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Research reveals which breast implants pose the greatest risk of implant-associated cancer

Researchers at Macquarie University’s MQ Health have revealed that women implanted with textured breast implants are at a significantly higher risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Read more at medxpress

USPSTF: Screen All Pregnant Women for Pre-eclampsia

All pregnant women should be screened for preeclampsia with blood pressure measurements throughout their pregnancy, according to the U.S. Preventive Services Task Force (USPSTF).

There is “adequate evidence” that screening for preeclampsia has a “substantial benefit” for both mother and infant and that any harms resulting from screening and treatment are “no greater than small,” stated Kristen Bibbins-Dimingo, PhD, MD, of the USPSTF, and colleagues.

Read more at MedPage Today.

Age linked to decreased pelvic floor strength

A new study published in Female Pelvic Medicine & Reconstructive Surgery found that decreased pelvic floor strength after childbirth is 2.5 times more likely to affect women over age 25 years than younger women (Female Pelvic Med Reconstr Surg 2017; 23: 136-140).

“In multivariate analysis, age alone was a predisposing factor for pelvic floor weakness after childbirth, even though we also assessed variables such as race, BMI, length of second stage labor, vacuum delivery, and episiotomy,” said lead author Lieschen Quiroz, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City.

“The issue of pelvic floor weakness is important, because one in five women are affected by pelvic floor dysfunction during their lifetime—often in the fifth or sixth decade of life—but the event that puts them at risk may have occurred years before at the time of vaginal delivery,” Dr. Quiroz said.

Since older women are at increased risk for pelvic floor weakness after vaginal delivery, it’s important that clinicians assess the pelvic floor strength of women over age 25 or 30 before childbirth, Dr. Quiroz noted. “If pelvic floor weakness is found, women can be referred to physical therapy to improve their pelvic floor strength,” she added.

In the study, 68 women with a singleton pregnancy planning a vaginal delivery were assessed for pelvic floor strength at 24 to 37 weeks and between 4 weeks and 6 months postpartum. The median follow-up time was 7 weeks postpartum. Sixty-six percent of the women experienced a vaginal delivery while 34% went into labor but had a Cesarean delivery. Pelvic floor strength was evaluated with a Peritron perineometer during pelvic floor contractions, and the women also underwent physical exams and 3D vaginal ultrasounds during pregnancy and postpartum clinical visits.

via ModernMedicine

Anti-inflammatory diet could reduce risk of bone loss in women

Anti-inflammatory diets — which tend to be high in vegetables, fruits, fish and whole grains — could boost bone health and prevent fractures in some women, a new study suggests.

Researchers examined data from the landmark Women’s Health Initiative to compare levels of inflammatory elements in the diet to bone mineral density and fractures and found new associations between food and bone health. The study, led by Tonya Orchard, an assistant professor of human nutrition at The Ohio State University, appears in the Journal of Bone and Mineral Research. Read more.

Researchers provide new insights into age-related female infertility

 

Researchers at the University of Montreal Hospital Research Center (CRCHUM) have discovered a possible new explanation for female infertility. Thanks to cutting-edge microscopy techniques, they observed for the first time a specific defect in the eggs of older mice. This defect may also be found in the eggs of older women. The choreography of cell division goes awry, and causes errors in the sharing of chromosomes. These unprecedented observations are being published today in Current Biology. Read more.

 

Obesity May Make Rheumatoid Arthritis Tough to Spot, Track

Blood tests to diagnose and monitor rheumatoid arthritis may be thrown off by obesity in women, a new study suggests.

“Physicians might assume that high levels of inflammation mean that a patient has rheumatoid arthritis or that their rheumatoid arthritis requires more treatment, when in fact a mild increase in levels of inflammation could be due to obesity instead,” explained study author Dr. Michael George, who’s with the University of Pennsylvania Health System in Philadelphia.

Blood tests for C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) can help physicians check the severity of inflammation in rheumatoid arthritis patients, the researchers said.

Previous studies have suggested that obese women may normally have higher CRP and ESR levels. So, the authors of this study decided to take a closer look at the issue.

The study included information from more than 2,100 people with rheumatoid arthritis. The researchers then compared that information to data from the general population.

A higher body mass index (BMI — an estimate of body fat based on weight and height) was associated with greater CRP in women with rheumatoid arthritis and women in the general population, especially in severely obese women. There was also a modest association between obesity and ESR.

Conversely, in men with rheumatoid arthritis, a lower BMI was associated with greater CRP and ESR.

The findings may help improve understanding of the link between weight and inflammation. It may also help doctors learn more about how this relationship differs between women and men, the study authors added.

The findings were published April 10 in the journal Arthritis Care & Research.

Read more at Medline

Sex trafficking and other violence prevention resources from the CDC

Sex trafficking exploits women, men, and children across the United States and around the world. Preventing this violation of health, safety, and human rights is necessary for the well-being of people and communities. People can learn more about the problem, and prevention practitioners can use resources to help prevent sex trafficking.

Read more here.

Early Use of Triple Drug Cocktail Improves Ovulation in PCOS

Early intervention with a combination of antiandrogen and insulin-sensitizing agents in adolescents with polycystic ovary syndrome (PCOS) may help improve their fertility and overall health later on, a small new study suggests.

The findings were presented April 4 at ENDO 2017: The Endocrine Society Annual Meeting by Lourdes Ibáñez, MD, PhD, professor of pediatrics and director of the fellowship program in pediatric endocrinology, University of Barcelona, Spain.

In a randomized trial of 36 adolescent girls who were not sexually active  who had polycystic ovary syndrome — characterized by hirsutism and oligomenorrhea — a three-drug combination of low-dose spironolactone, pioglitazone, and metformin (SPIOMET) improved ovulation rates more effectively than did the standard oral contraceptive ethinylestradiol-levonorgestrel treatment.

Read more here

More Hot Flashes May Signal CVD Risk

Frequent hot flashes in younger middle-aged women may be a sign of a higher risk of vascular disease, researchers found.

Writing in Menopause, the authors examined 272 non-smoking women ages 40 to 60 years. They examined their endothelial cell function and the effect of hot flashes on the ability of the inner lining of these blood vessels to dilate. While there was a significant association between hot flashes and endothelial cell function among women ages 40 to 53 years, there was no association for older women (ages 50 to 64 years). These associations occurred independent of other heart disease risk factors.

Read more here

Birth control pills may protect against some cancers for decades

When it comes to oral contraceptives, women often hear about the increased cancer risk they pose. A new study, however, finds that the using birth control pills may protect against certain cancers for at least 30 years.
From an analysis of more than 46,000 women, researchers from the University of Aberdeen in the United Kingdom found that women who had ever used oral contraceptive pills were at lower risk of colorectal, ovarian, and endometrial cancers, compared with women who had never used the pill.

Furthermore, the study found no link between the use of oral contraceptives during reproductive years and increased risk of new cancers in later life.

The study was led by Dr. Lisa Iversen, of the Institute of Applied Health Sciences at Aberdeen, and the findings were recently published in the American Journal of Obstetrics and Gynaecology.

According to the Centers for Disease Control and Prevention (CDC), around 16 percent of women in the United States aged between 15 and 44 years are currently using oral contraceptive pills as a method of birth control.

The “combined pill” is the most common form of oral contraceptive used. This contains synthetic versions of the hormones estrogen and progesterone.

Since naturally occurring estrogen and progesterone have been associated with cancer development, numerous studies have investigated whether oral contraceptives might play a role in cancer risk.

Read more at Medical News Today 

Test Strips For Early Cervical Cancer Detection

Purdue researchers are developing a test strip, similar to the common pregnancy test, to detect cervical cancer and eventually other types of cancer and diseases.

Cervical cancer, the fourth most common type of cancer for women, is often detected too late, especially among women living in poor countries. The World Cancer Research Fund International says about 84 percent of cases occur in underdeveloped nations.

Current detection is based on the human papillomavirus, or HPV, test, which doctors say isn’t always able to correctly classify whether somebody has a disease or not.

“This field really needs an additional way to test for cervical cancer. A test that can report cervical cancer right away is very instrumental in a lot of low- and middle-income countries where women often get HPV tests and then never come back,” said Joseph Irudayaraj, professor of biological engineering in Purdue’s School of Agricultural and Biological Engineering. “In higher-income countries, it’s important that anything beyond HPV tests have the ability to complement those tests.”

Here’s how it works:

The strip’s color changes within 15-30 minutes to indicate the presence of specific proteins associated with cervical cancer. Irudayaraj says he’s proven the concept and is working on a prototype.

One day researchers think this test could detect other types of cancers and other diseases, including infectious pathogens.

A USDA grant is funding the research in part. Scientists are also looking for corporate funding to advance the research.

via WVXU

No benefit in treating mildly low thyroid function in pregnancy according to NIH study

There appears to be no benefit to treating mildly low thyroid function during pregnancy, according to a study by a National Institutes of Health research network.

Markedly low thyroid function during pregnancy has long been associated with impaired fetal neurological development and increased risk for preterm birth and miscarriage. Similarly, some studies have indicated that even mildly low thyroid function (subclinical hypothyroidism) could possibly affect a newborn’s cognitive development and increase the chances for pregnancy and birth complications. Read more here.

World’s first ‘menstrual cycle on a chip’ created to develop individualized treatments for women suffering from reproductive problems

The world’s first ‘menstrual cycle on a chip’ could change the future of research into gynecological problems, scientists claim.

The cube-shaped device, called Evatar, is a palm-sized recreation of the female reproductive tract.

It is made with human tissue cultured from stem cells and contains 3D models of ovaries, fallopian tubes, womb, cervix and vagina, as well as the liver.

The creation of the novel tool marks the first time scientists have been able to mimic the interplay between tissues and hormones.

Researchers plan to use the device to investigate conditions such as endometriosis, fibroids, reproductive organ cancers and infertility.

Dr Teresa Woodruff, a professor of obstetrics and gynecology at Northwestern University in Chicago, Illinois, where the device was created, said: ‘This is nothing short of a revolutionary technology.

‘If I had your stem cells and created a heart, liver, lung and an ovary, I could test 10 different drugs at 10 different doses on you and say, “Here’s the drug that will help your Alzheimer’s or Parkinson’s or diabetes”.

‘This will help us develop individualized treatments and see how females may metabolize drugs differently from males.’

The landmark study shows how the 28-day menstrual cycle can be mimicked using ‘organ on a chip’ technology.

The researchers used human stem cells to culture a combination of tissues of the ovary, fallopian tube, womb, cervix and liver in the device for four weeks.

Each ‘organ’ occupies its own brown cube and a special fluid pumps through each pea-sized organ to perform the function of blood.

The organs are able to communicate with each other via secreted substances, including hormones such as estrogen, to closely resemble how they all work together in the body.

The project is part of a larger effort by the US National Institutes of Health to create a ‘body on a chip’.

Read more at The Daily Mail

 

How dietary factors influence disease risk

Having too much sugar, salt, or fat in your diet can raise your risk for certain diseases. Healthy eating can lower your risk for heart disease, stroke, diabetes, and other health conditions. A healthy eating plan emphasizes vegetables, fruits, whole grains, and fat-free or low-fat dairy products; includes lean meats, poultry, fish, beans, eggs, and nuts; and limits saturated and trans fats, sodium, and added sugars.

The major cardiometabolic diseases—heart disease, stroke, and type 2 diabetes—pose substantial health and economic burdens on society. To better understand how different dietary components affect the risk of dying from these diseases, a research team led by Dr. Dariush Mozaffarian of Tufts University analyzed data from CDC’s National Health and Nutrition Examination Survey (NHANES) and national disease-specific mortality data. The study was supported in part by NIH’s National Heart, Lung, and Blood Institute (NHLBI). Results appeared on March 7, 2017, in the Journal of the American Medical Association.

The researchers investigated the relationships of 10 different foods and nutrients with deaths related to heart disease, stroke, and type 2 diabetes. They also compared data on participants’ age, sex, ethnicity, and education. They found that nearly half of all the deaths in the United States in 2012 that were caused by cardiometabolic diseases were associated with suboptimal eating habits. Of 702,308 adult deaths due to heart disease, stroke, and type 2 diabetes, 318,656 (45%) were associated with inadequate consumption of certain foods and nutrients widely considered vital for healthy living, and overconsumption of other foods that are not.

The highest percentage of cardiometabolic disease-related death (9.5%) was related to excess consumption of sodium. Not eating enough nuts and seeds (8.5%), seafood omega-3 fats (7.8%), vegetables (7.6%), fruits (7.5%), whole grains (5.9%), or polyunsaturated fats (2.3%) also increased risk of death compared with people who had an optimal intake of these foods/nutrients. Eating too much processed meat (8.2%), sugar-sweetened beverages (7.4%), and unprocessed red meat (0.4%) also raised the risk of heart disease, stroke, and type 2 diabetes-related deaths.

The study showed that the proportion of deaths associated with suboptimal diet varied across demographic groups. For instance, the proportion was higher among men than women; among blacks and Hispanics compared to whites; and among those with lower education levels.

“This study establishes the number of cardiometabolic deaths that can be linked to Americans’ eating habits, and the number is large,” explains Dr. David Goff, director of the NHLBI Division of Cardiovascular Sciences. “Second, it shows how recent reductions in those deaths relate to improvements in diet, and this relationship is strong. There is much work to be done in preventing heart disease, but we also know that better dietary habits can improve our health quickly, and we can act on that knowledge by making and building on small changes that add up over time.”

These findings are based on averages across the population and aren’t specific to any one person’s individual risk. Many other factors contribute to personal disease risk, including genetic factors and levels of physical activity. Individuals should consult with a health care professional about their particular dietary needs.

—Tianna Hicklin, Ph.D.

via National Institutes of Health

New thinking about urinary tract infections

Urinary tract infections (UTIs) can be tricky in older age. They’re not always as easy to spot or treat as in youth. And the decades-long approach to treatment is changing. “We’ve been hasty in using antibiotics, and we’re learning there are significant consequences that can range from side effects of medication to infections with antibiotic-resistant bacteria,” says Dr. Helen Chen, a geriatrician at Harvard-affiliated Hebrew Rehabilitation Center.

About UTIs

UTIs can occur anywhere in the urinary tract. The most common places are the bladder (where urine is stored) and the urethra (the tube through which you urinate). Less common, but more serious, is infection of the kidneys, which filter waste and extra water from the blood and make urine. Infections may be triggered by sexual activity, catheters, kidney stones, decreased estrogen in the lining of the vagina, or urine that’s pooled in the bladder.

Classic symptoms include a burning feeling with urination, a sense of urgency to urinate, increased frequency of urination, blood in the urine, and fever. Some older adults with a UTI also develop confusion.

The tricky part

Some of these UTI symptoms are similar to the symptoms of other conditions common in older people. “That makes it hard to decide if you have a new infection, or if an existing problem is worse, or if you have something else,” says Dr. Chen. For example:

  • Many older adults already have issues with frequency or urgency from bladder problems or (for men) an enlarged prostate.
  • Confusion can be a medication side effect or a sign of another problem, such as dehydration or a disturbed metabolism (which might occur with abnormal blood levels of calcium or sugar).

Also complicating diagnosis is UTI testing. A urine sample checks for the presence of bacteria and white blood cells (which would suggest an infection). If this initial test is positive, it’s usually necessary to grow the bacteria in a lab to identify the specific type of bacteria. But older women can carry bacteria in their bladders without any symptoms. Doctors call this asymptomatic bacteruria rather than a bladder infection.

Rushing to judgment

Treating a UTI without classic symptoms, based instead on the presence of some bacteria and white blood cells in urine, may have several consequences. It may mean that an underlying condition (or a worsening condition) is not being addressed. And since treatment involves a course of antibiotics, unnecessary treatment may lead to antibiotic resistance.

While the risk of not giving an antibiotic to rid the bladder of bacteria is small, it can sometimes allow bacteria to spread to the kidney and then to the bloodstream. This can lead to sepsis, the body’s toxic and sometimes deadly response to infection.

Treatment

“Anyone with new classic symptoms should probably be treated for a UTI. However, if the only symptom is confusion, considering other causes or waiting a day or two to see if it resolves may be appropriate, if the family can observe the person and is okay with this,” says Dr. Chen.

If your doctor does prescribe an antibiotic, talk about potential side effects. Certain commonly used antibiotics called fluoroquinolones — such as levofloxacin (Levaquin) and ciprofloxacin (Cipro) — can be associated with damage to tendons, joints, nerves, and the central nervous system. The FDA advises that these medications should not be used as a first-line treatment for uncomplicated UTIs. Dr. Chen says other antibiotics, such as amoxicillin and clavulanic acid (Augmentin), cotrimoxazole (Bactrim), or nitrofurantoin (Macrobid), may be better options.

via Harvard Health Publications

AHA Guidelines: Time to Revisit Thinking on Pregnancy in Women with Complex Congenital Heart Disease

In a notable twist on conventional wisdom, a new American Heart Association scientific statement on managing pregnancy in patients with complex congenital heart disease (CHD) supports the notion that most women with complex CHD can have a successful pregnancy and normal vaginal delivery. To optimize outcomes, the statement notes, care should be collaborative and involve both a high-risk obstetrician and a cardiologist versed in CHD.

The new guidelines alter the idea that patients with complex CHD should avoid pregnancy out of concern about potential risks to the mother and child.

A stepped plan for complex pregnancies

“This is an excellent statement that provides a much-needed framework for caring for these patients, covering everything from pre-pregnancy counseling to pregnancy care to post-delivery care,” says obstetrician Jeff Chapa, MD, Head of Maternal-Fetal Medicine at Cleveland Clinic.

The guidelines provide a stepped assessment plan for general cardiologists to follow.

“The process makes it easy to assess risk prior to pregnancy, determine the frequency of follow-up needed once the patient becomes pregnant and identify the level of disease that warrants tertiary care,” says Dr. Chapa. “Knowing the changes that will occur can help with risk stratification and provide an idea of how well a patient is likely to do.”

Cardiologist David Majdalany, MD, Director of Cleveland Clinic’s Adult Congenital Heart Disease Center, trained under several members of the writing group behind the AHA guidelines, so he found no surprises in the document. But he’s delighted that a summary of the latest recommendations is finally at the disposal of all providers.

“Until now, we had only bits and pieces of information from various papers primarily written on individual defects,” Dr. Majdalany explains. “These guidelines coalesce what we know in a detailed document that discusses the pros and cons of pregnancy by every class of congenital lesion. This is very helpful.”

Validated by experience

The new guidelines’ recommendations align with the experience of Drs. Chapa and Majdalany in Cleveland Clinic’s Cardio-Obstetrics Clinic, where a high-risk obstetrician and a CHD cardiologist co-manage patients, with support from colleagues in virtually every subspecialty available when needed.

The decision of whether to proceed with a vaginal delivery is made jointly. “For example, with defects such as aortic root dilation, the patient is at risk for aortic dissection, so we would suggest avoiding natural delivery in such a case,” Dr. Majdalany notes.

Read more at Cleveland Clinic

 

Duke Team Reaches Milestone with Portable Cervical Cancer Screening Device

January was Cervical Health Awareness Month, and this year, that designation held special significance for Nimmi Ramanujam, professor of biomedical engineering and global health and director of the Center for Global Women’s Health Technologies.

Since 2012, she and her research team have been developing and testing a portable colposcope, called the “Pocket Colposcope,” to increase access to cervical cancer screening in primary care settings. Last month, 20 of these devices were produced for distribution to international partners.

SCREENING IS KEY TO EARLY DETECTION AND EFFECTIVE TREATMENT

According to the World Health Organization (WHO), more than 85 percent of the more than 270,000 annual deaths from cervical cancer occur in low and middle income countries. The disease is easily treatable if identified early, but because access to effective screening is limited in low-resource settings, early detection is often not possible.

And even if access to screening is available, for example via human papilloma virus (HPV) testing, a confirmatory test is needed before a woman can receive treatment. In the United States, this test is performed through colposcopy. However, a clinical colposcope is typically not available in a primary care setting, and in many low and middle income countries, often the alternative is to visualize the cervix with only the naked eye—a method that often results in missed diagnoses. The cost of a clinical colposcope—upwards of $20,000—presents yet another barrier.

The Pocket Colposcope is designed to address these barriers. It brings that secondary test—traditionally performed using a clinical colposcope by physicians at referral centers—to the primary care setting. In addition, it’s easy for a broad range of health care providers with different levels of training to use.

ABOUT THE POCKET COLPOSCOPE

After four generations of development, the team has created a beta prototype of the Pocket Colposcope in collaboration with product design and development company 3rd Stone Design, Inc.

The Pocket Colposcope is significantly less expensive, smaller and lighter than a traditional clinical colposcope. Weighing less than two pounds, it fits inside a pocket (hence the name). The device enables healthcare providers to zoom and capture images by pressing a button with their thumb. Images taken with the Pocket Colposcope are transmitted instantly to a smartphone, tablet or laptop.

Read more at Duke Global Health Institute

Promise of PARP Inhibitors for BRCA1/BRCA2 Cancers

For patients with triple-negative breast cancer and BRCA1/BRCA2 mutations, current treatment options may at times be limited; currently, there are no specific treatments for BRCA1/BRCA2-mutated cancers that address the genetic defects seen in these cancers. However, there is growing interest in the use of Poly (ADP-ribose) polymerase (PARP) inhibitors in this setting.

Promise of PARP inhibition in BRCA-mutated disease

“In patients with BRCA1/BRCA2 mutations, PARP inhibitors are one of the most promising treatments to be tested recently in clinical trials,” says Jame Abraham, MD, Director of Cleveland Clinic Cancer Center’s Medical Breast Oncology Program and Co-Director of the Comprehensive Breast Cancer Program.

PARP inhibitors interfere with base excision repair and therefore DNA repair, to effect death of tumor cells. PARP inhibitors can be highly lethal to tumor cells in patients who already have impaired DNA repair from BRCA mutation, Dr. Abraham says.

Although triple-negative breast cancer can be sporadic, these cancers share traits that involve DNA repair defects with those occurring in BRCA-mutated carriers. Eighty percent of hereditary BRCA-mutated cancers share the triple-negative breast cancer phenotype. The prevalence of BRCA1 and BRCA2 mutations in triple-negative breast cancer ranges from 4 to 14.3 percent, and an additional 27 to 37 percent have somatic inactivation of BRCA1.

As a class, PARP inhibitors can cause profound damage to cancer cells in breast cancers that involve DNA repair pathway defects. A number of PARP inhibitors are undergoing clinical development, but none is yet FDA-approved for breast cancer.

OlympiAD and OlympiA: Clinical trial experience with olaparib

Cleveland Clinic is currently participating in two phase III clinical trials evaluating olaparib as a treatment for metastatic breast cancer as well as for stage II/III BRCA1/BRCA2, HER2-negative and triple-negative disease.

OlympiAD, the phase III trial on olaparib in metastatic breast cancer is ongoing but no longer recruiting participants and results are expected soon. In the meantime, Cleveland Clinic is enrolling patients in the OlympiA study, a phase III trial with olaparib as an adjuvant treatment for earlier-stage breast cancers with DNA repair defects — that is, in women with stage II and stage III breast cancer who have completed local treatment and neoadjuvant or adjuvant chemotherapy.

“We have enough evidence from metastatic breast cancer trials to know that olaparib is active in stage IV breast cancer. So now we want to see what kind of benefit stage II/III breast cancer patients will derive from use of olaparib,” Dr. Abraham says.

Olaparib was the first PARP inhibitor approved by both the FDA and the European Medicines Agency for patients with BRCA1/2 mutant ovarian cancer. In 2014, the FDA approved olaparib for patients with germline BRCA-mutated ovarian cancer who have undergone three or more lines of chemotherapy. The treatment was approved along with the BRACAnalysis CDx, a companion diagnostic test.

Read more at Cleveland Clinic

USPSTF: Jury Still Out on Pelvic Exams for Most Gynecologic Conditions

There is insufficient evidence to recommend for or against pelvic exams for most gynecologic conditions among asymptomatic women of reproductive age, said the U.S. Preventive Services Task Force.

Other than cervical cancer, gonorrhea and chlamydia, which have been addressed in separate recommendation statements, the USPSTF cited “insufficient evidence” to assess the balance of benefits and harms of these screenings in asymptomatic, non-pregnant women 18 years of age and older, who are not at increased risk of any specific gynecologic condition.

Notably, the authors reported that they were only able to find “limited evidence” on the accuracy of these examinations to detect ovarian cancer, bacterial vaginosis, genital herpes, and trichomoniasis — with very few studies on screening for other gynecologic conditions with pelvic examination alone.

This final recommendation (I statement) was published on the USPSTF site and simultaneously in the Journal of the American Medical AssociationIt affirms a draft statement issued last June, with a clarification that the USPST is not recommending against screening, and that it did not consider costs in its review.

The Task Force found inadequate evidence of benefits or harms in routine screening, citing only a few studies that reported false-positive rates for ovarian cancer (ranging from 1.2% to 8.6%), and rates of surgery for patients with abnormal findings (ranging from 5% to 36%). No studies quantified the amount of anxiety associated with these examinations, they noted.

separate editorial in JAMA Internal Medicine singled out the high false-positive rates with ovarian cancer screening and suggested the associated harms may be “substantial.” George F. Sawaya, MD, of the University of California San Francisco, characterized pelvic exams as a “ritual,” citing a survey of U.S. ob/gyns where over 85% said they performed bi-manual examination even among patients who had undergone a total hysterectomy, including the removal of both tubes and ovaries.

Read more at MedPage Today

Less-Invasive Fibroid Treatment May Be ‘Under-Used’

A minimally invasive procedure for uterine fibroids may be “under-used” in U.S. hospitals, compared with surgery, a new study suggests.

The study looked at a national sample of hospitals and found that fewer fibroid patients are undergoing hysterectomy — surgical removal of the uterus.

But hysterectomy remains much more common compared with a less-invasive procedure called embolization.

Fibroids are non-cancerous growths in the wall of the uterus that are usually harmless. But when they cause problems — such as persistent pain and heavy menstrual bleeding — treatment may be necessary.

For women with severe symptoms, the go-to has traditionally been hysterectomy, or sometimes surgery to remove the fibroids only.

There are other options, though. One is embolization, which involves injecting tiny particles into the small uterine arteries supplying the fibroids. The particles block the fibroids’ supply of nutrients and cause them to shrink.

Embolization has been a widely accepted treatment for 10 to 15 years, said Dr. Prasoon Mohan, lead researcher on the new study.

Yet, his team found, it still lags far behind hysterectomy. From 2012 through 2013, hysterectomies were performed 65 times more often than embolization at U.S. hospitals.

When embolization was done, it was usually at a large medical center. Few women treated at smaller or rural hospitals had the procedure, the study found.

That points to a discrepancy in women’s access to the treatment, said Mohan, an assistant professor of interventional radiology at the University of Miami.

How often “should” embolization be done? There’s no way to define that, but Mohan said it seems clear that it’s not offered often enough.

“I think it’s definitely under-used, considering it’s minimally invasive, has a shorter hospital stay and is less expensive,” he said.

Read more at Medline Plus

Incontinence may reflect body fat, not just weight

Being overweight or obese is an established risk factor for urinary incontinence, but a recent study indicates that body composition may also play a role. A multicenter team of researchers examined data from 1,475 women enrolled in the Health, Aging, and Body Composition Study. The participants ranged in age from 70 to 79 at the beginning of the study.

The research team looked at body mass index (BMI), percentage of body fat, and the frequency and type of incontinence episodes among participants over three years. They found that both stress incontinence—episodes of spilled urine during exercise—and urge incontinence—sudden, uncontrollable urination—were twice as common in women with the highest BMIs or greatest proportion of body fat compared with those in the lowest categories. Women who lost grip strength—an indication of reduced muscle mass—also had increased episodes of stress incontinence. However, overweight women who reduced either their BMI or their body fat by 5% were less likely than women who didn’t lose weight or shed fat to experience new or persistent stress incontinence. The study was published online Dec. 5, 2016, by the Journal of the American Geriatrics Society.

These findings suggest that while weight loss alone may help alleviate both forms of incontinence, activities that increase muscle mass may be especially helpful for women with stress incontinence.

via Harvard Health Publications

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

CMV virus is way more common than Zika. But expectant mothers don’t know their babies are at risk.

WHEAT RIDGE — When Megan Wiedel was pregnant with her second child, she did just as her doctor told her to.

No raw fish. No soft cheeses. No lunch meat.

All along, a much bigger risk — one that her doctor never told her about — loomed.

So, unaware, when Wiedel’s first daughter sniffled, she held her. When Wiedel herself caught a cold in the second trimester, she shrugged it off. And when her second daughter, Anna, was born — at only 5 pounds, full term — and then failed the newborn hearing test, Wiedel and her husband tried not to worry as the pediatrician ordered more tests.

Two weeks later, the results came back. Anna would be deaf for the rest of her life. She might never be able to walk or even hold her head up. It was because she had a virus called CMV.

Wiedel hung up the phone and thought to herself: Why had she never heard about CMV?

“When you talk about it, it seems like it’s really rare,” Wiedel said. “But it’s not. A lot of kids have CMV.”

“That’s the hardest piece for me is that this is a preventable, prevalent, quiet disease.”

But, now, a small community of mothers and medical workers are trying to make CMV awareness a little less quiet.

Cytomegalovirus, or CMV, is the most common nongenetic cause of childhood deafness in the country. Every year, approximately 30,000 babies are born in the United States infected with CMV, and as many as 8,000 of those children suffer lifetime consequences from the disease — which can also include blindness, cognitive delays and microcephaly. As many as 400 infants die every year from CMV, according to the National CMV Foundation.
It is vastly more common than the Zika virus, which prompted alarm last summer for its potential to cause birth defects. But, while Congress invested $1.1 billion in fighting Zika, funding for CMV lags behind, and numerous studies show that as many as 85 percent of expectant mothers have no idea what CMV is. The American College of Obstetricians and Gynecologists does not advise doctors to talk to expectant mothers about CMV — despite the fact that it is an easily spread virus that is present in nearly every elementary school and day care center in the country.

At Children’s Hospital Colorado, physician assistant Shannon Hughes has developed an outpatient clinic for kids dealing with the aftereffects of CMV. The clinic has served about 40 kids in the past two years. Nearly all of the parents she meets had never heard of CMV before finding out that it would forever alter their children’s lives.

“Obviously, that has a big impact on them emotionally that they think they did something wrong and should have prevented it,” she said.

Neonatal nurse practitioner Erin Mestas, who also works at Children’s as well as at Poudre Valley Hospital, is also trying to raise awareness among both mothers and health care workers about CMV.

“There needs to be more education about CMV risk reduction,” Mestas said. “I think childbearing women need to be more educated.”

In some ways, CMV’s ubiquity accounts for its invisibility.

Most adults have been exposed to CMV at some point in their lifetimes, meaning they have antibodies to fight off a new CMV infection. For women with CMV antibodies, then, being exposed to the virus while pregnant is usually no big deal.

Read more at The Denver Post

 

10 Women Who Shaped and Advanced Women’s Health

In honor of Women’s History Month, Healthy Women put the spotlight on 10 women (but there are so many more!) who made important contributions to prioritizing women’s health.

1. Clara Barton, nurse/educator (1821–1912) 
Barton founded the American Red Cross in 1881. Since then, the organization has provided much-needed relief for the vulnerable in America—and abroad. Barton identified her calling while nursing wounded soldiers and searching for missing ones during the Civil War.

2. Elizabeth Blackwell, MD, author, educator (1821–1910)
In 1849, Blackwell became the very first woman to earn an MD degree from an American medical school. She was inspired to break barriers because her female friend wanted to see a female doctor. Now, half of medical school graduates are females.

3. Margaret Sanger, women’s rights activist (1879–1966)
Sanger’s research led to the discovery of a pill to prevent pregnancy, and she coined “birth control.” She founded the American Birth Control League, which is now known as Planned Parenthood. Sanger advocated for reproductive rights after caring for women who attempted self-induced abortions and suffered from poorly performed illegal ones.

4. Rebecca Lee Crumpler, MD (1831-1895)
In 1864, Crumpler became the first African-American woman to receive an MD degree. Her book, Book of Medical Discourses, was one of the first publications about medicine by an African American. In post-Civil War Richmond, Va., she cared for freed slaves who would not have otherwise had access to medical care.

5. Ina May Gaskin, MA, CPM (1940-)
Often described as “the mother of authentic midwifery,” Gaskin advocated for natural and home birth at a time when childbirth was seen as a medical problem. Her efforts empowered women to gain control of their bodies and have a say in how they wanted to deliver their babies.

6. Catherine Switzer, author, television commentator and marathon runner (1947-)
Switzer was the first woman to enter and run the Boston Marathon in 1967. She was able to enter because she didn’t use her full name, but when the race director saw a woman running, he tried to physically remove her from the race. Switzer stayed the course, finished and went on to advocate for the women’s marathon to be added to the Olympics.

7. Jane Fonda, actress (1937-) 
Fonda revolutionized women’s fitness in the ’80s and ’90s when she released her workout videos—donning leotards and legwarmers, of course! Her first tape, released in 1982, is the best-selling home workout video of all time.

8. Michelle Obama, U.S. First Lady, lawyer (1964-)
First Lady Michelle Obama turned children’s healthy eating and physical activity into a national conversation. She started a vegetable garden at the White House in 2009 and launched the Let’s Move campaign in 2010. From doing the dougie to competing in fitness competitions against Jimmy Fallon, Mrs. Obama has made healthy living fun—for kids and adults.

9. Nancy Brinker, founder and chair of global strategy of Susan G. Komen (1946-)
Susan G. Komen is widely known now for its global efforts to fight breast cancer. But Brinker founded the organization in 1982 when the disease was not discussed. She named the organization in honor of her sister who lost her battle to breast cancer in 1980.

10. Melinda Gates, business leader, philanthropist (1964-)
As cochair of the Bill and Melinda Gates Foundation, Melinda Gates has advocated for prioritizing women’s and children’s health around the world. The Gates Foundation invests in maternal and child health, family planning and nutrition programs in developing countries. In the United States, Melinda Gates has become a strong voice in reducing the gender gap.

These are just a small, but mighty, group of women who have fought for women’s health priorities, and we’re thrilled to celebrate them.

via Healthy Women

 

The Pap smear: groundbreaking, lifesaving — and obsolete?

Pap tests are one of the most familiar — and successful — cancer screening tests ever invented. Since their introduction in the 1950s, cervical cancer deaths in the US have fallen by more than 60 percent.

But now, a growing number of scientists say, the Pap may be past its prime.

In its place, they are calling for a simple test, one that’s already routinely used as a second-line test around the world: screening for human papillomavirus (HPV).

When the Pap was invented, no one knew what caused cervical cancer. But in the years since, we’ve come to understand that HPV causes almost all cases of cervical cancer, and vaccinating against the virus can essentially obliterate it.

So, testing for HPV would be an upstream way of testing for cervical cancer risk — allowing for earlier detection, cost savings, and even opening the door for at-home testing.

There are signs it’s catching on. Last year, the Netherlands wholesale switched from Pap tests to HPV tests, and Australia is set to follow in its footsteps this year. The journal Preventive Medicine devoted an entire issue to HPV testing in February. Clinical trials of at-home HPV testing are underway across the US, Europe, and Canada.

But some physicians fear the test isn’t good enough to replace the monolithic Pap smear — or feel that, even if it is, we shouldn’t fix what isn’t broken.

At Home Testing in Appalachia

Proponents of HPV self-testing say its biggest appeal is in expanding the reach of cancer screenings, both to impoverished areas abroad, and also to women closer to home.

A trial underway now looks to test that idea in a woefully underserved region of the US — Appalachia.

“Cervical cancer really is such a cancer of disparities,” said Emma McKim Mitchell, the lead investigator for the trial. In Appalachian Virginia, those disparities are glaring. The state overall has some of the lowest rates of cervical cancer in the country — but women living in its Appalachian counties are diagnosed with cervical cancer about 13 percent more often than women elsewhere in the state, according to the Appalachia Community Cancer Network.

The women in the study get information about screening and a take-home kit with a long swab and instructions. They insert the swab like a tampon to collect vaginal and cervical cells, put that into an included test tube, and then mail the sample to the lab. There, technicians, instead of looking for precancerous cells as in a Pap test, look for the DNA of the dozen or so carcinogenic HPVs.

A positive HPV test would, in turn, trigger another HPV test the next year. That’s due to the fact that about 90 percent of HPV infections clear on their own.

Two positive tests would then bring women into the clinic.

Read more at STAT NEWS

Epidemiology of Adnexal Tumors

The determination of the precise frequency of adnexal masses is impossible as some adnexal tumors go undiagnosed. A variety of age groups need to be considered while estimating the clinical significance of adnexal masses.

Children to adolescents
Nearly 80% of ovarian cysts in girls under 9 years are malignant and those are mostly germ cell tumors.

About half of the adnexal neoplasms in adolescent girls are mature cystic teratomas or dermoid cysts. Women who have a Y chromosome-carrying gonad stand a 25% chance of developing a cancerous growth.

Overall, about 10% of ovarian cancers were found to be hereditary. Patients with a family history of a non-polyposis colorectal cancer syndrome or breast-ovarian cancer syndrome were at an increased risk for developing cancerous tumors.

Endometriosis, though not common in adolescence, may be present in about half of women who have a painful mass. In adolescent women who are sexually active, tubo-ovarian abscess must be considered as a possible cause of an adnexal mass.

Adults
Most adnexal masses in reproductive age women are benign cysts. Only 10% of masses are malignant. The rate of malignancy is low in patients aged under 30.

About 25% of adnexal growths are endometriomas, 33% are mature cystic teratomas, and the rest are functional cysts or serous or mucinous cystadenomas.

No matter what the age group is, physicians must take into account the possibility of structural deformities and uterine masses. Also, in all premenopausal women, pregnancy-related adnexal masses such as ectopic pregnancy, corpus luteum cysts, theca lutein cysts, and luteomas should be considered.

Research findings
A research conducted by the Duke Evidence-based Practice Center on a contract with the Agency for Healthcare Research and Quality found that ovarian cancer is the leading cause of death from gynecologic malignancies in the US. The annual incidence of ovarian cancer was over 25,000 with an annual mortality of about 14,000.

Read more at News-medical.net

Common Virus Tied to Diabetes, Heart Disease in Women Under 50

A type of herpes virus that infects about half of the U.S. population has been associated with risk factors for Type 2 diabetes and heart disease in normal-weight women aged 20 to 49, according to a new UC San Francisco-led study.

A research team, headed by first author Shannon Fleck-Derderian, MPH, of the UCSF Department of Pediatrics, and senior author Janet Wojcicki, PhD, MPH, associate professor of pediatrics and epidemiology at UCSF, found that women of normal weight who were infected with cytomegalovirus (CMV), which typically causes no evident symptoms, were more likely to have metabolic syndrome. This condition includes risk factors such as excess abdominal fat, unhealthy cholesterol and blood fat levels, high blood pressure and elevated blood glucose.

In contrast, women infected with CMV who also had extreme obesity – defined as a body mass index (BMI) of at least 40 – were unexpectedly less likely to have metabolic syndrome than women with extreme obesity who were not infected with CMV.

The study appears Feb. 23, 2017, in the journal Obesity.

Weight Predicts Metabolic Syndrome in CMV+ Women

“The likelihood that women infected with CMV will have metabolic syndrome varies dramatically, depending on the presence, absence and severity of obesity,” Fleck-Derderian said. The UCSF research team did not find these same associations between CMV and metabolic syndrome in the men included in the study.

