versus controls, were significantly more likely to report sexual abuse and repeated severe physical abuse. The typical overweight person with BED is overly concerned with body shape and weight. BED is most likely to occur in young women of high socioeconomic status in industrialized countries, but it is not limited to this population (See Cases 1, 2, and 3).

Binge-eating disorder in children and adolescents

In children and adolescents, early identification and treatment of BED is vital (See Case 1). Loss of control over eating is associated with modifiable lifestyle factors. Often considered temporary, BED is actually a long-term chronic condition often associated with co-morbid obesity. Childhood factors that increase risk for BED include obesity, self-criticism, poor self-esteem, body dissatisfaction, and emotional abuse.5 In female adolescents and young adult women, BED is associated with pre-existing depressive symptoms and an increased risk for developing mood disorders.6

Specific goals of treatment for children and adolescents include treatment of underlying depression or anxiety, improvement of self-esteem, normalization of eating patterns, promotion of physical activity, and implementation of family therapy to address family dysfunction and engage family members in supporting the patient’s recovery. BED treatment outcomes can be optimized through early detection and referral to eating disorder specialists; incorporating a multidisciplinary treatment team to address the physical, psychological, nutritional, and spiritual aspects of BED; and combining cognitive behavioral therapy (CBT), a self-help program, and, when appropriate, pharmacotherapy.

Co-morbid psychiatric disorders

Co-morbid anxiety, mood, and disruptive behavior disorders are common in patients with BED, as are obsessive-compulsive disorder, post-traumatic stress disorder, and substance abuse. Co-morbid obesity increases psychopathology, emotional eating, concerns about weight and body shape,7 and perhaps a desire for bari­atric surgery.8 Obesity and BED are common in patients with bipolar disorder. In patients with personality disorders, alexithy­mia (a personality construct characterized by the subclinical inability to identify and describe emotions in the self) correlates more highly with BED than with other eating disorders.9

A case–control study showed that patients with BED, compared with controls, reported a significantly greater number of adverse life events during the year prior to symptom onset, suggesting that the accumulation of stressful events can trigger the disorder.10 Even after weight loss and CBT, patients with BED experienced higher morning basal cortisol levels than did a control group without BED.

Effects of disordered eating patterns on reproductive health

Disordered adolescent eating patterns affect one’s development, with implications for reproductive function. Behaviors associated with risk-taking and self-harm frequently co-exist with eating disorders and increase risks for unplanned pregnancy and sexually transmitted infections. Obesity is strongly associated with conditions that adversely affect reproductive function.

In anovulatory overweight or obese women, sustained gradual weight loss will regulate menstrual cycles and increase the chance of spontaneous ovulation and conception.11Lifestyle modification has been shown to improve reproductive function.

Effects of binge eating disorder on pregnancy

Pre-pregnancy and pregnancy dietary patterns of women with BED may influence pregnancy outcomes. Many obstetricians do not query patients about weight control or disordered eating during pregnancy, and many patients do not seek treatment. Studies evaluating maternal and fetal outcomes in women with eating disorders are limited.

Women with BED during pregnancy are considered high risk. BED treatment during pregnancy is important for long-term management and reduction of harmful behaviors such as smoking; in fact, treatment during pregnancy is particularly likely to produce long-lasting results.

Pregnant patients with BED need frequent prenatal visits to discuss problems related to both nutrition and BED. Healthcare providers (HCPs) should do the following:

• Empower women to discuss weight and body-image concerns during pregnancy;
• Educate patients that uneven weight gain patterns may occur in pregnancy;
• Inform patients that controlling BED during pregnancy reduces the risk for a large-for-gestational-age newborn;
• Provide or refer for dietary support and meal planning;
• Assess and/or refer for management of psychiatric co-morbidities;
• Provide a routine postpartum visit at 1-2 weeks to monitor for relapse or exacerbation of BED; and
• Provide nutritional and dietary counseling for breastfeeding mothers and for the first 6-12 months postpartum.12

Co-morbid physical disorders

Binge eating disorder is associated with multiple physical co-morbidities, with decreased HRQOL and physical and psychosocial functioning.13 A large majority of individuals with BED receive medical treatment for co-morbidities, particularly obesity-related conditions such as type 2 diabetes mellitus (DM). Weight loss in patients with type 2 DM and BED who control their eating habits is similar to that in persons who have never experienced BED. BED may precede bariatric surgery and/or re-emerge post-surgery.

Screening and diagnosis

Assessment for eating disorders, including BED, should be part of a routine health evaluation. HCPs can use an assessment tool or pose a simple screening question in a matter-of-fact, nonjudgmental, empathetic manner to facilitate open conversation: Do you have thoughts, feelings, or behaviors regarding eating, weight, or body image that occupy most of your time or that make you feel out of control? (See Cases 1, 2, and 3.) The SCOFF Questionnaire can be useful. Practical strategies for screening and diagnosis implemented by the authors include the following:
• Use an eating disorder screening question at routine visits as patients age from childhood through the older adult years;
• Engage patients in a conversation about possible BED;
• Maintain accurate chronological weight records;
• Be familiar with DSM-5 diagnostic criteria;
• Obtain a 24-hour written food intake and feelings journal for
7 consecutive days (including weekends) and review the journals with patients;
• Assess for underlying depression or anxiety; initiate medication if indicated;
• Use physical, nutritional, and psychological findings to incentivize patients to engage in treatment;
• Avoid references to calories, weight, and dieting that may exacerbate feelings of shame or excessive focus on food;
• Advocate an approach for treatment of BED and obesity that does not center on the need for dieting but, instead, emphasizes the importance of specialized psychological, medical, and nutritional care;
• Be familiar with eating disorder specialists in your geographic area and be able to implement the referral process; and
• Confirm that patients follow through with BED treatment.

Binge-eating disorder subtypes may manifest in difficult-to-treat food addictions, which are common in patients with co-existing histories of addictive personality or substance abuse disorder. A marker of substance dependence includes consumption of high-fat/high-sugar foods.14 A food addiction symptom count (using criteria similar to those for substance abuse disorder in the DSM-5) should be obtained for these patients.15 Emotions associated with binge eating may be experienced differently by individuals from specific ethnic, racial, and cultural groups.

Treatment

The American Psychiatric Association has established levels of care guidelines for patients with eating disorders, who can be difficult to treat. Many patients with BED experience shame, embarrassment, self-disgust, depression, and guilt as a result of their eating disorder. They tend to eat secretly or alone and may hide binge foods. Patients may deny that they have an eating disorder and may be reluctant to discuss BED with their HCP. Many patients who use binge eating to deal with difficult life situations are reluctant to eliminate this behavior and do not fully commit to a treatment program. Others welcome interventions that may improve HRQOL.

Nonpharmacologic approaches
Cognitive behavioral therapy, considered a first-line therapy for BED, and interpersonal psychotherapy are effective in patients with BED (See Cases 1, 2, and 3). Other nondrug approaches usually entail a combination of a lifetime nutritional plan, assertiveness training, improved stress management, and moderate exercise to increase lean muscle mass.

Pharmacotherapy
No agent is FDA-approved for the treatment of BED. An application for an indication for lisdexamfetamine dimesylate as a treatment for BED likely will be filed soon with the FDA. Multiple pharmacologic agents have demonstrated benefits at varying dosages in trials conducted between 2005 and 2010.

Antidepressants
Antidepressants address common mood-related co-morbidities. Of note, many patients with BED consume tryptophan-containing carbohydrates that synthesize serotonin. When these patients’ serotonin levels are low, cravings commence. Antidepressants that inhibit reuptake of serotonin can help decrease compulsive/binge eating. In many patients with co-morbid depression (or if CBT is unavailable), selective serotonin reuptake inhibitors (SSRIs) can decrease bingeing (and purging) by 50%, although some patients may not respond to treatment or may relapse with SSRI dis­continua­tion.16 Bupropion has beneficial effects on weight and does not have SSRI side effects. Bupropion dosages of 300-450 mg/day have been shown to be effective.17Psychostimulants
Agents used to treat attention defi­cit hyper­activity disorder (ADHD) affect dopamine/norepinephrine systems associated with both the etiology of BED and eating behavior/reward behavior. An epide­miologic relationship between BED and ADHD has been noted in adolescents18 and adults.19 An association has also been reported between bulimia nervosa (BN) and ADHD; a small study of patients with co-morbid BN and ADHD showed the efficacy of psycho­stim­­ulant medication. An ongoing study is comparing methyl­phen­i­date with CBT in the treat­ment of BED.20Pharmacotherapy during pregnancy
Few studies have evaluated the use of psychotropic agents during pregnancy other than a large cohort evaluation of SSRIs. Additional data may guide decision making regarding the use of agents such as bupropion, methylphenidate, memantine, naltrexone, sodium oxybate, topiramate, and zonisamide in pregnant women.

Conclusion

Binge-eating disorder is a complex, multifactorial condition that requires a comprehensive and integrated course of treatment. Nurse practitioners and other advanced practice HCPs caring for women are positioned to play important roles in patient assessment and management.

References
1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Washington, DC: American Psychiatric Association; 2013.

2. Witt AA, Lowe MR. Hedonic hunger and binge eating among women with eating disorders. Int J Eating Disord. 2014;47(3):273-280.

3. Jacobi C, Hayward C, de Zwaan M, et al. Coming to terms with risk factors for eating disorders: application of risk terminology and suggestions for a general taxonomy. Psychol Bull. 2004;130(1):19-65.

4. Jacobi C, Paul T, de Zwaan M, et al. Specificity of self-concept disturbances in eating disorders. Int J Eat Disord. 2004;35(2):204-210.

5. Dunkley DM, Mashib RM, Grilo CM. Childhood maltreatment, depressive symptoms, and body dissatisfaction in patients with binge eating disorder: the mediating role of self-criticism. Int J Eat Disord. 2010;43(3):274-281.

6. Skinner HH, Haines J, Austin SB, Field AE. A prospective study of overeating, binge eating and depressive symptoms among adolescent and young adult women. J Adolesc Health. 2012;50(5):478-483.

7. Vancampfort D, Vanderlinden J, De Hert M, et al. A systematic review on physical therapy interventions for patients with binge eating disorder. Disabil Rehabil. 2013;35
(26):2191-2196.

8. Bulik CM, Sullivan PF, Kendler KS. Medical and psychiatric morbidity in obese women with and without binge eating. Int J Eat Disord. 2002; 32(1):72-78.

9. Wheeler K, Gruner P, Boulton M. Exploring alexithymia, depression and binge eating in self-reported eating disorders in women. Perspect Psych Care. 2005;41(3):114-123.

10. Pike KM, Wilfley D, Hilbert A, et al. Antecedent life events of binge-eating disorder. Psychiatry Res. 2006;142(1):19-29.

11. Pandey S, Pandey S, Maheshware A, Bhattacharya S. The impact of female obesity on the outcome of fertility treatment. J Hum Reprod Sci. 2010;3(2):62-67.

12. Harris AA. Practical advice for caring for women with eating disorders during the perinatal period. J Midwifery Womens Health. 2010;55 (6):579-586.

13. Rieger E, Wilfley DE, Stein RI, et al. Comparison of quality of life in obese individuals with and without binge eating disorders. Int J Eat Disord. 2005;37(3):234-240.

14. Cooper R. Could your patient have an eating disorder? Nurs Womens Health. 2013;17(4):317-324.

15. Gearhardt AN, Corbin WR, Brownell KD. Preliminary validation of the Yale food addiction scale. Appetite. 2009;52(2):430-436.

16. Mehler PS, Anderson AE. Eating Disorders: A Guide to Medical Care and Complications. 2nd ed. Baltimore, MD: John Hopkins University Press; 2010.

17. Stahl SM, Pradko JF, Haight BR, et al. A review of the neuropharmacology of bupropion, a dual norepinephrine and dopamine reuptake inhibitor. Prim Care Companion J Clin Psychiatry. 2004;6(4):159-166.

18. Swanson SA, Crow SJ, Le Grange D, et al. Prevalence and correlates of eating disorders in adolescents: results from the national comorbidity survey replication adolescent supplement. Arch Gen Psychiatry. 2011;68(7):714-723.

19. Hudson J, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007;61(3):348-358.

20. Quilty LC, Kaplan A. Center for Addiction and Mental Health, Toronto, Ontario, Canada. Methylpheni­date versus cognitive behavior therapy in overweight or obese adult females. ClinicalTrials.gov. 2014.

Best practice recommendations for male sexual and reproductive healthcare

Healthcare providers (HCPs) working in the field of women’s sexual and reproductive healthcare (SRH) are accustomed to having a large body of clinical guidelines that establish the standard of care for women. With the advent of a national agenda to improve male SRH, it became critical to identify which services should be provided to which males and when—based on the best evidence available. A new publication from the Male Training Center (MTC) provides evidence-based and expert-informed recommendations for core clinical preventive care services for men of reproductive age.

Preventive Male Sexual and Reproductive Health Care: Recommendations for Clinical Practice, a recent groundbreaking publication by the MTC, presents an expansive rubric under which male SRH services are defined and recommendations for best practice are offered.1 After conducting systematic reviews of the literature and examining current practice guidelines from professional organizations, the MTC developed these recommendations in response to the lack of systematized standards for SRH services for men. The complete recommendations and detailed supporting discussions can be found on the MTC website. This article is a brief summary of the recommended male SRH core services.

Health history

In addition to a customary health history, a comprehensive SRH history includes not only the five P’s (partners, practices, protection from sexually transmitted infections [STIs], past history of STIs, and prevention of pregnancy) but also the development of a reproductive life plan, which helps direct pregnancy preparation and/or identify male fertility concerns. Assessment for gonadal toxins and excessive heat exposure is recommended. Exploration of factors that may compromise sexual function or responsible sexual decision making (e.g., depression; alcohol, drug, or tobacco use) should occur. Probes for difficulty with sexual function (e.g., premature ejaculation, erectile dysfunction [ED]) and intimate partner/sexual violence are suggested as standard practice. Determination of immunization needs is based on risk: HPV vaccination for all males aged 11-26 years; hepatitis B vaccination for males younger than 19 and those with a risk for acquiring the disease from intravenous (IV) drug use or sexual exposure; and hepatitis A vaccination for males with exposure risks.

Physical examination

Core components of the physical exam include height, weight, body mass index, and blood pressure (BP). An external genital exam is recommended to determine that normal adolescent development has occurred, to identify genital problems such as hydrocele and varicocele, to detect signs of an STI, and to serve as part of a male infertility evaluation. During the exam, hair distribution and skin qualities are assessed, and inguinal nodes, the penis, and the scrotal contents are palpated both to confirm presence of the vas deferens and epididymis and to identify common structural anomalies or signs of infection. In males who engage in receptive anal sex, evaluation of the perianal area is recommended. In asymptomatic males, routine screening for testicular cancer and the teaching of testicular self-exam are not recommended. No evidence suggests that these practices result in improved health outcomes; in fact, they are considered potentially harmful. In addition, hernia screening is no longer recommended as part of the routine physical exam unless a clinical indication exists.

Laboratory screening/testing

Chlamydia
At-risk males younger than age 25 should be screened using urine-based nucleic-acid amplification tests (NAATs). Individuals at risk include men who have sex with men (MSM) and those who reside in a community with a high prevalence of chlamydia (e.g., correctional institution, military barracks). All men diagnosed with chlamydia are advised to be re-screened 3 months after treatment to assess for re-infection. Men who have had anal-receptive sex should be screened for rectal infection using an NAAT rectal swab. Screening for pharyngeal infection is not recommended.

Gonorrhea
Routine screening for gonorrhea is not recommended unless men are at risk for this infection by virtue of their being MSM, having multiple sex partners, or having sex associated with illicit drug use. MSM should be screened annually for urethral, anal, and/or pharyngeal infection depending on sites of exposure. MSM with multiple or anonymous partners should be screened every 3-6 months. Men diagnosed with gonorrhea should be re-screened 3 months after treatment to assess for re-infection.

Syphilis
Routine syphilis screening is recommended only among high-risk populations such as MSM, commercial sex workers, males exchanging sex for drugs, and individuals residing in correctional facilities or high-prevalence communities. Screening schedules are based on the degree of risky sexual behavior and may be as frequent as every 3-6 months.

HIV/AIDS
All males aged 13-64 years should be screened for HIV/AIDS, and those considered to be at high risk should be screened at least annually. In addition to engaging in the high-risk sexual behaviors discussed earlier, having sex partners with HIV/AIDS or who use IV drugs greatly increases men’s risk for acquiring HIV/AIDS. The MTC guidelines support the CDC recommendation that HIV/AIDS testing be on an “Opt Out” basis.2

Hepatitis C
One-time testing for hepatitis C is recommended for persons born between 1945 and 1965 because of the high disease prevalence among this population. Men considered at increased risk for hepatitis C because of sexual practices, known exposure, or IV drug use should undergo routine testing based on risk exposure.

Hepatitis B, herpes simplex
Routine screening for hepatitis B and herpes simplex among asymptomatic males is not recommended.

Other tests
In addition to screening for infections, the MTC guidelines recommend screening for diabetes in adult males with sustained BPs >135/80 mm/Hg. The MTC follows the recommendation from the U.S. Preventive Services Task Force to not screen routinely for prostate cancer using a prostate-specific antigen (PSA) test, but it acknowledges the alternative recommendations from the American Urological Association, American Cancer Society, and American College of Preventive Medicine, all of which advise various screening schedules using PSA tests and digital rectal exams based on age or risk factors. Other tests to be excluded from routine screening—based on recommendations from healthcare organizations serving males—include urinalysis and hemoglobin/
hematocrit. Insufficient evidence exists to support routine screening of males for trichomonas or HPV or to support anal cytologic screening.

Sexual and reproductive healthcare counseling

A substantial portion of the MTC recommendations focuses on core elements of SRH counseling. One of the most important core elements entails education about condom use. In particular, the counseling guidelines detail how to teach men to put on and remove condoms, choose the right type of condom, and avoid substances that might destroy the integrity of the latex and result in an increased risk for STI transmission. In addition, recommendations are made for behavioral counseling (through a series of visits) designed to reduce high-risk sex practices. HIV pre-exposure and post-exposure prophylaxis may be considered for individuals at high risk.

Counseling and support strategies for males struggling with sexuality concerns are outlined in the MTC guidelines, and include a sexuality assessment tool and a sample assessment approach. Elements of respect, safety, support, individuality, equity, acceptance, honesty/trust, and communication are explored in this framework. In addition, indications and warning signs of an unhealthy relationship are offered to assist men in identifying and addressing relationship problems.

Counseling regarding pregnancy planning or prevention is another core element of male SRH. A review of all contraceptive methods, for males and for females, should be provided, with attention to safety, efficacy, and correct and consistent use in a patient-centered reproductive life plan. Included in the discussion of contraceptive methods is prevention of STIs and pregnancy. Men who are planning a pregnancy with a partner should undergo pre-conception counseling. This counseling should include discussions about optimizing their partnership (to ensure that all pregnancies are desired) and about enhancing parenting practices (to ensure best outcomes for their children). Strategies to help men achieve optimal fertility should be offered as well.

For men seeking an infertility evaluation, the assessment/counseling process includes a problem-specific history and a physical exam if a pregnancy does not occur within a year of unprotected sexual intercourse—or sooner if the man is known to have bilateral cryptorchidism or suspected infertility potential or if his partner has infertility risks. However, any man, regardless of his present partner, should be able to seek information about his fertility status. Counseling and referral should be available for semen analysis or for medical evaluation if a possible endocrine or urinary disorder is suspected.

Acknowledging that male sexual dysfunction encompasses a common group of disorders that require multidisciplinary care, the MTC recommends specific resources that provide evaluation and treatment guidelines for ED, Peyronie’s disease, priapism, and problems related to libido, orgasm, and ejaculation. Of note, ED can be a sign of early cardiovascular disease (CVD); recommendations for assessment of cardiovascular status are provided along with suggestions for healthy lifestyle interventions that can favorably affect ED as well as CVD.

Conclusion

The MTC’s new document provides a comprehensive resource useful to HCPs who want to provide SRH for men that is evidence based and expert informed. This document provides a foundational framework upon which HCPs can build research to close knowledge gaps and move closer to reproductive healthcare equity for all.

Wendy D. Grube is a Practice Assistant Professor and Director of the Women’s Health Gender-Related Nurse Practitioner Program at the University of Pennsylvania School of Nursing in Philadelphia. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article. She participates on the Men’s Health Technical Panel.

References
1. Marcell AV and the Male Training Center for Family Planning and Reproductive Health. Preventive Male Sexual and Reproductive Health Care: Recommendations for Clinical Practice. Philadelphia, PA: Male Training Center for Family Planning and Reproductive Health and Rockville, MD: Office of Population Affairs; 2014.

2. Centers for Disease Control and Prevention. 2010 STD Treatment Guidelines. Clinical Prevention Guidance. Updated January 28, 2011. www.cdc.gov/std/treatment/2010/
clinical.htm

Depression among women of childbearing age*

More than just feeling sad or down or having the blues, many women like yourself, in your late teens to early 50s, can develop a mental illness called depression. Yes, depression is an illness, not a sign of weakness, and it is treatable. If you think you might have depression, see your healthcare provider (HCP) to find out, and to get the treatment you need.

What is depression?

Many women, including pregnant women and women who have recently given birth, experience depression. Just like other illnesses, depression has symptoms, including:

  • A low or sad mood
  • Loss of interest in fun activities
  • Changes in eating, sleep, and energy
  • Problems in thinking, concentrating, and making decisions
  • Feelings of worthlessness, shame, or guilt
  • Thoughts that life is not worth living

When many of these symptoms occur together and last for more than 1-2 weeks at a time, this is depression. According to a national survey, about 11% of non-pregnant women of childbearing age experienced major depression in the previous year.1

What is postpartum depression?

Postpartum depression is depression that occurs after having a baby. Symptoms of postpartum depression are similar to those of depression, but they also include:

  • Trouble sleeping when your baby sleeps (more than the lack of sleep new moms usually get)
  • Feeling numb or disconnected from your baby
  • Having scary or negative thoughts about the baby, like thinking someone will take your baby away or hurt your baby
  • Worrying that you will hurt the baby
  • Feeling guilty about not being a good mom, or ashamed that you cannot care for your baby

According to the same national survey, 8%-19% of women who gave birth within the past year reported having frequent postpartum depression symptoms.

I just had a baby. Why am I having such a hard time now?

Being a mom is hard! For some women, the journey to becoming a mom is hard too. You may have heard of postpartum depression, but many women don’t know that depression can occur during pregnancy (it’s called perinatal depression) or with other events, such as losing a baby or having trouble getting pregnant. According to the same national survey mentioned above, about 8% of women who were pregnant during the past year experienced depression during their pregnancy.1

Did you know that the following experiences may put some women, including you, at higher risk for depression than others?

  • Having a hard time getting pregnant: Depression affects many women who experience infertility.
  • Having twins or triplets: Mothers of multiples, compared with women who give birth to just one baby, have a greater risk of developing depression.
  • Losing a baby: Women who experience miscarriage (losing a baby early in pregnancy), stillbirth (losing a baby late in pregnancy), or death of a newborn are more likely to experience depression.
  • Having a baby as a teen: Teen moms are more likely than older moms to have postpartum depression.
  • Having premature labor and delivery: These mothers have a significantly higher risk for depression.
  • Having a baby who is different: A mother’s risk for depression increases if the baby has a birth defect or disability.
  • Pregnancy and birth complications: Some studies have shown an increased risk for depression among women who experienced complications and hospitalization during pregnancy or an emergency C-section.
  • Having a baby who is sick or in the hospital: Women with sick or hospitalized babies may be at increased risk for depression, as well as stress and anxiety.
  • Having a healthy pregnancy and childbirth: Women having a difficult pregnancy or childbirth are not the only ones who experience depression. Depression can also occur among women with a healthy pregnancy and healthy birth.

That sounds like me. But how do I know if what I’m experiencing is depression? What should I do?

Depression is common. If you are worried about the way you have been feeling, you need to tell your HCP about your concerns. Answering these questions may help you determine whether what you are experiencing is depression. During the past 2 weeks, how often have you felt…

Little interest or pleasure in doing things?
Not at all
Several days
More than half the days
Nearly every day
Down, depressed, or hopeless?
Not at all
Several days
More than half the days
Nearly every day

If you answered “more than half the days” or “nearly every day” to either question, you may be depressed and should seek help from an HCP. Your HCP can help figure out whether you have depression or not, and she or he can help find the best treatment for you.

If I don’t do anything about my depression, will it eventually go away on its own?

The depression may eventually go away without help. It could also get worse instead of better. There are effective treatments for depression that may include medication or talking with a trained therapist. The best way to deal with depression is to see an HCP or a counselor. The earlier you seek help, the better you may do.

References
1. Ko JY, Farr SL, Dietz PM, Robbins CL. Depression and treatment among U.S. pregnant and nonpregnant women of reproductive age, 2005-2009. J Womens Health (Larchmt). 2012;21(8):830-836.

2. Davé S, Petersen I, Sherr L, Nazareth I. Incidence of maternal and paternal depression in primary care: a cohort study using a primary care database. Arch Pediatr Adolesc Med. 2010;164(11):1038-1044.

Content source: Centers for Disease Control and Prevention, Division of Reproductive Health, National Center for Chronic Disease Prevention, and Health Promotion. http://www.cdc.gov/reproductivehealth/Depression/

*Readers are invited to photocopy Patient education pages in the journal and distribute them to their patients.

Women’s health: More than an annual event*

As I write this column in mid-May, we are  week past Mother’s Day, and Women’s Health Week has just ended. During the 5th month of the year, healthcare providers (HCPs) and healthcare consumers are bombarded with messaging focused on the importance of women’s health. But then these messages go virtually silent until October—Breast Cancer Awareness Month. During the 10th month of the year, media attention will be drawn to breast cancer, the most frequently diagnosed cancer among women. By the end of October, the women’s health voice will once again be stilled until new messaging emerges during February, designated as American Heart Month, when we are encouraged to wear red to symbolize our solidarity in the fight against cardiovascular disease, the No. 1 cause of premature death among women. And so it goes.

On an individual level, as each woman makes her yearly appointment to see her HCP, she also tends to think of her health as an “annual event.” Most women perceive of this annual visit as the time to be screened for breast and cervical cancers and to address their family planning needs, menopausal symptoms, and/or other gynecologic health problems and concerns. But for HCPs who care for female patients, as well as for the patients themselves, women’s health is more than just an annual event.

Reproductive and maternal–child health

National and global statistics underscore the importance of women’s health status in affecting birth outcomes. The United States ranks 31st out of 178 countries on Save the Children’s Mothers’ Index.1 This ranking is based on a composite of five indicators related to maternal well-being: risk of maternal death, under 5-mortality rate (the probability per 1,000 live births that a newborn will die before reaching his or her 5th birthday), expected number of years of formal schooling, gross national income per capita, and women’s participation in national government.

Although the U.S. has placed in the top 10 on the Mothers’ Index as recently as 2006, next to Cyprus, our country has fallen farthest from the top. Of the 30 countries now ahead of the U.S. on this index, all but the Republic of Korea have a higher percentage of seats held by women in national government. When women have a voice in policy, issues important to women and children are more likely to emerge as national priorities.1 Worldwide, prematurity is the leading cause of newborn death (birth to 4 weeks) and the second leading cause of death in children younger than 5 years. The U.S. ranks 37th of 165 countries in the number of deaths due to prematurity, placing 6th among the top 10 countries responsible for 60% of the world’s premature births.1,2

The burden of perinatal morbidity and mortality extends to mothers as well. Since 1990, maternal mortality in this country has nearly doubled. Of approximately 4 million U.S. women each year who give birth, about 52,000 experience severe complications and 500-600 die of these complications. Of these maternal deaths, approximately one-half are preventable. Leading causes of these maternal deaths include thromboemboli, obstetric hemorrhage, and severe hypertension or preeclampsia.3,4

Of the 6.6 million pregnancies that occur in the U.S. each year, 3.4 million (51%) are unintended, occurring disproportionately in non-Hispanic black women, unmarried women, and women with less education and financial stability.5,6 Intendedness of pregnancy and birth spacing of approximately 2 years are linked to improved pregnancy outcomes. Care before, during, and between pregnancies—including reproductive life planning, optimization of nutrition and exercise, folic acid supplementation, screening for and management of chronic diseases, immunizations, management of infectious diseases, and attention to psychological and behavioral health—contributes to more favorable maternal and child outcomes.2

Sexual/gynecologic health

Sexually transmitted infections (STIs), when untreated, can increase the risk for contracting other STIs, including HIV infection, and lead to other reproductive health problems such as cervical cancer and infertility. STI rates are highest among individuals younger than 25 years, with more than 70% of gonorrhea and chlamydia cases occurring in women in this age group. Gynecologic problems are among the most common health-related complaints for reproductive-aged women. Of the top 10 sites of cancer occurrence in the U.S. population, 3 are woman specific. Lung and bronchial cancers are the leading cause of cancer death among women aged 34-85 years, but breast cancer is more commonly diagnosed and ranks as the second leading cause of cancer death. Recommended screenings can help detect infections that compromise reproductive health, as well as breast, cervical, colorectal, and other cancers, at earlier, more treatable stages.7

Women’s health across the lifespan

Both male and female life expectancies have increased over the years, with women now living approximately 4.8 years longer than men. However, female mortality rates have increased in more than 40% of U.S. counties, as compared with an increase in male mortality in only 3.4% of U.S. counties.7 Although women’s longevity outpaces that of men in all age groups, the most impoverished 40% of women, relative to the previous generation of women, are seeing life expectancy decline.8

While women live longer than men, they are not necessarily healthier.9Women are more likely than men to report activity limitations, with 70% of women older than 65 years reporting such limitations. The most commonly reported causes of activity limitations include back and neck problems, arthritis, depression, anxiety or emotional health problems, bone injuries, and weight problems. Overall, heart disease, cancer, and stroke are the leading causes of death in women, followed by chronic lower respiratory disease and Alzheimer’s disease. Overweight and obesity are key contributors to increased risk for chronic disease, including hypertension, type 2 diabetes mellitus, cardiovascular disease, liver disease, arthritis, cancer, and reproductive health disorders. In addition to chronic disease, women experience higher rates of mental illness than do men,10 with suicide recognized as one of the top 10 causes of death in women aged 18-64 years. Physical, behavioral, and mental health problems affecting women require recognition of gender-related differences in symptoms, diagnostic considerations, and treatment decisions.

More than one-third of women have experienced physical violence at the hands of an intimate partner, and 20% of homicides are directly related to intimate partner violence (IPV). IPV, the most common cause of violence-related deaths among 40- to 44-year-olds, is associated with long-term effects on physical, emotional, and sexual health.11 Despite increased attention on the effects of violence against women in their homes, their communities, within the military, and on college campuses, effective screening for such violence remains uneven in healthcare settings. Major HCP organizations, including the National Association of Nurse Practitioners in Women’s Health (NPWH), support universal screening for IPV and other forms of violence against women.

Importance of the well-woman visit

Although the snapshot of women’s health presented in this column may be somewhat disturbing, we can take this opportunity to sharpen our focus and improve the picture now. The well-woman visit (WWV) is designed to make a difference by helping patients identify their personal health risks, access healthcare appropriate to their own needs, and receive support in achieving their goal to be as healthy as possible. The WWV gives women a chance to partner with their HCP in order to do the following:

Access recommended health screenings and assessments;

Recognize and address emerging personal and/or family risk factors that may have direct impact on their present and future health status;

Attend to physical, emotional, behavioral, and environmental factors that affect health and well-being; and

Identify personal health goals and the strategies to achieve these goals.

These key components of the WWV directly address the many factors affecting women’s reproductive, gynecologic, and sexual health; maternal–child health outcomes; and overall health status from menarche through older adulthood. Under the Affordable Care Act, basic women’s preventive healthcare is covered with no cost-sharing (e.g., copayments, co-insurance, deductible costs) to the woman. The well-woman preventive care visit is defined as occurring “annually for adult women to obtain the recommended preventive services that are age and developmentally appropriate, including preconception and prenatal care….”12 In general, the WWV occurs once a year, although the U.S. Department of Health and Human Services recognizes that, depending on a woman’s health status, health needs, and other risk factors, several visits may be needed within a year to obtain all necessary recommended preventive services.12 The Table lists examples of the types of services that are available as part of the WWV without co-pays, co-insurance, or deductible costs to the woman.12,13

Conclusion

A woman’s physical and emotional health is influenced by biologic, psychosocial, behavioral, and environmental factors. In addition, the impact of gender differences on the manifestations of chronic disease and mental illness cannot be overlooked. Although events such as Mother’s Day, Women’s Health Week, Breast Cancer Awareness Month, American Heart Month, and other awareness campaigns serve to remind us of the importance of attention to women’s health, they cannot be the sole driver of our focus. Like the components of the WWV, women’s health is addressed and improved in a variety of steps, over time. In order to improve women’s health, regardless of life stage, women’s issues must be a key consideration in every policy decision—education, economics, and, of course, healthcare. In crafting policy related specifically to women’s health issues, one must consider how such policies…

Affect the overall health status of women;

Affect women’s access to and acquisition of high-quality primary and specialty healthcare through the life span—care that is delivered by women’s health-focused HCPs within the context of their patients’ personal, religious, cultural, and family beliefs14; and

Leverage the expertise of multiple types of gender-focused HCPs, including OB/GYN physicians, women’s health nurse practitioners, certified nurse-midwives and certified midwives, women’s health and perinatal clinical nurse specialists, and other HCPs working in women’s health by convening more comprehensive task forces, commissions, and other panels assembled to inform policy. =

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis, a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri, and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at sue@healthpolicyadvantage.com.

References

  1. Save the Children. State of the World’s Mothers 2014. Westport, CT: Save the Children; 2014.

2. Partnership for Maternal, Newborn & Child Health. Born Too Soon: The Global Action Report on Preterm Birth. Geneva, Switzerland: World Health Organization; 2012.

3. UNFPA. Trends in Maternal Mortality:1990-2010. Geneva, Switzerland: WHO; 2012.

4. The National Maternal Health Initiative. The Burden of Maternal Mortality and Morbidity in the United States.

Rockville, MD: HRSA Maternal Child Health Bureau; 2014.

5. Mosher WD, Jones J, Abma JC. Intended and unintended births in the United States: 1982-2010. Natl Health Stat Rep. 2013;24(55):1-28.

6. Guttmacher Institute. Unintended Pregnancy in the United States. December 2013. www.guttmacher.org/pubs/FB-Unintended-Pregnancy-US.html

7. U.S. Department of Health and Human Services. Health Resources and Services Administration. HRSA Maternal Child Health Bureau. Women’s Health USA 2013. http://mchb.hrsa.gov/whusa13/dl/pdf/hs.pdf

8. Bosworth BP, Burke K. Differential Mortality and Retirement Benefits in the Health and Retirement Study. April 8, 2014. www.brookings.edu/research/papers/2014/04/differential-mortality-retirement-benefits-bosworth

9. Kaiser Family Foundation. The role of Medicaid and Medicare in women’s health care. JAMA. 2013;309(19):1984. http://jama.jamanetwork.com/article.aspx?articleid=1687586

10. Substance Abuse and Mental Health Services Administration. Results From the 2010 Survey on Drug Use and Health: Mental Health Findings. 2011. www.samhsa.gov/data/NSDUH/2k10NSDUH/2k10Results.htm

11. Office of the Assistant Secretary for Planning and Evaluation. Screening for Domestic Violence in Health Care Settings. Washington, DC: USDHSS; 2013.

12. U.S. Department of Health and Human Services. Health Resources and Services Administration. Women’s Preventive Services Guidelines. www.hrsa.gov/womensguidelines/

13. Institute of Medicine. Clinical Services for Women: Closing the Gaps. Washington, DC: National Academies Press; 2011.

14. National Association of Nurse Practitioners in Women’s Health (NPWH). Mission Statement. 2014. www.npwh.org/i4a/pages/index.cfm?pageid=3333

 

Human papillomavirus (HPV)*

As parents, you do everything you can to protect your children’s health for now and for the future. Today, there is strong weapon to prevent several types of cancer in our kids: the HPV vaccine.

HPV and cancer

HPV is short for human papillomavirus, a common virus. In the United States each year, there are about 17,000 women and 9,000 men affected by HPV-related cancers. Many of these cancers could be prevented with vaccination. In both women and men, HPV can cause anal cancer and mouth/ throat (oropharyngeal) cancer. It can also cause cancers of the cervix, vulva, and vagina in women; and cancer of the penis in men.

For women, screening is available to detect most cases of cervical cancer with a Pap smear. Unfortunately, there is no routine screening for other HPV-related cancers for women or men, and these cancers can cause pain, suffering, or even death. That is why a vaccine that prevents most of these types of cancers is so important.

More about HPV

HPV is a virus passed from one person to another during skin-to-skin sexual contact, including vaginal, oral, and anal sex. HPV is most common in people in their late teens and early 20s. Almost all sexually active people will get HPV at some time in their lives, though most will never even know it. Most of the time, the body naturally fights off HPV, before HPV causes any health problems. But in some cases, the body does not fight off HPV, and HPV can cause health problems, like cancer and genital warts. Genital warts are not a life-threatening disease, but they can cause emotional stress, and their treatment can be very uncomfortable. About 1 in 100 sexually active adults in the United States has genital warts at any given time.

HPV vaccination is recommended for pre-teen girls and boys at age 11 or 12 years

HPV vaccine is also recommended for girls aged 13 through 26 years and for boys aged 13 through 21 years who have not yet been vaccinated. So if your son or daughter hasn’t started or finished the HPV vaccine series—it’s not too late! Talk to his or her healthcare provider (HCP) about getting the series for your child now. Two vaccines—Cervarix and Gardasil—are available to prevent the HPV types that cause most cervical cancers and anal cancers. One of the HPV vaccines, Gardasil, also prevents vulvar and vaginal cancers in women and genital warts in both women and men. Only Gardasil has been tested and licensed for use in males. Both vaccines are given in a series of 3 shots over 6 months. The best way to remember to get your child all three shots is to make an appointment for the second and third shot before you leave the HCP’s office after the first shot.

Is the HPV vaccine safe?

Yes. Both HPV vaccines were studied in tens of thousands of people around the world. More than 57 million doses have been distributed to date, and there have been no serious safety concerns. Vaccine safety continues to be monitored by the CDC and the FDA. These studies continue to show that HPV vaccines are safe.

The most common side effects reported are mild. They include pain where the shot was given (usually the arm), fever, dizziness, and nausea.

You may have heard that some kids faint when they get vaccinated. Fainting is common with preteens and teens for many health-related procedures, not just the HPV shot. Be sure that your child eats something before going to get the vaccine. It’s a good idea to have your child sit or lie  down while getting any vaccine, and for 15 minutes afterwards, to prevent fainting and any injuries that could happen from fainting.

The HPV vaccine can safely be given at the same time as the other recommended vaccines, including the Tdap, meningococcal, and influenza vaccines. Learn more about all of the recommended pre-teen vaccines at www.cdc.gov/vaccines/teens.

Help paying for vaccines

The Vaccines for Children (VFC) program provides vaccines for children aged 18 years or younger who  are under-insured, not insured, Medicaid-eligible, or American Indian/Alaska Native. Learn more about the VFC program at www.cdc.gov/Features/VFCprogram/.

Whether you have insurance, or your child is VFC-eligible, some HCPs’ offices may also charge a fee to give the vaccines.

For more information about the vaccinesrecommended for pre-teens and teens:800-CDC-INFO (800-232-4636) http://www.cdc.gov/vaccines/teens

 

Assessment and management of patients with obesity

Obesity is a disease, not a condition resulting from ill-advised behavioral choices. 1 After all, obesity meets the essential criteria of a disease: It has characteristic signs or symptoms; it manifests as an impairment in the normal functioning of some aspect of the body; and it results in harm or morbidity. As such, healthcare providers (HCPs) need to identify obesity in their patients, assess each patient’s risk for obesity-related complications, begin the weight-loss discussion in a thoughtful and constructive manner, and institute an individualized management plan.

Definitions and prevalence

Obesity can be defined as a body mass index (BMI) ?30 kg/m2 or it can be suggested by a waist circumference (WC) >35 inches (in women).2 But obesity is more than just a calculation or a measurement; it is a primary disease entity that can lead to cardiometabolic, biomechanical, and other complications (Figure 1).3,4CNER_Figure 1

 

 

 

 

 

 

 

 

 

 

 

 

Here is a number that matters: Almost 80 million U.S. adults—almost 35% of the adult population in this country—meet criteria for obesity,5 with certain geographic areas and certain ethnic groups overrepresented. Prevalence of obesity is higher in southern states and some Midwestern states than in other parts of the country,6 as illustrated by this CDC map. Non-Hispanic blacks have the highest age-adjusted rate of obesity (47.8%), followed by Hispanics (42.5%), non-Hispanic whites (32.6%), and non-Hispanic Asians (10.8%).5 Although overall obesity prevalence is similar in women and men at any given age, women have a higher prevalence of class II obesity (BMI, 35.0-39.9) and class III obesity (BMI ?40).7

Risk assessment

Given the high prevalence of obesity, HCPs will likely encounter many patients in their practices who are candidates for weight management. In each case in which obesity is identified, the first step needed is to assess the patient’s risk for obesity-related complications. This assessment includes calculating BMI, measuring WC, and screening for the presence of cardiovascular disease (CVD) risk factors and co-morbidities.8 Compared with body weight alone, BMI is a better, albeit indirect, measure of adiposity, which is associated with a host of cardiometabolic abnormalities. WC, an indicator of abdominal adiposity, should be measured in patients with a BMI ?35 (the WC cutoff of >35 inches in women adds little predictive value in those with a BMI >35), including those who are overweight (BMI, 25-29.9). Women whose WC exceeds 35 inches are at increased risk for developing hypertension (HTN), type 2 diabetes mellitus (T2DM), and CVD.

Therefore, HCPs need to check patients’ blood pressure (BP) to assess for HTN and order a fasting blood glucose (FBG) test, and even a 2-hour oral glucose tolerance test and HbA1c in high-risk individuals, to assess for T2DM and pre-diabetes.9 The metabolic syndrome, which increases risk for T2DM, CVD, and stroke, is identified in women by the presence of at least three of these five risk factors: WC >35 inches, triglycerides ?150 mg/dL, high-density lipo­protein cholesterol (HDL-C) <50 mg/dL, BP ?130/85 mm Hg, and FBG ?100 mg/dL.10

Some obesity-associated diseases and risk factors place patients in a very-high-risk category for subsequent mortality.8 Patients with obesity and co-morbid coronary heart disease (CHD), other atherosclerotic diseases, T2DM, metabolic syndrome, pre-diabetes, or sleep apnea require aggressive modification of risk factors in addition to clinical management of the co-morbid disease. Furthermore, obesity has an aggravating effect on CVD risk factors such as cigarette smoking, HTN, high concentration of low-density lipoprotein cholesterol, low concentration of HDL-C, impaired FBG, family history of premature CHD, and age ?55 years (in women). HCPs need to identify these risk factors to determine the intensity of the clinical intervention that a patient requires.
Obesity takes a toll not just in terms of its effect on CVD risk, but also on cancer risk. The Cancer Research UK study showed that women with obesity had a 25% risk of developing a weight-related cancer—including cancer
of the bowel, gallbladder, uterus, kidney, pancreas, or esophagus, as well as post-menopausal breast cancer—in their lifetime.11 Cancer risk in these women was 40% higher than that in their slimmer counterparts.

Initiating the conversation

Either a patient or an HCP can initiate the conversation regarding the need to lose weight. The situation is generally easier to handle when a patient expresses a desire to lose weight. She has already acknowledged existence of the disease—that is, the obesity—and is seeking treatment for it on her own. However, in many cases, the HCP must broach the topic, usually after a patient has come in for a routine visit and the findings from her history, physical examination, and laboratory tests indicate that steps must be taken to lower her risk for experiencing obesity-related complications—or to treat the complications that already exist.

To avoid discomfiting a patient in this situation, a panel of nurse practitioners convened by the American Nurse Practitioner Foundation (ANPF) recommends that the HCP show her objective data reflecting her disease and her risk for future complications—with an emphasis that obesity is a health problem—and then assess her motivation and readiness for change.7 In this context, the HCP and the patient need to synchronize their expectations and goals for weight loss therapy. HCPs now have reliable tools to help patients lose 5%-10% of their body weight. This weight loss may not produce the desired cosmetic outcome but will no doubt result in clinical benefits. The emphasis is on improving the health of the patient.

To inspire a patient with obesity to want to lose weight and to commit to follow a weight-loss treatment plan, the HCP can help her identify at least one compelling reason to lose weight.7 Common patient-centered reasons include (1) decreasing the risk of having a complicated pregnancy; (2) being able to play with children or grandchildren; (3) walking without becoming short of breath; (4) preventing other chronic diseases such as T2DM; and (5) improving existing weight-related complications such as sleep apnea or T2DM. Of note, some patients may not be aware of the health risks posed by obesity and will be motivated to lose weight once educated about the risks.

Approach to management

Once a patient with obesity is motivated and ready to lose weight, the HCP needs to work with her to devise a management plan. Both of them should agree on the goals of weight-loss therapy and on the purpose of long-term therapy. A realistic initial goal for many patients is a loss of 5% of body weight in 3 months. Three major management options—lifestyle modification, pharmacotherapy, and bariatric surgery—can bring about weight loss and reduce obesity-related morbidity and mortality.1 This article focuses on the first two options.

Lifestyle modification

A comprehensive weight-loss program starts with lifestyle modification comprised of dietary changes, increased activity, and behavioral control.12

Dietary changes

With regard to energy intake, the ANPF recommends a reduction of 500-1,000 kcal/day, which can be accomplished by limiting portion size, reducing fat and sugar intake, and using commercial weight-loss meal replacements.7 The patient can follow one of many diets shown to be safe and effective; examples are a low-carbohydrate diet,13 a low-fat diet,14 a Mediterranean diet,15 a low-glycemic-load diet,16 and a portion-controlled diet.17

Practical dietary tips include avoiding skipping meals and consuming small meals and between-meal snacks every 3-4 hours. With regard to food intake, moderation is the watchword. With regard to fluid intake, however, drinking eight 8-oz glasses of water a day is crucial unless contraindicated (e.g., in patients with renal failure).

Choice of a particular diet is less important than making a commitment and adhering to the diet,18 although following a regimen tailored for a co-morbidity makes sense. Because compliance is the key to success, the diet plan should accommodate the patient’s personal and cultural preferences. Regardless of the diet chosen, patients should monitor their caloric intake via a food diary and weigh themselves at least once a week.19

Increased activity

Choice of a particular activity (e.g., walking, swimming) depends on a patient’s preference and access to, say, a pool, as well as her current weight and health status. An assessment of mobility, cardiovascular (CV) status, and perhaps pulmonary function is needed before a patient embarks on a new exercise program.20 The goal is to increase energy expenditure.20 Exercising for ?150 minutes/week can lead to modest weight loss and help prevent weight regain; doubling this amount will promote more robust weight loss.21 As with food intake, patients should record their daily physical activity.

Exercise not only facilitates weight loss but also improves CV health by reducing BP, lipid levels, and visceral fat. These reductions are linked to improved glucose tolerance and insulin sensitivity in persons without diabetes and improved glycemic control in patients with T2DM.12 Enhanced physical fitness may even lessen obesity-related mortality. Of note, patients with obesity must modify their diet and increase physical activity in order to lose weight and reduce their risk for obesity-related complications. Another note: In addition to traditional exercise, patients can aim to increase energy expenditure throughout the day by reducing sedentary behaviors. For example, car owners can park twice as far from store entrances as they used to; city dwellers can walk instead of taking a bus, subway, or taxi; and office workers can use a standing desk instead of sitting at their desk.

Behavioral therapy

As applied to weight loss, behavioral therapy entails techniques for helping patients replace habits that contribute to excess weight and poor health with those that promote weight loss and good health.12 Key components of behavioral therapy include frequent encounters with HCPs, education, stimulus control, cognitive restructuring, goal-setting, self-monitoring, and social support.20 Group weight-loss programs in community settings, commercial weight-loss programs, and programs delivered by telephone, the Internet, or text message can all be effective, depending on patient preference.12

Pharmacotherapy

If a patient has not lost about 5% of her body weight after 3 months, or if she has lost weight but regained some, most, or all of it over time, she and her HCP should consider use of weight-loss medication as an adjunct to lifestyle modification. In some patients with severe complications who require clinically meaningful weight loss quickly, lifestyle modification and pharmacotherapy can be initiated concomitantly.

Rationale

In all human beings, calorie restriction triggers various biological adaptations designed to prevent starvation.22 These adaptations may even be potent enough to reverse the initial weight-loss success achieved with lifestyle modification. In persons with obesity, additional biological adaptations function to preserve, or even increase, their highest sustained lifetime body weight. As such, more biologically-based interventions are likely to be needed to counter the compensatory adaptations that maintain a person’s highest lifetime body weight.22 Other reasons for pharmacologic intervention in facilitating weight loss include the following:

  • Appetite-suppressing medication enhances a patient’s ability to adhere to a reduced-calorie diet.
  • Addition of a weight-loss medication consistently achieves greater weight loss, and for a longer duration of time, than that achieved by the lifestyle intervention alone.
  • Medication can help achieve the degree of weight loss needed to treat obesity-related complications.
  • The American Association of Clinical Endocrinologists (AACE), the American Society of Bariatric Physicians (ASBP), the American Heart Association (AHA), the American College of Cardiology (ACC), and The Obesity Society (TOS) all recommend use of medication for patients with obesity and sufficient health risk.20,23,24

Principles for use

The FDA indication for use of weight-loss medications is a BMI ?30 or a BMI of 27-29.9 with at least one obesity-related complication. The medication should be stopped if weight loss is <5% after 12 weeks on a maximal dosage. If one agent is ineffective or poorly tolerated, a different one can be tried. All of these agents are contraindicated for use during pregnancy. Pharmacotherapy is individually tailored to each patient’s needs. More data are needed regarding the safety of combination therapy and the use of medications beyond 2 years.

Options

Table 1 lists FDA-approved options for treating obesity.25-31Table 2. Weight-loss medications: Clinical trial information, accessible through this link, shows the results of clinical trials demonstrating the efficacy of these agents.32-39Figure 2 illustrates the comparative efficacy of these weight-loss medications.32-36,38-45
CNe_Table 1

 

CNE Figure 2

Guidelines for practice

The spectrum of obesity treatment guidelines ranges from those that are BMI-centric, wherein treatment indication is based on BMI and the treatment goal is to lose a given amount of weight (e.g., 5%-10%), to those that are complications-centric, wherein treatment indication is based on risk for, presence of, and severity of obesity-related complications and the treatment goal is to treat or prevent the complications.46Obesity treatment guide­lines from the National Heart, Lung, and Blood Institute (NHLBI), at one end of the spectrum, are based primarily on BMI and WC, although risk factors and co-morbidities are taken into account.8 The AACE, at the other end of the spectrum, recommends (1) evaluating patients with obesity for cardiometabolic and biomechanical complications; (2) selecting (a) therapeutic targets for improvements in complications, (b) treatment modality, and (c) treatment intensity; and (3) intensifying lifestyle and/or pharmacologic and/or surgical treatment modalities for greater weight loss if therapeutic targets for improvements in complications are not met.23Table 3 lists percentages of weight loss needed to achieve therapeutic benefits with regard to various obesity-related complications.4CNE_Table3

 

The AHA/ACC/TOS obesity guideline, which is closer to that of the NHLBI, recommends (1) identifying patients who need to lose weight, based on BMI and WC; (2) informing patients with CVD risk factors that lifestyle changes that produce even modest sustained weight loss of 3%-5% can result in clinically meaningful health benefits, and that greater weight loss produces greater benefits; (3) devising dietary strategies for weight loss; (4) devising a comprehensive lifestyle program that helps patients adhere to a lower-calorie diet and increase physical activity through use of behavioral strategies; and (5) selecting patients for whom bariatric surgery is advised—that is, those with a BMI ?40 or a BMI ?35 with obesity-related conditions.24 The approach of the ASBP to obesity management, which is closer to that of the AACE, focuses on treating diseases related to increased body fat and its adverse metabolic and biomechanical consequences, which may improve patient health, quality of life, body weight, and body composition.20

Conclusion

Obesity is a disease that requires permanent lifestyle changes. Lifestyle modification, enabled by dietary changes, increased physical activity, and behavioral therapy, is implemented first. If a patient does not reach her goals in terms of reducing her weight and her risk for obesity-related complications, medication is added. Most medications suppress appetite, enhance a patient’s ability to follow a reduced-calorie diet, and enable significantly greater weight loss than that achieved by lifestyle changes alone. In addition, medication use can help sustain weight loss and prevent weight regain over time.

For patients with obesity and obesity-related co-morbidities, weight loss is used therapeutically to treat the obesity-related complications. The role of the HCP is to diagnose the disease of obesity, assess the patient’s risk for obesity-related complications, discuss weight-loss strategies and goals with the patient, support the patient in implementing these strategies and reaching these goals, and provide regular follow-up and encouragement over the ensuing months, years, and decades.

For readers of the online issue who wish to participate in this CE program, click here.

Visit http://www.NPWomensHealthcare.com/?p=4144 for a complete list of references.

 

Assessment, diagnosis, and management of headache

Healthcare providers caring for women can use advanced clinical skills in assessment and accurate diagnosis of headaches. Accurate diagnosis is imperative in providing effective management and making appropriate referrals. The overall goal is to make the correct diagnosis, adequately treat the headaches, and minimize the frequency and severity of headaches in the future.

About 45 million individuals in the United States complain of headaches to their healthcare provider (HCP), accounting for nearly 8 million clinical visits per year.1 The female preponderance of headaches emerges at puberty, with females, relative to males, having a 1.5-fold greater risk of headaches and 1.7- fold greater risk of migraine.2 The most common primary headaches are migraine, tension, cluster, and chronic daily headache.3 Secondary headaches are symptoms of diseases or conditions that can be relatively minor (e.g., sinusitis) or quite serious or even life threatening (e.g., meningitis, brain tumor, cerebral aneurysm, head trauma).3  HCPs must use keen skills to evaluate each woman’s symptoms, formulate a diagnosis, and devise a management plan.

Assessment

Health history

A complete history is key in making the diagnosis. Although symptoms of various types of headache may overlap, a detailed history helps the HCP determine whether a secondary cause needs to be further investigated or if the symptoms fit with one of the primary headache types. The HCP needs to ask the patient about the following3-5:

onset, location, frequency, duration, severity, and character (e.g., throbbing versus constant) of the headache(s);

existence of any aura or prodrome;

any association between the headaches and sleep patterns, emotional factors, or food or alcohol intake;

any associated symptoms with the headache;

precipitating and alleviating factors;

a family history of headache;

any changes in vision;

any history of trauma;

any relationship between the headaches and the menstrual cycle or a change in the method of birth control;

use of illicit drugs including cocaine and methamphetamine; and

current medications, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, and glucocorticoids.