Scientific evidence indicates that metabolic syndrome may be triggered by long-acting, low-intensity inflammation. But while studies have implicated obesity in chronic inflammation, a large minority of individuals with obesity do not develop metabolic syndrome, and many normal-weight individuals do, leading researchers to search for additional drivers of chronic inflammation that also may influence risk for developing metabolic syndrome.

Read more at ScienceBlog

New Agents, Combinations Showing Durable Benefit in Triple-Negative Breast Cancer

The triple-negative breast cancer (TNBC) pipeline is transforming, experts say, with the potential additions of immunotherapy and PARP inhibitors. These agents are being explored both as monotherapy and in combination regimens with standard chemotherapy options.

At the 2016 San Antonio Breast Cancer Symposium, treatment with pembrolizumab (Keytruda) continued to show a consistent durable benefit with an additional year of follow-up for heavily pretreated patients with recurrent PD-L1–positive TNBC, according to findings from the phase Ib KEYNOTE-012 trial.

At a median follow-up of 10.7 months, the median progression-free survival (PFS) was 1.9 months (95% CI, 1.6-5.5), and the 12-month PFS rate was 17.8%. The median overall survival (OS) was 11.3 months (95% CI, 5.3-18.2), and the 12-month OS rate was 47.1%.

In a recent interview, Joyce A. O’Shaughnessy, MD, chair of Breast Cancer Research at Baylor-Sammons Cancer Center, Texas Oncology, addressed some of the key issues in breast cancer treatment and shared insights on where TNBC treatment is headed based on recent research findings.

Read more at Oncology Nursing News

Satisfaction, acceptability high with vaginal estradiol softgel capsules

Postmenopausal women with vulvar and vaginal atrophy reported high satisfaction and acceptability with vaginal estradiol softgel capsules compared with previously used therapies to treat their symptoms, study data show.

“[Vulvar and vaginal atrophy] is a chronic condition associated with genitourinary syndrome of menopause and affects 50% to 70% of postmenopausal women,” Sheryl A. Kingsberg, PhD, division chief, obstetrics and gynecology behavioral medicine, UH Cleveland Medical Center and professor of obstetrics and gynecology and psychiatry, Case Western Reserve University School of Medicine, told Endocrine Today. “Symptoms include pain with sexual activity, dryness and discomfort. Despite safe and effective prescription therapies, [vulvar and vaginal atrophy] remained under-treated. The availability of a new applicator-free delivery system may be one step to increasing discussion of [vulvar and vaginal atrophy] and treatments between women and [health care providers].”

Read more at Healio

NPs are a new lifeline for opioid addicts

WASHINGTON—Doctors working on the front lines of the nation’s heroin epidemic may be getting some fresh troops starting in 2017—battle-ready health professionals such as Danielle Eddings.

Eddings is a nurse practitioner in Springfield, Mo., eager to take advantage of a new federal law that will allow nurse practitioners and physician assistants to administer a highly effective anti-addiction medication called buprenorphine. Right now, only physicians can prescribe that drug, and they are limited to treating 275 patients per year.

That means a tide of patients get turned away every day at the Ozarks Community Hospital’s Northside Clinic where Eddings works, because the only doctor in the practice has hit his patient cap.

“There’s a dire need,” said Eddings, a psychiatric mental health nurse practitioner at the clinic. “There’s tons of people who can’t get treatment because it’s so limited.”

Congress approved a sweeping bill to address the opioid crisis earlier this year. That measure, now law, included a provision allowing certain non-physicians to treat addicts with buprenorphine.

Last week, federal health officials paved the way for that to take effect—detailing 24 hours of required training for nurse practitioners and physician assistants to complete before they can begin prescribing buprenorphine and similar medications. Buprenorphine is classified as a Schedule III narcotic, and it works by blocking opioid receptors in the brain and minimizing withdrawal symptoms.

It’s part of a treatment regimen called medication-assisted therapy, or MAT, and it’s been proven highly successful. Given in combination with behavioral therapy and other counseling, 70 to 80 percent of patients become stable.

Some doctors worry that allowing non-physicians to treat addicts with the medication will lower the quality of treatment and increase street access to another powerful drug with potential for misuse. But even those who express such concerns say the scope of the opioid crisis requires this expansion.

“We’re in the middle of an unprecedented epidemic,” said Dr. Arturo Taca, a St. Louis psychiatrist and president of the Midwest Society of Addiction Medicine. “There’s a lack of providers and a lack of experts in the field” to treat a growing number of patients suffering from addiction.

Taca said there are only about 30 addiction specialists practicing in Missouri, while the opioid problem in the state has risen rapidly. From 1999 to 2014, opioid-related death rates in Missouri have increased 7.6 times for women and 3.8 times for men, according to the state Department of Mental Health. More than 1,000 Missourians died in 2014 from opioid overdoses.

The trend is playing out across the country, where the nation’s approximately 5,000 addiction specialists struggling to respond, said Stuart Gitlow, past president of the American Society of Addiction Medicine and a Rhode Island physician.

Trying to get more doctors into the field won’t work, Gitlow said, because it’s more difficult and less profitable than other specialties. “So one of the decisions was ‘Okay, let’s go with PAs and NPs and see if that helps’,” he said.

While these are highly qualified professionals, Gitlow noted that they do not have same years-long medical training as doctors have and may have little to no addiction education.

Feds prosecute pain-clinic workers as drug dealers
“Imagine if we don’t have enough plumbers and as a result, I’m bringing in electricians to work on my sink,” he said. “We’re kind of sitting on pins and needles waiting to see how this will all work out.”

He and others say there’s no question the new rule will tap a vast new pool of providers for addiction treatment. There are about 220,000 licensed nurse practitioners in the U.S. and 110,000 physician assistants—and many of those folks are already lining up for the 24 hours of training.

Under the new rule, PAs and NPs will be able to treat 30 patients annually with buprenorphine starting in 2017 and then up to 100 patients each year after that.

“The interest is extremely high,” said Josanne K. Pagel, president of the American Academy of PAs and executive director of PAs at the Cleveland Clinic Health System.

Pagel noted that PAs already regularly see patients suffering from addiction but were limited in their ability to help them.

“We felt that our hands were tied,” she said. “PAs just need the tools to be able to treat them.”

Since passage of the addiction law, Pagel said, she’s been besieged with emails and phone calls from PAs eager to sign up for the training, which will focus on opioid detoxification, patient assessment, and the pharmacology of buprenorphine.

“I think it’s going to move the needle in combating this crisis,” Pagel said. “It’s going to make a difference.”

Eddings agreed and said she plans to complete the coursework in early January, so she can start seeing patients in Springfield.

Her boss, Dr. Salvador Ceniceros, said that could help cut the clinic’s approximately 75-person waiting list in half. But, he added, it’s still not enough.

“It will help, there’s no doubt,” he said. But he said it’s not unusual for his clinic to get 20 calls a day from new patients seeking treatment, and they need other care besides buprenorphine—including scarce counseling or therapy services.

“The numbers are just … you have no idea,” Ceniceros said.

via USA Today

Medical Therapy for Uterine Fibroids

Medical Therapy for Uterine Fibroids Draws Nearer as Phase 2 Trial Brings Promising Results

Women with large uterine fibroids suffer with many quality-of-life issues, including limitations on work, travel, hobbies and sexuality. Unfortunately, our treatment options are primarily surgical ‒ hysterectomy or myomectomy. There is a real need for medical options to help these patients, and Cleveland Clinic recently participated in a Phase 2 placebo-controlled dose-related trial (ASTEROID 1) to investigate the progesterone receptor modulator vilaprisan (Bayer Pharma AG) for this purpose. The study was sponsored by Bayer Pharma AG. Continue reading »

Irregular Sleep During Menopause May be Hard for Older Women’s Hearts

The sleep woes that many women suffer during menopause may be more than a nuisance: New research suggests a link between lost sleep and an increase in risk factors for heart disease and stroke.

When loss of sleep was measured both objectively and subjectively, the researchers found it correlated with a higher risk of plaque buildup in blood vessels and a thickening of artery walls. Continue reading »

When the warrior is a woman

Women comprise about 15% of active-duty military force members and 18% of National Guard and Reserve force members.Women serve in nearly every area of the military—including as fighter pilots, gunners, warship commanders, and military police— in locations stateside and abroad. They serve in every branch of the military. When they are discharged from the military, they become Veterans. At this time, 2.2 million women in the United States are Veterans.1

How many women use VA healthcare services? How is this population characterized?

Since 2000, the number of female Veterans using healthcare services provided by the U.S. Department of Veterans Affairs (VA) has more than doubled, from nearly 160,000 in fiscal year 2000 to more than 390,000 in fiscal year 2013.This growth has outpaced that of male Veterans. Among all female Veterans who served during Operation Enduring Freedom, Operation Iraqi Freedom, and/or Operation New Dawn (OEF/OIF/OND), 59.7% have received VA healthcare.Of this group who have received VA healthcare, 90.6% have used it more than once and 57.0% have used it 11 times or more. In fiscal year 2013, the average age of VA healthcare users was 48 years for women and 63 years for men.2

The VA serves women in every age bracket.Among female VA healthcare users, 43% are aged 18-44 years, 46% are aged 45-64 years, and the remainder are aged 65 years or older. Reproductive-aged women Veterans receive the gynecologic and obstetric care they need, and those in the menopausal years, many of whom served during the Vietnam or Gulf War eras, can rely on receiving more intensive healthcare because of their age.

In fiscal year 2012, 57% of women Veteran VA patients had some level of service-connected (SC) disability—that is, an injury or illness that occurred or worsened during service in the military.3 If a Veteran receives SC disability status, her SC disability is then assessed and rated for severity from 0% to 100%. In fiscal year 2012, 30% of women Veteran VA patients had an SC disability rating of 50% or higher.2

Women Veterans have higher physical and mental health burdens than their non-Veteran counterparts, as well as health burdens equal to or worse than those of male Veterans.They have substantial chronic disease and mental health problems; top diagnoses include post-traumatic stress disorder (PTSD), hypertension, depression, hyperlipidemia, chronic low back pain, gynecologic problems, and diabetes mellitus (DM). Among female OEF/OIF/OND Veterans, 20% have been diagnosed with PTSD and 20% have responded “yes” when screened for military sexual trauma (MST).1 In addition, women are the fastest growing segment of the homeless Veteran population, and are more likely to be homeless with children.

Recent research shows substantial co-morbidities among women Veterans, with 31% having physical and mental health conditions (vs. 24% of male Veterans). For example, among female Veterans with DM, 45% have a co-morbid serious mental illness or substance use disorder. Among female Veterans with cardiovascular disease, 21% have major depressive disorder.

Certain health risks may depend on the era of service.1,5,6 For example, women who served during the Vietnam War may present with diseases related to exposure to Agent Orange, such as Hodg kin’s disease, multiple myeloma, certain softtissue sarcomas, respiratory cancers, non-Hodgkin’s lymphoma, peripheral neuropathy, type 2 DM, Parkinson’s disease, and ischemic heart disease. Those who served during the Gulf War may present with chronic fatigue syndrome, fibromyalgia, gastrointestinal disorders, fatigue, skin disorders, headache, muscle pain, joint pain, neurologic or neuropsychological signs or symptoms (S/S), sleep disturbances, cardiovascular S/S, abnormal weight loss, or menstrual disorders. OEF/OIF/OND Veterans may be more likely to present with musculoskeletal and connective tissue disorders, mild depression, major depression, and readjustment difficulties.

Do women Veterans seek healthcare outside the VA system? What do providers need to know?

Approximately 83% of women Veterans seek healthcare outside the VA, either exclusively or along with the care that they receive from VA providers.7 Many healthcare providers (HCPs) may not realize that their patients are Veterans. Because such a large proportion of female Veterans receive healthcare outside the VA, either at academic centers or in private community practices, HCPs need to understand these women’s unique needs.

What can HCPs do? Because many female Veterans do not always identify themselves as such, HCPs should ask their patients “Have you served in the military?” If the answer is yes, HCPs should obtain a military history (branch of military, dates of service, occupation, deployment, reason for separation), including a description of their experiences in the military, and be familiar with local VA facilities so that they can refer Veterans appropriately. Women are eligible for VA healthcare if they have an honorable discharge and have completed 2 years of active duty service, were deployed in OEF/OIF/OND, or have experienced MST. A Veteran remains eligible for VA healthcare even if actively serving in the Guard or Reserve. Small copayments for some services are required. The sidebars list services available to women Veterans and additional resources.

How has the VA changed the face of women’s healthcare?

The VA created the Women’s Health Program in 1988 to streamline services for female Veterans in order to provide more cost-effective medical and psychosocial care. At that time, 4.4% of Veterans were women. The program was realigned within the Office of Public Health and Environmental Hazards in 2007, which increased the scope to include all women’s services. When the VA made additional alignment changes in 2011, the Women’s Health Program became part of the Office of Patient Care Services (PCS), The program’s name was changed to Women’s Health Services (WHS) in August 2012. Becoming part of PCS opened opportunities for WHS to collaborate with Primary Care, Mental Health, and Specialty Care.

The motto for WHS is “You served, you deserve the best care anywhere!” Women Veterans using VA healthcare services can expect:

• Women Veterans Program Managers to assist them at every facility;

• Comprehensive primary care, mental health services, and emergency and specialty care delivered by proficient and interested providers;

• Privacy, safety, dignity, and sensitivity to gender-specific needs;

• State-of-the-art healthcare equipment and technology;

and

• Pharmacy services by mail-order and online.1 

The goal of the VA is to ensure that every woman Veteran has access to a VA primary care provider (PCP) who can meet all her primary care needs, including gender- specific care. This approach ensures high-quality healthcare, with special emphasis on continuity of care and a strong relationship between PCP and patient.

Under ideal circumstances, female Veterans should receive complete primary care from one Designated Women’s Health Provider (DWHP) at one location.To provide enough DWHPs, along with nursing support, the national WHS office sponsors a 2.5-day national mini-residency program for PCPs and primary care nurses and offers it several times per year. The VA has also developed online training for core topics in women’s health. Every medical facility, including Medical Centers and Community-Based Outpatient Clinics (CBOCs), should have at least two DWHPs. Currently, all VA healthcare systems and 84% of CBOCs have at least one DWHP. These providers have an interest and special expertise in caring for women Veterans, many of whom have multiple physical and mental health co-morbidities.

The VA is working hard to ensure that every woman Veteran has access to the right kind of care at the right time and place. Facilities across the country are adding specialized equipment (e.g., digital mammography, DEXA scans) for women, updating facilities to ensure privacy and security, and expanding staff to provide convenient, equitable care.6

How is the VA addressing gender differences?

Beginning in 2008, the VA started a Women’s Health improvement initiative to focus on gender disparity data.8 Between 2008 and 2011, the VA saw tremendous reductions in gender disparity for many care measures, including Hypertension in Ischemic Heart Disease, A1C Testing for Diabetes, Retinal Exam in Diabetes, Nephropathy Screening in Diabetes, Pneumococcal Vaccine, Colorectal Cancer Screening, Depression Screening, PTSD Screening, and Alcohol Misuse Screening. Despite nationwide emphasis on gender differences in a variety of physical and mental health issues, gender gaps persisted for achieving these goals: LDL <100 in Ischemic Heart Disease, addressing A1C >9 in Diabetes, LDL <100 in Diabetes, and Influenza Vaccine. Analyses of best practices among VA networks revealed improvement based on education, support of leadership, collaborations among programs (Women’s Health, Primary Care, and Health Promotion Disease Prevention), and systems redesign. Success required multidimensional and multidisciplinary intervention aimed at patients, providers, and systems of care.

Progress is being made. Disparities in the rates of screenings and immunizations given to women and men VA patients are shrinking.8 For example, in 2008, 86% of eligible women Veterans received flu shots versus 94% of men. By 2011, there was only a 1% difference. One hundred percent of VA web pages have at least one topic of interest to women Veterans. Nearly half of these pages link to a facility-specific women’s health page and nearly one-third have images of women.

How does the VA fare with regard to provision of mental health services for women?

The VA provides a comprehensive system of mental health services for all Veterans, including psychological assessment and evaluation, outpatient individual and group psychotherapy, acute inpatient care, and residential-based psychosocial rehabilitation.2 Specialty services target problems such as PTSD, substance use problems, depression, and homelessness.

The VA has outpatient, inpatient, and residential services for women Veterans who have experienced MST and provides free care for all mental and physical health conditions related to MST.2 Veterans may be able to receive this free MST-related healthcare even if they are not eligible for any other VA care. An SC disability rating is not required, nor is the Veteran required to have reported the MST when it happened or have documentation that it happened. Every VA medical center has an MST Coordinator who specializes in this type of care and assists Veterans to access needed care. To accommodate female Veterans who do not feel comfortable in mixedgender treatment settings, many VA medical centers have women only programs or have specialized women’s treatment teams.

The VA offers a variety of programs designed to assist homeless Veterans, including special populations such as women with families.2 Programs include outreach and prevention, temporary and transitional housing, and permanent housing with supportive services. Among the homeless Veteran population, nearly 8% are female.2

The VA has dramatically increased mental health services because of the growing number of women Veterans, who use mental health services in larger numbers than their male counter-parts.Since 2012, more than 1,000 mental healthcare providers and more than 200 administrative support staff were hired, with a goal of hiring 1,600 providers and 300 support staff in 2013 alone.9 Mental health professionals include psychiatrists, psychologists, social workers, mental health nurses, licensed professional mental health counselors, licensed marriage and family therapists, and addiction disorder therapists. In addition, Veterans are being hired as Peer Specialists (up to 800 positions) who provide support to other Veterans. The number of phone lines for the Veteran Crisis Hotline has been increased by 50% to handle the additional volume of phone requests for mental healthcare services.

What type of maternity care does the VA offer?

Many female Veterans who served in OEF/OIF/OND are of reproductive age. Among these women, 81.1% were born in or after 1970 and 54.6% were born in or after 1980.2 With larger numbers of reproductive-aged women Veterans, the VA has recognized the need for expanded maternity care services. Maternity care is provided through outside community providers; costs are paid by the VA.10 The VA covers standard prenatal care, laboratory services, ultrasounds, and delivery costs. If a woman requires specialty care (such as Cardiology) during her pregnancy, her HCP can network within the VA if that service is available. Otherwise, necessary care is handled by other community providers. Each VA Medical Center has a Maternity Care Coordinator who contacts every pregnant Veteran at least every 2 months to review her physical and psychological needs, to ensure that she has the supplies and educational services that she requires, and to keep the Veteran in contact with her primary care and mental healthcare teams as needed. The newborn’s hospital healthcare is covered from birth through 7 days of life.10

What is the VA’s vision with regard to women’s healthcare?

The vision of the VA is to provide the highest quality care to every woman Veteran. Care of the highest quality….

• ensures that each woman Veteran coming to the VA will have her gender-specific primary care needs met by a proficient and interested PCP.

• includes privacy, dignity, and sensitivity to gender-specific needs.

• ensures that healthcare equipment and technology are state-of-the-art.

• ensures gender parity in performance measures.

• provides the right healthcare in the right place at the right time.

• builds necessary efficiencies into the delivery of women’s healthcare.

Each VA facility assesses its needs, strengths, and challenges to create a plan that works for its population of women Veterans, its areas of expertise, and its facilities, equipment, and staffing capacity. The VA is committed to exploring new approaches and pilot programs, all of which are designed to raise the standard to provide the best care anywhere.11 Beyond healthcare, the VA has a full range of benefits for women Veterans, including education and job training, vocational rehabilitation, benefits assistance, home loans, life insurance, and survivor and death/burial benefits.1 The VA is encouraging everyone to rethink the term Veteran (that former warrior might be a woman), to recognize the vital role women play in the military, and to appreciate what it means to be a woman Veteran.

Patrice C. Malena is Women Veterans Program Manager at Hampton VA Medical Center in Hampton, Virginia. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article. The content of this article does not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

References

1. Department of Veterans Affairs. Women Veterans Health Strategic Health Care Group. A Profile of Women Veterans Today. Rethink Veterans: Who is the Woman Veteran? April 2012.

2. Department of Veterans Affairs. Office of Public Affairs Media Relations. Women Veterans Health Care Fact Sheet. Updated July 2014.

3. Department of Veterans Affairs. Sourcebook: Women Veterans in the Veterans Health Administration, Volume2: Sociodemographics and Use of VHA and Non-VA Care (Fee). October 2012.

4. Department of Veterans Affairs. Report of the Under Secretary for Health Workgroup. Provision of Primary Care to Women Veterans. November 2008.

5. Department of Veterans Affairs. Office of Public Affairs. Federal Benefits for Veterans, Dependents and Survivors. Last updated April 21, 2015.

6. Department of Veterans Affairs. Women Veterans Health Strategic Health Care Group. On the Frontlines of VA Women’s Health: Enhancing Services for Women Veterans. August 2011.

7. Women Veterans Health Care. Resources for Non-VA Providers, Medical Students. Page last updated June 3, 2015.

8. Department of Veterans Affairs. Women Veterans Health Strategic Health Care Group, Office of Patient Care Services. Gender Differences in Performance Measures VHA 2008-2011; June 2012.

9. Department of Veterans Affairs. Office of Public and Intergovernmental Affairs. VA Hires More Mental Health Professionals to Expand Access for Veterans. February 11, 2013.

10. Department of Veterans Affairs. Women Veterans Health Care. FAQs. June 3, 2015.

11. Department of Veterans Affairs. Women Veterans Health Strategic Health Care Group. Guide to Moving Forward in Providing Comprehensive Health Care to Women Veterans. August 2008.

Strategies for effective group prenatal care with pregnant adolescents

Most females receive prenatal care via a traditional model focused on screening for health-related complications. A healthcare provider (HCP) offers this care on an individual and regular basis throughout the pregnancy. At minimum, each visit involves assessment of maternal weight and blood pressure (BP), fundal height, and fetal heart rate. The initial visit is more comprehensive than subsequent visits, and includes taking a personal and family history, conducting a complete physical examination, and ordering laboratory tests. Education is provided about prenatal care and avoidance of risky behaviors. Subsequent visits include screening for problems and provision of information about nutrition, pregnancy complications, childbirth, and infant care. When indicated, special fetal assessment tests may be recommended and the need for genetic counseling discussed.1

In 1993, CenteringPregnancy (CP) was introduced as an alternative model for delivering prenatal care.2,3 The CP model provides comprehensive prenatal care to small groups of women at similar points in their pregnancies. For participants in this group prenatal care (GPC) program, learning and support are enhanced by group dynamics and by the HCP’s leadership.Compared with traditional care, CP has been associated with improved patient satisfaction, knowledge, and attendance; similar or superior maternal/newborn health outcomes; and greater affordability.4-10

The advent of the Affordable Care Act of 2010, with its provision of access to healthcare for additional millions of Americans, has created a distinct need for innovative, cost-effective, high-quality prenatal care models. GPC can be both safe and affordable, provided at convenient times for better access, and directed at meeting a group’s special needs. GPC is ideal for pregnant adolescents: Management of adolescent pregnancy in group settings has been shown to foster optimal maternal and neonatal outcomes.4-7,11,12 The authors, with many years’ experience in delivering prenatal care to adolescents using the group model, discuss their own program.

Background information on CenteringPregnancy

The authors’ adolescent GPC approach was based on principles of CP. According to Rising,developer of CP, attending prenatal sessions can result in better pregnancy outcomes, with less maternal stress, lower rates of substance abuse, improved labor progress, higher infant birth weights, and higher 5- minute Apgar scores. The CP model, which includes essential components of traditional prenatal care within a group framework, integrates three major components of prenatal care: health assessment, interactive learning, and community building.13 CP groups comprise 8-12 females at similar points in their pregnancies. After a one-onone prenatal visit with an HCP, participants attend regular group sessionslasting 1.5-2 hours, usually held in the late afternoon or early evening, for the remainder of their care. The sessions, typically led by an HCP and a nurse, meet every 4 weeks until the 28th week and then every 2 weeks until delivery.

At the start of every group session,

each participant has a quick

private visit with a nurse and an

HCP for checks of weight, BP, fundal

height, and fetal heart tones

and for an opportunity to ask personal

questions. During this time,

the other participants chat or

watch an educational video. Once

individual checks are done, the

group session begins. Topics discussed

include nutrition, exercise

and relaxation, discomforts of

pregnancy, childbirth preparation,

infant care and feeding, postpartum

concerns, contraception,

communication/self-esteem, and

parenting skills. Participants are

encouraged to ask questions,

which can help others with similar

concerns,12 and they are invited to

bring a partner or a family member.

Additional prenatal visits are

necessary only if problems with

the pregnancy arise or if a participant

requires a confidential private

exam.

The CP structure comprises 13

essential elements,14 which are

also used in the authors’ prenatal

program: (1) Health assessment occurs

within the group space; (2)

Women are involved in self-care activities;

(3) A facilitative leadership

style is used; (4) Each session has

an overall plan; (5) Attention is

given to the core content, but emphasis

may vary; (6) There is stability

of group leadership; (7) Group

conduct honors the contribution of

each member; (8) The group is conducted

in a circle; (9) Group composition

is stable but not rigid; (10)

Group size is optimal to promote

the process; (11) Involvement of

family support is optional; (12) Opportunity

for socializing within the

group is provided; and (13) There is

ongoing evaluation of outcomes.

Primary differences between CP

and traditional prenatal care are

the time spent in care and the opportunity

for group interaction.

Traditional visits usually last

5-10 minutes, whereas CP visits

are about 90 minutes long. This

amount of time allows participants

Quiz Time February 2016

CDC follow-up guidelines after treatment for sexually transmitted diseases include:
a) Perform test of cure on all pregnant females 3-4 weeks after treatment for chlamydia.
b) Retest females and males 3 months after treatment for chlamydia or gonorrhea to detect repeat infection.
c) Retest females 3 months after treatment for trichomoniasis to detect repeat infection.
d) All of the above

The correct answer is d.

To find out more, read “Sexually transmitted diseases: An update on retesting guidelines and reinfection prevention strategies.”  See the February 2016 Issue here

Text message reminders to increase breast self-awareness practices in young women

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By Tara Fernandez Bertulfo, DNP, ARNP

Text message reminders were studied as an innovative, low cost method of improving adherence to monthly breast self examination/breast self-awareness among college-aged women. Results of this pilot study are presented and discussed in this article.

KEY WORDS: breast cancer, breast self-examination, breast self awareness, text message reminder, college-aged women

Each year in the United States, more than 200,000 women are diagnosed with breast cancer.1 Aside from nonmelanoma skin cancer, breast cancer is the most common form of cancer in women. Breast cancer is the No. 1 cause of cancer death in Hispanic women and the second most common cause of cancer death in women in all other ethnic groups in the U.S2

The major strategy to reduce breast cancer mortality is early detection. Breast cancers found during regular screening examinations, as opposed to those found because of symptoms, are more likely to be smaller and still confined to the breast; these two factors are the most important in determining prognosis.3 Early detection techniques include screening modalities such as mammography, clinical breast examination (CBE), breast self-examination (BSE), and breast self-awareness (BSA).

Breast self-examination

Breast self-examination, taught to women for years, consists of sequential steps (done in the shower, before a mirror, and lying down) and observations for changes or inconsistencies from one breast to the other.4 Premenopausal women are advised to perform BSE once a month—about 1 week following menses.

Breast self-awareness 

More recently, there has been a movement toward teaching BSA, a less formal approach to breast cancer self-screening. This approach places less emphasis on technique and timing and more  emphasis on a woman’s ability to be familiar with the look and feel of her breasts so that she can be alert to any changes that may occur and seek further evaluation by a healthcare provider (HCP).

With BSA, no formal method for examining the breasts is taught. Instead, women are encouraged to know their family history, understand risk reduction strategies, and be observant for any changes in their breasts by periodically viewing and feeling the entire area, including the breasts, collarbone, and underarms.5 To practice breast self-awareness, a woman is instructed to be alert to changes such as (a) a lump, hard knot, or thickening inside the breast or underarm area; (b) swelling, warmth, redness, or darkening of the breast; (c) change in the size or shape of the breast; (d) dimpling or puckering of the skin; (e) itchy, scaly sore or rash on the nipple; (f ) pulling in of the nipple or other parts of the breast; (g) nipple discharge that starts suddenly; or (h) pain in one spot that does not go away.6

Because BSE efficacy is controversial (related to inadequate evidence of lowered mortality as a result of its use), other than CBE, being breast aware is the only method that most women younger than 40 can use to screen
for breast cancer. Under ideal circumstances, HCPs should start educating and encouraging women to begin self-screening in early adulthood, before breast cancer risk begins to rise. The American Cancer Society,7 the National Comprehensive Cancer Network,8 the American Congress of Obstetricians and Gynecologists,9 and the Susan G. Komen Foundation6 now endorse BSA as an alternative to BSE.

Of note, women younger than 40 who have an increased risk for breast cancer (e.g., because of family history, a known genetic mutation, or a history of chest radiation) have different screening recommendations that include,
but are not limited to, CBE and BSA. Women who are older than 40, who may be having regular mammograms, should still be encouraged to remain breast aware.

Self-screening reminders

Multiple national and international studies have evaluated breast self-screening behavior.10-13 Commonly reported reasons for not performing the recommended self-screening are forgetting or being too busy.10,12,14 Many strategies to remind women to self-screen, including shower cards, oral contraceptive packaging, and, more recently, smartphone applications, have been used. However, among collegeaged women, one strategy that has not been widely tested is use of a text message reminder (TMR). With this strategy, a monthly text message reminds a woman to take a few minutes to focus on her breast health.

Several studies examining the use of text messaging in healthcare have shown that TMRs improve outpatient clinical attendance,15 improve adherence to asthma treatment,16 encourage weight loss,17 improve adherence to daily intake of vitamin C supplements,18 and support patients with diabetes.19 A study by Armstrong et al20 evaluated the effect of TMRs on adherence to sunscreen application among 70 participants from the general community. Throughout the 6-week study, half the participants received daily TMRs and half did not. TMR recipients, versus the controls, were nearly twice as likely to maintain a regimen of daily sunscreen use throughout the study period.

Text message reminders are easy to implement and may be particularly appealing to younger people, an important target population for the development of positive health habits. With this in mind, and with the goal of promoting monthly breast cancer self-screening in early adulthood, the investigator recruited college-aged women for
this pilot study. Pre- and post-intervention questionnaires were used to assess participants’ baseline selfscreening frequency and beliefs regarding its importance; their perceptions of the usefulness and acceptability of the TMR; and whether they performed selfscreening following its receipt.

Pilot study

Methods
A pilot project using a descriptive, one-group, pre-test/post-test study design was conducted to explore the usefulness and acceptability of a TMR to perform BSE.* The study was approved by the Institutional Review Boards at the institution where the investigator was a student and at the site where the study was conducted.

Participants and setting
A convenience sample (N = 62) was recruited from first-year, second-semester, baccalaureate nursing students
enrolled in nursing classes at a southern university. These students were chosen because they were in the age group of interest and because they had been previously instructed in BSE. As such, the study questions did not need to focus on whether participants knew how to examine their breasts, whether they had been formally taught this technique, or whether they felt comfortable with their skills in this area.

Procedure
After providing written informed consent, participants completed a self-administered baseline questionnaire and demographic form. The questionnaire, developed by the investigator, was used to establish the frequency with which the participants performed BSE, as well as their beliefs about BSE. Along with written informed consent, participants provided a mobile phone number to receive a text message and authorized the investigator to send them a TMR. The investigator then manually entered the mobile phone numbers into the Google Voice website. One week later, the investigator sent a text message, Time for your monthly breast self-exam, to each participant simultaneously via Google Voice.

About 1 month after the TMR was sent, participants were asked to complete a follow-up questionnaire developed by the investigator. The questionnaire was used to ascertain whether participants performed BSE, as well as their perceptions of the effectiveness and acceptability of the TMR.

Results
Demographic characteristics of the sample are shown in Table 1. Mean age of the participants was 22 years (SD, 1.44). Most participants were white, never-married women who did not have a family history of breast cancer. Data on BSE behaviors were collected from all participants at baseline (Table 2). Among the 34 participants who reported not having performed BSE in the past 3 months (n = 32) or who were uncertain about it (n = 2), reasons for not doing so included I forgot (n = 15), I don’t think about it (n = 15), I’m not sure what I’m feeling (n= 3), I’m too busy (n = 1), and I’m too young (n = 1).

Table 1

White spaceWhite space

Table 2 White space

White space

Table 3 shows participants’ beliefs about BSE at baseline. Among 11 beliefs examined, those with which participants agreed most strongly included the following: It is important to begin breast health screening at a young age; When a breast lump is found early, it is easier to treat; BSE is a valuable tool that can detect breast cancer earlier; BSE is quick and easy to do; and The women in my family would want me to perform BSE. Beliefs with which participants disagreed most strongly were as follows: I am too young to get breast cancer; and Breast self-exam is not necessary at my age.

Table 3

Overall performance of BSE increased significantly following the TMR (Table 4). When the 62 participants were asked whether the TMR helped them follow their plan to perform BSE, 47 (75.8%) agreed or strongly agreed with the statement, 9 (14.5%) disagreed, and 6 (9.7%) were uncertain. When asked whether they felt that the TMRs would help them make BSE part of their usual self-care routine, 58 participants (93.6%) agreed or strongly agreed.

Table 4

Of note, participants with a family history of breast cancer were no more likely than those without such a history to perform BSE after receiving the TMR. In addition, no association was found between whether or not participants
reported My healthcare provider encourages me to be aware of changes in the look and feel of my breasts and whether they performed BSE following the TMR.

Discussion
The baseline data showed that participants believed BSE was important for women in their age group. Nevertheless, 50% of participants had not performed BSE in the previous 3 months, with most reporting that they did not do so because they forgot or did not think about it. This study confirms findings from previously mentioned studies about the use of TMRs to improve adherence to health-promoting behaviors.

Although most participants found the TMR acceptable, helpful, and easy to use, the timing of the TMR was found to be an important factor in terms of both the decision to perform BSE (or not) and the amount of time between receiving the TMR and performing BSE. In consideration of this important finding, methods for allowing patients to choose the timing of a TMR should be considered for use in practice. This approach may help decrease the number of women who forget to perform BSE following the TMR, who have another priority at the time that the TMR is received, or who report the timing of the TMR as inconvenient.

Now that this trial is complete, women who were satisfied with the TMR were asked to inform their friends about it so that they, too, could register for the service. A plan is in place to promote this idea through student health services by advertising the availability of the TMR to young women who attend the clinic. This approach can help create initial knowledge of the innovation, which can then be reinforced by peer encouragement.

Limitations
This pilot study used a TMR to target forgetfulness; however, many other factors could contribute to non-adherence to BSE. Use of a control group would have strengthened the rigor of the study and will be considered for future research based on this pilot work. In addition, the sample for this study comprised nursing students from one southern university BSN program. Applicability of the findings to the general population of college-aged women is
unknown.

Implications for practice
In addition to promoting breast self-screening, TMRs could be used to help promote other aspects of health in young women. Text messages can remind young women of a return appointment for a DMPA injection, for chlamydia re-screening in 3 months following treatment, for annual checkups, and the like. These reminders can be implemented by college health centers, private offices, public health clinics, or any clinical setting that serves young women. Because TMR recipients would be providing their mobile phone numbers and granting permission for TMRs to be sent, and because no personal health information would be provided in these simple reminders, this system would not compromise HIPAA standards, particularly with regard to a reminder to self-screen for breast cancer. If a woman decides to receive multiple TMRs, and a particular reminder concerns a potentially sensitive situation such as a DMPA injection or chlamydia rescreening, the wording of the text message could be coded rather than explicit.

At the first clinic visit, the use and benefits of TMRs could be explained to the patient. The patient could then be asked (1) for permission to receive TMRs, (2) to provide a mobile phone number for this purpose, and (3) whether she prefers a specific day of the week or time of day to receive a TMR. At each subsequent visit, the patient could be asked to verify her mobile phone number and her preferences for the timing of TMRs.

Ease of implementation is a key factor for HCPs in a college health setting or other outpatient setting. Through use of Google Voice, one can send a large number of text messages at once free of charge. Text messages can be sent via Google Voice directly using a Google account; sent and received via email or IM interface by reading
and writing text messages in Gmail; or by adding contacts’ phone numbers in Google Talk (PC-to-phone texting). In addition, automated text message services send group text messages for a set fee, which decreases the amount of time required to send the TMRs and allows HCPs the opportunity to choose when the message will be sent.

Conclusion

Text message reminders are an innovative, easily implemented strategy that may increase adherence to breast cancer self-screening recommendations, as well as other self-care practices among college-aged women. Through use of current technology such as text messaging, HCPs can play a key role in endorsing positive health habits that may promote wellness in young women for a lifetime.

Tara Fernandez Bertulfo is a women’s health nurse practitioner and Clinical Assistant Professor at Georgia Baptist College of Nursing, Mercer University, in Atlanta, Georgia. 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. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute.
What You Need to Know About Breast Cancer (NIH Publication No. 09-1556). 2012. cancer.gov/cancertopics/
insides-wyntk-breast.pdf

2. Centers for Disease Control and Prevention. Breast Cancer Statistics. 2014. cdc.gov/cancer/breast/statistics/

3. American Cancer Society. Breast Cancer: Early Detection. 2014. cancer. org/acs/groups/cid/documents/
webcontent/003165-pdf.pdf

4. National Breast Cancer Foundation. Breast Self-Exam. 2012. nationalbreastcancer. org/breast-self-exam

5. M.D. Anderson Cancer Center. Breast Self Awareness. 2012.

6. Susan G. Komen Foundation. Breast Self-Awareness. 2015. komen.org/BreastCancer/Breast-SelfAwareness.html

7. American Cancer Society. Breast Cancer Prevention and Early Detection. Breast awareness and self-exam.
2014. cancer.org/cancer/breastcancer/moreinformation/breastcancerearlydetection/breast-cancerearly-detection-acs-recs-bse

8. National Comprehensive Cancer Network. Stage 0 Breast Cancer. NCCN Guidelines for Patients. 2014. nccn.org/patients/guidelines/stage_0_breast/files/assets/common/downloads/files/stage_0_breast.pdf

9. American Congress of Obstetricians and Gynecologists. Breast Screening: Mammography and Breast Self-Awareness. 2012. acog.org/Patients/FAQs/Breast-Screening-Mammography-and-Breast-Self-Awareness

10. Budden L. Registered nurses’ breast self-examination practice and teaching to female clients. J Community
Health Nurs. 1998;15(2):101-112.

11. Friedman LC, Nelson DV, Webb JA, et al. Dispositional optimism, self efficacy and health beliefs as predictors of breast self-examination. Am J Prev Med. 1994;10(3):130-135.

12. Mason TE, White KM. The role of behavioral, normative and control beliefs in breast self-examination.
Women Health. 2008;47(3):39-56.

13. Tavafian SS, Hasani L, Aghamolaei T, et al. Prediction of breast selfexamination in a sample of Iranian
women: an application of the Health Belief Model. BMC Womens Health. 2009;9(37):1-7.

14. Ahuja S, Chakrabarti N. To determine the level of knowledge regarding breast cancer and to increase
awareness about breast cancer screening practices among a group of women in a tertiary care hospital in
Mumbai, India. Internet J Public Health. 2009;1(1).

15. Koshy E, Car J, Majeed A. Effectiveness of mobile-phone short message service (SMS) reminders for ophthalmology outpatient appointments: observational study. BMC Ophthalmol. 2008;8:9.

16. Strandbygaard U, Thomsen SF, Backer V. A daily SMS reminder increases adherence to asthma treatment:
a three-month follow-up study. Respir Med. 2010;104(2):166-171.

17. Patrick K, Raab F, Adams MA, et al. A text message based intervention for weight loss: randomized controlled
trial. J Med Internet Res. 2009;11(1):e1.

18. Cocosila M, Archer N, Haynes RB, Yuan Y. Can text messaging improve adherence to preventive activities?
Results of a randomized controlled trial. Int J Med Inform. 2009; 78(4):230-238.

19. Waller A, Franklin V. Pagilari C, Greene S. Participatory design of a text message scheduling system to
support young people with diabetes. J Health Inform. 2006;12(4):304-318.

20. Armstrong AW, Watson AJ, Makredes M, et al. Text-message reminders to improve sunscreen use. Arch Dermatol. 2009;145(11):1230-1236.

*Because the terms breast self-examination, breast self-exam, and BSE are more widely recognized than the newer terms breast self-awareness and BSA, a decision was made to use the former terms in the questionnaires and TMR. In addition, because both BSE and BSA are tools that women can use to screen themselves for breast cancer, the specific technique used by the study participants to examine their breasts was not evaluated, and no distinction between the two screening methods was made.

Reproductive life plans among Spanish-speaking Hispanic women in the U.S.

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By Pamela E. Xandre, DNP, WHNP, FNP; Salma Shabaik, MD; and Anita L. Nelson, MD

Pregnancy and pre-conception care (PCC) are major concerns for reproductive-aged women. Although researchers are beginning to find an association between women’s intendedness of pregnancy and their reproductive health-related behaviors, little is known about this topic with respect to Hispanic women in the United States who speak only Spanish. The authors report findings from interviews with 263 members of this population to ascertain their thoughts regarding reproductive life plans and two other topics of interest—PCC and the danger of oral contraceptive use versus pregnancy.

Key words: reproductive life plan, Hispanic women, intendedness of pregnancy, pre-conception care

The ability to choose whether and when to bear children is a fundamental aspect of reproductive health. Yet for more than a decade, about one-half of all pregnancies in the United States have been unintended.1 This statistic represents an average; the proportion of unintended pregnancies varies substantially by demographic group. For example, when compared with non-Hispanic white women, Hispanic women have higher rates of unintended pregnancy, unintended births, and abortions and lower rates of contraception use.2 Rates of unintended pregnancy are substantially increased among poor and low-income women and decreased among higher-income women.2 Poor women are more likely than other women to have unprotected intercourse, and when they do use contraception, they report markedly higher rates of method failure.3,4

Although the reasons are not fully understood and are likely complex, ethnicity, race, culture, and
socioeconomic status all affect decision making about pregnancy and contraceptive use. These factors, alone or in combination, can facilitate or compromise a woman’s ability to formulate a reproductive life plan (RLP) and to meet her RLP goals. These factors can also affect a woman’s knowledge and decisions about pursuing pre-conception care (PCC).

Background

Between 2000 and 2010, the Hispanic population in this country grew by 43% and now comprises 16% of the total U.S. population.5 Compared with non-Hispanic women, Hispanic women have higher rates of unintended pregnancy and lower rates of contraception use. The growing Hispanic population in the U.S. means that healthcare providers (HCPs) will see more and more Hispanic women in their practices and need to know how to help these women make informed decisions about RLPs, use effective contraception when pregnancy is not desired, and obtain PCC to optimize pregnancy outcomes.

Several studies have sought to provide insight into the factors that influence Hispanic women’s decisions about and effective use of contraception. These factors include knowledge about contraception, level of acculturation, attitudes toward planning a pregnancy and toward unintended pregnancy, and attitudes and biases of their HCPs.1,6-8 However, these studies have not focused on Hispanic women who speak only Spanish, or on factors that might influence their RLPs and related decision making about contraceptive use and PCC.

The State of California provides comprehensive family planning and reproductive health services to low-income residents through Family Planning, Access, Care, and Treatment (Family PACT), a federally funded program. In 2010, Family PACT provided services to 1.8 million women and men.9

A sizable proportion of Family PACT clients are Hispanic women who speak only Spanish because they are recent immigrants to this country. This study was conducted with a sample of Spanish-speaking Hispanic women seen at a Family PACT clinic for contraceptive care to explore various aspects of the participants’ RLPs. This study was the first to use CDC guidelines on RLPs and PCC10 as a basis to explore these practices in female members of this ethnic group.

Purpose of study

With the ultimate goal of optimizing women’s health and knowledge before conceiving, the investigators designed a structured interview to determine whether a convenience sample of reproductive-aged, Spanish-speaking women seeking care in a family planning clinic had formulated RLPs. Definitions used by the American College [now Congress] of Obstetricians and Gynecologists (ACOG)11 and in the CDC guidelines for RLPs and PCC10 provided the basis for the interview questions posed in this study.

  • A reproductive life plan is defined as a strategy based on a woman’s values and resources to achieve a set of goals about having children, including whether to get pregnant, when to get pregnant, and how many children to have in her lifetime.10 The RLP includes a strategy for effective contraceptive use and options if pregnancy is not desired at all.
  • Core pre-conception care involves assessment of a woman’s undiagnosed, untreated, or poorly controlled health conditions; immunization history; medication use; nutritional concerns; genetic risks; substance use; and occupational or environmental exposures prior to conception.11

The investigators sought to answer three questions: (1) Do these women have RLPs? (2) Do they think that women should plan and prepare for pregnancy? and (3) How do they compare the health risks posed by use of birth control pills versus those posed by pregnancy?

Methods and materials

Approval to conduct this study was obtained from the John F. Wolfe Human Subjects Committee and the Research Committee of the Los Angeles Biomedical Research Institute. A 3- to 5-minute interview tool was developed and piloted with 25 potentially eligible women to determine understandability in Spanish and to correct questions that might be confusing. Questions about personal information and RLPs had single answers, and those about pregnancy planning and preparation were open ended (Box).

Neither the term reproductive life plan nor the abbreviation RLP was used when interviewing study participants. Instead, the investigators asked participants how many children they wanted to have and when they wanted to have them. Provision of answers to these questions was considered evidence that a woman had envisioned some form of an RLP for herself. With regard to the question about risks posed by oral contraceptive (OC) use versus pregnancy, the investigators chose to use the term birth control pill as a proxy not only for OCs but for all hormonal contraceptives because they believed that participants would be most familiar with this term.

Interviews were conducted from January 2013 through November 2013 by one of the authors whose first language is Spanish (PX). Prospective participants were approached in the waiting area of the Women’s Health Care Clinic at Harbor UCLA, which provides all types of birth control products to low-income women for free. Women were eligible for the study if they were non-pregnant, Spanish speaking, at least 18 years of age but premenopausal, and at risk for pregnancy. Exclusion criteria were prior hysterectomy or tubal sterilization and lack of ability to give consent. An explanation of the study—including any risks or benefits, assurances of confidentiality, and an option to withdraw at any time without consequences—was read to prospective participants in Spanish. Because the project was an interview with no personal identifiers and no interventions, the Institutional Review Boards approved a waiver of informed consent signature. If a woman gave verbal consent to participate, she was taken to an adjacent private area for the interview. The interviewer used a standard script to ensure uniformity of interview administration and to enable all the data to be merged.

Demographic information was solicited to characterize the study sample. Questions were read aloud and participants’ answers documented verbatim. Participants who did not mention any medical measures in their answer to the question of whether a woman should plan and prepare herself for pregnancy were asked a follow-up question about anything they thought a woman should do medically to plan and prepare for a pregnancy. Medical measures, as described in the CDC guidelines, entail pre-conception screening for health conditions and practices associated with adverse pregnancy outcomes (e.g., obesity, hypertension, smoking).10 The intent of the guidelines is to identify and modify risks before conception occurs. If a participant did not mention any of these medical measures or others, she was asked, Is there any reason for a woman to see a healthcare provider before getting pregnant?

Three investigators placed the participants’ answers to the question about the content of PCC into one of five categories: social, personal, financial, psychological, or medical. Of note, although social, financial, and psychological planning are parts of PCC, this study was designed, at least in part, to find out whether women would include medical measures as part of PCC. If the participants responded with answers that fell into more than one category, each category was tallied. The three investigators had 100% agreement on all category assignments.

Results

A total of 265 women whose primary spoken language was Spanish were approached to participate in the survey. No woman declined, but 2 were excluded because they were surgically infertile; therefore, data for this study were derived from 263 women.

Mean age of the sample was 34 years (range, 18-50 years). Among 263 participants, 4 (1.5%) were younger than 20, 54 (20.5%) were aged 20-25, 42 (15.9%) were aged 26-30, 48 (18.2%) were aged 31-35, and 115 (43.7%) were older than 35. Mean duration of formal education was 10 years (range, 0-18 years). Parity ranged from 0 to 7 births (mode, 2). The time that each woman took to respond to the question about her age was used as the comparator for the speed with which she answered questions about her RLP. Answers to questions were classified as “rapid” if a woman’s response time was at least as fast as when she answered the question about her age, “delayed” if they were more slowly provided, or “unsure” if a woman was unable to provide an answer.

Reproductive life plan

A total of 239 (91%) of the participants said that they knew how many children they wanted to have in their lifetime; among this group, nearly half wanted at least 3 children. A total of 226 women (85.9%) answered this question rapidly, 35 (13.3%) delayed their answers, and 2 (0.8%) were unsure. The 122 women who said that they wanted more children were asked how soon they wanted to become pregnant. Their responses and the speed/assurance of their responses (rapid, delayed, unsure) appear in Table 1.

Table 1

Birth control methods used by these participants were grouped by tiers of efficacy as defined by first-year failure rates in typical use.12Tier I methods include implants, intrauterine devices, and abstinence. Tier 2 methods include pills, patches, vaginal rings, and injections. Tier 3 methods include barrier methods and behavioral methods. Fewer than 20% of women who wanted to delay pregnancy for at least 3 years reported use of tier I methods (Table 2).

Table 2

Pre-conception care

A total of 252 participants (95.8%) said that a woman should plan and prepare for pregnancy. But when asked how a woman should prepare, only 10.7% provided answers that fell into the category of medical care. More than half of the answers related to financial preparation (26.4%) or mental preparation (26.7%). The remainder of the answers pertained to social preparation (6.3%) or other concerns (13.3%). Even when asked Do you think that there is anything the woman should do to prepare medically for pregnancy? only 2% of the women who had not initially spoken of the need for any medical preparation mentioned PCC at this second opportunity.

Hazards of OC use versus pregnancy

In the last section of the interview, 188 (71.5%) of the participants said that birth control pills were at least as hazardous to a women’s health as pregnancy, whereas only 56 (21.3%) knew that pregnancy was more dangerous than taking birth control pills. Nineteen subjects (7.2%) reported that they did not know which situation was more hazardous.

Discussion

Results of this study suggest that these traditional Hispanic women tended to prize relatively larger families—as compared with the average number of children in U.S. families (~2.4, depending on various definitions of a family by the 2010 Census Bureau).13 Most participants appeared certain about the number of children they wanted and how soon they wanted their next pregnancy. Nevertheless, fewer than one-fifth of those who wanted to delay their next pregnancy for 3 or more years were using a Tier 1 contraceptive method. About one-third were using the least effective Tier 3 methods.

Hispanic women, relative to their non-Hispanic counterparts, know less about reproduction and contraception use, which may partly account for their significantly lower rates of contraceptive use.3,4 Although the findings regarding the use of less effective contraceptive methods by Hispanic women are consistent with other existing research, the purported causes demonstrate that pregnancy planning and contraceptive decision making go beyond simple knowledge. A recent study conducted in Texas, another state with a large Hispanic population, related Hispanic women’s use of less effective contraceptive methods or inconsistent use of methods to their ambivalence about pregnancy.6 In this study, as many as one-third of participants who claimed they wanted no more children still said they would feel very happy or somewhat happy about becoming pregnant in the next 3 months.6 Another study on contraceptive use among young Hispanic women conducted in southeast Texas showed that women low in acculturation (defined by the language portion of the Short Acculturation Scale for Hispanics), compared with women high in acculturation, were more likely to use no contraception or cyclic contraception rather than Tier 1 methods.7 A study by the National Latina Institute for Reproductive Health showed that a large majority of Hispanic women do not use contraception consistently because of economic barriers and deeply rooted cultural and religious influences.2

When asked whether a woman should plan and prepare herself for pregnancy, nearly 96% of the participants responded in the affirmative. However, when asked how a woman should do so, fewer than 11% mentioned anything related to medical aspects of planning and preparation even when prompted. More than 89% gave answers related to psychological, financial, or social planning and preparation. Monitoring a woman’s pre-conception health was not mentioned. Based on these women’s responses, this study population seemed relatively unfamiliar with the importance of medical care prior to becoming pregnant to identify, intervene with, and monitor pre-conception risk to improve pregnancy outcomes. No other studies looking specifically at Hispanic women’s knowledge or attitudes related to PCC were found.

When asked whether they thought birth control pills or pregnancy was more hazardous to a woman’s health, more than 70% of participants chose the former—even though pregnancy is far more dangerous than use of any of the hormonal contraceptives.14 These women, like most U.S. wom­en, believe that pregnancy is a natural process that could not possibly be riskier to their health than hormonal contraceptive use. In fact, a study of English-speaking, reproductive-aged women’s knowledge of the health risks of pregnancy versus those risk of OC use showed the same misconceptions.14 Even the more highly educated, affluent women in this study considered OC use more hazardous than pregnancy.

Study limitations

Generalizability of these study findings is limited. The data were derived from an interview of Hispanic women, many of whom were recent immigrants to the U.S., at a single clinic for low-income women. The results do not represent women in general or Spanish-speaking Hispanic women. Another concern is that more than half (53.6%) of these participants had completed their families and wanted no more pregnancies. However, this subgroup provided the investigators with important insights into the mismatch between their pregnancy plans and their selection of less effective contraceptive methods.

Practice implications

This survey revealed three important points. First, HCPs need to be aware that many Spanish-speaking women may not have clearly defined their fertility goals. Rather than asking a woman whether she plans to get pregnant in the next year, HCPs should ask, How would you feel if you were to get pregnant in the next year? Her answer may reveal her commitment or ambivalence regarding pregnancy prevention, which is important to know when prescribing a user-dependent birth control method. For women seeking contraception who are ambivalent about pregnancy prevention, HCPs may want to plan for follow-up to address any concerns that might arise during early use of the method.15

Second, HCPs need to directly address women’s concerns about contraceptive safety.7,12 HCPs should assess each woman’s contraceptive experiences and preferences. This assessment may help uncover misconceptions, fears, or the influences of others on her contraceptive decision making.15 Use of less effective contraceptive methods (i.e., those in Tier 3) may reflect her concerns about the safety of using more effective methods (i.e., those in Tiers 1 and 2). Every time HCPs prescribe a particular method, a patient should be informed that this method is safer for her than pregnancy.

Third, to address a Spanish-speaking, reproductive-aged woman’s lack of familiarity with the importance of PCC, HCPs should routinely remind her that, if and when she wants to get pregnant, she should return to have her health status evaluated and to learn what she can do to improve the outcome of the intended pregnancy. Every family planning visit provides an opportunity for pre-conception counseling on healthy lifestyle behaviors and pre-pregnancy management of risk factors and medical conditions that influence pregnancy outcomes.

Conclusion

Lack of pregnancy planning and inconsistency between stated pregnancy plans and effective contraceptive use are common among U.S. women.16 The findings of this study reflect the need to continue to expand HCPs’ understanding of the causes for this inconsistency in both the general population and in specific populations.

Pamela E. Xandre is Assistant Professor at the School of Nursing, California State University, Long Beach. Salma Shabaik is a physician at Family Practice in Long Beach, California. Anita L. Nelson is Professor in the Department of Obstetrics and Gynecology at the David Geffen School of Medicine, University of California at Los Angeles. 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. Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006; 38(2):90-96.

2. Ranjit N, Bankole A, Darroch JE, Singh S. Contraceptive failure in the first two years of use: differences across socioeconomic subgroups. Fam Plann Perspect. 2001;33(1):19-27.

3. Sangi-Haghpeykar H, Ali N, Posner S, Poindexter AN. Disparities in contraceptive knowledge, attitudes, and use in Hispanic and non-Hispanic whites. Contraception. 2006;74(2): 125-132.

4. Schwarz EB, Smith R, Steinauer J, et al. Measuring the effects of unintended pregnancy on women’s quality of life. Contraception. 2008;78(3): 204-210.

5. Humes KR, Jones NA, Ramirez RR. Overview of race and Hispanic origin, 2010. Census Briefs. March 2011. census.gov/prod/cen2010/briefs/c2010br-02.pdf

6. Aiken AR, Potter JE. Are Latina women ambivalent about pregnancies they are trying to prevent? Evidence from the Border Contraceptive Access Study. Perspect Sex Reprod Health. 2013;45(4):196-203.

7. Roncancio AM, Ward KK, Berenson AB. The use of effective contraception among young Hispanic women: the role of acculturation. J Pediatr Adolesc Gynecol. 2012;25(1):35-38.

8. Rocca CH, Harper CH. Do racial and ethnic differences in contraceptive attitudes and knowledge explain disparities in method use. Perspect Sex Reprod Health. 2012;44(3):150-158.

9. California Department of Healthcare Services. Fact Sheet on Family PACT: An Overview. Updated January 2012. familypact.org/Providers/Fact-sheets/2-2012_FamPACT_FS_Overview_2-15ADA.pdf

10. Johnson K, Posner SF, Biermann J, et al. Recommendations to improve preconception health and health care—United States: a report of the CDC/ATSDR Preconception Work Group and the Select Panel on Preconception Care. Morbid Mortal Weekly Rep. 2006;55(RR-06):1-23.

11. American College of Obstetricians and Gynecologists. ACOG Committee Opinion number 313, September 2005. The importance of pre-conception care in the continuum of women’s health care. Obstet Gynecol. 2005;106(3):665-666.

12. Wysocki S. The state of hormonal contraception today: enhancing clinician/patient communications. Am J Obstet Gynecol. 2011;205(4 suppl):S18-S20.

13. United States Census Bureau. America’s Families and Living Arrangements: 2010. census.gov/
population/www/socdemo/hh-fam/cps2010.html

14. Nelson AL, Rezvan A. A pilot study of women’s knowledge of pregnancy health risks: implications for contraception. Contraception. 2012;85(1):78-82.

15. Gavin L, Moskosky S, Carter M, et al; Centers for Disease Control and Prevention. Providing quality family planning services: recommendations of CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014;63(RR-04):1-54.

16. Morgan SP, Rackin H. The correspondence between fertility intentions and behavior in the United States. Popul Dev Rev. 2010;36(1):91-118.

 

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.

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

 

PrEP for prevention: Practice update

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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

Female sexual dysfunction: Why is it so difficult to treat?

PDF 50

By Brooke M. Faught, MSN, WHNP-BC, IF

Many healthcare providers avoid addressing and treating sexual problems in women for a multitude of reasons, including the paucity of FDA-approved medications for female sexual dysfunction (FSD), concern about the additional time required during the patient visit, and confusion over billing and coding, leading to challenges regarding reimbursement. In this column, I describe the common barriers and misconceptions that impede successful evaluation and treatment of FSD.

Over recent years, multiple studies have demonstrated the high prevalence of sexual complaints in women. In fact, more women than men report problems with sexual functioning, including problems related to libido, arousal, orgasm, and pain. In the National Health and Social Life Survey, 43% of women reported one or more sexual problems, compared with 31% of men.1 Nearly 10 years later, the PRESIDE study demonstrated a 44% prevalence of female sexual dysfunction (FSD) in the United States.2 Despite these compelling statistics, research regarding treatments for sexual dysfunction and marketing for products designed to improve sexual function have been primarily geared toward men, not women. Although the focus may finally be shifting to women, why is FSD still so difficult to treat?

#1: Few FDA-approved treatments for FSD

In 1998, the FDA approved sildenafil (Viagra®) as the first medication for the treatment of erectile dysfunction (ED) in men, initiating a new kind of sexual revolution. Men with ED who had previously been rendered virtually abstinent were now able to resume satisfying sexual activity. Since that time, 27 medications have been approved by the FDA for the direct or indirect enhancement of sexual functioning in men. Until 2 months ago, the total number of FDA-approved medications for the treatment of low sexual desire in women was zero. But on August 18, 2015, the FDA made history by approving flibanserin (Addyi™), the first-ever medication for the treatment of hypoactive sexual desire disorder in women.3

#2: Too time consuming to address

One of the biggest complaints that I hear from healthcare providers (HCPs) regarding addressing their female patients’ sexual concerns is that it takes too much time in an already busy clinic setting. I recommend the use of any of the following validated questionnaires, which can facilitate discussions about this sensitive and complicated topic.

  • Sexual Function Questionnaire4
  • Female Sexual Function Index5
  • Female Sexual Distress Scale-Revised6
  • Decreased Sexual Desire Screener7
  • Hypoactive Sexual Desire Disorder Screener8
  • Abbreviated Sexual Function Questionnaire9
  • Sexual Quality of Life-Female10

#3: Not a profitable specialty

Although billing based on time spent face-to-face with a patient is not typically a lucrative method for running a practice, HCPs do have ways to enhance reimbursement when treating female patients with sexual complaints. For instance, offering services such as colposcopy, vulvovaginal biopsy, biothesiometry, perineometry, and trigger-point injections can provide a major increase in revenue when utilizing procedural modifiers. Even minor tests such as urinalysis, wet preps, and vaginal pH analysis can add profit to a patient encounter. When applicable, providing urogynecologic services such as urodynamics, tibial nerve stimulation and pessary placement/maintenance can further boost clinic revenue.

#4: Prevalence versus “distress”

Although nearly half of all surveyed women in the two aforementioned studies reported sexual complaints,1,2 only 12% reported experiencing distress related to their sexual problems.2 In order for a woman to meet criteria for an FSD diagnosis, she needs to be bothered by her condition. If she does not experience such distress, then treatment is unnecessary and unlikely to prove beneficial. HCPs need not create a diagnosis where none exists. At the same time, FSD is a true entity that deserves attention when warranted.

#5: Multifactorial etiology of FSD

Many factors affect female sexual functioning, including overall health, medication use, stress, pregnancy, menopause, drug and alcohol abuse, mental health, relationship status, and socioeconomic status. Existence of all these contributing factors necessitates that history taking in women with FSD be thorough. Although this list is not exhaustive, relevant health conditions for which to screen in women reporting sexual complaints include depression, diabetes, thyroid disease, hyperprolactinemia, cardiovascular disease, neurologic disease, androgen insufficiency, and estrogen deficiency.11 The Table lists commonly prescribed medication classes that can increase
FSD risk.11

FSH_Table

#6: Lack of provider training

In 2010, the Journal of Sexual Medicine published proceedings from the International Consultation in Sexual Medicine, which included this quote: Current sexual health education for undergraduate and practicing physicians is inadequate to meet the advancing science and technology and increasing patient demand for high-quality sexual health care.12 That being said, many academic programs for prospective physicians, nurse practitioners, and physician assistants are beginning to incorporate more sexual health training into their curricula, which will arm HCPs with the knowledge and confidence needed
to manage patients’ sexual problems or refer them to another provider when appropriate.

#7: Social stigma and patient unwillingness to discuss sensitive topics

In a study presented in 2010, Parish et al13 evaluated 75 videotaped patient–provider interactions regarding distressing low desire (DLD). HCPs underestimated the prevalence of distress in 82% of women who described themselves as very distressed with respect to their low desire. In this same study, 69% of women minimized their distress during the encounter with the provider but then acknowledged their distress after the visit. Although the impact of DLD was not addressed in any of the 75 interactions, after the visit, 95% of the patients reported that DLD affected their relationship and 98% reported that it affected their partners.

Conclusion

Considering the high prevalence of FSD, and the likelihood that it is distressing to at least a sizable minority of women who have it, HCPs must aim to identify it and treat it—despite the barriers that still exist. Addressing patients’ concerns in a holistic manner, establishing rapport, and providing a nonjudgmental environment for discussion about sensitive topics is the best method to facilitate success in this patient population.

Brooke M. Faught is a nurse practitioner and the Clinical Director of the Women’s Institute for Sexual Health (WISH), A Division of Urology Associates, in Nashville, Tennessee. 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. Shifren, Monz BU, Russo PA, et al. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112(5):970-978.

3. FDA News Release. FDA Approves First Treatment for Sexual Desire Disorder. August 18, 2015. fda.gov/News
Events/Newsroom/PressAnnouncements/ucm458734.htm

4. Quirk FH, Heiman JR, Rosen RC, et al. Development of a sexual function questionnaire for clinical trials of female sexual dysfunction. J Womens Health Gend Based Med. 2002;11(3):277-289.

5. Quirk F, Haughie S, Symonds T. The use of the sexual function questionnaire as a screening tool for women with sexual dysfunction. J Sex Med. 2005;2(4):469-477.

6. Derogatis L, Clayton A, Lewis-D’Agostino D, et al. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008;5(2):357-364

7. Clayton AH, Goldfischer ER, Goldstein I, et al. Validation of the decreased sexual desire screener (DSDS): a brief diagnostic instrument for generalized acquired female hypoactive sexual desire disorder (HSDD). J Sex Med. 2009;6(3):730-738.

8. Leiblum S, Symonds T, Moore J, et al. A methodology study to develop and validate a screener for hypoactive sexual desire disorder in postmenopausal women. J Sex Med. 2006;3(3):455-464.

9. Williams K, Abraham L, Symonds T. Psychometric validation of an abbreviated version of the sexual function questionnaire (ASFQ). Value in Health. 2010;13(7):A381.

10. Symonds T, Boolell M, Quirk F. Development of a questionnaire on sexual quality of life in women. J Sex Marital Ther. 2005;31(5):385-397.

11. Kingsberg SA, Janata JW. Female sexual disorders: assessment, diagnosis, and treatment. Urol Clin North Am. 2007;34(4):497-506.

12. 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.

13. Parish SJ, Hahn SR, Kingsberg SA, et al. Doctor-patient communication about desire with women who have distressing low desire in primary care and general OB/GYN practice. Presented at: The International Society for the Study of Women’s Sexual Health; 2010; St. Petersburg, Florida.

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

Dying to be thin: Recognizing and treating anorexia in adolescents

Ubiquitous images of waiflike models and other females in the media prompt many adolescent girls in the United States to curb their caloric intake and lose weight, even to a perilously low level. The authors provide up-to-date information regarding identification, assessment, and management of anorexia in adolescent girls so that nurse practitioners can intervene before this illness threatens these patients’ lives.

For most girls and women in the United States, images of extremely thin models and other females in the media do not greatly influence their own body image or their eating or exercise habits. For other girls and women, however, the focus on thinness becomes distorted, obsessive, and extreme, and contributes to the development of an eating disorder that can have catastrophic consequences.1 The reasons for this body image disturbance are likely related to a combination of psychological, environmental, and biologic factors; adolescent females seem to be among the most vulnerable. When adolescent girls, as opposed to women, develop an eating disorder, they present with greater emotional distress, functional impairment, and suicide risk; a dangerously lower body mass index (BMI); and an increased need for mental health assessment and treatment.2 Females with eating disorders, versus those with other psychiatric disorders, are more likely to attempt suicide and to undergo inpatient treatment.2,3

According to a recent cross-sectional survey, about 3% of girls aged 13-18 years have some form of eating disorder: 0.3% have anorexia, 0.9% have bulimia, and 1.6% have a binge eating disorder.4 In this study, although most teens with an eating disorder reported seeking some form of treatment, only a minority received treatment specifically for their eating or weight problems. To increase the likelihood that adolescent girls with anorexia, the most common eating disorder, receive the help they need from nurse practitioners (NPs) who see them for primary care, the authors provide background information about anorexia and then discuss its signs and symptoms (S/S), screening, diagnosis, and treatment.

Background information

Anorexia nervosa, an eating disorder characterized by immoderate food restriction, inappropriate eating habits or rituals, obsession with having a thin figure, and an irrational fear of weight gain, as well as a distorted body-image, tends to develop during adolescence, with peaks in onset at ages 14 and 18.5 Fear of gaining weight is the driving force behind anorexia; afflicted individuals refuse to sustain a minimally normal weight.6 To achieve their goal of losing weight, these individuals restrict their food intake and may exercise excessively. Some of them may use laxatives, diuretics, and enemas to accelerate weight loss.

Individuals with anorexia view themselves as fat despite being thin or even emaciated. They judge their self-worth by their weight, and they tend to have a greatly distorted body-image and cognitive thought process.6 Driven by perfectionism, even after receiving therapy, these girls find that they can never quite achieve their “ideal” weight.5

Signs and symptoms

The most obvious sign of anorexia is extreme thinness or emacia­tion.7 Other S/S related to body weight and body-image include a relentless pursuit of thinness, an unwillingness to maintain a normal or healthy weight, an intense fear of gaining weight, a distorted body-image, low self-esteem, and a denial of the danger of low body weight. Over time, anorexia takes a toll on the body; common physical manifestations of anorexia include dry skin, brittle hair and nails, lanugo (fine downy hair) all over the body, decreased blood pressure and heart rate, cold extremities, severe constipation, and mild anemia.5-8

Anorexia can have severe adverse effects on many body systems as well. It is associated with a reduction in bone density,1 which may lead to an increased risk for fractures. Some young patients with anorexia fail to reach their full adult growth potential. Anorexia can cause muscle weakness and wasting, and damage to the structure and function of the heart.7 In addition, anorexia can lead to cerebral atrophy and delayed neurocognitive development. When anorexia is untreated or inadequately treated, patients can die, usually of medical complications (e.g., arrhythmia, multi-organ failure) or from suicide.9

View: Eating disorders

Screening

One commonly used tool is the SCOFF screen,10 which asks patients with suspected eating disorders these questions:

  • Do you make yourself Sick because you feel uncomfortably full?
  • Do you worry you have lost Control over how much you eat?
  • Have you recently lost Over 15 pounds in a three-month
    period?
  • Do you believe yourself to be Fat when others say you are too thin?
  • Would you say that Food dominates your life?

A “yes” answer to two or more of these questions indicates that an eating disorder may be present. The Eating Disorder Examination, an interview of the patient by the healthcare provider (HCP),11 and the self-reported Eating Disorders Examination-Questionnaire12 are both considered valid screens for eating disorders and for determining specific features of a person’s condition (e.g., vomiting, laxative use).

Diagnosis

New diagnostic criteria

The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Health Disorders, Fifth Edition (DSM-5) states that anorexia, which primarily affects adolescent girls and young women, is characterized by distorted body image and excessive dieting that leads to severe weight loss, with a pathologic fear of becoming fat.9 The DSM-5 lists three diagnostic criteria for anorexia:

A. Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than that minimally expected.

B. Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight.

C. Disturbance in the way in which one’s body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight.

The new diagnostic criteria have several minor but important changes from previous editions. Criterion A focuses on behaviors such as restricting caloric intake, and no longer includes the word refusal in terms of weight maintenance because that implies intention on the part of the patient and can be difficult to assess.13 In the DSM-5, Criterion B is expanded to include not only overtly expressed fear of weight gain but also persistent behavior that interferes with weight gain.14 The DSM-IV-TR Criterion D15 requiring amenorrhea, or the absence of at least three menstrual cycles, has been deleted from the DSM-5. This criterion cannot be applied to males, pre-menarchal females, females taking oral contraceptives, or postmenopausal females. In some cases, individuals exhibit all other S/S of anorexia but still report some menstrual activity.

Diagnostic tests

Early detection of anorexia is important. As patients approach the 5-year mark of living with the illness, recovery becomes increasingly less likely.16 NPs should ask all female patients about their self-perception, self-image, and overall satisfaction with their body appearance. Height, weight, and BMI should be monitored at every visit. Additional testing is considered on a case-by-case basis. Laboratory tests such as complete blood count, electrolytes, liver function tests, serum albumin, urinalysis, and thyroid-stimulating hormone level are considered as part of the initial workup.17

Poor nutrition and extremely low caloric intake take a toll on the body not only in terms of appearance but also in terms of overall function. The hypovolemia that occurs in relation to anorexia can result in an atrophic heart and decreased cardiac output. An electrocardiogram and perhaps an echocardiogram should be included as part of the standard workup because of the high likelihood that arrhythmias will occur; arrhythmia is the most common cause of death in patients with anorexia. Prolonged QTc interval, bradycardia, heart block, and hypovolemia are just a few of the likely end points related to the atro­phic heart and the electrolyte imbalances.18Differential diagnosis

Many other diagnoses can contribute to, coexist with, or be solely responsible for extreme weight loss. When working up a patient with a suspected eating disorder, NPs must consider other diagnoses such as HIV/AIDS, major depression, anxiety disorder, post-traumatic stress disorder, sexual abuse, substance abuse, brain tumor, inflammatory bowel disease, malabsorption syndrome, lupus, cancer, and esophageal motility disorders.

Because isolated cases of anorexia—without other co-morbid conditions—are rare, NPs should screen patients with anorexia for depression, anxiety, and other mental health disorders. Monitoring for suicidal ideation and ascertaining a patient’s risk for suicide are vitally important.

Treatment

Nurse practitioners are key members of the healthcare team that formulates a comprehensive treatment plan for patients with anorexia. Despite treatment offered, relapse risk remains high. Thirty percent to 50% of treated individuals relapse after an inpatient stay, especially during the first 2 years post-discharge.8Pharmacotherapy

No drugs have been approved by the FDA for treatment of anorexia nervosa, and no research supports the use of medications to cure the disorder.6 However, once patients reach their maintenance weight, selective serotonin reuptake inhibitors may help reduce obsessive-compulsive behaviors.6 Several randomized controlled trials are currently assessing the possible benefit of olanzapine, aripiprazole, and quetiapine.19 The results of these studies are not yet available. Many patients in whom atypical antipsychotics are indicated will not take these medications because of their association with weight gain.6Non-pharmacologic approaches

Cognitive behavioral therapy (CBT) is the gold standard for treating patients with anorexia.20 CBT assists patients, who view their body with unrealistic scrutiny and resist gaining any weight, in changing their unhealthy body-image. A recent Cochrane review evaluated the efficacy of family-based therapy (FBT), also known as the Maudsley Approach, in treating anorexia.21 In this intensive outpatient treatment approach, parents play a major role in (1) helping restore their adolescent child’s weight to a normal level for her age and height, (2) returning control over eating to the child, and (3) encouraging normal adolescent development through an in-depth discussion of these crucial developmental issues as they pertain to their child.21 The review showed that FBT was slightly superior to usual care (i.e. patient-based care) in treating adolescents with anorexia. In a more recent comparative trial, FBT, with its focus on facilitation of weight gain, was as effective as systemic family therapy, which addresses general family processes, and could be delivered at lower cost.22Hospitalization

Because of the life-threatening effect of starvation on the body, many patients with anorexia require hospitalization.3 If a patient is experiencing an extreme electrolyte imbalance or weighs below 75% of ideal body weight, the treatment is immediate inpatient unit treatment with medical stabilization. Because of the urgent need to reintroduce food in patients with anorexia, a rare but potentially fatal condition called refeeding syndrome may occur. This syndrome, attributed to a metabolic alteration in serum electrolytes, sodium retention, and vitamin deficiencies, taxes the patient’s system by overburdening the body with fluids too quickly.6Treatment at a psychiatric facility

Many patients with anorexia are admitted to an inpatient psychiatric facility in a crisis state. A comprehensive assessment is necessary, and symptoms such as suicidal ideation must be managed immediately. Some inpatient psychiatric facilities such as the Remuda Ranch at the Meadows, in Wickenburg, Arizona,23 specialize in the treatment of eating disorders in females. At this facility, treatment duration is flexible; some patients stay 1-2 weeks, whereas others with more severe illness may remain in treatment for 30 days or longer. Each patient has an individualized treatment plan implemented by a team of HCPs that includes a psychiatric and primary care provider, a registered dietician, a licensed master’s or doctoral-level therapist, a psychologist, and registered nurses. Along with treating the patient’s eating disorder, the team treats coexisting problems such as depression, anxiety, substance abuse, and trauma.

Nurse practitioner role

Because NPs may be the first HCPs to come into contact with an adolescent with anorexia, they must be able to recognize the S/S of an eating disorder, screen for and diagnose the disorder, and treat or refer the patient to prevent further harm. Treatment may entail prescribing medications, which, although not curative, can lessen S/S. Pharmacotherapy for patients with eating disorders targets three domains: (1) remission of presenting S/S during acute treatment, (2) prevention of relapse in the post-acute phase, and (3) diversion of recurrences over the lifetime course.24 The treatment plan will also likely include CBT to enhance the patient’s self-image. If the NP is not well versed in providing CBT, a referral to a mental health specialist is advisable. FBT is also a reasonable therapeutic approach. In all cases, education of family members regarding anorexia and its treatment is vital. The Box lists useful resources for NPs and their patients.

Those NPs who are treating patients with anorexia should initially see these patients weekly to monitor their weight and to check their laboratory values. Frequency of weight monitoring and lab testing will decrease over time as patients demonstrate the ability to maintain a maximum tolerable weight. Reactions of patients with anorexia to requests to step on a scale range from reluctance to resistance to outright refusal. Refusal to be weighed is a patient’s right, and should be viewed as a protective mechanism in which the patient is avoiding a perceived negative stimulus, as opposed to a demonstration of defiance. In some instances, obtaining an accurate weight and completing certain tests are essential to rule out complications such as heart failure. Although most life-threatening sequelae that occur in the acute phase of anorexia subside in the post-acute phase, ongoing monitoring can help ensure that liver and kidney function have stabilized, that electrolyte and vitamin deficiencies have corrected, and that BMI remains at an acceptable level.

Nurse practitioners caring for patients with anorexia are members of a team of HCPs, which
usually includes a dietician, a counseling psychologist, and a psychia­trist. Some patients engage in only limited treatment with their NP, and periodically engage in more intensive treatment with a mental health specialist when their illness becomes more severe. Understanding that the treatment phase is often characterized by remissions and exacerbations helps NPs know what to expect. At the very least, NPs will play an integral part in keeping patients engaged in the treatment process. Supporting patients from their entry into treatment and through recovery can help them endure the extensive rehabilitative process and ultimately save their lives.

Erik Southard is the Director of the DNP Program, Department of Advanced Practice Nursing; Renee N. Bauer is Director of 2nd Degree Track, Department of Baccalaureate Nursing; and Andreas M. Kummerow is Director RN to BS Track, Department of Baccalaureate Nursing Completion, all at Indiana State University in Terre Haute. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

Useful Resources

References

1. Hudson LD, Court AJ. What pediatricians should know about eating disorders in children and young people. J Paediatr Child Health. 2012;48(10):869-875.

2. Stice E, Marti CN, Rohde P. Prevalence, incidence, impairment, and course of the proposed DSM-5 eating disorder diagnosis in an 8-year prospective community study of young women. Abnorm Psychol. 2013;122(2):445-457.

3. Dooley-Hash S, Banker JD, Walton MA, et al. The prevalence and correlates of eating disorders among emergency department patients aged 14-20 years. Int J Eat Disord. 2012;45(7):883-890.

4. 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.

5. Fursland A, Byrne S, Watson H, et al. Enhanced cognitive behavior therapy: a single treatment for all eating disorders. J Couns Dev. 2012; 90(3):319-329.

6. Halter MJ. Foundations of Psychiatric Mental Health Nursing: A Clinical Approach. 7th ed. St. Louis, MO: Saunders; 2014.