Answers to these questions will enable the HCP to  rule out certain types of headaches.3-5

Red flags in the history require that further evaluation be done for secondary causes. Sudden onset of a severe, intractable headache may suggest an intracranial disorder such as subarachnoid hemorrhage or meningitis.3 Severe headache triggered by sexual intercourse, cough, or exertion may be caused by an intracranial mass or subarachnoid hemorrhage.5 New onset of headaches in persons older than 50, new onset of severe headaches during pregnancy or postpartum, or new headache types in patients with cancer or immunosuppression are of particular concern.3,5  Any headache described as the “worst headache ever” requires immediate attention.

Physical examination

Physical examination of a patient presenting with a chief complaint of headache includes a general survey, vital signs, focused assessment of the head and neck, and a full neurologic exam.5-7 The focused exam begins in a systematic manner starting with the scalp, which is assessed for swelling and tenderness. The temporal arteries are palpated. Nodularity, tenderness, and a diminished or absent pulse on one side are considered abnormal findings consistent with temporal arteritis.5,7,8

Next, the HCP assesses the temporomandibular joint for tenderness or crepitance, 6,7 the eyes for lacrimation and conjunctival injection, and the periorbital area for eyelid swelling, ptosis, or miosis.5,6,9 Visual acuity, extra-ocular movements, visual fields, and pupillary size and response to light are checked for abnormalities and fundi are assessed with an ophthalmoscope for presence of spontaneous venous pulsations and/or papilledema.5-7The nares are assessed for purulence, the sinuses palpated for tenderness, and the oropharynx examined for presence of purulence, erythema, and swelling.10 Assessment includes percussion of dentition for presence of tenderness.6 The HCP examines the patient’s neck utilizing flexion (unless contraindicated) to assess for discomfort and/or stiffness,6 and listens for bruits in the neck, which may suggest arteriovenous malformation. 3The cervical spine is palpated to assess for tenderness.6

Red flags in the physical examination include, but are not limited to, fever, weight loss, altered mental status, weakness, papilledema, focal neurologic deficits, proximal artery tenderness, and meningismus. 6 All pertinent negative and positive physical exam findings, along with history findings, help the HCP further differentiate between primary and secondary headaches.

Diagnosis and treatment

Because of overlapping symptomatology among the different headache types, the diagnosis of a particular headache type can be challenging. In addition, the HCP must discern between a primary headache, which, although painful, is usually not harmful, and a secondary headache such as subarachnoid hemorrhage or transient ischemic attack, which could lead to a stroke.1

Migraine

Migraines present as severe, disabling, unilateral headaches often described as pulsating in nature. 11 Symptoms may worsen with routine physical activity. Sensitivity to light, sound, and smells is often present, as are nausea and stiff neck.11 Some migraineurs describe having prodromal symptoms (e.g., drowsiness, restlessness, decreased concentration, gastrointestinal upset) that may last for hours to days before the migraine.7 Twenty percent to 30% of migraineurs experience an aura. Aura consists of fully reversible visual, sensory, or speech disturbances that develop gradually before the headache and that last no longer than 60 minutes.7,11 Despite all these symptoms, neurologic examination findings in patients with migraine headache are negative or normal.

Migraines are 2-3 times more common in women than in men and vary in severity. 11 In females, prevalence of migraines diminishes after age 50 or after menopause unless estrogen replacement therapy is used.11

Treatment for migraine is either abortive, halting an existing headache, or preventive, lessening the frequency and severity of the headaches. First-line abortive therapy for mild to moderate, non-disabling migraine includes simple analgesics, combination analgesics, and NSAIDs.7,12 Metoclopramide may be added for nausea relief and may promote absorption of oral pain medications. 7Abortive therapy for moderate to severe headaches and those not relieved by analgesics may include drugs that affect serotonin, including the triptans (oral, intranasal, subcutaneous), combination triptan/NSAIDs, ergotamine tartrate, dihydroergotamine, and acetaminophen-isometheptene- dichlor alphen a zone.7, 12,13 A weak opioid analgesic such as a butalbital compound or acetaminophen- codeine may be tried if the aforementioned agents are ineffective.12,13

Prevention includes elimination or reduction of identified triggers (e.g., aged cheeses, red wine, monosodium glutamate, artificial sweeteners, caffeine overuse or withdrawal, too much or too little sleep).7 Pharmacologic prophylaxis is considered when migraineurs have more than one headache per week. 7,12,13 Drug classes that have proved useful in preventive therapy include beta blockers, calcium channel blockers (CCBs), antidepressants, anti-seizure medications, and some antihistamines.7,12,13

Cluster headache

Cluster headaches usually occur at night and are severe and unilateral.14 Although cluster headaches have been found to be 6 times more prevalent in males than in females, more and more women—typically between ages 20 and 40—are being diagnosed with this condition. 14,15 Cluster headaches are frequently misdiagnosed as migraine, sinusitis, or allergies. 5 The patient may describe sharp, unilateral orbital, supraorbital, or temporal pain accompanied by autonomic symptoms on the affected side (e.g., teary eye, nasal congestion or runny nose, ptosis, eyelid swelling, conjunctival injection).1,7,9,14 Unlike migraineurs, who prefer to remain at rest in a dark room, patients with cluster headache tend to be restless.14

Episodes may last 15-180 minutes, and may occur once every other day to as often as 8 times daily.7.9,14 These headaches typically occur daily for several weeks, followed by a period of remission.7.9 Treatment entails alleviating pain at the onset of the attack and instituting preventive strategies such as smoking and alcohol cessation.16 Following onset of an acute attack, oxygen therapy and sumatriptan injection have been found to be the most effective treatment modalities. 16 The CCB verapamil can be started at the beginning of a cluster headache, continued until the patient is headache-free for at least 7-14 days, and then slowly tapered and discontinued.7-9

Tension headache

Tension headaches can be episodic (usually associated with a stressful event) or chronic (usually associated with muscular contraction in the neck and scalp).17 Definitive diagnosis includes two of these traits: pressing or tightening pain; occipitofrontal location; bilateral pain, with mild to moderate intensity; and lack of effect of physical activity 17 These head aches are typically self-limiting and non-debilitating and have no associated symptoms. Physical exam findings are normal. Relief is generally achieved with acetaminophen or NSAIDs.7,12  Treatment modalities for chronic tension headache include lifestyle modifications such as regular exercise, stretching, stress management, relaxation techniques, and adequate sleep. Other treatments include use of hot or cold packs, ultrasound, improvement of posture, trigger point injections, and occipital nerve blocks.7.17

Chronic daily headache

This type of headache occurs on 15 or more days per month for at least 3 months and is typically related to medication overuse, although it may represent chronic (transformed) migraine.12,18,19Medication overuse headache results from taking acute headache medication for 2-3 days per week.12,18 Treatment for chronic daily headache includes preventive medications to decrease reliance on acute medications, and assistance with withdrawal symptoms such as nausea, vomiting, and restlessness. 18Transformed migraine is a constant (24-hour) headache with intermittent, superimposed migraine symptoms.19As many as 80% of patients with transformed migraine have coexisting depression; treatment focuses on counseling and biofeedback in addition to medication needed to treat depression.19

“Choosing Wisely” initiative

With regard to headache assessment, diagnosis, and management, the American Headache Society endorses the “Choosing Wisely” initiative.20 The initiative lists five suggestions:

Avoid neuroimaging studies in patients with stable headaches that meet criteria for migraine.

When indicated, magnetic resonance imaging is preferred over computed tomography except in emergency settings when hemorrhage, acute stroke, or head trauma is suspected.

Do not recommend surgical deactivation of migraine trigger points outside of a clinical trial.

Do not prescribe opioid- or butalbital-containing medications as first-line treatment for recurrent headache disorders.

Do not prescribe frequent or long-term use of over-the-counter medications for headache.

Conclusion

Headaches are common occurrences in women;  skilled HCPs are positioned to assess, diagnose, treat, and prevent headaches in these individuals. Familiarity with various types of headaches and their causes, appropriate treatment modalities, and preventive strategies can assist HCPs in management of women presenting with headache. =

Janis R. Guilbeau and Christy M. Lenahan are Assistant Professors at the University of Louisiana at Lafayette. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

References

  1. Winland-Brown JE, Keller MB. Neurological problems. In: Dunphy LM, Winland-Brown JE, Porter BO, Thomas DJ. Primary Care: Art and Science of Advanced Practice Nursing.  4th ed. Philadelphia, PA: F.A. Davis; 2015:77-148.

  2. International Association for the Study of Pain. Epidemiology of Headache. 2011. www.iasp-pain.org/files/Content/ContentFolders/GlobalYearAgainstPain2/HeadacheFactSheets/1-Epidemiology.pdf

  3. Bautista C, Grossman S. Somatosensory function, pain, and headache. In: Grossman SC, Porth CM. Porth’s Pathophysiology: Concepts of Altered Health States. 9th ed. Philadelphia, PA: Wolters Kluwer; 2014:422-451.

  4. Bajwa ZH, Wootton RJ. Evaluation of headache in adults. UptoDate. December 10, 2014. www.uptodate.com/contents/evaluation-of-headache-in-adults

  5. Hainer BL, Matheson EM. Approach to acute headache in adults. Am Fam Physician. 2013;87(10):682-687.

  6. Silberstein SD. Approach to the patient with headache. Merck Manual. April 2014. www.merckmanuals.com/professional/neurologic-disorders/headache/approach-to-the-patient-with-headache

  7. Hale N, Paauw DS. Diagnosis and treatment of headache in the ambulatory setting: a review of classic presentations and new considerations in diagnosis and management. Med Clin North Am.  2014;98(3):505-527.

  8. Docken WP, Rosenbaum JT. Clinical manifestations of giant cell (temporal) arteritis. UpToDate.  March 18, 2015. www.uptodate.com/contents/clinical-manifestations-ofgiant-cell-temporal-arteritis

  9. Weaver-Agostoni J. Cluster headache. Am Fam Physician. 2013;88(2):122-128.
  10. Brook I. Chronic sinusitis clinical presentation. Medscape. April 7, 2014. http://emedicine.medscape.com/article/232791-clinical
  11. International Association for the Study of Pain. Migraine. 2011. www.iasp-pain.org/files/ContenContentFolders/GlobalYearAgainstPain2/HeadacheFact-Sheets/2-Migraine.pdf

  12. Freitag FG, Schloemer F. Medical management of adult headache. Otolaryngol Clin North Am. 2014;47(2):221-237.

  13. Cunha JP. Migraine headache. Emedicine Health. March 16, 2015. www.emedicinehealth.com/migraine_headache/article_em.htm
  14. American Headache Society Committee on Headache Education. Cluster Headache and Other Medical Conditions. 2011. www.achenet.org/resources/cluster_headache_and_other_medical_conditions/

  15. Cleveland Clinic Foundation. Diseases & Conditions: Cluster Headaches. 2014. http://my.clevelandclinic.org/health/diseases_conditions/hic_Cluster_Headaches

  16. Simon H. Headaches – cluster. University of Maryland Medical Center. September 18, 2013. http://umm.edu/health/medical/reports/articles/headaches-cluster

  17. Blanda M. Tension headache clinical presentation. Medscape. October 1, 2014. http://emedicine.medscape.com/article/792384-clinical
  18. Silberstein SD. American Headache Society. Medication Overuse Headache. www.americanheadachesociety.org/assets/1/7/Stephen_Silberstein_-_Medication_Overuse_Headache.pdf

  19. National Headache Foundation. Transformed Migraine 2015. http://www.headaches.org/2007/10/25/transformed-migraine-more-commonly-known-as-chronicmigraine/

  20. Loder E, Weizenbaum E, Frishberg B, Silberstein S; American Headache Society Choosing Wisely Task Force. Choosing wisely in headache medicine: the American Headache Society’s list of five things physicians and patients should question. Headache. 2013;53(10):1651-1659.

Will the first medication to treat low sexual desire in women be approved?

Female sexual dysfunction (FSD) affects an estimated 43% of women in the United States.1  FSDs include impaired sexual interest/arousal disorder, sexual pain disorder, and orgasmic disorder. But the most common FSD by far is hypoactive sexual desire disorder (HSDD), reported by as many as 1 in 10 women. 2 HSDD can be definitively diagnosed with reliable and validated screening tools. 3 Women’s healthcare providers are on the front line in terms of caring for women with HSDD, but we lack FDA-approved options to provide relief for them.

But now there is hope. As the August 2015 issue of Women’s Healthcare: A Clinical Journal for NPs goes to press, the FDA will have made its decision regarding whether to approve flibanserin for the treatment of HSDD in premenopausal women. Flibanserin, a non-hormonal drug, is thought to work by correcting an imbalance in the levels of neurotransmitters in the brain that affect sexual desire. 4 More specifically, flibanserin increases dopamine and norepinephrine, both of which drive sexual excitement, and transiently decreases serotonin, which drives sexual safety/inhibition.

Two months ago, an FDA advisory committee voted to recommend approval of flibanserin to treat HSDD in premenopausal women. Although the FDA is not required to accept the advisory committee’s recommendation, the agency agreed to consider it as part of the new drug application review. Readers can check www.npwh.org for the latest information on the FDA decision.

During the open comment portion of the hearing prior to this vote, Gay Johnson, CEO of NPWH, spoke on behalf of the association and in support of both women with HSDD and the providers who struggle to treat these women every day.  In her statement, Ms. Johnson said, “Women’s sexual health is complex and multidimensional and often overlooked in primary care because of many factors, including cultural conditioning of women and providers. Historically, women’s sexuality has been viewed as something tied to the obligation to have sexual relations for reproduction, but not the desire to have sexual relations to achieve personal pleasure. Thankfully, now, in the 21st century, women’s sexual health is seen as a valid component of overall wellness. Women’s sexual dysfunction is now recognized as a real health condition, of real women, that decreases quality of life and negatively impacts relationships.”

Ms. Johnson clarified that NPWH is not advocating for the approval of any specific drug. She stated, “Each HSDD medical treatment option should receive fair consideration and the side effect/adverse event profile evaluated while considering the significant impact of the condition.  Women are intelligent, insightful decision makers and can be trusted the risks of side effects/adverse events and the benefits of any treatment according to the impact of HSDD on their personal lives and relationships.”

In both its educational and advocacy endeavors, NPWH supports nurse practitioners in providing high-quality healthcare for women, which includes addressing their sexual concerns. Our Women’s Sexual Health Course for NPs, offered for the first time in June 2014 and again in June 2015, has been extremely well received, filling to capacity several weeks ahead of time and garnering positive feedback from participants. Women’s Healthcare, our journal, includes a Focus on Sexual Health department article in each issue, and our annual conference always includes course on sexual health topics. Our advocacy work is ever-present as we actively support evidence-based treatments for all FSDs. As such, we applaud the FDA’s recognition of HSDD as a health problem that merits pharmacologic treatment and we encourage the FDA to consider approval of medications that have demonstrated efficacy and safety in treating women’s most common sexual complaint.

Susan Rawlins is Director of Education for the National Association of Nurse Practitioners in Women’s Health and a women’s health nurse practitioner at the Greater Texoma Health Clinic in Denison, Texas.  The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

  1. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281(6):537-544.
  2. Parish SJ, Rubio-Aurioles E. Education in sexual medicine: proceedings from the International Consultation in Sexual Medicine, 2009. J Sex Med. 20100;7(10):3305-3314.
  3. Kingsberg SA, Woodard T. Female sexual dysfunction: focus on low desire. Obstet Gynecol. 2015;125(2):477-486.
  4. Sprout Pharmaceuticals, Inc. FDA Advisory Committee Recommends Approval for Sprout Pharmaceuticals’ ADDYI TM (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women. June 5, 2015. http://www.sproutpharma.com/news-center/

Individualizing contraception

Contraceptive counseling: Why is it so important?

The disconnect between two seemingly contradictory facts— effective contraception is widely available, but almost half of pregnancies in the United States are unintended—highlights the need for better communication between healthcare practitioners (HCPs) and their patients about contraception and the development of strategies to increase patient adherence to and satisfaction with contraceptive regimens. Women also need more information about how to use and obtain emergency contraceptives (ECs).

Among the 6.4 million pregnancies that occur in the United States each year, 49% are unintended. 1 Of these unintended pregnancies, 29% happen earlier than desired and 20% happen after women have reached their desired family size. In addition, of these unintended pregnancies, 52% occur in the absence of the use of contraception, 43% occur with inconsistent or incorrect use, and 5% occur with consistent use and method failure. When asked about reasons for their nonuse of contraception, women report problems accessing or using methods (40%), infrequent sex (19%), lack of caring about whether pregnancy occurs (18%), underestimation of the risk of pregnancy (7%), and other reasons (16%).1

Contraceptives vary in terms of efficacy. Although all contraceptive are highly effective with perfect use, the most effective agents—the hormonal intrauterine contraceptive (IUC), the copper T-380A intrauterine device (IUD), and the subdermal implant— have high levels of efficacy with typical use because there is no user component that may result in incorrect or inconsistent use. Based on typical-use data, the oral contraceptive (OC), the vaginal ring, the patch, and the injection are less effective than IUCs and the implant—primarily because they require user actions and decision making. The least effective options are those that are coitus dependent: condoms, withdrawal, other barrier  methods, and spermicides.2Of note, the highest levels of satisfaction with contraceptives are reported by users of IUCs and the ring.3

Forty-six percent of women discontinue a birth control method because of dissatisfaction. 4 To reduce this discontinuation rate, HCPs need to provide effective counseling. Such counseling requires asking patients about their goals and attitudes regarding contraception and then listening carefully to their answers. That way, HCPs can be confident that they are prescribing the form of contraception that will best meet patients’needs and with which they will be most satisfied. Reports suggest that inconsistent use of combined OCs (COCs)—that is, those containing an estrogen and a progestogen—is more common among women who are not completely satisfied with their method.4

Healthcare practitioners must provide each patient with a knowledge base so that she can make informed decisions about birth control and birth control options. In the process, HCPs may need to correct deeply entrenched misinformation. HCPs also must provide anticipatory guidance about the use and the side effects of contraceptives and ECs. The bottom line: Patients need to leave the office knowing what to expect from the contraceptive they have selected and they need to know how to obtain and use an EC in the event of contraceptive mishap (e.g., torn condom, dislodged diaphragm) or nonadherence.

Strategies for selecting a contraceptive

Strategy 1: Set the stage for an effective visit. Although HCPs are pressed for time, they can obtain key information to help them partner with a patient and help her select the most appropriate contraceptive option for her before she even enters the examination room. When a patient calls to schedule an appointment with a goal of contraceptive counseling, she can be referred to the Association of Reproductive Health Professionals method match website.

This website will enable the patient to become familiar with the options and evaluate them prior to her visit. On standard forms that a patient completes in the waiting room, HCPs can include questions about pregnancy plans. Do you desire a pregnancy within 1 year? Within 1-3 years? Within 3-5 years? Not for 5-10 years or more? Not at all? Her answer will help you narrow down the list of options. Next, ask the patient about her contraceptive history: What forms of contraception have you used? What did you like/dislike about each method?

Discuss contraception prior to the physical examination, while the patient is still clothed; she is unlikely to give you her full attention if she is trying to keep the paper drape closed. Have samples of the contraceptive products in the exam room so that the patient can see and handle them.

Strategy 2: Analyze perfect use versus typical use. The level of participation and decision making required of patients in the use of a contraceptive method accounts for the gap between perfect use and typical use. The more user participation that is needed (e.g., remembering to take a pill every day), the greater the gap between perfect use and typical use. Although all contraceptives used correctly and consistently offer excellent efficacy, first-year rates of unintended pregnancy associated with typical use range from 8% with OCs to less than 1% for long-acting reversible contraceptives (LARCs; i.e., IUCs and implants) that require no patient participation or decision making.5

Therefore, each patient should be asked about how she will manage the use of contraceptives that require daily, monthly, or quarterly actions on her part. Ask her, “If you choose condoms or OCs, will you be able to manage them? These forms of contraception take more work on your part. Conversely, a long-acting method frees you from having to think about it; put it in and forget it.” The rate of non-LARC contraceptive failure is particularly high for adolescents. Among users of OCs, the patch, or the ring, the yearly failure rate in the first year of use is 8.2% among women aged 30 years or older and 13.4% among adolescents.6,7

Strategy 3: Teach patients that LARCs are more effective than other methods in preventing unplanned pregnancy, especially over time. Long-term use of agents that require decision making on a patient’s part, as compared with long-term use of LARCs, is associated with increased risk of incorrect or inconsistent use and pregnancy. This finding was confirmed in a recent study of 7,486 women using LARCs (i.e., IUCs or implants) or another commonly prescribed contraceptive (OC, patch, ring, or depot medroxyprogesterone acetate [DMPA] injection).7The contraceptive failure rate among participants using non-LARCs— that is, OCs, the patch, or the ring—was 4.55 per 100 participant- years, as compared with 0.27 among participants using LARCs (adjusted hazard ratio [HR], 21.8; 95% confidence interval (CI), 13.7-34.9). Rates of unintended pregnancy were similarly low among participants receiving the DMPA injection and those using an IUD or an implant. In this investigation, for users of OCs, the patch, or the ring, the contraceptive failure rate increased over time, from about 5% in year 1 to nearly 8% in year 2 and more than 9% in year 3. LARCs, including DMPA, had failure rates of less than 1% for each of the 3 years. Therefore, the need for correct and consistent use of contraception should be reviewed at each patient visit, year after year.

Strategy 4: Assess the options that best meet an individual patient’s needs. Ask each patient how the methods that interest her will fit into her life—now and, in light of ongoing concerns regarding adherence, in the future. How will each method fit into her schedule? For example, how will she remember to take the pill or change the patch? Which bleeding patterns will be acceptable? If, in the first few months, a patient does not know when bleeding is likely to occur, will this be a problem for her? Is privacy of the method a concern? Are there any financial barriers? If so, are there assistance programs or installment payment plans available? Review the patient’s record for any conditions (e.g., dysmenorrhea, heavy menstrual bleeding, menstrual migraine, acne) that could be simultaneously managed by specific methods. Finally, determine whether the patient has any contraindications to any birth control methods. For example, use of combined hormonal contraceptives is contraindicated in patients with migraine with aura and in users of certain types of anticonvulsants.

Strategy 5: Dispel myths, especially those related to IUCs. To dispel common misconceptions about IUCs, discuss their mechanism of action with patients These devices prevent fertilization; they do not cause abortions.2,8 Another myth to dispel is any association between IUC use and an increased risk of ectopic pregnancy. The contraceptive effectiveness of these devices is 99.9%; the risk of pregnancy is very small. In the event that pregnancy should occur, the possibility of an ectopic pregnancy is of concern, but the likelihood  such an occurrence is minute.2,8

Testing for sexually transmitted infections (STIs) in women scheduled to undergo IUC insertion is generally not done unless they are at risk for chlamydia and gonorrhea (e.g., women aged 25 years or younger). Risk of pelvic inflammatory disease is higher at IUC insertion only if a woman tests positive for chlamydia or gonorrhea.2,8

Strategy 6: Help your patient be successful in adhering to her contraception regimen. Once a woman has selected a contraceptive, help her be successful in its use. This checklist can help ensure that she has the tools she needs for success. Your patient…

Leaves the office knowing, in simple terms, how the option she has selected works;

Understands how to use the method correctly;

Is aware of the side effects, which you have explained using simple terms;

Knows the warning signs that signal potential complications and what her course of action should be;

Understands the indications for EC use and knows where and how to obtain an EC;

Realizes that, if she doesn’t like her contraceptive choice, she can return to your office for assistance in choosing a different method that is better suited to her needs;

Has resources to help her remember key points about the contraceptive she has chosen, including handouts and information about websites that provide accurate information;

Knows that she will still need to protect herself against STIs.

Emergency contraception

Many HCPs are uncomfortable with the topic of emergency contraception and do not discuss it unless a patient asks about it. In patients’ best interest, though, HCPs need to use every visit as an opportunity to discuss contraception and the potential need for an EC. ECs are defined as contraceptives intended to prevent pregnancy within the first few days of unprotected sex. The most commonly used ECs contain oral levonorgestrel (LNG). Ulipristal acetate, a selective progesterone receptor modulator, is another oral EC. Another effective method of EC available is the copper IUD, which is used off label for this indication.

Levonorgestrel agents are available in two over-the-counter dosing regimens.9-14The onetablet regimen contains LNG 1.5 mg. On label, this product is taken within 72 hours after unprotected intercourse, when it is most effective. Off label, it can be used up to 120 hours after intercourse. The second regimen is a two-tablet product that also contains a total of 1.5 mg of LNG (0.75 mg per pill). The package labeling states that one pill is taken immediately after unprotected intercourse and the second pill, 12 hours later. Off-label directions are to take both pills at  once, preferably within 72 hours of unprotected intercourse. For both LNG regimens, greatest efficacy  is achieved when the medication is taken within 72 hours of unprotected intercourse, but efficacy has been demonstrated up to 120 hours after unprotected intercourse. After EC use, a highly effective contraceptive should be started; a backup method (e.g., condoms) is needed for 7 days.

Ulipristal acetate 30 mg is available by prescription.13-16 This product can be used during the first 120 hours after unprotected intercourse. Unlike other agents, ulipristal acetate maintains efficacy during the full 120 hours after intercourse. This EC, which is highly effective in obese women as well as their normal-weight counterparts, may be ordered from an online prescription service. After use, a highly effective contraceptive should be started; a backup method is needed for 14 days.

The copper IUD can provide emergency contraception within 5 days of unprotected intercourse. Although use of the copper IUD is off label for this indication, one advantage is that this product can then be retained as a long-acting contraceptive. Efficacy of this EC method was shown in a prospective study of 542 women who presented for emergency contraception. 17The 1-year cumulative pregnancy rate in women choosing the copper IUD was 6.5%, as compared with 12.2% in those choosing oral LNG (HR, 0.53; 95% CI, 0.29-0.97; P = .041]. Thus, 1 year after presenting for emergency contraception, women choosing the copper IUD were half as likely as those choosing oral LNG to have a pregnancy.

Strategy 7: Ensure access to ECs. Results of a 2013 patient survey by NPWH have shown that more than 75% of HCPs do not discuss emergency contraception with their patients. However, patients who find themselves in need of an EC should learn about it through communication with their HCP. Furthermore, a 2011 survey distributed to the email database of NPWH (N = 10,800) and completed by 699 clinicians showed important gaps in best practices in patient care among the respondents:

• 55.3% reported that they review EC options with each reproductive aged patient.

• Although 88.2% of respondents  said that they tell patients about LNG, only 26.5% reported discussing ulipristal acetate; 21.9%, the copper IUD; and 16.1%, the Yuzpe method.

• Only 44.3% of respondents said that they provide information and/or a prescription for an EC to all patients who do not desire pregnancy.

In view of the fact that 49% of pregnancies in the U.S. are unintended, HCPs are advised to review EC use and availability at each office visit by (1) explaining what EC does, how it works, and when to use it; (2) providing an anticipatory prescription; and (3) reviewing and dispelling myths about ECs. Concerns about ECs’ mechanisms of action remain associated with major barriers to use.14 Many women believe that ECs are abortifacients with long-term effects on health and fertility. 18A patient’s poor understanding of reproductive physiology may result in confusion as to when ECs are most effective. 19,20

Case studies

Case 1: Tanya is 24 years old, is 5’5″, weighs 121 lb (body mass index [BMI], 20.1 kg/m2), and has no prior pregnancies or health problems. Tanya schedules a visit to request a different OC because of bothersome light bleeding for the past 3 months.  She currently uses a COC containing ethinyl estradiol 20 mcg and norethindrone. Further discussion reveals that Tanya skips taking her birth control pill no more than once a week. She has had three male partners in the past 3 months and reports condom use about half the time. She reports smoking about 10 cigarettes a day,

Assessment. Begin by doing a workup concerning the abnormal bleeding, which may or may not be related to the COC regimen. Rule out pregnancy and STIs and perform speculum and bimanual examinations. Because Tanya has no mucopurulent cervicitis, discharge, or tenderness, and her test results are all negative, you conclude that the irregular bleeding is a side effect of the COC use. As you recall, the longer a patient uses a method, the more likely she is to use it incorrectly.

Counseling. Develop strategies to encourage correct and consistent COC use. In this case, consider changing formulations to reduce side effects. Review all the options with Tanya. Take this opportunity to discuss nondaily methods. Although Tanya is not a heavy smoker, remind her that her nicotine intake could be sufficient to induce breakthrough bleeding. Discuss safer sex and the importance of protecting herself from STIs. Review the indications for EC use. Make sure she knows how and where to obtain an EC. Provide a prescription for an EC product.

Patient decision. Tanya is interested in using a nondaily contraceptive and wants to try the ring. Discuss the use, side effects, and warning signs, and reinforce the fact that the ring will not protect against STIs. If the device is expelled or if Tanya is not punctual about replacing the ring, she will need to use an EC following unprotected intercourse. Schedule a follow-up visit to discuss Tanya’s satisfaction with the ring. At a follow-up visit, Tanya indicates that she likes the ring and has had no episodes of unscheduled bleeding.

Case 2: Annette is 17 years old, is 5’7″, weighs 220 lb (BMI, 34.5 kg/m2), and has had no prior pregnancies. Annette has scheduled her appointment for contraceptive counseling and looks to you for advice.

Assessment. Annette’s history includes obesity, migraine with aura, dysmenorrhea, and menorrhagia. Her partner uses condoms about half the time. She worries about weight gain with hormonal contraceptives. She is uncertain about her ability to remember to take a daily pill. Because of her migraine with aura, methods that contain estrogen are contraindicated. A patient with migraine without aura could use estrogen products as long as her blood pressure is monitored and her headache severity and frequency are not adversely affected. Progestin-only pills (POPs) would be a good option if Annette had indicated a willingness to use them consistently. DMPA can be associated with weight gain, which is already a concern for her.

The LNG intrauterine system (IUS) represents a good option because it may help alleviate Annette’s cramping and bleeding, which would be likely to increase her satisfaction with this method. An implant might be a good choice, but she likes the longer duration associated with the LNG IUS. The 10-year duration of the copper IUD appeals to her, but she would like the reduction in menstrual problems that may result from use of the LNG IUS.

Patient decision. Annette selects the LNG IUS. Review the mechanism of action, side effects, and warnings, with an emphasis on the transitional bleeding interval. Although bleeding patterns will likely normalize within 3 months, tell her that it may take 6 months. This strategy accounts for the variability in duration and reduces the potential for frustration. Review safer sex and condom use at the initial discussion and before and after placement of the device.

Case 3: Regina is 44 years old, is 5’5″, weighs 200 lb (BMI, 33.3 kg/m2), and has no history of pregnancy. Regina has scheduled a visit for her well-woman examination. She has not been sexually active since her divorce, but she has started a relationship that she believes may become serious. Therefore, you initiate a discussion about contraception.

Assessment. Regina’s history is unremarkable except for a cholecystectomy at age 30. Her menstrual history remains normal, with menses marked by predictable intervals, duration, and cramps, all of which indicate ovulation. She takes naproxen sodium for moderate to severe cramps. Regina has a demanding job in advertising and travels often, noting fatigue associated with erratic schedules and frequent time zone changes. Her variable schedule makes it difficult to sustain an exercise regimen. She indicates that she would like to exercise more regularly to lose weight. Regina and her husband got divorced 5 years ago; early in the marriage, they had decided not to have children. He underwent a vasectomy. A nonsmoker, she drinks wine 1-2 times a week in social settings.

Counseling. Regina does not use contraception. However, data show that unplanned pregnancy is most likely among younger and older women. Convey to Regina that in women of her age, pregnancy is associated with an increased risk for maternal mortality, spontaneous abortion, and fetal abnormalities. Discuss ECs, safer sex, and STI risk.

Patient decision. Based on her profile, Regina is eligible for any contraceptive, although the patch may be less effective because she weighs more than 198 lb. Other less-than-optimal choices are COCs or POPs because she has indicated that she has an irregular daily routine and schedule. She is more interested in an IUD; either the LNH IUS or the copper IUD is appropriate for her. She considers each option: 5-year versus 10-year efficacy and hormonal versus nonhormonal characteristics.

Regina wants to do some research on her own. Refer her to a reliable website such as www. arhp.org/methodmatch. She plans to start Weight Watchers and a swimming routine that she can implement in many of the hotels at which she stays. You and Regina decide that she will call you as soon as she makes her decision about which IUC to use, and that, in the meantime, she will keep condoms available for use if needed. At her next visit, Regina informs you that she has decided to use the copper IUD because she prefers a nonhoromal method.

A final word about contraceptives and weight gain

Two of the tree cases discussed in the article involve women who are obese. Sixty-four percent of women in this country are overweight and 36% are obese. 21 Therefore, body weight may be an important consideration when choosing a contraceptive; some options may be associated with a tendency for a weight gain and some may not be as effective in obese women.

In terms of the former concern, four randomized, placebo-controlled trials showed no evidence supporting a casual association between use of COCs or a combination patch and weight gain. 22 Results of a similar review were inconclusive with regard to progestin-only contraceptives. 23 However, a prospective study of 450 adolescents showed that among those using DMPA, those who were already obese gained significantly more weight than did their non-obese counterparts. 24 Also, the obese DMPA users gained significantly more weight than did obese COC users or obese nonusers of hormonal contraception. With regard to contraceptive efficacy, the patch may be less effective in women weighing 198 lb or more. 25 With regard to EC efficacy in obese women, ulipristal acetate may be a better choice than LNG-containing ECs.  26

Conclusion

Even though information about contraceptives is readily available in print and online, and even though contraceptives themselves are easily available and, in many cases, fully covered by health insurance payments to pharmacies, many adolescents and women are not using these products correctly, consistently, and persistently. HCPs, including nurse practitioners, can fill in the knowledge gap by making sure to discuss contraceptive needs with all their patients, and to find the product or products that will work best for them.

References

1.  Frost JJ, Darroch JE, Reme L. Improving contraceptive use in the United States. In Brief. Guttmacher Institute. 2008. www.guttmacher.org/pubs/2008/05/09/ImprovingContraceptiveUse.pdf

2. Hatcher RA, Trussell J, Nelson AL, el al, eds. Contraceptive Technology: Twentieth Revised Edition. New York, NY: Ardent Media, Inc.;2011.

3. Revisiting Your Women’s Health Care Visit. Harris Interactive for the Association of Reproductive Health Professionals. Conducted June 30–July 14, 2004.

4. Moreau C, Cleland K, Trussell J. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception. 2007;
76(4):267-272.

5. Trussell J, Guthrie KA. Choosing a contraceptive: efficacy, safety, and personal considerations. In: Hatcher RA, Trussell J, Nelson AL, et al, eds. Contraceptive Technology: Twentieth Revised Edition. New York, NY: Ardent Media; 2011:45-74.

6. Kost K, Singh S, Vaughan B, et al. Estimates of contraceptive failure from the 2002 National Survey of Family Growth. Contraception.2008;77(1):10-21.

7. Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007.

8. Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet. 2000;356(9234):1013-1019.

9. Arowojolu AO, Okewole IA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception. 2002;66(4):269-273.

10. Piaggio G, von Hertzen H, Grimes DA, Van Look PF. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1999;353(9154):721.

11. von Hertzen H, Piaggio G, Ding J, et al; WHO Research Group on Postovulatory Methods of Fertility Regulation. Low dose mifepristone and two  regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet. 2002;360(9348):1803-1810.

12. Ngai SW, Fan S, Li S, et al. A randomized trial to compare 24 h versus 12 h double dose regimen of levonorgestrel for emergency contraception. Hum Reprod. 2005;20(1):307-311.

13. The Emergency Contraception Website. www.not-2-late.com

14. Reproductive Health Technologies Project website. www.rhtp.org

15. Glasier A, Cameron ST, Blithe D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84(4):363-367.

16. Moreau C, Trussell J. Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Contraception. 2012;86(6):673-680.

17. Turok DK, Jacobson JC, Dermish AI, et al. Emergency contraception with a copper IUD or oral levonorgestrel: an observational study of 1-year pregnancy rates. Contraception. 2013 Nov 22. Epub ahead of print.

18. Corbett PO, Mitchell CP, Taylor JS, Kemppainen J. Emergency contraception: knowledge and perceptions in a university population. J Am Acad Nurse Pract. 2006;18(4):161-168.

19. Gemzell-Danielsson K, Berger C, P G L L. Emergency contraception —mechanisms of action. Contraception. 2013;87(3):300-308.

20. Shoveller J, Chabot C, Soon JA, et al. Identifying barriers to emergency contraception use among young women from various sociocultural groups in British Columbia, Canada. Perspect Sex Reprod Health.
2007;39(1):13-20.

21. National Institute of Diabetes and Digestive and Kidney Diseases. Weight-control Information Network. Overweight and Obesity among Adults Age 20 and Older, United States, 2009–2010. http://win.niddk.nih.gov/statistics/#b

22. Gallo MF, Lopez LM, Grimes DA, et al. Combination contraceptives: effects on weight. Cochrane Database Syst Rev. 2011;(9):CD003987.

23. Lopez LM, Edelman A, Chen-Mok M, et al. Progestin-only contraceptives: effects on weight. Cochrane Database Syst Rev. 2011;(4):CD008815.

24. Bonny AE, Ziegler J, Harvey R, et al. Weight gain in obese and non-obese adolescent girls initiating depot medroxyprogesterone, oral contraceptive pills, or no hormonal contraceptive method. Arch Pediatr Adolesc Med. 2006;160(1):40-45.

25. Ortho Evra website. JanssenPharmaceuticals, Inc. 2014. http://www.orthoevra.com/

26. Batur P. Emergency contraception: separating fact from fiction. Cleve Clin J Med. 2012;79(11):771-776.

 

 

After Hobby Lobby: Where do women’s rights fit in?

The Affordable Care Act (ACA) seeks to improve population health outcomes by making preventive health services affordable and accessible. To achieve this aim, the ACA requires health plans to cover preventive services that have strong scientific evidence of their health benefits, with no cost sharing by patients (i.e., no co-payment, co-insurance, or deductible) when these services are delivered by a network provider. With limited exceptions, all FDA approved contraceptive methods are covered under the Women’s Preventive Services Guidelines. 1

However, on June 30, 2014, the U.S. Supreme Court issued one of its most highly anticipated rulings regarding women’s health. In a 5-to-4 ruling in Burwell v. Hobby Lobby Stores,2 the Court stated that “closely held” corporations do have religious rights and, as such, should be permitted an exemption from compliance with the contraceptive mandate issued by the U.S. Department of Health and Human Services (HHS).

How did we get here?

In accordance with the ACA, required preventive services, to be covered with no cost sharing on the patient’s part, include (1) evidence-based services that have received a U.S. Preventive Services Task Force (USPSTF) rating of “A” or “B”; (2) immunizations recommended by the CDC’s Advisory Committee on  Immunization Practices; (3) evidence-informed screenings and guidelines for infants, children, adolescents, and women supported by the Health Resources and Services Administration (HRSA, a division of HHS); and (4) USPSTF breast cancer screening, mammography, and prevention recommendations considered the most current other than those issued in or around November 2009.3

The Institute of Medicine (IOM) was then charged with convening an expert committee to review which preventive services are necessary for women’s health and should be considered in the development of comprehensive guidelines for preventive services for women, as well as with identifying any gaps in the USPSTF’s A- and B-rated preventive services for women.4 The IOM panel included recommendations for women that met the following criteria:

The condition to be prevented affects a broad population;

The condition to be prevented has a large potential impact on health and well-being; and

The quality and strength of the evidence is supportive of the recommendation.

Within this framework, the IOM panel recommended that preventive services for women that are to be provided without cost sharing include the “full range of FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity.” 4In making this recommendation, the IOM panel cited systematic evidence reviews and other peer-reviewed studies pointing to the efficacy of these interventions in reducing the number of unintended pregnancies, as well as their favorable effect on women’s health and pregnancy outcomes.4 (pp102-110) Based on the IOM recommendation, HRSA issued regulations requiring inclusion of all FDA-approved contraceptive methods as a preventive health benefit.

Exempt from this contraceptive mandate were religious employers; non-profit entities, including churches, their integrated auxiliaries, and conventions or associations of churches; and the exclusively religious activities of any religious order.1,5 In addition, HHS rules issued in June 2013 provided an accommodation for other non-profit religious organizations that object to the contraceptive mandate. The accommodation permitted religious organizations that met certain requirements to self-certify as non-profit religious organizations. Such organizations could then avoid contracting, paying for, or otherwise making available contraceptive coverage by notifying their health insurance issuer of their self-certified status as a religious organization.6

Understanding Hobby Lobby

Burwell v. Hobby Lobby Stores arose from cases brought by three closely held, for-profit corporations. 2 These companies sued HHS, seeking to prohibit application of the contraceptive mandate in – sofar as it required them to provide coverage for four “objectionable” contraceptive methods. In particular, Conestoga Wood Companies, a woodworking company owned by the Hahn family, sought to prohibit application of the contraceptive mandate with regard to two forms of emergency contraception and two types of intra uterine devices. The Hahns, devout Mennonites, believed that because these contraceptive methods may operate after fertilization of the egg, these products are “against their moral conviction to be involved in the termination of human life.”2(p12)

Likewise, Hobby Lobby, a chain of arts and craft stores, and Mardel, an affiliated business that operates 35 Christian bookstores, brought suit to stop application of the contraceptive mandate with regard to the same four contraceptives that the Hahns found objectionable.2 Hobby Lobby is owned by David Green and family and Mardel by one of Davi Green’s sons. Like the Hahns, the Greens believe that life begins at conception. Therefore, providing access to contraceptives with potential to operate after fertilization of the ovum would violate their religious beliefs. The owners of Conestoga, Hobby Lobby, and Mardel do not object to the other FDA-approved methods of birth control.2 (p14) The decisions by lower courts in this matter differed, resulting in the matter being brought to the Supreme Court.

In a narrow 5-4 opinion, the Court held that the HHS contraceptive mandate, as it applies to closely held corporations, violates the Religious Freedom Restoration Act (RFRA). The RFRA prohibits the federal government from taking any  action that substantially burdens a person’s exercise of religion, unless that action constitutes the “least restrictive means” of serving a “compelling government interest.” 7Although the RFRA does not define the term “person,” the Court here applied the definition under the Dictionary Act, which defines “person” to include “corporations, companies, associations, firms … as well as individuals.”8Although the Court acknowledged that the contraceptive mandate may serve a compelling government interest, requiring these closely held companies to arrange for coverage of the objectionable contraceptive methods or to suffer penalties if they refuse to do so, it also posed a “substantial burden” on their free exercise of religion.2

In an eloquent dissent, Justice Ruth Bader Ginsburg challenged the majority’s assertion that the ruling was narrow in scope, and referred to the Court’s holding as a decision of “startling breadth” that would allow commercial entities to “opt out of any law (save tax laws) they judge incompatible with their sincerely held beliefs.”9The dissent argued against the interpretation of the word “person” to include a for-profit corporation in this instance. In addition, Justice Ginsburg pointed out that the decision to claim contraceptive health benefits is a woman’s decision, and that women with beliefs similar to those of the Hahns and Greens would not be compelled by the plan to access the objectionable methods. In closing, Justice Ginsburg accused the Court of “stepping onto a minefield … by its immoderate reading of the RFRA.”9

Where are we now?

Following the Hobby Lobby decision, Senators Patty Murray (D-WA) and Mark Udall (D-CO) introduced the Protect Women’s Health from Corporate Interference Act.10 This bill was intended to restore the ACA’s contraceptive coverage requirement and protect coverage of other health services from being denied based on an employer’s beliefs by prohibiting employers from refusing to provide health coverage guaranteed to employees under Federal law. The procedural vote to take up the bill narrowly failed in the Senate, by a vote of 56-43, just 4 votes short of the 60 votes needed to move the bill forward.11

In the wake of Hobby Lobby, various executive departments have issued guidance and fact sheets, and have proposed rules regarding ACA implementation with regard to contraceptive coverage. In July 2014, the U.S. Department of Labor issued a Frequently Asked Questions (FAQ) response regarding health plans’ disclosure of changes to contraceptive coverage.12 According to the FAQ, a plan subject to the provisions of the Employee Retirement Income Security Act (ERISA) must disclose information relevant to coverage of preventive services. The Department of Labor regulations require that the summary plan description include an explanation of preventive services, including contraception, covered by the plan. Expedited disclosure requirements are in place for plans that reduce or eliminate aspects of preventive services coverage after having provided the services.13

In August 2014, HHS issued a proposed rule in response to the Hobby Lobby decision in an attempt to help ensure that women whose contraceptive coverage is being threatened continue to receive the coverage to which they are entitled under the ACA.14 The proposed rule expands the availability of the accommodation for non-profit religious organizations to avoid contracting, arranging, paying, or referring for contraceptive services to include a closely held, for-profit entity that has a religious objection to providing coverage for some or all contraceptive services. Under the proposed rule, the closely held, for profit entity may not be publicly traded and must be owned by a limited number of persons or have a minimum percentage of ownership concentrated among a smaller group of people. The comment period for the proposed rule is scheduled to close prior to publication of this article.

Summary

The Supreme Court’s Hobby Lobby decision has the potential to undermine the ACA’s provision establishing a federal guarantee of coverage for a full range of FDA-approved contraceptive methods as a key preventive health service for women.1 By limiting the ability of some women to choose among all FDA-approved contraceptive methods, based on their employer’s values and belief system, this decision may create uneven access to evidence-based healthcare services shown to have a profound impact on women’s overall health and well-being. =

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at skendig@npwh.org.

References

1. Health Resources and Services Administration website. Women’s Preventive Services Guidelines. 2012.

http://www.hrsa.gov/womensguidelines/

2. Burwell v. Hobby Lobby Stores. 13-354, s.l. : U.S. Supreme Court, June 30, 2014.

3. 42 USC § 300gg-13 (a)(1)-(5). 2010. Coverage of preventive health services.

4. Institute of Medicine. Clinical Preventative Services for Women: Closing the Gap. Washington, DC: National Academies Press; 2011.

5. 26 USC § 6033(a)(3(A)(1)(3). Returns by exempt organizations.

6. U.S. Department of Health and Human Services. Coverage of Certain Preventive Health Services under the Affordable Care Act – Final Rules. 78 Fed. Reg. 39870-39899. July 2, 2013.

7. Religious Freedom Restoration Act (RFRA). 42 USC § 2000bb-1(a)(b).

8. Dictionary Act. 1 USC § 1.

9. Ginsburg RB. Burnwell v. Hobby Lobby (dissent). 13-354 and 13-356 , s.l. : U.S. Supreme Court, 2014.

10. Murray/Udall. Protect Women’s Health from Corporate Interference Act. s.l. : 113th Congress, 2014.

11. Cunningham PW. Democratic bid to reverse Hobby Lobby fails. July 16, 2014. http://dyn.politico.com/printstory.cfm?uuid=74A8B33D-2EF4-4C9B-ADBE-19F7D09DA6BA

12. U.S. Department of Labor. FAQs about Affordable Care Act implementation (Part XX). July 17, 2014. http://www.dol.gov/ebsa/faqs/faq-aca20.html

13. Centers for Medicare and Medicaid Services website. Center for Consumer Information & Insurance Oversight. Women’s Preventive Services Coverage and Non-Profit Religious Organizations. Fact Sheet: Women’s Preventive Services Coverage, Non-Profit Religious Organizations, and Closely-Held For-Profit Entities.  CMS-CCIIO. August 22, 2014. http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/womens-preven-02012013.html

14. U.S. Department of Health and Human Services. Coverage of Certain Preventive Services Under the Affordable Care Act. 79 Fed. Reg. 51118. August 27, 2014.

Standardizing care for sexual assault survivors

Across the United States, women seek immediate care following sexual assault can expect to receive thorough and uniform care in a variety of clinical settings. This approach to the acute care of sexual assault survivors comes as a result of the evolving and growing role of sexual assault nurse examiners (SANEs)—nurses who are educated and prepared to follow standardized guidelines and criteria. However, the follow-up care that sexual assault survivors receive from their regular healthcare providers (HCPs) can vary greatly. Many women receive inadequate post-assault care, which may compromise their recovery and even exacerbate the aftereffects of an already harrowing experience. Ensuring that follow-up examinations are every bit as thorough and uniform as the initial care should be a priority for HCPs.

Incomplete or inadequate care in the weeks and months following a sexual assault can lead to longtermphysical and mental sequelae. To limit these sequelae, clear-cut standardized clinical guidelines are needed. Using current national recommendations and reports from experts in the field,1-12 together with her own clinical experience and input and advice of 17 community-based advanced practice nursing colleagues who comprised a focus group, the author developed and copyrighted a clinical practice guideline tool that can be used in primary care practices. This tool—a Clinical Flow Sheet Post Sexual Assault©—incorporates all aspects of a patient’s recovery and well-being to support a holistic recuperation. =

Jennifer A. Korkosz is Assistant Professor at the Daniel K. Inouye Graduate School of Nursing, Uniformed Services University of the Health Sciences, in Bethesda, Maryland. The views expressed in this project are those of the author and do not reflect the official policy or position of the United States Air Force, Department of Defense, or the U.S. government.

References

1. Ackerman DR, Sugar NF, Fine DN, Eckert LO. Sexual assault victims: factors associated with follow-up care. Am J Obstet Gynecol. 2006;194(6):1653-1659.

2. Bates CK. Patient Information: Care After Sexual Assault (Beyond the Basics). 2012. http://www.uptodate.com/contents/care-after-sexual-assault-beyond-the-basics

3. Coker AL, Davis KE, Arias I, et al. Physical and mental health effects of intimate partner violence for men and women. Am J Prev Med. 2002;23(4):260-268.

4. Kapur NA, Windish DM. Health care utilization and unhealthy behaviors among victims of sexual assault in Connecticut: results from a population-based sample. J Gen Intern Med. 2011;26(5):524-530.

5. Linden JA. Clinical practice: care of the adult patient after sexual assault. N Engl J Med. 2011;365(9):834-841.

6. McCall-Hosenfeld JS, Freund KM, Liebschutz JM. Factors associated with sexual assault and time to presentation. Prev Med. 2009;48(6):593-595.

7. Mishel MH. Theories of uncertainty in illness. In: Smith MJ, Liehr PR, eds. Middle Range Theory for Nursing. 3rd ed. New York, NY: Springer Publishing Company; 2014:53-86.

8. Wadsworth P, Van Order P. Care of the sexually assaulted woman. J Nurse Pract. 2012;8(6):433-440.

9. Zinzow HM, Resnick HS, Barr SC, et al. Receipt of post-rape medical care in a national sample of female victims. Am J Prev Med. 2012;43(2):183-187.

10. Prins A, Ouimette P, Kimerling R. Primary Care PTSD Screen (PC-PTSD). 2003. http://www.ptsd.va.gov/professional/assessment/screens/pc-ptsd.asp

11. Maurer DM. Screening for depression. Am Fam Physician. 2012;85(2):139-144.

12. Spitzer RL, Kroenke K, Williams JBW, Lowe B. A brief measure for assessing generalized anxiety disorder. Arch Intern Med. 2006;166:1092-1097.

Preconception care for women with diabetes

Preconception care for women with diabetes mellitus (DM) is essential in terms of fostering good preg- nancy outcomes. The authors discuss elements of preconception care, which include assessment for complications of DM, identification and discontinuation of teratogenic medications, and optimization of blood glucose control before attempts at pregnancy are made.

Diabetes mellitus (DM) is present in nearly 10% of women of childbearing age, and about 1% of all pregnancies are complicated by the disease.Uncontrolled DM during pregnancy increases the risks for maternal, fetal, and neonatal complications, including pre-eclampsia, miscarriage, fetal demise, congenital defects, and neonatal hypoglycemia and hyperbilirubinemia.Therefore, preconception care should be a routine part of healthcare for reproductive-aged women with DM who have the potential to become pregnant.1-3

Reproductive life planning

Women with DM are at increased risk for adverse health outcomes as a result of pregnancy, especially when pregnancy is unintended. DM increases the risk for cardiovascular disease (CVD) and renal disease, which may be exacerbated by pregnancy. Many drugs used in the treatment of DM and its complications are teratogenic, and prolonged hyperglycemia further increases the risk for fetal developmental abnormalities.1 Therefore, effective contraception is essential to prevent unintended pregnancy or to delay conception while treatment of DM is optimized to improve pregnancy outcomes.1,2 Women who express concern about the safety of contraceptives should be advised that the risks of unplanned pregnancy outweigh those of any contraceptive method.2,4

Until they are ready to become pregnant, women with DM who are of childbearing age and sexually active should use the most reliable form of contraception that is acceptable to and appropriate for them.1,2,4 Long-acting reversible contraceptives (LARC), including subdermal implants and intrauterine contraceptives, are the most effective forms of reversible contraception available. These methods do not rely on user compliance and are appropriate for most females, including adolescents and nulliparous women.4 Depot medroxyprogesterone acetate (DMPA); contraceptive pills, patches, and vaginal rings; and diaphragms are effective when used consistently and correctly but have higher typical-use failure rates than LARC.4 Condoms, spermicides, withdrawal, and fertility awareness methods are the least reliable forms of contraception, but condoms should be used in addition to a more reliable method to reduce the risk of acquiring a sexually transmitted infection.4

Long-acting reversible contraceptive methods and progestin-only pills are safe and appropriate for use in women with DM regardless of disease duration or presence of cardiovascular or other complications.4 Combined hormonal contraceptives (CHCs) and DMPA are safe for use in women with DM of less than 20 years’ duration without retinopathy, nephropathy, neuropathy, or other vascular disease.4 CHCs and DMPA must be avoided in women with any of these conditions or DM of greater than 20 years’ duration.4 Healthcare providers (HCPs) prescribing contraceptives for women with DM should refer to the U.S. Medical Eligibility Criteria for Contraceptive Use, 2016 for specific information about the efficacy and safety of each method.4

These recommendations apply to sexually active adolescents with DM, who may be unaware of the risks of DM during pregnancy.5 Under ideal circumstances, parents of female adolescents with DM, who are instrumental in guiding their daughters in self-care, should participate in preconception counseling sessions.5

Preconception counseling and evaluation

Preconception counseling improves DM knowledge, enhances patient engagement and self-efficacy, and improves pregnancy outcomes.6 HCPs should explain to patients the benefits of a team approach, and offer referral to a certified diabetes educator, registered dietician (RD), or others who can address their particular needs and concerns.6 Specific goals of preconception counseling include education about the risks of poorly controlled DM during pregnancy and about strategies to achieve and maintain glycemic control prior to conception and throughout pregnancy.3

When pregnancy is desired or anticipated, every effort should be made to achieve hemoglobin A1C values as close to normal as is safely possible.1,2 In addition, HCPs need to assess for women’s use of teratogenic medications, and change or discontinue these agents prior to discontinuing contraception.2 Preconception evaluation for women with DM also includes assessment for nephropathy, retinopathy, and neuropathy, which may progress during pregnancy; CVD or CVD risk; and thyroid disease.2,3

Preconception management

Medical nutrition therapy (MNT) is a cornerstone of DM management.3 In the preconception period, MNT goals are to meet women’s nutritional needs and to achieve and maintain glycemic control and a healthy body weight.2 Referral should be made to an RD with expertise in MNT in women with DM, both before and during pregnancy.3 The U.S. Preventive Services Task Force recommends that all women planning or capable of pregnancy take a daily supplement containing 400-800 mcg of folic acid to prevent neural tube defects (NTDs) in infants.7 Presence of DM increases NTD risk.The American Diabetes Association (ADA) recommends that women with DM who are planning a pregnancy take a prenatal vitamin containing at least 400 mcg of folic acid.2

Glycemic control

An elevated glucose level increases the risk for fetal developmental abnormalities in the first trimester.For women who maintain good glycemic control prior to and throughout the first trimester of pregnancy, the risk for complications is similar to that of women without DM.3 Glycemic targets are individualized based on health status and risk for hypoglycemia.2 The ADA recommends achieving an A1C <6.5%, or as low as can be safely achieved without hypoglycemia, prior to conception.2

Insulin

Insulin is the preferred medication for managing type 1 or type 2 diabetes mellitus during pregnancy; HCPs may consider initiating insulin prior to conception when indicated.2,3 Data from human studies indicate that most insulins are safe to use in pregnancy.2,8 Glulisine and degludec have not been studied in humans, however8; HCPs should consider switching women using either of these agents to an insulin that has been studied in humans prior to conception.2

Metformin

Human data suggest that metformin is safe for use in pregnancy and is less likely than insulin or some other oral antidiabetics to cause hypoglycemia.2,8 Women using metformin before conception may continue the drug but should understand that it may be insufficient to maintain glycemic control during pregnancy.2 Metformin crosses the placenta; although no fetal adverse effects have been found, no long-term studies of its safety during pregnancy have been reported.2

Sulfonylureas

Some studies support the use of sulfonylureas in pregnancy, but the FDA has not approved these drugs for use during pregnancy.3 Glipizide has not been studied in humans in terms of its potential teratogenic effects. Animal studies show a low risk of fetal harm from glipizide, but the drug can cause prolonged fetal hypoglycemia and is not recommended for use late in pregnancy. Glyburide has shown minimal risk of fetal hypoglycemia in human studies, as well as no teratogenicity.8 Women taking sulfonylureas who are contemplating or attempting pregnancy should consider changing to insulin in the preconception period. Other classes of oral antidiabetics are not well studied in pregnancy and are not recommended.3

Hypertension

Hypertension (HTN), common in patients with DM, increases the risk for CVD and microvascular disease.Chronic HTN in pregnancy increases the risk of poor pregnancy outcomes and maternal end-organ damage.1 DM increases the risks for pre-eclampsia and the development and/or progression of retinopathy and nephropathy, which may be exacerbated by HTN.The goal of hypertensive management before and during pregnancy is to optimize blood pressure (BP) control—target BP goals of 110-129/65-79 mmHg are reasonable—using medications with good safety profiles for mother and fetus.Unsafe antihypertensives should be avoided in women at risk for pregnancy and discontinued in those contemplating pregnancy.1,2

Antihypertensives contraindicated in pregnancy include angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, which have been linked to fetal renal dysplasia, oligohydramnios, and intrauterine growth restriction.2 Chronic diuretic use may decrease maternal plasma volume and inhibit uteroplacental circulation.2 Antihypertensives that are safe for use in pregnancy include labetalol, methyldopa, diltiazem, clonidine, and prazosin.2

Dyslipidemia

Dyslipidemia, another common co-morbidity in DM, contributes to CVD risk. Although many women with DM take antihyperlipidemics, most of these medications should not be used during pregnancy. Statins are contraindicated in pregnancy; other antihyperlipidemics, including ezetimibe, bile acid sequestrants, fibrates, and niacin, are not recommended because of insufficient data evaluating risk.9 Women using antihyperlipidemics should be counseled about fetal risks and discontinue these agents prior to conception.2 Omega-3 fatty acids are the only pharmacologic treatment for dyslipidemia known to be safe during pregnancy.9

Overweight/obesity

Overweight/obesity (OW/O) is associated with adverse maternal and fetal outcomes, including pre-eclampsia, macrosomia, and cesarean delivery, and has adverse effects on BP, lipid profile, and glycemic control. Diet and exercise are the cornerstones of weight management; women with DM and OW/O can benefit from referral to an RD. Women should strive to follow a healthful diet that includes monounsaturated fats, fruits, vegetables, and whole grains and limits refined sugar, and engage in ≥150 minutes of moderate-intensity exercise each week.Currently available medications for treatment of obesity are contraindicated in pregnancy; if medications are prescribed for weight loss, they must be discontinued before pregnancy is attempted.8 Women who attempt weight loss through bariatric surgery should delay conception for 12-18 months following surgery to minimize the adverse effects of postsurgical nutritional deficiencies.10

Nephropathy

Healthcare providers should assess patients’ renal function prior to conception and advise them that nephropathy may progress during pregnancy.2 HCPs and patients should aim to optimize control of risk factors for nephropathy, including elevated BP and elevated blood glucose.2

Retinopathy

Retinopathy may occur or progress during pregnancy.Women with DM who are contemplating pregnancy should be referred for a dilated retinal examination prior to conception and should undergo follow-up eye exams every trimester and as indicated during the first postpartum year.2 Optimization of blood glucose control may decrease the risk for progression of retinopathy.2

Conclusion

Nearly half of all pregnancies are unplanned.1 For women with DM, unplanned pregnancy carries a significant risk for poor maternal, fetal, and neonatal outcomes. HCPs should address reproductive life planning and preconception care components with all reproductive-aged patients with the potential to become pregnant. For those with DM, an additional focus on the unique preconception considerations to reduce risks related to DM and promote healthy pregnancy outcomes is important. Optimization of glycemic control; discontinuation of teratogenic medications; management of cardiovascular, renal, and ophthalmic risks; and patient education are essential components of preconception care that can reduce the risks for adverse maternal and fetal effects and optimize pregnancy outcomes.

Cynthia S. Watson and Janis R. Guilbeau are nursing faculty at the University of Louisiana at Lafayette. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

References

References

  1. Farahi N, Zolotor A. Recommendations for preconception counseling and care. Am Fam Physician. 2013;88(8):499-506.
  2. American Diabetes Association. Management of diabetes in pregnancy. Diabetes Care. 2016;39(suppl 1):S94-S98.
  3. American Academy of Clinical Endocrinologists. AACE Diabetes Resource Center. Management of Pregnancy Complicated by Diabetes.
  4. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. July 29, 2016.
  5. Charron-Prochownik D, Fischl AR, Choi J, et al. Mother-daughter dyadic approach for starting preconception counseling at puberty in girls with diabetes. Res J Womens Health. 2014;1.
  6. American Diabetes Association. Foundations of care and comprehensive medical evaluation. Diabetes Care. 2016;39(suppl 1):S23-S35.
  7. U.S. Preventive Services Task Force. Folic acid supplementation for the prevention of neural tube defects. U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2017;317(2):183-189.
  8. Epocrates. Endocrine/metabolism drugs. 2016.
  9. Mukherjee M. Dyslipidemia in pregnancy. Am Coll Cardiology. 2014.
  10. Narayanan RP, Sayed AA. Pregnancy following bariatric surgery—medical complications and management. Obes Surg. 2016;26(10):2523-2529.

Infertility evaluation and treatment

How common is infertility?

After 1 year of having unprotected sex, 15% of couples are unable to conceive—that is, to get pregnant. After 2 years, 10% of couples still have not had a successful pregnancy.

What are the causes of female infertility?

For about a third of couples who have difficulty conceiving, the woman is found to have the problem. In order for a woman to conceive, she needs to ovulate (produce and release eggs from your ovaries), have patent Fallopian tubes (that is, tubes free of blockages), and have a healthy uterus that can support a pregnancy. Fertility can be affected by problems with the menstrual cycle, by a disease or a condition, by lifestyle factors, and/or by age-related factors.

What are the causes of male infertility?

For more than a third of couples who have difficulty conceiving, the man is found to have the problem. To impregnate a woman, a man must have sperm that can reach and combine with a woman’s egg. Sperm are made and stored in the testicles. During sex, sperm mix with seminal fluid, or semen, and are ejaculated by the penis into the woman’s reproductive tract. Infertility in a man is often related to low sperm production, which may be due to a varicocele, an enlarged vein in the testicle. Other causes of male infertility are hormone imbalances, medication or steroid use, and blockages in the reproductive organs.

How is female infertility evaluated?

In addition to a health history and physical exam, your healthcare provider will likely order blood tests to check for conditions such as a thyroid disorder or a high level of the hormone prolactin. Other blood tests may check:

A progesterone level late in the second half of your menstrual cycle to tell if ovulation has occurred and if your ovaries are producing a normal amount of this hormone.

Follicle-stimulating hormone and estradiol levels in the first few days of the menstrual cycle to evaluate ovarian function.

Anti-Müllerian hormone (AMH) level to evaluate ovarian reserve (your remaining egg supply).

Because some of these tests must be done at specific times in the menstrual cycle and repeated for accuracy, this part of your evaluation may take several weeks.

Other tests may be done to examine your Fallopian tubes and determine if a blockage is preventing movement of the egg from the ovaries or preventing the egg and sperm from reaching each other. These tests include a hysterosalpingogram, transvaginal ultrasound (TVUS), and laparoscopy. TVUS can also be used to assess your ovaries, including the number of remaining follicles you have, and it can be used to assess the uterus.

How is male infertility evaluated?

A health history and physical exam are also part of the man’s evaluation. The most common lab test for male infertility is a semen analysis to assess the quantity and quality of the sperm. A man may need to provide a semen sample on more than one occasion because sperm production can vary over time, depending on his activities and stress level.

How is female infertility treated?

Treatment options depend on the cause. If you have a problem with ovulation, you may try a medication that will help your ovaries produce and release eggs. If you have a blockage in a Fallopian tube, you may need to undergo a minor surgical procedure to remove it. If neither medication nor surgery is an option or if the treatment does not work, you may be able to use an assisted reproductive technology (ART) such as in vitro fertilization.

How is male infertility treated?

Medication can treat problems such as hormone imbalances. Surgery can help repair blockages in the tubes that transport sperm from the testicles to the penis. Surgery can be used to repair a varicocele. If medication or surgery does not restore fertility, ART may be considered.

Resources: National Institutes of Health. Eunice Kennedy Shriver National Institute of Child Health and Human Development. When should I consult a healthcare provider? How is infertility diagnosed?

* Readers are invited to photocopy or download a PDF Patient Education pages in the journal and distribute them to their patients.

Maternal Mental Health: Perinatal Depression and Anxiety Patient Safety Bundle

In 2015, the Council on Patient Safety in Women’s Health Care convened an interdisciplinary workgroup to develop an evidence-based patient safety bundle addressing maternal mental health. The 13-member workgroup was co-chaired by NPWH Director of Policy Susan Kendig, JD, MSN, WHNP-BC, FAANP, and American Congress of Obstetricians and Gynecologists representative John P. Keats, MD. The workgroup collaborated over several months, reaching consensus and approval of the Maternal Mental Health: Perinatal Depression and Anxiety Patient Safety Bundle in 2016.

The bundle has four key components: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning (Box). Rather than introducing new guidance, the bundle summarizes existing recommendations and matches them with specific resources to facilitate the implementation of best practices in all maternity care settings. The bundle is designed to be applicable in any setting where prenatal and/or postpartum care is provided. It can be adapted for implementation in preconception/interconception care as well.

Why is a maternal mental health bundle important?

First, healthcare providers (HCPs) need to know what is meant by the term bundle as it applies to healthcare. A bundle is a small set of evidence-based interventions that combines medical and improvement science to achieve improved outcomes. When care processes are grouped into simple bundles, HCPs are more likely to implement them by making fundamental changes in how the work is done. When the care processes are evidence based, subsequent outcomes will improve. Bundled interventions encourage interdisciplinary teams to organize work, adapt the delivery system, and deliver all of the bundle components. An emphasis is placed on improving process reliability. The endpoint is improvement of clinical outcomes.1 

Second, HCPs need to recognize the scope of maternal mental health safety issues. Perinatal mood and anxiety disorders are among the most common complications of pregnancy. Perinatal depression affects one in seven women.2,3 Anxiety disorders affect 13%-21% of women during pregnancy and 11%-17% postpartum.4 When unrecognized or untreated, these conditions can have a devastating effect on women, their infants, and their families. The spectrum of adverse effects includes poor adherence to healthcare recommendations, smoking, substance abuse, loss of financial and interpersonal resources, and a potential adverse effect on maternal–infant bonding/attachment. Depressive psychosis, an extreme form of perinatal depression, can lead to maternal suicide and/or infanticide. In fact, maternal suicide within a year of delivery is emerging as a major cause of maternal mortality and is probably underreported. Because perinatal mood and anxiety disorders are associated with increased risks for maternal and infant morbidity and mortality, they represent a vital patient safety issue.5

Where can HCPs find information about the bundle?

A commentary, Consensus Bundle on Maternal Mental Health: Perinatal Depression and Anxiety, published in the March 2017 issue of the journal Obstetrics and Gynecology, provides information to assist with bundle implementation. This commentary includes a discussion concerning each item within the four key bundle components. In addition, it provides a table listing useful patient/provider educational resources and the websites where these resources can be obtained. Because NPWH provided leadership both in the development of the bundle and in the writing of the commentary (Susan Kendig is the lead author), we at Women’s Healthcare are able to provide you with a link to the full article in Obstetrics and Gynecology.

What is the Council on Patient Safety in Women’s Health Care?

The Council on Patient Safety in Women’s Health Care is a broad consortium of organizations across the spectrum of women’s health established for the promotion of safe healthcare for every woman. The council has a mission to “continually improve patient safety in women’s healthcare through multidisciplinary collaboration that drives culture change” and a vision of “safe healthcare for every woman.” The council membership comprises 19 organizations, including NPWH, as well as patient advocates. NPWH participates in a number of workgroups convened by the council.

One of the major accomplishments of the council has been the development and dissemination of evidence-based patient safety bundles to support ongoing improvement of clinical care and patient outcomes. The council website provides access to live and archived webinars on a variety of topics relevant to promoting a culture of safety in women’s healthcare. The website also provides information on all of the patient safety bundles along with safety resources and tools.

Recommendations

I strongly encourage you to read the commentary, Consensus Bundle on Maternal Mental Health: Perinatal Depression and Anxiety, and to share the information with colleagues who provide prenatal, postpartum, and pre/interconception care. If you provide this care in your own clinical setting, consider using the bundle to facilitate a standardized process to ensure that maternal mental health is always addressed. The bundle is not intended to dictate practice. It is, as described previously, a set of evidence-based interventions that combines medical and improvement science to achieve improved outcomes. The interventions can be adapted in consideration of local resources, but standardization within an institution is important for consistent and safe care.

If you have implemented the bundle in your healthcare setting, please consider writing a short commentary for our journal on the process and outcomes thus far. You can submit your commentaries to me at bkelsey@healthcommedia.com. By sharing our experiences, we can strengthen the resolve to make sure that maternal mental health is always regarded as a safety issue and that it is addressed in an evidence-based manner.

Beth Kelsey is Assistant Professor and DNP Program Director at the School of Nursing, Ball State University, in Muncie, Indiana. She is editor-in-chief of Women’s Healthcare: A Clinical Journal for NPs and NPWH Director of Publications. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

  1. Reser R, Pronovost P, Haraden C, et al. Using a bundle approach to improve ventilator care processes and reduce ventilator-associated pneumonia. Jt Comm J Qual Patient Saf. 2005;31(5):243-248.
  2. Gaynes BN, Gavin N, Meltzer-Brody S, et al. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005;(119):1-8.
  3. Wisner KL, Sit DK, McShea MC, et al. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013;70(5):490-498.
  4. Fairbrother N, Young AH, Janssen P, et al. Depression and anxiety during the perinatal period. BMC Psychiatry. 2015;15:206.
  5. Kendig S, Keats JP, Hoffman MC, et al. Consensus bundle on maternal mental health: perinatal depression and anxiety. Obstet Gynecol. 2017;129(3):422-430.

Human Sex Trafficking

The National Association of Nurse Practitioners in Women’s Health (NPWH) recognizes the critical role of women’s health nurse practitioners (WHNPs) and other nurse practitioners (NPs) who provide healthcare for adolescent and adult females in terms of identifying, assessing, and responding to the needs of trafficked female individuals. Adolescent and young adult females comprise the majority of trafficked persons in the United States and globally, most specifically as victims of sex trafficking. NPs must be well prepared to identify, assess, and provide care for these individuals and have access to the resources to do so.

Many trafficked persons are seen in healthcare settings, yet they remain unidentified.2 Healthcare providers (HCPs) either are not aware of or do not respond to signs, when present, that a patient may be a victim of sex trafficking. A validated screening tool is not yet available. However, NPs can draw from existing evidence in related areas—especially intimate partner violence, sexual assault, homeless and runaway youth, child abuse and neglect, and individuals experiencing trauma in general—for clinical guidance. In addition, NPs can consider practice recommendations from colleagues in social service, advocacy, healthcare, and law enforcement who have expertise in human trafficking identification and intervention.

NPWH supports a comprehensive, coordinated, multidisciplinary approach to meet sex-trafficked individuals’ complex needs and help them address the challenges they face. To that end, NPWH supports research initiatives to develop a validated screening tool to better identify patients who are victims of sex trafficking, as well as to better understand the most effective manner in which to meet their emergency, short-term, and long-term healthcare needs.

Legislation and regulatory policies should focus on eliminating the demand for trafficked individuals in the first place, and on targeting persons and agencies that condone human trafficking. NPWH supports the development of legislation, regulatory policies, and advocacy efforts that protect the safety, rights, dignity, and cultural values of trafficked individuals.

NPWH will provide leadership and collaborate with other organizations and agencies to deliver NP education, develop policies, and conduct or support research in a concerted effort to increase knowledge and provide resources for NPs to identify, assess, and respond to the needs of trafficked female individuals.

Background

In 2000, the U.S. Trafficking Victims Protection Act (TVPA) updated post-Civil War slavery statutes to further guarantee freedom from slavery and involuntary servitude.3 For this purpose, sex trafficking was defined as the recruitment, harboring, transportation, provision, or obtaining of a person, through force, fraud, or coercion, for the purpose of commercial sex act.3 Severe forms of trafficking in persons was defined as sex trafficking in which the person induced to perform such act has not attained 18 years of age or sex trafficking for the purpose of subjection to involuntary services, servitude, peonage, debt bondage, or slavery.3 The TVPA was re-authorized most recently in 2013.4 Today, the terms modern slavery, trafficking in persons, and human trafficking are used as umbrella terms meeting the TVPA definition.

Accurate statistics for the incidence and prevalence of human trafficking are elusive because of the clandestine nature of the crime and trafficked individuals’ reluctance to identify themselves. Worldwide, it is estimated that 20.9 million persons are victims of trafficking and that among this group, 4.5 million (22%) are victims of forced sexual exploitation.5 Within the U.S., trafficked individuals may be transported across borders from other countries or they may already reside here. Data from a Bureau of Justice Statistics report for January 2008 through June 2010 identified 527 confirmed victims of trafficking, with 80% of these cases being classified as sex trafficking, 10% as labor trafficking, and 10% as undetermined.1 Eighty-three percent of the sex-trafficked individuals in this report were U.S. citizens, with 94% of them being female. The commercial sexual exploitation of minors comprised 64% of the cases. Of note, these data reflect only reported and investigated cases; the numbers may greatly under-represent the true extent of the problem. In 2015, the National Human Trafficking Resource Center (NHTRC) hotline received 21,957 calls across all states, with 4,314 calls reporting sex trafficking.6 

Females at high risk for being victims of sex trafficking include those who are young, live in extreme poverty, have limited education and work opportunities, engage in drug use, and/or have a history of instability or abuse in their families of origin. They may be more vulnerable if they have mental or physical disabilities. Adolescent females who are runaways and/or homeless are particularly vulnerable.2,7

Trafficked individuals face numerous barriers to disclosing their situation to HCPs. They may fear harm to themselves, family members, or friends; fear deportation if not legally in the U.S.; have language barriers; distrust authority figures; feel they do not have any options; be ashamed of their situation and the stigma they believe it carries; or have a criminal record. Traffickers may use monitoring devices to track these individuals’ every move to deter them from seeking help. In addition, some trafficked individuals may not under-stand the concept of coercion or that they are victims of an illegal activity.2

Patients who have been trafficked are at high risk for long-term physical and mental health con-sequences related to inflicted trauma and depriva-tion of their basic needs for survival. Health conse-quences may include unintended pregnancies; sexually transmitted infections (STIs), including HIV; poor dentition compounding malnutrition; depression; post-traumatic stress disorder (PTSD); and suicidal ideation. Commonly reported physi-cal symptoms include fatigue, headaches, back pain, and weight loss.8

Implications for women’s healthcare and WHNP practice

WHNPs and other NPs who provide women’s healthcare should be aware of indicators that raise suspicion that an individual presenting to a healthcare setting may be in an exploitative circumstance. Warning signs identified by anti-trafficking experts include:

Hypervigilant, fearful, or submissive demeanor; evidence of being controlled;

Provision of vague answers to questions or a script-like recitation of her history;

Delay between the onset of an injury or illness and the seeking of healthcare, in context with other indicators;

Discrepancies between an individual’s explained cause and the clinical presentation of her injuries;

Accompaniment by another person who answers questions for the individual and refuses to leave her alone during the visit;

Inability to produce identification documents;

Signs of physical abuse (e.g., cigarette burns, bruising), sexual abuse, medical neglect, torture, depression, PTSD, and/or alcohol or substance use disorder;

Tattoos or other markings indicating a claim of ownership by another;

Recurrent STIs;

Trauma to her genitals or rectum; and/or

History of repetitive abortions or miscarriages.2,7,9,10

WHNPs are particularly qualified through their educational preparation to recognize and provide needed healthcare services and referrals for adolescent and adult females who are victims of sexual, physical, and/or emotional abuse. Trauma-informed care for these patients places an emphasis on helping the individual feel safe and reclaim control of her life and decisions. Goals of a trauma-informed approach in care are to avoid re-traumatization, to emphasize the patient’s strengths and resilience, to support development of healthy short- and long-term coping mechanisms, and to promote healing and recovery.2

No official guidelines are available regarding the most effective manner in which to provide for the emergency, short-term, and long-term healthcare needs of trafficked patients. However, expert opinion supports these approaches:

Foster trust and relationship building, which includes an assurance of confidentiality.

Ensure privacy prior to discussing potential trafficking with the patient.

Recognize potential danger to the patient and/or her family members if she reports the crime.

Incorporate safety planning for both the patient and staff.

Use a trauma-informed approach in assessment and treatment.

Provide care for any immediate needs (e.g., treat STIs, diagnose a pregnancy).

Provide culturally appropriate services.

Mitigate language barriers; provide a professional interpreter when needed.

Establish a list of local resources for collaboration that provides wraparound services for the individual.

Contact the NHTRC hotline at 1-888-373-7888 for guidance on the next steps and referrals if needed.2,7,11

The NHTRC provides detailed information for HCPs concerning identification, assessment, and response to the needs of patients who have been trafficked.

Recommendations

WHNPs and other NPs who provide healthcare for adolescent and adult females should:

Be familiar with and educate staff about warning signs indicating that a patient may be a victim of sex trafficking;

Establish a plan in the healthcare setting for safety of both the patient and staff;

Establish partnerships with local social service providers, mental health providers, religious leaders, legal advocates, and law enforcement representatives for comprehensive services;

Serve as change agents in their communities through mentoring programs for at-risk youth, advocacy for policy changes to aid recovery of trafficked individuals, and engagement in activities that will promote greater cultural awareness of gender inequalities; and

Assess their own learning needs with regard to the unique and complex needs of trafficked individuals and seek continuing education as appropriate.

NPWH will provide leadership and resources to ensure that:

Educational programs for NP students with a population focus that includes adolescent and adult females impart evidence-based knowledge and skill building for the development of competencies to identify trafficked individuals and provide healthcare and appropriate referrals for them; and

Continuing education programs are available for NPs to obtain evidence-based knowledge and competencies to identify and provide healthcare and appropriate referrals for trafficked individuals.

References

1. Banks D, Kyckelhahn T. Characteristics of Suspected Human Trafficking Incidents, 2008-2010. Washington, DC: U.S. Department of Justice, Office of Justice Programs, Bureau of Justice Statistics; 2011. 

2. Alpert EJ, Ahn R, Albright E, et al. Human Trafficking: Guidebook on Identification, Assessment, and Response in the Health Care Setting. Waltham, MA: MGH Human Trafficking Initiative, Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, and Committee on Violence Intervention and Preven-tion, Massachusetts Medical Society; 2014.

3. 106th U.S. Congress. Victims of Trafficking and Violence Protection Act of 2000, Public Law 106-386. 2000. 

4. U.S. Department of State. U.S. Laws on Trafficking in Persons. 2016. 

5. International Labor Organization. ILO 2012 Global Estimate of Forced Labor: Executive Summary. 2012. 

6. National Human Trafficking Resource Center. 2015 NHTRC Annual Report. 2016. 

7. Clawson H, Dutch N, Solomon A, Grace L. Human Trafficking Into and Within the United States: A Review of the Literature. U.S. Department of Health and Human Services, Office of the Assistant Secretary of Planning and Evaluation; 2009. 

8. World Health Organization. Understanding and Addressing Violence Against Women: Human Trafficking. 2012. 

9. Baldwin SB, Eisenman DP, Sayles JN, et al. Identification of human sex trafficking victims in health care settings. Health Hum Rights. 2011;13(1):36-49. 

10. National Human Trafficking Resource Center. Identifying Victims of Human Trafficking: What to Look for in a Healthcare Setting. 2016. 

11. Dovydaitis T. Human trafficking: the role of the health care provider. J Midwifery Womens Health. 2010;55(5):462-467. 

Evaluation of women with infertility

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Key words: infertility, infertility evaluation, ovulatory dysfunction, ovarian reserve, tubal patency

Advanced practice nurses (APNs) may be the first point of contact in a woman’s lengthy fertility journey. Although caring for a patient with infertility is within the scope of practice of APNs, this process can be intimidating and complex. APNs need to set realistic expectations, educate patients, and provide initial management. The author discusses the initial evaluation of a woman with infertility prior to a referral to a reproductive endocrinology and infertility specialist if necessary.

As many as 15% of couples trying to conceive a child are diagnosed with infertility, defined as the inability to conceive within 1 year despite unprotected intercourse.1 Because advancing maternal age is a driving force in the decline of fertility, the time span in the definition may reasonably be altered to 6 months for women older than 35 years. Overall fertility rates, which peak between the ages of 20 and 24 years, are 4%-8% lower in women aged 24-29, 15%-19% lower in those aged 30-34, 26%-46% lower in those aged 35-39, and as much as 95% lower in those aged 40-45.1 

Infertility is a complex diagnosis that can greatly affect physical, mental, and financial aspects of a couple’s life together.2 In general, infertility is considered a couple’s diagnosis because 35%-40% of cases are due to male factors, 30%-40% to female factors, and up to 30% to a combination of male and female factors or unexplained factors.1 Common causes of infertility in women are ovulatory dysfunction and tubal/peritoneal pathology, and a common cause of infertility in men is a sperm abnormality.3 

Referral to a specialist in reproductive endocrinology and infertility (REI) is considered early in the assessment of infertility in a woman with endometriosis, tubal disease, a history of three or more spontaneous abortions, or previous ovulation induction, or in a case of male factor infertility. When known risk factors exist, or when a woman is older than 35 years, APNs should not wait to initiate assessment and referral until a couple has tried to conceive for a full year. However, women who have not previously tried ovulation induction medications, are anovulatory, have polycystic ovary syndrome (PCOS), or have unexplained infertility may be treated by an APN for 3-6 months prior to referral.4 Male factor infertility may be addressed with an intrauterine insemination if an andrology laboratory is available. Knowing the appropriate components and timing of an infertility assessment is essential.

History

The APN takes a thorough history from each partner. The APN needs to learn how long the couple has been trying to conceive and the results of any previous evaluation to ensure that testing is not repeated unnecessarily.

The woman

A full menstrual history is obtained, including age at menarche, cycle length, characteristics of bleeding, and presence or absence of moliminal symptoms (e.g., bloating, breast tenderness). Absence of moliminal symptoms may suggest anovulation.1 The woman is asked about prior contraception use; her obstetric history, including pregnancy outcomes and complications (e.g., ectopic pregnancy, cesarean delivery, dilation and curettage procedures); past surgeries; current medications; recent weight changes; signs and symptoms of thyroid disease; pelvic or abdominal pain; galactorrhea; hirsutism; and dyspareunia. A history of chlamydia, gonorrhea, or pelvic inflammatory disease (PID) increases the potential for tubal damage and raises suspicion of tubal infertility disease.1,5 

A thorough family history includes a discussion of reproductive outcomes and the existence of birth defects, mental retardation, early menopause, and/or genetic abnormalities.1 The American Congress of Obstetricians and Gynecologists recommends taking a detailed family history and, depending on a woman’s ethnicity, performing preconception carrier screening for cystic fibrosis, sickle cell disease, Tay-Sachs disease, thalassemia, familial dysautonomia, and Canavan disease.6 

The man

Male infertility may be influenced by lifestyle factors (e.g., obesity; use of certain medications, alcohol, or tobacco) or a genetic condition (e.g., cystic fibrosis) or it may be idiopathic. Evaluation begins with a thorough reproductive history to assess for coital frequency and timing, duration of infertility, results of any past evaluations, childhood illnesses (e.g., mumps), systemic illness (e.g., diabetes mellitus, hypertension), past genitourinary surgery (e.g., orchiectomy, hernia repair), sexual history (e.g., erectile dysfunction, history of sexually transmitted infections), and exposure to environmental toxins.7 The history entails a thorough review of systems, a complete family reproductive history, and a social history, including use of recreational drugs, steroids, tobacco, or alcohol (these substances can affect semen parameters).

Physical examination

The woman

The APN performs a targeted physical examination to explore causes of infertility. Weight and body mass index (BMI) are calculated. Ovulatory dysfunction may occur at any BMI level but is more common when it falls outside the healthy range (20-24 kg/m2).1  The thyroid is assessed for enlargement, presence of nodules, or tenderness. Signs of androgen excess (e.g., hirsutism, acne) are noted, as are characteristics of any breast/nipple discharge. Abdominal and bimanual exams are performed to assess for tenderness, organ enlargement, and masses. Pelvic tenderness in the posterior cul-de-sac or uterosacral ligaments may indicate endometriosis. The uterus is palpated for enlargement or immobility, which may indicate fibroids, uterine anomaly, endometriosis, or pelvic adhesions.8 A speculum exam is done to assess the cervix for the presence of abnormalities, secretions, or discharge, which may suggest a pelvic infection.

The man

In the absence of a history of trauma, surgery, genital abnormality, or sexual dysfunction, the physical exam of the man may be deferred pending a semen analysis. An abnormal history or semen analysis finding warrants a physical exam by a urologist or an REI specialist. If a physical exam by the APN is deemed appropriate in a given case, it consists of an inspection of the penis, noting the location of the urethral meatus and the presence of hypospadias; palpation of the testes; ascertainment of the presence and consistency of the vas deferens and the epididymis; and determination of the presence of a varicocele. The APN notes the presence of secondary sex characteristics such as stature, hair distribution, and breast tissue distribution. A digital rectal exam may be considered to evaluate the prostate.1 

Diagnostic testing

Ovulatory function

In order for a woman to conceive, several components are necessary: ovulation, patent Fallopian tubes, a suitable uterine environment, and motile sperm capable of fertilization. Ovulatory dysfunction accounts for up to 40% of female infertility cases and is identified in about 15% of couples.1  Ovulation may be assessed by a mid-luteal progesterone level, an ovulation predictor kit, basal body temperature (BBT) measurements, or mid-cycle ultrasound. In some cases, a menstrual history may be sufficient. If a woman does not have regular and predictable menstrual cycles occurring every 21-35 days, further evaluation is necessary.

A mid-luteal progesterone level is assessed 7 days before expected menses; for a woman with a regular 28-day cycle, progesterone is assessed on cycle day 21.8 For a woman with irregular cycles, this assessment may occur later in the menstrual cycle. A progesterone level greater than 3 ng/mL provides evidence of recent ovulation, although levels greater than 10 ng/mL better reflect good luteal function.9 If the progesterone level is less than 3 ng/mL, the level is rechecked 5-7 days later. If the level remains low, the woman is further evaluated for anovulation.

A woman may choose to use an ovulation predictor kit, also known as a urine luteinizing hormone (LH) kit, to track her ovulation. A woman begins using daily test strips several days before anticipated ovulation to identify the mid-cycle LH surge that precedes ovulation by about 36 hours. The test kit identifies peak fertility as the day of the surge and the following day. The kit is not reliable for all women, particularly those with premature ovarian failure or PCOS, because LH levels may already be elevated.

Although not widely recommended, another option for ovulation detection is the BBT method, an inexpensive way to look retrospectively at the ovulation time frame. An oral temperature is taken at the same time every morning before rising. About 2 days following ovulation, a woman’s temperature rises roughly 0.5° F. Charting this temperature shift can help a woman better identify her ovulation pattern and peak fertility in subsequent months. Of note, evaluating an increase in cervical mucus or using an ovulation predictor kit has been found to be more reliable than BBT in terms of attempting to achieve a pregnancy in the current cycle.10

Ovarian reserve

Oocytes decrease in quantity and quality as women age and are incapable of regenerating. The number of human oocytes peaks at 6-7 million at 20 weeks’ gestation; by the time a female reaches puberty, only 300,000-500,000 oocytes remain. During her lifetime, a woman will ovulate 400-500 eggs. To assess a woman’s fertility potential and determine a treatment plan, the APN must first assess ovarian reserve, which is done by measuring basal follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) levels and performing ovarian imaging early in the follicular phase to evaluate the antral follicle count (AFC).

There is debate regarding the age at which to begin ovarian reserve testing. Current thinking is to recommend such testing for women older than 35 years who have not conceived after 6 months of regular unprotected intercourse.11 The APN may consider testing a woman at an earlier age if certain risk factors are present: anovulation, family history of early menopause, certain genetic conditions such as fragile X or Turner syndrome, history of endometriosis or pelvic infection, previous ovarian surgery, history of cancer treated by gonadotoxic therapy or pelvic radiation, and tobacco use.

Ovarian reserve testing is not infallible and it does not determine the end of a woman’s reproductive capability, nor does it predict the rate in which reproductive potential will diminish. The purpose is to assess the quality and quantity of the remaining oocytes to predict reproductive potential and, for the APN, the time to refer to a specialist. When results fall outside the normal range, the APN can encourage the patient to pursue more aggressive treatment options, which often include referral to an infertility specialist. Ovarian reserve can be assessed by measuring/doing the following:

Basal follicle-stimulating hormone/estradiol

Low estradiol levels early in each menstrual cycle trigger increased secretion of gonadotropin-releasing hormone, leading to increased release of FSH. Then, as the developing cohort of follicles produces estradiol and inhibin B, the increased FSH is suppressed by negative feedback. As a woman ages, a smaller cohort of follicles is available to produce estradiol and inhibin B, which increases secretion of FSH. The robust secretion of FSH stimulates rapid follicular growth and higher estradiol levels, resulting in a shorter follicular phase.11

Estradiol and FSH levels are measured on menstrual cycle days 2-4. FSH values greater than 10 mIU/ mL are associated with diminished ovarian reserve and poor response to ovarian stimulation. Because each menstrual cycle can vary, a single elevated FSH level does not predict an inability to conceive and, therefore, has limited reliability.12 During follicular development, estradiol is released from the developing follicles. In the early follicular phase (typically, cycle day 2-4), the estrogen level is usually less than 50 pg/mL. An elevated value (>60-80 pg/mL) may indicate oocyte depletion.13 For measurements to be meaningful, both FSH and estradiol levels are drawn on menstrual cycle days 2-4.

Clomiphene citrate challenge test

The CCCT may be considered for ovarian reserve testing, although it does not clearly improve FSH and estradiol test accuracy for predicting poor ovarian response or pregnancy after in vitro fertilization (IVF).14 The test requires measurement of cycle day 3 FSH and estradiol levels, followed by administration of clomiphene citrate 100 mg on cycle days 5-9. An FSH level is drawn again on cycle day 10; it should remain below 10 mIU/mL. If either the FSH or the estradiol level on day 3 or the FSH on day 10 is elevated, the patient likely has impaired ovarian function and a referral is warranted. Use of the CCCT has declined because newer tests such as AMH and AFC are simpler and have high predictive values.11

Serum anti-Müllerian hormone

Anti-Müllerian hormone is secreted by the granulosa cells of the pre-antral follicles and is reflective of the primordial oocyte pool.15 As women age and the number of oocytes decreases, the AMH level drops as well. The AMH level may be an earlier predictor of decreased ovarian reserve than FSH levels; it begins to decline early in the ovarian aging process, whereas elevated serum FSH levels are not found until cycles are already irregular.16 The advantage of determining the AMH level is that it remains constant throughout the menstrual cycle and may be drawn at any time.11 Evidence suggests that AMH levels may be diminished with oral contraceptive use and in women with obesity.17 By contrast, women with PCOS have been noted to have AMH levels 2-3 times higher than unaffected women. Overall, an AMH value of 1.0 mg/mL predicts an FSH value of 10.0 mIU/mL. Higher AMH levels suggest normal ovarian function, whereas lower levels have been associated with poor ovarian stimulation and poor pregnancy outcomes.18 Women whose levels fall outside the normal range should be referred to an REI specialist.

Antral follicle count

Ultrasound, although expensive, is another useful tool in evaluating ovarian reserve. AFC is the sum of the antral follicles in both ovaries early in the follicular phase (cycle days 1-4). Antral follicles have been defined as measuring 2-10 mm in diameter. A total of 3-6 antral follicles is considered low, and is associated with poor response in IVF. However, a low value is not predictive of a patient’s ability to conceive.19 No single test has 100% specificity and sensitivity; biochemical assays and imaging should be used in combination to most accurately evaluate ovarian reserve.

Tubal patency

Impaired tubal patency is another common cause of infertility. When tubal disease is suspected by patient history (e.g., chlamydia, gonorrhea, PID, previous ectopic pregnancy, tubal surgery), a hysterosalpingogram (HSG) is considered.8 An HSG can evaluate tubal patency and may have some therapeutic benefit. HSG is typically performed in the late follicular phase, or 2-5 days after the end of menstruation. An HSG can document tubal patency and uterine abnormalities, including filling defects (polyps and fibroids) and uterine malformations (e.g., septum, bicornuate uterus). If an abnormality is noted, a referral is warranted.

Semen analysis

For the male partner, a semen analysis is considered early in the evaluation. This analysis is the most accurate evaluation of male fertility and can be used as a cost-effective way to quickly exclude male factors as the cause of a couple’s infertility. If the semen analysis yields normal results, attention is then focused on the female partner.

Prior to semen collection, the male partner should have an abstinence window of 2-5 days (2-3 days is preferred).20 The analysis may be performed in a fertility center or a urology office where an andrology lab is available. The semen sample is collected in a sterile container provided by the lab. If the man chooses to collect the sample outside the lab, it must be kept warm and delivered within 1 hour of collecting. Normal results for a semen analysis include a volume of 1.5 mL or greater, more than 39 million sperm per ejaculate, total motility of 40%, progressive motility (linear movement) of 32%, and 4% normal forms. If the analysis yields abnormal findings, efforts are made to identify modifiable factors to improve the natural ability of the man’s sperm to fertilize an ovum. Because semen samples can fluctuate, the semen analysis is repeated in 4-6 weeks. If results remain abnormal on repeat evaluation, referral to an infertility specialist is advised.7 

Conclusion

A diagnosis of infertility is life altering for many couples, with lasting psychological impact. The cause of infertility is often multifactorial and complex, leading to frustration in both providers and patients. Because of the substantial emotional, financial, and physical burden to patients, providers must practice with a holistic and therapeutic approach. APNs are in an excellent position to provide this holistic care for their patients, addressing aspects of both physical and emotional well-being. Resources for patients are listed in the Box.

Much of fertility testing is cycle dependent and cannot be completed at a single visit. Therefore, a month or more may be spent completing diagnostic testing before treatment takes place. The APN must assess patient expectations and explain that the evaluation takes time. Once test results are received, the APN may decide to treat with ovulation induction medication (e.g., clomiphene citrate) and timed intercourse for several months or refer to an REI specialist. Because of the length and intimacy of the evaluation, patients may feel more comfortable working with an APN with whom they have already established a trusting relationship before referral to a specialist.

References

  1. Fritz MA, Speroff L. Clinical Gynecologic Endocrinology and Infertility. 8th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
  2. Benyamini Y, Gozlan M, Kokia E. Variability in the difficulties experienced by women undergoing infertility treatments. Fertil Steril. 2005;83(2):275-283.
  3. Hull M, Glazener C, Kelly NJ, et al. Population study of causes, treatment, and outcome of infertility. BMJ. 1985;291:1693-1697.
  4. Devine KS. Caring for the infertile woman. MCN Am J Matern Child Nurs. 2003;28(2):100-105.
  5. Akande VA, Hunt LP, Cahill DJ, et al. A cohort study of the prediction of Chlamydia infection causing subfertility, the value of treatment independent management and prognosis for pregnancy in 1119 women following laparoscopy. Presented at: British Congress of Obstetrics and Gynaecology; 2011; Birmingham, UK.
  6. American Congress of Obstetricians and Gynecologists. Preconception Carrier Screening. August 2012.
  7. Practice Committee for the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile male: a committee opinion. Fertil Steril. 2015;103(3):e18-e25.
  8. Practice Committee for the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2015;103(6):e44-e50.
  9. Quaas A, Dorkras A. Diagnosis and treatment of unexplained infertility. Rev Obstet Gynecol. 2008;1(2):69-76.
  10. Barron ML, Fehring RJ. Basal body temperature measurement: is it useful to couples seeking pregnancy? J Matern Child Nurs. 2005;30(5):290-296.
  11. Practice Committee of the American Society for Reproductive Medicine. Testing and interpreting measures of ovarian reserve: a committee opinion. Fertil Steril. 2015;103(3):e9-e17.
  12. Kwee J, Schats R, McDonnell J, et al. Intercycle variability of ovarian reserve tests: results of a randomized study. Hum Reprod. 2004;19(3):590-595.
  13. Cahill DJ, Wardle PG. Management of infertility. BMJ. 2002;325(7354):28-32.
  14. Hendriks DJ, Mol BW, Bancsi LF, et al. The clomiphene citrate challenge test for the prediction of poor ovarian response and nonpregnancy in patients undergoing in vitro fertilization: a systematic review. Fertil Steril 2006;86(4):807-818.
  15. Nelson SM. Biomarkers of ovarian response: current and future applications. Fertil Steril. 2013;99(4):963-969.
  16. de Vet A, Laven JS, de Jong FH, et al. Antimüllerian hormone serum levels: a putative marker for ovarian aging. Fertil Steril. 2002;77(2):357-362.
  17. Kallio S, Puurunen J, Ruokonen A, et al. Antimüllerian hormone levels decrease in women using combined contraception independently of administration route. Fertil Steril. 2013;99(5):1305-1310.
  18. Singer T, Barad DH, Weghofer A, Gleicher N. Correlation of antimüllerian hormone and baseline follicle stimulating hormone levels. Fertil Steril. 2009;91(6):2616-2619.
  19. Hendriks DJ. Mol BW, Bancsi LF, et al. Antral follicle count in the prediction of poor ovarian response and pregnancy after in vitro fertilization: a meta-analysis and comparison with basal follicle stimulating hormone level. Fertil Steril. 2005:83(2):291-301.
  20. Cooper TG, Noonan E, von Eckardstein S, et al. World Health Organization reference values for human semen characteristics: Hum Reprod Update. 2010;16(3):231-245.

Web resources (for the Box)

B. reproductivefacts.org/Booklet_Infertility_An_Overview/

C. reproductivefacts.org/FACTSHEET_Diagnostic_Testing_for_Female_Infertility/

D. acog.org/Patients/FAQs/Evaluating-Infertility

E. brighamandwomens.org/Departments_and_Services/obgyn/Services/infertility-reproductive-surgery/infertility-services/education-consent-forms.aspx

F. aafp.org/afp/2015/0301/p308-s1.html

G. cdc.gov/reproductivehealth/Infertility/

Inside Knowledge: Get the Facts About Gynecologic Cancer

The Inside Knowledge campaign raises awareness of the five main types of gynecologic cancer: cervical, ovarian, uterine, vaginal, and vulvar. Inside Knowledge encourages women to pay attention to their bodies, so they can recognize any warning signs and seek medical care.

New television and radio public service announcements in English and Spanish feature actress Cote de Pablo, talking about her own cervical cancer scare, and sharing advice for other women. And check out the new posters telling Cote’s story, as well as our Behind-the-Scenes videos from filming!

Inside Knowledge also has new TV and radio PSAs that highlight gynecologic cancer symptoms. The PSAs encourage women to learn the symptoms, and pay attention to what their bodies are telling them.

Inside Knowledge has resources for women, and for health care providers and organizations to share with their patients and communities.

Read more and access the resources here at the CDC’s website

Prevention and Management of Opioid Misuse and Opioid Use Disorder Among Women Across the Lifespan

The National Association of Nurse Practitioners in Women’s Health (NPWH) supports the role of women’s health nurse practitioners (WHNPs) and other nurse practitioners (NPs) who provide healthcare for women across the lifespan in the provision of safe and effective treatment of pain. In certain cases, this treatment may include the prescription of opioid pain relievers (OPR). NPWH acknowledges that NPs must use evidencebased strategies to reduce harm from the misuse of OPR and to prevent the development of opioid use disorder (OUD). These strategies include screening for opioid use/misuse/abuse, educating patients about the risks associated with OPR misuse, and following evidence-based guidelines when prescribing OPR.1,2 In addition, when OUD is identified, NPs qualified to provide medication-assisted treatment (MAT) should follow evidence-based guidelines and prescribe within federal and state regulations.

Use of OPR in general should be reserved for acute pain resulting from severe injuries, medical conditions, or surgical procedures, and only when non-opioid alternatives are ineffective or contraindicated. When OPR are prescribed, they should be given at the lowest necessary dose for the shortest duration (usually <14 days).2 Although many NPs in primary care treat acute pain, the treatment of chronic pain is best achieved through a multimodal and multidisciplinary approach that includes a team member with expertise in pain management. This approach is particularly advantageous when chronic pain management includes OPR use.1,2 NPs should consider evidence-based nonpharmacologic therapies and non-opioid medications as first-line treatment for chronic pain. Primary care NPs with adequate training who prescribe OPR for chronic pain should follow evidence-based guidelines such as those provided by the CDC.1

Whether prescribing OPR for acute or chronic pain, NPs should use risk-mitigation strategies to reduce the potential for harm from misuse or abuse. These strategies include checking state prescription drug monitoring programs when available to assess a patient’s history of controlled substance use, avoiding concurrent prescription of benzodiazepines, and establishing realistic treatment goals with patients. In addition, overdose mitigation includes consideration of co-prescribing the opioid antagonist naloxone when appropriate, along with education about its use to reverse respiratory depression from OPR overdose.1-3

For individuals with OUD, MAT has proven to be clinically effective.4-7 MAT entails the use of medications along with counseling and behavioral therapies to treat OUD and to prevent opioid overdose.4 This recovery-oriented treatment approach has been shown to improve patient survival, increase retention in treatment, decrease drug-related criminal activity, increase patients’ ability to gain and maintain employment, and improve birth outcomes among pregnant women with OUD.The Comprehensive Addiction and Recovery Act (CARA) was signed into law in July 2016.The law includes a section authorizing NPs who meet certain criteria, including participation in a mandatory 24-hour education program, to receive a waiver to prescribe the opioid agonist buprenorphine as a crucial component of treatment for OUD. NPs who receive this education and waiver are able to work within their individual state prescribing laws to provide increased access to OUD treatment.

NPWH will provide leadership and collaborate with other organizations and agencies to deliver NP education, develop policies, and conduct and/or support research, all in a concerted effort to increase knowledge and provide resources for NPs to prevent and reduce harm from OPR misuse. NPWH will actively monitor and engage in the process needed to implement CARA so that access to treatment for OUD can reach all women in need.

Background

Pain can be acute or chronic in nature. Acute pain may be related to disease, injury, or recent surgery and typically diminishes with tissue healing. Chronic pain is consistent pain that lasts more than 3 months; usually has neurologic, emotional, and behavioral components; and often affects function, social roles, and quality of life.1,2 At least 116 million adults in the United States have chronic pain conditions.9

Some efforts to improve pain management, despite clinicians’ best of intentions, have had adverse effects. The number of prescriptions for OPR quadrupled between 1999 and 2013.10,11 During this same time period, deaths from opioid use/misuse have also quadrupled.10 In 2014, more than 28,000 persons in the U.S. died of opioid overdoses, with at least half of these overdoses involving prescription OPR.10 These overdose death rates are highest among persons aged 25-54 years.10 

Lethal overdose is not the only risk associated with prescription OPR. Every day, more than 1,000 persons are seen in emergency departments (EDs) for reasons related to misusing prescription OPR.12 Hospital admissions for nonfatal overdoses are on the rise. Other serious consequences include falls and fractures in older adults, sleep-disordered breathing, cardiac arrhythmias related to methadone use, and immunosuppression.2

More than 4 million persons in this country abuse or are dependent on opioids.13 In fact, as many as 1 in 4 persons receiving prescription OPR in primary care settings for chronic noncancer pain struggles with addiction.14 More than 60% of persons taking OPR for at least 3 months are still taking them 5 years later.2 Abuse of OPR results in more than $72 billion in medical costs each year, which is similar to the cost of chronic diseases such as asthma and HIV infection.3

About 25% of persons who abuse OPR obtain them through their own prescriptions, and about 50% of persons who abuse prescription OPR obtain them for free or buy them from friends or relatives.15 Others get OPR by stealing from friends or relatives or from drug dealers.15 If unable to obtain prescription OPR, persons with OUD may turn to heroin. In fact, dependence on or abuse of prescription OPR has been associated with a 40-fold increased risk of dependence on or abuse of heroin.16

The increase in OPR prescriptions has not been accompanied by an overall change in the amount of pain reported. Recent systematic reviews have shown at most only modest benefits of OPR for chronic pain when balanced with potential risk of harm.17,18

The use of safer and more effective treatments for chronic pain could reduce the number of persons who develop OUD or experience an overdose or other adverse event related to opioid use. Studies have supported a range of effectiveness for nonpharmacologic approaches to chronic pain management that include behavioral, psychological, and physical-based therapies and non-opioid pharmacologic treatments such as acetaminophen, non-steroidal anti-inflammatory drugs, and selected anticonvulsants and antidepressants. Use of multiple modalities is likely to be more effective than a single modality.1,2 Because of the complexities involved, the initiation of treatment and the ongoing care for patients with chronic pain are most safely and effectively directed by a multidisciplinary team that includes pain management specialists.1,2

The CDC’s OPR prescribing guidelines include a recommendation for clinicians to offer or facilitate MAT for patients with OUD.1 MAT is underutilized, with only 20% of adults with OUD receiving needed treatment each year. Cost and access are primary barriers.19 With implementation of CARA, NPs, as part of the treatment team, will be able to prescribe some of the medications used in MAT, thereby expanding access to patients.

Implications for women’s healthcare and WHNP practice

Although both men and women experience opioid misuse/abuse and related fatalities, certain gender-related differences exist. Women, when compared with men, are more likely to be prescribed OPR, to use these agents long term, and to receive prescriptions for higher doses.20 Every 3 minutes, a woman goes to the ED for a reason related to prescription OPR misuse/abuse.21 Evidence suggests that women, relative to men, may progress to dependence on OPR at a more accelerated rate.22 

Men are more likely than women to die of an opioid overdose, but the gap is closing. Prescription OPR overdoses in women cause more deaths than do overdoses of benzodiazepines, antidepressants, and heroin combined.21 In fact, for women, OPR are involved in 7 out of 10 prescription drug-related deaths. Intentional OPR overdoses are involved in 1 in 10 suicides among women.2020

The potential for adverse events related to OUD extends to women across the lifespan and beyond the direct health effects. OUD places women at risk for behaviors that further jeopardize their well-being, including prostitution, stealing, and other criminal activities that are often associated with violence. Women with OUD may engage in these risky behaviors in order to support themselves and their addiction. These behaviors place these women at risk for experiencing legal ramifications of their criminal activities, being victims of violence, and acquiring sexually transmitted infections. Women who inject opioids through intravenous or intradermal routes are at added risk for contracting HIV and hepatitis C infections.3,23

Nurse practitioners should ask female patients of all ages about the use of prescription OPR and other medications for nonmedical reasons as part of routine alcohol and substance use screening. Validated screening tools are available to use with adolescents, pregnant women, and adults.23,24 Early identification of opioid misuse/abuse allows NPs to provide evidence-based brief interventions,25 actively participate in MAT if they meet criteria for prescribing treatment medication, and/or make referrals for additional services when needed.

AdolescenceAttention to prevention, as well as early identification of opioid misuse and OUD in adolescents, is critical. In 2014, 467,000 adolescents were nonmedical users of OPR, with 168,000 having OUD.13 Most adolescents who misuse OPR get the drugs from a friend or relative rather than through their own prescription.26 Girls aged 12-17 years may be particularly vulnerable. These girls are more likely than males in this age group to use psychoactive drugs, including OPR, for nonmedical reasons, and they are more likely to become dependent.27 NPs should screen adolescents for opioid misuse and OUD. It is particularly important to follow state and federal regulations regarding confidentiality when an adolescent needs OUD treatment.28

The reproductive yearsSubstance abuse, including abuse of opioids, is most prevalent during the reproductive years. OPR are widely prescribed for women in this age group. NPs should assess pregnancy status, sexual activity, and contraceptive use before prescribing OPR to reproductive-aged women.10 For women who are pregnant or could become pregnant while using OPR, NPs should discuss potential risks versus benefits, as well as alternative treatments. Data are limited, with a few studies suggesting a small increased risk for birth defects (e.g, neural tube defects, gastroschisis, congenital heart defects) associated with maternal OPR use, particularly when drug exposure occurs in early pregnancy.29-31 As would be done with all patients, when OPR are indicated for treatment of acute pain in women who are pregnant, NPs should prescribe the lowest dose for the shortest duration of use. Care of pregnant women taking OPR for chronic pain should be multidisciplinary.

Medication-assisted treatment is important for pregnant women with OUD. Withdrawal from opioid use during pregnancy has been associated with adverse outcomes such as preterm labor and fetal demise.23 Continuous exposure to opioids in utero —whether opioid use is illicit, prescribed for maternal pain, or through MAT—may lead to neonatal opioid withdrawal syndrome (OWS). Neonates with known in utero opioid exposure should be monitored for and treated as needed for withdrawal symptoms. The range and severity of symptoms experienced by neonates are related to the type of opioid, the duration of exposure, and concomitant exposure to other substances while in utero.32,33

Many pregnant women with OUD are late in seeking prenatal care and are erratic in attending appointments.23 But early, regular prenatal care is essential for women with OUD so that they can receive support and early treatment referrals to reduce their risks of harm and adverse pregnancy outcomes. Laws that require reporting of substance abuse during pregnancy may deter women with OUD from seeking prenatal care.34,35 NPWH opposes policies that require reporting or criminalization of substance abuse during pregnancy and supports repeal of existing laws with such mandates. WHNPs and other NPs who provide healthcare for pregnant women are on the forefront to identify, support, and provide appropriate referrals and collaborative care for pregnant women with OUD.