7. National Institute of Mental Health. What Are Eating Disorders? www.nimh.nih.gov/health/topics/
eating-disorders/index.shtml

8. Berends T, van Meijel B, van Eldburg A. The Anorexia Relapse Prevention Guidelines in practice: a case report. Perspect Psychiatr Care. 2012;48(3):149-155.

9. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Health Disorders: Fifth Edition. Washington, DC: American Psychiatric Publishing; 2014.

10. Morgan JF, Reid F, Lacey JH. The SCOFF questionnaire, a new screening tool for eating disorders. West J Med. 2000;172(3):164-165.

11. Fairburn CG, Cooper Z, O’Connor M. Eating disorder examination. In: Fairburn CG. Cognitive Behavior Therapy and Eating Disorders. New York, NY; Guilford Press; 2008. http://rcpsych.ac.uk/pdf/EDE_16.0.pdf

12. Fairburn CG, Beglin S. Eating disorder examination-questionnaire. Appendix in: Fairburn CG. Cognitive Behavior Therapy and Eating Disorders. New York, NY: Guilford Press; 2008. https://www.rcpsych.ac.uk/
pdf/EDE-Q.pdf

13. Mannix M. DSM-5 updates for eating disorders: implications for diagnosis and clinical practice. Brown Univ
Child Adolesc Behav Letter. 2012;28(12):3.

14. American Psychiatric Association. Highlights of Changes from DSM-IV-TR to DSM-5. 2013. www.
dsm5.org/Documents/changes%20from%20dsm-iv-tr%20to%20dsm-5.pdf

15. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Health Disorders: Fourth Edition-Text Revision. Washington, DC: American Psychiatric Publishing; 2000.

16. Ben-Tovim D. Clinical eating disorders: outcome, prevention and treatment of eating disorders. Curr Opin
Psychiatry. 2003;16(1):65-69.

17. Richardson B. Pediatric Primary Care, Practice Guidelines for Nurses. 2nd ed. Burlington, MA: Jones & Bartlett; 2013.

18. Casiero D, Frishman WH. Cardiovascular complications of eating disorders. Cardiol Rev. 2006;14(5):
227-231.

19. Watson HJ, Bulik CM. Update on the treatment of anorexia nervosa: review of clinical trials, practice guidelines and emerging interventions. Psychol Med. 2013;43(12): 2477-2500.

20. Watson, HJ, Allen K, Fursland A, et al. Does enhanced cognitive behaviour therapy for eating disorders improve quality of life? Eur Eat Disord Rev. 2012;20(5):393-399.

21. Fisher C, Hetrick S, Rushford N, Family therapy for anorexia nervosa. Cochrane Database Syst Rev. 2010;
14(4):CD004780.

22. Agras SW, Lock J, Brandt H, et al. Comparison of 2 family therapies for adolescent anorexia nervosa. JAMA Psychiatry. 2014;71(11):1279-1286.

23. Remuda Ranch website. From the /Desk of the CEO. https://www
.remudaranch.com/alumni-link-newsletter-articles/248-from-the-desk-of-the-ceo

24. Kruger S, Kennedy SH. Psychopharmacotherapy of anorexia nervosa, bulimia nervosa and binge-eating disorder. J Psychiatry Neuro­sci. 2000;25(5):497-508.

Editor-in-chief’s message

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By Beth Kelsey, EdD, APRN, WHNP-BC

Dear Colleagues,

Three full years have elapsed since we celebrated the rollout of the Affordable Care Act (ACA) provision requiring coverage of women’s preventive services recommended by the Institute of Medicine. This provision includes a requirement that most insurance plans cover FDA-approved female contraceptive methods with no co-payment or deductible. The coverage must also include clinical services, including patient education and counseling needed for provision of these contraceptive methods.

Health insurance carriers must cover at least one product in each of the 18 distinct female contraceptive method categories that the FDA has identified in its current Birth Control Guide.1 Many women who could not previously afford contraceptives or whose choices were limited because of prohibitive costs now have access to effective methods that meet their own particular needs.

Despite the existence of this ACA provision for the past 3 years, insurance carriers vary in terms of how they are adhering to the guidelines for contraceptive coverage—thereby keeping many women from fully benefiting from this provision. In fact, two recent studies evaluating health insurance coverage revealed numerous violations of the requirements by a large number of insurance carriers across several states.2,3 The National Women’s Law Center (NWLC) reviewed more than 100 plan documents from issuers in the new marketplaces in 15 states, and found that 33 insurance carriers in 13 states offered birth control coverage that did not comply with the ACA.2 The Kaiser Family Foundation described contraceptive policies used by health insurance carriers as being not easily accessible and not clearly defined.3

The most commonly identified violation in these studies was a failure to cover all FDA-approved methods. The method(s) not covered varied with different carriers but included progestin implants, contraceptive patches and vaginal rings, over-the counter contraceptives, and the emergency contraceptive pill Ella. Several insurance carriers were found to impose impermissible cost-sharing on methods such as IUDs and sterilization. Some carriers imposed limitations and cost-sharing on the services associated with provision of contraceptive methods, including office visits for injectable contraceptives and birth control counseling. Other violations included requiring cost-sharing for brand-name contraceptives without generic equivalents and excluding sterilization coverage for dependent children, which includes adults up to age 26. In May 2015, as a result of these two studies’ findings, the U.S. Departments of Health and Human Services, Labor, and Treasury issued FAQs About Affordable Care Act Implementation to help insurance companies and consumers better understand the scope of coverage of preventive services required under the ACA.4

We must ensure that our patients have access to all FDA-approved female contraceptive methods and related services, with no co-payment or deductible. We have a voice. In one state, after the regional Planned Parenthood and the NWLC brought violations to the attention of insurance regulators, a bulletin clarifying the requirements was sent to health insurance carriers. NWLC operates a national hotline (1-866-745-5487) and website to assist women having difficulty securing coverage for birth control by providing information on the requirements, assisting with filing appeals with insurance companies, and filing complaints with government agencies that regulate insurance plans.

Through the ACA, we have made a tremendous step forward in enhancing access to care for women. As always, however, there are hurdles to overcome and there are risks that the gains we have made will be reversed. Together we can be a mighty force in overcoming these hurdles and in protecting the good work that has been done.

Beth Kelsey, EdD, APRN, WHNP-BC

References

  1. FDA Office of Women’s Health. Birth Control Guide. fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf
  2. National Women’s Law Center. State of Birth Control Coverage: Health Plan Violations of the Affordable Care Act. April 29, 2015. nwlc.org/sites/default/files/pdfs/stateofbirthcontrol2015final.pdf
  3. Kaiser Family Foundation. Coverage of Contraceptive Services: A Review of Health Insurance Plans in Five States. April, 2015. http://files.kff.org/attachment/report-coverage-of-contraceptive-services-a-review-of-health-insurance-plans-in-five-states
  4. Department of Health and Human Services. FAQS About Affordable Care Act Implementation (Part XXVI). May, 11, 2015. cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf

Chest pain in a young woman

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By Lisa Morrow, DNP, FNP, LAc

Chest Pain_201635228_CMYK

LT is a 23-year-old woman who pre­sents to the clinic for the first time for contraception. She has never been pregnant, has regular menses, and has used only condoms in the past for birth control. Her body mass index is 22.5 kg/m2 and she is physically active, engaging in 1 hour of aerobic exercise 5 days a week. She has never smoked. At this visit, the nurse practitioner (NP) determines that LT’s health history is negative for any cardiac disease, hypertension, thromboembolism, known thrombogenic disorders, diabetes, and malignancies. Her family history is negative for cardiac disease, thromboembolism, and known thrombophilias. LT’s blood pressure (BP) is 100/70 mm Hg. She is taking no medications.

LT’s only health history of note includes diagnoses for seasonal affective disorder and panic/anxiety disorder. She had been taking es­citalopram (Lexapro®), a selective serotonin reuptake inhibitor (SSRI), to treat her panic/anxiety symptoms, but she discontinued the medication 2 months previously because she was feeling less anxious and was concerned about SSRI-related side effects. Her panic/anxiety symptoms had worsened when she began her graduate school program but improved when she met her current partner. She still experiences panic/anxiety symptoms (mostly chest tightness) when preparing for examinations. The chest tightness does not affect her ability to speak or exercise. Her most recent panic attack occurred 5 months ago.

LT expresses an interest in using the vaginal contraceptive ring. She has no known contraindications for use of a combined hormonal contraceptive (CHC).1 The NP provides a prescription for the vaginal contraceptive ring and instructs LT on Quick Start.

One month after starting the vaginal contraceptive ring, LT presents to the clinic with a complaint of chest pain that has been increasing in severity over the past 3 weeks. She describes having a fever and body aches that started 3 weeks ago, accompanied by chest pain, a non-productive cough, and fatigue on exertion. The fever, body aches, and cough have subsided. She describes the persisting chest pain as tightness accompanied by a feeling that she has phlegm in her throat that she cannot dislodge by coughing and an inability to get enough air on inspiration. The chest pain became more severe the previous evening while she was cheering at a sporting event.

What other elements of LT’s current health history would be useful to know now?

On further questioning, the NP finds that LT’s chest pain worsens upon exertion. LT experiences chest pain and shortness of breath (SOB) when walking up hills on which she used to run without any problem. Whereas she used to be able to talk while sprinting, she now finds talking difficult even when walking because of the pain and SOB. She reports the ability to climb three flights of stairs without stopping but has decreased her exercise to twice a week and for only 30 minutes. The chest pain is not worsened by deep breathing, coughing, or changes in body position.

The patient describes the pain as being localized bilaterally above each nipple, with the affected areas about the size of a dime. She points to the area above each nipple in the third intercostal space to indicate the location. She denies nausea or vomiting; diaphoresis; radiation of pain to the shoulder, back, neck, or jaws; palpitations; hemoptysis; leg pain or swelling; or any tearing sensation. She has had no trauma to the chest or legs and has not had any prolonged or confined travel or other prolonged immobilization recently. She has no history of respiratory conditions, including asthma. She denies having any increased stressors in her life, any intimate partner violence, or use of cocaine or other stimulants.

What differential diagnoses would you be considering at this point?

Emergent considerations that the NP wants to be able to exclude are myocardial infarction (MI), pulmonary embolism (PE), pneumothorax, and aortic dissection. Other diagnoses the NP might consider, given some of LT’s symptoms, are pneumonia, myo­carditis, pericarditis, and panic disorder.

What would you include in your problem-focused physical examination?

LT’s vital signs are heart rate, 80 beats/minute; BP, 92/70 mm Hg; respiration rate, 12/minute; temperature, 98.2°F; and oxygen saturation, 99%. The NP immediately notices that LT has rapid speech and is fidgeting. Her skin is pink, with no rashes or bruising, and is warm, without diaphoresis. Chest pain is elicited when she climbs three flights of stairs, but her oxygen saturation remains at 99%-100%. Bilateral chest pain is reproducible upon palpation in the area above the nipples. She experiences SOB, manifested as difficulty speaking, when she and the NP climb stairs together, but she does not try to slow down.

Further chest examination reveals equal expansion, normal cardiac rhythm with no extra heart sounds or murmurs, no diminished or abnormal breath sounds, and no extra lung sounds. LT’s abdominal examination results are within normal limits. She has no tenderness, redness, or swelling of her extremities.

Can you rule out PE based on the history and physical exam findings?

The CDC estimates that 60,000-100,000 Americans die of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and PE, each year.<sup.2 Undiagnosed PE has a 25% mortality rate. VTE, although uncommon, is one of the most serious possible adverse events related to CHC use. To put the risk for this patient in perspective, the rate of VTE is 29/10,000 woman-years in pregnant women, 9-10/10,000 woman-years in CHC users, and 4-5/10,000 woman-years in CHC nonusers.3

LT does not present with the classic picture of a PE. The PE Wells rule lists specific clinical features and assigns points to each feature to predict the likelihood of PE based on clinical findings.4 Point values for clinical characteristics are as follows: clinical signs of DVT, 3; alternative diagnosis less likely than PE, 3; previous DVT or PE, 1.5; heart rate >100 beats/minute, 1.5; recent (within the past 30 days) surgery or immobilization, 1.5; hemoptysis, 1; and cancer (treated within the past 6 months), 1. The clinical probability of PE is “low” with a total score of 0-1, “intermediate” with a total score of 2-6, and “high” with a total score >6.

Using the Wells scoring system, the NP notes that LT has no signs or symptoms of DVT, her heart rate is <100 beats/minute, and she does not have hemoptysis. She has not had extended immobilization or surgery in the past 4 weeks, has no previous history of DVT/PE, and no history of malignancy, and it does not seem at this point that an alternative diagnosis is less likely than PE. The Wells score for LT would be 0, indicating a low clinical probability of PE.

Nevertheless, the NP recognizes that the Wells rule, in isolation, cannot be used to exclude PE. What other factors should the NP take into account? What should she do next?

The fact that LT’s respiratory and chest pain symptoms have persisted over a 3-week period and are worsened by exertion is troubling in this otherwise healthy young woman. A further concern is that the symptoms started after recent initiation of a CHC. Because the NP wants to rule out a potentially life-threatening condition, she sends LT to the emergency department for further evaluation. Of note, LT removed her vaginal contraceptive ring 4 days ago and is due to insert a new ring in 3 days. The NP instructs her not to insert a new ring until the reason for her chest pain is determined.

Which laboratory and diagnostic tests are indicated in this case?

The gold standard to diagnose or exclude a PE entails a plasma D-dimer enzyme-linked immunosorbent assay (ELISA), chest radiography, and/or helical computed tomography (CT) pulmonary angiography. A plasma D-dimer ELISA has a 0.95 sensitivity (0.85-1.00) for negative likelihood; a negative D-dimer can exclude PE when the chest radiograph is negative.5 A positive D-dimer alone is of little clinical value in diagnosing PE. PE has occurred in 1.5% of patients with a negative CT pulmonary angiogram at 3 months.6

LT’s chest radiogram is negative, but her D-dimer ELISA is elevated, indicating the need for CT pulmonary angiography. The diagnosis of PE is confirmed with the CT pulmonary angiogram. LT is admitted to the hospital to start anticoagulation and is discharged to home 2 days later. Prior to her discharge, LT receives education about her oral anticoagulation therapy, the possibility that her PE was an adverse effect of CHC use, and the need to discuss other contraceptive methods with her primary care provider (PCP). She is advised to follow up with her PCP in 2 weeks and with the hematologist in 6 months.

At her 2-week follow-up visit, LT states she has had no chest pain or difficulty breathing since her hospitalization. She is taking her oral anticoagulant without difficulty. She expresses concern about her future risk for another PE and reports that she read on the Internet about genetic predispositions to getting blood clots. The NP reviews measures that LT can take to reduce her risks for DVT and PE, which include not smoking, maintaining a healthy weight, and using strategies during prolonged confined travel such as taking breaks to stretch and exercising her legs to avoid venous stasis. She advises LT that she should not use hormonal contraceptives that contain estrogen.1 LT chooses to use a nonhormonal intrauterine contraceptive, which is placed at this visit.

Should LT be tested for inherited or acquired thrombophilias?

An unrecognized acquired thrombophilia such as antiphospholipid syndrome or an inherited thrombogenic mutation (e.g., factor V Leiden; prothrombin mutation; protein S, protein C, or antithrombin deficiency) may contribute to a first VTE in a CHC user.1 A retrospective cohort study of 160 women with a first VTE while using a combination oral contraceptive (COC) showed that the cumulative incidence of recurrent VTE was 5.1% after 1 year and 14.2% after 5 years.7 Significant factors associated with recurrence were renewed COC use (hazard ratio [HR], 8.2 [2.1-32.2]), antiphospholipid syndrome (HR, 4.1 [1.3-12.5]), and protein C deficiency or factor II prothrombin mutation (HR, 2.7 [1.1-7]). Use of a progestin-only contraceptive (HR, 1.3 [0.5-3.0]) and factor V Leiden (HR, 1.3 [0.5-3.4]) did not increase re­currence.

The genetic framework underlying VTE is complex and likely interplays with risk factors such as recent hospitalization, smoking, obesity, and CHC use. Decisions regarding duration of anticoagulant therapy and the need for thromboprophylaxis during pregnancy are best considered in terms of clinical risk factors. Testing for inherited thrombophilias provides an uncertain estimate of risk and is not recommended in most circumstances.8,9

LT has a follow-up appointment with a hematologist in 6 months. She will discontinue the anticoagulant 2 weeks prior to this visit so that the workup will not be affected by the medication. The hematologist will reassess LT’s risk factors and the need for further testing.

Reflection on this case

LT’s only identified risk factor for VTE when she presented with chest pain and SOB was the use of a CHC. Results of studies looking specifically at the vaginal contraceptive ring and risk for VTE are mixed.10,11 However, several cases of VTE have been reported in women with no other identified risk factors besides vaginal contraceptive ring use.10,11

Other diagnoses such as MI, pneumothorax, myocarditis, pericarditis, and pneumonia were unlikely given LT’s history and physical exam findings. The history of panic/anxiety could have led the NP to initially consider panic attacks as the origin of LT’s chest pain. The patient’s rapid speech and fidgeting were a clear indication of anxiety, which could have been related directly to pain. Anxiety (sense of doom) and restlessness are also common findings with PE. The NP was correct to maintain heightened suspicion for PE in this otherwise healthy young woman presenting with chest pain and SOB who had recently initiated a CHC.

Recommendations for practice

Nurse practitioners should always conduct an appropriate workup to rule out VTE risk factors prior to prescribing a CHC for a given patient. All women using a CHC should be advised of symptoms of VTE that must be immediately reported to their provider. Routine screening for thrombogenic mutations is not appropriate because these conditions are rare and the cost of testing is high.1 NPs should re-evaluate CHC users for risk factors at regular visits. NPs should always initiate testing to rule out or confirm PE if another cause of chest pain and/or SOB in a CHC user is not apparent. An elevated D-dimer indicates the need for urgent chest radiography, and, if inconclusive, a CT pulmonary angiogram.

A helpful tool to use when considering contraceptive options for patients seeking family planning guidance is the Medical Eligibility Criteria for Contraceptive Use, published by the World Health Organization and most recently updated in 2010.12 Tables in this document include recommendations for the use of contraceptive methods by women and men with particular characteristics or medical conditions.13 Each condition was defined as representing either a person’s characteristics (e.g., age, history of pregnancy) or a known pre-existing medical/pathologic condition (e.g., diabetes and hypertension). NPs should check the CDC’s MMWR website for up-to-date information regarding medical eligibility criteria for contraceptive use.

Lisa Morrow is a graduate of the Columbia University DNP program and a family nurse practitioner and attending at Bronx Lebanon Hospital Center and Wellness Center Ambulatory Clinic, both in New York, New York. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

Acknowledgment
The author thanks her mentors at Columbia, Elsa Wuhrman, DNP, FNP, ACNP-BC and Susan Doyle-Lindrud, DNP, AOCNP, DCC, for their guidance in the preparation of this manuscript.

References
1. Centers for Disease Control and Prevention. United States Medical Eligibility Criteria (US MEC) for Contraceptive Use. Updated October 26, 2014. www.cdc.gov/reproductivehealth/unintendedpregnancy/usmec.htm

2. Centers for Disease Control and Prevention. Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) – Blood Clot Forming in a Vein. June 8, 2012. www.cdc.gov/ncbddd/dvt/data.html

3. Reid R, Leyland N, Wolfman W, et al; Society of Obstetricians and Gynaecologists of Canada. SOGC clinical practice guidelines: oral contraceptives and the risk of venous thromboembolism: an update: no. 252, December 2010. Int J Gynaecol Obstet. 2011;112(3):252-256.

4. Wells PS, Anderson DR, Rodger M, et al. Derivation of a simple clinical model to categorize patients’ probability of pulmonary embolism: increasing the model’s utility with the SimpliRED D-dimer. Thromb Haemost. 2000;83(3):416-420.

5. Stein PD, Hull RD, Patel KC, et al. D-dimer for the exclusion of acute venous thrombosis and pulmonary embolism: a systematic review. Ann Intern Med. 2004;140(8):589-602.

6. Agnelli G, Becattini C. Acute pulmonary embolism. N Engl J Med. 2010;363(3):266-274.

7. Vaillant-Roussel H, Ouchchane L, Dauphin C, et al. Risk factors for recurrence of venous thromboembolism
associated with the use of oral contraception. Contraception. 2011;84(5):e23-e30.

8. Baglin T. Inherited and acquired risk factors for venous thromboembolism. Semin Respir Crit Care Med. 2012;33(2):127-137.

9. Baglin T, Gray E, Grieves M, et al. Clinical guidelines for testing for heritable thrombophilia. Br J Haematol. 2010;149(2):209-220.

10. Sidney S, Cheetham TC, Connell FA, et al. Recent combined hormonal contraceptives (CHCs) and the risk of thromboembolism and other cardiovascular events in new users. Contraception. 2013;87(1):93-100.

11. Roumen FJ, Mishell DR Jr. The contraceptive vaginal ring, NuvaRing®, a decade after its introduction. Eur J Contracept Reprod Health Care. 2012;17(6):415-427.

12. World Heath Organization, Medical Eligibility Criteria for Contraceptive Use, Fourth Edition. 2009. http://whqlibdoc.who.int/publications/2010/9789241563888_eng.pdf?ua=1

13. Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: Adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition. www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a1.htm?s_cid=rr5904a1_e

Postpartum depression screening in a pediatric clinic setting

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By Ilana L. Farb, APRN, DNP, WHNP-BC, ANP-BC and Diane M. Schadewald, DNP, MSN, RN, FNP-BC, WHNP-BC

Postpartum depression (PPD), which affects about 14% of mothers in the United States,1 can occur at any time throughout the first year after giving birth. Screening for PPD usually occurs only at the 6-week visit to the mother’s obstetric healthcare provider (HCP), resulting in missed opportunities to diagnose the disorder from 6 weeks through 12 months postpartum. Implications for a child whose mother has PPD include slow growth, impaired emotional and cognitive development, and weak attachment.2,3

Purpose

Because PPD can develop in any woman at any time during the first year following childbirth, more frequent screening could help identify the disorder in more women who have it and enable them to be treated in a more timely manner. The purpose of this project was to ascertain the feasibility and usefulness of implementing PPD screening using the Edinburgh Postnatal Depression Scale (EPDS)4 at the 2-, 4-, 6-, 9- and 12-month well-child visits in a pediatric clinic setting.

Method

The 10-question EPDS was used to evaluate a total of 71 participants during well-child visits at 2, 4, 6, 9, or 12 months. Mothers completed the EPDS while waiting for their child to be seen by the pediatric HCP. Scores were calculated by a nurse and shown to the HCP. If a score was >10, the HCP referred the mother to be evaluated for PPD.

Results

Of the 71 participants, 6 (8.5%) scored >10 on the EPDS and were referred for further evaluation. Among these 6 mothers, 1 was referred at the 6-month visit, 2 at the 9-month visit, and 3 at the 12-month visit.

Limitations

The DNP project was intended to last 8 weeks, but it ended after 5 weeks because (1) the number of participants accrued at the 5-week mark was close to the desired number of participants for the project; (2) the pediatric NP who was the primary contact at the clinic resigned for reasons unrelated to the project; and (3) the clinic was in the process of implementing an electronic medical record system, which took away time from the DNP project. Further evaluation of screening for PPD in pediatric clinics is needed to ascertain whether these results can be duplicated.

Implications for women’s health

In this project, the mothers referred for additional assessment for PPD were within 6-12 months post delivery. Without the increased frequency of screening as implemented in this project, some or all of these women might not have been identified as having symptoms of PPD, and further evaluation and treatment might not have been initiated in a timely manner.

This DNP project demonstrated the feasibility of screening for PPD during the first year after birth in a pediatric clinic setting. Identifying women who need additional counseling and resources to work through the difficulties of PPD is important. Not all of these women will experience symptoms by the time of their 6-week postpartum check. The optimal place to screen mothers for PPD may be at a pediatric clinic, where mothers take their infants at regular intervals for well-child visits through the first year of the child’s life.

Ilana L. Farb is a women’s health nurse practitioner at Obstetrics, Gynecology & Infertility in Edina, Minnesota. Diane M. Schadewald is Clinical Associate Professor at the University of Wisconsin-Milwaukee.

References

1. 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.

2. Mishina H, Hayashino Y, Takayama JI, et al. Can pediatricians accurately identify maternal depression at well child visits? Pediatr Int. 2010;52(2):284-289.

3. Cogill S, Caplan H, Alexandra H, et al. Impact of maternal postnatal depression on cognitive development of young children. Br Med J (Clin Res Ed). 1986;292 (6529):1165-1167.

4. Choi SK, Kim JJ, Park YG, et al. The simplified Edinburgh Postnatal Depression Scale (EPDS) for antenatal depression: is it a valid measure for pre-screening? Int J Med Sci. 2012;9(1):40-46.

We invite DNP students or recent graduates to submit reports on their capstone projects for publication consideration. Please see our Guidelines for Authors for more information.

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

 

shutterstock_271823513_CMYK

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.

Focus on sexual health

PDF 50

By Brooke M. Faught, MSN, WHNP-BC, IF

Menopause affects many areas of a woman’s body, including vulvar and vaginal tissue. Most women present with some degree of atrophic vulvovaginal tissue changes in the years following menopause, and up to nearly half of all menopausal women are symptomatic. In 2014, a name change was proposed to include the entire genitourinary tract, not just the vulva and vagina, with regard to all the changes that occur in this area of the body as a result of menopause: genitourinary syndrome of menopause (GSM). Women’s healthcare providers have a variety of FDA-approved options to treat women presenting with symptomatic GSM, including local hormonal therapies, a nonhormonal oral tablet, and an intra­vaginal CO2 laser device.

For years, the terms vulvovaginal atrophy (VVA) and atrophic vaginitis have been used to describe menopause-related changes to the vulvovaginal tissue. These terms have been used despite the negative connotation of the word atrophy and the specificity to vulvar and vaginal tissue. In May 2013, two organizations, the International Society for the Study of Wom­en’s Sexual Health (ISSWSH) and The North American Menopause Society (NAMS), came together to develop more appropriate nomenclature through a terminology consensus conference. Late last year, the more appropriate and all-encompassing term genitourinary syndrome of menopause was adopted to replace the terms vulvovaginal atrophy and atro­phic vaginitis.1 The term genitourinary syndrome of menopause, or GSM, acknowledges the full spectrum of menopause-related atrophic changes that occur within the entire genitourinary tract.1

The terms VVA, atrophic vaginitis, and GSM are used interchangeably throughout this column. Readers will continue to see the terms vulvovaginal atrophy and atrophic vaginitis in the literature for some time because these terms were used in research completed before adoption of the term GSM.

During perimenopause and the years following, the drastic decline in circulating sex hormones, including estrogen, progesterone, and testosterone, results in changes to multiple areas of the body. Some of the more widely recognized symptoms of menopause, including hot flashes, weight gain, and mood changes, diminish over time as the body acclimates to functioning without cyclical changes in hormone levels. By contrast, the effects of the ongoing hypoestrogenic state of menopause on genitourinary tissue intensify, at least in women who do not receive any type of treatment for them.2 Objective findings related to this hypoestrogenic state include vaginal tissue thinning, diminished elasticity, and increased friability, which can result in petechiae, fissuring, erosions, and, in severe cases, stenosis.3 Symptoms related to these physical changes—that is, the symptoms of GSM—include vulvovaginal dryness, itching and burning, painful intercourse, dysuria, urinary urgency and frequency, and recurrent urinary tract infections.1

The average age of menopause in the United States is 51 years. Because life expectancy in this country continues to climb,4 the population of menopausal women is steadily rising, and women may expect to live up to 40% of their lives in a postmenopausal state.5 Of the millions of women who spend years or decades in a perimenopausal and then a postmenopausal state, nearly half will experience bothersome symptoms of GSM/VVA.6 Given these numbers, GSM is an area that warrants major interest in the healthcare community.

Despite the widespread prevalence of GSM, healthcare providers (HCPs) must keep in mind that many women are not comfortable discussing symptoms of GSM with their HCP, and vice versa. According to the Women’s Voices in the Menopause international survey, nearly 80% of online respondents felt that women were not comfortable discussing vaginal atrophy.7 The Real Women’s Views of Treatment Options for Menopausal Vaginal Changes (REVIVE) survey reported that only 56% of women had ever discussed their VVA symptoms with an HCP.8 In the VIVA (Vaginal Health: Insights, Views & Attitudes) survey, 80% of respondents stated that vaginal discomfort adversely affected their lives, and 75% of respondents reported adverse consequences on their sex lives.9

In the recent past, nonhormonal lubricants and local hormonal therapies were the only treatment options for women with GSM. To date, six FDA-approved therapies for VVA/GSM are available (Box). Intravaginal CO2 laser therapy, approved in late 2014, offers a unique, nonpharmacologic option for women, including breast cancer survivors, who are not candidates for hormonal treatment.

FoSH_FDA

Regardless of the treatment chosen, HCPs caring for women must encourage open communication regarding symptoms of GSM with patients who may be otherwise unlikely to initiate conversation on such sensitive matters. With healthcare advances, many treatment options are available for all degrees of GSM severity and all circumstances.

Brooke M. Faught is a nurse practitioner and the Clin­ical Director of the Women’s Institute for Sexual Health (WISH), A Division of Urology Associates, in Nashville, Tennessee. The author states that she serves on the speakers’ bureau for Actavis Pharma, Inc., and Shionogi Inc.

References
1. Portman D, Gass M. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and The North American Menopause Society. Menopause. 2014;21(10):1063-1068.

2. North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013;20(9):888-902.

3. Tan O, Bradshaw K, Bruce RC. Management of vulvovaginal atrophy-related sexual dysfunction in postmenopausal women: an up-to-date review. Menopause. 2012;19(1):109-117.

4. U.S. Census Bureau. Statistical Abstract of the United States. 2012. https://www.census.gov/prod/2011pubs/
12statab/pop.pdf

5. Parish SJ, Nappi RE, Krychman ML, et al. Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy. Int J Womens Health. 2013;5:437-446.

6. Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med. 2009;6(8):2133-2142.

7. Nappi RE, Kokot?Kierepa M. Women’s voices in the menopause: results from an international survey on vaginal atrophy. Maturitas. 2010;67(3):233-238.

8. Kingsberg SA, Wysocki S, Magnus L, et al. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10(7):1790-1799.

9. Simon JA, Kokot-Kierepa M, Goldstein J, Nappi RE. Vaginal health in the United States: results from the Vaginal Health: Insights, Views & Attitudes survey. Menopause. 2013;20(10):1043-1048.

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 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.

References

  1. Mechanick JI, Garber AJ, Handelsman Y, Garvey WT. American Association of Clinical Endocrinologists’ position statement on obesity and obesity medicine. Endocr Pract. 2012;18(5):642-648.
  2. World Health Organization. Obesity and overweight. Fact sheet No. 311. Updated January 2015. http://www.who.int/mediacentre/factsheets/fs311/en/
  3. Centers for Disease Control and Prevention. Overweight and Obesity. Adult Obesity Facts. Last updated September 2014. http://www.cdc.gov/obesity/data/adult.html
  4. Daniel S, Soleymani T, Garvey WT. A complications-based clinical staging of obesity to guide treatment modality and intensity. Curr Opin Endocrinol Diabetes Obes. 2013;20(5):377-388.
  5. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
  6. Centers for Disease Control and Prevention. Overweight and Obesity. Obesity Prevalence Maps. Last updated September 2014. http://www.cdc.gov/obesity/data/prevalence-maps.html
  7. American Nurse Practitioner Foundation. Nurse Practitioners and the Prevention and Treatment of Adult Obesity. 2013. http://anp-foundation.org/wp-content/uploads/2013/07/ObesityWhitePaperv11.pdf
  8. NHLBI Obesity Education Initiative. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. October 2000. www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf
  9. American Diabetes Association. Standards of Medical Care in Diabetes—2012. Diabetes Care. 2012;35:S11-S63.
  10. Grundy SM, Brewer HB Jr, Cleeman JI, et al. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004;109(3):433-438.
  11. MedlinePlus. Obesity Raises Women’s Cancer Risk by 40 Percent, Study Finds. March 17, 2015. http://www.nlm.nih.gov/medlineplus/news/fullstory_151517.html
  12. Wadden TA, Webb VL, Moran CH, Bailer BA. Lifestyle modification for obesity: new developments in diet, physical activity, and behavior therapy. Circulation. 2012;125(9):1157-1170.
  13. Atkins RC. Dr. Atkins’ New Diet Revolution. New York, NY: Avon; 2002.
  14. Krauss RM, Eckel RH, Howard B, et al. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the Nutrition Committee of the American Heart Association. Circulation. 2000;102(18):2284-2299.
  15. Shai I, Schwarzfuchs D, Henkin Y, et al; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008;359(3):229-241.
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  17. Tsai AG, Wadden TA. The evolution of very-low-calorie diets: an update and meta-analysis. Obesity (Silver Spring). 2006;14(8):1283-1293.
  18. Dansinger ML, Gleason JA, Griffith JL, et al. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005;293(1):43-53.
  19. The National Weight Control Registry. http://www.nwcr.ws/
  20. Seger JC, Horn DB, Westman EC, et al. American Society of Bariatric Physicians. Obesity Algorithm: Adult Adiposity Evaluation and Treatment. 2013. www.obesityalgorithm.org
  21. Strasser B. Physical activity in obesity and metabolic syndrome. Ann N Y Acad Sci. 2013;1281:141-159.
  22. Ochner CN, Tsai AG, Kushner RF, Wadden TA. Treating obesity seriously: when recommendations for lifestyle change confront biological adaptations. Lancet Diabetes Endocrinol. 2015;3(4):232-234.
  23. Garber AJ, Abrahamson MJ, Barzilay JI, et al; American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013;19(2):327-336.
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  28. Qsymia prescribing information. Vivus, Inc. 2012-2014. https://qsymia.com/hcp/include/media/pdf/prescribing-information.pdf
  29. Belviq prescribing information. Arena Pharmaceuticals. August 2012. https://www.belviqhcp.com/media/1001/belviq_prescribing_information.pdf
  30. Contrave prescribing information. Takeda Pharmaceuticals America, Inc. 2014. http://general.takedapharm.com/content/file.aspx?filetypecode=CONTRAVEPI&CountryCode=US&LanguageCode=EN&cacheRandomizer=ef10a935-77f9-4f19-8bfd-5eefd179c8d1
  31. Saxenda prescribing information. Novo Nordisk. December 2014. http://www.novo-pi.com/saxenda.pdf
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  35. Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9774):1341-1352.
  36. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012;95(2):297-308.
  37. Garvey WT, Ryan DH, Henry R, et al. Prevention of type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended release. Diabetes Care. 2014;37(4):912-921.
  38. Greenway FL, Fujioka K, Plodkowski RA, et al; COR-I Study Group. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376(9741):595-605.
  39. Wadden TA, Hollander P, Klein S, et al; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013;37(11):1443-1451.
  40. Allison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity (Silver Spring). See comment in PubMed Commons below2012;20(2):330-342.
  41. Astrup A, Carraro R, Finer N, et al; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012;36(6):843-854.
  42. Apovian CM, Aronne L, Rubino D, et al; COR-II Study Group. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013;21(5):935-943.
  43. Fidler MC, Sanchez M, Raether B, et al; BLOSSOM Clinical Trial Group. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011;96(10):3067-3077.
  44. Munro JF, MacCuish AC, Wilson EM, Duncan LJ. Comparison of continuous and intermittent anorectic therapy in obesity. Br Med J. 1968;1(5588):352-354.
  45. Ryan DH, Peterson C, Troupin B, et al. Weight loss at 6 months with V1-0521 (PEN/TPM combination) treatment. Presented at: 69th Annual Scientific Sessions of the American Diabetes Association; June 5, 2009.
  46. Garvey WT. New tools for weight-loss therapy enable a more robust medical model for obesity treatment: rationale for a complications-centric approach. Endocrine Pract. 2013;19(5):864-874.

 

The Patient-Centered Outcomes Research Institute: Research to answer questions important to patients and clinicians

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By Amanda Greene, PhD, MPH, FNP, RN; Annie Lewis-O’Connor, NP-BC, MPH, PhD; Maureen B. Fagan, DNP, WHNP-BC, FNP-BC; and Julie A. Miller, PhD

The Patient-Centered Outcomes Research Institute (PCORI) funds comparative clinical effectiveness research to provide reliable evidence to help patients and their healthcare providers (HCPs) make informed decisions. All the projects PCORI funds must involve patients, as well as other healthcare stakeholders, including HCPs such as nurse practitioners (NPs), throughout the research process. NPs, with their invaluable experience in interacting with patients and their families, are playing important roles in helping PCORI choose which projects to fund and in leading and guiding research projects. This article provides an overview of PCORI’s work and describes how NPs can become involved in this work.

Key words: Patient-Centered Outcomes Research Institute, PCORI, patient-centered outcomes research, comparative effectiveness research, clinical research, nursing research

When nurse practitioners (NPs) meet with patients or their family members, they are likely to be asked many difficult questions. Common inquiries include:

  • What will happen to me?
  • What are my options, and what are their potential benefits and harms?
  • What can I do to improve the outcomes that are most important to me?
  • How can I make the best decisions about my health and healthcare?

Answering these questions requires NPs to use the best available evidence and to translate findings from clinical research into information that patients can act on.

However, many research findings are not directly relevant to patients’ individual circumstances, and they do not measure outcomes most important to patients and their families. To address this problem, the Patient-Centered Outcomes Research Institute (PCORI) funds research to help patients and their families and caregivers—as well as nurses, NPs, physicians, and others in the healthcare community—answer relevant questions.

What is PCORI?

PCORI is an independent research institute whose establishment was authorized by Congress in 2010. PCORI was created to improve the quality and relevance of research evidence available to help patients, family members, caregivers, healthcare providers (HCPs), employers, insurers, and policy makers reach informed decisions about health and healthcare. This work is accomplished by funding patient centered outcomes research (PCOR), primarily comparative clinical effectiveness research (CER) (Box). PCOR considers patients’ needs and preferences to focus on outcomes that are most important to them, whereas CER directly compares existing healthcare interventions, considering potential benefits and harms, to determine which ones work best for which patients.

PCORI is implementing a new model of research. Although traditional research often uses patients as study participants, it does not routinely seek input from patients, caregivers, HCPs, or the larger healthcare community. In the PCORI model, patients and other stakeholders serve as active team members throughout the research process.1 In addition, the institute engages patients, HCPs, and other healthcare stakeholders in its funding decisions and in other activities.2

PCORI has been building a rich and diverse research portfolio since awarding funding in 2012 for an initial round of Pilot Projects, studies designed to address a broad range of questions about methods for engaging patients in the health research and dissemination process. As of June 27, 2015, PCORI has funded 400 projects in 39 states plus the District of Columbia and Quebec.

What are PCORI’s goals?

For all the advances that clinical studies have produced, many questions remain about which approaches to disease prevention, diagnosis, treatment, and healthcare delivery work best in specific situations. Patients, along with their caregivers and HCPs, require more information that they can understand and readily use. To help meet this need, PCORI has three overarching goals:

  • To increase the quantity, quality, and timeliness of useful research information;
  • To speed implementation and use of research evidence; and
  • To encourage research funded by others to be patient-centered.

PCORI-funded studies engage patients and other stakeholders in planning and conducting studies, analyzing results, and disseminating research findings. For example, these individuals may provide input regarding which interventions are practical and which outcomes should be measured.