Mothers receiving MATwith the exception of those who are HIV positive or continuing to use illicit substances—should be encouraged to breastfeed.23,28,36 Breastfeeding supports mother–infant bonding and may reduce the severity and duration of neonatal OWS.37,38 Minimal levels of methadone or buprenorphine are found in breast milk, regardless of the maternal dosage.22,39 Both medications are considered safe during breastfeeding.23,36,39 It is important to maintain open lines of communication for early identification of relapse. If relapse does occur, mothers should be provided with assistance to transition to bottle feeding with formula or donor milk.36

Older ageAlthough women older than 65 years are generally at low risk for opioid abuse, specific concerns regarding their use of OPR still exist. WHNPs and other NPs who provide healthcare for older women should be cognizant of potential increased risks with OPR use related to reduced renal function and drug clearance, co-morbidities, polypharmacy, and impaired cognition, as well as an increased risk for falls and fractures.1 Even women older than 65 can experience OUD.

Recommendations

Women’s health NPs and other NPs who provide healthcare for women should:

Use evidence-based guidelines for management of acute and chronic pain.

Use risk-mitigation strategies when prescribing OPR for acute or chronic pain.

Assess pregnancy status, sexual activity, and contraceptive use, as well as discuss potential risks and benefits, before prescribing OPR to women who are pregnant or could become pregnant.

Use a nonjudgmental, respectful approach when broaching the topic of substance use/abuse.

Screen all women at least annually—at well-woman visits, initial prenatal visits, and other visits when indicated—for substance use/abuse with a validated screening tool. Include questions concerning use of prescription drugs for nonmedical purposes.

Provide an evidence-based brief intervention when substance abuse is identified and make referrals for additional services as needed. Know which services are available in the community.

Use evidence-based guidelines if prescribing OUD treatment medication in collaboration with an MAT team.

Collaborate in specialty care for pregnant women with OUD.

Be aware of state reporting laws for substance abuse during pregnancy and advocate for retraction of legislation that exposes pregnant women with substance use disorders to criminal or civil penalities.

References

1. Dowell D, Haegerich TM, Chou R. CDC. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49.

2. Washington State Agency Medical Directors’ Group. Interagency Guideline on Prescribing Opioids for Pain. 2015.

3. U.S. Department of Health and Human Services, Behavioral Health Coordinating Committee, Prescription Drug Abuse Subcommittee. Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities. 2013.

4. SAMHSA. Medication and Counseling Treatment. 2015.

5. Addiction Treatment Forum. MAT with Methadone or Buprenorphine: Assessing the Evidence for Effectiveness. 2014.

6. Fullerton CA, Kim M, Thomas CP, et al. Medication- assisted treatment with methadone: assessing the evidence. Psychiatr Serv. 2014;65(2):146-157.

7. Thomas CP, Fullerton CA, Kim M, et al. Medication-assisted treatment with buprenorphine: assessing the evidence. Psychiatr Serv. 2014;65(2):158-170.

8. U.S. Congress. S.524 – Comprehensive Addiction and Recovery Act of 2016.

9. Tsang A, Von Korff M, Lee S, et al. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain. 2008;9(10): 883-891.

10. CDC. Wide-Ranging Online Data for Epidemiologic Research (Wonder). Atlanta, GA: CDC, National Center for Health Statistics; 2016.

11. Frenk SM, Porter KS, Paulozzi LJ. Prescription Opioid Analgesic Use Among Adults: United States, 1999–2012. NCHS Data Brief, No. 189. Hyattsville, MD: National Center for Health Statistics; February 2015.

12. SAMHSA. Highlights of the 2011 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. The DAWN Report. Rockville, MD: SAMHSA; 2013.

13. SAMHSA. Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health. 2015.

14. Boscarino JA, Rukstalis M, Hoffman SN, et al. Risk factors for drug dependence among out-patients on opioid therapy in a large US health-care system. Addiction. 2010;105(10):1776-1782.

15. Jones CM, Paulozzi LJ, Mack KA. Sources of prescription opioid pain relievers by frequency of pastyear nonmedical use: United States 2008-2011. JAMA Intern Med. 2014;174(5):802-803.

16. CDC. Vital Signs: Demographics and Substance Use Trends Among Heroin Users – United States, 2002-2013. MMWR Morb Mortal Wkly Rep. 2015;64(26):719-725

17. Agency for Healthcare Research and Quality. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain. 2014.

18. Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev. 2010;(1):CD006605.

19. Saloner B, Karthikeyan S. Changes in substance abuse treatment use among individuals with opioid use disorders in the United States, 2004-2013. JAMA. 2015; 314(14):1515-1517.

20. CDC. Vital signs: overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013; 62(26):537-542.

21. CDC. Vital Signs: Prescription Painkiller Overdoses: A Growing Epidemic Among Women. July 2013.

22. SAMHSA. Substance Abuse Treatment. Addressing the Specific Needs of Women: A Treatment Improvement Protocol. Tip 51. Rockville, MD: US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. 2009. store.

23. American College of Obstetricians and Gynecologists. Committee on Health Care for Underserved Women and the American Society of Addiction Medicine. Committee Opinion No. 524: Opioid Abuse, Dependence, and Addiction in Pregnancy. May 2012. Reaffirmed 2014.

24. National Institute on Drug Abuse. Chart of Evidence-Based Screening Tools for Adults and Adolescents. Revised September 2015.

25. SAMHSA. Quick Guide for Clinicians Based on TIP 34: Brief Interventions and Brief Therapy For Substance Abuse. Rockville, MD: SAMHSA; 2015.

26. National Institute on Drug Abuse. Drug Facts: Prescription and Over-the-Counter Medications. Bethesda, MD: NIDA; 2015.

27. National Institute on Drug Abuse. Research Reports: Misuse of Prescription Drugs. Last updated August 2016.

28. American Society of Addiction Medicine. National Practice Guidelines for the Use of Medication in the Treatment of Addiction Involving Opioid Use. 2015.

29. Broussard CS, Rasmussen SA, Reefhuis J, et al; National Birth Defects Prevention Study. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol. 2011;204(4):314.e1-11.

30. Whiteman VE, Salemi JL, Mogos MF, et al. Maternal opioid drug use during pregnancy and its impact on perinatal morbidity, mortality, and the costs of medical care in the United States. J Pregnancy. 2014:1-8.

31. Yazdy MM, Mitchell AA, Tinker SC, et al. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol. 2013;122(4):838-844.

32. Hudak ML, Tan RC; Committee on Drugs; Committee on Fetus and Newborn; American Academy of Pediatrics. Neonatal drug withdrawal. Pediatrics. 2012; 129(2):540-560.

33. SAMHSA. A Collaborative Approach to the Treatment of Pregnant Women with Opioid Use Disorders. Rockville, MD: SAMHSA; 2016.

34. American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. Committee Opinion No. 473: substance abuse reporting and pregnancy: the role of the obstetrician-gynecologistObstet Gynecol. 2011;117(1):200-201. Reaffirmed 2014.

35. Guttmacher Institute. Substance Abuse During Pregnancy. Washington, DC: Author; 2014.

36. Reece-Stremtan S, Marinelli KA. ABM clinical protocol # 21: guidelines for breastfeeding and substance use or substance use disorder, revised 2015. Breastfeed Med. 2015;10(3):135-141.

37. McQueen KA, Murphy-Oikonen J, Gerlach K, Montelpare W. The impact of infant feeding method on neonatal abstinence scores of methadone-exposed infants. Adv Neonat Care. 2011;11(4):282-290.

38. Pritham UA. Breastfeeding promotion for management of neonatal abstinence syndrome. J Obstet Gynecol Neonat Nurs. 2013;42(5):517-526.

39. Wong S, Ordean A, Kahan M; Society of Obstetricians and Gynecologists of Canada. SOGC clinical practice guideline: substance use in pregnancy: no. 256, April 2011. Int J Gynaecol Obstet. 2011;114(2):190-202.

Approved by the NPWH Board of Directors: December 2016

Bone densitometry: Performance, interpretation, and clinical application

The authors discuss how to determine who is a candidate for bone densitometry, interpret the results, ascertain when treatment is indicated, and choose among various treatment options.

CASE PRESENTATIONS

You see a 70-year-old mother and her 50-year-old daughter in your practice. You order bone density scans for each of them. Although the scans show that each woman has a T-score of –2.3 at the femoral neck, you will be treating only the older woman with medication.

The daughter underwent a total abdominal hysterectomy 6 months previously and was started on estrogen therapy. She has no history of fracture and reports no use of corticosteroids, no smoking, and minimal intake of alcohol. Pertinent physical examination and laboratory findings are:

• Height, 62 inches; weight, 110 lb;

• Hyperextensible joints;

• Small bone structure;

• Tandem gait excellent; and

• Complete blood count (CBC), complete metabolic panel (CMP), vitamin D, parathyroid hormone (PTH), and 24-hour urinary calcium values all within normal limits.

Based on her FRAX® results (more about this tool later), her 10-year fracture risk is 7.3% for a fragility fracture and 0.5% for a hip fracture. You make sure that she has adequate calcium and vitamin D intake through diet and supplements, and you recommend that she engage in activities that maintain her good balance, engage in weight-bearing exercise, and work out with light weights.

The mother fractured her hip 2 years previously after tripping on a dog toy. She reached menopause at age 45 but chose to forgo hormone therapy. She does not take steroids, smoke, or drink alcohol. Her own mother sustained a hip fracture at age 85. Pertinent physical exam and lab findings are:

• Height, 62 inches; weight, 120 lb;

• Flexibility normal;

• Small bone structure;

• Slight limp from hip fracture;

• Tandem gait done with some difficulty; and

• CBC, CMP, vitamin D, PTH, and 24-hour urinary calcium values all within normal limits.

Based on her FRAX results, her 10-year fracture risk is 35% for a fragility fracture and 14% for a hip fracture. History of a hip fracture alone merits osteoporosis treatment. You recommend adequate calcium and vitamin D intake through diet and supplements, balance training and weight-bearing exercises, and pharmacotherapy with an oral bisphosphonate.

Why did both women undergo bone density scans? And, given the fact that mother and daughter got the same T-score, why is the mother, but not the daughter, a candidate for pharmacotherapy? Some background information is needed to answer these questions.

Osteoporosis is a skeletal disease characterized by low bone mass and microarchitectural deterioration of the bone tissue, with a consequent increase in bone fragility that increases the risk for fracture.1 Approximately 10 million persons in the United States have osteoporosis and another 44 million have osteopenia (low bone mass that is less severe than osteoporosis), placing them at increased risk for fracture.2 Fifty percent of women experience an osteoporosis-related fracture in their lifetime, an incidence greater than that of myocardial infarction, stroke, and breast cancer combined.2 Of note, especially for healthcare providers (HCPs) who see young female patients, osteoporosis is not just a disease of bone loss, which commonly occurs as people age. Osteoporosis can also develop in people who do not reach peak bone mass during childhood and adolescence—without the accelerated bone loss that can accompany aging.1

Instead of testing bone strength, which is inappropriate in humans, HCPs can check their patients’ bone mineral density (BMD), which accounts for about 70% of bone strength and serves as a proxy measure for it.1 BMD is ascertained most commonly by dual-energy x-ray absorptiometry  (DXA) of the hip and spine—or in rare cases, the forearm. DXA is used to establish or confirm a diagnosis of osteoporosis, to help predict future fracture risk, and to monitor patients over time, particularly those undergoing osteoporosis treatment.3, 4

Areal BMD can be expressed in absolute terms of grams of mineral per square centimeter scanned (g/cm2) and as a relationship to two norms: the BMD of a young-adult reference population (T-score) and the BMD of an age-, sex-, and race- or ethnicity-matched reference population (Z-score). T-scores and Z-scores are calculated by determining the difference between a patient’s BMD and the mean BMD of the reference population, divided by the standard deviation (SD) of the reference population. Spine and hip BMD measurements in postmenopausal white women are interpreted using the World Health Organization’s T-score definitions of osteoporosis and osteopenia (Table 1).5

Osteoporosis is defined clinically as a fragility fracture of the hip or spine in the absence of other metabolic bone disease, a BMD of –2.5 or lower at any location, or a FRAX score indicating a 10-year risk of a major fragility fracture equal to or greater than 20% or a 10-year risk of hip fracture equal to or greater than 3%.The Fracture Risk Assessment Tool,or FRAX, is a computer-based algorithm that calculates fracture probability from clinical risk factors—age, sex, body mass index, smoking, alcohol use, prior fracture, parental history of hip fracture, corticosteroid use, rheumatoid arthritis (RA), and secondary osteoporosis—and BMD at the femoral neck.8

Fracture

Bone mineral density and fracture risk are inversely related. Each 1 SD decrease in BMD is associated with a 1.6- to 2.6-fold increase in risk of fracture, depending on the skeletal site.Along with low BMD, non-skeletal factors—especially the tendency to fall—contribute to fragility fracture risk. About 90% of fragility fractures occur after falls.10 The pathogenesis of falls in older adults is complex and is related to factors such as age-related deficits in visual, proprioception, and vestibular systems; frailty and de-conditioning; health conditions such as neuropathy, or prior stroke; use of certain medications (e.g., hypnotics, antihypertensives) and polypharmacy; and environmental factors (e.g., poor lighting, loose rugs).11, 12

More than 2 million fragility fractures occur each year in the U.S., accounting for $17 billion in healthcare costs.13 Seventy percent of fragility fractures occur in women. Despite these numbers, fewer than 25% of women aged 67 or older with an osteoporosis-related fracture undergo BMD measurement or begin osteoporosis treatment.12

Vertebral fracture, the most common osteoporotic fracture, may occur in the absence of trauma or after minimal trauma (e.g., bending, lifting).14 Although most vertebral fractures are clinically silent at first, they can eventually cause pain, disability, deformity, and mortality.15 Hip fracture, the most serious consequence of osteoporosis,12 is associated with chronic pain and disability, loss of independence, decreased quality of life, and increased mortality—8% to 36%—within a year.4 More than half of hip fracture survivors cannot live independently; many require longterm nursing home care.16

Although for many years there was awareness of the morbidity and mortality associated with fragility fractures, real progress came only with the ability to diagnose osteoporosis before fractures occur and the development of effective treatments.Measurement of BMD with DXA, which entered routine clinical practice in the late 1980s, has played a vital role in both of these developments. Although BMD correlates with fracture risk, HCPs should keep in mind that most fractures occur in patients with osteopenia. Therefore, patients with osteoporosis or with osteopenia may need treatment.

Osteoporosis workup

According to guidelines published by the American Association of Clinical Endocrinologists and the American College of Endocrinology (AACE/ACE) in 2016, all postmenopausal women aged 50 years or older should undergo clinical assessment for osteoporosis and fracture risk, starting with a detailed history and physical examination.12 HCPs should check for prior non-traumatic fractures, low body weight (<127 lb), height loss or kyphosis, a family history of osteoporosis and/or fractures, smoking, early-onset menopause, and excessive alcohol intake (3 drinks/day). HCPs should also assess each woman’s risk factors for falling.

The AACE/ACE recommends lateral spine imaging with standard radiography or vertebral fracture assessment (VFA).12 VFA is a method for imaging the thoracic and lumbar spine by DXA for the purpose of detecting vertebral fracture deformities in patients with unexplained height loss, self-reported but undocumented prior spine fractures, or steroid therapy equivalent to 5 mg/day prednisone for 3 months or longer.

The AACE/ACE recommends BMD measurement in women at increased risk for osteoporosis and fractures who are willing to consider pharmacologic treatment if osteopenia or osteoporosis is documented.12 Candidates for BMD measurement include all women aged 65 years or older, as well as younger postmenopausal women who (1) have a history of fracture without major trauma, (2) are on long-term systemic steroids, (3) have radiographic osteopenia, or (4) have clinical risk factors for osteoporosis.12 Three major health organizations—the U.S. Preventive Services Task Force, the National Osteoporosis Foundation (NOF), and the American Congress of Obstetricians and Gynecologists—offer similar screening recommendations.17-19

The AACE/ACE advises that treatment decisions for osteoporosis or osteopenia include consideration of fracture probability.12 Therefore, BMD results should be combined with other clinical risk factors for accurate fracture risk assessment. The FRAX tool can be used to calculate patients’ probability of fracture over 10 years.

In terms of the first question posed at the beginning of this article—Why did both women undergo bone density scans?—the answer is that both the mother and the daughter met criteria for BMD testing: The mother is 70 years old, and the daughter is a 50-year-old postmenopausal woman with low body weight and a mother who sustained a hip fracture.

Management

If postmenopausal osteoporosis is documented based on clinical and imaging fi ndings, HCPs should first ascertain whether it might be secondary to another cause. Certain health conditions that cause or exacerbate bone loss may be asymptomatic and require laboratory testing for detection. Lab tests include a CBC, a CMP, 25-hydroxyvitamin D, PTH, bone-specifi c alkaline phosphatase, and a 24-hour urine collection for calcium and creatinine.12 When indicated, HCPs should address causes of secondary osteoporosis and correct any calcium and/or vitamin D deficiencies. The general approach to management of osteoporosis and osteopenia is as follows:

Nutritional and nonpharmacologic interventions

All women, not just those with low bone mass—should aim for an adequate intake of vitamin D and calcium, participation in weight-bearing and muscle-strengthening exercises, smoking cessation as applicable, minimization of alcohol intake as applicable, and treatment of risk factors for falling. Many scientific organizations recommend an intake of 1,000 IU/day of vitamin D for adults aged 50 or older.12 Serum 25-hydroxyvitamin D levels should be measured in those at risk for vitamin D defi ciency, and vitamin D supplements should be prescribed as needed.4 Adults aged 50 or older are advised to consume 1,200 mg/ day of calcium through diet and a supplement, if needed.20

Measures to reduce falls include individual risk assessment; Tai Chi, yoga for seniors, and other exercise programs; home safety assessment, especially when done by an occupational therapist, and modification as needed; withdrawal of psychotropic medications if possible; and appropriate correction of visual impairment.Measures to be taken inside the home include anchoring rugs, minimizing clutter, removing loose wires, using nonskid mats, installing handrails where needed, adding lighting to stairwells and hallways, wearing sturdy shoes, and avoiding potentially dangerous activities.12

Pharmacotherapy

The AACE and NOF strongly recommend pharmacotherapy for persons with:

• Osteopenia and a history of a fragility fracture of the spine or hip;

• A T-score of –2.5 or lower in the spine, femoral neck, total hip, or distal one-third radius; or

• A T-score between –1.0 and –2.5 in the spine, femoral neck, total hip, or distal one-third radius and a 10-year risk of hip fracture equal to or greater than 3% or a 10-year risk of a major osteoporosis-related fracture equal to or greater than 20%.4,12

In terms of the second question posed at the beginning of this article—Why is the mother, but not the daughter, a candidate for pharmacotherapy?—the answer is that the 50-year-old daughter does not meet criteria for pharmacologic intervention; her BMD is in the osteopenia range, but she has no history of fracture and her FRAX scores do not show a high enough 10-year fracture risk to merit treatment. By contrast, the 70-year-old mother has osteopenia, a personal history of fracture, a maternal history of fracture, and FRAX scores that are high enough to warrant treatment.

Healthcare providers can choose among a variety of medications (Table 2), depending on patients’ health status and fracture risk.4,12 Four agents—alendronate, risedronate, zoledronic acid, and denosumab—have evidence for “broad spectrum” anti-fracture efficacy and are considered initial options in most cases.

Patients with moderate fracture risk, but no fragility fractures, can be started on an oral agent—that is, alendronate or risedronate. Patients with the highest fracture risk are usually started on an injectable such as teriparatide, denosumab, or zoledronic acid. The injectables are also appropriate for patients with upper gastrointestinal (GI) problems who might not tolerate oral medications, those with lower GI problems who might not absorb oral medications, and those with difficulty remembering to take oral medications on a regular basis or coordinating an oral bisphosphonate (BP) with other oral medications or their daily routine.

Bisphosphonates

Three of the aforementioned firstline agents, alendronate, risedronate, and zoledronic acid, are BPs; another member of this class is ibandronate. These agents, which are approved for both prevention and treatment of osteoporosis, have proven anti-fracture efficacy as well; on average, they reduce the incidence of vertebral and hip fractures by 50% over 3 years and they may increase BMD. The major downside is that nearly all oral BP products must be taken on an empty stomach and swallowed with a full glass of water, with at least a half hour intervening before anything other than water is ingested. Many BP users report painful swallowing, nausea, heartburn, or esophageal irritation. Other side effects include hypocalemia; bone, joint, or muscle pain; rash/allergy; and renal dysfunction. Presence of hypocalcemia is a contraindication to BP use. BPs should be used with caution, if at all, in patients with reduced renal function.

Two serious, but rare, adverse effects of long-term BP treatment are osteonecrosis of the jaw (ONJ) and atypical fracture of the femur (AFF). Pain in the thigh or groin area, which can be bilateral, often precedes an AFF. To put the risks of ONJ and AFF in perspective, out of 100,000 postmenopausal women, 50,000 will experience an osteoporosis-related fracture. By contrast, out of 100,000 persons on osteoporosis medication for 5 years, 1 may develop ONJ and 16, AFF.21

Calcitonin

Salmon calcitonin is approved for the treatment of osteoporosis in women who are at least 5 years postmenopausal when alternative treatments are not suitable. Calcitonin reduces vertebral fracture occurrence by about 30% in persons with prior vertebral fractures, but it has not been shown to reduce the risk of nonvertebral fractures and it has only a weak effect on BMD. The most common side effects of nasally administered calcitonin are nasal discomfort, rhinitis, and epistaxis.

Raloxifene

Raloxifene, an estrogen agonist/antagonist, is approved for prevention and treatment of postmenopausal osteoporosis, as well as for the reduction of breast cancer risk. Raloxifene is contraindicated in women of childbearing potential and in those with a history of venous thromboembolism (VTE). Raloxifene has been shown to reduce the risk of vertebral fracture (by 30%-55%), but not nonvertebral fracture or hip fracture. Adverse effects of  this agent include VTE (a 3-fold increased risk, but the absolute risk is low), menopausal symptoms, and leg cramps.

Of note, estrogen therapy is FDA approved only for osteoporosis prevention, not treatment. Likewise, a medication that combines conjugated estrogens with the estrogen agonist/antagonist bazedoxifene is approved to prevent, not treat, osteoporosis after menopause, as well as to treat moderate to severe vasomotor symptoms.

Denosumab

Denosumab, a fully human monoclonal antibody, is approved for treatment of osteoporosis in postmenopausal women at high risk of fracture. This agent decreases bone resorption, increases BMD, and reduces fracture risk by 20%-70% over 3 years, depending on the site. Given subcutaneously (SC) every 6 months, denosumab must be administered by an HCP. Denosumab may be considered for use in certain patients with renal insuffi ciency; impaired renal function does not signifi cantly alter the metabolism or excretion of the drug.22 Denosumab may cause hypocalcemia, which must be corrected before treatment is started. Potential side eff ects include back pain, musculoskeletal pain, cystitis, and hypercholesterolemia. Denosumab has been associated with cellulitis and skin rash, as well as ONJ and AFF in rare cases.

Teriparatide

Recombinant human PTH, or teriparatide, builds bone—as opposed to reducing bone resorption. It is approved for initial treatment of women with postmenopausal osteoporosis who are at high risk of fracture or have failed or been intolerant of previous osteoporosis therapy. Administered SC by patients themselves, teriparatide reduces fracture risk by 50%-65%, depending on the site, after 18 months of therapy. Use of this agent is limited to 2 years. It is contraindicated in patients with pre-existing hypercalcemia, severe renal impairment, or a history of bone metastases or skeletal malignancies, and in those who are at an increased baseline risk for osteosarcoma.23 Potential side effects include orthostatic hypotension, dizziness, myalgias, arthalgias, leg cramps, transient hypercalcemia, increased serum uric acid, hypercalciuria, headache, and nausea.

Monitoring treatment response

After initiating treatment, patients are seen 1-3 months later to check their adherence to the medication regimen and for lab testing. Patients are seen at least yearly to assess their response. Stable or increasing BMD at the spine and hip, as well as no fractures, indicates a satisfactory response.12 Therefore, serial central DXA, performed 1-2 years after initiating therapy and every 2 years thereafter, is a vital component of osteoporosis management. The decision to test BMD every 2 years is based on the time it takes for treatment-related improvement in BMD to occur and on Medicare and health insurance company reimbursement.

Yearly height measurement is also a crucial determinant of osteoporosis treatment efficacy. Patients who lose 2 cm (0.8 in) of height either acutely or cumulatively should undergo repeat vertebral imaging to determine whether new or additional vertebral fractures have occurred since the previous test.4

Duration of pharmacologic treatment

In 2016, the American Society for Bone and Mineral Research issued guidelines for long-term BP treatment.24 The society recommends that, after 5 years of oral therapy or 3 years of IV therapy, HCPs reassess patients’ fracture risk. For women at high risk, HCPs should consider continuing treatment for up to 10 years (oral) or 6 years (IV), with periodic evaluation. Although the risk of AFF, but not ONJ, increases with BP treatment duration, it is outweighed by the benefit of vertebral fracture risk reduction. For women not at high fracture risk, a drug holiday of 2-3 years can be considered after 3-5 years of treatment. By contrast, a drug holiday is not recommended for denosumab users because BMD benefits are rapidly lost with drug discontinuation. Treatment with teriparatide, which is taken for no longer than 2 years, is followed by treatment with an antiresorptive agent to prevent BMD decline and loss of fracture efficacy.

All non-BP osteoporosis medications produce temporary beneficial effects that wane upon discontinuation. By contrast, BPs may allow residual protection against fracture even after treatment cessation. Therapy should be resumed if a fracture occurs, if BMD declines beyond the least significant change (a value computed by each testing facility for relevant measurement sites to determine the magnitude of diff erence that represents a real change), or patients meet initial treatment criteria.

Conclusion

Healthcare providers can decrease postmenopausal patients’ risk of developing osteoporosis and/or experiencing a fragility fracture by clinically assessing them for these risks, ordering radiographic imaging and BMD measurement via DXA as indicated, and prescribing nondrug interventions and pharmacotherapy as needed. Patients who adhere to and tolerate their drug regimens can reduce their fracture risk, depending on the medication and the site, by about half. Patients on osteoporosis medication should be monitored at least once yearly to assess response to treatment, which is gauged by height measurement (every year), BMD via DXA (every 1-2 years), and absence of new fractures.

References

1. National Institutes of Health. Osteoporosis Prevention, Diagnosis, and Therapy. NIH Consensus Statement; March 27-29, 2000.

2. National Osteoporosis Foundation. Osteoporosis Fast Facts. 2015.

3. Blake GM, Fogelman I. The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. Postgrad Med J. 2007;83(982):509-517.

4. Cosman F, de Beur SJ, LeBoff MS, et al. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporosis Int. 2014;25(10):2359-2381.

5. World Health Organization. Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis: Technical Report Series 843. Geneva, Switzerland: WHO; 1994.

6. Unnanuntana A, Gladnick BP, Donnelly E, Lane JM. The assessment of fracture risk. J Bone Joint Surg Am. 2010;92(3):743-753.

7. FRAX® Fracture Risk Assessment Tool. n.d.

8. Kanis JA, Hans D, Cooper C, et al; Task Force of the FRAX Initiative. Interpretation and use of FRAX in clinical practice. Osteoporos Int. 2011;22(9):2395-2411.

9. Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ. 1996;312(7041):1254-1259.

10. Tinetti ME. Clinical practice. Preventing falls in elderly persons. N Engl J Med. 2003;348(1):42-49.

11. Berry SD, Kiel DP. Falls as risk factors for fracture. In: Marcus R, Feldman D, Nelson DA, Rosen CJ, eds. Osteoporosis. 3rd ed. San Diego, CA: Academic Press; 2008.

12. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis – 2016. Endocr Pract. 2016;22(suppl 4):1-42.

13. Burge R, Dawson-Hughes B, Solomon DH, et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007;22(3):465-475.

14. International Osteoporosis Foundation. Vertebral Fracture Initiative. Part I: Overview of Osteoporosis: Epidemiology and Clinical Management.

15. Lewiecki EM, Laster AJ. Clinical review: Clinical applications of vertebral fracture assessment by dual-energy x-ray absorptiometry. J Clin Endocrinol Metab. 2006;91(11):4215 4222.

16. Orwig DL, Chan J, Magaziner J. Hip fracture and its consequences: differences between men and women. Orthop Clin North Am. 2006;37(4):611-622.

17. U.S. Preventive Services Task Force. Final Recommendation Statement: Osteoporosis: Screening. April 2016.

18. National Osteoporosis Foundation. Bone Density Exam/Testing. 2016.

19. American College of Obstetricians and Gynecologists. Osteoporosis Guidelines Issued. August 21, 2012.

20. Institute of Medicine Committee to review dietary reference intakes for vitamin D and calcium. In: Ross AC, Taylor CL, Yaktine AL et al, eds. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academies Press; 2011.

21. Kaiser Permanente. Southern California. Fracture Liaison Service. 2013.

22. Block GA, Bone HG, Fang L, et al. A single-dose study of denosumab in patients with various degrees of renal impairment. J Bone Miner Res. 2012;27(7):1471-1479.

23. Quattrocchi E, Kourlas H. Teriparatide: a review. Clin Ther. 2004;26(6):841-854.

24. Adler RA, El-Hajj Fuleihan G, Bauer DC, et al. Managing Osteoporosis in Patients on Long Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2016;31(1):16-35.

Prevention of Alcohol-Exposed Pregnancies

The National Association of Nurse Practitioners in Women’s Health (NPWH) supports women’s health nurse practitioners (WHNPs) and other nurse practitioners (NPs) who provide healthcare for reproductive-aged women in the use of evidence-based strategies to prevent alcohol-exposed pregnancies (AEP). Use of these strategies should extend to alcohol screening at least yearly for all adolescent and adult patients. In addition, all sexually active, reproductive-aged women who could become pregnant and who drink alcohol should be counseled about the potentially deleterious effects of alcohol on a developing fetus. They should be advised to use effective contraception to prevent pregnancy or to stop drinking alcohol. Women who are trying to get pregnant should be advised to abstain from drinking alcohol. Pregnant women should be screened for alcohol use at their initial prenatal visit and during each trimester thereafter.1 For those who screen positive for risky alcohol use, NPs should provide a brief behavioral intervention, refer them to specialty services as needed, and plan appropriate follow-up.

Furthermore, NPWH recognizes that early and regular prenatal care for women with alcohol dependence is essential in order to encourage healthy behaviors and provide support and early treatment referrals to reduce risks of harm. Laws that require reporting of alcohol/substance abuse during pregnancy as potential child abuse or ne glect may deter women with alcohol dependence from seeking prenatal care.2,3 Therefore, NPWH opposes policies that require reporting or criminalization of alcohol/substance abuse during pregnancy and supports repeal of existing laws with such mandates. NPWH will provide leadership and collaborate with other organizations and agencies to deliver education and skills training for NPs, develop policies, and conduct and/or support research in a concerted effort to prevent AEP.

Background

Prenatal alcohol exposure is the No. 1 preventable cause of birth defects and intellectual and developmental disabilities in children. Alcohol, a known teratogen, readily crosses the placenta and persists in amniotic fluid after a woman’s serum alcohol level metabolizes to zero. Toxicity is dose related, with the greatest risk to the fetus in the first trimester.With regard to preventing fetal alcohol spectrum disorders (FASD) and other adverse pregnancy and birth outcomes associated with prenatal alcohol exposure, there is no known safe amount of alcohol use at any time during pregnancy

FASD is an umbrella term describing a range of possible effects that include physical, intellectual, behavioral, and learning disabilities and language delays, with lifelong implications for individuals prenatally exposed to alcohol.5 FASD are completely preventable if alcohol is not consumed during pregnancy. But many pregnant women do drink alcohol; the estimated prevalence of FASD in first-grade students in the United States is 2%-5%.The lifetime cost of caring for an infant with fetal alcohol syndrome, a single disorder within the FASD continuum, is approximately $2 million.In addition to FASD, alcohol use during pregnancy is associated with increased risks for spontaneous abortion, intrauterine growth restriction, stillbirth, preterm birth, and sudden infant death syndrome.8

In 2005, the U.S. Surgeon General advised that pregnant women not drink any alcohol, pregnant women who have already consumed alcohol stop doing so, and women considering becoming pregnant abstain from drinking alcohol.9 Despite this recommendation, the number of women who drink alcohol while pregnant has not decreased significantly.10 Ten percent of pregnant women report drinking some amount of alcohol in the past month and 3.1% report binge drinking.10

The fact that about one-half of all pregnancies are unplanned poses a particular challenge to the prevention of AEP. Approximately 3.3 million reproductive-aged women report drinking alcohol in the past month and having sex without using contraception.11 An additional challenge is that only 1 in 6 U.S. adults reports ever having talked with a healthcare professional about their drinking.11 Therefore, many adults may be unaware of the potential risks of alcohol use to their own health or to the health of a developing fetus.

Implications for women’s healthcare and WHNP practice

Strong evidence suggests that alcohol screening and brief intervention (SBI) is effective in reducing risky alcohol use among women of childbearing age.12,13 Leading U.S. healthcare organizations and agencies, including the U.S. Preventive Services Task Force,14 the CDC,11 and the American College of Obstetricians and Gynecologists,15 recommend that alcohol SBI be implemented at least yearly for all adults in primary care settings. Likewise, all pregnant women should be screened at the first prenatal visit and once during each trimester thereafter.

Alcohol SBI involves using a validated screening tool to identify a woman’s drinking patterns, whether her alcohol consumption is creating a health risk for herself or others, and whether she has symptoms of dependency. If at-risk drinking is identified, the NP engages the woman in a brief motivation-enhancing intervention to reduce drinking. The main goal of alcohol SBI is to motivate patients to be aware of their alcohol consumption patterns, understand the associated risks and options for reducing or eliminating the risk, and make their own decisions. Referral to specialty care for further assessment and treatment is made if a woman is unable to moderate risky alcohol use on her own. The CDC’s Planning and Implementing Screening and Brief Intervention for Risky Alcohol Use: A Step-by-Step Guide for Primary Care Practices provides guidance for incorporating universal alcohol SBI within clinical practice.This guide includes information on the use of a variety of screening tools validated for use with adults, including pregnant women.

WHNPs and other NPs who provide healthcare for reproductive-aged women have a responsibility to provide clear, fact-based information regarding risks associated with drinking any amount of alcohol during pregnancy. Furthermore, they have the responsibility to identify women with at-risk drinking habits and provide counseling and referrals for treatment as appropriate.

Recommendations

WHNPs and other NPs who provide healthcare for reproductive-aged women should:

Adopt a non-judgmental respectful approach when broaching the topic of alcohol use.

Counsel each reproductive-aged woman in their care that there is no safe amount of alcohol consumption during pregnancy and provide fact-based information regarding risks.

Provide alcohol screening with a validated screening tool annually and during each trimester of pregnancy.

Provide an evidence-based brief intervention when at-risk alcohol use is identified.

Advise all pregnant women who drink alcohol  to stop doing so.

Advise all women planning a pregnancy who drink alcohol to stop doing so.

Advise all sexually active women who drink alcohol and could become pregnant to use effective contraception to prevent pregnancy or to stop drinking.

Recognize that not all women are able to stop using alcohol without support.

Refer women for additional services if they cannot stop drinking on their own. Know which services are available in the community.

Provide follow-up as needed to monitor women’s drinking, provide encouragement and support, and, if necessary, refer for specialized help.

Be aware of state reporting laws for alcohol/substance abuse in pregnancy and advocate for retraction of legislation that exposes pregnant women with alcohol dependence to criminal or civil penalties.

NPWH will provide leadership and resources to ensure that:

Educational programs for NP students with a population focus that includes reproductive-aged women impart evidence-based knowledge and skill building for the development of competencies to conduct effective alcohol SBI to prevent or address alcohol use during pregnancy.

CE programs are available for NPs to obtain evidence-based knowledge and competencies to conduct effective alcohol SBI to prevent or address alcohol use during pregnancy.

References

1. Nocon J. Chapter 15: Substance use disorders. In Mattison DR, ed. Clinical Pharmacology During PregnancyAmsterdam: Academic Press, an Imprint of Elsevier; 2013.

2. ACOG. Committee on Health Care for Underserved Women. Committee opinion no. 473: Substance abuse reporting and pregnancy: the role of the obstetriciangynecologist. Obstet Gynecol. 2011;117(1):200-201. Reaffirmed 2014.

3. Guttmacher Institute. Substance Abuse During Pregnancy. Washington, DC: Author; 2014.

4. Mattison DR, ed. Clinical Pharmacology During Pregnancy. Amsterdam: Academic Press, an Imprint of Elsevier; 2013.

5. Sokel RJ, Delaney-Black V, Nordstrom B. Fetal alcohol spectrum disorder. JAMA. 2003;290(22):2996-2999.

6. May PA, Baete A, Russo J, et al. Prevalence and characteristics of fetal alcohol spectrum disorders. Pediatrics. 2014;134(5):855-866.

7. CDC. Planning and Implementing Screening and Brief Intervention for Risky Alcohol Use: A Step-by-Step Guide for Primary Care Practices. Atlanta, GA: CDC National Center on Birth Defects and Developmental Disabilities; 2014.

8. Bailey BA, Sokol RJ. Prenatal alcohol exposure and miscarriage, stillbirth, preterm delivery, and sudden infant death syndrome. Alcohol Res Health. 2011;34(1):86-91.

9. U.S. Department of Health and Human Services. U.S. Surgeon General Releases Advisory on Alcohol Use in Pregnancy. Washington, DC: US Department of Health and Human Services; 2005.

10. Tan CH, Denny CH, Cheal NE, et al. Alcohol use and binge drinking among women of childbearing age – United States, 2011-2013. MMWR Morb Mortal Wkly Rep. 2015;64(37):1042-1046.

11. Green PP, McKnight-Eily LR, Tan CH, et al. Vital signs: alcohol-exposed pregnancies—United States, 2011-2013. MMWR Morb Mortal Wkly Rep. 2016; 65(4):91-97.

12. Bertholet N, Daeppen JB, Wietlisbach V, et al. Reduction in alcohol consumption by brief alcohol intervention in primary care: systematic review and metaanalysis. Arch Intern Med. 2005;165(9):986-995.

13. Jonas DE, Garbutt JC, Amick HR, et al. Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2012;157(9):645-654.

14. Moyer VA; Preventive Services Task Force. Screening and behavioral counseling interventions in primary care to reduce alcohol misuse: U.S. preventive services task force recommendation statement. Ann Intern Med. 2013;159(3):210-218.

15. ACOG. Committee on Health Care for Underserved Women. Committee opinion no. 496: At-risk drinking and alcohol dependence: obstetric and gynecologic implications. Obstet Gynecol. 2011;118(2 pt 1):383-388. Reaffirmed 2013.

Approved by the NPWH Board of Directors: August 2016

Zika virus infection: Latest recommendations for providers caring for reproductive-aged women

The Zika virus, a mosquito-borne flavivirus,is becoming a growing concern for U.S. women in their childbearing years. The dramatic increase in the number of cases of Zika virus infection (ZVI), as well as its correlation with neurologic deficits (e.g., microcephaly in newborns), has made it crucial for healthcare providers (HCPs) to know as much as possible about identifying, treating, and preventing ZVI. This article offers up-to-date information for HCPs caring for reproductive- aged women—particularly those who are considering pregnancy or who are already pregnant— about when to test for ZVI, whom to test, and how to best inform patients about ZVI transmission and prevention.

CDC guidance for caring for pregnant women2

All pregnant women in the U.S. and U.S. territories should be assessed for possible Zika virus exposure at each prenatal care visit. Pregnant women should not travel to an area with active Zika virus transmission. Pregnant women who must travel to one of these areas should strictly follow steps to prevent mosquito bites during the trip. In addition, to avoid contracting ZVI, pregnant women whose sex partner has traveled to or resides in an area with active Zika virus transmission should use condoms or other barrier methods or abstain from sex for the duration of the pregnancy.

Part of the concern about ZVI is the lack of signs and symptoms (S/S) in up to 80% of persons infected and the vague, mild, flulike symptoms in the remaining portion, which makes identifying the disease so difficult. When S/S of ZVI do occur, they typically include rash, low-grade fever, arthralgia, fatigue, headache, and conjunctivitis.The rash, which tends to be the most prominent sign, is usually pruritic and maculopapular. It begins proximally and spreads to the extremities, with spontaneous resolution in 1-4 days.1

Symptomatic pregnant women

Pregnant women who report S/S of ZVI should be tested for it (Figure). Testing recommendations are the same regardless of the circumstances of possible exposure; however, the type of testing recommended depends on the time of evaluation relative to symptom onset. Testing of serum and urine by real-time reverse transcriptase polymerase chain reaction (rRT-PCR) is advised for pregnant women who seek care less than 2 weeks after symptom onset. This recommendation extends the previous recommendation for testing of serum from less than 1 week after symptom onset to less than 2 weeks. A positive rRT-PCR result confirms the diagnosis of recent maternal ZVI. Women with a negative rRT-PCR result should undergo both Zika virus IgM and dengue virus IgM antibody testing. If either antibody test yields positive or equivocal results, a plaque reduction neutralization test (PRNT) should be performed on the same IgM-tested sample or a subsequently collected sample to rule out false-positive results.

Pregnant women who seek care 2-12 weeks after symptom onset should first undergo Zika virus and dengue virus IgM antibody testing (see the Figure). If the Zika virus IgM antibody testing yields positive or equivocal results, reflex rRT-PCR testing should be automatically performed on the same serum sample to determine whether Zika virus RNA is present. A positive rRT-PCR result confirms the diagnosis of recent maternal ZVI. If the rRT-PCR result is negative, a positive or equivocal Zika virus IgM antibody test result should be followed by PRNT. Positive or equivocal dengue IgM antibody test results with a negative Zika virus IgM antibody test result should also be confirmed by PRNT.

Asymptomatic pregnant women

Testing recommendations for asymptomatic pregnant women with possible Zika virus exposure differ based on the circumstances of possible exposure (i.e., ongoing vs. limited exposure) and the elapsed interval since the last possible Zika virus exposure (see the Figure). Asymptomatic pregnant women living in areas without active Zika virus transmission who are evaluated less than 2 weeks after possible Zika virus exposure should be offered serum and urine rRT-PCR testing (see the Figure). A positive rRT-PCR result confirms the diagnosis of recent maternal ZVI. However, because viral RNA in serum and urine declines over time and depends on multiple factors, asymptomatic pregnant women with a negative rRT-PCR result require additional testing to exclude infection. These women should return 2-12 weeks after possible Zika virus exposure for Zika virus IgM antibody testing. A positive or equivocal IgM antibody test result should be confirmed by PRNT.

Asymptomatic pregnant women living in an area without active Zika virus transmission, and who seek care 2-12 weeks after possible Zika virus exposure, should be offered Zika virus IgM antibody testing (see the Figure). If the Zika virus IgM antibody test yields  positive or equivocal results, reflex rRT-PCR testing should be performed on the same sample. If the rRTPCR result is negative, PRNT should be performed.

As recommended in previous guidance, IgM antibody testing is recommended as part of routine obstetric care during the first and second trimesters for asymptomatic pregnant women who have an ongoing risk for Zika virus exposure (i.e., residence in or frequent travel to an area with active Zika virus transmission) (see the Figure). Reflex rRT-PCR testing is recommended for women who have a positive or equivocal Zika virus IgM antibody test result because rRT-PCR testing provides the potential for a definitive diagnosis of ZVI. Negative rRT-PCR results after a positive or equivocal Zika virus IgM antibody test result should be followed by PRNT. The decision to implement testing of asymptomatic pregnant women with ongoing risk for Zika virus exposure should be made by local health officials based on information about levels of Zika virus transmission and laboratory capacity.

Symptomatic and asymptomatic pregnant women who seek care more than 12 weeks after symptom onset or possible Zika virus exposure

For these women, IgM antibody testing might be considered. If fetal abnormalities are present, rRT-PCR testing should also be performed on maternal serum and urine. However, a negative IgM antibody test or rRT PCR result more than 12 weeks after symptom onset or possible exposure does not rule out recent ZVI because IgM antibody and viral RNA levels decline over time. Given the limitations of testing beyond 12 weeks after symptom onset or possible exposure, serial fetal ultrasonography should be considered.

Management

Management of confirmed ZVI is supportive, and includes rest, fluids, fever control, and analgesics.1 The Table provides recommendations for prenatal and postnatal management of pregnant women with laboratory evidence of confirmed or possible ZVI.

CDC guidance for HCPs caring for women of reproductive age3

Reproductive-aged women and their partners need counseling and education in accordance with their pregnancy intentions.

For couples who are not pregnant and are not planning to become pregnant in the near future

Healthcare providers should discuss strategies to prevent unintended pregnancy with these couples. When helping women choose a contraceptive method, its safety, effectiveness, availability, and acceptability should be considered. Women should be counseled to select the most effective method that they can use correctly and consistently. Long-acting reversible contraceptives, including subdermal implants and intrauterine devices, provide highly effective reversible birth control.

Couples in whom one partner has had possible Zika virus exposure will want to maximally reduce their risk for sexually transmitting Zika virus to the uninfected partner. They should use condoms consistently and correctly or abstain from sex for at least 6 months for men or 8 weeks for women after symptom onset (if symptomatic) or after the last possible Zika virus exposure (if asymptomatic). Some couples may choose to use condoms or abstain from sex for a shorter or longer period than recommended depending on their individual circumstances and risk tolerance.

For couples planning to conceive who do not live in areas with active Zika virus transmission

These couples should consider avoiding nonessential travel to areas with active Zika virus transmission. Women who have had possible Zika virus exposure through travel or sexual contact and do not have ongoing risks for exposure should wait at least 8 weeks from symptom onset (if symptomatic) or their last possible exposure (if asymptomatic) to attempt conception. Women who wait at least 8 weeks to conceive may have an increased likelihood that Zika virus no longer presents a risk for maternal–fetal transmission.

The CDC recommends that men with possible Zika virus exposure, regardless of symptom status, wait at least 6 months from symptom onset (if symptomatic) or their last possible exposure (if asymptomatic) before attempting conception with their partner. The recommendation to wait at least 6 months for asymptomatic men, as opposed to the previous recommendation to wait at least 8 weeks, is based on the range of time after symptom onset that Zika virus RNA has been detected in semen of symptomatic men and the absence of definitive data that the risk for sexual transmission differs between symptomatic and asymptomatic men. Zika virus has not been definitively cultured from semen more than 3 months after symptom onset. It is unknown whether detection of Zika virus RNA in semen indicates presence of infectious virus and the potential for transmission.

For couples who want to conceive, in which one or both partners live in areas with active Zika virus transmission

For these couples, any partner who experiences symptoms of ZVI should be tested for it. Men with results that indicate recent ZVI or unspecified flavivirus infection should wait at least 6 months from symptom onset to attempt conception with their partner; women with results that indicate recent ZVI or unspecified flavivirus infection should wait at least 8 weeks from symptom onset to attempt conception. Partners who have had symptoms of ZVI with negative Zika virus test results should talk with their HCP about timing of conception in the setting of ongoing risk for possible exposure.

Couples living in an area with active Zika virus transmission should be counseled on the possible risk for ZVI during the periconception period. The CDC has developed tools to assist HCPs with preconception counseling. HCPs should provide counseling about the potential consequences to the fetus associated with ZVI during pregnancy, such as microcephaly and other serious brain abnormalities. Women should discuss their reproductive life plans with their HCP, in the context of potential and ongoing Zika virus exposure. HCPs should review factors that might influence pregnancy timing (e.g., unknown duration of Zika virus outbreak, fertility, age, reproductive history, health history, personal values and preferences). For couples who choose to conceive, HCPs should emphasize the use of mosquito bite prevention strategies while attempting pregnancy and during pregnancy.

Conclusion

The Zika virus has been declared a public health emergency because of the ease of transmission, the relatively benign and asymptomatic viral infection it causes, and its correlation with major neurologic complications in newborns whose mothers contracted ZVI during pregnancy. A continued response from government agencies, local health officials, HCPs, and researchers remains underway to shed new light onto this growing concern. As this epidemic continues to unfold, it remains crucial to educate women of childbearing age and their partners about the inherent risks of the Zika virus and avoidance of infection.

Jessica L. Isnetto is a faculty member at Kaplan University in Orlando, Florida. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Ploudre AR, Bloch EM. A literature review of Zika virus. Emerg Infect Dis. 2016;22(7):1185-1192.

2. CDC. Update: Interim Guidance for Health Care Providers Caring for Pregnant Women with Possible Zika Virus Exposure — United States, July 2016.

3. CDC. Update: Interim Guidance for Preconception Counseling and Prevention of Sexual Transmission of Zika Virus for Persons with Possible Zika Virus Exposure — United States, September 2016.

Seeing our invisible patients: The importance of providing inclusive sexual and reproductive healthcare to LGBTQ populations

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The author encourages healthcare providers to become more competent and inclusive in caring for patients who identify as lesbian, gay, bisexual, transgender, or gender-queer or non-conforming.

Statement of the problem

Women who identify as lesbian or bisexual (also known as sexual minority women, or SMW), as well as those who were assigned female gender at birth but identify as transgender, gender-queer, or gender non-conforming (TQ), represent subsets of the LGBTQ population. These groups have historically experienced discrimination and stigma in healthcare. As a result, they may be less likely than heterosexual women or cis-gender women (those whose gender identity matches the female sex they were assigned at birth) to seek sexual and reproductive healthcare. Even if they seek this type of care, they may not be properly assessed, managed, or educated if their healthcare providers (HCPs) lack the knowledge and communication skills they need to provide inclusive sexual and reproductive care to SMW and TQ patients. In a video from the National LGBT Education Center, LGBT individuals share some of the experiences, both bad and good, that they have had with HCPs.

Dearth of research

Perpetuating this healthcare disparity is a dearth of research on LGBTQ-specific healthcare needs (with the exception of HIV/AIDS and mental health problems in gay men). Only in the past 5 years have the many health disparities experienced by LGBTQ individuals and the need for LGBTQ-specific research become a topic of conversation on a national level. From 1989 until 2011, 0.5% of studies funded by the National Institutes of Health (NIH), the largest funder of medical research in the world, pertained to LGBTQ health, and of that 0.5%, only 13.5% was allocated to SMW and 0.2% to transgender men.1 In 2011, the CDC identified health disparities related to sexual orientation as one of the main gaps in current health disparities research.2 In the same year, the Institute of Medicine reported the inadequacy of LGBTQ health research, identified challenges in conducting research on these populations, and established recommendations for the NIH, including implementation of a research agenda designed to advance knowledge and understanding of LGBTQ health.3

Dearth of educational programs

The curricula in most clinical education programs do not include adequate LGBTQ-related content. One study that specifically assessed inclusion of LGBTQ-related content in medical school curricula in the United States and Cana da found, on average, 5 hours of instruction in this area.Although corresponding studies assessing nursing school curricula have not been reported, they would likely reveal similarly discouraging findings. Educating future HCPs, through both classroom instruction and clinical experiences, to care for LGBTQ patients will help increase the number of HCPs who are competent and comfortable in this area.

Ways to provide competent and inclusive healthcare for LGBTQ populations

As a basic foundation in this regard, HCPs must understand the differences among the terms sex assigned at birth, sexual orientation, and gender identity. Sex assigned at birth, also referred to as biological sex, is based objectively on genital appearance, hormones, and chromosomes. Sexual orientation refers to the object of a person’s physical and/or emotional attraction. Gender identity represents how one perceives oneself—as female, as male, or somewhere in between.

Both U.S. society and the healthcare community within it are hetero-normative and cis-normativeinadvertently creating an environment that is a source of implicit discrimination toward LGBTQ populations.In a heteronormative society, heterosexuality is the expected and “normal” sexual orientation. Similarly, in a cis-normative society, being cis-gender—having a gender identity that matches one’s sex assignment at birth—is expected and “normal.” By these definitions, anyone who lives/behaves as anything other than heterosexual or who identifies as anything other than cisgender is considered “abnormal.”

Recognize and aim to overcome health disparities

Although the literature has been sparse, newly emerging studies provide information about the sexual and reproductive health behaviors of young SMW populations. In general, researchers have found that SMW (and/or sexual minority teens), compared with their heterosexual counterparts:

• display a greater number and range of sexually risky behaviors (e.g., younger age at sexual debut, greater number of sex partners, greater use of alcohol or drugs during sexual encounters, greater likelihood of having unprotected sex)6-11;

• with the exception of lesbians11 have higher rates of sexually transmitted infections (STIs)7,8,10;

• have similar rates of unwanted pregnancy and higher rates of abortion6,8,10;

• have lower rates of contraceptive and gynecologic care seeking, including a lesser likelihood of getting Pap tests and the HPV vaccine series12-15;

• have a greater likelihood of being subjected to intimate partner violence (IPV)6-8; and

• may have an elevated risk for breast cancer because of their increased rate of nulliparity, older age at first live birth, and greater rates of obesity and alcohol consumption.16

Fewer studies have addressed the sexual and reproductive health disparities that affect TQ populations, which also include gender non-binary individuals, who reject the assumption that gender is strictly an either/or option of male/female that matches the sex they were assigned at birth.17 Instead, these individuals view gender identity as a spectrum of possibilities. No epidemiologic studies on transgenderism in the U.S. have been published, and demographic studies based on national surveys have been limited because of a lack of questions about gender identity.18

About 0.3% of adults in the U.S. (~1 million persons) are thought to identify as transgender.18 Most of the available literature concerns transgender females (i.e., persons who are assigned the male sex at birth but who identify as female). In studies conducted in countries outside the U.S., the prevalence of transgender males (i.e., persons who are assigned the female sex at birth but who identify as male) has been reported as 1:30,400 to 1:200,000.19

Many transgender individuals have experienced discrimination in healthcare, particularly after disclosing their gender identity to their HCP. Experiences of hostility and/or insensitivity from their own HCP can cause mistrust of HCPs in general.20 This cycle can lead to a lack of utilization of healthcare services, particularly when care is not critical for survival.

Despite the lack of research, transgender males do express concerns related to their sexual and reproductive healthcare, particularly with respect to discrimination, lack of validation of their gender identity, physical discomfort during examinations, fertility preservation, and pregnancy. Another fact to keep in mind: Although a person born with a uterus and ovaries may not identify as female, this person may wish to have biological children. In a cross-sectional Web-based survey of transgender males who had been pregnant and delivered a baby, two-thirds of the pregnancies were planned, and pregnancy, delivery, and birth outcomes did not differ according to whether or not the patient had used testosterone prior to pregnancy.21

Avoid faulty assumptions

Not all patients are heterosexual and cis-gender. If a reproductive-aged patient states that she is sexually active, an HCP should not necessarily follow up with the question “What type of birth control are you using?” First, the HCP needs to determine the patient’s sexual orientation; she may not need to practice birth control. Instead of giving patients two gender options—“male” and “female”—on intake forms, the HCP can provide a box labeled “other” that can be filled in with the patient’s stated identity.

These concepts also apply to the way that visit types are labeled in the office. Visits related to contraception care are often termed family planning visits, and those that occur yearly are often termed well-woman exams. The terminology for these visit types can be off-putting to persons, including staff members, who may not use contraceptives for birth control and for those who may not identify as women even though they have female genitalia and reproductive organs. HCPs should aim to create an inclusive office atmosphere so that SMW and TQ patients can build trust in their provider and receive healthcare that meets their needs.

Create an inclusive environment

Providers should not assume that a patient coming into the office for contraceptive care or for a yearly checkup is heterosexual and cis-gender. One of the first things any patient does in an office visit is complete intake and health history forms. Forms are more inclusive when the term partner or spouse is used instead of husband or wife and when transgender and other identitywith a write-in area, are added to the cis-gender options of male and female. HCPs need to ask patients who identify as transgender, gender-queer, or gender non-conforming about their preferred names and which gender pronouns they use (e.g., he, she, they). Preferred names may differ from the legal documentation on their driver’s licenses and insurance cards; HCPs must avoid using a name that the patient no longer uses or that may cause distress. Questions about preferred names and gender pronouns are appropriate and polite, and demonstrate from the outset of the professional relationship that the HCP and the staff acknowledge and validate all their patients’ sexual orientations and gender identities.

Non-discrimination policies need to be posted in check-in areas and/or waiting rooms where they are easily visible. Information about and examples of patient non-discrimination policies are available through the Human Rights Campaign Healthcare Equality Index website. Staff members need to know these policies and adhere to them. After all, the first person with whom a patient has contact in a healthcare setting is usually not the HCP but, rather, the office reception staff. The National LGBT Health Education Center, a program of The Fenway Institute, offers online webinars and video training sessions that can be used to help educate clinical and administrative office staff members.

Follow health screening and preventive health recommendations

Recommendations are implemented for SMW and TQ patients within the same parameters as for heterosexual and cis-gender female patients. Screening for STIs and HIV is based on behaviors and risk factors, not on sexual orientation or gender identity. HCPs need to ask patients about the types of sexual behaviors in which they engage so that the types of STI screenings and the sites of sampling can be determined. HCPs also need to advise patients to catch up on their HPV vaccinations if they have not completed them.

Providers need to ask patients whether they have a partner with whom it would be possible to get pregnant, and whether they are having penetrative vaginal sex with this partner. If so, and if the patient does not desire a pregnancy, HCPs need to discuss and offer all available and appropriate contraceptive options. HCPs need to inform SMW and TQ patients that, even if they are not engaging in what is typically considered heterosexual or cis-normative sex, they could still be at risk for cervical dysplasia or cancer and should undergo cervical cancer screening according to current guideline recommendations. Screening for a history of or current IPV needs to be included.

Clinical breast exams need to be performed and screening mammography recommendations followed, even in patients who have had “top surgery” or a bilateral mastectomy because these individuals may have residual breast tissue. Because this topic may be a sensitive one, HCPs must allow adequate time to communicate openly and compassionately about it.

Enhance competence and understanding

Conferences and webinars on providing healthcare to LGBTQ patients, many with continuing education credit, are available from organizations such as the World Professional Association for Transgender Health, UCSF Center of Excellence for Transgender Health, The Fenway Institute, and Health Professionals Advancing LGBT Equality (formerly the Gay and Lesbian Medical Association). These organizations and others have developed vetted lists of articles, publications, and online training sessions that can be used as resources (Table). For HCPs seeking more intensive education in LGBTQ health, graduate certificate programs are available through institutions such as Drexel University in Philadelphia, The George Washington University in Washington, DC, and New York University in New York City.

Conclusion

Healthcare providers who manage the sexual and reproductive health concerns of heterosexual and cisgender women are used to providing sensitive and compassionate care during vulnerable stages throughout the lifespan. They need to expand their knowledge and understanding, and acknowledge their implicit assumptions and biases, if they exist, in order to provide the same quality of care to SMW and TQ patients. These populations are often overlooked or “invisible” in healthcare settings, or they experience discrimination, stigma, and hostility, precluding their full access to and utilization of routine and preventive care.

Nationally representative research is needed to fully reveal the health disparities and risk factors that burden these populations. Curricula must be expanded to prepare future HCPs to adequately address these concerns and provide competent and inclusive sexual and reproductive healthcare. HCPs need to use available evidence, create inclusive office environments, and commit to continuing education that expands knowledge about LGBTQ healthcare needs for themselves and their staff to help make a meaningful difference and have a beneficial effect in caring for these populations.

References

1. Coulter RWS, Kenst KS, Bowen DJ, Scout. Research funded by the National Institutes of Health on the health of lesbian, gay, bisexual, and transgender populations. Am J Public Health. 2014;104(2):e105-e112.

2. CDC. CDC Health Disparities and Inequalities Report – United States, 2011. MMWR Suppl. 2011;60(1):1-2.

3. The National Academies Press. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. March 31, 2011.

4. Obedin-Maliver J, Goldsmith ES, Stewart L, et al. Lesbian, gay, bisexual, and transgender-related content in undergraduate medical education. JAMA. 2011;306(9):971-977.

5. Morrison S, Dinkel S. Heterosexism and health care: a concept analysis. Nurs Forum. 2012;47(2):123-230.

6. Tornello SL, Riskind RG, Patterson CJ. Sexual orientation and sexual reproductive health among adolescent women in the United States. J Adolesc Health. 2014;54(2):160-168.

7. Oshri A, Handley ED, Sutton TE, et al. Developmental trajectories of substance use among sexual minority girls: associations with sexual victimization and sexual health risk. J Adolesc Health. 2014;55:100-106.

8. McCauley HL, Silverman JG, Decker MR, et al. Sexual and reproductive health indicators and intimate partner violence victimization among female family planning clinic patients who have sex with women and men. J Womens Health (Larchmt). 2015; 24(8):621-628.

9. Matthews AK, Cho YI, Hughes T, et al. The relationships of sexual identity, hazardous drinking, and drinking expectancies with risky sexual behaviors in a community sample of lesbian and bisexual women. J Am Psychiatr Nurses Assoc. 2013;19(5):259-270.

10. Herrick A, Kuhns L, Kinsky S, et al. Demographic, psychosocial, and contextual factors associated with sexual risk behaviors among young sexual minority women. J Am Psychiatr Nurses Assoc. 2013;19(6):345-355.

11. Estrich CG, Gratzer B, Hotton AL. Differences in sexual health, risk behaviors, and substance use among women by sexual identity: Chicago, 2009-2011. Sex Transm Dis. 2014; 41(3):194-199.

12. Lindley LL, Barnett, CL, Brandt HM, et al. STDs among sexually active female college students: does sexual orientation make a difference? Perspect Sex Reprod Health. 2008; 40(4):212-217.

13. Waterman L, Voss J. HPV, cervical cancer risks, and barriers to care for lesbian women. Nurse Pract. 2015; 40(1):46-53.

14. Charlton BM, Corliss HL, Missmer SA, et al. Influence of hormonal contraceptive use and health beliefs on sexual orientation disparities in Papanicolaou test use. Am J Public Health. 2014;104(2):319-325.

15. McRee A-L, Katz ML, Paskett ED, Reiter PL. HPV vaccination among lesbian and bisexual women: findings from a national survey of young adults. Vaccine. 2014;32(37):4736-4742.

16. Clavelle K, King D, Bazzi AR, et al. Breast cancer risk in sexual minority women during routine screening at an urban LGBT health center. Womens Health Issues. 2015;25(4):341-348.

17. Green ER, Maurer, L. Teaching Transgender Toolkit: A Facilitator’s Guide to Increasing Knowledge, Decreasing Prejudice and Building Skills. Ithaca, NY: Planned Parenthood of the Southern Finger Lakes; 2015.

18. Stroumsa D. The state of transgender health care: policy, law, and medical frameworks. Am J Public Health. 2014;104(3):e31-e38.

19. World Professional Association for Transgender Health. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, Version 7.

20. Bradford J, Reisner SL, Honnold JA, Xavier J. Experiences of transgender- related discrimination and implications for health: results from the Virginia Transgender Health Initiative Study. Am J Public Health. 2013; 103(10):1820-1829.

21. Light AD, Obedin-Maliver J, Sevelius JM, Kerns JL. Transgender men who experienced pregnancy after female-to-male gender transitioning. Obstet Gynecol. 2014;124(6):1120-1127.

Web resources (Table)

E. lgbt.ucsf.edu/lgbt-education-and-training

F. http://transhealth.ucsf.edu/

G. glma.org/index.cfm?fuseaction=Page.viewPage&pageId=534

H. fenwayhealth.org/the-fenway-institute/

I. mazzonicenter.org/training-and-resources

J. straightforequality.org/Healthcare

K. wpath.org/site_page.cfm?pk_association_webpage_menu=2577&pk_association_webpage=6633

L. hrc.org/hei/the-national-lgbt-health-education-center#.VttJLVKzWu4

Ten questions patients are being encouraged to ask (are you proactively answering them?)

The communication gap between healthcare providers (HCPs) and patients has been met with its fair share of commentary, research, and critique. One thing we can likely all agree on:

For patients to safely use their medications—and reap the most benefit—they need a clear understanding of how and when to take them and what to be on the lookout for in terms of potential risks and side effects. Studies have shown that all too commonly, patients lack key information or are not aware of risks associated with the medications they take. Clear communication at the start of a new drug regimen can help maximize the helpful effects and minimize possible adverse effects of medications.

With the ultimate goal of reducing adverse drug reactions and improving medication adherence, the National Council on Patient Information and Education (NCPIE), in collaboration with the FDA, launched the Talk Before You Take (TBYT) public education initiative to increase medication safety communications between HCPs and patients. TBYT encourages patients to proactively ask, and HCPs to proactively address, 10 questions about all new medications prescribed:

1. What’s the name of the medicine, and what is it for?

2. How and when do I take it, and for how long?

3. What side effects should I expect, and what should I do about them?

4. Should I take this medicine on an empty stomach or with food?

5. Should I avoid any activities, foods, drinks, alcoholic beverages, or other medicines while taking this prescription?

6. If it’s a once-a-day dose, is it best to take it in the morning or in the evening?

7. Will this medicine work safely with any other medicines I’m taking, including over-the-counter medicines?

8. When should I expect the medicine to begin to work, and how will I know if it’s working?

9. How should I store it?

10. Is there any additional written information I should read about the medicine?

Do you and your teams proactively address these questions with patients when a new medicine is prescribed?  Initiatives to improve medication safety, such as

Talk Before You Take, are most effective when HCPs are aware and involved. NPWH serves on NCPIE’s advisory board and supports its activities to educate and mobilize consumers around safe use of medications. To facilitate clear conversations about medication use, the campaign provides information for HCP offices and handouts for patients, all available at TalkBeforeYouTake.org.

W. Ray Bullman is Executive Vice President of the National Council on Patient Information and Education.

Recognition and prevention of stroke in women

Stroke is a debilitating event with lifelong implications for patients and their families. The sooner that symptoms of a stroke are recognized and treatment is initiated, the greater the likelihood that long-term sequelae can be mitigated or even prevented. Even better is preventing stroke before it happens in persons who are at risk.

A stroke is a syndrome of neurologic deficit arising from a vascular disorder that causes brain injury.1 In an ischemic stroke, which accounts for 87% of all strokes, arterial blood flow to the brain is interrupted as a result of a cerebral thrombosis or embolism.1 A transient ischemic attack (TIA) is caused by temporary clots that may presage a full-blown stroke in the future if preventive measures are not instituted. With a TIA, symptoms occur over a short period of time and resolve on their own. A hemorrhagic stroke, which accounts for 13% of all strokes, occurs when a weakened blood vessel ruptures in the setting of hypertension (HTN), an aneurysm, or an arteriovenous malformation.1

Incidence

In the United States, 6.8 million persons are stroke survivors; among these stroke survivors, 3.8 million are women.2 Stroke is the fifth-leading cause of death for men, but the third-leading cause for women.2 In the U.S., more than half (53.5%) of the estimated 795,000 new or recurrent strokes occur in women each year, resulting in about 55,000 more strokes in women than in men. Also, women who have a stroke, compared with their male counterparts, are institutionalized more often and have a poorer recovery and a worse quality of life.2

Symptoms

The National Stroke Association describes stroke symptoms as:

Sudden numbness or weakness of the face, arm, or leg, usually on one side;

Sudden confusion, difficulty with speech, or difficulty understanding speech;

Sudden difficulty seeing with one or both eyes;

Sudden difficulty walking, dizziness, or loss of balance or coordination; and/or

Sudden severe headache with no known cause.3 

Warning symptoms of a stroke should be known by both healthcare providers (HCPs) and the general public. One measure to promote stroke awareness is the FAST method (Sidebar).4 The key is to quickly recognize a stroke and call 9-1-1 for assistance as needed.

Risk factors

Many risk factors for stroke, including higher age, physical inactivity, prior cardiovascular disease, obesity, poor diet, smoking, and metabolic syndrome,  have a similar prevalence in women and men.2 Other stroke risk factors, including HTN, diabetes mellitus (DM), atrial fibrillation (AF), migraine with aura, depression, and psychosocial stress, are more prevalent and/or more dangerous in women than in men.Stroke risk factors that are specific to women include pregnancy, pre-eclampsia, gestational diabetes, combined oral contraceptive (COC) use, and possibly postmenopausal hormone therapy (HT) use.2 

Strategies for stroke prevention

These general measures can be taken, as needed, to reduce modifiable stroke risk factors2,5,6:

Smoking cessation: Smoking cessation is one of the best measures for stroke prevention.

Lifestyle changes: Following a healthful diet (e.g., Mediterranean diet or DASH diet) and increasing physical activity (at least 40 minutes 3-4 days/week) can help reduce body weight and levels of low-density lipoprotein cholesterol.

Statin pharmacotherapy: This regimen is recommended for patients with a high 10-year risk for a cardiovascular or cerebrovascular event. HCPs can access a risk calculator here.

Blood pressure reduction: HTN, more prevalent in women than in men after age 55, is considered the most modifiable risk factor for stroke. Maintaining a normal blood pressure (BP), and undergoing regular screening and treatment of HTN—with lifestyle changes and medication, as needed—are crucial to primary stroke prevention.

Blood glucose control: DM is a risk factor for stroke.

Atrial fibrillation control: Depending on a woman’s AF type and risk for hemorrhagic complications, she should be on anticoagulant therapy and possibly low-dose aspirin therapy.

Avoidance of exogenous estrogen use: This recommendation depends on a woman’s risk/benefit profile.

At-risk pregnant women

To prevent pre-eclampsia, women with chronic primary or secondary HTN or previous pregnancy-related HTN should take low-dose aspirin from the 12th week of gestation until delivery.1 Oral calcium supplementation (≥1 g/day) should be considered for women with low dietary intake of calcium (<600 mg/day). Women with severe HTN in pregnancy should be treated with safe and effective antihypertensives such as methyldopa, labetalol, or nifedipine. Consideration should be given to treating women with moderate HTN in pregnancy—again, with safe and effective antihypertensives. Atenolol, angiotensin receptor blockers, and direct renin inhibitors are contraindicated during pregnancy.

Combined oral contraceptive users

Aggressive therapy of additional stroke risk factors may be reasonable in COC users. Although routine screening for pro-thrombotic mutations before initiation of hormonal contraception is not useful, BP measurement is recommended. COC use may be harmful in women with stroke risk factors such as cigarette smoking or a history of thromboembolic events and should be reconsidered.

Hormone therapy users

Hormone therapy (e.g., conjugated equine estrogens,  alone or with medroxyprogesterone) should not be used for primary or secondary prevention of stroke in postmenopausal women. Selective estrogen receptor modulators such as raloxifene and tamoxifen should not be used for primary prevention of stroke.

Migraineurs with aura

Because of the link between higher migraine frequency and stroke risk, treatments to reduce migraine frequency may be reasonable, although evidence is lacking that this approach reduces the risk of a first stroke. Because of the increased stroke risk seen in female migraineurs with aura who smoke, smoking cessation in this group is strongly advised.

Women with atrial fibrillation

Considering the increased prevalence of AF with age and the higher risk of stroke in elderly women with AF, active screening (in particular of women older than 75 years) in primary care settings using pulse taking followed by an ECG is recommended. Oral anticoagulation is not recommended in women aged 65 years or younger with AF alone and no other risk factors. Antiplatelet therapy is a reasonable therapeutic option for selected low-risk women. New oral anticoagulants are a useful alternative to warfarin for prevention of stroke and systemic thromboembolism in women with paroxysmal or permanent AF and pre-specified risk factors who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure, lower weight, or advanced liver disease.

Women with depression or psychosocial stress

No specific recommendations regarding stroke prevention were provided for this group. More research is needed to establish which women are at greater risk for stroke and which interventions, if any, may be helpful in reducing stroke risk.

Conclusion

Both women and their HCPs need to be able to recognize stroke symptoms and take action as quickly as possible if an ongoing stroke is suspected. For women at risk for stroke, implementing measures that will reduce stroke risk is vital. HCPs caring for women should be particularly alert to the risks that are more prevalent and dangerous in women and those that are specific to women, and should guide these women accordingly in terms of recommending appropriate prophylactic measures.

Janis R. Guilbeau and Cynthia Watson are nursing faculty at the University of Louisiana at Lafayette. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Grossman S. Porth C. Porth’s Pathophysiology: Concepts of Altered Health States. 9th ed. Philadelphia, PA: Wolters Kluwer Lippincott Williams & Wilkins; 2014.

2. Bushnell C, McCullough LD, Awad IA, et al., on behalf of the American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Council for High Blood Pressure Research. Guidelines for the Prevention of Stroke in Women: A Statement for Healthcare Professionals From the American Heart Association/ American Stroke Association. Stroke. 2014;45(5):1545-1588.

3. National Stroke Association. Reducing Risk and Recognizing Symptoms. August 2009.

4. National Stroke Association. Act FAST. 2016.

5. CDC. Preventing Stroke: Healthy Living. Page last updated April 30, 2015.

6. Meschia JF, Bushnell C, Boden-Albala B, et al; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, Council on Functional Genomics and Translational Biology, and Council on Hypertension. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014;45(12):3754-3832.

Interventions to increase LARC acceptances, with a focus on IUCs

Before reading the article, click here to take the pretest. 

Long-acting reversible contraceptives, or LARC, are growing in popularity because they are highly effective, safe, and well tolerated. In addition, LARC methods require virtually no effort on the part of users besides seeing their healthcare provider (HCP) for insertion and removal. The authors describe their experience in “getting to yes”—that is, in encouraging HCPs to offer LARC methods in a patient-friendly environment and patients to consider using them—so that teens and women have access to all methods, autonomy over their method decision, and decreased risk of unintended pregnancy.

Key words: long-acting reversible contraceptives, LARC, intrauterine contraceptive, IUC, IUD, LNG-IUS

Of the 6.1 million pregnancies in the United States each year, 45% are unintended—either mistimed (27%) or unwanted (18%).1,2 Ninety-five percent of unintended pregnancies occur in females who do not use contraceptives (54%) or who use them inconsistently (41%).These unintended pregnancies may end in abortion (42%) or birth (58%),both of which have socioeconomic, fiscal, and health-related consequences. Births resulting from unintended or closely spaced pregnancies can have a variety of adverse maternal and child health outcomes.1 Furthermore, females who have children before they are ready are less likely to reach their educational, career, financial, and/or family-related goals.

Unintended pregnancies can be avoided by correct and consistent use of a birth control method. Among all reversible methods, those that require the least amount of effort by the user have been demonstrated to be the most effective at pregnancy prevention.

Background information on LARC

Long-acting reversible contraceptives, or LARC, include the subdermal implant and intrauterine contraceptives (IUCs).Both implants and IUCs are highly effective in preventing pregnancy and are FDA-approved for 3-10 years of use. In addition, these methods are reversible and do not impair fertility once they are removed; users who wish to become pregnant can have them removed at any time. LARC methods are the most effective forms of reversible birth control available: During the first year, fewer than 1% of implant or IUC users will become pregnant.4 Failure rates associated with the use of other contraceptives are considerably higher.

Devices

The implant is a single, matchstick-sized, etonogestrel-containing rod that is placed in the subdermal tissue of the inside aspect of the upper non-dominant arm.5 The implant, which is marketed as Nexplanon®, contains barium, allowing localization with radiography. The implant is FDA-approved for 3 years of use.

Intrauterine contraceptives, either an intrauterine device (IUD) or an intrauterine system (IUS), are T-shaped devices containing copper or levonorgestrel (LNG).Four IUCs are available, the Copper T 380A (ParaGard®) and three LNG-IUS products: Mirena®, Skyla®, and Liletta®. The copper IUD is effective immediately following placement7 and is FDA approved for 10 years of use.Mirena is FDA approved for 5 years of use, and Skyla and Liletta for 3 years of use.6 Data collection for Liletta is ongoing; it is expected that the manufacturer will ultimately seek approval for up to 7 years of use. If an LNG-IUS product is placed during the first 7 days of the menstrual cycle or immediately following birth, a miscarriage, or a first-trimester abortion, then back-up contraception is not needed.6,8 Otherwise, a backup method is recommended for the first 7 days.

Of note, LARC methods do not protect users against sexually transmitted infections (STIs). Condoms are needed for protection against STIs.

Medical eligibility criteria

All teenagers and women should be considered candidates for LARC use until proven otherwise.9-11 Readers can access the CDC’s Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use. Information from the CDC is also available as a free iPhone or iPad app at the iTunes store or as an eBook available on an eReader app.

Trends in LARC use

LARC methods are gaining in popularity for many reasons, but mainly because of their high efficacy.12 According to an analysis of National Survey for Family Growth (NSFG) data, the proportion of female U.S. contraceptors using the IUD or implant increased from 2.4% in 2002 to 3.7% in 2007 and to 8.5% in 2009.13 According to a more recent analysis of the NSFG data, the prevalence of LARC use among contraceptors rose from 8.5% in 2009 to 11.6% in 2012, a significant increase.14,15 Much of this trend was driven by IUC use, which increased from 7.7% to 10.3%; implant use remained low (1.3%) and did not change significantly between these two time periods.

The Contraceptive CHOICE Project

Although increased use of LARC methods has been encouraging, uptake is still relatively low—especially considering the high rate of unintended pregnancy in this country, the superior efficacy of these methods, and the many non-contraceptive benefits they offer. The next logical question is, What can be done to increase education about and access to LARC methods for reproductive-aged females who wish to prevent pregnancy?

Purpose and methods

The Contraceptive CHOICE Project was undertaken to remove educational, financial, and access barriers to contraception; to promote the most effective methods of birth control; and to reduce unintended pregnancy in the St. Louis, Missouri, area.16 Objectives of the project were to increase uptake of LARC; to measure/analyze method choice, satisfaction, side effects, and continuation across all reversible contraceptive methods; and to provide enough no-cost contraception to exert a population impact on unintended pregnancies particularly with respect to teen pregnancy and repeat abortion.

Enrollment began in August 2007 and ended in September 2011. Prospective enrollees ranged in age from 14-45 years, wanted to avoid pregnancy for ≥1 year, and were willing to initiate a new form of reversible contraception.17,18 Recruitment was done via word of mouth, referral from private and community healthcare providers (HCPs), and from the two abortion facilities in the St. Louis region. Participants underwent standardized evidencebased contraceptive counseling by trained non-clinicians. The counseling was structured on effectiveness tiers, and included the risk and benefits of each method. Tier 1 contraceptives—the most effective methods, which include LARC (IUCs and the implant)— were described first. Next, the counselor described tier 2 methods or refillables: depot medroxy-progesterone acetate (DMPA), and the pill/patch/ring (PPR). Tier 3 methods, including the diaphragm, the condom, the sponge, spermicide, withdrawal, and fertility awareness-based methods, were described last. Participants received their chosen contraceptive free of charge, and they could switch methods as frequently as they wanted for the duration of their study participation (2-3 years).

Results

Contraceptive choices of the entire cohort and of the teen cohort alone are shown in the FigureAmong 9,256 adult and teen participants, 75% chose a LARC method; among teens alone, 71% chose a LARC method.

Continuation rates

Among LARC users, adults and teens had high continuation rates—87% and 82%, respectively— at 12 months.19,20 Non- LARC users had much lower 12- month continuation rates: 59% for adults and 49% for teens. Among LARC users, continuation rates at 24 months were still high: 78% for adults and 67% for teens.20 Only 42% of adult non-LARC users and 37% of teen non-LARC users continued using the contraceptive method they chose at baseline for 24 months. At 3 years, continuation rates were 67.2% among LARC users and 31.0% among non-LARC users.21

Satisfaction levels

Twelve-month satisfaction levels mirrored continuation rates. A greater proportion of LARC users than non-LARC users reported being very satisfied or somewhat satisfied with their method (81.2% vs. 48.8%).19 This differential in satisfaction between LARC users and non-LARC users held true for adults (82% vs. 50%) and for teens (75% vs. 42%). Satisfaction was similarly high among users of the subdermal implant, copper IUD, or LNG-IUS (range, 72% for teen users of the copper IUD to 84% for adult users of the LNG-IUS) and similarly low among users of DMPA or PPR (range, 31% for teen users of the ring to 52% for adult users of DMPA or the ring).

Unintended pregnancy and abortion rates

Even more important, among 7,486 participants included in this analysis, 334 (4.5%) experienced unintended pregnancies.4 Failure rates among PPR users were 4.8%, 7.8%, and 9.4% in years 1, 2, and 3, respectively; corresponding rates among LARC users were 0.3%, 0.6%, and 0.9%
(P <.001). Failure rates among DMPA users were similar to those of the LARC users. LARC methods were highly effective in preventing pregnancy regardless of a user’s age, whereas teen PPR users were twice as likely as adult PPR users to become pregnant.

One of the primary outcomes of interest was the percentage of abortions that were repeat abortions.18 Using vital statistics data from Missouri’s state health department, the investigators found a significant difference in the proportion of repeat abortions between the St. Louis region and Kansas City in 2009 (respective rates, 46% vs. 49%; P = .02) and 2010 (respective rates, 44% vs. 51%; P <.01). In addition, they detected a significant decline in the proportion of repeat abortions over time in the St. Louis region (= .002). Another analysis revealed that pregnancy, birth, and abortion rates among teens in the CHOICE Project were substantially lower than national rates among sexually experienced teens.22 Respective annual rates of pregnancy, birth, and abortion were 34.0, 19.4, and 9.7 per 1,000 teen CHOICE Project participants, as compared with 158.5, 94.0, and 41.5 per 1,000 sexually experienced U.S. teens in 2008.

Summary of main findings

LARC methods, as compared with shorter-acting methods, were associated with higher continuation rates and user satisfaction levels, regardless of age. In addition, LARC methods were associated with lower rates of unintended pregnancy and, as a consequence, lower rates of birth and abortion. An informative video about the Contraceptive CHOICE Project is available at Pathway to Choice. Box 1 shows how CHOICE got to yes.

Barriers to IUC use, and how to overcome them

In order for the encouraging results of the CHOICE Project to translate to other populations throughout the country, barriers must be overcome. From this point onward, this article focuses on IUCs.

The National Committee for Quality Assurance has issued a White Paper, Women’s Health: Approaches to Improving Unintended Pregnancy Rates in the United States, that describes numerous barriers that impede our nation’s ability to reduce the rate of unintended pregnancy. To read a summary of these barriers, click here. To read the entire White Paper, click here.

Provider barriers

Many HCPs have concerns about prescribing and placing IUCs. Many of these concerns are easily addressed.

Lack of training

If an HCP’s training occurred prior to 2001, she or he may not have received instruction in IUC placement. To acquire such training, HCPs can seek out instructors provided by product manufacturers or academic institutions, or they can attend conferences where such training is provided. HCPs need not be certified by the manufacturer to place IUCs; any HCP who feels comfortable with the instructions and the procedure may place them.

Too few patients to gain competency

An HCP such as a primary care provider or a rural health provider may not see enough patients to maintain a comfortable competency in IUC placement. This barrier may or may not be surmountable; each HCP has her or his own threshold for a feeling of competency. One approach is to form a collaborative relationship with a high-volume provider who can offer ongoing support and training. In addition, if HCPs view each patient encounter with a reproductive-aged female as an opportunity to address her goals with respect to pregnancy and/or pregnancy prevention, then they will likely be providing many more contraceptive services than they think.

Fear of litigation

Some HCPs may fear litigation if complications arise; some of the items in the bulleted list in the next section can help dispel this fear. Concerns based on myths Each of these myths surrounding IUCs is debunked.

Teenagers and nulliparous women are not appropriate candidates for IUCs. Evidence shows that these females are excellent candidates for IUCs, which are highly effective regardless of age or parity.10

Young women won’t like IUCs because placement is too painfulPlacement comfort varies from patient to patient. Many young women tolerate the placement procedure very well.23

Most patients cannot afford IUCsMany women have coverage for IUCs.24 More will be able to get them as the Affordable Care Act (ACA) continues to implement the 2011 Institute of Medicine recommendations.

Women should have IUC counseling at one visit and return for IUC placement at the next visitTwo-thirds of women prefer to have the IUC placed on the same day it is prescribed.25 Adding a second visit places an extra barrier between the patient and her receiving the desired contraceptive, thereby increasing her risk for unintended pregnancy.

Patients won’t keep their IUCsIUCs had the highest continuation rates of any method offered in the CHOICE Project.26

Patients already know what they want. When CHOICE Project participants were advised of all their birth control options and allowed to choose what they wanted, 58% chose an IUC. In the real world, only 10% of U.S. females choose an IUC.14,15 Many females are unfamiliar with LARC methods or harbor misconceptions about them. They cannot know what they want unless they are fully informed about the options.

HCPs don’t have time to tell patients about every methodTrained staff members can inform patients of their options, starting with the most effective methods.27 In addition, HCPs can provide decision aids that patients can use in the waiting room before their visits.

High upfront cost

The high cost to stock IUCs, with a delay in reimbursement, may keep some HCPs from offering them. The ACA has helped in that the cost of a contraceptive and its placement should be fully covered, with no cost share to the patient. However, barriers do remain: Some health insurance plans exclude contraceptive coverage for religious reasons, small companies need not comply, and some state plans do not cover at 100% or have restrictions on use.

Concern about a prospective IUC user being pregnant 

According to the U.S. Selected Practice Recommendations for Contraceptive Use, an HCP can be reasonably certain that a patient is not pregnant if she has no signs or symptoms (S/S) of pregnancy, has a negative urine pregnancy test result, and meets any one of these criteria8:

• ≤7 days after the start of her normal menses;

• abstinence since the start of her last normal menses;

• correct and consistent use of contraception;

• ≤7 days after spontaneous or induced abortion;

• within 4 weeks postpartum; or

• fully or nearly fully breastfeeding, amenorrheic, and <6 months postpartum.

Concern about a prospective IUC user having an STI

At-risk patients can be tested for gonorrhea and chlamydia at IUC placement.10 If a positive result is noted, the device can still remain in place. The HCP can treat the infection, offer expedited partner therapy as per CDC guidelines, inform patients about the warning S/S of pelvic inflammatory disease (PID; e.g., new-onset abdominal or pelvic pain, foul-smelling vaginal discharge, pain during or shortly after sex, fever, abnormal uterine bleeding), and retest in 3 months. However, if an HCP suspects active infection at the time, the device should not be placed. Instead, the patient is tested and treated as needed. No evidence suggests that IUCs increase the risk for developing an STI.

Patient barriers

These barriers include lack of knowledge about IUCs, negative influence of friends or the media, lack of access to HCPs who can provide IUCs, and cost concerns. The CHOICE Project overcame these barriers by having non-clinicians educate participants about all birth control methods. HCPs provided same-day LARC placement as per the U.S. Selected Practice Recommendations for Contraceptive Use guidelines.The birth control methods were provided free of charge. In Open the Dialogue, CHOICE Project participants describe how they felt when education, access, and cost barriers were removed and they could choose any birth control method they wanted.

IUC risks and side effects

One of the main concerns about IUC placement is uterine perforation, which occurs in about 1 in 1,000 placements.3 Red flags indicating acute uterine perforation include the uterus sounding to a depth greater than that appreciated on bimanual examination, sudden loss of resistance, and patient pain disproportionate to that expected. Vaginal bleeding is unlikely.

Another concern is PID, which develops in fewer than 1% of IUC users, usually during the first 20 days post-placement. Appropriate precaution—screening highrisk women at the time of placement and delaying placement in those with active cervicitis—is the best way to minimize this risk. In very rare cases, pregnancy may occur with the IUC in place; if so, there is a higher chance that it will be an ectopic pregnancy. IUC users with a positive pregnancy test result need to be promptly evaluated to rule out ectopic pregnancy and undergo pregnancy options counseling.

With the copper IUD, menstrual pain and bleeding may increase at first.3 Intermenstrual bleeding may occur as well. These side effects are common in the first few months of use and tend to subside within a year. The LNG-IUS may be associated with spotting, irregular bleeding, and menstrual cramping in the first few months of use. Again, these side effects tend to diminish over time. Some users may experience LNG-related effects such as headache, nausea, depression, and breast tenderness.

Creating a LARC-friendly practice

Healthcare providers who wish to create a LARC-friendly practice know that LARC methods are the most effective reversible methods. They know that every patient is a LARC candidate until proven otherwise. They have ensured that all office staffers are knowledgeable about LARC, can follow an effectiveness tier-based counseling approach as per the CDC guidelines, and promote LARC use. After all, support staff members’ perceptions can greatly affect patients’ decisions. Other tenets of a LARC-friendly practice include the following:

• Every effort is made to help patients obtain the method of their choice.

• Same-day LARC placement is the standard.

• All HCPs have received proper LARC training.

• LARC methods are stocked if possible.

More information about setting up a LARC-friendly practice, including an introductory video, is available at the LARC First website. A message from the authors appears in Box 2.

Conclusion

Long-acting reversible contraceptives are the most effective birth control methods on the market. As shown in the CHOICE Project, IUCs and implants are superior to other methods in terms of continuation rates and satisfaction levels. As such, LARC methods should be considered first-line options for all females, including adolescents and nul liparous women. LARC method efficacy does not depend on user compliance. HCPs should provide counseling and reassurance so that patients know what to expect at the time of placement, as well as possible side effects. Same-day IUC placement should be the standard. As providers of healthcare to teenage girls and women, HCPs are privileged to be able to have a dramatic impact on patients’ lives with such a simple intervention.

References

1. Guttmacher Institute. Unintended Pregnancy in the United States. Fact Sheet. March 2016.

2. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374(9):843-852.

3. American Congress of Obstetricians and Gynecologists. Long-Acting Reversible Contraception (LARC): IUD and Implant. May 2016.

4. Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007.

5. Association of Reproductive Health Professionals. Choosing a Birth Control Method. Implant. Updated June 2014.

6. Association of Reproductive Health Professionals. Choosing a Birth Control Method. Intrauterine Contraception. Updated June 2014.

7. Trussell J. Contraceptive failure in the United States. Contraception. 2011;83(5):397-404.

8. Centers for Disease Control and Prevention. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. July 29, 2016.

9. ACOG Practice Bulletin. Long-Acting Reversible Contraception. #121, July 2011.

10. CDC. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. July 29, 2016.

11. MacGregor KE, Khadr SN. Contraception for adolescents (American Academy of Pediatrics). Arch Dis Child Educ Pract Ed. 2016;101(2):61-64.

12. Branum AM, Jones J, for the Centers for Disease Control and Prevention. Trends in Long-acting Reversible Contraception Use Among U.S. Women Aged 15–44. NCHS Data Brief No. 188, February 2015.

13. Finer LB, Jerman J, Kavanaugh MLO. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012;98(4):893-897.

14. Kavanaugh ML, Jerman J, Finer LB. Changes in use of long-acting reversible contraceptive methods among U.S. women, 2009-2012. Obstet Gynecol. 2015;126(5):917-927.

15. Guttmacher Institute. Use of Long-Acting Reversible Contraceptive Methods Continues to Increase in the United States. Press release. October 8, 2015.

16. Contraceptive CHOICE Project.

17. Secura GM, Allsworth JE, Madden T, et al. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010;203(2):115.e1-7.

18. Peipert JF, Madden T, Allsworth JE, Secura GM. Preventing unintended pregnancies by providing no-cost contraception. Obstet Gynecol. 2012;120(6):1291-1297.

19. Rosenstock JR, Peipert JF, Madden T, et al. Continuation of reversible contraception in teenagers and young women. Obstet Gynecol. 2012;120(6):1298-1305.

20. O’Neil-Callahan M, Piepert JF, Zhao Q, et al. Twenty-four-month continuation of reversible contraception. Obstet Gynecol. 2013;122(5): 1083-1091.

21. Diedrich JT, Zhao Q, Madden T, et al. Three-year continuation of reversible contraception. Am J Obstet Gynecol2015;213(5):662.e1-8.

22. Birgisson NE, Zhao Q, Secura GM, et al. Preventing unintended pregnancy: the Contraceptive CHOICE Project in review. J Womens Health (Larchmt). 2015;24(5):349-353.

23. McNicholas CP, Madden T, Zhao Q, et al. Cervical lidocaine for IUD insertional pain: a randomized controlled trial. Am J Obstet Gynecol. 2012;207(5):384.e1-6.

24. Clinical Preventive Services for Women: Closing the Gaps. Washington, DC: The National Academies Press; 2011.

25. Stanek AM, Bednarek PH, Nichols MD, et al. Barriers associated with the failure to return for intrauterine device insertion following firsttrimester abortion. Contraception2009;79(3):216-220.

26. Peipert JF, Madden T, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011;117(5):1105-1113.

27. Madden T, Mullersman JL, Omvig KJ, et al. Structured contraceptive counseling provided by the Contraceptive CHOICE Project. Contraception. 2013;88(2):243-249.

Updated contraception resources from the CDC

The U.S. Medical Eligibility Criteria for Contraceptive Use, 2016 (MEC)1 and the U.S. Selected Practice Recommendations for Contraceptive Use, 2016 (SPR)2 were both released to the public on July 29, 2016. The MEC provides guidance to healthcare providers (HCPs) regarding safe use of contraceptive methods by individuals with certain personal characteristics (e.g., age, smoking status, postpartum status) or medical conditions (e.g., hypertension, diabetes, headaches). The SPR, a companion document to the MEC, provides guidance for common contraceptive management topics such as how to be reasonably certain that a woman is not pregnant, when to start contraception, which exams and tests are medically indicated prior to starting a contraceptive method, what type of follow-up is needed, and how problems should be managed.

The first edition of the MEC was published in 20103 and the first edition of the SPR, in 2013.4 The 2016 updates were made after a thorough review of the scientific evidence and consultation with national experts. A summary of the MEC changes since 2010 is provided in Appendix A of the 2016 edition and a summary of the SPR changes since 2013 appears on page 2 of the 2016 SPR.1, 2

MEC updates

The 2016 MEC provides more than 1,800 recommendations for more than 60 personal characteristics and medical conditions.1 As in the 2010 edition, the 2016 MEC continues to use four categories of medical eligibility to help HCPs assess the safety of a particular contraceptive method for persons with specific personal characteristics or medical conditions (Box). HCPs are reminded that although the MEC recommendations provide guidance, individual circumstances should always be considered in contraceptive method counseling and decisions. Take-home messages in the 2016 MEC remain the same as those in the 2010 edition:

Most women can safely use most contraceptives.

Women with medical conditions associated with an increased risk for adverse health events as a result of pregnancy need highly effective contraception for reproductive life planning.

Women, men, and couples should be informed of  the full range of methods to decide what will be best for them.

Use of the MEC can help HCPs decrease barriers to choosing safe and effective contraceptive methods.

New recommendations

New to the 2016 MEC are recommendations for women with multiple sclerosis (MS) or cystic fibrosis (CF) and for women taking selective serotonin reuptake inhibitors (SSRIs) or St. John’s wort. Ulipristal acetate (UPA) has been added to the recommendations on emergency contraception (EC).

Multiple sclerosis

HCPs should check the MS subsection of the Neurologic Conditions section of each appendix. In Appendix C, Classifications for Progestin-Only Contraceptives (POCs), depot medroxyprogesterone acetate (DMPA) is listed in category 2 for women with MS, with the comment that these women’s bone health may be compromised due to disease- related immobility and use of corticosteroids. Use of DMPA, which has been associated with small changes in BMD, might be of concern in this patient population. The other POCs, the subdermal implant and progestin-only pills (POPs), are listed in category 1 for women with MS. In Appendix D, Classifications for Combined Hormonal Contraceptives (CHCs), CHCs are listed in category 3 for women with MS who have prolonged immobility and in category 1 for women with MS who do not have prolonged immobility. Of note, although no data suggest an increased risk for venous thromboembolism (VTE) in women with MS using CHCs, these women are at overall higher risk than unaffected women for VTE.

Cystic fibrosis

HCPs should check the CF subsection of the Respiratory Conditions section of each appendix. CF is described as a condition associated with an increased risk for adverse health events as a result of pregnancy. Certain drugs used to treat CF (e.g., lumacaftor) might reduce the effectiveness of hormonal contraceptives, including oral, injectable, transdermal, and implantable contraceptives. In Appendix C, Classifications for POCs, DMPA is listed in category 2 for women with CF, with the comment that these women have a higher prevalence of osteopenia, osteoporosis, and fragility fractures than the general population. Use of DMPA, which has been associated with small changes in BMD, might be of concern in this patient population. The other POCs in women with CF are listed in category 1.

Selective serotonin reuptake inhibitors 

HCPs should check the Drug Interactions section in each appendix for specific information about this drugclass. In Appendix A, SSRIs are listed in category 1 for all contraceptives. Available data, albeit limited, show no decrease in the effectiveness of hormonal contraceptives in SSRI users. Likewise, available data show no difference in the effectiveness or in the adverse effects of SSRIs in women using hormonal contraceptives versus those not using them. The comments sections of Appendix C and Appendix D note that drugs that are inhibitors of CYP3A4 or CYP2C9 have the potential, at least in theory, to raise levels of contraceptive steroids, which might increase adverse events. The SSRI fluvoxamine is known to be a moderate inhibitor of both CYP3A4 and CYP2C9; however, no clinical or pharmacokinetic studies were identified to explore these potential drug–drug interactions.

St. John’s wort

HCPs should check the Drug Interactions section in each appendix for information about this herbal product. In Appendix A, St. John’s wort is listed in category 1 for intrauterine devices (IUDs) and DMPA, and in category 2 for the implant, POPs, and CHCs. With regard to the implant, POPs, and CHCs, as noted in Appendix C and Appendix D, limited available data raise concern that St. John’s wort might decrease the effectiveness of hormonal contraceptives by increasing the metabolism of estrogen and progestins. Interactions may be dependent on the dose of St. John’s wort. Also, the concentration of active ingredients in St. John’s wort products may vary. Any potential impact of this herbal product on the contraceptive effectiveness of DMPA is less likely than with the other POCs because of the higher dose of progestin.

Ulipristal acetate

HCPs should check Appendix J, Classifications for  Emergency Contraception, for more information about UPA, which has been added to the EC appendix. Like levonorgestrel (LNG) and combined oral contraceptives (COCs) used for EC, UPA is listed in category 2 for women with a history of severe cardiovascular disease, severe liver disease, or obesity, and in those who use a CYP3A4 inducer (e.g., bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate, efavirenz, lumacaftor). Of note, for women who are obese or who use strong CYP3A4 inducers, UPA, LNG, and COCs used for EC are listed in category 2 because of possibly reduced effectiveness. There are no personal characteristics or medical conditions that place UPA, LNG, or COCs used for EC in category 3 or 4.

Women who are breastfeeding and have taken UPA are advised to express and discard breast milk for 24 hours after taking the medication. This recommendation has been made because UPA is excreted in breast milk, with highest concentrations in the first 24 hours.

Other MEC revisions

Revisions to recommendations have been made for postpartum and breastfeeding women, as well as for several medical conditions. The revisions to recommendations for postpartum and breastfeeding women include those presented in the 2011 CDC revised recommendations for these populations related to use of the IUD, POCs, and CHCs.5 Appendix B, Classifications for IUDs, includes changes for women with gestational trophoblastic disease, HIV infection, and certain factors related to sexually transmitted infections. Appendix D, Classifications for CHCs, includes changes for women with migraines, superficial venous disease, or known dyslipidemias, and for women on antiretroviral therapy.

SPR updates

As in the 2013 edition, the 2016 SPR provides information organized by contraceptive method.2 Charts and algorithms are included in appendices that summarize guidance across all methods for when to start, examinations and tests that are needed, routine followup, and management of bleeding irregularities. SPR updates are consistent with changes in the 2016 MEC. Take-home messages in the 2016 SPR remain the same as in the 2013 edition:

Most women can start most methods anytime.

Few, if any, exams or tests are needed.

Routine follow-up is generally not required.

Regular contraception should be started after emergency contraception.

Anticipatory counseling for potential contraceptive-related bleeding changes and proper management are important.

Use of the SPR can help HCPs decrease medical barriers to accessing and using contraception.

New recommendation: use of medications to ease IUD insertion

Misoprostol is not recommended for routine use before IUD insertion but might be helpful in some circumstances—for example, in a woman with a recent failed insertion. A paracervical block with lidocaine might reduce pain during IUD insertion.

Updated recommendation: when to start regular contraception after taking UPA

Under ideal circumstances, women should start or resume a hormonal contraceptive method no sooner than 5 days after taking UPA because of a risk that hormonal contraceptives might decrease the effectiveness of UPA. However, if the chosen hormonal method would require an additional visit to an HCP (e.g., DMPA, implant, IUD), the risk of reduced effectiveness needs to be weighed against the risk that a regular contraceptive method might not be started. Women who have taken UPA should abstain from sexual intercourse or use a barrier method for 7 days after starting or resuming regular contraception or until the next menses, whichever comes first. Any nonhormonal contraceptive method can be started immediately after taking UPA.

Useful tools for HCPs

The CDC provides a variety of useful tools and aids to facilitate use of the MEC and SPR in clinical practice. The summary MEC chart has been updated, as has the MEC and SPR Smartphone app. Printable PDF versions of When to Start Contraceptive Methods and Routine Follow-up and What to Do If Late, Missed, or Delayed CHC are available. 

Beth Kelsey is Assistant Professor and DNP Program Director at the School of Nursing, Ball State University, in Muncie, Indiana. She is editor-in-chief of Women’s Healthcare: A Clinical Journal for NPs and Publication Coordinator for NPWH. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Centers for Disease Control and Prevention (CDC). U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. July 29, 2016.

2. CDC. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. July 29, 2016.

3. CDC. U.S. medical eligibility criteria for contraceptive use, 2010. June 18, 2010.

4. CDC. U.S. selected practice recommendations for contraceptive use, 2013. MMWR. 2013;62(RR-5):1-46.

5. CDC. Update to CDC’s U.S. medical eligibility criteria for the use of contraceptive methods, 2010: revised recommendations for the use of contraceptive methods during the postpartum period. MMWR. 2011;60(26):878-883.

The Doctor of Nursing Practice for Women’s Health Nurse Practitioners

The National Association of Nurse Practitioners in Women’s Health (NPWH) supports a pragmatic approach for the continuing evolution to the Doctor of Nursing Practice (DNP) degree as entry level for women’s health nurse practitioners (WHNPs). During the transition, study of the impact of DNP education on quality, access, and cost of healthcare should be ongoing. Policies must be in place to ensure that currently practicing WHNPs are not disenfranchised from practice in any way. Furthermore, NPWH advocates for concerted strategies to maintain an adequate number of highly qualified WHNPs to meet the healthcare needs for individuals and communities.

Background

In October 2004, the American Association of Colleges of Nursing (AACN) published a position paper with the recommendation to transition the entry-level degree for advanced practice registered nurses (APRNs) from the master’s degree to the DNP by the year 2015.The AACN position paper outlined several trends to support the need for a practice doctorate for advanced nursing practice. These trends included continuing expansion of scientific knowledge, technology and informatics advances, increasing complexity of healthcare systems, the need for improved patient outcomes, and the need for parity with other healthcare professionals.

The Institute of Medicine (IOM) 2011 report, The Future of Nursing: Leading Change, Advancing Care, recognized that more would be expected of the APRN as the healthcare system grows in complexity, scientific knowledge continues to expand, and technology advances.2 APRNs would need competence in aspects of healthcare that require additional coursework and aligned clinical experiences. Further, the IOM report recognized the importance of DNP-prepared APRNs as clinical scholars who translate research and positively affect individual and population health outcomes at organizational and systems levels.

Based on the AACN’s Essentials of Doctoral Education for Advanced Nursing Practice, DNP curricula go beyond that of master’s programs.3 DNP programs prepare APRNs as leaders in evidence- based practice, quality improvement, systems thinking, and clinical scholarship. DNP curricula provide critical learning in the areas of informatics and technology, healthcare policy and advocacy, population health, and inter-professional collaboration to improve healthcare.

In 2015, the National Organization of Nurse Practitioner Faculties (NONPF) reaffirmed a commitment to advancing the DNP degree as entry level for the NP role.4 Further, NONPF recommended that all NP programs provide a postbaccalaureate to DNP with a seamless, integrated curriculum that prepares graduates with NP core competencies,population-focused  competencies,and competencies of the DNP Essentials.3

Significance to women’s healthcare and WHNP practice

NPWH affirms that master’s and certificate programs have fully prepared WHNPs with the competencies required to provide safe, quality healthcare for women. NPWH also recognizes the growing complexity of healthcare environments and the continuously expanding body of scientific knowledge regarding women’s health and healthcare needs. DNP education provides WHNPs with advanced competencies significant to providing women’s healthcare and enhancing NP practice.

Women benefit when WHNPs are prepared with the highest level of scientific knowledge and the ability to translate that knowledge quickly and effectively into practice. Proficiency in leading quality improvement strategies that create and sustain positive change at organizational and policy levels leads to improved health outcomes. Advanced preparation in the inter-professional dimension of healthcare enables WHNPs to facilitate collaborative team functioning. DNP-prepared WHNPs provide a critical interface between practice, research, and policy, with a focus on women’s health.

NPWH also recognizes challenges that must be addressed regarding the move to the DNP as entry level for WHNP practice. The DNP degree will require longer educational programs that add to educational costs. Longer educational programs may also slow the number of WHNPs prepared to meet national healthcare shortages. Financial gain for the WHNP prepared at the DNP level is not guaranteed.

NPWH recommendations

DNP education must include availability for preparation in the WHNP population focus.

• The DNP curriculum for the WHNP population focus must incorporate the WHNP Guidelines for Practice and Education.7

NPWH and other APRN organizations must collaborate to address the challenges presented in making the transition to the DNP as entry into practice for APRNs in an informed and equitable manner.

NPWH and other APRN organizations must participate in and support research to study the impact of DNP education on quality, access, and cost of healthcare.

NPWH will continue to advocate at organizational and legislative levels to ensure that policies and regulations support the practice of all WHNPs. NPWH will support only those policies and regulations for NP practice, education, and reimbursement that do not disenfranchise WHNPs without DNP degrees.

References

1. American Association of Colleges of Nursing. AACN Position Statement on the Practice Doctorate in Nursing. October 2004.

2. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2011.

3. American Association of Colleges of Nursing. The Essentials of Doctoral Education for Advanced Nursing Practice. 2006.

4. National Organization of Nurse Practitioner Faculties. The Doctorate of Nursing Practice NP Preparation: NONPF Perspective. 2015.

5. National Organization of Nurse Practitioner Faculties. Nurse Practitioner Core Competencies. 2012.

6. Population Focused Competencies Task Force. Population-Focused Nurse Practitioner Competencies2013.

7. National Association of Nurse Practitioners in Women’s Health. Women’s Health Nurse Practitioner: Guidelines for Practice and Education. 7th ed. 2014.

Boosting HPV vaccination rates: A call to action

Faculty

Nancy R. Berman, MSN, ANP-BC, NCMP, FAANP, is a nurse practitioner at Michigan Healthcare Professionals in Farmington Hills and a Clinical Instructor in the Department of Obstetrics and Gynecology at Wayne State University School of Medicine in Detroit, both in Michigan.

Intended audience

This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners, certified nurse-midwives, and other advanced practice clinicians who care for women.

CE approval period

Now through May 31, 2017

Estimated time to complete this activity

1 hour

CE approval hours

1.0 contact hour of CE credit, including 1.0 contact hour of pharmacology content

Needs assessment

Most cervical cancers are preventable. The incidence of cancer related to HPV infection has declined significantly since the inauguration of screening programs in the U.S. more than 50 years ago. However, too many women are still developing cervical cancer, and 4,400 are dying of it each year. More cases of cervical cancer could be prevented with increased uptake of HPV vaccination, increased addition of HPV testing in screening, and improved access to cervical cancer screening in under-screened and unscreened populations.

Goal statement

Nurse practitioners and other advanced practice clinicians who care for women will make a strong recommendation that children aged 11 or 12 get fully immunized against HPV so as to prevent HPV-related diseases in the future.

Educational objectives

At the conclusion of this educational activity, participants should be able to:

1. Understand the efficacy, safety, and immunogenicity of the HPV vaccine, including the new 9-valent vaccine.

2. Be familiar with all of the ACIP guidelines for the HPV vaccine.

3. Boost HPV vaccine uptake in their patient population.

Accreditation statement

This activity has been evaluated and approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women’s Health (NPWH), and has been approved for 1.0 contact hour of CE credit, including 1.0 contact hour of pharmacology content.

Faculty disclosures

NPWH policy requires all faculty to disclose any affiliation or relationship with a commercial interest that may cause a potential, real, or apparent conflict of interest with the content of a CE program. NPWH does not imply that the affiliation or relationship will affect the content of the CE program. Disclosure provides participants with information that may be important to their evaluation of an activity. Faculty are also asked to identify any unlabeled/unapproved uses of drugs or devices made in their presentation.

Nancy R. Berman, MSN, ANP-BC, NCMP, FAANP, has disclosed that she has financial relationships with Hologic and Shionogi.

Disclosure of unlabeled use

NPWH policy requires authors to disclose to participants when they are presenting information about unlabeled use of a commercial product or device or an investigational use of a drug or device not yet approved for any use.

Disclaimer

Participating faculty members determine the editorial content of the CE activity; this content does not necessarily represent the views of NPWH or Merck & Co., Inc. This content has undergone a blinded peer review process for validation of clinical content. Although every effort has been made to ensure that the information is accurate, clinicians are responsible for evaluating this information in relation to generally accepted standards in their own communities and integrating the information in this activity with that of established recommendations of other authorities, national guidelines, FDA-approved package inserts, and individual patient characteristics.

Successful completion of this activity

Successful completion of this activity, J-16-02, requires participants to:

1. “Sign In” at the top right-hand corner of the website if you have an NPWH account. You must be signed in to receive credit for this course. If you do not remember your username or password, please follow the “Forgot Password” link and instructions on the sign-in page. If you do not have an account, please click on “Create an Account.”

2.Read the learning objectives, disclosures, and disclaimers on the next page.

3.Check “Agree to Terms” on the next page and then click the “Continue” button.

4. Study the material in the learning activity during the approval period (now through May 31, 2017).

5.Complete the posttest and evaluation. You must earn a score of 70% or better on the posttest to receive CE credit.

6.Print out the CE certificate if successfully completed.

Commercial support

This activity is supported by educational grants from Merck & Co., Inc.

Before reading the article, click here to take the pretest.