With their invaluable experience in interacting with patients and their families, NPs are playing important roles in helping PCORI choose which projects to fund and in guiding research projects as they unfold.3,4 Currently, PCORI has two nurses in leadership positions: One, an NP, serves on the Board of Governors and chairs the Engagement, Dissemination, and Implementation Committee, and the other chairs the Methodology Committee. Twelve nurses serve on multi-stakeholder advisory panels and many others review applications for research funding and serve on research teams around the country. PCORI welcomes input from NPs interested in any type of PCOR.

 

PCORI_Definitions

What types of research does PCORI support?

PCORI developed a framework to guide funding of research that will help patients and caregivers make better-informed health decisions. This framework addresses five research priority areas:

  • Assessment of prevention, diagnosis, and treatment options;
  • Improving healthcare systems;
  • Communication and dissemination research;
  • Addressing disparities; and
  • Accelerating PCOR and methodological research.

PCORI funds studies that investigators propose on a wide range of topics within these areas.

PCORI supports studies in a variety of formats. Some are randomized controlled trials, in which researchers randomly assign participants to an intervention and then measure particular outcomes. However, this powerful clinical tool may be impractical for assessing rare outcomes, effects that take a long time to develop, variation in response between subgroups, or the interventions that work best under usual circumstances (rather than the ideal circumstances of many traditional clinical trials).

To address these challenges, PCORI funds pragmatic clinical studies. These studies are conducted in routine clinical settings and are often large. Study participants represent the breadth of the relevant patient population. PCORI provides a list of topics of particular interest for pragmatic clinical studies.

The institute occasionally posts announcements seeking proposals for research on a specific topic. PCORI has not typically specified a research design in these targeted funding announcements, preferring to let investigators propose a means to address the questions presented. Projects currently under way that were funded under targeted announcements include testing the effectiveness of transitional care, preventing injuries from falls in the elderly, and treating severe asthma in African-American and Hispanic/Latino populations.

Under its priority of accelerating PCOR, the institute is funding the development of PCORnet, the National Patient-Centered Clinical Research Network. Designed to support large-scale, efficient CER, this initiative brings together clinical data networks based in healthcare systems and in patient-directed organizations. PCORnet will enable large-scale research to be conducted with enhanced efficiency in real-world healthcare delivery systems.

When funding research, PCORI pays particular attention to conditions that affect large numbers of people across a range of populations; conditions that place a heavy burden on individuals, families, specific populations, and society; and rare diseases, which are difficult to study. In addition, PCORI gives priority to racial and ethnic minorities, older adults, children, and low-income and rural populations.

About 9% of PCORI’s current studies focus on women’s health problems. These studies range from comparing options for management of uterine fibroids to engaging communities in the fight to reduce preterm birth. Other studies focus on imaging modalities for breast cancer survivors, decisions related to contralateral prophylactic mastectomy, prevention of unnecessary cervical cancer screening and treatment, and contraceptive counseling. In addition, PCORI is investigating how to facilitate translation of research findings into everyday practice by advanced practice nurses and other HCPs.

How is PCORI improving engagement in research?

A guiding principle of PCORI is that engagement of healthcare stakeholders can encourage research to be more patient-centered, useful, and reliable, and ultimately lead to greater adoption of research results. Stakeholders are defined by PCORI as the broad range of “communities” that have a stake in the effectiveness of our healthcare system. These communities include not only patients, caregivers and family members, and HCPs—and the organizations that represent them—but also payers (public and private insurers), purchasers of health benefits (e.g., employers), the life sciences industry, policy makers, hospitals and health systems, and training institutions. However, many researchers do not have experience working with community partners as they plan, conduct, and disseminate research. In addition, patients, HCPs, and other stakeholders may lack experience in research activities. Because engagement in research can take many forms, PCORI is exploring how best to meaningfully involve individuals, communities, institutions, and organizations in clinical research.

One way PCORI engages multiple voices is by requiring that all its governing and advisory groups (e.g., its Board of Governors, advisory panels, and application review teams) include patients, HCPs, researchers, and other stakeholders. All participants have equal voices in decisions, which include refining and prioritizing research questions and recommending engagement efforts.

To support engagement, PCORI is developing tools for creating and maintaining research partnerships. One of these tools, the PCORI Engagement Rubric, provides guidance on ways to involve patients, their families, and other stakeholders in conducting research and provides sample engagement plans from funded research.

Promising practices for meaningful engagement in the conduct of research are being explored through funding opportunities such as the Eugene Washington PCORI Engagement Awards and the Pipeline to Proposal Awards. These awards enhance the capacity of patients and other stakeholders to participate in and support research.

How can NPs participate in PCORI activities?

PCORI invites NPs to participate in a wide variety of activities that will help the institute meet its goals. These activities range from suggesting a research question to serving on an advisory panel to directing a research project. NPs, with their expertise in patient-centered care, can help inform research processes and facilitate interaction with patients. Specific ways for NPs to participate in PCORI activities include the following:

Suggest a patient-centered research question

PCORI’s selection of research questions starts with gathering suggestions from patients, HCPs, and other healthcare stakeholders. With the unique lens through which they view health and healthcare, NPs are well positioned to identify gaps in healthcare evidence. Professional organizations such as the National Association of Nurse Practitioners in Women’s Health have research agendas5 that may inspire NPs to propose potential topics.
After a topic is submitted to PCORI (readers can click on the heading of this section to do so), it is assessed for patient-centeredness, disease burden, potential for improving practice, timeliness, and potential impact. Topics are prioritized by the multi-stakeholder advisory panels and selected by PCORI’s Board. Suggested research questions have resulted in funding announcements in areas of special interest for women’s HCPs, including treatment options for uterine fibroids, effectiveness of transitional care, and obesity treatments for underserved populations.

Participate in PCORI events

PCORI convenes representatives from across the healthcare community for information exchange, discussion, and partnership building via webinars, workshops, and roundtables. In June 2014, PCORI held a webinar entitled PCORI in Practice: Highlighting Opportunities for Nurses, which is archived on the PCORI website. In January 2014, representatives of nursing professional societies attended a PCORI roundtable to share ideas on which programs, activities, and information would be most useful to members of those societies. More information about upcoming events can be found on the website or by subscribing to PCORI email alerts.

Review funding applications

Each research application received by PCORI is evaluated by a panel of two scientists, one patient, and one other stakeholder, such as a nurse. Scores from all types of reviewers have equal weight. First, applications are scored via an online system. Then all the reviewers meet in person to discuss the applications. Training/support for reviewers includes an online training program, mentoring from experienced reviewers, and communication with PCORI Merit Review Officers. Reviewers are compensated, and travel and related costs for the in-person meeting are reimbursed.

Currently, 4% of PCORI reviewers are nurses. NPs are encouraged to apply to become reviewers. Frontline expertise and experience in direct patient care across the age continuum in a variety of settings can help PCORI fund user-driven research that is patient-centered, useful, and usable, as well as scientifically rigorous.

Serve on advisory panels

Applying to one of PCORI’s advisory panels is another way that NPs can get involved. These multi-stakeholder panels include patients, caregivers, HCPs, policy makers, researchers, and payers. The seven PCORI advisory panels address these areas:

  • Assessment of Prevention, Diagnosis, and Treatment Options
  • Improving Healthcare Systems
  • Addressing Disparities
  • Communications and Dissemination Research
  • Patient Engagement
  • Clinical Trials
  • Rare Disease

The first four advisory panels above align with PCORI’s National Priorities and Research Agenda and help the institute prioritize topics submitted. The lattermost three panels provide advice and guidance to the institute and its awardees.

One of the authors (Annie Lewis-O’Connor), who is an NP, served on the Advisory Panel on Improving Healthcare Systems. With her perspective on nursing and advanced nursing practice, Lewis-O’Connor contributed to discussions about prioritizing research topics for PCORI funding. She was able to educate panel members about opportunities in healthcare that are not well understood, as well as about burdens that have a major impact on health and health outcomes. Lewis-O’Connor notes that participating on a PCORI advisory panel provides an innovative opportunity to collaborate with patients and other healthcare stakeholders.

Apply for a Pipeline to Proposal Award

Patient engagement in research requires making new connections between researchers and patients, HCPs, and other stakeholders. PCORI’s Pipeline to Proposal Awards build and strengthen such relationships, particularly in communities that have been underrepresented in research. This program builds the capacity for community partnerships to create research questions and submit PCOR proposals that can be considered for PCORI funding. In addition, the program increases the number of patients, researchers, and other stakeholders ready to participate in PCOR and explores methods for engaging and communicating with patients, researchers, and other stakeholders. Three of PCORI’s first 30 Pipeline to Proposal Awards went to projects led by nurses. Many other projects have nurses as important partners.

Among the projects for which a nurse is the principal investigator, one created a community team to identify opportunities for CER to reduce infant mortality. In an ongoing project, a community/clinical/academic partnership focused on asthma is creating a sustainable pathway for patient and parent input on research opportunities and building infrastructure to conduct CER. In another project, a community work group is targeting increased capacity of Mexican American families to identify strategies to promote healthful eating and physical activity, thereby reducing health disparities related to obesity. The Table lists examples of PCORI-funded research led by nurse scientists.

 

PCORI_Table

 

PCORI recently announced a second round of Pipeline to Proposal Awards to 47 projects, 5 of which are led by nurses. One project of special interest to nurses is titled Assessing Health Outcomes in Rural Areas Where Nurse Practitioners Provide Primary Care and another is titled Developing a Student/Family-Centered School Health Collaborative.

Apply for an Engagement Award

Readers who have ideas about ways to increase meaningful engagement of patients and healthcare stakeholders in the research process can apply to lead projects awarded to their organizations by the Eugene Washington PCORI Engagement Awards program. Within this program, Knowledge Awards increase evidence about how patients and other stakeholders view, receive, and make use of patient-centered CER. Training and Development Awards build capacity among patients and stakeholders to participate as full, meaningfully engaged partners in PCOR and CER. Dissemination Awards develop and strengthen channels for disseminating and implementing study findings. In addition, PCORI provides support for conferences, workshops, and other formal meetings to facilitate knowledge sharing and explore issues related to PCOR and CER.

Examples of Engagement Awards led by nurses include engaging the women’s health and research communities in PCORI activities and testing best practices in training for academic/community research partnerships. Other Engagement Awards include preparing a network of community health centers to implement PCOR in their practices and connecting parents of children with complex health conditions to each other and their HCPs to address common challenges.

Become a pcori ambassador

The goal of PCORI’s volunteer Ambassador program is to help patients, HCPs, organizations, and other stakeholders share the promise of PCOR with their communities and promote sharing and use of information generated from PCORI-funded projects. Ambassadors do not speak or act on behalf of PCORI but, rather, are partners aligned with its principles. They play an important role in building a PCOR community.

For now, PCORI invites only those individuals and organizations that have participated in its activities to become PCORI Ambassadors, but the institute plans to open the application process to others in the near future. Ambassadors complete an online training program that provides information on PCORI, its engagement program, and the Ambassador role. PCORI provides a toolkit that includes slides, talking points, and guidance on writing letters to the editor, opinion pieces, and blog posts. Among PCORI’s more than 100 Ambassadors, about 20 are HCPs; among these 20 HCPs, at least 6 are nurses, and among these nurses, at least 2 are NPs.

Apply for a research award

Nurse practitioners with research experience should consider applying for a research award. Another option is to become a co-investigator on a research team funded by PCORI. NPs can explore research opportunities within their orga­nization, connecting with researchers, patients, and other stakeholders to explore research gaps. Nurses, including at least 3 NPs, lead at least 15 PCORI-funded research projects. Nurse-led projects address topics such as activity coaching to improve outcomes in chronic obstructive pulmonary disease, using technology to improve health in diabetes, bringing care to patients with kidney disease, dealing with cancer symptoms by self-care management, and reducing health disparities for Appalachian patients with cardiovascular risk factors.

Conclusion

PCORI produces and promotes high-integrity, evidence-based information to help people make informed healthcare decisions and to improve healthcare delivery and outcomes. This goal is accomplished by funding comparative CER that is patient-centered and guided by patients, caregivers, HCPs, and the broader healthcare community. HCPs, including NPs, represent critical stakeholders whose experience and expertise are needed to ensure that PCORI-funded research addresses questions important to patients and that findings are accessible and understandable. NPs can participate in a wide variety of PCORI activities ranging from initiating PCOR to helping translate and disseminate findings. PCORI invites NPs to participate in all its activities. =

Amanda Greene is a Health Research Evaluator, NIH Common Fund, Office of Strategic Coordination, in Bethesda, Maryland. Annie Lewis-O’Connor is Director, Women’s CARE Clinic, Brig­ham and Women’s Hospital, in Boston, Massachusetts. Maureen B. Fagan is Associate Chief Nurse, Connor’s Center for Women and Newborn-OB/GYN, and Executive Director, Center for Patients and Families, Brigham and Women’s Hospital, in Boston, Massachusetts. Julie A. Miller is Senior Editor at the Patient-Centered Outcomes Research Institute in Washington, DC.

Disclosures

Amanda Greene was employed as a program officer by PCORI at the time she helped draft this manuscript. Annie Lewis-O’Connor was a member of the PCORI Advisory Panel on Improving Healthcare Systems. Maureen B. Fagan was a member of a PCORI Merit Review Panel. Julie A. Miller is currently employed as a senior editor by PCORI.

References

1. Frank L, Forsythe L, Ellis L, et al. Conceptual and practical foundations of patient engagement in research at the Patient-Centered Outcomes Research Institute. Qual Life Res. 2015;24(5):1033-1041.

2. Fleurence R, Selby JV, Odom-Walker K, et al. How the Patient-Centered Outcomes Research Institute is engaging patients and others in shaping its research agenda. Health Aff (Millwood). 2013;32(2):393-400.

3. Newhouse R, Barksdale DJ, Miller JA. The Patient-Centered Outcomes Research Institute: research done differently. Nurs Res. 2015;64(1):72-77.

4. Barksdale DJ, Newhouse R, Miller JA. The Patient-Centered Outcomes Research Institute: information for academic nursing. Nurs Outlook 2014;62(3):192-200.

5. NPWH Research Agenda for Nurse Practitioners in Women’s Health 2013-2016: Priorities for Evidence-Based Practice. www.npwh.org

The clinician speaks: “Why I am an abortion provider”

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By Amy J. Levi, PhD, CNM, WHNP-BC; Elizabeth Banks, FNP-C, MSN; Jessica Dieseldorff, FNP, MSN; and Victoria S. Tueros, FNP, MSN

Nurse practitioners (NPs) play an essential role in the prevention of unintended pregnancy through provision of contraceptive services and reproductive education and counseling. When unintended pregnancy does occur, NPs are there to provide options that include counseling, prenatal care, and/or needed referrals. Continuity of care and access to safe first-trimester abortion for women who decide to terminate an unintended pregnancy can be improved when NPs who choose to do so are also able to provide this service. In this article, the authors provide background information regarding the provision of abortion services by NPs, and three NPs share their experiences in this regard.

Unintended pregnancy remains a significant public health problem in the United States; current estimates identify 51% of pregnancies as unintended—that is, mistimed or unplanned.1 Of these unintended pregnancies, 27% are carried to term, 33% end in miscarriage, and 40% result in termination, by the use of either medication or uterine evacuation.1 Despite healthcare providers’ (HCPs’) and women’s best efforts to prevent unintended pregnancies, these events still occur, and many women choose termination as the best option for them. Termination of a pregnancy is a decision that women make within the complex reality of their own lives, and the decision to terminate a pregnancy, like all healthcare decisions, needs to be supported by NPs within the context of patient-centered care.2

The nurse practitioner role

Nurse practitioners have long been in the forefront of reproductive healthcare in the United States.3 The Patient Protection and Affordable Care Act requires that contraceptive care be included as part of preventive services for insured women without additional charge.4 Much of this contraceptive care is provided by NPs in primary care and reproductive health settings. Contraceptive care requires a wide range of skills, including patient education and counseling, as well as clinical expertise in intrauterine contraceptive (IUC) placement, contraceptive implant insertion, and unintended pregnancy management.5 As primary care providers, NPs are well positioned to take on responsibility for both unintended pregnancy prevention and management.6

The occurrence of unintended pregnancy continues despite the high rate of contraceptive use and the high efficacy rate for popular contraceptives. Up to 51% of unintended pregnancies occur in a cycle in which women have been using some form of contraception.7 Based on the perfect-use effectiveness rate for oral contraceptives, 3 pregnancies will still occur for every 1,000 women using this method alone.8 Therefore, the need for safe, accessible abortion will continue, and NPs represent a cadre of HCPs who can ensure continuity of care for unintended pregnancy, focusing on the needs of women who may already be their patients.

The number of abortion providers in the United States has declined steadily in the past decade; 89% of all counties in this country have no abortion provider at all.9 As a result, many women may need to travel to obtain abortion care, creating an increase in cost and possibly delaying an abortion past the first trimester, when terminations are safest. First-trimester abortions are among the safest gynecologic procedures available, and are part of a strategy to reduce the need for second-trimester abortions, which carry more risk of complications.10 An increase in the number of abortion providers, especially in counties lacking these providers or having too few of them, could make a safe procedure more accessible to more women. The contribution of NPs to this effort demonstrates the value of this previously underutilized workforce to address an important health problem for many women.

Provision of uterine vacuum aspiration is similar to many other clinical skills performed by NPs; this process includes dilating the cervical canal to enter the uterus in much the same way as is done for IUC placement or for intrauterine insemination. It involves instrumentation of the endometrium, as does endometrial biopsy. Many NPs are skilled in the use of ultrasonography (USG), another component of pregnancy termination skills. For NPs involved in reproductive healthcare, vacuum aspiration of the uterus for pregnancy termination can be easily added to the list of gynecologic services they provide.

Several recent studies support the safety of both medication and aspiration abortions provided by NPs and midwives.11 The largest of these studies compared complication rates for procedures performed by physicians with those performed by NPs, certified nurse-midwives (CNMs), and physician assistants (PAs).12 The results demonstrated that the risk difference for complications between the two groups was not clinically significant.

Despite these encouraging findings, NPs are restricted from providing abortions in many states. In fact, in 38 states, physicians are the only HCPs who can provide abortion services.13 In the remaining 12 states, NPs can prescribe medication abortions. In addition, in 6 of these 12 states—California, Montana, New Hampshire, New York, Oregon, and Vermont—NPs can provide aspiration abortions.

Three nurse practitioners speak

Nurse practitioners who choose to provide abortion services give varying reasons for doing so. A primary reason is the desire to provide continuity of care for women for whom they are already providing other reproductive healthcare services. NPs emphasize patient-centered care when a woman is diagnosed with an unplanned or mistimed pregnancy, and support her decision to parent, choose adoption, or terminate her pregnancy. Provision of an abortion, as chosen by the patient based on her needs, is simply part of the continuum of care. Three NPs describe their own journeys to becoming abortion providers.

Diane

My story started in a southeastern metropolitan area in the summer of 1992, when I had been hired as an educator for Planned Parenthood in a neighboring community. A friend called and asked if I would drive her to another city and hold her hand. She didn’t want to have her abortion in the town where we lived because she was afraid she would see people she knew, and she would be embarrassed and stigmatized. Despite all the reassurance I could give her about the sensitive and confidential care she would receive at our home clinic, we ended up on a road trip that changed her life and mine.

After witnessing my friend’s turning point, her taking control of her future, I felt called to be with other women making this profound and personal decision. I worked on call as a pre-abortion counselor. When I went to graduate school to become a nurse practitioner, I knew I wanted to come back to abortion care.

Over the 14 years during which I’ve been a women’s healthcare provider, my role in abortion care has slowly evolved. I have worked my way up from hand-holder and counselor to recovery room nurse, USG examiner, laminaria inserter, and medication abortion provider. For the past 3 years, I have been part of a research project training clinicians (NPs, PAs, and CNMs) to do in-clinic abortions up to 14 weeks. By participating in this research study, I hope that I will be enabling other advanced practice nurses (APNs) to become abortion providers and enabling more women to gain access to the early abortion services they need.

Having done almost 300 early abortions to date, I feel competent in the required skills, which are used in other procedures I do all the time (e.g., IUC insertion, colposcopy, biopsy). Every time I meet a woman on the day of her abortion, I remember the feeling I had 20 years ago. I’m honored when a woman trusts me to help her. Sometimes she wants to tell me her story and her reasons. I listen intently. Sometimes she just needs a quiet place to get through a harrowing day in her life. I am happy to witness her relief when I tell her the procedure is over.

Teresa

I have been working in the field of reproductive health and abortion services for 30 years. My initial experience was as a clinician doing pre-operative assessments and counseling. Since then, my career has evolved to include colposcopy, medication abortion services, and now the direct provision of first-trimester aspiration abortions. Over the years, I have met hundreds of women, some with similar stories and some with unique ones. My most memorable patient story demonstrates perfectly why APNs should be able to add abortion to their list of skills in reproductive health.

One day our medical assistant came to me to say that our next patient was very nervous. She was sure of her decision and had good support at home, but she was “just so afraid of the pain that might be involved.” When I read her patient record, I immediately recognized her name—I had seen her in the past for dysplasia and cancer screening services. When I entered the room she smiled, let out a huge sigh of relief, and said, ”Oh my gosh, are you the person who is going to do my abortion? You did my colposcopy and you were so gentle. I’m so glad it’s you again.” I smiled back, feeling so appreciated—and grateful that I had been given the opportunity to help and support women in this way.

After providing abortions for more than 200 women, I feel that this procedure is just one more skill in which I have become proficient. As a nurse practitioner, I have been trained to look at the whole person and consider all her needs to optimize her health outcomes. I feel that I can now do this for women seeking abortions as well. I look forward to a time when all APNs who want to offer this service to their patients are able to do so.

Barbara

Around 2005, two important factors converged to spur me to seek uterine aspiration training. I am of an age in which abortion has always been legal and I have taken it for granted that undergoing this procedure is a woman’s choice. However, in 2005, it seemed a real possibility that we might see a change in the composition of the Supreme Court and, as a result, the overturning of Roe v. Wade. The other motivating factor came in the form of the person who served as Director of Clinical Services where I worked. She was proactive and progressive, and believed that NPs could provide vacuum aspiration abortions because our state does not have a “physician-only” abortion law. My state also has a strong nurse practice act, which allows APNs to practice to the extent of their education. This person encouraged me to seek training in early aspiration abortion, which led to an opportunity to train with several physicians who all willingly shared their pearls of wisdom with me.

That was 7 years ago. I have participated in more than 3,000 aspiration abortions since then. My state does not restrict performance of abortion to physicians only; this procedure is treated like any other—performance of it is based on a clinician’s education and competency. I continue to feel privileged to assist women with this unique aspect of their healthcare, which I view as part of a continuum of their reproductive healthcare.

My journey continues to evolve as my patients share their stories with me. I believe more than ever that every aspect of abortion care is important and deserves careful attention. From the moment a woman discovers an unplanned pregnancy she faces new challenges. Even her first contact with clinic staff is an experience that she will remember. The process of assessing each patient when we first meet in the examination room, providing her USG, counseling her, and performing the aspiration abortion is incredibly inspiring as I see a woman transform from someone who may be anxious, angry, frightened, or all of the above to someone who is relieved and grateful for her care. I have come to appreciate the importance of how we NPs talk to patients, and of how our patience, kindness, and understanding help women get through very trying circumstances.

Conclusion

These stories demonstrate the power of nurse practitioners to provide care for women managing unintended pregnancy. NPs can support access to safe abortion care by increasing the number of providers for this much-needed clinical procedure and reducing the burden of obtaining access to care that many women need. The patient-centered care that is provided by NPs can be enhanced by adding this skill to their list of reproductive healthcare services.

Amy J. Levi is the Albers Professor of Midwifery at the University of New Mexico in Albuquerque. Elizabeth Banks is Director of Clinical Services at Planned Parenthood Columbia Willamette in Portland, Oregon. Jessica Dieseldorff is Quality Management Clinician/Clinician II at Planned Parenthood Mar Monte in San Jose, California. Victoria S. Tueros is a Family Nurse Practitioner in the Women’s Clinic at Family Health Centers Logan Heights in San Diego, California. 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. Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am J Public Health. 2014;23(3):e1-e9.

2. Kane R. Conscientious objection to termination of pregnancy: the competing rights of patients and nurses. J Nurs Manag. 2009;17(7):907-912.

3. Auerbach DI, Pearson ML, Taylor D, et al. Nurse Practitioners and Sexual and Reproductive Health Services: An Analysis of Supply and Demand. Santa Monica, CA: RAND Corporation; 2012.

4. Johnson K. Women’s health and health reform: implications of the Patient Protection and Affordable Care Act. Curr Opin Obstet Gynecol. 2010;22(6):492-497.

5. Bednash G, Worthington S, Wysocki S. Nurse practitioner education: keeping the academic pipeline open to meet family planning needs in the United States. Contraception. 2009;80(5):409-411.

6. Levi AJ, Simmonds K, Taylor D. The role of nursing in the management of unintended pregnancy. Nurs Clin North Am. 2009;44(3):301-314.

7. Jones RK, Frohwirth L, Moore AM. More than poverty: disruptive events among women having abortions in the USA. J Fam Plann Reprod Health Care. 2012;39(1):36-43.

8. Trussell J. Contraceptive failure in the United States. Contraception. 2011;83(5):397-404.

9. Jones RK, Jerman J, Abortion incidence and service availability in the United States, 2011. Perspect Sex Reprod Health. 2014;46(1):3-14.

10. Pazol K, Creanga AA, Burley KD, et al. Abortion surveillance – United States, 2010. MMWR Morbid Mortal Wkly Rep. 2013;62(8):1-44.

11. Renner RM, Brahmi D, Kapp N. Who can provide effective and safe termination of pregnancy care? A systematic review. Br J Obstet Gynaecol. 2013;120(1):23-31.

12. Weitz TA, Taylor D, Desai S, et al. Safety of aspiration abortion performed by nurse practitioners, certified nurse midwives, and physician assistants under a California legal waiver. Am J Public Health. 2013;103(3):454-461.

13. Guttmacher Institute. State Policies in Brief. As of July 1, 2014: An Overview of Abortion Laws. http://
www.guttmacher.org/statecenter/spibs/spib_OAL.pdf

NPWH 2014 conference abstracts

This issue of Women’s Healthcare: A Clinical Journal for NPs features abstracts presented at the 17th Annual NPWH Premier Women’s Healthcare Conference in Savannah, Georgia, in October 2014. Please join us in congratulating the first- and second-place poster award winners and the four podium presenters, all of whom received cash scholarships supported through a grant from Teva Women’s Health.

The second-place poster award winner, Ilana Moshe, RN, DNP, WHNP-BC, ANP-BC, wrote an abstract entitled “Postpartum Depression Screening in a Pediatric Clinic Setting” that will be converted into the first entry in our new department, Capstone Corner; please look for it in the August 2015 issue of Women’s Healthcare. Abstracts submitted by the four podium presenters and the first-place poster winning-authors appear here in the May 2015 issue.

We are proud of the high-quality work done by our colleagues in women’s healthcare. We look forward to receiving abstracts on other important women’s health research and innovative clinical projects for consideration at future NPWH conferences.

Aimee Chism Holland, DNP, WHNP-BC, NP-C, RD

NPWH Research Committee Chair

Click here for a PDF of the NPWH 2014 conference abstracts.

Fertility preservation for young cervical cancer survivors

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By Aimee Chism Holland, DNP, WHNP-BC, FNP-BC, RD; Deborah Kirk Walker, DNP, FNP-BC, NP-C, AOCN; Sigrid Ladores, PhD, PNP; and Karen Meneses, PhD, RN, FAAN

About 68% of invasive cervical cancer cases diagnosed in the United States involve women of childbearing age. Current treatment options for young patients with cervical cancer may cause hormonal and/or structural modifications to the reproductive system that could compromise pregnancy potential. Although clinical guidelines are available to help preserve fertility in these patients, gaps in practice remain, suggesting that the fertility-sparing needs of cervical cancer survivors are not routinely met. The authors provide nurse practitioners with current evidence about fertility-sparing treatments and with counseling considerations for young cervical cancer survivors.

Key words: cervical cancer survivor, fertility-sparing treatment, pregnancy, infertility, conization, trachelectomy

Cervical cancer was once the leading cause of gynecologic cancer in the United States. Following introduction of the use of the Pap smear in the 1940s, the incidence of cervical cancer has declined dramatically.<sup.1 Because use of the Pap smear is so effective and so widespread, the diagnosis of cervical cancer, when it is found, is usually made when a woman is younger (and still fertile) and when the disease is at an earlier stage (and therefore more easily treated).

In 2014, the American Cancer Society projected that 12,360 new cases of cervical cancer would be diagnosed in the U.S.2 Approximately 68% of cervical cancer cases are diagnosed in women of childbearing age.3,4 For young women, a diagnosis of cervical cancer once meant a hysterectomy and loss of the ability to bear a child. Today, fertility-sparing treatment (FST) options exist for women with early-stage cervical cancer, as well as more advanced fertility preservation and assisted reproductive technology (ART) approaches for those who are not candidates for FST.5

Young cervical cancer survivors may not know about FST options, and thus fear that treatment for cancer may compromise their future ability to conceive.6 Survivors also tend to be anxious about pregnancy outcomes after completing cancer treatment.7,8 Evidence suggests that they will want to discuss future fertility options with their healthcare provider (HCP).9 The American Society of Clinical Oncology (ASCO) and the American Society of Reproductive Medicine have published guidelines recommending that, prior to treatment, HCPs educate patients diagnosed with cervical cancer about the treatment’s potential effects on their fertility, along with fertility-preservation options.10,11 However, many HCPs are uninformed themselves and do not routinely offer fertility-preservation counseling prior to cancer treatment.12,13 The purpose of this article is to provide HCPs with current evidence about FST for cervical cancer and with counseling recommendations for young cervical cancer survivors.

Diagnosis and staging of cervical cancer

A Pap smear is used to screen for cervical cancer but not to make the diagnosis. A histology report from a cervical biopsy confirms the diagnosis and type of cervical cancer. After diagnosis, a workup is done to determine disease stage (Table 1).5

A clinical staging system is used for cervical cancer (rather than the surgical criteria used for most other gynecologic cancers). Two different staging systems are available. The International Federation of Gynecology and Obstetricsn (FIGO) staging system is based on a physical examination, diagnostic procedures, and imaging studies. Stages IA1, IA2, and IB1 are con­sidered early stages of cervical cancer.5,14 In stages IA1 and IA2, cancer is confined to the cervix and diagnosed only microscopically. Stage IB1 describes cancer confined to the cervix with a clinically visible tumor ?4 cm, stromal invasion that further describe tissue involvement (Table 2).5,15,16

Fertility-sparing cervical cancer treatment

The National Comprehensive Cancer Network (NCCN) recommends cone biopsy or radical trachelectomy for treatment for up to cervical cancer stage IB1 in women who want to preserve their fertility.5 This recommendation has not always existed; trends in surgical management of low-risk early-stage lesions have changed over the past 20 years. Hysterectomy was the only cure for cervical cancer stage IB1 until Dargent developed the fertility-sparing radical vaginal trachelectomy (RVT) technique in 1994.,sup>17 Prior to RVT, women with stage IA1 or IA2 lesions were the only cervical cancer survivors able to preserve their fertility.15

Cone biopsy

This term refers to a wedge-shaped excision of cervical tissue for both diagnostic evaluation and removal of abnormal tissue. Two methods of obtaining a cone biopsy with fertility sparing in mind are cold knife conization (CKC) and the loop electrosurgical excision procedure (LEEP). Cone biopsy is used to treat small lesions when there is no risk of dissecting across a gross neoplasm.5 Given that adequate margins and correct orientation are obtained, CKC and LEEP are appropriate measures for cervical cancer stage IA1 without lymphovascular space invasion.5 Negligible risks exist for cervical cancer stage IA1 recurrence following this treatment.5

Potential risks regarding future fertility following a cone biopsy include cervical stenosis and preterm delivery.18,19 Cervical stenosis occurs in 2%-3% of patients after CKC and in 3%-4% post-LEEP.19 Because of scar tissue formation that can occur after a cone biopsy, fertility may be compromised until the tissue is removed from the cervix. Long and Leeman19 reported that a history of a cone biopsy increased the odds of a preterm delivery by 2.19 (95% confidence interval, 1.93-2.49); risk correlated with the depth of the transformation zone removed. In this study, a greater risk existed for preterm delivery when a cone biopsy sample was thicker than 1.2 cm and larger than 6 cm2. However, Bevis and Biggio18 reported that evidence for the effects of conization procedures on fertility was conflicting because of the different types of procedures performed and the varying quality of control groups.

Fanfani et al20 performed a multicenter retrospective analysis of reproductive outcomes in 23 early-stage cervical cancer survivors who had undergone coni­zation treatment. Among 10 patients who tried to conceive, 6 achieved a spontaneous pregnancy and 4 received conception assistance via in vitro fertilization and embryo transfer (1 of whom achieved a pregnancy). In total, 70% of the young survivors achieved a pregnancy after cone biopsy treatment.

Trachelectomy

This fertility-sparing surgical procedure is performed to eradicate cervical cancer. In an RVT, the uterine corpus, ovaries, and Fallopian tubes are preserved, but the cervix, upper portion of the vagina, and the supporting ligaments are removed. A cerclage is placed at the location of the isthmus to close the opening of the uterus.7 RVT is an option for patients with stage IA2 or IB1 lesions 2 cm and ?4 cm, and provides a larger resection of the parametria.5

Most women who undergo RVT are able to conceive spontaneously, but a small number will require conception assistance.21 The 5-year cumulative pregnancy rate for women trying to conceive post-RVT is 52.8%; the cervical cancer recurrence rate after the procedure continues to be low.7 Potential risks of either trachelectomy procedure with regard to future fertility include miscarriage, preterm delivery, anovulation, and isthmic stenosis.7,21

Koh et al5 reported that, worldwide, more than 300 pregnancies have been confirmed following a trachelectomy for cervical cancer. Risk for second trimester miscarriage following a trachelectomy is 10%. However, 72% of women have carried a pregnancy to term. Park et al22 conducted a retrospective chart review of 55 young early-stage cervical cancer survivors who underwent laparoscopic abdominal trachelectomy. Ten of 18 patients attempting a pregnancy conceived; 6 of the 10 experienced preterm delivery. Overall, 55.6% of the survivors achieved a pregnancy, with 60% delivering preterm.

Fertility preservation procedures

Most women with cervical cancer at stage IB2 or greater are not candidates for FST. Radiation therapy is most often used for patients with higher stage IB disease, often called bulky disease. Radiation therapy is also used following a primary radical hysterectomy or in conjunction with chemotherapy in advanced disease. Radiation that includes the ovaries can damage oocyte quality and sex hormone production. Chemotherapy is not used in patients with milder forms of cervical cancer who are considering FST options.

Women planning to undergo radiation still have fertility preservation options, including the ART procedures of oocyte or embryo cryopreservation prior to cancer treatment.23 Cryopreservation of unfertilized oocytes, as opposed to embryos, may be considered for patients who do not have a male partner, do not wish to use donor sperm, or have religious or ethical reasons for avoiding embryo freezing. Because oocytes are highly sensitive to radiation injury, a procedure called ooph­oropexy (ovarian transposition) may be used. With ooph­oropexy, ovaries are sutured to the posterior uterus to protect them during pelvic radiation.

Before or after cancer treatment, survivors may benefit from ovarian stimulation medications that help promote follicular development. However, guidelines from both the American Congress of Obstetricians and Gynecologists and ASCO indicate insufficient evidence regarding the effectiveness of gonadotropin-releasing hormone analogs to suppress and protect ovarian function during cytotoxic treatment.24

Counseling before treatment

These counseling recommendations concerning fertility preservation were issued by ASCO: (1) Assume that patients with cancer want to discuss fertility preservation; address the possibility of infertility before cancer treatment starts and work with an interdisciplinary team to formulate a plan and make appropriate referrals; (2) Present oocyte and embryo cryopreservation as established fertility preservation methods; (3) Discuss the option of ooph­oropexy when pelvic radiation will be performed; (4) Inform patients of their individual risk for infertility, based on disease stage and treatment, as high, medium, low, or nonexistent; and (5) Inform patients about the use of conservative gynecologic surgery and radiation options.11

Several organizations and advocacy groups are available for young cervical cancer survivors with fertility concerns both before and after treatment (Table 3). ASCO created a video that can educate young patients about fertility preservation options and support networks.

Counseling after treatment

A woman who has undergone FST for cervical cancer faces many challenges. She may experience distress, depression, anxiety, and/or fear, and, depending on her own innate coping ability and her support system, may require psychological assessment and referral. HCPs can evaluate patients for these psychological reactions with tools such as the Functional Assessment of Cancer Therapy-Cervical Cancer Subscale and the NCCN Distress Thermometer for Patients, and make referrals as needed.

Cervical cancer and its treatment can adversely affect sexual health, causing problems such as decreased libido, fatigue, vaginal stenosis, and dyspareunia (Table 4).25-27 Many women hesitate to mention sexual problems on their own, so HCPs need to inquire about them and make referrals to a counselor who specializes in sex therapy, a gynecologist, or a physical therapist who specializes in pelvic pain and sexual dysfunction.* Many of the physical and psychological complaints involving sexual function resolve with-in the first year after treatment but may last up to 2 years or long­er.25,26

With regard to dyspareunia in particular, asking patients whether they experience it is the first step in helping resolve the problem. Nonpharmacologic and pharmacologic treatments, along with alternate positioning during intercourse, can be offered. HCPs can recommend over-the-counter vaginal moisturizers and lubricants to assist with vaginal dryness, dyspareunia, and sexual stimulation. In addition, prescription-strength topical lidocaine, estradiol vaginal cream, or ospemifene may help.

Undergoing ART can be arduous for women who endure painful and costly treatments. As of 2008, only 15 states have mandates that require health insurance carriers to provide full or partial coverage of costs related to infertility treatments.28 Most couples or individual women pay for infertility treatments out of pocket. Each ART cycle requires a woman to invest her body, mind, time, and money to realize her dream of motherhood, and she may be placing herself at risk for developing anxiety and depression.29-31

Even if a woman succeeds in achieving pregnancy through ART, the process is often fraught with anxiety.32,33 Young female cancer survivors have reported that they have a hopeful yet worried outlook on fertility and motherhood.34 This worry is especially true for cervical cancer survivors who have had trachelectomy surgery, as reported by Lloyd et al,7 wherein several participants described how they were fearful during pregnancy and attempted to be “model” pregnant women who followed every recommendation to reduce risks associated with preterm labor and miscarriage.

Consultations with specialists in reproductive endocrinology and/or high-risk obstetrics may be helpful. Pregnancy loss after infertility treatment can be devastating to these women, who view their pregnancy as “precious” and a “miracle,” and can have a profound impact on their psychological well-being.7 HCPs should prompt­ly refer these cancer survivors to mental health counselors who specialize in infertility and pregnancy loss.

Conclusion

Sixty-eight percent of cervical cancer cases diagnosed in the U.S. involve reproductive-aged women.2 Many of these women desire future pregnancies and want to discuss treatment options and future fertility. An interdisciplinary care approach for these women is necessary, with an emphasis placed on both successful cancer treatment and fertility preservation. FST options are available for women with early-stage cancer up to IB1. Fertility preservation procedures are available for women who are not candidates for FST. National guidelines are available regarding treatment and counseling for reproductive-age women with cervical cancer. The role of HCPs such as women’s health nurse practitioners is to educate young cervical cancer patients and survivors about their treatment options, manage pre- and post-treatment care, and provide referrals to specialists as needed.