Cervical cancer, caused in nearly all cases by human papillomavirus (HPV), is considered a vaccinepreventable disease. Anogenital warts and other forms of cancer can also be caused by HPV, and can be reduced in frequency with HPV vaccination. Despite the proven efficacy and safety of the three available HPV vaccines—one of which targets up to nine different HPV genotypes—only about one-third of girls in the United States have received the three recommended doses. The author reviews information about the HPV vaccines and the guidelines for their use, and offers strategies for healthcare providers to implement in order to improve HPV vaccine uptake in their age-appropriate patients.

Human papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States.Almost all sexually active adults are or will be infected by HPV at some point in their lives, even if they have had sex with only one other person. Although the vast majority of HPV infections are asymptomatic and resolve spontaneously, a few persist and can lead to cancer.2 Persistent infections with oncogenic HPV types can cause cancers of the cervix, vulva, vagina, anus, and penis, as well as the oropharynx. Infection with non-oncogenic HPV types can cause anogenital warts.

About 79 million persons in the U.S. are already infected with HPV, and 14 million persons acquire HPV infection each year.3 An estimated 17,600 women and 9,300 men receive a diagnosis of an HPVrelated cancer each year. For U.S. women, cervical cancer is the most common HPV-related cancer; approximately 11,000 women are diagnosed with it annually and 4,400 women die of it. For U.S. men, oropharyngeal cancer is the most common HPV-related cancer; about 7,200 U.S. men are diagnosed with it each year.

In an Annual Report to the Nation on the Status of Cancer, Jemal et alreported that many types of HPV-related cancers were on the rise, some disproportionately affecting certain racial and ethnic minorities. For example, from 2000 to 2009, oral cancer rates increased 4.9% for Native American men, 3.9% for white men, 1.7% for white women, and 1% for Asian men. Anal cancer rates doubled from 1975 to 2009. Vulvar cancer rates rose for white women and African-American women and penile cancer rates increased among Asian men.

Most cervical cancers are preventable. The incidence of this disease has declined significantly since the inauguration of screening programs in the U.S more than 50 years ago.5 However, too many women are still developing cervical cancer, and 4,400 are dying of it each year. More cases of cervical cancer could be prevented with increased uptake of HPV vaccination, increased addition of HPV testing in screening, and improved access to cervical cancer screening in under-screened and unscreened populations.

HPV vaccines

For decades, the best that healthcare providers (HCPs) could offer patients in terms of lowering their risk for developing HPV-related cancers were screenings for cervical cancer precursors and for anal pre-cancers and cancers (in highrisk populations) and inspection for vulvar pre-cancers and cancers. But in June 2006, the FDA approved the first vaccine to prevent disease caused by any of four HPV genotypes: 6 and 11, which cause anogenital warts; and 16 and 18, which are the most common causes of cervical cancer.6

Three HPV vaccines are on the market in the U.S. (Table).The bivalent HPV (2vHPV), quadrivalent HPV (4vHPV) and 9-valent HPV (9vHPV) vaccines each target HPV 16 and 18, the types that cause about 70% of cervical cancers and most other HPV-linked cancers in women and men.3,7 The 9vHPV vaccine targets five additional cancer-causing types (HPV 31, 33, 45, 52, 58), which account for about 15% of cervical cancers. The 4vHPV and 9vHPV vaccines also protect against HPV 6 and 11, the types that cause 90% of anogenital warts.

Efficacy

Clinical trials have suggested that HPV vaccines, if used optimally, could likely prevent most cervical cancers.2 Of 10,000 young women vaccinated as part of clinical trials before they could have been exposed to oncogenic forms of HPV, none developed HPV 16- or 18-associated cervical lesions, which are precursors to invasive cancer.8,9 HPV vaccines have been shown to prevent other HPV 16- or 18-associated anogenital pre-cancers and HPV 6- or 11-associated genital warts with similar efficacy.9,10 Women who received the 2vHPV vaccine as part of a clinical trial had a much lower prevalence of oral HPV infection than did participants who had not received the HPV vaccine.11

In a study reported in March 2016, Markowitz et al12 analyzed 4vHPV type prevalence (i.e., types 6, 11, 16, and 18) in cervicovaginal specimens from females aged 14- 34 years in NHANES (National Health and Nutrition Education Survey) in the pre-vaccine era (2003-2006) and during 4 years of the vaccine era (2009-2012). Within 6 years of HPV vaccine introduction, there was a 64% decrease in 4vHPV type prevalence among females aged 14-19 and a 34% decrease in 4vHPV type prevalence among those aged 20-24 years. There was no decrease in 4vHPV type prevalence in older age groups.

Because the HPV vaccine has been available for only 10 years, it will take a while to assess its efficacy in preventing invasive cancers that take years or decades to develop following persistent infection.

Safety

Three population-based safety studies of the HPV vaccine have been conducted in the U.S.13-15 These studies have identified no serious safety concerns, although one study showed an increased risk of syncope on the day of vaccination and skin infections in the 2 weeks following vaccination.15 Gee et al12 evaluated the risk for venous thromboembolism (VTE) in persons aged 9-26 years, and found no increased risk of VTE following vaccination with the 4vHPV vaccine. Chao et al14 found no association between 4vHPV vaccine use and 16 autoimmune conditions.

According to ongoing safety monitoring by the CDC, most reports of adverse reactions to the vaccine are non-serious.16 Among the 7.6% of reports classified as serious, the most common side effects are headache, nausea, vomiting, and fever. Syncope is a common non-serious problem in both female and male adolescents who receive the HPV vaccine. Of note, syncope is not specific to the HPV vaccine. It is recommended that after receiving the injection, patients remain seated for 15 minutes before leaving the clinical setting.

Impact

Drolet et al17 conducted a systematic review and meta-analysis of 20 studies in 9 high-income countries to assess population-level consequences and herd effects after female HPV vaccination programs  and to verify whether the high efficacy reported in randomized controlled trials was materializing in real-world situations. The investigators found that in countries with female vaccination coverage >50%, HPV type 16/18 infections decreased significantly, by 68%, and anogenital warts decreased significantly, by 61%, between pre- and post-vaccination periods in girls aged 13-19 years. In addition, significant reductions were recorded in HPV types 31, 33, and 45 in this age group of girls, suggesting cross-protection. Furthermore, the incidence of anogenital warts declined significantly in boys younger than 20 years and in women aged 20-39 years, suggesting herd effects. In countries with female vaccination coverage <50%, significant reductions in HPV types 16/18 infection and in anogenital warts occurred in girls younger than 20, with no indication of cross-protection or herd effects.

Duration of immunity

According to a 2011 review, the HPV vaccine was found to provide protection against persistent cervical HPV 16/18 infections for up to 8 years—the maximum time of research follow-up at that point.18 More will be known about the total duration of protection as research continues. To date, no evidence suggests waning immunity such as that seen with the menin go coccal conjugate vaccine, which now requires a second dose. Multiple cohort studies are in progress to monitor the duration of immunity.

More about the 9-valent vaccine

To gain the recent endorsement of the CDC’s Advisory Committee on Immunization Practices (ACIP), the 9vHPV vaccine had to demonstrate efficacy, immunogenicity, and safety.19 In particular, the newest vaccine had to show efficacy in terms of preventing infection and disease related to HPV 31, 33, 45, 52, and 58 in a susceptible population and of generating an antibody response to HPV 6, 11, 16, and 18 that was non-inferior to that generated by the 4vHPV vaccine. Studies conducted by Joura et al20 and Luxembourg et al21 showed precisely that.

In 7 pre-licensure studies, the 9vHPV vaccine was evaluated in more than 15,000 females and males.22 In some studies, the 9vHPV vaccine was compared with the 4vHPV vaccine. The 9vHPV vaccine caused slightly more reactions— primarily swelling and redness—at the injection site. As with the 4vHPV vaccine, side effects associated with the 9vHPV vaccine were generally mild. A video summarizing information about the 9vHPV vaccine is available here.

ACIP guidelines

Routine immunizations for 11- and 12-year-olds include HPV vaccination. HCPs should recommend the HPV vaccine on the same day and in the same way as the other vaccines for preteens.

Age, gender, and vaccine type

ACIP recommends that routine HPV vaccination be initiated at age 11 or 12, although the vaccination series can be started as early as age 9.19 Vaccination is also recommended for females aged 13-26 and for males aged 13-21 who have not been vaccinated previously or who have not completed the 3-dose series. HPV vaccination is recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) who have not been vaccinated previously or have not completed the 3-dose series. Females should receive the 2vHPV, 4vHPV, or 9vHPV vaccine and males should receive the 4vHPV or 9vHPV vaccine. The dosing schedule for each vaccine type is shown in the Table. If the vaccine schedule is interrupted, the vaccination series need not be restarted.

Interchangeability

ACIP recommends that, whenever possible, the HPV vaccination series for females be completed with the same HPV vaccine product.16 If vaccination providers do not know or do not have available the HPV vaccine product previously administered to a given patient, or are in settings transitioning to the 9vHPV vaccine, any available HPV vaccine product may be used to continue or complete the series for females for protection against HPV 16/18, and the 4vHPV or 9vHPV vaccine may be used to continue or complete the series for males.19 There are no data on the efficacy of fewer than 3 doses of 9vHPV.

Concomitant administration with other vaccines

HPV vaccine can be administered at the same visit as other ageappropriate vaccines, such as the tetanus/diphtheria/acellular pertussis (Tdap) and quadrivalent meningococcal conjugate vaccines.16 Giving all indicated vaccines togethe at a single visit increases the likelihood that adolescents will receive each vaccine on schedule. Each vaccine should be administered using a separate syringe at a different anatomic site.

History of sexual abuse or assault

The newest vaccination schedule issued by ACIP recommends that the HPV vaccine be given as early as age 9 or 10 if a child has a history of sexual abuse.23 Studies estimate that 1 in 4 girls and 1 in 20 boys will experience sexual abuse before age 18.

HPV vaccine coverage rates

The HPV vaccine has been available for almost 10 years. Despite its proven efficacy and safety, HPV vaccine coverage rates have been low. In 2012, only 53.8% of 13- to 17- year-old girls had received the first HPV vaccine dose and only 33.4% had completed all 3 recommended doses.24 These rates were substantially lower than HPV vaccine coverage rates in other high-income countries such as Australia and the United Kingdom (71.2% and 60.4%, respectively; Figure).2 More recent reports have indicated some improvement in HPV vaccine coverage rates. For example, in 2014, among girls aged 13-17, 60.0% received at least one dose and 39.7% received the 3 recommended doses.25 The improvement was laudable but insufficient: 6 of every 10 girls in this country are not fully vaccinated against HPV.

Strategies to boost vaccination rates

And, thus, a call to action: Concerted efforts are needed to increase HPV vaccine uptake and achieve its potential to prevent cancers.2 These efforts should promote both initiation of the first dose and completion of all 3 doses for age-eligible adolescents, as well as eligible young adults. What can HCPs do to improve vaccination rates?

1. Keep up to date on what you can do to prevent HPV-related cancers

The CDC launched a new website, HPV: You are the key to cancer prevention, for HCPs so that everything about HPV vaccination is found in one place. The website is easy to navigate; it has only 1 page and 3 tabs: Know the Facts, Commit to the Cause, and Lead the Conversation.26 The recommendations described in items 2, 3, 4, and 6 were also derived from this new CDC website.26

2. Make a strong recommendation

The high coverage rates for the Tdap and meningococcal conjugate vaccines suggest that most preteens and teens are not only going to see their HCP, but they are also getting at least one of the recommended adolescent vaccines.25 However, according to the 2013 National Immunization Survey-Teen, one-third of the parents of girls and more than half of the parents of boys said their child’s HCP had not recommended HPV vaccination—the No. 1 reason for failure to vaccinate their children.27,28 Had the HPV vaccine been administered during visits when another vaccine was given, vaccination coverage for ≥1 dose could have reached 91% by age 13 for adolescent girls born in 2000.25 Evidence shows that an HCP recommendation to get vaccinated is the single most influential factor in determining whether parents gets an immunization for their child!24 HCPs should provide clear and strong recommendations that the HPV vaccine series be given to preteens.

3. Seize the day

Timing is everything.26 Making a strong pitch for preteens to be vaccinated is necessary, but not sufficient. HCPs should take advantage of appropriate opportunities to vaccinate their preteen patients against HPV—for example, during school or camp physical exams—when these patients are still coming in for regular office visits. Once these patients go to college or to work, they are less likely to see their HCP for yearly checkups. To make a timely recommendation, HCPs should do it the same way and the same day that they recommend the Tdap and meningococcal vaccines.

4. Use a reminder system

Reminder systems shown to increase HPV vaccination rates include a reminder letter and direct messaging via automated text, prerecorded voice, and/or postcard.29,30

5. Educate mothers during their routine visits

Another useful strategy is to educate mothers when they are being screened for cervical cancer about the role of HPV infection in cervical cancer. HCPs should explain to mothers that they are undergoing an HPV test to determine whether the virus is present on their cervix, and that their preteen daughters or sons can be vaccinated to be protected from being infected by the HPV types in the vaccine. HCPs can simply say: “HPV is the cause of cervical cancer. We are screening you with the HPV test and the Pap test to detect any existing HPV infection or cervical pre-cancers, which we can then treat to keep them from progressing to cancer. But we can vaccinate your daughters and sons to prevent HPV infection and therefore prevent cervical pre-cancer and cervical cancer.”

6. Address parents’ specific concerns

If a parent’s main concern is side effects, HCPs can say: “Vaccines, like any medication, can have side effects. With the HPV vaccine, the most common side effect is pain and redness at the site of the injection. These symptoms should go away quickly. In addition, the HPV vaccine has not been linked to any serious or long-term side effects.”26 If a parent’s main concern is effect on fertility, HCPs can say, “No scientific data suggest that getting the HPV vaccine has any effect on future fertility. In fact, not getting the HPV vaccine can put a woman’s fertility in jeopardy. Persistent HPV infection can cause cervical cancer, and the treatment of cervical cancer can leave a woman unable to have children. Even treatment for cervical pre-cancer can put a woman at risk for problems with her cervix during pregnancy, causing preterm delivery or other problems.”

7. Hand out written materials

Written materials are helpful in supporting patient education. Patients can refer to them later, after they have spoken to you. Many written materials are available in languages other than English. Spanish-language materials are particularly easy to find. Patient factsheets regarding the HPV vaccine are available on the CDC website.

Conclusion

Considering how effective the HPV vaccine will be in preventing cervical cancer, as well as other HPV-related cancers in both females and males, virtually all preteen girls and boys and all eligible young women and men should be immunized. Vaccination uptake rates, although increasing slowly, are still much too low. These rates will rise dramatically only when HCPs across the country heed the call to action and educate parents about the efficacy and safety of this vaccine and take advantage of opportunities to initiate and complete administration of the 3-dose series.

References

1. Centers for Disease Control and Prevention (CDC). Genital HPV Infection – Fact Sheet. Last updated February 3, 2016.

2. President’s Cancer Panel Annual Report 2012-2013. Accelerating HPV Vaccine Uptake: Urgency for Action to Prevent Cancer.

3. CDC. Clinician Factsheets. HPV Vaccination Information for Clinicians. Page last updated December 29, 2015.

4. Jemal A, Simard EP, Dorell C, et al. Annual Report to the Nation on the Status of Cancer, 1975-2009, featuring the burden and trends in human papillomavirus (HPV)-associated cancers and HPV vaccination coverage levels. J Natl Cancer Inst. 2013; 105(3):175-201.

5. National Cancer Institute. A Snapshot of Cervical Cancer: Incidence and Mortality. November 5, 2014.

6. FDA. June 8, 2006 Approval Letter — Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant.

7. CDC. Clinician Factsheets. Supplemental Information and Guidance for Vaccination Providers Regarding Use of 9- Valent HPV Vaccine. Page last updated December 29, 2015.

8. Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-ofstudy analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012;13(1):89-99.

9. Muñoz N, Kjaer SK, Sigurdsson K, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPVassociated genital diseases in young women. J Natl Cancer Inst. 2010;102(5):325-339.

10. Palefsky JM, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011; 365(17):1576-1585.

11. Herrero R, Quint W, Hildesheim A, et al. Reduced prevalence of oral human papillomavirus (HPV) 4 years after bivalent HPV vaccination in a randomized clinical trial in Costa Rica. PLoS One. 2013;8(7):e68329.

12. Markowitz LE, Liu G, Hariri S, et al. Prevalence of HPV after introduction of the vaccination program in the United States. Pediatrics. 2016;137(3):1-9.

13. Gee J, Naleway A, Shui I, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine. 2011;29(46):8279-8284.

14. Chao C, Klein NP, Velicer CM, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271(2):193-203.

15. Klein NP, Hansen J, Chao C, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012;166(12):1140-1148.

16. Markowitz LE, Dunne EF, Saraiya M, et al; CDC. Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP)MMWR. 2014;63(RR-05):1-30.

17. Drolet M, Bénard É, Boily MC, et al. Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and metaanalysis. Lancet Infect Dis. 2015;15(5):565-580.

18. Romanowski B. Long term protection against cervical infection with the human papillomavirus: review of currently available vaccines. Hum Vaccine. 2011;7(2):161-169.

19. Petrosky E, Bocchini JA Jr, Hariri S, et al; CDC. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the Advisory Committee on Immunization Practices. MMWR. 2015;64(11):300-304.

20. Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711-723.

21. Luxembourg A, Bautista O, Moell er E, et al. Design of a large outcome trial for a multivalent human papillomavirus L1 virus-like particle vaccine. Contemp Clin Trials. 2015;42:18-25.

22. Markowitz L. CDC Expert Commentary. Common Questions About 9-Valent HPV Vaccine. Medscape Pharmacists. June 22, 2015.

23. Advisory Committee on Immunization Practices (ACIP). Recommended Immunization Schedules for Persons Aged 0 Through 18 Years. United States. 2016.

24. CDC. Human papillomavirus vaccination coverage among adolescent girls, 2007-2012, and postlicensure vaccine safety monitoring, 2006-2013—United States. MMWR. 2013; 62(29):591-595.

25. CDC. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2014. MMWR. 2015;64(29):784- 792.26. CDC.

26. Human Papillomavirus (HPV). For Clinicians. HPV: You Are the Key to Cancer Prevention. Page last updated September 30, 2015.

27. CDC. Human Papillomavirus Vaccination Coverage Among Adolescents, 2007–2013, and Postlicensure Vaccine Safety Monitoring, 2006–2014 — United States. MMWR. 2014;63(29):620-624.

28. Newitt VN. HPV vaccination: Are you doing enough to make sure that your patients are protected? Nurse Pract Perspect. 2015;2(4):32-36.

29. Chao C, Preciado M, Slezak J, Xu L. A randomized intervention of reminder letter for human papillomavirus vaccine series completion. J Adolesc Health. 2015;56(1):85-90.

30. Bar-Shain DS, Stager MM, Runkie AP, et al. Direct messaging to parents/guardians to improve adolescent immunizations. J Adolesc Health. 2015;56(5 suppl):S21-S26.

Collaboration in practice: A framework for team-based care

Since passage of the Affordable Care Act in 2010, alternate care delivery models such as patient- centered health homes and accountable care organizations have emerged as tools for payment and healthcare delivery system reform. The intent of such clinical integration models is to drive improvement in individual and population health outcomes and in the quality and efficiency of healthcare service delivery.Although these models hold promise in moving our healthcare system from a disjointed paradigm to a seamless, value-driven standard, fragmentation persists at all levels of the healthcare continuum. Establishment of a well-functioning team is one mechanism by which healthcare providers (HCPs) can achieve the goal of patient-centric, well-coordinated, safe, and responsive healthcare.2

Healthcare providers have been challenged to respond to an evolving health policy landscape that demands movement to coordinated, value-driven care models in the face of HCP shortages and shrinking resources. In response to this changing landscape, and, reflective of his own commitment to a team approach to care, John Jennings, ACOG’s 2014 President, chose—as the priority issue of his presidential year—revision of ACOG’s Guidelines for Implementing Collaborative Practice (1995) to better reflect the demands of today’s healthcare system. To meet this charge, ACOG convened an interdisciplinary task force comprising delegates from nine different organizations representing physicians, nurse practitioners, midwives, physician assistants, clinical pharmacists, and consumers. The resulting Collaboration in Practice: Implementing Team-Based Care represents a paradigm shift for healthcare service delivery in which patients are integral participants; all team members are valued equally; and all HCPs are supported in practicing to the full extent of their education, certification, and experience and accept accountability for their practice. To date, this document has been endorsed or supported by 21 national organizations, including NPWH and our sister NP organizations AANP, GAPNA, NAPNAP, and NONPF.3 The Executive Summary of this document is available here.

Team-based care and collaboration

In crafting this document, the writing team worked with the following definitions. Team-based care is defined as the “provision of health services to individuals, families, and/or their communities by at least two healthcare providers who work collaboratively with patients and their families…to accomplish shared goals…”Effective implementation of team-based care requires interprofessional collaborationdefined as “a process involving mutually beneficial participation between autonomous individuals whose relationships are governed by shared norms and visions.”3

The terms team-based care and collaboration have sometimes been used in regulatory policies in a way that places barriers to qualified HCPs’ ability to practice to the full extent of their education, certification, and experience. However, implementing team-based care delivery models does not require team-based licensure or integrated regulatory frameworks. In some cases, linked licensure and restrictive regulations may inhibit the flexibility and innovation required for team-based, patient-centered care. Of note, the ACOG document uses the terms team-based care and collaboration in their truest forms, denoting an equitable practice environment wherein each team member’s knowledge and skills are valued contributions to the team’s work. As such, the terms team-based care and collaboration should not be construed as recommended policy constructs within the context of this document.

Core concepts: Application to women’s health practice

Collaboration in Practice identifies six principles as core components guiding team-based care, all of which are relevant to women’s healthcare and WHNP practice. First and foremost, successful team-based care recognizes the patient and family as central, actively engaged members of the healthcare team.4 In 2008, the National Priorities Partnership identified patient and family engagement as one of six priorities with the most potential to reduce harm, eliminate disparities, decrease disease burden, and remove inefficiencies in healthcare delivery.4 Given the disparities in maternal/child and women’s health outcomes across the lifespan,5 a team-based approach that supports active patient engagement and shared decision making holds merit as one strategy to improve women’s health outcomes.

The second, third, and fourth guiding principles recognize the importance of shared vision, role clarity, and accountability, respectively, as important components of team-based care. These principles underscore the value of mutual respect that recognizes the expertise of each team member. Likewise, there exists an expectation of professional accountability to one’s own practice and to the team. Maintaining competencies through continuous learning is an expectation within an accountable practice. Although regulation of scope of practice resides within the purview of each state, the document urges professional organizations to continue to provide guidance for clinical practice and promote uniform educational requirements and standards of care and conduct. The Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th edition (2014), available hereprovides a population-focused framework for WHNPs.

Communication, the fifth guiding principle, underscores the need for clear transfer of information regarding patient status and team tasks. The document recognizes the fluid nature of teams and appreciates evolving trends in healthcare. Teams range from a typical model wherein care is provided at a discrete location by a selected team of HCPs to virtual teams wherein care is provided by multiple HCPs across a variety of settings in disparate locations—in some instances using telehealth as a tool to expand access.The sixth guiding principle recognizes the fluid and dynamic nature of patient-centered care. Team leadership is described as being situational and dynamic. Within this principle, team leadership is determined in response to patient need at any given moment in time, rather than ownership by a specific role or discipline.

Women’s healthcare providers practicing in the maternal/child healthcare field may recognize parallels between team-based care and perinatal regionalization, a concept supported by the maternal/child healthcare community for more than two decades. Perinatal regionalization, which seeks to assure that high-risk pregnant women and/or infants receive the appropriate level of care at the appropriate time in order to optimize patient outcomes in high-risk situations, can be viewed as a key example of a virtual model for team-based care. In this model, communication to facilitate seamless transitions in care among community-based HCPs and perinatal care providers must be established to achieve optimal pregnancy outcomes. In-person or virtual consultation, education, and skill building help support open communication, professional accountability, and fluid team leadership. Just as the team-based care model recognizes the important role of each member, perinatal regionalization recognizes the important role of the community-based team, the perinatal center team, and wraparound service providers, all of whom contribute to an optimal outcome.7,8 Although perinatal regionalization serves as one example of the breadth of a team-based care model, the concept is transferable across a variety of healthcare settings and specialties, within a traditional or a virtual setting.

Conclusion

Women’s healthcare has always been a team-based endeavor recognizing the important role of access to gender-focused care throughout the lifespan, with attention to the realities of women’s lives outside the hospital and clinic walls. In this regard, it is especially fitting that women’s healthcare providers led the way in bringing together a diverse group of HCPs to chart a path applicable across specialties and disciplines. Furthermore, the collaborative process used in developing this document mirrored the equitable, collaborative approach recommended as a pathway to successful implementation of team-based care. NPWH was proud to be part of the working group that helped shape the concepts put forth in this document.

The aforementioned Executive Summary of the Collaboration in Practice document provides an overview of the process and key points. All of the essential elements of the work, including recommendations for implementing an equitable, accessible, reimbursable, patient-centric model of care, are elaborated in the full report. The Collaboration in Practice team invites you to consider how the full report can be used to enhance your practice and improve patient outcomes.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri- St. Louis; a consultant at Health Policy Advantage,LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She served as the NPWH delegate to ACOG’s Collaborative Practice Task Force. She can be reached at 314-629-2372 or at skendig@npwh.org.

References

1. Guterman S, Drake H. Developing innovative payment approaches: finding the path to high performanceThe Commonwealth Fund. May 2010.

2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.

3. Executive Summary: Collaboration in Practice: Implementing Team-Based Care. Report of the American College of Obstetricians and Gynecologists’ Task Force on Collaborative Practice. Obstet Gynecol. 2016;127(3):612-617.

4. National Priorities Partnership. National Priorities and Goals: Aligning Our Efforts to Transform America’s HealthcareWashington, DC: National Quality Forum; 2008.

5. Kendig S. Women’s health: more than an annual event. Womens Healthcare. 2014;2(3):36-39.

6. ACOG Task Force on Collaborative Practice. Collaboration in Practice: Implementing Team-Based CareWashington, DC: ACOG; 2016.

7. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care, 7th edition. Elk Grove Village, IL: AAP; Washington, DC: ACOG; 2012.

8. Obstetric Care Consensus No. 2: Levels of Maternal Care. Obstet Gynecol. 2015;125(2):502-515.

Early pregnancy loss management for nurse practitioners and midwives

Early pregnancy loss (EPL), or miscarriage, is a common phenomenon in pregnancy; up to 30% of pregnancies result in miscarriage in women who have identified themselves as being pregnant.Various treatment modalities can be used to assist women who have experienced EPL, including expectant management, pharmacologic treatment, and vacuum aspiration. Patients should be assessed for their preferences for management of EPL based on their priorities for care. The role of the nurse practitioner or midwife in counseling women who have experienced EPL is to help them manage symptoms, resolve the passage of tissue, and cope with the emotional experience of losing a pregnancy.

Early pregnancy loss (EPL), or miscarriage—the spontaneous loss of a pregnancy before 13 weeks’ gestation1—is a devastating problem for women who lose a highly desired pregnancy. In addition to the emotional turmoil caused by the interruption of a wanted pregnancy, these women are faced with managing the physical reality of resolving a nonviable gestation. Nurse practitioners (NPs) and midwives are frequently the first providers to encounter women who have bleeding early in an already-diagnosed pregnancy. In addition to providing much needed emotional support and compassion, providers can help women and their families move through the steps of completing the process of EPL.

Most bleeding in pregnancy is the result of a disruption in the complex processes associated with implantation, including the formation of the decidua and the actual burrowing of the blastocyst into the uterine lining.2 Bleeding in the first trimester occurs in up to 40% of pregnancies; more than half of these pregnancies progress normally, with preterm delivery and low birth weight as possible outcomes.Although cervical polyps or friability, vaginal laceration, irritation, or neoplasm may also lead to bleeding in early pregnancy, the possibility of pregnancy loss or ectopic pregnancy must always be considered.3

Causes of early pregnancy loss

The three main causes of problematic bleeding leading to EPL are spontaneous abortion, ectopic pregnancy, and gestational trophoblastic disease (GTD).Ultrasound guidance and serum hCG assessment can assist in the diagnosis of ectopic pregnancy and GTD and in the assessment of pregnancy viability.3 Once ectopic pregnancy and GTD have been ruled out, the problematic bleeding can be classified as a threatened abortion, an incomplete abortion, or a complete abortion. A threatened abortion occurs when vaginal bleeding occurs in the absence of cervical dilatation; 30%-50% of women with these symptoms go on to have a complete abortion.3 An incomplete abortion is diagnosed when some fetal or embryonic tissue remains in the uterus. A complete abortion reflects the passage of all pregnancy tissue.

Management of early pregnancy loss

The focus of EPL management is on meeting the needs of each individual woman. After establishing that the patient is clinically stable, the provider should offer appropriate emotional support; regardless of whether or not the pregnancy was planned, the woman is experiencing the loss of the pregnancy and maybe a change in her sense of self. The provider should establish the meaning of the pregnancy for the woman, and recognize that her management options for resolving the EPL should be guided by her medical needs and by her self-identified needs and preferences.

One way to assess the needs and preferences of a woman experiencing an EPL is to ask her these questions: What are your priorities related to the timing and cost of the process? What is your previous experience with miscarriage and/or abortion? How do you feel about taking medications or undergoing a procedure, either in the office or the hospital? How do you assess your own ability to manage the pain and bleeding that you will experience?4 Her responses to these questions can guide the provider in helping her choose how to resolve the EPL.

Early pregnancy loss can be resolved in one of three ways: expectant management (watchful waiting); medication management to complete the process of uterine evacuation; or an aspiration procedure to empty the uterus, either in an inpatient or outpatient setting.Each approach has benefits and minimal risks. These approaches vary slightly in terms of efficacy, depending on how much tissue remains inside the uterus. All of these approaches are considered acceptable and should be offered to women experiencing EPL. However, if a woman presents with heavy bleeding or is medically unstable, the situation requires immediate resolution; her preference for expectant management or medication management cannot be honored because neither is a safe option.

Expectant management

In 85% of cases, EPL resolves with expectant management within 2 weeks of the first signs and symptoms (S/S) of miscarriage. Within an additional 2 weeks, 10% of the remaining cases resolve. Aspiration intervention is recommended for the resolution of pregnancies that continue after 4 weeks of bleeding.A woman who chooses expectant management must be counseled about the possibility of a prolonged period of waiting for resolution, as well as what to expect when she finally passes the pregnancy tissue. She may experience a short period of intense cramping and bleeding, followed by mild bleeding and/or spotting for up to 2 weeks. During this period of time, she needs to monitor her temperature and report any S/S that would indicate infection, such as a malodorous discharge or flu-like S/S. The provider should ascertain the woman’s ease of access to emergency resources if needed and encourage follow-up within 2 weeks of the passage of tissue to ensure that the pregnancy has been completely resolved.

Many women choose expectant management because it does not require any intervention, and can generally be experienced privately and without any increased cost or provider visits. However, they need to understand that they may see the pregnancy tissue and they may have considerable pain and bleeding with this option. In addition, they must have ready access to care if bleeding becomes excessive.

Medication management

Use of medications can enhance the speed with which the pregnancy tissue is passed. The most widely used medication for this purpose is misoprostol, a prostaglandin antagonist that has a variety of off-label obstetric and gynecologic uses in addition to its FDA-approved indication for the prevention of gastric ulcers and as part of the medication abortion regimen.Misoprostol causes cervical softening and uterine contractions that accelerate passage of the pregnancy tissue, producing the same symptoms as expectant management but within 24-48 hours of administration of the medication. Use of misoprostol to accelerate resolution of EPL is successful in about 90% of cases after two doses.7 Women should be counseled to expect the same S/S as with expectant management, but within a shorter time period. If no tissue passes, and increased bleeding does not occur, women should return for an assessment of retained products of conception. Misoprostol users should also have access to analgesics, and they should be aware of potential side effects: fever, nausea, diarrhea, and/or shaking. Over-the-counter medications can be used to treat fever and gastrointestinal side effects, and application of warm blankets can reduce shaking.

Aspiration management

An aspiration procedure may be the choice of women who prefer an expedient and closely managed process for resolution of the EPL. If ultrasound dating  shows a gestational age of less than 12 weeks 6 days, uterine evacuation can be performed in an outpatient clinic or ambulatory surgical center. In some places, aspiration procedures can be performed only in a hospital, but this approach consumes more resources and has not been shown to improve outcomes.In these circumstances, providers should counsel women about other settings in the community that offer outpatient management services and facilitate their obtaining care if they choose an outpatient procedure.

Aspiration management provides clear advantages for a woman who prefers to have a procedure that can be scheduled, has a limited impact on the amount of time before normal activities can be resumed, and during which she can receive additional pain management. Uterine evacuation with either a manual or electric vacuum procedure is highly successful but does carry minimal risks of infection, uterine perforation, cervical trauma, or damage to the endometrium.9

Resources

Various resources are available to NPs and midwives to help counsel women facing a decision about how to manage an EPL. TEAMM (Training, Education & Advocacy in Miscarriage Management), a project of the Department of Obstetrics and Gynecology at the University of Washington, provides educational materials and training for practitioners and educational materials for women about outpatient manual vacuum aspiration.10 The University of California San Francisco’s website, Innovating Education in Reproductive Health, has information about managing EPL, including a video and patient education materials for decision making following EPL.11

Conclusion

Early pregnancy loss can be a devastating experience for a woman, but the compassion and understanding of her provider can assist her in identifying the safest and most satisfying way for her to resolve her physical S/S while she is processing her emotional experience. Whether a woman chooses an inpatient or outpatient procedure, takes medication, or elects to wait for the natural course of miscarriage to occur, reviewing all the possibilities for resolution is an important part of the NP’s or midwife’s responsibility in caring for women who are undergoing an EPL.

Amy J. Levi is the Leah L. Albers Professor of Midwifery at the University of New Mexico in Albuquerque. Tara Cardinal is a Consultant at Training, Education and Advocacy in Miscarriage Management in Seattle, Washington. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Wang X, Chen C, Wang L, et al. Conception, early pregnancy loss, and time to clinical pregnancy: a populationbased prospective study. Fertil Steril. 2003;79(3):577-584.

2. Lykke JA, Dideriksen KL, Lidegaard O, Langhoff-Roos J. First-trimester vaginal bleeding and complications later in pregnancy. Obstet Gynecol. 2010;115(5):935-944.

3. Isoardi K. Review article: the use of pelvic examination with the emergency department in the assessment of early pregnancy bleeding. Emerg Med Australas. 2009;21(6):440-448.

4. Wallace RR, Goodman S, Freedman LR, et al. Counseling women with early pregnancy failure: utilizing evidence, preserving preference. Patient Educ Couns. 2010;81(3):454-461.

5. Nanda K, Lopez LM, Grimes DA, et al. Expectant care versus surgical treatment for miscarriage. Cochrane Database Syst Rev. 2012;3:CD003518.

6. Webber K, Grivell RM. Cervical ripening before first trimester surgical evacuation for non-viable pregnancy. Cochrane Database Syst Rev. 2015;11:CD009954.

7. Hasan R, Bhal K, Joseph B. The need for repeat evacuation of retained products of conception: how common is it? Obstet Gynaecol. 2013;33(1):75-76.

8. Dalton VK, Harris L, Weisman C, et al. Patient preferences, satisfaction, and resource use in office evacuation of early pregnancy failure. Obstet Gynecol. 2006;108(1):103-109.

9. Jurkovic D, Overton C, Bender-Atik R. Diagnosis and management of first trimester miscarriage. BMJ. 2013;346:f3696.

10. TEAMM Training, Education & Advocacy in Miscarriage Management. 2016.

11. Innovating Education in Reproductive Health. Early Pregnancy Loss.

Message from the CEO

In case you haven’t noticed, NPWH is striving to provide more and more educational offerings for nurse practitioners. We just completed our complimentary continuing education (CE) 1-day regional course, Managing Women’s Health Issues Across a Lifespan, in Pasadena, California. I am pleased to report that the attendees found the content very informative and the expert faculty highly inspiring. They felt it was worthwhile to give up a Saturday in order to learn more about long-acting reversible contraceptives, endometriosis, genitourinary syndrome of menopause, and obesity, and to earn free CE credits. We are working toward providing more of these regional courses covering additional hot topics in women’s health next year.

Another update: We are building out our Well Woman Visit mobile app to include assessment and treatment options for irritable bowel syndrome. Stay tuned for the announcement indicating that this updated app is available to download. For those of you who haven’t already downloaded our mobile app, please visit npwh.org or go to the Apple Store and download it for free. The app is available for both Apple’s iOS and Google’s Android operating systems. We have received praise from members of organizations such as the American Association of Nurse Practitioners, who recognize that our WWV app is easy to use, is scientifically sound, and serves as a handy and immediate reference during a patient visit.

And here’s more good news: Registration is still open for the Women’s Sexual Health Course for NPs, which will be held on June 23-26, 2016, in San Diego, California. This is the only post-graduation educational offering on women’s sexual health for nurse practitioners. You will receive not only CEs but also a Certificate of Completion, which documents that you have gained knowledge in the area of women’s sexual health.

And, finally, the 19th Annual NPWH Premier Women’s Healthcare Conference, our national clinical conference, is almost here! This year, our conference takes place in the vibrant city of New Orleans on September 28-October 1, 2016. The conference program guide, which appears on pages 23-26 of this issue, reveals the variety of leading-edge topics we are offering this year, along with courses covering essential primary skills to incorporate into your practice. You’ll want to register early to take advantage of the discount; the complete program guide, including the registration form, is available at npwh.org. As always, NPWH takes great pride in offering up-to-date women’s health content imparted by experts in their fields so that you can gain the knowledge and skills you need to provide high-quality healthcare to women of all ages.

Gay Johnson

Chief Executive Officer, NPWH

Get your child vaccinated against HPV!

Why does my child need the HPV vaccine?

The HPV vaccine protects against cancers caused by human papillomavirus (HPV). HPV is a very common virus; nearly 80 million people in the United States—about 1 in 4—are infected by it. About 14 million people, including teens, are newly infected with HPV each year. HPV can cause cancer of the cervix, vagina, or vulva in women; cancer of the penis in men; and cancer of the anus or the back of the throat in both women and men.

When should my child be vaccinated?

Your daughter or son should get the HPV vaccine at age 11 or 12. The vaccine is given in three shots. The second shot is given 1 or 2 months after the first shot. The third shot is given 6 months after the first shot.

Why is the HPV vaccine recommended at such a young age?

For the vaccine to be effective, it should be given before a person is exposed to HPV. Exposure to this virus occurs with sexual activity with another person. Most people first engage in sex in their teenage or young adult years. Therefore, it is best to start the vaccination series early—before a person has sex and could potentially be exposed to HPV. Also, the HPV vaccine produces a stronger immune response in preteens than it does in older teens and young adults.

Who else should get the HPV vaccine?

Teen girls and boys who did not start or finish the HPV vaccine series when they were younger should get it now. Young women can get the HPV vaccine through age 26, and young men can get it through age 21. Men between the ages of 21 and 26 who have sex with men and/or who have poor immune systems (including those with HIV infection) can get the HPV vaccine if they did not get it when they were younger.

Is the vaccine still effective if a young person has had sex?

Yes. Even though HPV infection usually happens soon after someone has sex for the first time, a person might not be exposed to any or all of the HPV types that are in the vaccine. Females and males in the age groups recommended for vaccination are likely to get at least some protection from the vaccine.

How well does the HPV vaccine work?

Very well! Clinical trials have shown that the vaccines provide close to 100% protection against pre-cancers and genital warts caused by HPV.

How long will the HPV vaccine provide protection?

Studies show that the vaccine offers protection against HPV infection and HPV-related disease that lasts for at least 8-10 years. The vaccine has been available for only 10 years, so more will be known as time goes on. There is no evidence to suggest that the HPV vaccine loses the ability to provide protection over time.

Will the vaccine require a booster?

In the U.S., the HPV vaccine series requires three shots given over 6 months; booster doses are not recommended. Like all vaccines, HPV vaccine is monitored continually to make sure it remains safe and effective. If protection from HPV vaccine doesn’t last as long as it should, then the CDC will review the data and determine if a booster shot should be recommended.

Does someone need to restart the HPV vaccine series if too much time passes between the shots?

No. If someone waits longer than that the recommended interval between shots, she or he need not restart the series. Even if months or years have passed since the last shot, the series should still be completed.

What are some possible side effects of HPV vaccination?

Vaccines, like any medicine, can have side effects. Many people who get the HPV vaccine have no side effects at all. Some people report having very mild side effects such as pain, redness, or swelling in the arm where the shot was given; fever; headache or fatigue; nausea; muscle or joint pain; and brief fainting spells. Sitting or lying down for 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. On very rare occasions, severe allergic reactions may occur after vaccination.

Will the vaccine cause cancer?

The HPV vaccine cannot cause HPV infection or cancer. By contrast, not receiving the HPV vaccine at the recommended ages can leave a person vulnerable to cancers caused by HPV. Will the vaccine cause my daughter to have trouble getting pregnant later on? No data suggest that the HPV vaccine has an effect on a woman’s ability to get pregnant in the future. In fact, getting vaccinated and protecting against cervical cancer can help women have healthy pregnancies and healthy babies. Not getting the HPV vaccine leaves people vulnerable to HPV infection; for women, this could lead to cervical cancer. Treatment of cervical cancer could leave a woman unable to have children. Even the treatment of cervical pre-cancers caused by HPV can cause preterm labor or problems at the time of delivery.

Readers are invited to photocopy Patient Education pages in the journal and distribute them to their patients.

Resources

Centers for Disease Control and Prevention. HPV Vaccines: Vaccinating your Preteen or Teen. Page last updated January 26, 2015.

Centers for Disease Control and Prevention.Fact Sheet for Parents Questions and Answers. Page last updated December 28, 2015.

Doctoral degrees: Looking at the options

Nurse practitioners (NPs) may choose to return to graduate school for a variety of reasons. This choice may be fueled by a desire to teach, conduct research, improve the quality of healthcare and/or healthcare systems, or expand one’s knowledge base. In recent years, anticipation that, at some point in the future, a doctorate of nursing practice (DNP) would be the required degree for entry into advanced practice nursing has spurred many master’sprepared NPs to consider a doctoral degree. The decision to pursue any doctoral degree should be a thoughtful one based on specific career goals, knowledge about available options, and ability to commit the time, energy, and financial resources required.

A doctorate in nursing or education is a terminal degree, representing the highest level of formal education. Nurses with doctoral degrees are vital to the advancement of nursing science, nursing education, and patient and population health. In addition, doctorally prepared nurses are needed to meet future demands in education, policy development, and interdisciplinary collaboration with others in the healthcare community.1 In its 2011 landmark publication The Future of Nursing: Leading Change, Advancing Health, the Institute of Medicine recommended that efforts be made to double the number of nurses with doctorates by 2020 to meet these demands.2 Doctoral options for NPs include a doctorate of philosophy (PhD) in nursing, the aforementioned DNP, and the doctorate of education (EdD). Each option has a different type of educational and outcomes focus.

PhD

The curriculum for the PhD in nursing focuses primarily on nursing theory, research, and the development of nursing knowledge and nursing science. An informal online review of PhD programs in each region of the United States revealed 36-47 as the typical range of credit hours needed to complete doctoral coursework. A dissertation is completed after doctoral coursework, with an additional 12-20 credits awarded for conducting and documenting a research study.

Most academic institutions offer part- and full-time study options. A PhD program takes 3-6 years to finish, with 7 years usually being the maximum time allowed for completion. Clinical hours are not a component of a PhD curriculum, but some mentored teaching experience may be included. The PhD curriculum typically includes courses focused on advanced qualitative and quantitative research methods, theory and knowledge development, and advanced healthcare statistics. Some PhD programs may require students to submit a scholarly portfolio that includes a résumé or curriculum vitae, accomplishments such as published works, continuing education hours earned, professional goals, and evaluation of those goals.

Many individuals with a PhD in nursing choose to teach in undergraduate- and/or graduate-level nursing programs. According to the American Association of Colleges of Nursing (AACN), a PhD program should instillteaching, leadership, and mentorship skills, as well as interdisciplinary communication skills.3 One benefit of having a PhD in nursing is the opportunity to develop and participate in research specifically pertinent to nursing science. Although having a PhD degree is not essential in terms of obtaining funding for research from various sources or partnering with expert peers on scientific projects, it is certainly helpful.4 This research can directly affect nursing practice, health policy, and the formation of subsequent evidence-based theories.5 Nurses with PhD degrees who are employed in academic settings can enjoy professional growth, satisfaction, increased independence, and co-worker support.6, 7

Academic salaries for nurses with PhD degrees may not be competitive with those of faculty in other professionsor with those of nurses in clinical and administrative roles.7 This deficit may be somewhat balanced by an academic calendar and work schedule that allow time for thoughtful development and design of scholarly works. In addition, because of increased demand, PhD-prepared nurses may be able to negotiate their contract conditions and salaries upon hire. A global nursing faculty shortage exists because of an aging faculty, a reduced hiring pool of younger faculty, and increased dependence on adjunct faculty.NPs who choose to advance their education with a PhD will likely have a wide selection of positions to choose from and/or migrate to in the future. Some NPs with a PhD degree may find roles pertaining to a research specialty and becoming a nurse scientist appealing, whereas others may choose to remain in the academic setting. The ultimate goal of earning a PhD in nursing is to conduct research leading to the development or testing of theoretical frameworks and to contribute to nursing knowledge in areas such as health promotion, disease prevention, end-of-life care, and symptom and pain management in both acute and chronic illnesses.7

DNP

The DNP is the nursing doctorate degree that has gained a great deal of attention in recent years. The DNP curriculum prepares graduates to be clinical scholars and leaders in healthcare system change.5,9 Courses found in a typical DNP curriculum focus on epidemiology, health policy, evidence-based practice, societal health trends, quality improvement (QI), and patient safety. DNP program requirements include 1,000 post-baccalaureate clinical hours. Clinical hours completed in a master’s-degree program count toward this total. Students typically complete a comprehensive clinical- or community-based project. DNP programs can be completed on a part- or full-time basis depending on the options offered by each institution and individual student needs. Based on an unofficial online survey of DNP programs in each region of the U.S., the number of post-MSN credit hours ranges from 35 to 45 to obtain a DNP degree.

DNP graduates are prepared to provide the leadership to integrate evidence-based practice in providing care for patients, families, and populations for improved health outcomes.9  This degree prepares advanced practice nurses to continue working with patients in the clinical or community setting at the highest level of nursing practice. NPs with a DNP degree may be actively involved in strengthening healthcare through quality initiatives—that is, specific areas in which better nursing practice can make a difference in improving care. For example, quality initiatives in women’s health may involve maternal mortality, infant mortality, or preterm births. Quality initiatives encourage nurse leaders to get involved, partner with other disciplines, and further their understanding of the  healthcare system.10 DNP degrees may help facilitate parity of NPs with other healthcare professionals who need to earn doctoral degrees, improve the image of nursing, and attract more individuals to nursing, as well as increase the supply of faculty for clinical instruction in selected academic environments.10

Major concerns still need to be addressed regarding DNP education. DNP programs lack consistency with regard to what constitutes clinical hours to meet the 1,000- hour clinical requirement. The same concern exists for the scholarly projects required in most DNP programs.11 Project criteria vary widely, with some resembling research similar to a dissertation, others focusing on evidence-based QI endeavors, and still others consisting of an extensive literature review of a healthcare topic.

To address these concerns, AACN’s board created a task force in early 2014 to develop a white paper. In August 2015, AACN published The Doctor of Nursing Practice: Current Issues and Clarifying Recommendations: Report from the Task Force on the Implementation of the DNP.12 The white paper describes characteristics of the DNP project, practice experiences, and practice hours. It is anticipated that DNP programs will incorporate the task force’s recommendations into their curricula.

DNP-prepared NPs can prosper in primary care settings because of their patient-centered focus, and they can help alleviate the nursing faculty shortage, especially in the role of clinical instructor. DNP graduates can contribute to the academic setting, although some research-intensive institutions do not allow faculty with DNPs to enter tenure-track positions. A challenge for DNP-prepared NPs working in the healthcare setting may be the lack of knowledge that many current or potential employers have about the benefits that these providers can bring to the organization.13, 14 DNP educators and graduates need to educate healthcare organization employers in this regard. Studies that demonstrate improved healthcare and healthcare outcomes are important.

EdD

Nurse practitioners who want to develop skills in teaching, curriculum design, and evaluation might choose to obtain the EdD. This doctoral degree focuses on preparing graduates as education researchers and scholars to add to the body of knowledge and improve educational practices and outcomes. Some EdD programs have a nursing focus, but many of them are more generalized to include individuals from a variety of professions. A typical EdD curriculum ranges from 50 to 60 credit hours and includes courses addressing teaching and learning theories, educational trends, leadership, and research with a dissertation component. NPs who wish to work with students and influence the future of the nursing profession may choose this degree.14 The EdD degree can be completed in 3-4 years, but part- and full-time status requirements vary by school. NPs with an EdD degree can thrive in the academic setting because of their background in educational theory and applied teaching methods. EdD-prepared NPs may also hold educational leadership positions in healthcare systems and health-related business, not-for-profit, and governmental organizations.

Other considerations

Prospective doctoral students should consider several other factors when contemplating a terminal degree. Although time and cost may be primary considerations, NPs should evaluate circumstances surrounding their personal lives and individual goals. For instance, a spouse, children, and job demands can influence the decision to start a doctoral program. However, with self-evaluation and an understanding and encouraging support system, NPs pursuing doctoral education can thrive and adequately balance all aspects of their lives.

Another consideration is an individual’s learning needs and preferences. A doctoral program with classes offered solely at a university campus may benefit certain students, whereas others may be more successful with an exclusively online program. A program with live classes allows for in-person communication with professors and classmates, and can facilitate communication on an interdisciplinary level as well. NPs considering an online format will want to explore how professor and peer interaction is fostered through distance modalities. A major plus of an online program is that it can provide more flexibility with regard to a student’s work and family obligations. Hybrid programs with both live and online components are also widely available, and often provide some balance between the advantages and disadvantages of each.

Prospective doctoral students should examine a variety of schools for program format, curriculum requirements, and faculty expertise. Open houses and conferences offer multiple opportunities to learn more about various programs and ask questions to help determine the best path for each student. Once a student decides on pursuing a doctorate degree to become a researcher, clinician, or educator, finding a mentor already in the selected role can provide valuable guidance throughout the instruction and training process. In addition, NPs should explore part- and full-time option availability and accreditation status before choosing a program. AACN lists the main differences between the PhD and DNP degrees. In addition, AACN has compiled a list of Commission on Collegiate Nursing Education (CCNE)-accredited DNP programs with links to various schools’ websites (organized by state). Furthermore, AACN provides a comprehensive list of PhD and EdD programs with more detailed school and contact information. With regard to DNP programs, they should be both regionally and nationally accredited in order for students to obtain recognition for title and job purposes after graduation. The quality of a doctoral program can enhance the student experience and influence potential employers at the completion of the degree.

Conclusion

Nurse practitioners with doctoral degrees are needed in academic and patient education, research, health policy, and QI efforts. Many factors should be considered when choosing among options for doctoral degrees. NPs with a variety of doctoral degrees can complement each other and work together to further nursing education, implement changes, and favorably affect patient care outcomes.

Cathy R. Kessenich is Professor of Nursing and Department of Nursing Director at the University of Tampa in Tampa, Florida. Sasha T. Persaud works in pediatrics and is an MSN student and former graduate assistant in the nursing department at the University of Tampa. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Fortier ME. So you want to get a doctorate. Am Nurse Today. 2013;8(5):41-44.

2. Institute of Medicine. The Future of Nursing: Leading Change, Advancing Health. 2010.

3. American Association of Colleges of Nursing. The Research-Focused Doctoral Program in Nursing: Pathways to Excellence. 2010.

4. Nardi DA, Gyurko CC. The global nursing faculty shortage: status and solutions for change. J Nurs Scholar. 2013;45(3):317-326.

5. Melnyk BM. Distinguishing the preparation and roles of doctor of philosophy and doctor of nursing practice graduates: national implications for academic curricula and health care systems. J Nurs Educ. 2013;52(8):442-448.

6. Dreher HM, Glasgow MES, Cornelius FH, Bhattacharya A. A report on a national study of doctoral nursing faculty. Nurs Clin North Am. 2012;47(4):435-453.

7. McDermid F, Peters K, Jackson D, Daly J. Factors contributing to the shortage of nurse faculty: a review of the literature. Nurs Educ Today. 2012;32(5):565-569.

8. Duke University School of Nursing PhD Program.

9. Moore K. How DNP and PhD nurses can collaborate to maximize patient care. Am Nurse Today. 2014;9(1):48-49.

10. Dunbar-Jacob J, Nativio DG, Khalil H. Impact of doctor of nursing practice education in shaping health care systems for the future. J Nurs Educ. 2013;52(8):423-427.

11. Grey M. The doctor of nursing practice: defining the next steps. J Nurs Educ. 2013;52(8):462-465.

12. American Association of Colleges of Nursing. The Doctor of Nursing Practice: Current Issues and Clarifying Recommendations: Report from the Task Force on the Implementation of the DNP. August 2015.

13. Stoeckel P, Kruschke C. Practicing DNPs’ perceptions of the DNP. Clin Schol Rev. 2013;6(2):91-97.

14. Evans JD. Factors influencing recruitment and retention of nurse educators reported by current nurse faculty. J Prof Nurs. 2013;29(1):11-20.

Women in clinical trials: FDA Office of Women’s Health efforts

During the fall of 2015, NPWH CEO Gay Johnson and I attended an FDA Office of Women’s Health (FDA OWH) meeting regarding the exciting work being done to foster inclusion of diverse populations of women in clinical trials. The FDA OWH campaign, to be launched in 2016, aims to encourage women to make a difference for themselves and others through participation in clinical trials.1

Why do we need more women in clinical trials?

Although the drug development process routinely includes an analysis of sex differences in terms of drug safety and efficacy, this was not always the case. Prior to 1993, male physiology was presumed to be the norm for scientific research. For the most part, restrictive FDA guidelines excluded women of childbearing potential from the early phases of clinical trials—except in situations involving life-threatening conditions.

In 1992, the General Accounting Office (GAO) issued a report stating that women were indeed under-represented in drug development trials and that there was a need for increased study of gender differences in prescription drug testing.2 The GAO report was followed by development of a Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (Gender Guideline), which set the stage for the creation of the FDA OWH.3 After the Gender Guideline was issued, women’s participation in clinical trials improved. A 2001 GAO report showed that women comprised a majority—52%—of the clinical trial participants in studies conducted for the 36 new drug applications approved between August 1998 and December 2000.A 2013 FDA report showed that women were adequately represented in most of the clinical trials used as the basis for safety and effectiveness decisions about FDA-approved products.5

Women’s participation in clinical trials is important because the same dose of the same drug may have different pharmacokinetics and/or pharmacodynamics in women versus men. Such differences in drug disposition can manifest as differences in drug safety and efficacy.6 For example, women are almost twice as likely as men to experience an adverse drug reaction. Sex differences have been reported across all phases of drug disposition, and may be related to body weight, body makeup, interactions with endogenous sex steroid hormones, physiologic changes in pregnancy, and other factors. The FDA OWH plays an important role in increasing understanding of sex differences in therapeutic interventions, which can in turn lead to more precise dosing regimens, greater efficacy, decreased side effects, and fewer adverse drug events for both women and men.6

A refresher on the FDA OWH

The FDA OWH was created in 1994 to provide leadership and policy direction for the FDA with regard to women’s health issues. The Office’s purpose is to protect and advance the health of women through policy, science, and outreach; advocate for inclusion of women in clinical trials; and foster appropriate analysis of sex and gender effects.3 Since its inception, the FDA OWH has established a science program for women’s health research to inform sound policy and regulation development, and has provided support for multiple women’s health research studies covering a broad range of topics that affect women throughout the lifespan.