Aimee Chism Holland is Assistant Professor, Coordinator of the Dual Adult/Gerontology Primary Care and Women’s Health Nurse Practitioner Specialty Track; Deborah Kirk Walker is Assistant Professor; Sigrid Ladores is Assistant Professor; and Karen Meneses is Professor and Associate Dean for Research, all at the School of Nursing at The University of Alabama at Birmingham. 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. American Cancer Society. What is cervical cancer? October 2014. www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cancer-what-is-cervical-cancer

2. American Cancer Society. What are the key statistics about cervical cancer? October 2014. www.cancer.org/
cancer/cervicalcancer/detailedguide/cervical-cancer-key-statistics

3. Centers for Disease Control and Prevention. Gyencological Cancers: What are the Risk Factors? March 2014. www.cdc.gov/cancer/cervical/basic_info/risk_factors.htm

4. National Cancer Institute. SEER Cancer Statistics Review, 1975-2011. September 2014. www.seer.cancer.
gov/csr/1975_2011/

5. Koh WJ, Greer BE, Abu-Rustum NR, et al. Cervical cancer. J Natl Compr Canc Netw. 2013;11(3):320-343.

6. Kola S, Walsh JC. Patients’ psychological reactions to colposcopy and LLETZ treatment for cervical intraepithelial neoplasia. Eur J Obstet Gynecol Reprod Biol. 2009;146(1):96-99.

7. Lloyd PA, Briggs EV, Kane N, et al. Women’s experiences after a radical vaginal trachelectomy for early stage cervical cancer. A descriptive phenomenological study. Eur J Oncol Nurs. 2014;18(4):362-371.

8. Wenzel L, Dogan-Ates A, Habbal R, et al. Defining and measuring reproductive concerns of female cancer survivors. J Natl Cancer Inst Monogr. 2005(34):94-98.

9. Maltaris T, Seufert R, Fischl F, et al. The effect of cancer treatment on female fertility and strategies for preserving fertility. Eur J Obstet Gynecol Reprod Biol. 2007;130(2):148-155.

10. Ethics Committee of American Society for Reproductive Medicine. Fertility preservation and reproduction in patients facing gonadotoxic therapies: a committee opinion. Fertil Steril. 2013;100(5):1224-1231.

11. Loren AW, Mangu PB, Beck LN, et al. Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013;31(19):2500-2510.

12. Gorman JR, Usita PM, Madlensky L, Pierce JP. Young breast cancer survivors: their perspectives on treatment decisions and fertility concerns. Cancer Nurs. 2011;34(1):32-40.

13. Kim SS, Klemp J, Fabian C. Breast cancer and fertility preservation. Fertil Steril. 2011;95(5):1535-1543.

14. Lea JS, Lin KY. Cervical cancer. Obstet Gyncol Clin North Am. 2012;39(2):233-253.

15. American Joint Committee on Cancer. What is Cancer Staging? 2014. https://cancerstaging.org/references-tools/Pages/What-is-Cancer-Staging.aspx

16. Pecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet. 2009;105(2):103-104.

17. Dargent D, Mathevet P. Schauta’s vaginal hysterectomy combined with laparoscopic lymphadenectomy. Baillieres Best Pract Res Clin Obstet Gynaecol. 1995;9(4):691-705.

18. Bevis KS, Biggio JR. Cervical conization and the risk of preterm delivery. Am J Obstet Gynecol. 2011;
205(1):19-27.

19. Long S, Leeman L. Treatment options for high-grade squamous intraepithelial lesions. Obstet Gynecol Clin North Am. 2013;40(2):291-316.

20. Fanfani F, Landoni F, Gagliardi ML, et al. Sexual and reproductive outcomes in early stage cervical cancer patients after excisional cone as a fertility-sparing surgery: an Italian experience. J Reprod Infertil. 2014; 15(1):29-34.

21. Wong I, Justin W, Gangooly S, et al. Assisted conception following radical trachelectomy. Hum Reprod. 2009;
24(4):876-879.

22. Park JY, Kim DY, Suh DS, et al. Reproductive outcomes after laparoscopic radical trachelectomy for early-stage cervical cancer. J Gynecol Oncol. 2014;25(1):9-13.

23. Wang ET, Pisarska MD. Preserving fertility in women facing cancer. Contemporary OB/GYN. 2013;58(12):22-32.

24. American Congress of Obstetricians and Gynecologists. Committee opinion no. 607: gynecologic concerns in children and adolescents with cancer. Obstet Gynecol. 2014; 124(2 pt 1):403-408.

25. Carter J, Sonoda Y, Baser RE, et al. A 2-year prospective study assessing the emotional, sexual, and quality of life concerns of women undergoing radical trachelectomy versus radical hysterectomy for treatment of early-stage cervical cancer. Gynecol Oncol. 2010;119(2):358-365.

26. Froeding LP, Ottosen C, Rung-Hansen H, et al. Sexual functioning and vaginal changes after radical vaginal trachelectomy in early stage cervical cancer patients: a longitudinal study. J Sex Med. 2014;11(2):595-604.

27. Miller M. Sexual Dysfunction in Women. March 2014. www.clinicalkey.com

28. Henne MB, Bundorf MK. Insurance mandates and trends in infertility treatments. Fertil Steril. 2008;89(1): 66-73.

29. Gonzalez LO. Infertility as a transformational process: a framework for psychotherapeutic support of infertile women. Issues Ment Halth Nurs. 2000;21(6):619-633.

30. Sandelowski M. A theory of the transition to parenthood of infertile couples. Res Nurs Health. 1995;18(2): 123-132.

31. Su TJ, Chen YC. Transforming hope: the lived experience of infertile women who terminated treatment after in vitro fertilization failure. J Nurs Res. 2006;14(1):46-54.

32. Hammarberg K, Fisher JR, Wynter KH. Psychological and social aspects of pregnancy, childbirth and early parenting after assisted conception: a systematic review. Hum Reprod Update. 2008;14(5):395-414.

33. Ladores S. The early postpartum experience of previously infertile mothers. Podium presentation at: 25th International Research Congress, Sigma Theta Tau International: Engaging Colleagues – Improving Global Health Outcomes; July 2014; Hong Kong.

34. Gorman JR, Bailey S, Pierce JP, Su HI. How do you feel about fertility and parenthood? The voices of young female cancer survivors. J Cancer Surviv. 2012;6(2):200-209.

*Editor’s Note: In the current issue of Women’s Healthcare: A Clinical Journal for NPs, Tammy M. DeBevoise, PT, DPT; Angela F. Dobinsky, PT, DPT; Caitlin B. McCurdy-Robinson, PT, DPT; Christina M. McGee, PT, DPT, ATC, LAT; Cody E. McNeely, PT, DPT; Sara K. Sauder, PT, DPT; and Kimberlee D. Sullivan, PT, DPT, WCS, BCB-PMD present a feature-length article on pelvic floor physical therapy.

Managing nausea and vomiting of pregnancy

PDF 50

By Stefanie Tyler, MSN, WHNP-BC and Jamille Nagtalon-Ramos, MSN, WHNP-BC, IBCLC

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

Despite its pervasive nature and potential severity, nausea and vomiting of pregnancy (NVP) is frequently regarded as something a woman must endure—even though effective management of the condition can greatly improve quality of life, reduce risks for maternal and fetal complications, and cut healthcare and societal costs. To help healthcare providers and their pregnant patients reach these goals, this article details the scope, etiology, impact, assessment, and management of NVP.

Key words: nausea and vomiting of pregnancy, NVP, quality of life, pyridoxine, doxylamine

Scope of the problem

The traditional classification of nausea and vomiting of pregnancy (NVP)—that is, the continuum ranging from mild to moderate to severe—is inadequate to characterize this condition’s full effect.1-3 According to a recent meta-analysis, about 70% of pregnant women experience NVP, and about 1.2% suffer from hyperemesis gravidarum (HG), the most severe form of NVP.4Symptoms, including nausea, gagging, retching, dry heaving, and vomiting, may persist ‘round the clock—despite the common term morning sickness.3,5 In a recent literature review, mean onset of NVP was day 39 from the last menstrual period (LMP)6; 13% of women began to experience NVP before day 28 and 90% before day 56 (i.e., the end of week 8 after their LMP). Peak incidence of NVP occurred dur­ing weeks 7-9. By week 16, NVP ceased in 91% of women. Recent reports indicate that NVP persists beyond week 20 in 2.5%-10% of women.7,8

Etiology

To address the unpleasant symptoms of NVP and the adverse impact of the condition on quality of life (QOL), it would be useful to know the etiology. Unfortunately, although several theories have been proposed, the etiology of NVP has not yet been clearly defined.9 NVP is most likely due to a complex interplay of hormonal, metabolic, physiologic, and psychosocial factors.5 Because of the close temporal association between peak human chorionic gonadotropin (hCG) concentrations and peak NVP symptoms, one of the most likely candidates for the emetogenic stimulus arising from the placenta is the rising level of hCG or one of its isoforms.10 Other authors theorize that NVP may serve as the body’s natural mechanism for avoiding ingestion of teratogenic substances during embryogenesis.11,12

Impact

Although the etiology of NVP has not been precisely determined, its effect on pregnant women is clear. Studies utilizing a wide range of measurement tools have identified detrimental and far-reaching consequences of NVP on maternal QOL.7 In particular, women report adverse effects of NVP on physical functioning, energy, social functioning, work, performance of household duties, and parenting.13,14 A prospective study of 367 pregnant women who completed a QOL questionnaire showed that those with moderate to severe NVP had scores similar to those of women with breast cancer or myocardial infarction, and those with severe NVP had QOL likened to postnatal depression.15

In fact, studies suggest that NVP of any magnitude can jeopardize women’s mental health.15 An interesting aspect of the burden that NVP places on a woman and her psyche is that this condition is considered a normal part of pregnancy; frequent nausea and vomiting (N/V) in any other setting would be considered pathologic and worthy of evaluation, diagnosis, management, and emotional support. As a result, NVP might not be taken as seriously because it is so common and because it is temporary, leading some sufferers to feel frustrated and guilty that they are even complaining about their symptoms.16

Nausea and vomiting of pregnancy can take a physical and psychological toll on a pregnant woman, and may have an adverse effect on her partner, family members, and even co-workers. However, mild to moderate NVP has not been shown to harm the fetus and may, in fact, be associated with favorable pregnancy outcomes, particularly in terms of rates of miscarriage, congenital malformations, and preterm births.17 Of note, though, infants of HG sufferers may be born prematurely, be small for gestational age, have significantly lower birth weights, or have 5-minute Apgar scores<7.18

Assessment

The first step in assessment of a pregnant patient who reports experiencing distressful N/V is to rule out other possible causes of the N/V besides pregnancy itself. Healthcare providers (HCPs) should ask about the onset, timing, and severity of the N/V; aggravating and alleviating factors; and appearance of the vomitus.3,8 A clinical picture of a positive pregnancy test result coupled with N/V that (1) began 30-60 days after a patient’s LMP, (2) occurs nearly every day between 9 AM and noon, and (3) is relieved to some degree by eating dry foods or carbohydrates is likely to represent NVP.

Differential diagnosis

Although NVP is the most obvious diagnosis when a pregnant wom­an presents with N/V, it is not the only possibility. An important distinguishing feature of NVP is that it begins prior to 10 weeks’ gestation; N/V onset after 10 weeks usually has an alternate cause. A history and physical examination should rule out these conditions19,20:

  • Gastrointestinal disorders such as gastroenteritis, cholecystitis, hepatitis, peptic ulcer disease, pancreatitis, appendicitis, and Helicobacter pylori infection;
  • Genitourinary tract disorders such as pyelonephritis or uremia;
  • Metabolic disorders such as diabetic ketoacidosis, porphyria, Addison’s disease, and hyper/hypothyroidism;
  • Neurologic disorders such as vestibular lesions, migraines, and central nervous systemtumors; and
  • Infections and drug toxicity/intolerance.

NVP is a diagnosis of exclusion.3

Physical findings

Certain physical findings may suggest conditions other than pregnancy that are causing the N/V. These findings include abdominal pain/tenderness that precedes N/V or that is out of proportion to the N/V (although some epigastric pain secondary to prolonged retching may occur with NVP); fever, which is not present in NVP; and concurrent neurologic findings such as headache, neck stiffness, and/or changes in vision.20

Testing

When a cause of N/V other than pregnancy is suspected, HCPs should order laboratory tests for urinary ketones, blood urea nitrogen, creatinine, liver enzymes, electrolytes, amylase, and thyroid-stimulating hormone.8 Ultrasonography is recommended to check for multiple gestation or molar gestation. If other causes of N/V have been ruled out, and if a woman’s symptoms are severe and persistent, HCPs should investigate possible complications such as dehydration and thiamine deficiency.

Providers may base their initial approach to NVP management on a woman’s subjective description of her symptoms. To obtain a more complete picture, they can add objective measures that not only help define the magnitude of the problem but also help them monitor treatment response. Several objective measures are available, including the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) scale,21 the Nausea and Vomiting of Pregnancy Instrument,22 the modified PUQE scale,23 the Health-Related Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL) questionnaire,24,25 and the 24-hour PUQE (PUQE-24) scale.26

Management

Clinical evidence suggests that use of antiemetics earlier in pregnancy may improve maternal QOL, prevent severe NVP—along with associated maternal and fetal complications—and reduce hospital-related costs.17,27 Because the etiology of NVP has not been determined, management is directed at symptoms. A reasonable approach, which is individually tailored, depends on symptom severity and the potential impact of treatment on the patient and the fetus. For mild to moderate NVP, dietary and lifestyle alterations may be sufficient. Some patients may prefer to try OTC (over-the-counter) or CAM (complementary and alternative medicine) therapies before progressing to pharmacologic interventions. However, pharmacologic treatment may be necessary and beneficial for some patients if symptoms persist. Patients with severe NVP may require hospitalization and extensive medical management.

Avoidance of triggers

Many women with NVP report that certain odors stimulate or exacerbate N/V. Avoiding stimuli such as pungent odors from food and perfumes or visual stimuli may alleviate their symptoms.28 A suggested strategy is to maintain a food diary, which may help determine tastes, textures, and odors that trigger N/V.

Dietary alterations

The most common dietary recommendations are to eat frequent small meals/snacks composed of high-carbohydrate, low-fat foods, with protein added to every snack and meal; and to avoid an empty stomach.19,29-31 For many women, eating dry food or carbohydrates before getting out of bed in the morning is helpful. Drinking liquids in between meals, instead of with meals, helps avoid gastric distention. Patients should be reassured that their diet during pregnancy, even if not “ideal,” will not harm the fetus.

These dietary recommendations apply to women with HG. However, in women with HG who have sustained significant weight loss, nutritional deficiencies may result in a compromised fetus or, at the least, cause some harm to the mother.31 In these cases, more aggressive interventions are needed.

OTC and CAM therapies

Systematic reviews of random­-
iz­ed and/or controlled trials have shown that pyridoxine (vitamin B6) improves mild to moderate nausea but does not significantly reduce vomiting27,32 or it has limited evidence of efficacy.5 When used as monotherapy, the initial dosage of pyridoxine is 25 mg orally every 6-8 hours; the maximum dosage suggested for pregnant women is 200 mg/day.33 A 2014 systematic review and meta-analysis of randomized trials showed that ginger, relative to placebo, improved nausea but not vomiting.34 A common dosage is powdered ginger 500-1,000 mg/day.8

Acupressure using a wristband or manual pressure at the P6 (Nei-Guan) point, located 4.5 cm above the wrist on the palmar side of the forearm, is a common treatment for NVP.35 One such wristband, PrimaBella®, has been approved by the FDA for this indication.36 However, a 2014 systematic review of randomized trials did not find P6 acupressure wristbands to be significantly more effective than placebo.5

Clinical evidence to support the efficacy of hypnosis or psycho­therapy as a primary treatment for NVP is insufficient. Supportive therapy, counseling, or a review of psychological factors in cases with persistent NVP symptoms, is recommended.

Pharmacotherapy

Dietary changes and OTC/CAM therapy, if tried, may not be sufficient in easing NVP symptoms. If so, patients may benefit from pharmacotherapy.

Doxylamine/pyridoxine

The American Congress of Obstetricians and Gynecologists has stated that pyridoxine, alone or in combination with doxylamine, an H1-receptor antagonist usually used as an antihistamine or hypnotic, is safe and effective for NVP and should be considered first-line pharmacotherapy.37 If OTC pyridoxine 25 mg TID alone is inadequate in easing symptoms, patients can add OTC doxylamine 12.5 mg (one-half tablet of Unisom SleepTabs) TID. However, this OTC regimen has its drawbacks: (1) several Unisom products are available; only one of them contains doxylamine; (2) patients must split the small 25-mg tablet in half to get the correct dose; (3) patients must take two separate pills 3-4 times a day; and (4) these immediate-release OTC formulations may not “cover” patients 24/7.3

In April 2013, the FDA approved Diclegis,® a combination of delayed-release doxylamine 10 mg and pyridoxine 10 mg, for the treatment of NVP.38 This product is the only FDA Pregnancy Category A-approved therapy specifically indicated for NVP.3,39 Diclegis is initially given as two delayed-release pills at bedtime; if symptoms are not adequately controlled, the dose can be increased to a maximum of four tablets daily (one in the morning, one mid-afternoon, and two at bedtime).3,40

A doxylamine-pyridoxine combination pill, previously called Bendectin, was removed from the U.S. market in 1983 following unfounded allegations that it caused birth defects. Since that time, numerous meta-analyses and studies have supported the safety of this product—in fact, no other agents given in pregnancy have more conclusive safety data with regard to teratogenicity.39,41 In addition, a major trial, which was requested by the FDA before it would grant approval for Diclegis, showed evidence of efficacy.42 In this double-blind study, 161 women with NVP were randomized to receive extended-release doxylamine-pyridoxine (n = 131) or placebo (n = 125) for 14 days; active treatment, as compared with placebo, resulted in a significantly larger improvement in NVP symptoms based on both PUQE score (–4.8 ± 2.7 vs. –3.9 ± 2.6; P = .006) and QOL. If delayed-release doxylamine-pyridoxine alone does not relieve patients’ symptoms to a sufficient extent, then alternate or additional interventions can be explored.

H1-receptor antagonists

Other H1-receptor antagonists besides doxylamine can be tried, including diphenhydramine (e.g., Benadryl®), dimenhydrinate (e.g., Dramamine®), meclizine (e.g., Antivert®), cyclizine (Marezine®), and hydroxyzine (e.g., Vistaril®). If any of these agents is added to dox­yl­amine or Diclegis, low doses are used to avoid compounding antihistamine side effects such as excess drowsiness. Pooled data from seven controlled trials indicated that antihistamines are effective in reducing vomiting in pregnant women and appear to have a protective effect in terms of the risk for fetal malformations.24 A pre­vious meta-analysis of 24 controlled studies enrolling a total of more than 200,000 women using antihistamines during pregnancy had shown no link of the drugs to birth defects or serious adverse maternal or fetal outcomes.43 Because no specific H1-receptor blocker dosing guidelines concerning pregnant women are available, standard adult dosages are recommended—for example, diphenhydramine 25-50 mg orally (PO) every 4-6 hours or 10-50 mg intravenously (IV) or intramuscularly (IM) every 4-6 hours as needed; meclizine 25 mg PO every 4-6 hours as needed; and dimenhydrinate 50-100 mg PO or rectally (PR) every 4-6 hours as needed.44

Dopamine antagonists

For women who do not respond to doxylamine and/or pyridoxine, another option is to substitute or add a drug from an different category such as a dopamine antagonist. Within this category are pheno­thia­zine antiemetics (e.g., prochlorperazine [Compazine®], promethazine [Phenergan®]) and meto­clopramide (Reglan®), which has antiemetic and prokinetic effects.3

A major downside of the phenothiazines is that, although effective as antiemetics, these agents can cause sedation, hypotension, dry mouth, and extrapyramidal symptoms. Although the FDA has placed phenothiazines in Pregnancy Category C, multiple observational studies of patients exposed to various these agents have failed to demonstrate an increased risk for major malformations.45

No specific dosing guidelines for the phenothiazines exist for pregnant women. Possible regimens are those established for adults and include promethazine 12.5-25 mg PO or PR every 4-6 hours as needed (promethazine has a black-box warning for severe tissue injuries with IV or subcutaneous administration) and prochlorperazine 5-10 mg PO or 10-25 mg PR every 6 hours as needed.44

In terms of metoclopramide, a Pregnancy Category B agent, the largest study to date, published in 2013, showed no increased risk for major congenital malformations with more than 28,000 first-trimester exposures.46 A randomized controlled trial comparing metoclopramide and prometh­azine for the treatment of HG showed no difference in efficacy, although metoclopramide was less sedating.47 Recommended dosing is metoclopramide 5-10 mg PO or IV every 6 hours as needed.44

5-HT3 antagonists

If NVP symptoms are still inadequately controlled, women can try a serotonin 5-hydroxytryptamine 3-receptor (5-HT3) antagonist
such as ondansetron (Zofran®), granisetron (Kytril®), or dolasetron (Anzemet®). Although these agents are used primarily for chemotherapy-related N/V, they are widely used for NVP—especially because, until early 2013, there were no FDA-approved drugs for NVP.3,48 In fact, the use of ondansetron for NVP has increased from 50,000 monthly prescriptions in 2008 to 110,000 monthly prescriptions in 2013, despite unresolved concerns regarding fetal safety (e.g., risk for cleft palate in the newborn49) and FDA warnings about serious maternal dysrhythmias.3,48

Using a large Danish birth registry, two groups of researchers reached different conclusions regarding the safety of ondansetron: Pasternak et al50 reported that ondansetron was not associated with increased rates of spontaneous abortion, stillbirth, major birth defects, preterm delivery, low birth weight, or small size for gestational age, whereas Andersen et al51 found a 2-fold increased risk for cardiac malformations.

Data from a large Swedish birth registry and a Swedish registry of prescribed drugs were reviewed to investigate the teratogenic effects of ondansetron.52 A total of 1349 infants born of women who had taken ondan­setron in early pregnancy between 1998 and 2012 were identified. Although no significant increase in risk for major malformations was found, the risk of a cardiovascular defect, particularly a cardiac septum defect, was significantly increased in infants whose mothers had taken ondansetron during pregnancy.

Information is limited regarding the effectiveness of ondansetron for treatment of NVP. The results of one study suggest that this agent can decrease vomiting but is only modestly effective in limiting nausea.53

Corticosteroids

Given the risk of maternal side effects, possible fetal risks (oral cleft, hypospadias, and other malformations), and uncertain efficacy, corticosteroids are reserved for treatment of refractory NVP or HG after the first trimester.49,54 If the benefit of treatment is thought to outweigh the risk, the recommended dosage is methylprednisolone 16 mg IV every 8 hours for 48-72 hours. Methylprednisolone can be stopped abruptly if there is no response, and tapered over 2 weeks in women who experience symptom relief.33 After IV therapy, women can follow an oral prednisone taper regimen.

Conclusion

Nausea and vomiting of pregnancy is a prevalent condition with major clinical impact for many women. After ruling out other possible causes of the N/V, HCPs can offer patients multiple therapeutic options such as dietary approaches, OTC/CAM therapies, and pharmacotherapeutic options to improve their QOL and the overall pregnancy experience. A period of time may be needed to fine-tune the therapeutic intervention that works best for each woman.

References

1. American College of Obstetrics and Gynecology. ACOG Practice Bulletin: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2004;103(4):803-814.

2. Jewell D, Young G. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2003;(4):CD000145.

3. Clark SM, Dutta E, Hankins GD. The outpatient management and special considerations of nausea and vomiting in pregnancy. Semin Perinatol. 2014;38(8):496-502.

4. Einarson TR, Piwko C, Koren G. Prevalence of nausea and vomiting of pregnancy in the USA: a meta analysis. J Popul Ther Clin Pharmacol. 2013;20(2):e163-e170.

5. Matthews A, Haas DM, O’Mathúna DP, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2014;3:CD007575.

6. Gadsby R, Barnie-Adshead AM. Literature Review of Nausea and Vomiting of Pregnancy. 2011. https://www.pregnancysickness
support.org.uk/documents/NVP-lit-review.pdf

7. Wood H, McKellar LV, Lightbody M. Nausea and vomiting in pregnancy: blooming or bloomin’ awful? A review of the literature. Women Birth. 2013;26(2):100-104.

8. Niebyl JR, Briggs GG. The pharmacologic management of nausea and vomiting of pregnancy. J Fam Pract. 2014;63(2):S31-S37.

9. Patil CL, Abrams ET, Steinmetz AR, Young SL. Appetite sensations and nausea and vomiting in pregnancy: an overview of the explanations. Ecol Food Nutr. 2012;51(5):394-417.

10. Goodwin TM. What is the fundamental stimulus in NVP? Presented at: Exploring Nausea and Vomiting of Pregnancy (NVP). Sponsored by the NICHD Center for Research for Mothers and Children, Pregnancy and Perinatology Branch, Perinatology Research Branch. Bethesda, MD: September 20-21, 2000.

11. Flaxman SM, Sherman PW. Morning sickness: a mechanism for protecting mother and embryo. Q Rev Biol. 2000;75(2):113-148.

12. Swallow BL, Lindow SW, Masson EA, Hay DM. Women with nausea and vomiting in pregnancy demonstrate worse health and are adversely affected by odours. J Obstet Gynaecol. 2005;25(6):544-549.

13. Smith C, Crowther C, Beilby J, Dandeaux J. The impact of nausea and vomiting on women: a burden of early pregnancy. Aust N Z Obstet Gynecol. 2000;40(4):397-401.

14. Lee NM, Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin North Am. 2011;40(2):309-334.

15. Lacasse A, Rey E, Ferreira E, et al. Nausea and vomiting of pregnancy: what about quality of life? BJOG. 2008a;115(12):1484-1493.

16. Munch S, Korst LM, Hernandez GD, et al. Health-related quality of life in women with nausea and vomiting of pregnancy: the importance of psychosocial context. J Perinatol. 2011;31(1):10-20.

17. Koren G, Madjunkova S, Maltepe C. The protective effects of nausea and vomiting of pregnancy against adverse fetal outcome—a systematic review. Reprod Toxicol. 2014;47:77-80.

18. Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;
5(2):78-84.

19. Niebyl JR. Clinical practice. Nausea and vomiting in pregnancy. N Engl J Med. 2010;363(16):1544-1550.

20. Firoz T, Maltepe C, Einarson. A. Nausea and vomiting in pregnancy is not always nausea and vomiting of pregnancy. J Obstet Gynaecol Can. 2010;32(10):970-972.

21. Koren G, Boskovic R, Hard M, et al. Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2002;186(5 suppl understanding):S228–S231.

22. Swallow BL, Lindow SW, Masson EA, Hay DM. Development of an instrument to measure nausea and vomiting in pregnancy. J Obstet Gynaecol. 2002;22(5):481-485.

23. Lacasse A, Rey E, Ferreira E, et al. Validity of a modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) scoring index to assess severity of nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2008b;198(1):71.e1-e7.

24. Magee LA, Chandra K, Mazzotta P, et al. Development of a health-related quality of life instrument for nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2002;186(5 suppl understanding):S232-S238.

25. Lacasse A, Bérard A. Validation of the nausea and vomiting of pregnancy specific health related quality of life questionnaire. Health Qual Life Outcomes. 2008;9(6):32.

26. Ebrahimi N, Maltepe C, Bournissen FG, Koren G. Nausea and vomiting of pregnancy: using the 24-hour Pregnancy-Unique Quantification of Emesis (PUQE-24) scale. J Obstet Gynaecol Can. 2009;31(9):803-807.

27. Koren G, Maltepe C. Pre-emptive therapy for severe nausea and vomiting of pregnancy and hyperemesis gravidarum. J Obstet Gynecol. 2004; 24(5):530-533.

28. Gordon A, Platt J. Nausea and vomiting in pregnancy. In: Rakel D, ed. Integrative Medicine. Saunders; 2012:491-497.

29. Ebrahimi N, Maltepe C, Einarson A. Optimal management of nausea and vomiting of pregnancy. Int J Womens Health. 2010;4(2):241-248.

30. Maltepe C, Koren G. The management of nausea and vomiting of pregnancy and hyperemesis gravidarum—a 2013 update. J Popul Ther Clin Pharmacol. 2013;20(2):e184-e192.

31. Einarson A, Maltepe C, Boskovic R, Koren G. Treatment of nausea and vomiting in pregnancy: an updated algorithm. 2007;53(12):2109-2111.

32. Tiran D. Nausea and vomiting in pregnancy: an ‘alternative’ approach to care. Br J Midwifery. 2014;22(8):
544-550.

33. Smith JA, Refuerzo JS, Ramin SM. Treatment and outcome of nausea and vomiting of pregnancy. UpToDate. Last updated October 27, 2014. http://www.uptodate.com/contents/treatment-and-outcome-of-nausea-and-vomiting-of-pregnancy

34. Viljoen E, Visser J, Koen N, Musekiwa A. A systematic review and meta-analysis of the effect and safety of ginger in the treatment of pregnancy-associated nausea and vomiting. Nutr J. 2014;13:20.

35. Roscoe JA, Matteson SE. Acupressure and acustimulation bands for control of nausea: a brief review. Am J Obstet Gynecol. 2002;186(5 suppl understanding):S244-S247.

36. PrimaBella website. https://www.reliefband.com/primabella.html

37. American Congress of Obstetricians and Gynecologists. Guideline Summary: Nausea and vomiting of pregnancy. 2009. http://www.guideline.gov/content.aspx?id=10939&search=nausea+AND+pregnancy

38. FDA News Release. FDA approves Diclegis for pregnant women experiencing nausea and vomiting. April 8, 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm347087.htm

39. Nuangchamnong N, Niebyl J. Doxylamine succinate-pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview. Int J Womens Health. 2014;12(6):401-409.

40. Diclegis Highlights of Prescribing Information. Duchesnay Inc. 2013. https://www.diclegis.com/pdf/Diclegis
_Full_Prescribing_Information.pdf

41. Madjunkova S, Maltepe C, Koren G. The delayed-release combination of doxylamine and pyridoxine (Diclegis®/Diclectin®) for the treatment of nausea and vomiting of pregnancy. Paediatr Drugs. 2014a;16(3):199-211.

42. Koren G, Clark S, Hankins GD, et al. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010;203(6):571.e1-e7.

43. Seto A, Einarson T, Koren G. Pregnancy outcome following first trimester exposure to antihistamines: meta-analysis. Am J Perinatol. 1997; 14(3):119-124.

44. Klasco RK, ed. DrugdexAE system. Greenwood Village, CO: Thomson Micromedex. Expired June 2006.

45. Mazzotta P, Magee LA. A risk-benefit assessment of pharmacological and nonpharmacological treatments for nausea and vomiting of pregnancy. Drugs. 2000;59(4):781-800.

46. Pasternak B, Svanström H, Mølgaard-Nielsen D, et al. Metoclopramide in pregnancy and risk of major congenital malformations and fetal death. JAMA. 2013;310(15):1601-1611.

47. Tan PC, Khine PP, Vallikkannu N, Omar SZ. Promethazine compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. Obstet Gynecol. 2010;115(5):975-981.

48. Koren G. Treating morning sickness in the United States—changes in prescribing are needed. Am J Obstet Gynecol. 2014;211(6):602-606.

49. Anderka M, Mitchell AA, Louik C, et al; National Birth Defects Prevention Study. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94(1):22-30.

50. Pasternak B, Svanström H, Hviid A. Ondansetron in pregnancy and risk of adverse fetal outcomes. N Engl J Med. 2013b;368(9):814-823.

51. Andersen JT, Jimmenez-Solem E, Andersen NL. Ondansetron use in early pregnancy and the risk of congenital malformations. Int Soc Pharmacoepidemiol. 2013. Abstract 25, Pregnancy session 1. http://www.motherisk.org/videos/index.jsp

52. Danielsson B, Wikner BN, Källén B. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol. 2014; 50:134-137.

53. Madjunkova S, Maltepe C, Farine D, Koren G. Patterns of antiemetic use among american women with nausea and vomiting of pregnancy. Obstet Gynecol. 2014b;123(suppl 1):155S.

54. Park-Wyllie L, Mazzotta P, Pastuszak A, et al. Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies. Teratology. 2000;62(6):385-392.

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Pelvic floor physical therapy: More than Kegels

PDF 50

By Tammy M. DeBevoise, PT, DPT; Angela F. Dobinsky, PT, DPT;
Caitlin B. McCurdy-Robinson, PT, DPT; Christina M. McGee, PT, DPT, ATC, LAT; Cody E. McNeely, PT, DPT; Sara K. Sauder, PT, DPT; and Kimberlee D. Sullivan, PT, DPT, WCS, BCB-PMD

Nurse practitioners commonly see patients with disorders or symptoms related to pelvic floor muscle (PFM) dysfunction who may be candidates for pelvic floor physical therapy. In this article, the authors discuss their approach to the evaluation and treatment of these patients. The aim of this collaboration between NP and pelvic floor physical therapist is to improve health outcomes and quality of life for women with PFM dysfunction.

Key words: pelvic floor physical therapy, pelvic floor muscle dysfunction, pelvic pain, urinary dysfunction, bowel dysfunction

Nurse practitioners (NPs) who provide care for women see many patients who have symptoms that are related, at least in part, to dysfunction of the pelvic floor muscles (PFMs). Understanding of the pelvic floor structure, and how dysfunction of the muscles in this area contributes to gynecologic, urinary, and gastrointestinal problems, is important in both making diagnoses and formulating treatment plans. In these cases, a physical therapist who specializes in pelvic floor dysfunction can be a valuable partner in both confirming the diagnosis and providing therapy. Collaboration between NP and physical therapist can improve health outcomes and quality of life (QOL) for women who have discomfort, pain, and interruption of activities of daily living because of PFM dysfunction.

Pelvic floor physical therapy

The pelvic floor consists of a group of muscles that work to provide support to visceral organs, resistance to intra-abdominal pressure, maintenance of continence, and performance of sexual functions.1,2 The levator ani and coccygeus make up the deep pelvic floor (Figure 1), which acts like a hammock, attaching from the pubic bone and slinging back to the coccyx and sacrum. The rectum, urethra, and vagina all pass through the pelvic floor; dysfunction in the PFMs can affect any or all of these structures (Figure 2). Females of any age and in any life stage, including pregnant women,3 postpartum women,4 elderly women,5 and even girls,6 can experience PFM dysfunction. Many females with PFM dysfunction can benefit from pelvic floor physical therapy (PT).*

Pelvic floor PT addresses the muscles, ligaments, connective tissues, lymphatic system, and joints inside and surrounding the pelvic girdle, often in intimate regions that few people associate with muscles. Pelvic floor PT is similar to other types of PT in that the focus is on movement disorders such as hypermobility and hypomobility. The main goal of pelvic floor PT is to promote maximal function and QOL, specifically pertaining to muscles that can influence basic activities of daily life such as urination, defecation, and sexual activity.7

Common diagnoses warranting referral to pelvic floor physical therapists

Pelvic floor physical therapists assess and treat a variety of conditions, including urinary/fecal urgency, frequency, and incontinence; constipation; pelvic organ prolapse; and prenatal and postpartum conditions such as low back pain, sacroiliac pain, and dia­stasis recti. In addition, they can treat pain in the abdomen, low back, or pelvis that arises during urination, defecation, sexual activity, or even just sitting. These physical therapists have advanced training in the pelvic floor to evaluate and treat joint dysfunction, muscle imbalances, and nerve entrapment, which can contribute to the aforementioned complaints. Some of the most common referrals to pelvic floor physical therapists are for management of the symptoms of urinary incontinence (UI), chron­ic pelvic pain (CPP), constipation, and pelvic organ prolapse.

Urinary incontinence

Urinary incontinence affects approximately 19% of women aged 19-44 years, 25% of those aged 45-64 years, and 30% of those aged 65 years or older.8 Pelvic floor physical therapists can instruct patients in pelvic floor strengthening exercises to address muscle weakness and/or over-activity that contributes to UI. Research supports the recommendation that PFM training be included in first-line conservative management programs for women with stress, urge, or mixed UI.9 Pelvic floor PT results in significant reductions in both symptom-related distress and symptom impact.10

Chronic pelvic pain

Chronic pelvic pain is defined as pelvic pain lasting more than 6 months. The list of specific diagnoses that fall under the CPP umbrella is quite extensive and includes dyspareunia, vulvodynia, vaginismus, endometriosis, pudendal neuralgia, and interstitial cystitis. CPP affects 14%-24% of women during the reproductive years.11 This pain can manifest as urinary frequency/urgency, a sensation of incomplete emptying of the bladder, decreased urine flow, constipation, burning and pain in the pelvic area, pain during and/or following intercourse, and pain in the low back and hips. Physical therapists who specialize in pelvic floor PT can address the muscular and skeletal dysfunctions that are contributing to CPP. The musculoskeletal (M-S) system has been found to be involved in the genesis and perpetuation of CPP; in fact, strong evidence indicates that 80% of women with CPP pre­sent with dysfunction of the M-S system.12

Constipation

Constipation is one of the most common gastrointestinal problems in the United States, affecting up to 28% of the population.13 Persons of any age, race, or sex can experience constipation, but it is most prevalent in women and greatly increases in persons older than 70. Constipation can result from impaired muscle coordination or overactivity around the rectum and anus, which can delay stool evacuation.14 Pelvic floor physical therapists can assist with muscle re-training through biofeedback and rectal neuro­muscular training9 to address these deficits and improve ease of defecation.

Pelvic organ prolapse

This disorder, which results from relaxation of the PFMs and supportive tissues of the vaginal walls, may affect up to 60%-65% of premenopausal primiparous women.15,16 Pelvic organ prolapse occurs when one or more organs such as the bladder, uterus, or rectum descend from their normal position within the pelvis. This phenomenon may occur as a result of injuries sustained during childbirth, aging, a woman’s tissue composition, chronic coughing, straining due to chronic constipation, and repetitive heavy lifting. Patients may experience a sensation of pelvic pressure, low back pain, a protrusion from the vaginal opening, and/or discomfort during intercourse. Pelvic floor physical therapists can provide education and lifestyle modifications to prevent the prolapse from worsening, as well as address muscle weakness that may be present to increase support to the organs.