Research funded by the FDA OWH focuses on topics or issues with regulatory impact, thereby providing a mechanism for science to inform policy. Funding mechanisms include intramural grants to support research within the FDA targeting gaps in knowledge, special funding initiatives to support FDA scientists in studying pressing women’s health needs, and extramural contracts providing an avenue to convene with outside experts to answer regulatory research questions.3 These examples demonstrate how FDA OWH funded research has contributed to knowledge regarding the effects of sex differences on disease presentation and response to interventions, and its subsequent effect on health policy and regulation:

• Shaping policy regarding inclusion of women in clinical trials is a core FDA OWH commitment. Following release of the 1993 Gender Guideline, the newly created FDA OWH further clarified the effect of the Gender Guideline by funding a study reviewing protocol criteria for sex-based exclusions. Since this time, the FDA OWH has continued to monitor trends related to gender analysis and inclusion of women in clinical trials.

• The FDA OWH science and policy planning function has contributed significantly to improved understanding of gender differences in clinical presentation and therapeutic interventions. Early research supported by the FDA OWH elucidated (1) the effect of longer corrected QT intervals in women, (2) the effect of sex hormones on this phenomenon, and (3) the risks to women’s health that are related to the effect of certain drugs on women’s QT intervals. This information has led to regulatory requirements regarding relevant black box warnings, re-labeling of approved drugs, and development of draft guidance to protect women’s health.3

• Drug/dietary supplement interactions can lead to altered drug or hormone metabolism. FDA-funded studies have suggested a relationship between the use of the over-the-counter dietary supplement St. John’s wort and decreased efficacy of oral contraceptives. Similarly, FDA-funded studies have shown the effect of Echinacea in compromising the safety and efficacy of drugs such as warfarin that have narrow therapeutic windows.3

FDA OWH and FDA resources for providers and patients

Healthcare providers (HCPs) can access the FDA OWH website for basic information and links to additional resources. To help HCPs understand sex and gender differences with regard to disease conditions and therapeutic interventions, the FDA OWH and the NIH offer a three-course series on sex- and gender-related differences. The series provides information regarding physiologic differences and their influence on health and disease; behavior; and disease manifestation, treatment, and outcome. On the FDA’s Women in Clinical Trials page, patients can find links to a fact sheet, videos, and other resources designed to help them understand the role of clinical trials in protecting and promoting women’s health. And on the FDA’s For Women page, patients can find various gender-focused patient information tools related to chronic disease conditions and other women’s health issues.

Conclusion

Women’s health research provides valuable insights as to how sex differences can affect women’s health outcomes. Likewise, inclusion of more diverse populations of women in clinical trials will better inform HCPs as to the potential of the effect of ethnicity overlaid with gender in the efficacy of therapeutic interventions. During 2016, the FDA OWH and NIH Office of Research on Women’s Health are focused on inclusion of diverse population of women in clinical trials. The links provided in this column can help nurse practitioners working in women’s health to better inform their patients about opportunities for participation in studies that can “Make a Difference” in finding optimal, targeted assessment and intervention strategies to promote and protect the health of all women.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri- St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH). She can be reached at 314-629-2372 or at skendig@npwh.org.

References

1. U.S. Food and Drug Administration. Women in Clinical Trials. November 25, 2015.

2. U.S. Government Accountability Office. Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drugs Testing. HRD-93-17. October 29, 1992.

3. Obias-Mannos D, Scott PE, Kaczmarczyk J, et al. The Food and Drug Administration Office of Women’s Health: impact of science on regulatory policy. J Womens Health (Larchmt). 2007;16(6):807-817.

4. U.S. Government Accountability Office. Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement. GAO-01-754. July 6, 2001.

5. U.S. Food and Drug Administration. FDA Report. Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products. August 2013.

6. Fadiran EO, Zhang L. Chapter 2: Effects of sex differences in the pharmacokinetics of drugs and their impact on the safety of medicines in women. In: Harrison-Woolrych M, ed. Medicines for Women. Switzerland: Springer International Publishing; 2015.

Expedited partner therapy for chlamyida

You may have chlamydia. If you do, you need to be treated for it. Your sex partner was recently treated for chlamydia, an infection you can get if you have sex with a person who is already infected. Many people with chlamydia do not know they have an infection because they feel fine.

Your partner may have given you a prescription or pills (azithromycin; also called Zithromax or a Z-Pak) for you to take. This medicine was given to your partner by a healthcare provider to treat you. This type of treatment is sometimes called expedited partner therapy. It’s better for you to go to your own provider to get tested for chlamydia and other sexually transmitted diseases (STDs). But if you can’t go to get tested, then you should take the medicine in this package.

If you are a female and have symptoms of belly or pelvic pain, especially during sex, you should go see a healthcare provider to make sure that you do not have pelvic inflammatory disease (PID). PID can be very dangerous and lead to infertility, pregnancy problems, or pain that lasts a long time.

If you have any questions, please call your healthcare provider. If you think you may be having a bad reaction to this medicine, call your provider or drugstore. If you are having a serious reaction, such as trouble breathing, which is very rare, go to your nearest emergency room and bring the empty medicine packet with you.

Directions for taking azithromycin (Zithromax) 250 mg tablets

This medicine is very safe. However, you should not take it if you ever had an allergic reaction (such as a rash, trouble breathing, closing of your throat, swelling of the lips and tongue, or hives) after taking any medicines. If you are unsure about whether you have ever had an allergy to any medicines, call your provider or drugstore before taking this medicine. If you have a serious, longterm illness such as kidney disease, liver disease, heart disease, or stomach problems, talk to your provider before taking this medicine.

Swallow all of the enclosed pills. These pills should be taken one after another at the same time, not on separate days. Some people have a mild upset stomach, which does not last long, after taking this medicine.

After taking the medicine, do not have sex for at least 7 days. Do not share this medicine or give it to anyone else. It is important to tell any person with whom you’ve have had sex in the past 60 days to go to a healthcare provider and get tested for chlamydia.

Adapted from the Partner Study, Public Health – Seattle & King County and the STD Treatment Guidelines, CDC.

Gonorrhea is another STD for which expedited partner therapy is available. To find out more about gonorrhea, log on to cdc.gov. To find out more about chlamydia, log on to cdc.gov.

*Healthcare providers need to conform to their state legal requirements with respect to the use of expedited partner therapy. If the information in this Patient education page is applicable to the patients in your state and in your practice, then you are invited to photocopy the page and distribute it to patients who can benefit from this information.

Message from the CEO

February may have been the shortest month of the year, but all of us at NPWH made the most of it by preparing for a busy and productive year. We welcome a new board chair, Jacki Witt, who is from Kansas City, Missouri, and three new board members: Diana Drake, from Minneapolis, Minnesota; Shelagh Larson, from Fort Worth, Texas; and Jordan Vaughan, from Nashville, Tennessee. We are also pleased to announce that Beth Kelsey, Editor-in-Chief of this journal, has added a new role: NPWH Publication Coordinator. Congratulations to all!

In January, we launched “Women’s Health Wisdom,” NPWH’s own blog! The purpose of the blog is to share thoughts, updates, and new information and opportunities related to women’s health policy, primary care, sexual health, pregnancy, pre-conception, postpartum concerns, heart health, mental health, overactive bladder, and many other topics. You can access the new blog by clicking here or by logging on to the NPWH website.

In April, we are offering a new regional CE course, Managing Women’s Health Issues Across a Lifespan. This live, interactive, 1-day meeting will be held at the Sheraton Pasadena Hotel in Pasadena, California. The course will include topics such as LARC, endometriosis, obesity, and genitourinary syndrome of menopause. You can register for this course here. See the back cover of this issue for much more information. And we proudly present the third annual Women’s Sexual Health Course for NPs on June 23-26, 2016, at the Sheraton Mission Valley San Diego Hotel in San Diego, California. New to the sexual health course this year will be a post-conference session for hands-on vulvoscopy training. The program guide for the Women’s Sexual Health Course for NPs appears on pages 8-12 in the journal; registration is available at npwh.org.

Make the most of this exciting year of 2016 by joining NPWH! You won’t want to miss out on all the exciting activities we have planned. And you will want to take advantage of the membership discounts and value-added features that we provide throughout the year.

– Gay Johnson

Chief Executive Officer, NPWH

The cervical cancer screening dilemma: Choosing the optimal screening strategy

Faculty

Kim Choma, DNP, APN, WHNP-BC, is a Part-time Lecturer at Rutgers University School of Nursing in Camden, New Jersey.

Charles F. Dubin, MD, is a Assistant Clinical Professor at the UCLA David Geffen School of Medicine, University of California at Los Angeles in Los Angeles, California.

Intended audience

This continuing education (CE) activity has been designed to meet the educational needs of women’s health nurse practitioners (NPs), adult NPs, family NPs, and certified nurse midwives (CNMs) involved in women’s health.

CE approval period

Now through March 31, 2017

Estimated time to complete this activity

1 hour

CE approval hours

1.0 contact hour of CE credit

Needs assessment

The essence of the cervical cancer screening (CCS) dilemma is which screening test(s) to use and how frequently to screen. Major national health organizations may differ somewhat in terms of their specific recommendations, but their

general objectives are to prevent morbidity and mortality from cervical cancer (Saslow et al, 2012 [this article presents recommendations from the American Cancer Society, the American Society of Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology]; U.S. Preventive Services Task Force, 2012; American College of Obstetrics and Gynecology, 2012) and to prevent overzealous management of precursor lesions that most likely will regress or disappear.

Educational objectives

At the conclusion of this educational activity, participants should be able to:

1.Understand the importance of maximizing the benefits of cervical cancer prevention while minimizing the harms associated with overtreatment.

2. Evaluate current available options for CCS: cervical cytology, primary HPV testing, and co-testing.

3.Determine the optimal interval for CCS for each patient.

Accreditation statement

This activity has been evaluated and approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women’s Health (NPWH), and has been approved for 1.0 contact hour of CE credit.

Faculty disclosures

NPWH policy requires all faculty to disclose any affiliation or relationship with a commercial interest that may cause a potential, real, or apparent conflict of interest with the content of a CE program. NPWH does not imply that the affiliation or relationship will affect the content of the CE program. Disclosure provides participants with information that may be important to their evaluation of an activity. Faculty are also asked to identify any unlabeled/unapproved uses of drugs or devices made in their presentation.

Kim Choma, DNP, APN, WHNP-BC, has disclosed that she serves on the Speakers’ Bureau and advisory board of Hologic.

Charles Dubin, MD, reports that he serves on the Speakers’ Bureau of Hologic, Myriad Genetics, and Phenogen Sciences.

Disclosure of unlabeled use

NPWH policy requires authors to disclose to participants when they are presenting information about unlabeled use of a commercial product or device or an investigational use of a drug or device not yet approved for any use.

Disclaimer

Participating faculty members determine the editorial content of the CE activity; this content does not necessarily represent the views of NPWH or Hologic. This content has undergone a blinded peer review process for validation of clinical content. Although every effort has been made to ensure that the information is accurate, clinicians are responsible for evaluating this information in relation to generally accepted standards in their own communities and integrating the information in this activity with that of established recommendations of other authorities, national guidelines, FDA-approved package inserts, and individual patient characteristics.

Successful completion of this activity

Successful completion of this activity, J-16-01, requires participants to:

1. “Sign In” at the top right-hand corner of the page (npwh.org/courses/home/details/559) if you have an NPWH account. You must be signed in to receive credit for this course. If you do not remember your username or password, please follow the “Forgot Password” link and instructions on the sign-in page. If you do not have an account, please click on “Create an Account.”

2.Read the learning objectives, disclosures, and disclaimers on the next page.

3.Check “Agree to Terms” on the next page and then click the “Continue” button.

4. Study the material in the learning activity during the approval period (now through March 31, 2017).

5.Complete the posttest and evaluation. You must earn a score of 70% or better on the posttest to receive CE credit.

6.Print out the CE certificate if successfully completed.

Commercial support: This activity is supported by educational grants from Hologic.

Before reading the article, click here to take the pretest.

The authors evaluate current available options for cervical cancer screening (CCS), with an emphasis on the importance of maximizing the benefits of cancer prevention while minimizing the harms associated with overtreatment. Two major dilemmas are addressed: Which CCS method is recommended for women aged 30-65? and What is the optimal interval between screenings for women in any age group?

Cervical cancer screening (CCS) has been one of the most successful screening programs in United States history, reducing cervical cancer-related incidence and mortality by 45% and 49%, respectively, since 1980.1 Until fairly recently, yearly cytology testing was recommended to maximize detection of pre-cancerous lesions. The discovery that infection with the human papillomavirus (HPV) underlies the pathophysiology of nearly all cervical cancers led to the incorporation of HPV testing in general screenings of women aged 30 years or older, starting in 2003.2, 3

Unlike few other forms of cancer, cervical cancer is nearly always

preventable.4 Under optimal circumstances, each potential case of cervical cancer can be forestalled by identifying and treating

disease that progresses, at most, to the high-grade cancer precursor stage.5, 6 At the same time, healthcare professionals (HCPs) want to minimize the harms associated with overtreatment of benign

lesions not destined to become cancerous.6

The cervical cancer screening dilemma

The essence of the CCS dilemma is which screening test(s) to use and how frequently to screen. Major national health organizations may differ somewhat in their specific recommendations, but their general objectives are to prevent morbidity and mortality from cervical cancer and to prevent overzealous management of precursor lesions that most likely will regress or disappear.6, 7

Which cervical cancer screening tests are available?

Two tests, cervical cytology and the HPV test, are used to screen for cervical cancer. In essence, though, HCPs have three CCS options: cytology alone, the HPV test alone (known as the primary HPV test), and co-testing with both methods.

Cervical cytology

A sample of cervical cells is examined under a microscope to screen for premalignant cells that could signal the presence of cancer precursors.8 Cervical cells collected by an HCP are smeared on a glass slide (traditional or conventional cytology—that is, the Pap test) or added to a preservative fluid (liquid-based thin-layer test). Liquid-based cytology, because of its greater sensitivity than conventional cytology in detecting disease, enables extension of the screening interval from 1 year to up to 3 years—without significantly diminishing CCS effectiveness.9

HPV testing

The causal role of persistent HPV infection in the development of cervical cancer and its precursors has been well documented.10 A landmark 2010 study showed that, over a 60-year study period, the 8 most common HPV types identified were (in descending order of frequency) 16, 18, 45, 33, 31, 52, 58, and 35.11 Together, these genotypes account for 91% of all cases of cervical cancer. HPV 16, 18, and 45 were found in 75% of the most common type of cervical cancer (squamous cell) and in 94% of the second most common form (adenocarcinoma). A study of more than 20,000 women showed that those infected with HPV types 16 and/or 18, versus those infected with other high-risk types, had a 10 times greater risk of developing cervical cancer.12 Because HPV cannot be cultured, in most cases its accurate identification relies on molecular biology techniques.13 Molecular assays use primers and probes that identify a region of HPV DNA or HPV mRNA. Of note, HPV tests used in clinical practice need to be FDA approved for validity.6

Co-testing

Recent incorporation of HPV DNA testing into CCS strategies offers the benefits of increasing early disease detection (up to 100% sensitivity) 14 and increasing the length of the interval between screenings—thereby lessening harms such as the adverse psychosocial impact of screening positive, the need for additional visits and procedures, and the treatment of lesions that would have resolved on their own.6 Even more recently, HPV infection can be identified by HPV mRNA testing, which, like standard HPV DNA testing, has up to 100% sensitivity15 but also offers improved specificity, with a 24% reduction in false-positive results.16

Which approaches to screening are recommended for women aged 21-29?

According to guidelines issued in 2012 by the American Cancer Society (ACS), the American Society of Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP), CCS should begin at age 21.6 Women aged 21-29 should undergo cervical cytology every 3 years.6 The same year, the U.S. Preventive Services Task Force (USPSTF) and the American Congress of Obstetricians and Gynecologists (ACOG) issued similar recommendations.17, 18 These organizations all advised against HPV co-testing in women younger than 30; although HPV is commonly present in women in this age group, most of them successfully fight off the infection within a few years.19 An updated Practice Bulletin from ACOG published in January 2016 reinforces the recommendations for women aged 21-29 based on level A evidence: Co-testing in these women and annual cytology should not be performed.20 Until more longterm, level A evidence studies are available to support future updates to the 21-29 age group, HCPs are encouraged to follow the consensus guidelines.6 Although primary HPV testing was not recommended at the time of the ACS/ASCCP/ASCP, USPSTF, and ACOG updates in 2012—in fact, its use was specifically discouraged in women in their 20s—the body of evidence supporting this CCS approach has grown. Findings from the Addressing the Need for Advanced HPV Diagnostics (ATHENA) study (2008-2012) supported the safety and effectiveness of primary HPV testing.21, 22 In 2014, the FDA approved the use of the cobas HPV test as a primary screen for cervical cancer in women aged 25 years or older.23 As a result, interim clinical guidance issued by the Society of Gynecologic Oncology (SGO) and the ASCCP in 2015 supported primary HPV testing as a possible alternative to cytology-based screening and co-testing, but starting no sooner than age 25.24

Which approaches to screening are recommended for women aged 30-65?

Again, HCPs have three CCS options: cervical cytology, primary HPV testing, and co-testing. The ACS/ASCCP/ASCP recommends cytology alone every 3 years or cotesting every 5 years.6 The USPSTF endorses cytology every 3 years, with co-testing as an option in women who want to extend their screening interval to 5 years.17 ACOG supports the options of cytology at 3-year intervals and co-testing at 5-year intervals, with the latter preferred.18 None of these organizations advocates the use of primary HPV testing as an alternative to cytology or co-testing.

Co-testing for women aged 30 or older was approved by the FDA in 2006. But how does co-testing compare with primary HPV testing— as advocated in the interim guidance report—and with cervical cytology alone in predicting outcomes in women in the 30- to 65-year age group?

Studies supporting co-testing 

Blatt et al25 conducted a retrospective study to assess the sensitivity of various testing options for biopsy-proven cervical intraepithelial neoplasia grade 3 or worse (CIN3+). The authors evaluated 256,648 cervical biopsies from women aged 30-65 who had undergone a co-test and colposcopy within 1 year of each other (colposcopy was performed a mean of 54 days after the co-testing result). Among the samples, 4,090 (1.6%) exhibited CIN3+. A positive co-test result was 98.8% sensitive for diagnosing CIN3+, compared with the 94% sensitivity of a positive HPV test result and the 91.3% sensitivity of a positive cytology result. Looked at another way, in this group of women, use of cytology alone would have missed 8.7% of the CIN3+ cases and use of the HPV test alone would have failed to catch 6% of the CIN3+ cases, whereas co-testing would have missed only 1.2% of these cases. Therefore, co-testing identified 80% of the CIN3+ cases that would have been missed by screening with the primary HPV test. Of the 526 confirmed cases of cervical cancer in this study, 98 (18.6%) were HPV test negative and 64 (12.2%) were cytology negative, whereas only 29 (5.5%) were cotest negative. Co-testing identified 70% of cervical cancers that would have been missed by screening with the HPV test alone.

Additional studies conducted over the past 11 years showed that primary HPV testing missed a substantial proportion of cervical cancers, and were in concordance with the landmark study by Blatt and colleagues.11, 26-29

Studies supporting primary HPV testing

The aforementioned interim guidance from the SGO/ASCCP was based, in large part, on the results of several large trials demonstrating that a negative HPV test result provides greater reassurance of low CIN3+ risk than does a negative cytology result. For example, Dillner et al30 evaluated primary data from seven HPV screening studies in six European Union countries, each investigating the predictive value of primary HPV testing for future CIN3+. The cumulative incidence rate of CIN3+ after 6 years was considerably lower among women negative for HPV at baseline (0.27%) than among women with negative results on cytology (0.97%). The cumulative incidence rate among women who were cytology-negative/HPV-positive rose continuously over time, reaching 10% at 6 years, whereas the rate among women who were cytologypositive/HPV-negative remained below 3%.

Other recent studies provided evidence that a negative HPV test result, as compared with a negative cytology result, offers greater reassurance that a woman will be free of CIN3+ over time.31-33 In these studies, participants underwent co-testing. In essence, the investigators found that the HPV test results, relative to the cytology results, were more predictive of outcomes over 3-5 years. That is, the cytology portion of the cotest did not add much information to the HPV portion, suggesting, to some at least, that HPV testing could be used by itself.

The first dilemma: Which CCS method is recommended for women aged 30-65?

The findings of the studies supporting primary HPV testing are open to interpretation. For example, Gage et al32 compared the risks of CIN3+ and of cervical cancer alone for HPV testing every 3 years, cytology testing every 3 years, and co-testing every 5 years among more than 1 million women in the Kaiser Permanente population who were aged 30-64 years and who tested HPV-negative and/or cytology-negative in routine screening. Investigators found that 3-year risks following an HPV-negative result were lower than 3-year risks following a cytology-negative result (CIN3+, 0.069% vs. 0.19%; P <.0001; cancer, 0.011% vs. 0.020%; P<.0001) and 5-year risks following an HPV-negative/Pap-negative co-test result (CIN3+, 0.069% vs. 0.11%; P <.0001; cancer, 0.011% vs. 0.014%; P = .21). That is, the 3- year safety (i.e., reassurance against future risk of pre-cancer and cancer) conferred by a negative HPV test result exceeded the 3-year safety conferred by a negative cytology result or the 5-year safety conferred by a negative cotest result. However, a closer look at the data shows that if HPV testing had been compared with cotesting at the 3-year checkpoint instead of the 5-year checkpoint (the recommended interval), negative co-testing results at baseline were slightly more reassuring than negative HPV results at baseline for CIN3+ and for cancer.

In addition, as HPV-infected cervical cells progress toward cervical cancer, HPV DNA levels decline.34 Depending on the age at which CCS begins and the frequency with which it is performed, relying initially, solely, or mainly on the results of HPV DNA screening tests might miss fastgrowing cancers. Although as HPV integrates itself into the human genome and HPV DNA levels decrease, HPV E6/E7 mRNA levels increase, suggesting that the assay that particularly targets this protein, as compared with the HPV DNA assays, is more specific in indicating lesion severity.35 

Furthermore, with cytology alone, adenocarcinoma and its precursors are difficult to identify— simply because of the cervical anatomy and the detection methods used. Cervical adenocarcinoma is usually farther away from the transformation zone, the area targeted most readily with the use of cervical sampling devices. Cytology alone has been relatively ineffective in identifying glandular lesions associated with adenocarcinoma. Addition of HPV testing to cytology—that is, co-testing—should enhance identification of adenocarcinoma and its precursor, adenocarcinoma in situ (ACIS).18

At this point in time, co-testing seems a reasonable option in women aged 30-65 years because it offers optimal sensitivity and specificity in identifying cervical cancer precursors.

What is the optimal screening interval for cervical cancer screening?

The 2012 ACS/ASCCP/ASCP and ACOG guidelines’ recommended screening intervals are 3 years for liquid-based cytology testing and 5 years for co-testing.6, 18 The updated Practice Bulletin from ACOG states that co-testing every 5 years is preferred, but that screening with cytology alone every 3 years is acceptable.20 ACOG recommends against annual testing. The USPSTF recommends cytology every 3 years for women younger than 30.17 For women aged 30-65 who want to extend their screening interval to 5 years, adding HPV testing is advised. The interim guidance provided by the SGO/ASCCP recommends that re-screening after a negative primary HPV test result occur no sooner than every 3 years—but only in women aged 25 years or older.24

For decades in the past, women underwent conventional Pap testing every year—their single best option for identifying cervical cancer precursors in a timely fashion. But there was a distinct downside to this yearly testing, which often yielded results—atypical squamous cells of undetermined significance (ASCUS) or a higher-grade lesion—that would lead to colposcopy and, depending on the results of the cervical biopsies, a loop electrosurgical excision procedure or conization. Most of these cytologic abnormalities, as well as the HPV infections underlying them, resolve on their own. Screening women every year, then, is bound to lead to unnecessary diagnostic and therapeutic procedures. These procedures are, at the very least, unpleasant and worrisome and at worst, harmful.36-41

The second dilemma: What is the optimal interval between screenings for women in any age group? 

Since the CCS guidelines were published in 2012 and the interim guidance was published last year, a different perspective on the CCS interval has been offered. According to a commentary by Kinney et al,42 which was based on a modeling study for the USPSTF that was published in 2013,43 women who comply with the CCS recommendations and increase the co-testing interval from 3 years to 5 years are increasing their risk for unfavorable consequences, with an additional 1/369 diagnosed with cancer in her lifetime and 1/1,639 dying of cancer. Adoption of a 3-year co-testing interval instead of a 5-year co-testing interval between screenings would “cost” 409 additional colposcopies and 14.3 additional women treated for each cancer death prevented. Many women and their HCPs might argue that the extra screenings, tests, treatments, and related harms are worth it to save even a small number of lives. In  addition, as noted in the discussion of the first CCS dilemma, results of the study by Gage et al32 suggest that the optimal interval for co-testing may be 3 years, not 5 years. Finally, there is considerable clinician resistance to the 5-year screening interval recommended for a negative co-test result.42

Based on what is known to date, HCPs should consider the optimal CCS screening interval to be 3 years, both for cytologic testing in women aged 21-29 or older and for co-testing in women aged 30-65. 

At what age can cervical cancer screening safely be stopped?

According to the ACS/ASCCP/ASCP, CCS can safely be stopped in women older than 65 who have had adequate negative prior screening (three consecutive negative cytology results or two negative co-test results within the previous 10 years, with the most recent test performed within the past 5 years) and no history of CIN2+ within the past 20 years.6 The USPSTF and ACOG are in general agreement with these criteria.17, 18 For women older than 65 with a history of CIN2, CIN3, or ACIS, routine screening should continue for at least 20 years.6, 18 According to the USPSTF, women older than 65 who have never been screened, women who do not meet the criteria for adequate prior screening, or women for whom the adequacy of prior screening cannot be accurately accessed or documented should undergo routine CCS.17 Likewise, routine screening should continue for at least 20 years after spontaneous regression or appropriate management of a highgrade pre-cancerous lesion, even if this extends screening past age 65.

Conclusion

The best approach to prevent cervical cancer entails screening and vaccination. The goals of maximizing benefits and minimizing harms for patients are guiding principles at the forefront of CCS. To this end, using the evidence to date, which includes the 2012 guidelines, the interim guidance published last year, and the updated ACOG practice bulletin, cytology screening every 3 years in women aged 21-29 and co-testing every 3 years in women aged 30-65 are reasonable recommendations to balance patient harms and clinician resistance to 5- year screening intervals.

References

1. National Cancer Institute. A Snapshot of Cervical Cancer: Incidence and Mortality. November 5, 2014.

2. FDA Patient Safety News: Show #16, June 2003.

3. National Cancer Institute. HPV Testing to Screen for Cervical Cancer.

4. Centers for Disease Control and Prevention. CDC Vital Signs. Cervical cancer is preventable. November 2014.

5. Cox JT, Castle PE, Behrens CM, et al; Athena HPV Study Group. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from

the ATHENA HPV study. Am J Obstet Gynecol. 2013;208(3):184.e1-184.e11.

6. Saslow D, Solomon D, Lawson HW, et al; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. J Low Genit Tract Dis. 2012;16(3):175-204.

7. American Society for Colposcopy and Cervical Pathology (ASCCP). Cervical Cancer Screening Recommendations. PowerPoint Presentation. 2012.

8. Kelsey B. The role of HPV testing: co-test or primary screen? Womens Healthcare. 2015;3(2):29-32.

9. Gibb RK, Martens MG. The impact of liquid-based cytology in decreasing the incidence of cervical cancer. Rev Obstet Gynecol. 2011;4(suppl 1):S2-S11.

10. Bosch FX, Lorincz A, Muñoz N, et al. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002;55(4):244-265.

11. de Sanjose, S, Quint WG, Alemany L, et al; Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048-1056.

12. Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005; 97(14):1072-1079.

13. Abreu ALP, Souza RP, Gimenes F, Consolaro MEL. A review of methods for detect human Papillomavirus. Virol J. 2012;9:262.

14. HC2 High-Risk HPV DNA Test® Package Insert (B). Kaiser Study Data. Test Performance Versus Consensus Histology Results (CIN2-3+) Ages <30.

15. Arbyn M, Roelens J, Cuschieri K, et al. The APTIMA HPV assay versus the Hybrid Capture 2 test in triage of women with ASC-US or LSIL cervical cytology: a meta-analysis of the diagnostic accuracy. Int J Cancer. 2013; 132(1):101-108.

16. Aptima® HPV Assay Package Insert.

17. United States Preventive Services Task Force. Screening for Cervical Cancer. 2012.

18. Committee on Practice Bulletins—Gynecology. ACOG Practice Bulletin Number 131: screening for cervical cancer. Obstet Gynecol. 2012;120(5):1222-1238.

19. Bosch FX, Broker TR, Forman D, et al. Comprehensive control of human papillomavirus infections and related diseases. Vaccine. 2013;31(31 suppl 7):H1-H31.

20. American Congress of Obstetricians and Gynecologists. Practice Bulletin Number 157. Cervical Cancer Screening and Prevention. Obstet Gynecol. 2016;127(1):185-187.

21. Cox JT, Castle P, Behrens C, et al. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Obstet Gynecol. 2013;208(3): 184.e1-c11.

22. Wright TC, Stoler M, Behrens C, et al. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015; 136(2):189-197.

23. U.S. Food and Drug Administration. FDA approves first human papillomavirus test for primary cervical cancer screening. FDA News Release April 24, 2014.

24. Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015; 125(2):330-337.

25. Blatt AJ, Kennedy R, Luff RD, et al. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathol. 2015;123(5):282-288.

26. de Cremoux P, Coste J, Sastre-Garau X, et al; French Society of Clinical Cytology Study Group. Efficiency of the hybrid capture 2 HPV DNA test in cervical cancer screening. A study by the French Society of Clinical Cytology. Am J Clin Pathol. 2003; 120(4):492-499.

27. Naucler P, Ryd W, Tørnberg S, et al. Efficacy of HPV DNA testing with cytology triage and/or repeat HPV DNA testing in primary cervical cancer screening. J Natl Cancer Inst. 2009;101(2):88-99.

28. Li Z, Austin RM, Guo M, Zhao C. Screening test results associated with cancer diagnoses in 287 women with cervical squamous cell carcinoma. Arch Pathol Lab Med. 2012;136(12): 1533-1540.

29. Zhao C, Li Z, Austin RM. Cervical screening test results associated with 265 histopathologic diagnoses of cervical glandular neoplasia. Am J Clin Pathol. 2013;140(1):47-54.

30. Dillner J, Rebolj M, Birembaut P, et al; Joint European Cohort Study. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ. 2008;337:a1754.

31. Katki HA, Kinney WK, Fetterman B, et al. Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology: a population-based study in routine clinical practice. Lancet Oncol. 2011;12(7):663-672.

32. Gage JC, Schiffman M, Katki HA, et al. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014;106(8).

33. Ronco G, Dillner J, Elfström, EM, et al; International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014;383(9916):524-532.

34. Doorbar J. Molecular biology of human papillomavirus infection and cervical cancer. Clin Sci (Lond). 2006;110(5):525-541.

35. Lie AK, Kristensen G. Human pap illomavirus E6/E7 mRNA testing as a predictive marker for cervical carcinoma. Expert Rev Mol Diagn. 2008; 8(4):405-415.

36. Sawaya G, Kuppermann M. Identifying a “range of reasonable options” for cervical cancer screening. Obstet Gynecol. 2015;125(2):308-310.

37. Sharp L, Cotton S, Cruickshank M, et al; TOMBOLA Group. The unintended consequences of cervical screening: distress in women undergoing cytologic surveillance. J Low Genit Tract Dis. 2014;18(2):142-150.

38. Sutthichon P, Kietpeerakool C. Perioperative complications of an outpatient loop electrosurgical excision procedure: a review of 857 consecutive cases. Asian Pac J Cancer Prev. 2009;10(3):351-354.

39. Kyrgiou M, Koliopoulos G, Martin- Hirsch P, et al. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and metaanalysis. Lancet. 2006;367(9509): 489-498.

40. Ørtoft G, Henriksen TB, Hansen ES, Petersen LK. Preterm birth and previous conisation of the cervix. Br J Obstet Gynaecol. 2010;117(9):1158-1169.

41. Arbyn M, Kyrgiou M, Simoens C, et al. Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: meta-analysis. BMJ. 2008;337:a1284.

42. Kinney W, Wright TC, Dinkelspiel HE, et al. Increased cervical cancer risk associated with screening at longer intervals. Obstet Gynecol. 2015; 125(2):311-315.

43. Kulasingam SL, Havrilesky LJ, Ghebre R, Myers ER. Screening for cervical cancer: a modeling study for the US Preventive Services Task Force. J Low Genit Tract Dis. 2013; 17(2):193-202.

Lung cancer screening*

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KEY POINTS

  • Tests are used to screen for different types of cancer.
  • Three screening tests have been studied to see if they decrease the risk of dying from lung cancer.
  • Screening with low-dose spiral computed tomography (CT) scans has been shown to decrease the risk of dying from lung cancer in heavy smokers.
  • Screening with chest x-rays and/or sputum cytology does not decrease the risk of dying from lung cancer.

Tests are used to screen for different types of cancer.

Some screening tests are used because they have been shown to be helpful both in finding cancers early and in decreasing the chance of dying from these cancers. Other tests are used because they have been shown to find cancer in certain people; however, it has not been proven in clinical trials that use of these tests will decrease the risk of dying from cancer.

Scientists study screening tests to find those with the fewest risks and most benefits. Cancer screening trials also are meant to show whether early detection (finding cancer before it causes symptoms) decreases a person’s chance of dying from the disease. For some types of cancer, finding and treating the disease at an early stage may result in a better chance of recovery. Clinical trials that study cancer screening methods are taking place in many parts of the country. Information about ongoing clinical trials is available from the National Cancer Institute website.

Three screening tests have been studied to see if they decrease the risk of dying from lung cancer.

  • Low-dose spiral CT scan (LDCT scan): A procedure that uses low-dose radiation to make a series of very detailed pictures of areas inside the body. It uses an x-ray machine that scans the body in a spiral path. The pictures are made by a computer linked to the x-ray machine. This procedure is also called a low-dose helical CT scan.
  • Chest x-ray: An x-ray of the organs and bones inside the chest. An x-ray is a type of energy beam that can go through the body and onto film, making a picture of areas inside the body.
  • Sputum cytology: Sputum cytology is a procedure in which a sample of sputum (mucus that is coughed up from the lungs) is viewed under a microscope to check for cancer cells.

Screening with low-dose spiral CT scans has been shown to decrease the risk of dying from lung cancer in heavy smokers.

The National Lung Screening Trial studied people aged 55 years to 74 years who had smoked at least 1 pack of cigarettes per day for 30 years or more. Heavy smokers who had quit smoking within the past 15 years were also studied. The trial used chest x-rays or LDCT scans to check for signs of lung cancer.

The scientists found that LDCT scans were better than chest x-rays at finding early-stage lung cancer. Screening with LDCT also decreased the risk of dying from lung cancer in current and former heavy smokers. A Guide is available for patients and healthcare providers to learn more about the benefits and harms of LDCT screening for lung cancer.

Screening with chest x-rays and/or sputum cytology does not decrease the risk of dying from lung cancer.

Chest x-ray and sputum cytology are two screening tests that have been used to check for signs of lung cancer. Screening with chest x-ray, sputum cytology, or both of these tests does not decrease the risk of dying from lung cancer.

*National Cancer Institute. Updated April 27, 2015. Readers are invited to photocopy Patient education pages in the journal and distribute them to their patients.

Formation of a peer review group for advanced practice nurses

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By Simone J. van der Linden, MANP, BEd, RN; Leni van Doorn, MSc, MANP, RN; Judith P. van Eck, MANP, RN; Wanda Geilvoet, MANP, RN; and Greta Mulders, MANP, RN

A group of Dutch advanced practice nurses (APNs) describe their process of forming a peer review group (PRG) to share cases and provide feedback to one another. The purpose of the PRG is to help APNs expand their knowledge base and hone their clinical skills, with the ultimate goal of improving patient care.

In 1996, Dr. Els Borst, former Minister of Health of the Netherlands, proposed that specially trained master’s-prepared nurses assume certain tasks of physicians in order to help meet the growing need for healthcare in the midst of a physician shortage. In light of the increased number of elderly and chronically ill patients today, this need is even more pressing.1 The consequence of Dr. Borst’s proposal was the inauguration of the first Master’s in Advanced Nursing Practice (MANP) program in Groningen, the Netherlands, at the Hanze University of Applied Sciences in 1997.

Since that time, the training and the work accountability of advanced practice nurses (APNs) in the Netherlands have been extended. A major change occurred in March 2009, when Dutch APNs were granted official registration numbers and legal title protection. Nurses can be registered as APNs only after earning a master’s degree from a certified university and undergoing training on the job at a certified healthcare institute with a certified medical and nursing trainer.

Dutch APNs can be registered in one of five nursing specialties: (1) acute care in somatic disorders, (2) intensive care in somatic disorders, (3) chronic care in somatic disorders, (4) preventive care in somatic disorders and (5) mental health. Like physicians, APNs must attend conferences offering staff development workshops and be actively employed for at least 24 hours a week. In 2014, more than 2,500 APNs were registered in the Netherlands.2

After initial registration, APNs must re-register every 5 years to maintain an active license. Since 2010, one of the requisites for re-registration has been participation in peer review (PR). Guidelines of the Dutch Nursing Specialty Registration Board (DNSRB) require APNs to participate in a PR group (PRG) for at least 40 hours per 5-year period.3 In addition, to ensure competence and continuous professional development, periodic self-appraisal and peer feedback must be in place for all levels of nursing.4

Defining peer review

Peer review is a systematic process by which one assesses, monitors, and makes judgments about the quality of care provided to patients by others, as measured against established standards of practice.5,6 Nursing PR is an evaluation of one’s professional nursing practice, including identification of opportunities to improve care, by persons with the appropriate expertise to perform the evaluation.7 Because they undergo PR, APNs are a group of healthcare providers (HCPs) whose personal competencies in various nursing specialties are compared—with those of other APNs and with objective criteria—with the aim of improving daily practice.3 PR, recognized as a measure of accountability and a means to evaluate and improve practice,4 enhances development of the APN profession and improves the quality of patient care.

Peer review has multiple benefits for APNs. It facilitates an open and safe learning environment. It provides APNs with an opportunity to reflect on questions and problems together. Because of the interactive setting, APNs invariably learn something new.8 PR even offers APNs a break in an otherwise hectic workday. PR can help APNs evaluate the quality of care they have delivered, and gain insight into their greatest strengths and weaknesses as HCPs. With feedback and recommendations from the group, APNs can gain new knowledge and improve their skills.

Creating and working as a PRG

Because the APN profession is relatively new in the Netherlands, the nursing education department of the Erasmus Medical Center Rotterdam had no experience in starting or structuring a PRG. Five years ago, five pioneering APNs working on an internal medicine unit decided to create such a PRG. These APNs found several examples of PRGs in the literature and took the initiative in creating a framework, based on non-empirical research, that took into account the criteria requisites of the DNSRB.

To initiate an effective PRG, some basic steps are essential. The first step is to form a group of 3-5 APNs in the same specialty who have similar interests within their specialty. The next step is to elect a chair to serve a 1-year term. The chair then makes a yearly schedule so that members can plan to attend all PRG meetings. To meet the criterion of spending 40 hours in the PRG over 5 years, the group must meet for about 2 hours every 3 months.

At each meeting, members take turns serving as the contributor, who presents a case related to her work field. One week before the meeting, the contributor sends a recap of the case—along with corresponding literature, protocols, and guidelines—to PRG members so that they can read background material and analyze the case. Each case submitted for PR must have these elements:

  • The patient’s presenting complaint, personal and family health history, and physical examination findings;
  • An analysis of the case, with corresponding literature or guidelines to clarify or substantiate the diagnosis or the problem;
  • A list of dilemmas that can occur or that did occur with the presented case, as well as learning points, and
  • Learning objectives extracted from the presented case for discussion.

At the meeting, the contributor uses PowerPoint to present the case and then leads the discussion regarding dilemmas and learning goals. A member who is appointed secretary for each meeting takes notes and creates a report of the thoughts and views exchanged during the meeting. The report includes a summary of the case, the learning goals of the contributor, and feedback/recommendations from the group. After the meeting, the report is sent to the PRG members. Reports of PRG meetings are saved in a digital portfolio.

At the next PRG meeting, notes of the previous meeting are discussed. The chair asks the previous contributor whether she used feedback from the last PRG meeting and applied it to her practice. The process gives the contributor an opportunity to reflect on her own goals and improve the quality of her work.

Choosing the best method to present a case

Within the first year of the PRG’s existence, all five members had submitted a case. The group then met to determine the best format for presenting a case. The PRG considered three options: the testing method, the Balint method, and the research method. These methods were evaluated in terms of whether they enhanced the professionalism of the APN through the sharing of knowledge, expertise, and thoughts. The group was most satisfied with the testing method, which is particularly suitable for case study discussion and for evaluation of clinical guidelines and protocols. With this method, the group works together, sharing ideas and coming to an agreement on how practice can be improved. One downside of the testing method is that the personal learning goals of the APN are not included.

Gaining competencies

In the Netherlands, the focus of learning is to gain competencies. A framework used for the competency-based approach is that of the Canadian Medical Education Directives for Specialists (CanMEDS) (Figure).9 The CanMEDS framework describes seven different roles of an HCP: professional, communicator, collaborator, manager, health advocate, scholar, and, in the center, medical expert. APNs who have gained the first six competencies can become medical experts (the center of the honeycomb), but they cannot become medical experts if they fail to gain one of the six competencies surrounding the central competency. APNs need to enhance themselves in all seven competencies in order to become better HCPs.

Figure

Achieving the best practice

A combined framework using both the testing method and the CanMEDS framework was determined to be the best practice. This combined framework was deemed to be the best way to prepare a case for discussion and to give the PRG and the contributor the clearest insight into the questions and learning issues provided by the case. The testing method is an ideal way to discuss problems or questions regarding certain procedures and guidelines within the safe confines of a group. In addition, each group member can impart information and share expertise via the group discussions, which can then be absorbed by the other members and translated into their own practices.

Discussion

The PRG found that, over a 4-year period, a combined approach—the testing method and the CanMEDS framework—constituted the best practice for structuring a case for discussion and determining the contributor’s own learning issues. The DNSRB also recommends use of CanMEDS competencies in this regard. If the combined framework does not work well for a given PRG, it may be related to poor group dynamics, lack of a safe environment, or a tendency for members discussing a case to highlight their feelings rather than their own practice. Some PRG members indicated that they sometimes felt vulnerable. It takes courage to learn from colleagues. According to Karas-Irwin and Hoffmann,4 a caring environment imbued with genuine respect enhances PRG interactions. By participating in a PRG, APNs in the Netherlands not only meet the needs and criteria of the DNSRB, but also enhance their professional skills and build their knowledge base.

Implications for APNs in the United States

Although there is no specific requirement to participate in PR as part of APN licensure in the United States, PR is recognized as an important component of practice and professional responsibility.10,11 The opportunity to come together as a small group of APNs with similar clinical practices and interests on a regular basis to review challenging cases provides a collegial environment for learning from each other. Peer assessments can play an important role in enhancing quality of care for complex patients with multiple interrelated chronic conditions, especially as seen in the U.S. with its aging population and the increasing prevalence of obesity and its co-morbidities.

Simone J. van der Linden is an APN in the Department of Hematology, Cancer Institute; Leni van Doorn is an APN in the Department of Medical Oncology, Cancer Institute; Judith P. van Eck is an APN in the Department of Medicine, Section of Endo­crinology; Wanda Geilvoet is an APN in the Department of Medicine, Section of Endocrinology; and Greta Mulders is an APN in the Department of Hematology, all at Erasmus Medical Centre, Rotterdam, The Netherlands. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

Acknowledgment
The authors thank L. Maas, RN, MS, Rotterdam University, Master’s in Advanced Nursing Practice Program, Rotterdam, the Netherlands.

References
1. Statistics Netherlands. Dutch population expected to reach 17.5 million in 2038. cbs.nl/en-GB/menu/themas/
bevolking/publicaties/artikelen/archief/2008/2008-085-pb.htm

2. Dutch Nursing Association. 2013. venvnvs.nl/files/2014/09/Jaarverslag-VVN-VS-okt13-okt14-def.pdf

3. Dutch Nursing Specialty Registration Board. Intercollegiale Toetsing Verpleegkundig Specialisten. 2010.
verpleegkundigspecialismen.nl/Portals/45/20100203%20Intercollegiale%20Toetsing%20Verpleegkundig%20
Specialisten%20_3.pdf

4. Karas-Irwin BS, Hoffmann RL. Facing the facts: in-person peer review. Nurs Manage. 2014;45(11):14-17.

5. Sherwood GD, Brown M, Fay V, Wardell D. Defining nurse practitioner scope of practice: expanding primary care services. Internet J Adv Nurs Pract. 1997;1(2). geide.org/uploads/6/4/8/8/6488798/definingscope.pdf

6. Smith MA, Atherly AJ, Kane RL, Pacala JT. Peer review of the quality of care. Reliability and sources of variability for outcome and process assessments. JAMA. 1997;278(19):1573-1578.

7. Spiva LA, Jarrell N, Baio P. The power of nursing peer review. J Nurs Adm. 2014;44(11):586-590.

8. de Haan E. Leren met Collega’s. Uitgeverij Van Gorcum; 2009.

9. Frank JR, Jabbour M, Fréchette D, et al. Report of the CanMEDS Phase IV Working Groups. Ottawa, Canada: The Royal College of Physicians and Surgeons of Canada; 2005.

10. National Organization of Nurse Practitioner Faculties. Nurse Practitioner Core Competencies. 2012. c.ymcdn.com/
sites/www.nonpf.org/resource/resmgr/competencies/npcorecompetenciesfinal2012.pdf

11. National Association of Nurse Practitioners in Women’s Health/Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.

We invite readers to submit articles on Professional development topics—for example, processes that foster learning or quality improvement in clinical practice or that promote the business aspect of being an NP. Please see our Guidelines for Authors for more information about this short-form article option.

Overactive bladder: Assessing patient goals and implementing individualized treatment

 

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Overactive bladder (OAB) is a common condition affecting women in every age bracket. OAB symptoms need no longer undermine a woman’s quality of life. After ascertaining a patient’s goals, a healthcare provider can devise an individualized treatment plan that may include simple lifestyle changes, an FDA-approved medication regimen, and nonpharmacologic interventions such as pelvic floor muscle exercises, bladder training, and use of a pessary.

Key words: overactive bladder, OAB, urinary incontinence, nocturia, anticholinergics, beta-3 adrenergic agonist

Anita Padd, age 69, is a retired registered nurse who presents with a list of urinary complaints that she attributes to the fact that, when she was working, she was too busy to take time to go to the bathroom. A week before her appointment, Anita had attended a luncheon sponsored by a nurse practitioner (NP) who recently opened a pelvic health center around the corner. Anita says that she is glad both that she attended the luncheon—“For the first time in years, I realized that I am not alone and that help is available for my bladder problems”—and that she has made an appointment to see this NP.

Why are so many women experiencing bladder problems now?

Anita, born in 1946, was among the first Baby Boomers to turn 65. She, like many of her peers, is healthier than members of previous generations and has lived long enough to develop one or more chronic health conditions such as hypertension, diabetes, and overactive bladder (OAB). According to the U.S. Census Bureau, in 2014 there were 76.4 million Baby Boomers—that is, persons born between 1946 and 1964.1 The number and proportion of elderly persons in the country will keep rising for many years to come.
Anita believes that her bladder problem is a normal consequence of aging. She has been managing the problem by restricting her fluid intake and wearing pads. She tells the NP that she didn’t broach the topic to her primary care provider (PCP) because she was embarrassed and because she feared that surgery was the only treatment available.

Are Anita’s perceptions/concerns about her bladder problem common?

Results of a 2012 nationwide survey of women aged 40-65 years showed that those who had mild to moderate OAB symptoms (n = 652), as compared with those who had no OAB symptoms (n = 1,017), tended to feel much less “in charge” of their lives and their health and were much more fearful of public embarrassment related to not being able to reach a toilet in time to avoid having an accident.2 OAB sufferers were also more likely to think that bladder problems, like wrinkles and gray hair, were a normal part of aging.

Anita’s PCP has never screened her for urinary problems. Like many PCPs, she manages hundreds of patients with multiple conditions and feels that investigating a condition such as OAB would be “opening Pandora’s box.” Like her patient, this PCP is not aware of conservative treatments for bladder problems and is confused by all the medications on the market.

How common is OAB? Should healthcare providers (HCPs) be routinely screening their patients for it?

The prevalence of OAB among women is 15%-17%.3,4 In raw numbers, at least 11-16 million women in the United States have OAB symptoms.4 Most women with OAB symptoms do not talk with their HCPs about their urinary dysfunction, and providers may not routinely inquire about it. As a result, only a small minority of women with OAB receive treatment for it.4
Healthcare providers who see women on a regular basis in their practice can fill the gap by routinely screening for OAB and by gaining the knowledge to treat it appropriately. In an NPWH member survey of 300 NPs that was conducted in 2013, 48.3% of respondents reported being confident in their ability to diagnose OAB and 41.1% felt sure of themselves with regard to treating OAB, but only 28.5% thought that most OAB sufferers in their practice had been identified (H.A.C., unpublished NPWH member survey data, 2013). With proper screening for OAB, most, if not all, of the patients with this condition can be identified and treated.

What exactly is overactive bladder?

Overactive bladder is a symptom complex consisting of urgency, frequency, and nocturia and, in 37% of cases, urge incontinence. Sudden and compelling urinary urgency, the hallmark of OAB, occurs as a result of premature and independent contractions of the bladder that escape inhibition by the central nervous system. Urinary frequency is defined as voiding 8 or more times in a 24-hour period.5 Nocturia entails awakening more than 2 times a night to urinate.5 For OAB sufferers who have urge incontinence, urine loss varies from a few drops to a “gush.”

The three main categories of urinary incontinence are urge incontinence, stress incontinence, and mixed incontinence. Urge incontinence is an involuntary loss of urine immediately preceded by or synchronous with a strong urge to void. Urine loss can be substantial, because bladder contractions may continue until the bladder is empty. Urge incontinence, also described as detrusor instability or detrusor hyperactivity,6 differs from a normal strong urge to void that can be controlled. It is due to spontaneous bladder spasm, which can result from dietary factors (bladder stimulants such as caffeine or alcohol), increased fluid intake, side effects of medication (e.g., diuretics, bethanechol), urinary tract infection/cancer, or nerve dysfunction associated with nerve trauma, diabetes, multiple sclerosis, or spinal cord injury.5,6 Many episodes of urge incontinence have triggers such as unlocking the door to one’s house upon return (key-in-lock syndrome), approaching a toilet, or hearing the sound of running water.7Stress incontinence is marked by an involuntary loss of urine due to increased abdominal pressure on the bladder that exceeds maximal urethral closure pressure.8 An episode of stress incontinence is precipitated by an activity such as coughing, sneezing, laughing, lifting, stepping off a curb, or tripping. Stress incontinence is due to an increase in abdominal forces in the presence of an anatomic weakness of the bladder neck, which typically maintains the seal of urine during activity. It can stem from a variety of situations (e.g., coughing) or conditions such as vaginal delivery, aging, estrogen deficiency associated with meno­pause, or obesity.6 Stress incontinence differs from urge incontinence in that it (1) is rarely associated with nocturia or an urge to urinate; (2) is precipitated by an activity such as coughing; and (3) often occurs at unexpected or inappropriate times.

Mixed incontinence is a combination of stress incontinence and urge incontinence. It is described as stress dominant or urge dominant. Its occurrence increases with aging.

Anita sits on the examination table at the NP’s office. Her complaints include (1) severe urgency to urinate when she arrives at home; (2) urinary frequency in the late morning; (3) nocturia: she needs to urinate 3-4 times a night, although she is thankful that she can usually go back to sleep; (4) urine leaking with position change when her bladder is full; and (5) feeling exhausted all the time. Anita indicates that she took hormone therapy years ago, but not recently. She reports vaginal dryness and long-standing constipation. She also reports that she takes cranberry pills because they are “good for the bladder.”

What does the workup for a patient with suspected OAB entail?

In its most recent guideline. the American Urological Association (AUA) lists these clinical diagnostic principles:

  • Minimum requirements are a careful history, physical examination, and urinalysis.
  • If deemed necessary, a urine culture and/or post-void residual assessment may be performed and information from bladder diaries and/or symptom questionnaires may be obtained.
  • Urodynamics, cystoscopy, and diagnostic renal and bladder ultrasound are not needed in the initial workup of a patient with an uncomplicated pre­sentation.9

History

The history includes a general health history and a focused history regarding lower urinary tract symptoms, including their onset, nature, duration, severity, and effect on quality of life.5 The HCP inquires about the presence or absence of diabetes, neurologic disorders, recurrent urinary tract infection, hematuria, kidney stones, previous lower abdominal or pelvic surgery, pelvic organ prolapse (POP), and vaginitis.10 In addition, the HCP asks the patient about her use of prescription and over-the-counter medications, particularly with regard to anticholinergics or antimuscarinics, antidepressants, antipsychotics, sedatives or hypnotics, diuretics, caffeine, alcohol, opioids, alpha-adrenergic blockers, alpha-adrenergic agonists, beta-adrenergic agonists, and calcium channel blockers.5 The HCP then poses screening questions specific to OAB:

  • Do you ever leak urine when you have a strong urge on the way to the bathroom? How often?
  • How frequently do you urinate during the day?
  • How many times do you get up to urinate after going to sleep? Is it the urge to urinate that wakes you?
  • How many pads a day do you wear for protection?
  • Does this problem inhibit any activity or prevent you from doing things you like to do?

Physical examination

A comprehensive physical examination for OAB includes a pulmonary and cardiovascular evaluation and neurologic, abdominal, pelvic, and rectal exams.9,10 The pelvic exam can reveal findings such as genitourinary syndrome of menopause (GSM; also known as urogenital atrophy, vulvovaginal atrophy, and atrophic vaginitis) or POP, which can cause or exacerbate urinary symptoms. Assessment of pelvic muscle tone is done by inserting 1 or 2 fingers 2 cm into the patient’s vagina, palpating at 5 and 7 o’clock, asking the patient to tighten her rectal muscles, comparing the contralateral sides, noting her muscle strength and endurance (i.e., her ability to hold for 10 seconds), monitoring for inappropriate use of accessory muscles (e.g., abdominal or gluteal muscles), and encouraging the patient to relax her abdominal muscles.

Bladder diary

If a patient answers affirmatively to any of the screening questions posed during the history, she is asked to complete a bladder diary that will be reviewed during a subsequent visit. This diagnostic tool shows a woman’s day-to-day bladder habits and voiding patterns. She is asked to document the time, type, and amount of fluid intake (the type of fluid can indicate whether she is ingesting bladder irritants), the time of each void, each accidental leaking, and a notation of the volume of urine loss in subjective terms: large (>¼ cup), medium (<¼ cup), or small (dribbles).
Readers can access a daily bladder diary from the National Institute of Diabetes and Digestive and Kidney Diseases.11 A 3-day bladder diary is ideal.5 To evaluate the data in the bladder diary, HCPs need to be familiar with normal voiding values, which are as follows:

  • Mean 24-hour urinary output (both men and women): 1,700 mL
  • Mean number of daily voids:
    6 to 7
  • Mean bladder capacity: 330 mL (individual patients vary considerably; 300-500 mL is considered the normal range).<supP12

Vaginal pH

Without estrogen, the pH of vaginal secretions changes and the normal discharge becomes more alkaline (usually above 4.5), which is due to a decrease in vaginal lactobacilli. These changes cause vaginal tissues to thin, which can have adverse implications for the urogenital tract. Vaginal pH (normal range, 3.5-4.5) can be easily and inexpensively measured in the office by collecting a sample from the upper lateral vaginal wall and using litmus paper for pH testing.

Anita’s bladder diary indicates that, despite her best intentions, she is ingesting a host of bladder irritants, including the aforementioned cranberry pills, orange juice, green tea, and lemon seltzer. She voids 11-12 times a day and 3-4 times a night, and feels the urge to void even after she has just emptied her bladder. The exam shows that Anita has weak pelvic muscle contractions, a grade 2 cystocele, and GSM related to long-term estrogen deficiency. Her urinalysis results are negative or normal and her vaginal pH is in the alkaline range.

How is OAB identified?

The condition is identified by the presence of urinary urgency and frequency, nocturia and, in more than one-third of cases, incontinence.

Based on findings from the workup, Anita’s NP concludes that she has OAB. In addition, Anita meets diagnostic criteria for mixed urinary incontinence, urge dominant; urinary frequency; pelvic floor muscle weakness; urogenital atrophy; and chronic constipation.

What are the goals of OAB treatment?

Treatment goals are individualized and may vary from symptomatic improvement to complete symptomatic relief of urgency, frequen­cy, nocturia, and urge incontinence. Asking patients with bladder control problems about their goals before treatment begins is useful in determining how aggressive the treatment should be.

At her initial appointment, although Anita is experiencing symptoms of both urge incontinence and stress incontinence, she reports that her most bothersome complaint is the nocturia. She states that she is tired all day as a result of awakening 3-4 times per night to urinate. She has even ceased participating in certain social activities because of her fatigue. When asked about her goals for treatment, Anita asserts that she does not want surgery or “anything invasive,” and that she would be delighted if she could get more sleep and was not always rushing to get to the bathroom. She and her HCP agree that the initial phase of treatment will focus on the urge aspect of her mixed incontinence symptoms.

What constitutes first-line treatment for OAB?

Many nonpharmacologic and pharmacologic approaches are available as first-line treatment for OAB.

Lifestyle changes

One of the simplest lifestyle changes is to avoid ingesting bladder irritants, many of which appear on the Carcio “C” List (Figure). Another easy approach is to manage fluid intake. The amount of fluid intake recommended depends on each patient’s body size, temperature, and physical activity level. In general, though, most women should aim to consume 4-8 cups of fluid (water plus all other liquids) a day. They should limit the amount of fluid ingested past 6 PM (or within 5 hours of the time when they plan to go to sleep). If they are excreting pale yellow urine, they are neither under-hydrating nor over-hydrating.

Figure

Pharmacotherapy

Two different classes of drugs, anticholinergics (antimuscarinics) and a beta-3 adrenergic agonist, are approved by the FDA for the treatment of OAB with symptoms of urge incontinence, urgency, and frequency (Table). The Sidebar lists pearls to prescribing these agents.
Anticholinergics work by blocking the effects of acetylcholine at muscarinic receptors in the bladder, thereby inhibiting involuntary detrusor contractions and reducing urgency.10 Side effects such as dry mouth, constipation, and blurred vision may be bothersome enough to prompt treatment discontinuation. Side effects are generally milder with extended-release formulations. Initiating the use of artificial saliva mouthwash and instituting measures to control constipation may enhance compliance with the regimen. All of the anticholinergics have similar efficacy in clinical trials; the key is finding a particular product that an individual patient can tolerate.
The beta-3 adrenergic agonist relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 adrenergic receptors, which increases bladder capacity.13 This agent can increase blood pressure.

Table

Other approaches to management

The AUA supports the use of behavioral therapies such as bladder training, bladder control strategies (e.g., urge suppression), pelvic floor muscle training (PFMT; also known as Kegel exercises), and fluid management as first-line therapy for all patients with OAB.9 Studies have suggested that PFMT, alone or combined with biofeedback training or electrical stimulation, may be effective for treating OAB.14-16 Avoidance of constipation, which can further weaken the pelvic floor as a result of chronic straining, is another strategy.17 Increasing the amount of dietary fiber to 30 g/day can help prevent constipation.
A vaginal pessary, a flexible device made of silicone indicated for the treatment of POP or stress urinary incontinence,17,18 can be used to treat symptoms of OAB. A retrospective parallel cohort study was conducted on women whose OAB was treated with a ring pessary or multi-component behavioral therapy (MCBT) over a 42-month period.19 The ring pessary and MCBT had similar cure rates (29 of 150 [19%] vs. 46 of 231 [20%], respectively; P = .889), regardless of whether women were premenopausal (4 of 31 [13%] vs. 14 of 68 [21%], P?=?.358) or postmenopausal (25 of 119 [21%] vs. 32 of 163 [20%]; P?=?.776). Pessaries are usually fitted by an HCP and require a prescription, but a new over-the-counter pessary is also available.
Vaginal estrogen, indicated for treatment of the symptoms of GSM, may help relieve symptoms of OAB. The epithelial linings of the vagina and urethra have the highest concentration of estrogen receptors in the body and are therefore highly sensitive to alterations in estrogen levels.20 The estradiol vaginal ring (Estring®), which works particularly well in older women, is changed every 3 months. It can be used in conjunction with a pessary, which is also changed every 3 months. Vaginal estrogen cream products include estradiol cream (Estrace® Cream) and conjugated equine estrogens cream (Premarin® Vaginal Cream), which are inserted with an applicator. These creams are considered messy by some women, but they do add lubrication. Estradiol vaginal tablets (Vagifem®), less messy than the creams, are a good choice for women with a stenotic introitus because of the smaller applicator.

Anita returns to the NP’s office after 3 weeks. She reports that she has modified her diet to decrease her intake of bladder irritants. She drinks an adequate amount of fluids each day but limits her fluid intake, with sips only, after 6 pm. She takes a daily medication to treat her OAB, and denies any dry mouth, constipation, or drowsiness. She uses a pessary, which she finds comfortable, and inserts an estradiol vaginal ring every 3 months. She takes a stool softener to reduce constipation. She has attended two pelvic floor rehabilitation sessions and does Kegel exercises at least twice daily, and she can now wait up to 2.5 hours in between voids. She needs to urinate only twice during the night and rarely experiences a leak with position changes. Although Anita wears a pad only when she goes out, for “insurance,” she really doesn’t need it any longer. As a result of this multifaceted therapeutic approach, her urinary urgency and frequency, nocturia, leaks, fatigue, and worries have all diminished.

Conclusion

Women’s healthcare providers can routinely screen their patients for symptoms of OAB. In those patients who screen positive and in whom other causes of the symptoms have been excluded, a tool such as a bladder diary can be used to identify OAB. HCPs can then educate patients about avoidance of bladder irritants and about techniques to strengthen their pelvic floor muscles. If these measures are unsuccessful, HCPs can prescribe an FDA-approved medication to further alleviate symptoms. In all cases, a treatment approach based on a woman’s own needs and goals is most likely to be successful.

References
1. Population Reference Bureau. Just How Many Baby Boomers Are There? April 2014. prb.org/Publications/
Articles/2002/JustHowManyBabyBoomersAreThere.aspx

2. Muller N. Anxiety and fears in women with overactive bladder. Ostomy Wound Manag. January 2013. .o-wm.com/files/owm/pdfs/OWM_January2013_Muller.pdf

3. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336.

4. Hartmann KE, McPheeters ML, Biller DH, et al. Treatment of overactive bladder in women. Evidence Report/Technology Assessment No. 187. 2009. ahrq.gov/clinic/tp/bladdertp.htm

5. Ellsworth PI. Overactive bladder. Medscape Drugs and Diseases. Updated April 25, 2014. emedicine.
medscape.com/article/459340-overview#aw2aab6b2b2

6. Brigham and Women’s Hospital website. Types of Incontinence and Risk Factors. Last modified on August 22, 2014. brighamandwomens.org/departments_and_services/obgyn/services/urogynecology/incontoverview.aspx

7. Carcio HA. Calming the overactive bladder: a nurse practitioner perspective. Womens Healthcare. 2014;
2(3):25-26, 49.

8. Tanagho EA, Bella AJ, Lue TF. Urinary incontinence. In: Tanagho EA, McAninch JW, eds. Smith’s General Urology. 17th ed. New York, NY: McGraw-Hill Medical. 2008:473-489.

9. Gormley EA, Lightner DJ, Burgio KL, et al; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012;188(6 suppl):2455-2463.

10. Association of Reproductive Health Professionals. Diagnosis and Management of Overactive Bladder. April 2011. arhp.org/Publications-and-Resources/Quick-Reference-Guide-for-Clinicians/OAB/Diagnosis

11. National Institute of Diabetes and Digestive and Kidney Diseases. Your Daily Bladder Diary. niddk.nih.gov/
health-information/health-topics/urologic-disease/daily-bladder-diary/Documents/diary_508.pdf

12. Parsons M, Amundsen CL, Cardozo L, et al. Bladder diary patterns in detrusor overactivity and urodynamic stress incontinence. Neurourol Urodyn. 2007;26(6):800-806.

13. Andersson KE, Martin N, Nitti V. Selective ?3-adrenoceptor agonists for the treatment of overactive bladder. J Urol. 2013;190(4):1173-1180.

14. Burgio KL. Update on behavioral and physical therapies for incontinence and overactive bladder: the role of pelvic floor muscle training. Curr Urol Rep. 2013;14(5):457-464.

15. Shamliyan TA, Kane RL, Wyman J, Wilt TJ. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008;148(6):459-473.

16. Liaw Y-M, Kuo H-C. Biofeedback pelvic floor muscle training for voiding dysfunction and overactive bladder. Incont Pelvic Floor Dysfunct. 2007;1:13-15.

17. Lukacz ES. Patient information: Urinary incontinence treatments for women (Beyond the Basics). UptoDate. Last updated May 11, 2015. uptodate.com/contents/urinary-incontinence-treatments-for-women-beyond-the-basics

18. Clemons JL. Vaginal pessary treatment of prolapse and incontinence. UptoDate. Last updated March 20, 2014. uptodate.com/contents/vaginal-pessary-treatment-of-prolapse-and-incontinence

19. Sze EH, Hobbs G. A retrospective comparison of ring pessary and multicomponent behavioral therapy in managing overactive bladder. Int Urogynecol J. 2014;25(11):1583-1588.

20. Brincat M, Muscat Baron Y, Galea R, Buhagiar A. Estrogen deficiency and connective tissues. In: Crosignani PG, Paoletti R, Sarrel PM, et al, eds. Women’s Health in Menopause: Behaviour, Cancer, Cardiovascular Disease, Hormone Replacement Therapy. Springer Science+Business Media Dordrecht; 1994.

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PrEP for prevention: Practice update

PDF 50

By Lorraine Byrnes, PhD, FNP-BC, PMHNP-BC

According to the Centers for Disease Control and Prevention (CDC), about 1.2 million persons are living with HIV in the United States, and about 20% of them are unaware of it.1 Lack of awareness of HIV status contributes to viral transmission. Healthcare providers (HCPs) play a vital role in the screening, diagnosis, and treatment of HIV infection, but they can also play an important role in HIV prevention. This article focuses on pre-exposure prophylaxis (PrEP), a safe and effective intervention that is rapidly becoming a major tool in HIV transmission prevention. The article also provides an overview of the assessment and management of patients prior to and during the use of PrEP.

The CDC estimates that 50,000 persons in the United States are newly infected with HIV every year.1 Most of the new cases involve men who have sex with men (MSM) (n = 30,689), but African-American women represent a disproportionate number of new infections (n = 5,300) when compared with white non-Hispanic women (n = 1,300) and Hispanic/Latina women (1,200).2

The birth rate among HIV-infected women has increased from 6,000-7,000 live births in 2000 to 8,700 live births in 2006, the last year reported.3 This increase in births may be related to the increased availability and use of antiretroviral medications, which significantly decrease mother-to-child transmission risk. Other factors are also in play. Study data suggest that women who are HIV positive and desire children, including those who disclose their seropositive status to their partners, may not be using condoms consistently.4,5 Little is known about birth rates in women who are HIV negative, desire children, and are in a relationship with an HIV-positive partner.

Pre exposure prophylaxis is the most recent intervention in the effort to fight the HIV epidemic. PrEP is a combination of two antiretrovirals, tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine (FTC) 200 mg, taken once daily. This treatment has been shown to reduce transmission risk by upwards of 92%.6 PrEP is available to adult men and women who are HIV negative but have an increased risk of exposure to HIV through sexual and/or injection drug use. PrEP is not approved for use in children or adolescents. Guidelines for PrEP were released in 2014 by the U.S. Public Health Service.<sup.6

Assessment

Health history
To identify and reduce their patients’ risk for contracting HIV infection, HCPs need to take a sexual history as part of primary care and specialty care services. Studies have shown that many HCPs do not ask about risky sexual behaviors and many patients do not disclose them.4,5,7 Assessment of patients’ sexual behaviors and their potential contribution to HIV risk should be part of every healthcare encounter. The 5 P’s of sexual health—partners, practices, protection from sexually transmitted infections (STIs), past history of STIs, and prevention of pregnancy—provide a framework to assess each patient.8

Many patients are not comfortable talking about their sexual practices, partners, and history. HCPs can facilitate this discussion by informing patients that they routinely take a sexual history so that they can provide appropriate sexual health care, and that all information provided is confidential. HCPs can begin by asking these questions, as recommended in the 2014 PrEP guidelines.6 In the past 6 months:

  • Have you had sex with men, women, or both?
  • How many men/women have you had sex with?
  • How many times did you have vaginal or anal sex when neither you nor your partner wore a condom?
  • How many of your sex partners were HIV-positive?
  • If you did have sex with HIV-positive partners, how many times did you have vaginal or anal sex without a condom?
  • Do you have sex with partners who do not know their HIV status?

Next, HCPs need to inquire about any past history of STIs, treatment, past or current symptoms, their partner(s)’ history of STIs, and whether they would like to be tested for HIV during this healthcare encounter. In addition, HCPs can ask patients if they have ever injected drugs not prescribed by their HCP. If the answer is yes, patients are asked whether they have shared injection or drug preparation equipment or been in a drug treatment program in the past 6 months.

If this assessment suggests that a given patient is at high risk for HIV infection, the HCP initiates a discussion about PrEP. Adult MSM who do not have acute or established HIV infection and are not in a monogamous relationship with a recently tested HIV-negative man are potential candidates if they have had anal sex with a male (receptive or insertive) without a condom and/or have had an STI diagnosed in the past 6 months. Adult men and women who are heterosexually or bisexually active who do not have acute or established HIV infection and are not in a monogamous relationship with a recently tested HIV-negative partner are potential candidates if they infrequently use condoms during sex with partner(s) of unknown HIV status who are at substantial risk for HIV infection. Any individual who is HIV negative and in an ongoing sexual relationship with an HIV-positive partner is a potential candidate. In addition, individuals who have used illicit injection drugs in the past 6 months that included sharing injection and drug preparation equipment or who have been in a drug treatment program in the past 6 months are potential candidates. If a patient found to be a potential candidate is interested in PrEP, then further evaluation is needed to determine whether this intervention is appropriate for him or her.

Physical examination and lab screening/testing
No specific physical examination is required prior to initiation of PrEP. However, HCPs should recognize and further investigate fever, rash, and cervical adenopathy as potential clinical signs of acute HIV infection. These findings are especially relevant if a patient reports having experienced viral infection symptoms such as fatigue, myalgia, headache, night sweats, and diarrhea in the prior 4 weeks.

Laboratory tests for prospective PrEP recipients include HIV testing, hepatitis B virus (HBV) screening, and renal function tests. HIV testing is done within 1 week of initiating PrEP. If the test result is positive, PrEP is not initiated because it does not provide adequate therapy for HIV; in addition, there is some concern about the development of drug resistance. If the test result is indeterminate, PrEP initiation is postponed until further testing determines HIV status.

Both TDF and FTC suppress replication of HBV as well as HIV, so the PrEP intervention may offer an additional benefit if a patient has active HBV infection. Reactivation of HBV infection may occur if PrEP is discontinued or taken inconsistently. If screening indicates that a patient is not infected by HBV or immune to it, HBV vaccination is recommended. Patients who have significantly reduced renal function should not take PrEP.

Pregnancy testing is done if indicated. Although data regarding the use of TDF/FTC in terms of fetal health and growth are limited, the FDA has approved PrEP use during pregnancy. No evidence exists of harm to fetuses exposed to TDF or FTC when used for treatment of HIV during pregnancy.6

Management

PrEP must be taken on a consistent basis for maximum prevention benefit. PrEP is safe and effective but may cause a loss of appetite, mild gastric upset, or mild headaches initially. HCPs need to counsel patients about these side effects and inform them about over-the-counter drugs that may lessen these effects. Patients are asked to contact their HCP if the side effects do not subside. PrEP reaches maximum intracellular concentrations in about 20 days; therefore, patients should be advised that effectiveness is not immediate.

All other medications that patients are taking should be reviewed. Drug interaction data are available for TDF, but not for FTC. TDF has no significant effect on oral contraceptive hormone levels. Serum concentrations of some drugs (e.g., acyclovir, valacyclovir, aminoglycosides) or of TDF may be increased when these agents are combined.6

Regardless of whether or not a patient decides to take PrEP, HCPs and patients need to discuss other ways to reduce HIV infection risk (e.g., limiting the number of sexual partners, always using a condom). For some individuals, multi-session behavioral counseling may be required. Women who have the potential to become pregnant should receive counseling and provision of contraception if they do not want to become pregnant, and pre-conception counseling if they are considering a pregnancy. Patients who report substance abuse should receive referrals for appropriate treatment.

Patients should receive information on the signs and symptoms of acute HIV infection and should be advised to contact their HCP if these occur. In addition, those patients who are taking PrEP need to know that they should not discontinue the regimen without first discussing it with their HCP.

Patients taking PrEP are seen for follow-up at least every 3 months. At these visits, HCPs need to assess them for side effects, medication adherence, and HIV risk behaviors, as well as for signs and symptoms of acute HIV infection. HIV testing is repeated at each follow-up visit. A pregnancy test is performed for women who could become pregnant, and STI tests are done as indicated. Renal function tests are conducted every 6 months.

These follow-up visits provide an important opportunity to reinforce the need for consistent medication use and to support HIV risk-reduction behaviors. Discussion about continuing PrEP should take into account personal preference, change in risk profile, and ability to adhere to the daily dosing regimen. PrEP must be discontinued if a patient’s HIV test result is positive or if renal function is significantly impaired.

Conclusion

PrEP is a safe and effective pharmacologic intervention for women and men at high risk for HIV infection. HCPs have the opportunity to improve the lives of their patients and provide preventive care in the fight against HIV.

Lorraine Byrnes is Associate Professor at Hunter Bellevue School of Nursing, Hunter College, City University of New York, in New York City. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

Resources

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References
1. Centers for Disease Control and Prevention. CDC Vital Signs: New Hope for Stopping HIV. 2011. cdc.gov/vitalsigns/HIVtesting/index.html

2. Centers for Disease Control and Prevention. Fact Sheets: HIV/AIDS. 2013. cdc.gov/hiv/library/factsheets/index.html

3. Centers for Disease Control and Prevention. HIV among Pregnant Women, Infants, and Children. 2015. cdc.gov/hiv/
group/gender/pregnantwomen/index.html

4. Sanders LB. Sexual behaviors and practices of women living with HIV in relation to pregnancy. J Assoc Nurses AIDS Care. 2009;20(1):62-68.

5. Sullivan K, Voss J, Li D. Female disclosure of HIV-positive serostatus to sex partners: a two-city study. Womens Health. 2010;50(6):506-526.

6. Centers for Disease Control and Prevention. Pre-Exposure Prophylaxis (PrEP). 2015. cdc.gov/hiv/prevention/
research/prep

7. Bernstein KT, Liu KL, Begier EM, et al. Same sex attraction disclosure to health care providers among New York City men who have sex with men: implications for HIV testing approaches. Arch Intern Med. 2008;168(13):1458-1464.

8. Centers for Disease Control and Prevention. A Guide to Taking a Sexual History. cdc.gov/STD/treatment/
SexualHistory.pdf

From practice to policy: The WHNP as advocate

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By Susan Kendig, JD, MSN, WHNP-BC, FAANP

As most of our readers know, the National Association of Nurse Practitioners in Women’s Health (NPWH) and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) released the 7th edition of the Women’s Health Nurse Practitioner: Guidelines for Practice and Education in December 2014. Many women’s health nurse practitioners (WHNPs) use this document to outline their clinical competencies, and faculty use it as a framework in developing WHNP program curricula. But the guidelines go beyond describing clinical practice components and educational requirements; they also include policy and advocacy competencies. In particular, the guidelines enumerate participating in legislative/policy-making activities that influence women’s health and serving as “a consultant and trusted source of information on women’s health for healthcare systems and policy-makers” as key WHNP leadership competencies.1

As core WHNP competencies, policy and advocacy align well with NPWH’s mission and values. NPWH’s mission is to “ensure the provision of quality primary and specialty healthcare to women of all ages by women’s health and women’s health-focused nurse practitioners.” This mission includes protecting and promoting a woman’s right to make her own choices regarding her health within the context of her personal, religious, cultural, and family beliefs. As a professional membership organization, NPWH strives to continuously improve access and quality of healthcare for women through excellence and innovation in continuing education and professional development; to demonstrate leadership in policy, practice, and research; and to provide support and services for our members. These policy-related values are key to achieving our mission:

  • To advocate for healthcare policies that support women and advanced practice registered nurses (APRNs) who care for them; and,
  • To collaborate with strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.2

How do these competencies affect clinical practice?

So, what does all of this mean in the real world of clinical practice? As most of our readers witness every day, policy decisions related to everything from reimbursement for healthcare service delivery to state-based APRN scope of practice regulations to decisions regarding availability of services, medications, or new technologies can affect women’s health—and the realization of NPWH’s mission. The following discussion provides just a few examples.

The Patient Protection and Affordable Care Act seeks to increase access to affordable health insurance, with the ultimate goal of increasing access to healthcare. One way that it does this is by providing a mechanism for federally supported Medicaid expansion to cover most low-income adults (i.e., those earning up to 138% of the federal poverty level). Yet, to date, approximately 20 states have not expanded Medicaid to this level of coverage.3 Most states provide Medicaid coverage during pregnancy; however, in non–Medicaid-expansion states, this coverage stops shortly after delivery. Although coverage of prenatal care facilitates a favorable pregnancy outcome, lack of coverage for care needed before and between pregnancies can have devastating effects on women and their children.

Consider the reproductive-aged woman with type 1 diabetes mellitus (T1DM). Diabetes in pregnancy can adversely affect both maternal and infant outcomes. Women with T1DM have higher rates of maternal mortality and morbidity, including increased rates of pre-eclampsia and cesarean section. Likewise, maternal T1DM increases the risks for fetal and neonatal loss, congenital anomalies, macrosomia, and a host of other neonatal complications. A patient with T1DM who qualifies for Medicaid during pregnancy but loses coverage soon after delivery will not have access to care for her chronic disease prior to her next pregnancy. This gap in care can allow her T1DM to spiral out of control, contributing to increased maternal and infant health problems or even death during subsequent pregnancies.4

In June 2015, the House Labor, Health and Human Services (LHHS) Subcommittee marked up its fiscal year 2016 spending bill, which contained a complete elimination of Title X. The following week, the Senate released a funding bill proposing $257.8 million for Title X, a decrease from the prior year’s $286.5 million budget.5 By the time this article goes to press, we should know how the Title X program fares in the 2016 budget. It is estimated that publicly funded healthcare providers, such as those funded through Title X, met an estimated 42% of the need for publicly supported contraceptive services and supplies in 2013.6 Cuts to, or elimination of, the Title X program would effectively bar many of these women from accessing similar services in the future. In the case of the patient with T1DM discussed earlier who has already lost access to care for her chronic disease, she will also lose family planning services, which may contribute to a shortened pregnancy interval and may increase the potential for a poor pregnancy outcome. Furthermore, because Title X clinics are staffed primarily by NPs, cuts to Title X could decrease women’s access to quality care by WHNPs and other NPs who provide family planning services.

Professional competencies plus organizational values in action

Although many of our readers in clinical practice may have little time to “participate in legislative and policy-making activities that influence women’s health” in the traditional sense, they are our greatest asset in terms of bringing women’s stories to the forefront. NPWH staff keep our fingers on the pulses of policy-makers with power to make decisions about how, where, and from whom each woman can access care that is “within the context of her personal, religious, cultural, and family beliefs,” but our organization’s members provide the stories that give life to the policy. It is through our organization’s members that we at NPWH learn about the challenges that women face in accessing woman-centric care to meet their needs, as well as the barriers faced by WHNPs in attempting to provide that care.

Conclusion

In keeping with the NPWH/AWHONN guidelines, WHNPs possess the leadership competencies to serve as trusted sources of information on women’s health. As NPWH Policy Director, I invite all of our readers to collaborate with NPWH as “strategic partners to enhance the effectiveness and timeliness of our efforts in the policy arena.” Please contact me at skendig@npwh.org to share your stories about policy issues affecting your practice and your patient population at the local, state, or national level. In this way, we can work together to become a collective voice for the women we serve in moving the policy needle to a place that supports women’s full access to the care that they need delivered by the providers they choose.

Susan Kendig is a teaching professor and WHNP Emphasis Area Coordinator at the University of Missouri-St. Louis; a consultant at Health Policy Advantage, LLC, in St. Louis, Missouri; and Director of Policy for the National Association of Nurse Practitioners in Women’s Health (NPWH).

References

  1. National Association of Nurse Practitioners in Women’s Health/Association of Women’s Health, Obstetric and Neonatal Nurses. Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th Edition. Washington, DC: NPWH/AWHONN; 2014.
  2. NPWH. Mission, Vision, and Values. Mission. 2015. https://www.npwh.org/pages/about
  3. Kaiser Family Foundation. Current Status of State Medicaid Expansion Decisions. July 20, 2015. http://kff.org/health-reform/slide/current-status-of-the-medicaid-expansion-decision/
  4. Negrato CA, Mattar R, Gomes MB. Adverse pregnancy outcomes in women with diabetes. Diabetol Metab Syndr. 2012;4(1):41.
  5. National Family Planning & Reproductive Health Association. Title X: Budget & Appropriations. http://www.nationalfamilyplanning.org/title-x_budget-appropriations
  6. Frost JJ, Frohwirth L, Zolna MR. Contraceptive Needs and Services, 2013 Update. Washington, DC: Guttmacher Institute; July 2015. www.guttmacher.org/pubs/win/contraceptive-needs-2013.pdf

Will the first medication to treat low sexual desire in women be approved?

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By Susan Rawlins, RN, MS, WHNP-BC

Female sexual dysfunction (FSD) affects an estimated 43% of women in the United States.1 FSDs include impaired sexual interest/arousal disorder, sexual pain disorder, and orgasmic disorder. But the most common FSD by far is hypoactive sexual desire disorder (HSDD), reported by as many as 1 in 10 women.2 HSDD can be definitively diagnosed with reliable and validated screening tools.3 Women’s healthcare providers are on the front line in terms of caring for women with HSDD, but we lack FDA-approved options to provide relief for them.

But now there is hope. As the August 2015 issue of Women’s Healthcare: A Clinical Journal for NPs goes to press, the FDA will have made its decision regarding whether to approve flibanserin for the treatment of HSDD in premenopausal women. Flibanserin, a non-hormonal drug, is thought to work by correcting an imbalance in the levels of neurotransmitters in the brain that affect sexual desire.4 More specifically, flibanserin increases dopamine and norepinephrine, both of which drive sexual excitement, and transiently decreases serotonin, which drives sexual satiety/inhibition.

Two months ago, an FDA advisory committee voted to recommend approval of flibanserin to treat HSDD in premenopausal women. Although the FDA is not required to accept the advisory committee’s recommendation, the agency agreed to consider it as part of the new drug application review. Readers can check www.npwh.org for the latest information on the FDA decision.

During the open comment portion of the hearing prior to this vote, Gay Johnson, CEO of NPWH, spoke on behalf of the association and in support of both women with HSDD and the providers who struggle to treat these women every day. In her statement, Ms. Johnson said, “Women’s sexual health is complex and multidimensional and often overlooked in primary care because of many factors, including cultural conditioning of women and providers. Historically, women’s sexuality has been viewed as something tied to the obligation to have sexual relations for reproduction, but not the desire to have sexual relations to achieve personal pleasure. Thankfully, now, in the 21st century, women’s sexual health is seen as a valid component of overall wellness. Women’s sexual dysfunction is now recognized as a real health condition, of real women, that decreases quality of life and negatively impacts relationships.”

Ms. Johnson clarified that NPWH is not advocating for the approval of any specific drug. She stated, “Each HSDD medical treatment option should receive fair consideration and the side effect/adverse event profile evaluated while considering the significant impact of the condition. Women are intelligent, insightful decision makers and can be trusted to evaluate the risks of side effects/adverse events and the benefits of any treatment according to the impact of HSDD on their personal lives and relationships.”

In both its educational and advocacy endeavors, NPWH supports nurse practitioners in providing high-quality healthcare for women, which includes addressing their sexual health concerns. Our Women’s Sexual Health Course for NPs, offered for the first time in June 2014 and again in June 2015, has been extremely well received, filling to capacity several weeks ahead of time and garnering positive feedback from participants. Women’s Healthcare, our journal, includes a Focus on Sexual Health department article in each issue, and our annual conference always includes courses on sexual health topics. Our advocacy work is ever-present as we actively support evidence-based treatments for all FSDs.

As such, we applaud the FDA’s recognition of HSDD as a health problem that merits pharmacologic treatment and we encourage the FDA to consider approval of medications that have demonstrated efficacy and safety in treating women’s most common sexual complaint.

Susan Rawlins is Director of Education for the National Association of Nurse Practitioners in Women’s Health and a women’s health nurse practitioner at the Greater Texoma Health Clinic in Denison, Texas. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281(6):537-544.

2. Parish SJ, Rubio-Aurioles E. Education in sexual medicine: proceedings from the International Consultation in Sexual Medicine, 2009. J Sex Med. 2010;7(10):3305-3314.

3. Kingsberg SA, Woodard T. Female sexual dysfunction: focus on low desire. Obstet Gynecol. 2015;125(2):477-486.

4. Sprout Pharmaceuticals, Inc. FDA Advisory Committee Recommends Approval for Sprout Pharmaceuticals’ ADDYI™ (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women. June 5, 2015. http://www.sproutpharma.com/news-center/

Assessment, diagnosis, and management of headache

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By Janis R. Guilbeau, DNP, FNP-BC and Christy M. Lenahan, DNP, MSN, FNP-BC

 

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Healthcare providers caring for women can use advanced clinical skills in assessment and accurate diagnosis of headaches. Accurate diagnosis is imperative in providing effective management and making appropriate referrals. The overall goal is to make the correct diagnosis, adequately treat the headaches, and minimize the frequency and severity of headaches in the future.

About 45 million individuals in the United States complain of headaches to their healthcare provider (HCP), accounting for nearly 8 million clinical visits per year.1 The female preponderance of headaches emerges at puberty, with females, relative to males, having a 1.5-fold greater risk of headaches and 1.7-fold greater risk of migraine.2 The most common primary headaches are migraine, tension, cluster, and chronic daily headache.3 Secondary headaches are symptoms of diseases or conditions that can be relatively minor (e.g., sinusitis) or quite serious or even life threatening (e.g., meningitis, brain tumor, cerebral aneurysm, head trauma).3 HCPs must use keen skills to evaluate each woman’s symptoms, formulate a diagnosis, and devise a management plan.

Assessment

Health history

A complete history is key in making the diagnosis. Although symptoms of various types of headache may overlap, a detailed history helps the HCP determine whether a secondary cause needs to be further investigated or if the symptoms fit with one of the primary headache types. The HCP needs to ask the patient about the following3-5:

  • onset, location, frequency, duration, severity, and character (e.g., throbbing versus constant) of the headache(s);
  • existence of any aura or prodrome;
  • any association between the headaches and sleep patterns, emotional factors, or food or alcohol intake;
  • any associated symptoms with the headache;
  • precipitating and alleviating factors;
  • a family history of headache;
  • any changes in vision;
  • any history of trauma;
  • any relationship between the headaches and the menstrual cycle or a change in the method of birth control;
  • use of illicit drugs including cocaine and methamphetamine; and
  • current medications, including aspirin, nonster­oidal anti-inflammatory drugs (NSAIDs), anticoagulants, and glucocorticoids.

Answers to these questions will enable the HCP to rule out certain types of headaches.3-5

Red flags in the history require that further evaluation be done for secondary causes. Sudden onset of a severe, intractable headache may suggest an intracranial disorder such as subarachnoid hemorrhage or meningitis.3 Severe headache triggered by sexual intercourse, cough, or exertion may be caused by an intracranial mass or subarachnoid hemorrhage.5 New onset of headaches in persons older than 50, new onset of severe headaches during pregnancy or postpartum, or new headache types in patients with cancer or immunosuppression are of particular concern.3,5 Any headache described as the “worst headache ever” requires immediate attention.

Physical examination

Physical examination of a patient presenting with a chief complaint of headache includes a general survey, vital signs, focused assessment of the head and neck, and a full neurologic exam.5-7 The focused exam begins in a systematic manner starting with the scalp, which is assessed for swelling and tenderness. The temporal arteries are palpated. Nodularity, tenderness, and a diminished or absent pulse on one side are considered abnormal findings consistent with temporal arteritis.5,7,8

Next, the HCP assesses the temporomandibular joint for tenderness or crepitance,6,7 the eyes for lacrimation and conjunctival injection, and the periorbital area for eyelid swelling, ptosis, or miosis.5,6,9 Visual acuity, extra-ocular movements, visual fields, and pupillary size and response to light are checked for abnormalities and fundi are assessed with an ophthalmoscope for presence of spontaneous venous pulsations and/or papilledema.5-7 The nares are assessed for purulence, the sinuses palpated for tenderness, and the oropharynx examined for presence of purulence, erythema, and swelling.10 Assessment includes percussion of dentition for presence of tenderness.6 The HCP examines the patient’s neck utilizing flexion (unless contraindicated) to assess for discomfort and/or stiffness,6 and listens for bruits in the neck, which may suggest arteriovenous malformation.3 The cervical spine is palpated to assess for tenderness.6

Red flags in the physical examination include, but are not limited to, fever, weight loss, altered mental status, weakness, papilledema, focal neurologic deficits, proximal artery tenderness, and meningismus.6 All pertinent negative and positive physical exam findings, along with history findings, help the HCP further differentiate between primary and secondary headaches.

Diagnosis and treatment

Because of overlapping symptomatology among the different headache types, the diagnosis of a particular headache type can be challenging. In addition, the HCP must discern between a primary headache, which, although painful, is usually not harmful, and a secondary headache such as subarachnoid hemorrhage or transient ischemic attack, which could lead to a stroke.1Migraine

Migraines present as severe, disabling, unilateral headaches often described as pulsating in nature.11 Symptoms may worsen with routine physical activity. Sensitivity to light, sound, and smells is often present, as are nausea and stiff neck.11 Some migraineurs describe having prodromal symptoms (e.g., drowsiness, restlessness, decreased concentration, gastrointestinal upset) that may last for hours to days before the migraine.7 Twenty percent to 30% of migraineurs experience an aura. Aura consists of fully reversible visual, sensory, or speech disturbances that develop gradually before the headache and that last no longer than 60 minutes.7,11 Despite all these symptoms, neurologic examination findings in patients with migraine headache are negative or normal.

Migraines are 2-3 times more common in women than in men and vary in severity.11 In females, prevalence of migraines diminishes after age 50 or after menopause unless estrogen replacement therapy is used.11
Treatment for migraine is either abortive, halting an existing headache, or preventive, lessening the frequency and severity of the headaches. First-line abortive therapy for mild to moderate, non-disabling migraine includes simple analgesics, combination analgesics, and NSAIDs.7,12 Metoclopramide may be added for nausea relief and may promote absorption of oral pain medications.7 Abortive therapy for moderate to severe headaches and those not relieved by analgesics may include drugs that affect serotonin, including the triptans (oral, intranasal, subcutaneous), combination triptan/NSAIDs, ergotamine tartrate, dihydroergotamine, and acetaminophen-isometheptene-dichlor­alphen­a­zone.7,12,13 A weak opioid analgesic such as a butalbital compound or acetaminophen-codeine may be tried if the aforementioned agents are ineffective.12,13

Prevention includes elimination or reduction of identified triggers (e.g., aged cheeses, red wine, monosodium glutamate, artificial sweeteners, caffeine overuse or withdrawal, too much or too little sleep).7 Pharmacologic prophylaxis is considered when migraineurs have more than one headache per week.7,12,13 Drug classes that have proved useful in preventive therapy include beta blockers, calcium channel blockers (CCBs), antidepressants, anti-seizure medications, and some antihistamines.7,12,13Cluster headache

Cluster headaches usually occur at night and are severe and unilateral.14 Although cluster headaches have been found to be 6 times more prevalent in males than in females, more and more women—typically between ages 20 and 40—are being diagnosed with this condition.14,15 Cluster headaches are frequently misdiagnosed as migraine, sinusitis, or allergies.5 The patient may describe sharp, unilateral orbital, supraorbital, or temporal pain accompanied by autonomic symptoms on the affected side (e.g., teary eye, nasal congestion or runny nose, ptosis, eyelid swelling, conjunctival injection).1,7,9,14 Unlike migraineurs, who prefer to remain at rest in a dark room, patients with cluster headache tend to be restless.14

Episodes may last 15-180 minutes, and may occur once every other day to as often as 8 times daily.7,9,14 These headaches typically occur daily for several weeks, followed by a period of remission.7,9 Treatment entails alleviating pain at the onset of the attack and instituting preventive strategies such as smoking and alcohol cessation.16 Following onset of an acute attack, oxygen therapy and sumatriptan injection have been found to be the most effective treatment modalities.16 The CCB verapamil can be started at the beginning of a cluster headache, continued until the patient is headache-free for at least 7-14 days, and then slowly tapered and discontinued.7,9Tension headache

Tension headaches can be episodic (usually associated with a stressful event) or chronic (usually associated with muscular contraction in the neck and scalp).17 Definitive diagnosis includes two of these traits: pressing or tightening pain; occipitofrontal location; bilateral pain, with mild to moderate intensity; and lack of effect of physical activity.17 These head­aches are typically self-limiting and non-debilitating and have no associated symptoms. Physical exam findings are normal. Relief is generally achieved with acetaminophen or NSAIDs.7,12 Treatment modalities for chronic tension headache include lifestyle modifications such as regular exercise, stretching, stress management, relaxation techniques, and adequate sleep. Other treatments include use of hot or cold packs, ultrasound, improvement of posture, trigger point injections, and occipital nerve blocks.7,17Chronic daily headache

This type of headache occurs on 15 or more days per month for at least 3 months and is typically related to medication overuse, although it may represent chronic (transformed) migraine.12,18,19 Medication overuse headache results from taking acute headache medication for 2-3 days per week.12,18 Treatment for chronic daily headache includes preventive medications to decrease reliance on acute medications, and assistance with withdrawal symptoms such as nausea, vomiting, and restlessness.18 Transformed migraine is a constant (24-hour) headache with intermittent, superimposed migraine symptoms.19 As many as 80% of patients with transformed migraine have coexisting depression; treatment focuses on counseling and biofeedback in addition to medication needed to treat depression.19

“Choosing Wisely” initiative

With regard to headache assessment, diagnosis, and management, the American Headache Society endorses the “Choosing Wisely” initiative.20 The initiative lists five suggestions:

  • Avoid neuroimaging studies in patients with stable headaches that meet criteria for migraine.
  • When indicated, magnetic resonance imaging is preferred over computed tomography except in emergency settings when hemorrhage, acute stroke, or head trauma is suspected.
  • Do not recommend surgical deactivation of migraine trigger points outside of a clinical trial.
  • Do not prescribe opioid- or butalbital-containing medications as first-line treatment for recurrent headache disorders.
  • Do not prescribe frequent or long-term use of over-the-counter medications for headache.

Conclusion

Headaches are common occurrences in women; skilled HCPs are positioned to assess, diagnose, treat, and prevent headaches in these individuals. Familiarity with various types of headaches and their causes, appropriate treatment modalities, and preventive strategies can assist HCPs in management of women presenting with headache.

Janis R. Guilbeau and Christy M. Lenahan are Assistant Professors at the University of Louisiana at Lafayette. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Winland-Brown JE, Keller MB. Neurological problems. In: Dunphy LM, Winland-Brown JE, Porter BO, Thomas DJ. Primary Care: Art and Science of Advanced Practice Nursing. 4th ed. Philadelphia, PA: F.A. Davis; 2015:77-148.

2. International Association for the Study of Pain. Epidemiology of Headache. 2011. www.iasp-pain.org/files/
Content/ContentFolders/GlobalYearAgainstPain2/HeadacheFactSheets/1-Epidemiology.pdf

3. Bautista C, Grossman S. Somatosensory function, pain, and headache. In: Grossman SC, Porth CM. Porth’s Pathophysiology: Concepts of Altered Health States. 9th ed. Philadelphia, PA: Wolters Kluwer; 2014:422-451.

4. Bajwa ZH, Wootton RJ. Evaluation of headache in adults. UpToDate. December 10, 2014. www.upto
date.com/contents/evaluation-of-headache-in-adults

5. Hainer BL, Matheson EM. Approach to acute head­ache in adults. Am Fam Physician. 2013;87(10):682-687.

6. Silberstein SD. Approach to the patient with head­ache. Merck Manual. April 2014. www.merckmanuals
.com/professional/neurologic-disorders/headache/approach-to-the-patient-with-headache

7. Hale N, Paauw DS. Diagnosis and treatment of headache in the ambulatory setting: a review of classic presentations and new considerations in diagnosis and management. Med Clin North Am. 2014;98(3):505-527.

8. Docken WP, Rosenbaum JT. Clinical manifestations of giant cell (temporal) arteritis. UpToDate. March 18, 2015. www.uptodate.com/contents/clinical-manifestations-of-giant-cell-temporal-arteritis

9. Weaver-Agostoni J. Cluster headache. Am Fam Physician. 2013;88(2):122-128.

10. Brook I. Chronic sinusitis clinical presentation. Medscape. April 7, 2014. http://emedicine.medscape.com/
article/232791-clinical

11. International Association for the Study of Pain. Migraine. 2011. www.iasp-pain.org/files/Content/
ContentFolders/GlobalYearAgainstPain2/HeadacheFactSheets/2-Migraine.pdf

12. Freitag FG, Schloemer F. Medical management of adult headache. Otolaryngol Clin North Am. 2014;
47(2):221-237.

13. Cunha JP. Migraine headache. Emedicine Health. March 16, 2015. www.emedicinehealth.com/migraine_
headache/article_em.htm

14. American Headache Society Committee on Headache Education. Cluster Headache and Other Medical Conditions. 2011. www.achenet.org/resources/cluster_headache_and_other_medical_conditions/

15. Cleveland Clinic Foundation. Diseases & Conditions: Cluster Headaches. 2014. http://my.clevelandclinic.org/
health/diseases_conditions/hic_Cluster_Headaches

16. Simon H. Headaches – cluster. University of Maryland Medical Center. September 18, 2013. http://umm.edu/
health/medical/reports/articles/headaches-cluster

17. Blanda M. Tension headache clinical presentation. Medscape. October 1, 2014. http://emedicine.medscape
.com/article/792384-clinical

18. Silberstein SD. American Headache Society. Medication Overuse Headache. www.americanheadache
society.org/assets/1/7/Stephen_Silberstein_-_Medication_Overuse_Headache.pdf

19. National Headache Foundation. Transformed Migraine. 2015. http://www.headaches.org/2007/10/25/
transformed-migraine-more-commonly-known-as-chronic-migraine/

20. Loder E, Weizenbaum E, Frishberg B, Silberstein S; American Headache Society Choosing Wisely Task Force. Choosing wisely in headache medicine: the American Headache Society’s list of five things physicians and patients should question. Headache. 2013;53(10):1651-1659.

CONTINUING EDUCATION: Assessment and management of patients with obesity

PDF 50By Mary Annette Hess, PhD, FNP-BC, CNS and W. Timothy Garvey, MD, FACE

Before reading the article, click here to take the pretest.

Obesity is a disease, not a condition resulting from ill-advised behavioral choices.1 After all, obesity meets the essential criteria of a disease: It has characteristic signs or symptoms; it manifests as an impairment in the normal functioning of some aspect of the body; and it results in harm or morbidity. As such, healthcare providers (HCPs) need to identify obesity in their patients, assess each patient’s risk for obesity-related complications, begin the weight-loss discussion in a thoughtful and constructive manner, and institute an individualized management plan.

Key words: obesity, risk assessment, obesity-related complications, dietary changes, weight-loss medications

Definitions and prevalence

Obesity can be defined as a body mass index (BMI) ?30 kg/m2 or it can be suggested by a waist circumference (WC) >35 inches (in women).2 But obesity is more than just a calculation or a measurement; it is a primary disease entity that can lead to cardiometabolic, biomechanical, and other complications (Figure 1).3,4CNER_Figure 1

 

 

 

 

 

 

 

 

 

 

 

 

Here is a number that matters: Almost 80 million U.S. adults—almost 35% of the adult population in this country—meet criteria for obesity,5 with certain geographic areas and certain ethnic groups overrepresented. Prevalence of obesity is higher in southern states and some Midwestern states than in other parts of the country,6 as illustrated by this CDC map. Non-Hispanic blacks have the highest age-adjusted rate of obesity (47.8%), followed by Hispanics (42.5%), non-Hispanic whites (32.6%), and non-Hispanic Asians (10.8%).5 Although overall obesity prevalence is similar in women and men at any given age, women have a higher prevalence of class II obesity (BMI, 35.0-39.9) and class III obesity (BMI ?40).7

Risk assessment

Given the high prevalence of obesity, HCPs will likely encounter many patients in their practices who are candidates for weight management. In each case in which obesity is identified, the first step needed is to assess the patient’s risk for obesity-related complications. This assessment includes calculating BMI, measuring WC, and screening for the presence of cardiovascular disease (CVD) risk factors and co-morbidities.8 Compared with body weight alone, BMI is a better, albeit indirect, measure of adiposity, which is associated with a host of cardiometabolic abnormalities. WC, an indicator of abdominal adiposity, should be measured in patients with a BMI ?35 (the WC cutoff of >35 inches in women adds little predictive value in those with a BMI >35), including those who are overweight (BMI, 25-29.9). Women whose WC exceeds 35 inches are at increased risk for developing hypertension (HTN), type 2 diabetes mellitus (T2DM), and CVD.

Therefore, HCPs need to check patients’ blood pressure (BP) to assess for HTN and order a fasting blood glucose (FBG) test, and even a 2-hour oral glucose tolerance test and HbA1c in high-risk individuals, to assess for T2DM and pre-diabetes.9 The metabolic syndrome, which increases risk for T2DM, CVD, and stroke, is identified in women by the presence of at least three of these five risk factors: WC >35 inches, triglycerides ?150 mg/dL, high-density lipo­protein cholesterol (HDL-C) <50 mg/dL, BP ?130/85 mm Hg, and FBG ?100 mg/dL.10

Some obesity-associated diseases and risk factors place patients in a very-high-risk category for subsequent mortality.8 Patients with obesity and co-morbid coronary heart disease (CHD), other atherosclerotic diseases, T2DM, metabolic syndrome, pre-diabetes, or sleep apnea require aggressive modification of risk factors in addition to clinical management of the co-morbid disease. Furthermore, obesity has an aggravating effect on CVD risk factors such as cigarette smoking, HTN, high concentration of low-density lipoprotein cholesterol, low concentration of HDL-C, impaired FBG, family history of premature CHD, and age ?55 years (in women). HCPs need to identify these risk factors to determine the intensity of the clinical intervention that a patient requires.
Obesity takes a toll not just in terms of its effect on CVD risk, but also on cancer risk. The Cancer Research UK study showed that women with obesity had a 25% risk of developing a weight-related cancer—including cancer
of the bowel, gallbladder, uterus, kidney, pancreas, or esophagus, as well as post-menopausal breast cancer—in their lifetime.11 Cancer risk in these women was 40% higher than that in their slimmer counterparts.

Initiating the conversation

Either a patient or an HCP can initiate the conversation regarding the need to lose weight. The situation is generally easier to handle when a patient expresses a desire to lose weight. She has already acknowledged existence of the disease—that is, the obesity—and is seeking treatment for it on her own. However, in many cases, the HCP must broach the topic, usually after a patient has come in for a routine visit and the findings from her history, physical examination, and laboratory tests indicate that steps must be taken to lower her risk for experiencing obesity-related complications—or to treat the complications that already exist.

To avoid discomfiting a patient in this situation, a panel of nurse practitioners convened by the American Nurse Practitioner Foundation (ANPF) recommends that the HCP show her objective data reflecting her disease and her risk for future complications—with an emphasis that obesity is a health problem—and then assess her motivation and readiness for change.7 In this context, the HCP and the patient need to synchronize their expectations and goals for weight loss therapy. HCPs now have reliable tools to help patients lose 5%-10% of their body weight. This weight loss may not produce the desired cosmetic outcome but will no doubt result in clinical benefits. The emphasis is on improving the health of the patient.

To inspire a patient with obesity to want to lose weight and to commit to follow a weight-loss treatment plan, the HCP can help her identify at least one compelling reason to lose weight.7 Common patient-centered reasons include (1) decreasing the risk of having a complicated pregnancy; (2) being able to play with children or grandchildren; (3) walking without becoming short of breath; (4) preventing other chronic diseases such as T2DM; and (5) improving existing weight-related complications such as sleep apnea or T2DM. Of note, some patients may not be aware of the health risks posed by obesity and will be motivated to lose weight once educated about the risks.

Approach to management

Once a patient with obesity is motivated and ready to lose weight, the HCP needs to work with her to devise a management plan. Both of them should agree on the goals of weight-loss therapy and on the purpose of long-term therapy. A realistic initial goal for many patients is a loss of 5% of body weight in 3 months. Three major management options—lifestyle modification, pharmacotherapy, and bariatric surgery—can bring about weight loss and reduce obesity-related morbidity and mortality.1 This article focuses on the first two options.

Lifestyle modification

A comprehensive weight-loss program starts with lifestyle modification comprised of dietary changes, increased activity, and behavioral control.12

Dietary changes

With regard to energy intake, the ANPF recommends a reduction of 500-1,000 kcal/day, which can be accomplished by limiting portion size, reducing fat and sugar intake, and using commercial weight-loss meal replacements.7 The patient can follow one of many diets shown to be safe and effective; examples are a low-carbohydrate diet,13 a low-fat diet,14 a Mediterranean diet,15 a low-glycemic-load diet,16 and a portion-controlled diet.17

Practical dietary tips include avoiding skipping meals and consuming small meals and between-meal snacks every 3-4 hours. With regard to food intake, moderation is the watchword. With regard to fluid intake, however, drinking eight 8-oz glasses of water a day is crucial unless contraindicated (e.g., in patients with renal failure).

Choice of a particular diet is less important than making a commitment and adhering to the diet,18 although following a regimen tailored for a co-morbidity makes sense. Because compliance is the key to success, the diet plan should accommodate the patient’s personal and cultural preferences. Regardless of the diet chosen, patients should monitor their caloric intake via a food diary and weigh themselves at least once a week.19

Increased activity

Choice of a particular activity (e.g., walking, swimming) depends on a patient’s preference and access to, say, a pool, as well as her current weight and health status. An assessment of mobility, cardiovascular (CV) status, and perhaps pulmonary function is needed before a patient embarks on a new exercise program.20 The goal is to increase energy expenditure.20 Exercising for ?150 minutes/week can lead to modest weight loss and help prevent weight regain; doubling this amount will promote more robust weight loss.21 As with food intake, patients should record their daily physical activity.

Exercise not only facilitates weight loss but also improves CV health by reducing BP, lipid levels, and visceral fat. These reductions are linked to improved glucose tolerance and insulin sensitivity in persons without diabetes and improved glycemic control in patients with T2DM.12 Enhanced physical fitness may even lessen obesity-related mortality. Of note, patients with obesity must modify their diet and increase physical activity in order to lose weight and reduce their risk for obesity-related complications. Another note: In addition to traditional exercise, patients can aim to increase energy expenditure throughout the day by reducing sedentary behaviors. For example, car owners can park twice as far from store entrances as they used to; city dwellers can walk instead of taking a bus, subway, or taxi; and office workers can use a standing desk instead of sitting at their desk.

Behavioral therapy

As applied to weight loss, behavioral therapy entails techniques for helping patients replace habits that contribute to excess weight and poor health with those that promote weight loss and good health.12 Key components of behavioral therapy include frequent encounters with HCPs, education, stimulus control, cognitive restructuring, goal-setting, self-monitoring, and social support.20 Group weight-loss programs in community settings, commercial weight-loss programs, and programs delivered by telephone, the Internet, or text message can all be effective, depending on patient preference.12

Pharmacotherapy

If a patient has not lost about 5% of her body weight after 3 months, or if she has lost weight but regained some, most, or all of it over time, she and her HCP should consider use of weight-loss medication as an adjunct to lifestyle modification. In some patients with severe complications who require clinically meaningful weight loss quickly, lifestyle modification and pharmacotherapy can be initiated concomitantly.

Rationale

In all human beings, calorie restriction triggers various biological adaptations designed to prevent starvation.22 These adaptations may even be potent enough to reverse the initial weight-loss success achieved with lifestyle modification. In persons with obesity, additional biological adaptations function to preserve, or even increase, their highest sustained lifetime body weight. As such, more biologically-based interventions are likely to be needed to counter the compensatory adaptations that maintain a person’s highest lifetime body weight.22 Other reasons for pharmacologic intervention in facilitating weight loss include the following:

  • Appetite-suppressing medication enhances a patient’s ability to adhere to a reduced-calorie diet.
  • Addition of a weight-loss medication consistently achieves greater weight loss, and for a longer duration of time, than that achieved by the lif