Pelvic floor physical therapy evaluation and treatment

Nurse practitioners who refer a patient to a pelvic floor PT clinic can lessen the patient’s anxiety by explaining what to expect from PT. The patient may feel relieved to be able to freely discuss a pelvic floor problem with someone who is well versed in bladder, bowel, and sexual dysfunction related to M-S dysfunction. At the first visit, the physical therapist will take a thorough history and perform an examination. The examination will likely entail an assessment of the PFMs, which may be performed vaginally, rectally, or simply by external palpation or visual assessment. An internal examination of the PFMs will allow the physical therapist to assess PFM strength, endurance, coordination, and tissue quality.
An external examination may include assessment of the spine, hip joints, sacroiliac joints, and connective tissue around the abdomen, hips, inner thighs, buttocks, hamstrings, external genitalia, and/or anus. The therapist will take note of any hypermobility or hypomobility in the joints and in the soft tissue, which can create problems in the PFMs. Based on the history and examination findings, the physical therapist will tailor a treatment plan to help the patient work toward her goals. PT diagnoses can generally be divided into two categories, those that involve weakness and those that involve increased tension.17 Although these two categories may seem to be discrete entities, some patients present with both muscle weakness and muscle tension.
Diagnoses that involve weakness of the pelvic floor can include UI or fecal incontinence, pelvic pressure or pain, and difficulty with bladder and bowel elimination. Treatment for these conditions generally focuses on attaining control of the pelvic floor and the surrounding musculature to develop strength, endurance, and coordination and to stabilize and control the pelvis and trunk as a system.18
Pelvic floor exercises are typically initiated in gravity-assisted or minimized positions and progress to sitting, then to standing, and eventually to functional movements such as bending, squatting, and lifting, depending on the patient’s diagnosis and functional limitations. In addition, addressing muscle groups such as the transverse abdominis, multifidi, adductors, and respiratory diaphragm can help provide pelvic stability and enhance a pelvic floor contraction.19,20 If a patient cannot voluntarily perform a pelvic floor contraction, neuromuscular electrical stimulation can be used, either via external electrodes at the perianal tissues or with an internal vaginal or rectal probe, to elicit a contraction or enhance a very weak contraction.21
Many patients seen by pelvic floor physical therapists have pain related to muscle tension in the pelvic floor. Patients may experience pain with sitting, sexual intercourse, tampon insertion, and/or gynecologic examination and/or they may have difficulty with evacuating urine or stool. Many patients subconsciously clench muscles in their abdomen and pelvic floor,22 which can lead to joint dysfunction, tightness or imbalance in muscle groups, and nerve entrapment.23 Teaching patients breathing patterns to achieve a drop of the diaphragm and pelvic floor can encourage relaxation and decrease pain during bladder and bowel evacuation or vaginal penetration.24
Manual therapy, including techniques such as myofascial release and connective tissue manipulation, is also used to address pain related to PFM tension.25 Manual therapy techniques involve forceful passive movement of the fascial elements through restrictive directions, allowing for muscular relaxation or decreasing painful scar tissue attachment, increasing general circulation, freeing tissue material, and releasing nerve entrapment by surrounding structures.7
Surface electromyography or biofeedback is utilized to enable patients to receive auditory and/or visual feedback on the contraction and relaxation of the PFMs while performing exercise and movements.26 Use of biofeedback can help patients develop an internal awareness of the state of the muscles to be used with daily activities and aid them in achieving higher or lower muscle tone, depending on their diagnosis.27
Throughout treatment for muscle weakness or tension, attention is given to educating patients about practical methods they can use to ease their symptoms. These methods include simple changes in the diet (e.g., eliminating carbonated beverages, acidic foods, artificial sweeteners, and alcohol), biomechanical changes with day-to-day tasks (e.g., correctly transitioning from sitting to standing, correctly retrieving items off the ground to avoid an increase in pressure on the pelvic floor), and assuming positions to maximize efficiency of bladder and bowel elimination.28 To reinforce the benefits of techniques used in the clinic, patients receive instructions in a home exercise program, which will enable them to eventually progress to independent management.29

Physical therapy frequency and duration

With any type of PT, the length of time before any positive results can be appreciated varies from person to person, depending on the diagnosis and the severity of symptoms. However, a general rule is that patients with pain conditions may need up to 8 treatments to notice any improvement and up to 12 treatments to see functional or QOL-altering changes. For patients with incontinence diagnoses, a favorable change can be expected at about 6 weeks, if not sooner. These time frames are generally related to the length of time needed to make physiologic adaptations in muscle tissue.
The typical frequency of visits to PT is once or twice a week, again depending on symptom severity. As a patient improves, the frequency of visits is tapered to weekly, then every other week, and then monthly until she is ready for discharge from PT care. Some patients complete PT and achieve symptom resolution in 3 months. For others, PT helps manage symptoms of an incurable disease so that they can continue performing their activities of daily living, recreational tasks, and work-related activities with less severe or less frequent symptoms.

Conclusion

Many women with problems related to PFM dysfunction see their NP as the initial healthcare provider. Because many of these patients can benefit from pelvic floor PT, it is to their advantage if their NP has a close working relationship with a physical therapist who specializes in pelvic floor PT. The best patient outcomes are promoted through ongoing NP–physical therapist collaboration, because management will likely include a combination of PT, pharmacotherapy, patient education, and counseling.
It is appropriate to refer a patient for pelvic floor PT for most M-S diagnoses related to the bladder or bowel, pelvic pain, or prenatal or postpartum conditions. The NP may consult with the physical therapist prior to a referral if there is a question as to whether a particular patient is a good candidate for PT.
To facilitate the search for a physical therapist with training in managing patients with pelvic floor diagnoses, readers can use state-by-state physical therapist locators available at the American Physical Therapy Association Section on Women’s Health websiteA30 and the Herman and Wallace Pelvic Rehabilitation Institute websiteB.31Tammy M. DeBevoise, Angela F. Dobinsky, Caitlin B. McCurdy-Robinson, Christina M. McGee, Cody E. McNeely, Sara K. Sauder, and Kimberlee D. Sullivan are physical therapists at Sullivan Physical Therapy in Austin, Texas. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.
Web resources
A. http://www.womenshealthapta.org/pt-locator/
B. http://hermanwallace.com/practitioner-directory

References
1. Corton MM. Anatomy of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 2009;36(3):401-419.
2. Herschorn S. Female pelvic floor anatomy: the pelvic floor, supporting structures, and pelvic organs. Rev Urol. 2004;6(suppl 5):S2-S10.
3. Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial. Neurourol Urodyn. 2014;33(1):67-71.
4. Hilde G, Stær-Jensen J, Siafarikas F, et al. Postpartum pelvic floor muscle training and urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2013;122(6):1231-1238.
5. Loertzer H, Schneider P. Stress incontinence in elderly women. Urologe A. 2013;52(6):813-820.
6. Kaijbafzadeh AM, Sharifi-Rad L, Ghahestani SM, et al. Animated biofeedback: an ideal treatment for children with dysfunctional elimination syndrome. J Urol. 2011;186(6): 2379-2384.
7. Guide to Physical Therapist Practice. 3rd ed. American Physical Therapy Association. 2003;81:13,133-143.
8. Shamliyan, TA, Kane RL, Wyman J, et al. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008; 148(6):459-473.
9. Hay-Smith E, Dumoulin C. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2010;1:CD005654.
10. Dusi, J, France DB, George S, et al. Assessing physical therapy outcomes for women with urinary incontinence. J Womens Health Phys Ther. 2012;36(2):78-89.
11. Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014;17(2):E141-E147.
12. Montenegro ML, Mateus-Vasconcelos EC, Candido dos Reis FJ, et al. Thiele massage as a therapeutic option for women with chronic pelvic pain caused by tenderness of pelvic floor muscles. J Eval Clin Pract. 2010;16(5):981-982.
13. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004;99(4):750-759.
14. Whitehead WE, Bharucha AE. Diagnosis and treatment of pelvic floor disorders: what’s new and what to do. Gastroenterology. 2010;
138(4):1231.e4-1235.e4.
15. Durnea CM, Khashan AS, Kenny LC, et al. Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women. Int Urogynecol J. 2014; 25(10):1363-1374.
16. Lien YS, Chen GD, Ng SC. Prevalence of and risk factors for pelvic organ prolapse and lower urinary tract symptoms among women in rural Nepal. Int J Gynaecol Obstet. 2012 Nov; 119(2): 185-8.
17. Sahrmann SA. Does postural assessment contribute to patient care? J Orthop Sports Phys Ther. 2002; 32(8):376-379.
18. Boyle R, Hay-Smith EJC, Cody JD, Mørkved S. Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence
in antenatal and postnatal women. Cochrane Database Syst Rev. 2012;10:CD007471.
19. Kitani LJ, Apte GG, Dedrick GS, et al. Effect of variations in forced expiration effort on pelvic floor activation in asymptomatic women. J Womens Health Phys Ther. 2014; 38(1):19-27.
20. Fira J, Thompson M, Smith SS. Paradoxical findings in the treatment of predominant stress and urge incontinence: a pilot study with exercise and electrical stimulation. J Womens Health Phys Ther. 2013; 37(3):113-123.
21. Newman DK. Managing and Treating Urinary Incontinence. Baltimore, MD: Health Professions Press; 2002:111-123.
22. Costilla VC. Foxx-Orenstein AE. Constipation: understanding mechanics and management. Clin Geriatr Med. 2014;30(1):107-115.
23. Boissonnault WJ. Primary Care for the Physical Therapist: Examination and Triage. 2nd ed. St. Louis, MO: Elsevier Saunders; 2010:70-72, 77, 163.
24. Laycock J, Haslem J. Therapeutic Management of Incontinence and Pelvic Pain. London, UK: Springer Publishers; 2002:244.
25. Marques A, Stothers L, Macnab A. The status of pelvic floor muscle training for women. Can Urol Assoc J. 2010;4(6):419-424.
26. Artibani W, Cerruto MA. Dysfunctional voiding. Curr Opin Urol. 2014;24(4):330-335.
27. Rett MT, Simoes JA, Herrmann V, et al. Management of stress urinary incontinence with surface electromyography-assisted biofeedback in women of reproductive age. Phys Ther. 2007;87(2):136-142.
28. Johanson J. Review of the treatment options for chronic constipation. MedGenMed. 2007;9(2):25.
29. Magee D. Orthopedic Physical Assessment. 3rd ed. Philadelphia, PA: WB Saunders; 2013.
30. Women’s Health American Physical Therapy Association. www.womenshealthapta.org/pt-locator/
31. Herman and Wallace Pelvic Rehabilitation Institute. http://hermanwallace.com/practitioner-directory

*Editor’s note: In the current online issue of Women’s Healthcare: A Clinical Journal for NPs, Aimee Chism Holland, DNP, WHNP-BC, NP-C, RD; Deborah Kirk Walker, DNP, FNP-BC, NP-C, AOCN; Sigrid Ladores, PhD, PNP; and Karen Meneses, PhD, RN, FAAN discuss fertility preservation for young cervical cancer survivors. In their article, these authors recommend consultation with a pelvic floor physical therapist, among other specialists, for cervical cancer survivors who are experiencing sexual problems related to their disease and/or its treatment.

The PICSSL model: A new strategy for addressing patients’ intimacy and sexuality concerns

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By Maureen A. Ryan, DNP, NP-C, CHWC

With her own Path to Intimacy, Connection, Sexual Satisfaction, & Love (PICSSL) model, the author aims to increase healthcare providers’ knowledge and confidence in caring for patients who are experiencing problems related to intimacy and sexuality. Various intimacy enhancers, body connection enhancers, and sexual satisfaction enhancers are described.

Key words: intimacy, sexuality, sexual dysfunction, sex therapy, mindfulness, PICSSL model

Studies have established that sexual satisfaction, along with mental and physical health, is essential to a woman’s well-being and overall quality of life.1 Unfortunately, studies have also shown that a large proportion of adults in the United States suffer from a sexual dysfunction.2 Given that many healthcare providers (HCPs) feel that they lack the ability to adequately address issues of sexuality beyond strictly physical health-related concerns, many patients with intimacy- and sex-related problems do not receive the help they need.3 HCPs who see these patients on a regular basis, and who have already gained their trust, have an opportunity to provide the guidance needed. To facilitate this process, the author has developed the Path to Intimacy, Connection, Sexual Satis­faction, & Love (PICSSL) model (Figure).

In order to best help their patients, HCPs must first assess their own attitudes about intimacy and sexuality, especially if these attitudes include resistance, discomfort, or a tendency to be judgmental. After all, a person’s sexuality—whether one is talking about an HCP or a patient—is affected by culture, religion, family history, and personal history, among other factors, all of which must be taken into account. Before helping patients, HCPs must be aware of their own beliefs and biases. Because PICSSL is a wellness model, and not a pathology model, its principles are relevant to HCPs too. HCPs will likely serve their patients best if they apply the tools of this model to their own relationships as well.

The PICSSL model

 

The PICSSL model guides both HCP and patient in heightening self-awareness and enhancing decision-making skills with regard to intimacy- and sex-related concerns. Each patient develops a vision of the relationship she desires and then identifies motivating factors that will propel her toward realizing her vision. Such motivators may include a desire for emotional intimacy, for love, or to meet a partner’s needs. Barriers to realizing the patient’s vision are reframed without negativity, and interventions—the action plan—are devised to overcome the barriers. In order to identify and address problems related to intimacy and sexual problems, the HCP draws from three compartments in the PICSSL toolbox: intimacy enhancers, body connection enhancers, and sexual satisfaction enhancers.

Intimacy enhancers

Intimacy enhancers facilitate an emotional connection between partners. Intimacy enhancers include self-care practices, a group of qualities represented by the mnemonic “A PIE,” and a group of suggestions called the “7 C’s.” In addition, the author describes seven different types of intimacy.

Self care

Many people engage in maladaptive behaviors (e.g., overeating, substance abuse) to numb unpleasant feelings.4 By listening attentively and empathetically to a patient who is troubled, the HCP can enable her to unearth buried pain, and possibly reduce her need to anesthetize herself. Then the HCP can guide her toward developing better self-care practices—that is, adaptive behaviors and selection of healthful options. The patient can track her progress via journaling and report back to her HCP.

To start, the HCP, adopting a holistic approach, assesses the patient’s diet, sleep habits, exercise regimen, stress levels, and level of self-compassion. Safe sex practices and prevention of sexually transmitted infections are discussed. Healthful coping strategies for stress reduction (e.g., exercise, meditation, yoga) are encouraged. Although the patient may believe that taking time to care for her own needs is selfish, the HCP can help the patient reframe this concept. The patient learns to see self care as necessary to recharge herself and have something of herself to give to a partner.

A PIE

Appreciation, Presence, Intention, and Empathy are the basic ingredients in the recipe for emotional intimacy. Absence of any or all of these ingredients can result in relational dysfunction. The clinical relationship provides an opportunity for the HCP to model behaviors that the patient can then display to her partner. For example, the HCP can express appreciation for a specific admirable quality or deed of the patient by saying I admire your devotion to your aging parents or I thank you for always arriving on time for your appointments. The patient not only learns how to express appreciation for a specific quality or behavior, but also experiences how it feels to receive appreciation.

  • A – Appreciation. Appreciation stems from openheartedness, acceptance, and kindness. The role of appreciation with regard to enhancement of intimacy can be a topic of discussion, and readings can be recommended to reinforce it.5What do you feel when you hear words of appreciation? Is it difficult for you to express appreciation? If yes, what stops you from doing so? Expression of appreciation can greatly enhance a relationship. People want to feel valued. The patient is asked to focus on what she appreciates about her partner in the moment—maybe the feel of his or her skin or the warmth of his or her body.
  • P – Presence. This quality can be displayed by the HCP and elicit a feeling in the patient. To display presence, the HCP, before meeting with the patient at a given visit, needs to release personal and work-related distractions and be able to fully receive the patient when she arrives. When the HCP is truly present in the moment and pays attention to the patient, the HCP is saying I see you, I hear you, I value you. You have my undivided attention. The patient can then model this behavior with her partner. Presence can be healing.
  • I – Intention. A conscious intention is a vision, plan, or goal that opens up a person to what is possible. It is the North Star that guides a person to her intended destination. The HCP can ask the patient what she wants in terms of her intimate and sexual relationships. Many people know what they do not want but have not thought about what they do want. The patient may prefer to write down her intentions and then visualize these intentions as if she is already experiencing what she desires.
  • E – Empathy. Empathy is the ability to understand and share the feelings of another person, a quality that the HCP is well positioned to display in the clinical setting. To display empathy, the HCP needs to listen to what the patient is saying and understand the feelings behind the words. Empathy creates a sense of safety and trust where intimacy can flourish.

The 7 C’s

The 7 C’s remind couples of their Commitment to maintain their relationship and hold it as a priority. Empathy, active listening, touch, and attending to verbal and nonverbal cues can both facilitate and enhance intimate Communication. Scheduling dates and sex nights on the Calendar may not seem spontaneous or romantic, but it provides an opportunity to spark the imagination, which fuels desire and allows anticipation to build.6 A deeply felt emotional, mental, and physical Connection with a partner builds trust and nurtures emotional intimacy, a prerequisite to satisfying sex for many women. Courage, a willingness to tell one’s “story” with one’s whole heart,4 may leave a person feeling vulnerable; however, allowing oneself to be authentically seen nurtures the seeds of intimacy, where love and belonging can grow. Extending Compassion toward oneself and one’s partner enhances feelings of acceptance and unconditional love. Confidence, a belief in one’s own value, along with that of one’s partner and the relationship, is essential to preserve and maintain the intimate partnership.

Seven types of intimacy

Sexologist Marilyn Volker uses the acronym “ASPIRES” to identify seven different types of intimacy.7 A couple can feel close to each other if just a few types of intimacy are present, but most people crave multiple types of intimacy with a partner.7 When interwoven, each type of intimacy strengthens the relationship.

Affection is a feeling of tenderness and fondness toward another person. Social intimacy refers to the process wherein a couple enhances closeness with each other by socializing with others. Physical intimacy refers to the sharing of leisure activities. Intellectual intimacy entails sharing a cerebral connection through conversation about areas such as politics, religion, science, culture, and literature. Romantic intimacy is more difficult to define because it varies with the individual; it may be expressed by giving one’s partner chocolates and flowers, drinking a glass of wine together, or gazing at a sunset together. Emotional intimacy involves opening oneself up and sharing one’s innermost feelings with a partner. Many women feel emotional intimacy when their partner turns toward them, establishing eye contact or what is known as the anchoring gaze.8Sexual intimacy involves physical touch, and encompasses foreplay, intercourse, and orgasm. Some couples may not be sexually intimate for one reason or another, but they have a solid relationship because other aspects of intimacy are strong.

Body connection enhancers

Body connection enhancers heighten pleasure, excitement, and eroticism. The HCP can give the patient written materials about these practices and products and refer the patient to educational resources such as A Woman’s Touch: Sexuality Resource Center9 and the Sinclair Institute.10 The HCP and the patient can then discuss the patient’s progress in terms of implementing these interventions, thereby promoting the feedback/support loop between HCP and patient as well as promoting adoption of healthy behaviors.

Personal hygiene

Personal hygiene is important not only for one’s self-esteem but also as an essential ingredient in partner attraction. The HCP may need to tactfully remind the patient about personal hygiene practices.

Breathwork and other relaxation techniques

Some people are too preoccupied, negative, and anxious to be able to experience intimacy and enjoy sex. To promote positivity and relaxation—and better sex—the HCP can teach the patient the practice of mindfulness, wherein one focuses on being completely aware and non-judgmental in the present moment. Mindfulness has been found to be an effective treatment for a variety of sexual dysfunctions.11 Mindfulness allows one to be more present and attentive to sensual sensations. This practice entails conscious breathing, which is considered the antidote to the stress response in that it returns the breath to a deeper, more relaxed pattern and stimulates the vagus nerve, which controls the para­sympathetic nervous system and triggers the relaxation response.12

Other approaches include conscious muscle relaxation, use of visual imagery, and meditation. When body and mind are relaxed, the five senses are better able to be stimulated. Focusing on sensual experiences may in turn facilitate mental and physical relaxation while arousing feelings of sexual intimacy and affection.

Exercise and yoga

Encouraging the patient to participate in a regular exercise regimen will support her sex life.
Exercise improves mood and increases energy, strength, and endurance, all of which enhance sexual functioning. A positive relationship exists between body image and sexual functioning and sexual satisfaction.13

The practice of yoga draws attention into the present moment and enhances body awareness. Yoga calms the busy mind and induces a state of relaxation; these effects are linked to an improved sexual response.14

Body mapping

Many couples have sexual experiences that are boring and unsatisfying because they have failed to communicate their sexual desires and fantasies to each other. Body mapping is a tool to enhance communication between sex partners, enabling them to have a more personalized and erotic experience. Couples who use this tool start with a drawing of the front and back of two nude bodies representing themselves and their partner. They number the order in which they wish that their body parts be touched, and use colors such as green for go and red for no. Creativity and attitudes of openness, curiosity, and acceptance are encouraged. The only rule is that neither partner can criticize or demean the other partner.

The next step is for the couple to touch each other on the top of the hands, forearms and arms, shoulders, upper back, back of the neck, head, and forehead to facilitate a sense of safety and security. Next, the couple can start—slowly and thoughtfully—touching each other’s body parts in the order indicated on the body map. The couple can then move on—slowly and thoughtfully—to touch erogenous areas such as the insides of the hands and arms, the front and sides of the neck, the ears, the mouth, and the top of the chest; these touches are likely to trigger a longing to be touched on the breasts, thighs, belly, hips, buttocks, and genitals. Arousing a woman’s desire naturally, rather than racing for her breasts and genitals, is more likely to lead to pleasure and satisfaction for both partners.

Self pleasuring and sexual aids

Many women, alone or with a partner, use sexual aids to enhance their sexual experience. Vibrators can relieve anorgasmia in women whose genital sensation or arousal is diminished, and they can increase the ease and the intensity of orgasm in anyone.15,16 First-time users of vibrators may find massager products less intimidating than traditional sex toys.15

Pelvic floor health and lubrication

A strong pelvic floor is needed to maintain urinary continence, support pelvic structures, and enhance sexual function. Kegel exercises are used to promote strength of the pelvic floor musculature, which can enhance orgasm intensity.17 Most women experience symptomatic vulvovaginal atrophy after meno­pause.18 Relieving vaginal dryness may enhance a woman’s interest in sex, subjective arousal, and capacity to reach orgasm. Restoring a natural pH and lubrication to the vulva and vagina through use of vaginal lubricants, moisturizers, and, in some cases, exogenous estrogen can minimize dryness.18

Sexual satisfaction enhancers

With a positive attitude, willingness, and openness to new possibilities, a woman can reawaken her libido and increase her sexual satisfaction.

Sexual empathy

Sexual empathy entails understanding one’s partner’s sexual desires and fantasies, and providing opportunities to explore these wishes.19 The HCP can suggest that the patient and her partner engage in listening exercises—to put themselves in each other’s shoes and to learn what excites the other person.

Creating an environment

The HCP can encourage the patient to imagine and create an environment that will enhance feelings of relaxation and sexual desire—quite a joyful project. The patient is asked to sketch out on paper an ideal—no holds barred—to set the stage for her to explore her deepest desires and fulfill them. Creating an environment conducive to sexual exploration involves details such as sleep/wake patterns, lighting, music, scent, and timing.

Foreplay

Touch releases oxytocin, an anti-stress hormone that promotes bonding.20 Touch is the essence of foreplay, so the HCP can initiate a conversation with the patient about the types of foreplay with which she is familiar and that she enjoys. Then they may discuss foreplay practices that the patient may not have experienced but that she might be interested in pursuing. Openness, playfulness, and curiosity can lead to new avenues of pleasure. The HCP can ascertain whether any forms of foreplay elicit discomfort. If so, measures can be taken to work around or alleviate the discomfort. Many guides to kissing and sexual positions and techniques are available; even YouTube is a good resource.

Sensate focus

Couples with sexual concerns tend to gradually avoid physical and sexual contact over time. Avoidance of sex damages their connectedness and alienates them from each other, both psychologically and physically. Sensate focus, an exercise developed by Masters and Johnson to enhance emotional and physical intimacy, enables couples to reconnect slowly, safely, and in a mutually satisfying manner.21 Sensate focus involves structured and progressive touching between two partners, advancing from initially non-genital touch to more pleasure-oriented touch in subsequent stages.22 This approach is similar to that described in the section on body mapping. However, the focus is on sensual, rather than erotic, pleasure. In fact, overt sexual activity is prohibited during the early stages, which greatly reduces performance anxiety and heightens desire.

Novelty and fantasy

Couples who share exciting experiences, compared with couples with more mundane habits, report greater relationship satisfaction and more romantic feelings. New and exciting adventures release dopamine, causing feelings of exhilaration, hope, and romantic love.23 Adventurousness in one’s activities (e.g., travel, hiking, dining in new restaurants) can lead to adventurousness in the bedroom. Seeing a partner in a new light creates an air of mystery and fuels passion.6 The HCP can ask the patient to write down (for no one to see if she chooses) a list of the most exciting sexual activities she can imagine—giving full rein to her fantasies. The patient has an opportunity to pretend, to explore untested parts of herself. Engaging in sex play using fantasy, erotica, and vibrators can serve to heighten sexual arousal and enable her to live out her previously unrealized or even unconscious desires.

Making love mindfully

Making love with intention, attention, and attitude deepens intimacy and sexual pleasure. The direct, moment-to-moment awareness of what is happening as it is happening helps a woman notice subtle pleasurable sensations.23 Couples stuck in mediocrity can approach lovemaking as if it were the last time—or the first time. The HCP can recommend exercises such as slow touch and eye gazing. A practical point to mention to the patient: Many women do not experience orgasm with intercourse; in fact, most of them require clitoral stimulation to do so. To facilitate the process, the woman can touch her clitoris or position herself so that her partner can manually stimulate her.

Educational materials and bibliotherapy

Numerous books, films, and websites are available to educate the patient about sexual communication and techniques.9,10 Reading erotica and watching erotic films can fuel desire and arousal; such materials can evoke strong responses and can deepen a couple’s communication.

Practice implications

Through gentle questioning during the initial evaluation, the HCP ascertains whether a health-related intervention and/or psychiatric intervention is needed. Addressing organic dysfunction may involve referral to a specialist and maintaining communication with that specialist in the course of the intervention. Depending on the particular intimacy- or sex-related problem, the HCP can then proceed with an intervention plan or to refer the patient to a psychotherapist or sex therapist with appropriate training.

From the start, the HCP needs to establish a nonjudgmental, receptive tone. “Homework” assignments may be given as suggested in this article, and a schedule of follow-up sessions can support cultivation of healthy behaviors and attitudes. In some cases, a partner can be brought in for a consultation. Topics and techniques discussed in this article must be approached with empathy. Awareness of the predispositions, sensitivities, and cultural norms of the patient informs HCPs in their work. The medium is the message: Invaluable in helping couples step out of their usual sexual scripts and open themselves up to new possibilities and experiences are such styles as normalizing/destigmatizing, a sexually positive approach, and humor.

Conclusion

Problems with intimacy and sexuality can emerge at any stage of the lifespan as a result of a multiplicity of factors, including physical or emotional trauma, relationship problems, mental illness, injury, physical illness or disability, pregnancy, perimenopause, and advanced age. All of these conditions require sensitivity on the part of the HCP to changes that the patient has endured and the effects of these changes on her state of mind and relationships.

The HCP should push through his or her own vulnerability and find the courage to initiate these important conversations so patients need not suffer in silence. Many intimacy- and sex-related concerns can be managed with patient education and with empathetic listening. The HCP’s willingness to open this dialogue may lead couples to more joy-filled, meaningful, and purposeful lives.

The PICSSL model offers the HCP a toolbox of intimacy, body connection, and sexual satisfaction enhancers to help patients achieve greater intimacy and sexual health. Equipped with this knowledge, the HCP can facilitate love and connection in a society in which both are so intrinsic to health, happiness, vitality, and wholeness. The Box contains a list of resources for patients and for HCPs.

Maureen A. Ryan is a sexual wellness coach and Director of the Mind-Body Connection for Adult Health NP, PLLC, in Amherst, New York. The author states that she does do not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Rosen RC, Bachmann GA. Sexual well-being, happiness, and satisfaction, in women: the case for a new conceptual paradigm. J Sex Marital Ther. 2008;34(4):291-297.

2. Lewis RW, Fugl-Meyer KS, Bosch R, et al. Epidemiology/risk factors of sexual dysfunction. J Sex Med. 2004;
1(1):35-39.

3. 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.

4. Brown B. The power of vulnerability. Presented at: TEDxHouston; June, 2010; Houston, TX. www.ted.
com/talks/brene_brown_on_vulnerability

5. Chapman GD. The Five Love Languages: The Secret to Love That Lasts. Chicago, IL: Northfield Publishing; 2010.

6. Perel E. Mating in Captivity: Unlocking Erotic Intelligence. New York, NY: Harper Collins Publishers; 2006.

7. Volker M. Personal Communication, December 9, 2010.

8. Fisher H. Why We Love: The Nature and Chemistry of Romantic Love. New York, NY: Henry Holt; 2004.

9. A Woman’s Touch: Sexuality Resource Center website. https://sexualityresources.com/

10. Sinclair Better Sex Video Series website. www.sinclairinstitute.com/

11. Brotto LA, Basson R. Group mindfulness-based therapy significantly improves sexual desire in wom­en. Behav Res Ther. 2014;(57):43-54.

12. Komisaruk BR, Whipple B, Crawford A, et al. Brain activation during vaginocervical self-stimulation and orgasm in women with complete spinal cord injury: fMRI evidence of mediation by the vagus nerves. Brain Res. 2004;1024(1-2);77-88.

13. Pujois Y, Meston CM, Seal BN. The association between sexual satisfaction and body image in women. J Sex Med. 2010;7(2 pt 2):905-916.

14. Kabat-Zinn J. Full Catastrophe Living (Revised Edition); Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness. New York, NY: Bantam Books; 2003.

15. Daneback K, Mansson SA, Ross MW. Online sex shops: purchasing sexual merchandise on the Internet. Int J Sex Health. 2011;23(2):102-110.

16. Herbenick D, Reece M, Sanders, SA, et al. Women’s vibrator use in sexual partnerships: results from a nationally representative survey in the United States. J Sex Marital Ther. 2010;36(1):49-65.

17. Komisaruk BR, Whipple B, Nasserzadeh S, Beyer-Flores C. The Orgasm Answer Guide. Baltimore, MD: The Johns Hopkins University Press; 2010.

18. Carter J, Goldfrank D, Schover LR. Simple strategies for vaginal health promotion in cancer survivors. Int Soc Sex Med. 2010;8(2):549-559.

19. Nelson T. Getting the Sex You Want: Shed Your Inhibitions and Reach New Heights of Passion Together. Beverly, MA: Quayside Publishing Group; 2008.

20. Mahoney S. How love keeps you healthy. Prevention. 2006;58(2):164-213.

21. Masters WH, Johnson VE. Human Sexual Inadequacy. Boston, MA: Little Brown; 1970.

22. Brotto LA. Mindful sex. Can J Human Sexuality. 2013;22(2):63-68.

23. Brandon M. Monogamy: The Untold Story. Santa Barbara, CA: ABC-CLIO; 2010.

Practical strategies for the diagnosis and management of binge eating disorder

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By Amy McKeever, PhD, CRNP, WHNP-BC and Laura J. Clauss, APRN, NP-C, CEDS, F-IADEP

Faculty

Amy McKeever, PhD, CRNP, WHNP-BC
Assistant Professor, College of Nursing, Villanova University, Villanova, Pennsylvania
Laura J. Clauss, APRN, NP-C, CEDS, F-IAEDP
President, CEO, and Medical Director, The Center for Eating Disorders Management, Inc., Bedford, New Hampshire

Intended audience
Nurse practitioners (NPs) and other advanced practice healthcare providers (HCPs) who care for women.

Continuing education (CE) approval period
Now through February 29, 2016

Estimated time to complete this activity
1 hour

Program description/identification of need
Gap 1: In 2013, binge eating disorder (BED) was designated as a formal diagnosis in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. BED is underdiagnosed and undertreated. NPs in women’s health are the primary HCP and contact for many women, and are positioned to identify patients with BED and provide treatment and/or referral.
Gap 2: Many HCPs, including NPs, who care for women are insufficiently educated about the etiology of BED and its association with genetic and environmental factors, as well as its prevalence in women with obesity.
Gap 3: Various pharmacologic agents have been studied with regard to their efficacy in patients with BED, many of whom have co-morbidities. HCPs need information about the usefulness of currently available and investigational agents to treat both BED and common co-morbidities.

Gaps in practice
Gap 1: NPs in women’s health, as well as other HCPs who specialize in the care of women, are well positioned to screen for and diagnose BED. This activity will better enable them to do so.
Gap 2: A multifaceted approach to treatment for BED is required. HCPs need information about appropriate treatment options, and need to know which members of the health-management team are best positioned to offer these options.
Gap 3: Many patients with BED have co-morbidities associated with obesity. Identification of pharmacologic agents that will improve symptoms of both BED and co-morbid conditions can help optimize patient outcomes.

Educational objectives
At the conclusion of this activity, participants should be better able to:
• Discuss current diagnostic criteria for BED.
• Apply effective patient–HCP communication strategies regarding BED and its effects, including those related to fertility and future pregnancy.
• Evaluate nonpharmacologic and pharmacologic approaches to BED treatment.
• Monitor patient progress, adjust treatment plans, and make referrals as appropriate.

Credit designation statement
This Activity (No. J-15-02) has been evaluated and approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women’s Health (NPWH) for 1.0 contact hour of CE credit, including 0.5 contact hours of pharmacology content. Each participant should claim only those contact hours that he/she actually spent in the educational activity.

Accreditor disclosure of conflicts of interest policy
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. Conflicts of interest were resolved according to NPWH policy prior to development of content. The faculty report that they have nothing to disclose.

Disclosure of unlabeled use
NPWH policy requires authors to disclose to participants when 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. This monograph contains a discussion of unapproved uses for these drugs: topiramate, zonisamide, naltrexone, methylphenidate, and lisdexamfetamine dimesylate.

Disclaimer
Participating faculty members determine the editorial content of CE activities; this content does not necessarily represent the views of NPWH or Shire. 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-15-02, requires participants to 1. Go to https://healthmonix.com/npwh/; click on “Sign In” in the right hand corner of the page. Sign in if you have an NPWH account, or create an account; 2. Go to the “NPWH E-Learning Portal” ; 3. Click on the title of this journal article; 4. Complete the posttest and evaluation; 5. 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: Shire

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

The authors discuss the etiology of binge eating disorder (BED), as well as techniques for screening and diagnosis and recommended treatments. They also describe common mental and physical co-morbidities in patients with BED and the disorder’s potential effects on reproductive health and pregnancy. Three relevant case studies—of a teenage girl, a woman in the middle of her reproductive years, and a woman nearing menopause—illustrate how healthcare providers can evaluate and manage patients with BED.

Key words: binge eating disorder, disordered eating, co-morbidities, cognitive behavioral therapy, pharmacotherapy

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.

 

Managing female sexual dysfunction

 

By Casey B. Giebink, MSN, NP-C, WHNP-BC and Ivy M. Alexander, PhD, APRN, ANP-BC, FAAN

Although about one-third of women report concerns with sexual functioning, many healthcare providers (HCPs) do not feel comfortable screening for, diagnosing, or managing female sexual dysfunction (FSD). The authors offer guidance to HCPs for screening and diagnosing a variety of FSD disorders. In addition, the authors discuss pharmacotherapeutic options for managing these conditions, as well as these agents’ benefits, risks, and monitoring parameters.

Key words: female sexual dysfunction, estrogen, testosterone, bupropion, ospemifene, flibanserin

Female sexual dysfunction (FSD) is highly prevalent among women in the United States, yet patients rarely discuss sexual concerns with their healthcare provider (HCP). Investigators of the Women’s International Study of Health and Sexuality sent questionnaires to 2,050 U.S. women regarding health status, sexual desire, and distress caused by low desire.1 The study showed that 24%-36% of women aged 20-70 years could be classified as having low sexual desire. This prevalence highlights the need for HCPs to know how to communicate with, identify, and manage patients’ sexual concerns. To this end, the authors provide evidence-based recommendations drawn from the current literature regarding assessment and diagnosis of FSD, with an emphasis on pharmacologic options available to treat FSD. Most of the pharmacologic options for desire, arousal, and orgasm problems are prescribed off label.

Common barriers to identifying and managing FSD

Despite the high prevalence of FSD, many women do not broach the topic with their HCP, and many HCPs do not screen their patients for sexual disorders.2 In fact, fewer than 20% of HCPs ask about their patients’ sexual activity, including difficulties, enjoyment, and frequency.3

Urologists, gynecologists, and psychiatrists are the HCPs most likely to inquire about sexual functioning.4 However, one study showed that among 187 urologists, only 10% asked every patient about sexual function on a regular basis, as opposed to 87% who asked about sexual activity when the chief complaint was related to abdominal pain, urgency/frequency, incontinence, or a urinary tract infection.5 A survey of the attitudes of nurse practitioners (NPs) and physician assistants (PAs) toward management of sexual dysfunction revealed that only one-half felt comfortable discussing the topic and only 21% of NPs and 11% of PAs felt confident in managing FSD.6 Nevertheless, most NPs and PAs had a positive attitude toward the possibility of evaluating and managing their female patients’ sexual concerns.6

Various factors may hinder HCP–patient communication regarding sexual concerns. Potential barriers for HCPs include lack of time, lack of knowledge about FSD management options, and lack of training in how to communicate about FSD; barriers for patients include embarrassment and a belief that their HCP cannot help them.7 Some HCPs fear embarrassing or offending patients if they raise the topic,3 although most patients will discuss their sex practices if the HCP initiates the conversation.8

Even if a patient does discuss her sexual problems with her HCP, her concerns may not be properly addressed. One survey showed that among 3,807 women who considered seeking help for sexual dysfunction, fewer than half reported feeling hope, relief, validation, or satisfaction after discuss­ing their concerns with a provider.9 In addition, patients were disappointed by their HCPs’ inability or unwillingness to evaluate, treat, and follow up on their complaints.9

Overcoming the barriers

Healthcare providers can increase the likelihood that FSD will be identified and addressed by initiating the conversation with patients, which will strengthen the HCP–patient relationship and help normalize patients’ concerns.9 Once both parties are comfortable, the HCP can take a sexual history, perform a thorough physical examination, and order appropriate laboratory tests.

History
To transition smoothly into taking a sexual history, HCPs can incorporate questions into the genitourinary/gynecologic/obstetric review of systems.10 Some patients may feel uneasy answering these questions, so HCPs can explain why such questions are being posed. For example, one can say, “I will be asking you some questions about your sexual activity to get a better idea of you as a whole and to ensure we are providing the most comprehensive care possible.” Informing women that FSD is common can facilitate a frank conversation.10

Screening for FSD with just a few questions can be informative. A literature review by Giraldi et al11 indicated that although multiple FSD screening tools are available, few standardized and culturally acceptable questionnaires are validated in general populations and can be used to assess for FSD in women with or without a partner and independent of the partner’s gender. As a result, HCPs can develop their own unbiased FSD screening questions based on their unique patient population. A patient’s sexual orientation should not be assumed; instead, HCPs need to ask about any and all sexual partners. Brief questions regarding sexual satisfaction and pain and the ability to reach an orgasm can determine if further screening is warranted.12 Three targeted questions include the following13:

• Do you have any questions or concerns about your sexual activity?
• Have you experienced any changes in sexual response, lubrication, or pain with sexual activity?
• Are you aware of any changes in your level of interest or desire for sexual activities?

If a woman—premenopausal or postmenopausal—answers “yes” to any of these questions, then further investigation is needed.

For a specific problem, HCPs need to explore the nature of the problem, its severity and duration, the degree of distress it causes, and any history of similar problems.13 The patient is asked to use her own words to describe any sexual difficulties she may be having.14 Because sexual functioning is multifaceted, HCPs need to consider a woman’s physical, surgical, medication, and social histories to uncover all possible factors causing or contributing to the sexual dysfunction (Table 1).14-16Physical examination
A physical exam is conducted to identify or exclude conditions that might cause or exacerbate FSD. This exam includes a general systemic survey with a focused cardiovascular exam, which can uncover systemic perfusion abnormalities that might contribute to FSD.15 A neurologic assessment of the effects of light touch and pressure on the external genitalia may reveal locations with hypersensitivity. A genitourinary exam is done to evaluate for structural abnormalities such as an imperforate hymen or vaginal septum and to look for signs of estrogen depletion (e.g., loss of vaginal rugae, pale mucosa, thin lining).15 An evaluation of pelvic muscle tone is important; both high tone and low tone can be associated with FSD. This evaluation is best done using a perineometer, a device placed within the vagina that provides feedback on the tone of the levator ani complex and obturator internus muscles.17 In the absence of this device, HCPs can evaluate tone during an internal exam by asking the woman to squeeze and relax the vaginal muscles.17 Of note, many women with FSD have normal physical exam findings.

Laboratory testing
Evaluating certain lab values can aid in identifying health conditions that may be contributing to sexual dysfunction. These lab tests include a complete blood count, fasting prolactin, a lipid profile, blood glucose, and thyroid hormone levels.18 Abnormal test results may reveal an underlying condition (e.g., anemia, thyroid disease, dyslipidemia, metabolic disorders, hormonal imbalances) causing or exacerbating the FSD.19 Evaluating the calculated free androgen index can also help in classifying sexual complaints; age-based normative values have been established.20 When a patient’s primary complaint is dyspareunia, vaginal, cervical, and/or vulvar cultures can be obtained to rule out infectious causes.14

DSM-5 changes to FSD diagnoses

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), which was published by the American Psychiatric Association in 2013, includes revisions to previous editions based on new research.21 Specific to the category of sexual dysfunction, the DSM-5 now requires that symptoms be present for at least 6 months. In addition, the DSM-5 includes gender-specific diagnoses, combines disorders that were previously separate, and removes the subtype of FSD due to psychological factors versus combined factors. Research suggests that sexual response cannot be categorized into specific stages and is not always linear. As a result, the DSM-5 combines sexual arousal disorder and sexual desire disorder into female sexual interest/arousal disorder. Another combined disorder in the DSM-5 is genito-pelvic pain/penetration disorder, which was developed because of the difficulty distinguishing between vaginismus and dyspareunia.

Treatment approaches

Initial management of FSD requires treating any contributing underlying physical conditions. If treatment of these conditions does not result in restoration of sexual function, other interventions for FSD are considered. Although this article focuses on pharmacotherapeutic options, patients can try nonpharmacologic interventions such as cognitive behavioral therapy (CBT), sex therapy, self-stimulation, and lubricating gels (Table 2).22,23 If nonpharmacologic therapies do not offer relief, pharmacologic options are considered.

Estrogen
Declining estrogen levels after menopause can lead to vulvovaginal atrophy (VVA), which can result in vaginal dryness, itching, and pressure and can lead to pain during sexual activity.24 Painful intercourse (dyspareunia) can diminish sexual pleasure and desire for sex. Exogenous estrogen therapies, both systemic and topical, are used to increase vaginal lubrication and promote a more pleasurable sexual experience.25

Compared with systemic estrogen products, vaginal estrogen products have been found to heighten genital vasculature (despite resulting in lower systemic levels of estrogen); systemic estrogen is more useful for relieving vasomotor symptoms (VMS) accompanying menopause.25 Conjugated estrogens vaginal cream (Prem­arin® Vaginal Cream) has an FDA indication for treatment of moderate to severe dyspareunia, a symptom of VVA due to meno­pause.26 Although estrogen therapies alone have not been found to directly increase sexual desire, they diminish dyspareunia, which may indirectly increase a woman’s interest in sexual activity.25

Many formulations of systemic and vaginal estrogen are available. If a woman’s FSD complaint is related to VVA, a vaginal formulation is preferred.27 Three vaginal estrogen formulations are available: creams, a ring, and a tablet (Table 3).27 For the tablet and creams, a higher dose and/or dosing frequency is typically used for 1-2 weeks until relief is achieved; a tapered dose can then be used for maintenance.27 Whereas most women find relief after 3 weeks of treatment, some may require up to 4-6 weeks.28 Low-dose vaginal estrogen therapy can be used indefinitely because of the low adverse effect profile; however, given limited data on use beyond 1 year, women should be evaluated annually to determine the need for continued treatment.29

The most common side effects of topical estrogen cream are headache, breast pain, pelvic pain, vasodilation, leukorrhea, metrorrhagia, vaginitis, and vulvovaginal disorder.26 Most side effects subside with ongoing use. Although systemic estrogen use has been linked to an increased risk for endometrial hyperplasia, venous thromboembolism, and breast cancer, little evidence suggests an increased risk with topical estrogen use.27 The North American Menopause Society (NAMS) released new guidelines for prescribing hormone therapy.30 According to these 2012 guidelines, topical estrogen is less likely than standard-dose oral estrogen to cause blood clots or stroke; however, more research is needed to reach definitive conclusions. A Cochrane review showed no increase in endometrial proliferation with vaginal estrogen versus placebo.27 Nevertheless, local estrogens can be absorbed into the bloodstream and increase the amount of systemic estrogen. Given the limited research, HCPs need to use clinical judgment when prescribing estrogen and monitor women closely for vaginal spotting/bleeding and other worrisome complaints.

Testosterone
If estrogen alone does not ease FSD symptoms, off-label addition of testosterone to estrogen therapy (ET) may increase libido and enhance sexual response.31 Use of testosterone in women is off label; this agent is prescribed with caution after patients are educated about the risks. A 2005 Cochrane review of 23 trials concluded that addition of testosterone therapy (TT) to ET improved sexual desire in postmenopausal women.32 The likely mechanism of action of combined therapy was related to the fact that use of exogenous testosterone increases circulating free testosterone and decreases sex hormone-binding globulin (SHBG). The subsequent increase in bioavailable testosterone may correlate with increased sexual desire.

Limited data on the long-term effects of TT led the FDA to reject a proposed testosterone patch for women with FSD. However, a 1% testosterone gel, FDA-approved for use in men only, is often prescribed off label to postmeno­pausal women with sexual dysfunction.33 One study showed that a dosage of 10 mg/day, applied in a thin layer to 15 cm2 of the inner thigh, led to mean testosterone levels of 3.0 nmol/L, which is in the high-normal range for premenopausal women (?2.5-3.0 nmol/L).33 The advantage of the transcutaneous route of administration over other routes (e.g., subcutaneous implant, intramuscular injection) is that it avoids the high hormone levels in the hepatic portal vein, which helps minimize assault to the liver.33

The most common short-term side effects of TT in women are hirsutism, acne, and a deepened voice, all of which are mild and reversible.34 Long-term side effects of concern are cardiovascular disease (CVD) and breast cancer. Preliminary studies have shown that TT reduces high-density lipoprotein cholesterol levels and increases low-density lipoprotein cholesterol levels; however, no study has looked at the correlation between TT in women and CVD.32 Studies examining the effects of TT on breast cancer risk are incon­clu­sive.32 Absolute contraindications to TT include a history of breast cancer, endometrial cancer, veno­thrombotic events, or CVD.14

When prescribing TT, HCPs should ask women to undergo baseline and annual breast exams and mammography, along with a pelvic exam—with special consideration paid to abnormal bleeding.14 In addition, women must be regularly evaluated for acne, hirsutism, and androgenic alopecia.14 Laboratory parameters monitored at baseline, after 3-6 months of use, and then periodically thereafter include SHBG, total testosterone, fasting lipid panel, and liver function tests.14

In 2005, NAMS published a position statement regarding the role of TT in postmenopausal women. The society concluded that TT is a valuable pharmacologic option for postmenopausal women who pre­sent with symptoms of decreased sexual desire.35 Nevertheless, NAMS cautions that insufficient data are available regarding the safety and efficacy of TT in women for longer than 6 months.35 Given these data, testosterone is prescribed with caution, with extensive patient education.

Bupropion
Bupropion is a norepinephrine and dopamine reuptake inhibitor antidepressant without serotonergic effects.36 Although bupropion is most commonly used as an antidepressant, this agent is used off label to treat sexual dysfunction in non-depressed women.37 The exact mechanism of bupropion’s efficacy for this indication is unknown but may be related to increased uptake of dopamine and norepinephrine, both of which are correlated with increased sexual responsiveness.36

The prescribed dosage of bu­pro­pion should not exceed 400 mg/day for the sustained-release formulation or 450 mg/day for the immediate- or extended release formulations; higher dos­ages can increase the incidence of side effects such as headache, agitation, insomnia, nausea, and possibly seizures.38 Bupropion is not prescribed to patients with a history of anorexia, bulimia, or seiz­ure disorders. Bupropion users must be monitored for neuro­psychiatric changes such as hostility, agitation, depression, and suicidality.39 Patients are counseled that treatment efficacy may not occur for 4-6 weeks.

Bupropion is a promising non-hormonal treatment option for FSD. Preliminary studies have shown encouraging results; however, more extensive research is needed before FSD can be listed as an indication for bupropion use.40Ospemifene
In 2013, the FDA approved ospemifene (OsphenaTM) for treatment of moderate to severe dyspareunia caused by VVA in menopausal women.41 Ospemi­fene, an oral selective estrogen receptor modulator, is the only non-estrogen compound approved in the U.S. to treat moderate to severe dyspareunia.42 This medication can be offered to women who are not candidates for ET but who have FSD related to dyspareunia. In two 12-week phase III clinical trials, ospemifene significantly improved vaginal dryness and dyspareunia, vaginal maturation index, and vaginal pH.43 The most effective dosage is 60 mg/day.43

The most common adverse effect of ospemifene is VMS.43 This agent is contraindicated in women with genital bleeding of unknown cause, estrogen-dependent neoplasia, personal history of deep vein thrombosis, pulmonary embolism, stroke, or myocardial infarction. Ospemifene should not be prescribed to women with a history of breast cancer or who are at high risk for breast cancer. Pre-clinical and clinical trials show a promising effect of ospemifene on bone density and breast tissue, but long-term data on the safety of this medication are limited.42Flibanserin
Flibanserin, an oral agent proposed for treatment of premeno­pausal hypoactive sexual desire disorder, has been shown to significantly increase sexual desire and the number of sexually satisfying events among women taking 100 mg at bedtime.44 The FDA initially rejected this medication in 2010.44 When Sprout Pharmaceuticals reapplied for approval in 2013, flibanserin was once again rejected; this time, the FDA indicated that additional studies in healthy subjects were needed to evaluate drug interactions and the drug’s possible adverse effect on driving.45 Sprout is expecting to resubmit the proposal by the end of the first quarter of 2015.45 No more information on the proposal was available as this article went to press.

Conclusion

Given the prevalence of FSD, HCPs must know how to screen for and diagnose FSD, and then manage it or know when to refer. HCPs need to take a short sexual history in all women, and ask them whether they have concerns about their sexual activity or about changes in their sexual desire or response. If the history uncovers a possibility of FSD, a thorough physical exam and lab testing are done. For women in whom FSD is diagnosed, nonpharmacologic interventions include CBT, sex therapy, self-stimulation, and lubricants. Two medications—conjugated estrogens vaginal cream and ospemifene —have a specific indication for dyspareunia. Although no pharmacologic agent has been approved by the FDA to treat desire, arousal, or orgasmic dysfunction in women, interest in such agents is growing. In each case, HCPs weigh the risks and benefits of specific treatments, offer extensive patient counseling, and provide close follow-up.

Casey B. Giebink is an adult and women’s health nurse practitioner at Medstar Georgetown University Hospital, Department of Ob&Gyn in Washington, DC. Ivy M. Alexander is an adult nurse practitioner specializing in midlife women’s health at the University of Connecticut Health Center in Storrs and Clinical Professor at the University of Connecticut School of Nursing. 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. Leiblum SR, Koochaki PE, Rodenberg CA, et al. Hypoactive sexual desire disorder in postmenopausal women: US results from the Women’s International Study of Health and Sexuality (WISHeS). Menopause. 2006;13(1):46-56.

2. Harsh V, McGarvey EL, Clayton AH. Physician attitudes regarding hypoactive sexual desire disorder in a primary care clinic: a pilot study. J Sex Med. 2008;5(3):640-645.

3. Loeb DF, Aagaard EM, Cali SR, Lee RS. Modest impact of a brief curricular intervention on poor documentation of sexual history in university-based resident internal medicine clinics. J Sex Med. 2010; 7(10):3315-3321.

4. Tsimtsiou Z, Hatzimouratidis K, Nakopoulou E, et al. Predictors of physicians’ involvement in addressing sexual health issues. J Sex Med. 2006;3(4):583-588.

5. Bekker M, Beck J, Putter H, et al. The place of female sexual dysfunction in the urological practice: results of a Dutch survey. J Sex Med. 2009;6(11):2979-2987.

6. Mansell D, Salinas G, Sanchez A, Abdolrasulnia M. Attitudes toward management of decreased sexual desire in premenopausal women: a national survey of nurse practitioners and physician assistants. J Allied Health. 2011;40(2):64-71.

7. Roos A-M, Thakar R, Sultan A, Scheer I. Female sexual dysfunction: are urogynecologists ready for it? Int Urogynecol J. 2009;20(1):89-101.

8. Julien JO, Thom B, Kline NE. Identification of barriers to sexual health assessment in oncology nursing practice. Oncol Nurs Forum. 2010;37(3):E186-E190.

9. Berman L, Berman J, Felder S, et al. Seeking help for sexual function complaints: what gynecologists need to know about the female patient’s experience. Fertil Steril. 2003;
79(3):572-576.

10. Peck SA. The importance of the sexual health history in the primary care setting. J Obstet Gynecol Neonatal Nurs. 2001;30(3):269-274.

11. Giraldi A, Rellini A, Pfaus J, et al. Questionnaires for assessment of female sexual dysfunction: A review and proposal for a standardized screener. J Sex Med. 2011;8(10):2681-2706.

12. Andrews WC. Approaches to taking a sexual history. J Womens Health Gend Based Med. 2000;9 (suppl 1):S21-S24.

13. Sarrel PM. Sexual dysfunction: treat or refer. Obstet Gynecol. 2005;
106(4):834-839.

14. Basson R, Wierman ME, Van Lankveld J, Brotto L. Summary of the recommendations on sexual dysfunctions in women. J Sex Med. 2010;7(1 pt 2):314-326.

15. Zakhari R. Female sexual dysfunction: a primary care perspective. J Am Acad Nurse Pract. 2009;21(9): 498-505.

16. Kaplan C. Assessing & managing female sexual dysfunction. Nurs Pract. 2009;34(1):42-48.

17. Rogalski M, Kellogg-Spadt S, Hoffmann A, et al. Retrospective chart review of vaginal diazepam suppository use in high-tone pelvic floor dysfunction. Int Urogynecol J. 2010;21(7):895-899.

18. Wylie K, Daines B, Jannini EA, et al. Loss of sexual desire in the postmenopausal woman. J Sex Med. 2007;4(2):395-405.

19. Krychman ML, Dizon D, Amsterdam A, Spadt SK. Evaluation of the female with sexual dysfunction. In: Mulhall JP, Incrocci L, Goldstein I, Rosen R, eds. Cancer and Sexual Health. Humana Press; 2011:351-356.

20. Guay A, Jacobson J, Munarriz R, et al. Serum androgen levels in healthy premenopausal women with and without sexual dysfunction: Part B: Reduced serum androgen levels in healthy premenopausal women with complaints of sexual dysfunction. Int J Impot Res. 2004;16(2):121-129.

21. American Psychiatric Association. Highlights of Changes from DSM-IV-TR to DSM-5. 2013. http://www.psychiatry.org/dsm5

22. Leiblum SR, Wiegel M. Psychotherapeutic interventions for treating female sexual dysfunction. World J Urol. 2002;20(2):127-136.

23. Palacios S, Graziottin A. Patient scenario: A 53-year-old woman with hypoactive sexual desire disorder. Maturitas. 2009;63(2):164-168.

24. Katz A. When sex hurts: Meno­pause-related dyspareunia. Am J Nurs. 2007;107(7):34-36.

25. Long CY, Liu CM, HSU SC, et al. A randomized comparative study of the effects of oral and topical estrogen therapy on the vaginal vascularization and sexual function in hysterectomized postmenopausal wom­en. Menopause. 2006;13(5):737-743.

26. Premarin Vaginal prescribing information. Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. May 2012. http://labeling.pfizer.com/showlabeling.aspx?id=132

27. Simon JA. Identifying and treating sexual dysfunction in postmenopausal women: the role of estrogen deficiency and estrogen therapy. J Womens Health (Larchmt). 2011;20(10):1453-1465.

28. Sturdee DW, Panay N, International Menopause Society Writing Group. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric. 2010; 13(6):509-522.

29. North American Menopause Society. Estrogen and progestogen use in postmenopausal women: position statement of the North American Menopause Society. Menopause. 2010;17(2):242-255.

30. North American Menopause Society. The 2012 hormone therapy position statement of The North American Menopause Society. Menopause. 2012;19(3):257-271.

31. Raghunandan C, Agrawal S, Dubey P, et al. A comparative study of the effects of local estrogen with or without local testosterone on vulvovaginal and sexual dysfunction in postmenopausal women. J Sex Med. 2010;7(3):1284-1290.

32. Somboonporn W, Davis S, Seif MW, Bell R. Testosterone for peri-and postmenopausal women. Cochrane Database Syst Rev. 2005;
(4)CD004509.

33. Nathorst böös J, Jarkander-Rolff M, Carlström K, et al. Percutaneous administration of testosterone gel in postmenopausal women-a pharmacological study. Gynecol Endocrinol. 2005;20(5):243-248.

34. Kingsberg SA, Simon JA, Goldstein I. The current outlook for testosterone in the management of hypoactive sexual desire disorder in postmenopausal women. J Sex Med. 2008;5(suppl 4):182-193.

35. North American Menopause Society. The role of testosterone therapy in postmenopausal women: position statement of the North American Menopause Society. Menopause. 2005;12(5):496-511.

36. Segraves RT, Clayton A, Croft H, et al. Bupropion sustained release for the treatment of hypoactive sexual desire disorder in premenopausal women. J Clin Psychopharmacol. 2004;24(3):339-342.

37. Segraves RT, Croft H, Kavoussi R, et al. Bupropion sustained release (SR) for the treatment of hypoactive sexual desire disorder (HSDD) in nondepressed women. J Sex Marital Ther. 2001;27(3):303-316.

38. Ginzburg R, Wong Y, Fader JS. Effect of bupropion on sexual dysfunction. Ann Pharmacother. 2005; 39(12):2096-2099.

39. GlaxoSmithKline. Wellbutrin: Medication Guide. 2009.

40. Safarinejad MR, Hosseini SY, Asgari MA, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of bupropion for treating hypoactive sexual desire disorder in ovulating women. BJU Int. 2010;106(6):832-839.

41. US Food and Drug Administration. FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex. 2013. www.fda.gov/NewsEvents/Newsroom/Press
Announcements/ucm341128.htm

42. Soe L, Wurz G, Kao CJ, DeGregorio M. Ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy: potential benefits in bone and breast. Int J Womens Health. 2013;5:605-611.

43. North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. 2013;20(9):888-902.

44. Thorp J, Simon J, Dattani D, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY Study. J Sex Med. 2012;9(3):
793-804.

45. Reuters. PR Newswire. Sprout Pharmaceuticals receives clear guidance from FDA on path forward to resubmit new drug application for flibanserin, the first potential medical treatment for hypoactive sexual desire disorder in premenopausal women. February 11, 2014. www.reuters.com/article/2014/02/11/sprout-pharmaceutical-idUSnPn
CGr7Dhn+164+PRN20140211

Not your mother’s WHNP guidelines

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By Susan Kendig, JD, MSN, WHNP-BC, FAANP

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.

Best practice recommendations for male sexual and reproductive healthcare

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By Wendy D. Grube, PhD, CRNP

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

Editor-in-chief’s message

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Dear Colleagues,

In so many ways, NPWH and its members are showing that women’s health is about much more than just obstetrics and gynecology. But then, we have known this for a long time. Here are a few examples.

Sue Kendig, NPWH Director of Policy, describes the process and outcome of revising the Women’s Health Nurse Practitioner: Guidelines for Practice and Education in this issue of the journal. As a member of the task force for this 7th edition and for the previous edition of the Guidelines, I can confirm that we definitely did our homework to produce a document that reflects the expanded scope of practice for today’s WHNP. NPWH members have free access to the Guidelines on the NPWH website.

NPWH is a leading organization in the field of evidence-based sexual healthcare, providing the first national Women’s Sexual Health Course for NPs in 2014. The course was so successful that it will be offered again this year. We at Women’s Healthcare, NPWH’s
official journal, are proud to present a new department, Focus on sexual health, in this issue. Brooke M. Faught, MSN, WHNP, Clinical Director of the Women’s Institute for Sexual Health in Nashville, Tennessee, has authored the inaugural article for this department. This issue of the journal also features an article on female sexual dysfunction by Casey B. Giebink, MSN, NP-C, WHNP-BC, and Ivy M. Alexander, PhD, APRN, ANP-BC, FAAN. And in our Assessment & management department, Wendy Grube, PhD, CRNP, a member of the task force that developed Preventive Male Sexual and Reproductive Health Care: Recommendations for Clinical Practice, summarizes the key points in this groundbreaking publication.

NWPH is developing a strong presence with regard to mental health as well. In the past year alone, we have offered articles on depression in women, self-esteem, postpartum depression, sexual assault, and depression in adolescents. Appearing now or coming soon are articles on binge eating disorder, PCOS psychosocial effects, and anorexia in adolescents.

To honor our Million Hearts® partnership commitment, we have been providing many evidence-based continuing education (CE) activities that give advanced practice nurses the tools they need to promote heart health. In the August 2014 issue of Women’s Healthcare, we published a CE article by Tamera Lea Pearson, PhD, MSN, FNP, ACNP, entitled Cardiovascular Disease in Women: A Journey Toward a Focus on Prevention. At the 2014 NPWH conference in Savannah, Megan McCarthy, MSN, NP-C, presented The Angina Monologues—Update on New Ways to Detect and Prevent Heart Attacks in Women and Jaye M. Shyken, MD, presented Long-Term Health Consequences of Pregnancy Complications, which included a discussion about the relationship between pre-eclampsia and gestational diabetes with future cardiovascular disease. In that vein, Suzanne Shugg, DNP, ACNP, a clinical lipid specialist who runs a Preventive Cardiology Clinic in Berkeley Heights, New Jersey, shares her insights on this topic in her article Pregnancy’s Effects on Cardiovascular Health: A Woman’s First “Cardiac Stress Test” in this issue of the journal. This issue also provides a Million Hearts® tip sheet on Improving Medication Adherence Among Patients with Hypertension. This coming year, an NPWH task force will develop a white paper on evidence-based best practices and policy recommendations to promote cardiovascular health and wellness for women, including those who are at high risk for cardiovascular disease.

You can rely on NPWH, and Women’s Healthcare, to continue to provide cutting-edge, evidence-based women’s healthcare information to support you in providing high quality care for women from menarche through senescence.

Beth Kelsey, EdD, APRN, WHNP-BC

 

Pregnancy’s effects on cardiovascular health: A woman’s first “cardiac stress test”

 

The effects of pregnancy on a woman’s heart, especially with respect to her changing lipid profile and her risk for developing gestational diabetes mellitus or pre-eclampsia, can sometimes predict her future cardiovascular (CV) status. As such, the state of pregnancy may serve as a “cardiac stress test” that can warn her healthcare provider about potential CV problems that perhaps can be forestalled or mitigated.

Key words: pregnancy, lipid profile, gestational diabetes,
pre-eclampsia, cardiovascular disease

After becoming pregnant, a woman is likely to focus on the health of her growing fetus; she may not necessarily consider the effects of pregnancy on her own health, except in terms of how it may affect her future child. In essence, though, pregnancy can have a profound effect on a woman’s health and may, in fact, be her first “cardiac stress test.” Even an otherwise healthy woman experiences a rise in total cholesterol (TC), triglycerides (TG), and possibly blood pressure (BP) during pregnancy. A woman who gains excessive weight or makes poor lifestyle choices during pregnancy can heighten the metabolic changes already occurring and place her at risk for developing gestational diabetes mellitus (GDM) or pre-eclampsia. These events may not only jeopardize the pregnancy outcome but may also increase the woman’s risk for developing cardiovascular disease (CVD) in the future.

A woman’s CV status during pregnancy gives her healthcare provider (HCP) a glimpse into how her body may react, both in the short term and in the long term, when she is under major physical stress. The onset of GDM or hypertension (HTN; a sign of pre-eclampsia) during pregnancy may provide HCPs with a unique opportunity to identify young women who may be at increased risk for developing CVD in the future.1 Of note, the positive association of GDM and pre-eclampsia with post-pregnancy CV risk may be due largely to pre-pregnancy risk factors such as obesity, dyslipidemia, and HTN, rather than reflecting a direct influence of the pregnancy complication.1 But these pre-pregnancy risk factors may not become clinically apparent until a pregnancy places its own particular stresses on the heart.

Normal metabolic changes during pregnancy

During pregnancy, maternal metabolism adapts to benefit the growth and development of the fetus.2 This process can be divided into two phases: Phase 1 comprises the first and second trimesters and phase 2 comprises the third trimester. During phase 1, fetal energy demands are limited, but maternal visceral fat stores increase. This latter effect is attributable in part to maternal behavioral changes, including hyperphagia, and increased adipose tissue lipogenesis. Also during phase 1, insulin sensitivity is normal or slightly improved, with normal peripheral sensitivity to insulin and normal hepatic basal glucose production.2 In the midst of this metabolic environment, pregnancy-related endocrine changes (e.g., rising levels of estrogen, progesterone, and cortisol) favor lipogenesis and accumulation of fat.2

During phase 2 of pregnancy, the anabolic state switches to a catabolic state.2 Increasing insulin resistance results in increased hormone-sensitive lipase activity and decreased lipoprotein lipase activity, which in turn result in a marked increase in lipolysis rates and increased delivery of free fatty acids to the liver. The free fatty acids are channeled into hepatic TG synthesis and increased secretion of very-low-density lipoproteins (VLDL).2 At a similar time, estradiol acts to increase hepatic VLDL production, promote apolipoprotein A1 (Apo A1) production, and reduce hepatic lipase activity, resulting in increased production of high-density lipoproteins (HDL).2

Lipid profile changes during pregnancy

Plasma lipid concentrations rise markedly as pregnancy advances.2 For example, plasma TC and TG concentrations climb by 25%-50% and 200%-400%, respectively. The increase in TG is due mainly to that of VLDL-TG, which rises threefold between the end of the first trimester and late pregnancy. VLDL is composed of two fractions, VLDL1, which is secreted by the liver to supply tissues with TG fatty acids in the post-absorption state, and VLDL2, which is a major precursor of the cholesterol-transporting particles intermediate-density lipoprotein and low-density lipoprotein (LDL). As plasma TG increase with advancing gestation, VLDL1 and VLDL2 increase by an average of fourfold.

The abundance of VLDL-TG is caused by their enhanced liver production and
delayed lipolysis in the presence of increased cholesterol ester transfer protein activity, which takes place mid-gestation. Exchange of TG for esterified cholesterol is facilitated between VLDL and either LDL or HDL. TG accumulate in the lipoprotein fractions of higher densities, LDL and HDL.3 By the third trimester, most women have a lipid profile that would be considered highly atherogenic in the non-pregnant state.4,5

In a normal pregnancy, HDL cholesterol (HDL-C) levels are elevated by the end of the first trimester and peak at the end of the second trimester (total rise, about 40%).2
The increase in HDL-C is due mainly to increasing estrogen concentrations, which promote Apo A1 production and reduce hepatic lipase activity. In the latter phase of pregnancy, elevated TG adversely affect LDL composition, causing a shift to small dense particles, which are more atherogenic. LDL-C concentrations rise by about 70% during a normal pregnancy. After delivery, women can expect their lipid values to return to normal in 4 weeks to 3 months.

Effects of exaggerated lipid alterations: Gestational diabetes and pre-eclampsia

Additional maternal metabolic stresses such as obesity and other risk factors for DM may exacerbate the alterations in lipoprotein metabolism that take place ina normal pregnancy.2

For example, obese pregnant women, versus their leaner counterparts, have higher serum TG and VLDL-C levels and lower HDL-C levels.2 This dysregulation of maternal lipid metabolism may predispose them to GDM and pre-eclampsia.

Gestational diabetes mellitus
Gestational diabetes mellitus is defined as any degree of glucose intolerance that is first detected during pregnancy.2 Four percent to 9% of pregnancies are affected by GDM. In a normal pregnancy, the normal progression of insulin resistance is compensated by increased insulin secretion by the pancreas’ beta cells. Women with GDM have an imbalance between insulin resistance and insulin secretion capacity, resulting in increased circulating glucose levels. A recent study showed that, during the first trimester of pregnancy, women who had relatively lower levels of adiponectin, an adipokine suspected of having insulin-sensitizing properties, were more likely to develop increased insulin resistance and GDM.6Pre-eclampsia
This condition, which is characterized by elevated BP and, in most cases, large amounts of protein in the urine, affects 2%-4% of pregnan­cies.2 Although the cause and the pathogenesis of pre-eclampsia have not been definitively established, the hyperlipidemia of normal pregnancy (i.e., the elevated TC and TG) becomes more extreme in women who develop pre-eclampsia. The exaggerated rise in TG leads to increased production of small dense LDL (almost 3 times the level seen in normal pregnancy) and reduced HDL-C. This lipid profile may contribute to endothelial dysfunction.

Complicating the picture, factors released from the placenta enhance peripheral lipolysis, which is already being stimulated by hormone-sensitive lipase, resulting in an increased flux of free fatty acids to the liver. These free fatty acids are channeled primarily into hepatic TG synthesis, resulting in increased secretion of TG-rich lipoproteins. Accumulation of TG occurs in the hepatocyte when this pathway is saturated. Increased concentrations of VLDL1 in the circulation drive production of atherogenic lipoproteins. This pathway plays a role in the formation of lipid-laden macrophages (foam cells) in the spiral arteries of the decidua basalis and may be involved in enhanced placental production of the pro-inflammatory mediators in pre-eclampsia.

Use of lipid-lowering medications during pregnancy

Women with previously diagnosed hyperlipidemia who become pregnant while taking a statin should stop this treatment immediately.7,8 Statins are Category X medications; that is, they are contraindicated in pregnant women, with positive evidence of serious fetal abnormalities in animals. As Category C agents, fibrates (e.g., gemfibrozil, fenofibrate), ezetimibe, niacin, and prescription omega-3-acid ethyl esters are also to be avoided in pregnancy; animal studies have shown adverse fetal effects. The bile acid sequestrant cholestyramine is designated Category C, but colesevelam, a Category B bile acid sequestrant, can be used safely in pregnancy. This agent has been reported to lower LDL-C by about 15%.7

Beneficial effects of breastfeeding on maternal lipid profiles

A woman’s body continues to change after she gives birth. All women should be encouraged to breastfeed exclusively for the first 6 months of life.9 As stated earlier, during gestation, visceral fat accumulates and insulin resistance and lipid and TG levels rise. These changes appear to reverse more quickly, and more completely, with lactation.10 Data from several large cohort studies suggest that breastfeeding has beneficial effects on adiposity, lipids, and glucose homeo­stasis.10 Researchers have found protective associations between duration of breastfeeding and incidence of hyperlipidemia, HTN, type 2 DM, the metabolic syndrome, and myocardial infarction (MI).11

During pregnancy, dramatic changes occur in a woman’s physiology as she accommodates the demands of “metabolizing for two.” These changes both support the
developing fetus and allow for accumulation of energy stores in anticipation of lactation. This accumulation is characterized by well-described increases in visceral fat, insulin production, insulin resistance, and circulating lipid levels. After birth, lactation is thought to play a central role in mobilizing these accumulated fat stores and resetting maternal metabolism, thereby reducing maternal risk for metabolic disease. The longer a woman lactates, the more completely she off-loads these accumulated stores. Conversely, when a woman does not lactate, adverse metabolic changes persist for a longer period of time, increasing her disease risk.11

Effects of GDM and pre-eclampsia on mothers’ future health

Women with a history of gestational glycosuria or GDM are likely to have higher levels of fasting glucose and insulin many years after the pregnancy.12 Nearly 50% of women with a history of GDM go on to develop type 2 DM within 10 years. Nearly two decades after pregnancy, women with a history of gestational HTN or pre-eclampsia, compared with women who were normotensive during pregnancy, have elevated body mass index (BMI), waist circumference, and BP.

Women with a history of pre-eclampsia, versus those without pre-eclampsia, are twice as likely to develop CVD (e.g., coronary heart disease, MI, heart failure).13 These women are also more likely to develop CVD earlier in life. Although pre-eclampsia is a CVD risk factor that cannot necessarily be modified, pregnant women can help prevent pre-eclampsia in the first place by limiting weight gain. Women with a history of pre-eclampsia should take extra care to control other CVD risk factors (e.g., high LDL-C, low HDL-C, HTN) as they age.

In the Avon Longitudinal Study of Parents and Children, researchers studied the associations of pregnancy diabetes mellitus (pre-gestational DM, GDM, and glycosuria) and hypertensive disorders of pregnancy (HDP; gestational HTN and pre-eclampsia) with a wide range of CV risk factors measured 18 years post-pregnancy (mean age at outcome assessment, 48 years) in a prospective cohort of more than 3,000 women.12 Pregnancy DM was associated with higher glucose concentrations 18 years post-pregnancy, even when potential confounders, including pre-pregnancy BMI, were controlled for. In addition, pregnancy DM was associated with higher glucose; GDM and glycosuria were associated with higher insulin and pro-insulin; and glycosuria was associated with higher TG levels. Both gestational HTN and pre-eclampsia were associated with a greater number of CV risk factors 18 years post-pregnancy: higher BMI, waist circumference, systolic and diastolic BP, insulin, pro-insulin, and TG, and lower HDL-C.

These results suggest that pre-eclampsia, relative to GDM, is a stronger marker of future CVD; in the study, pre-eclampsia was associated with a greater number of CV risk factors, whereas GDM was linked to greater glycemia later in life.12 The results also suggest that the mechanisms underlying these associations are different; in the study, pregnancy DM and HDP were associated with different CV risk factors. Therefore, how a woman fares during pregnancy may serve as an early cardiac stress test revealing future CVD risk.

Clinical recommendations

Pre-conception
HCPs should advise women aged 20 years or older who are considering pregnancy and who have not had a lipid profile in the past 5 years to have this screening.14 Women whose lipid values are outside the normal range should institute lifestyle changes and, if necessary, medication to normalize their values before trying to become pregnant. Women with a cholesterol disorder such as familial hyper­choles­terol­emia (FH), an autosomal dominant disorder, should be counseled on the risk of pregnancy to their own health, as well as the chance of passing on the disorder to future children.15 A woman with heterozygous FH has a 50% chance of passing on the mutated gene to each child. A woman with homozygous FH, a much more severe form of FH than heterozygous FH, will definitely pass on a copy of the mutated gene—and, therefore, at least heterozygous FH, to her children. HCPs should counsel women using a statin, fibrate, or ezetimibe who are trying to become pregnant (or who learn that they are pregnant) to stop the medication immediately and contact the HCP who prescribed it.

During pregnancy
Women who are pregnant must be counseled on the proper amount of weight they should gain and be given nutrition recommendations. Moderate aerobic exercise (150 minutes/week) is safe and appropriate for most pregnant women. Women who have been inactive, are obese, or have other CVD risk factors should consult with their HCP to determine the level of exercise and monitoring they need.

Women whose lipid values are highly elevated at the beginning of pregnancy (e.g., TC >300 mg/dL, LDL-C >190 mg/dL, TG >500 mg/dL) should have their lipid profiles checked monthly. They should follow a diet designed for their lipid abnormality. For example, women with elevated TG should follow a low-fat, carbohydrate-controlled diet.14
Pregnant women should be counseled on recommended weight gain based on their pre-pregnancy BMI: a total of 11-20 lb if they were obese before pregnancy and 15-25 lb if they were overweight before pregnancy.16 The goal is to reduce DM and CVD risk in both mother and child.

After delivery
Breastfeeding is recommended to boost infants’ immune systems and aid in maternal weight loss, which can also help lower mothers’ TC and TG values. In addition, breastfeeding leads to increased maternal insulin sensitivity. Lipid profiles should be ordered every 3 months for women whose lipid values were elevated during pregnancy. Like pregnant women, breastfeeding women should delay use of cholesterol-lowering agents, again with the exception of colesevelam. Statins, fibrates, ezetimibe, and niacin are not recommended for use by nursing mothers. At 6 months post-delivery, women whose LDL-C is >190 mg/dL and/or whose TG are >500 mg/dL 6 months postpartum should give strong consideration to stopping breastfeeding so that they can take cholesterol-lowering medication to reduce CV risk.

Conclusion

Attention to a woman’s CV health pre-conception, during pregnancy, and postpartum allows HCPs to identify risk factors, encourage heart-healthy behaviors, and use pharmacotherapy effectively and safely when needed to treat dyslipidemia. This care can help reduce the risk for CVD in women as they age.

The courses of women’s pregnancies may provide HCPs with insight into their future CV health. Identifying dysglycemic pregnancies will simultaneously identify women who are at increased subsequent cardiometabolic risk.17 Women who have or who have had pre-eclampsia, versus those who have not, are twice as likely to develop CVD (e.g., coronary heart disease, MI, heart failure). When a dysglycemic pregnancy or pre-eclampsia is detected, HCPs have the opportunity to go beyond managing the condition during pregnancy to attenuating the risk for future CVD with targeted intervention. Heart health belongs in all women’s healthcare, including throughout the reproductive years.

Suzanne Shugg is a clinical lipid specialist and a fellow of the National Lipid Association. She runs a Preventive Cardiology Clinic at Summit Medical Group in Berkeley Heights, New Jersey, and is an adjunct graduate professor at Rutgers University. Suzanne has set up and assisted in setting up other preventive cardiology clinics in the United States, and she sits on the board of the LP(a) Foundation. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

Acknowledgment

The author sends a special thanks to Thomas Dayspring, MD, for his invaluable contribution to the world of lipidology, as well as his guidance and mentorship.

References
1. Romundstad PR, Magnussen EB, Smith GD, Vatten L. Hypertension in pregnancy and later cardiovascular risk. Circulation. 2010;122(6):579-584.

2. Huda SS, Sattar N, Freeman DJ. Lipoprotein metabolism and vascular complications in pregnancy. Clin Lipidol. 2009;4(1):91-102.

3. Herrera E, Ortega-Senovilla H. Maternal lipid metabolism during normal pregnancy and its implications to fetal development. Clin Lipidol. 2010;5(6): 899-911.

4. Martin U, Davies C, Hayavi S, et al. Is normal pregnancy atherogenic? Clin Sci (Lond). 1999;96(4):421-425.

5. Lippi G, Albiero A, Montagnana M, et al. Lipid and lipoprotein profile in physiological pregnancy. Clin Lab. 2007;53(3-4):173-177.

6. Lacroix M, Battista MC, Doyon M, et al. Lower adiponectin levels at first trimester of pregnancy are associated with increased insulin resistance and higher risk of developing gestational diabetes mellitus. Diabetes Care. 2013; 36(6):1577-1583.

7. Women with FH and Pregnancy. FH Foundation website. 2014. http://
thefhfoundation.org/about-fh/women-with-fh-pregnancy/

8. U.S. Food and Drug Administration. High Cholesterol—Medicines to Help You. Updated February 23, 2010. www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118595.htm

9. World Health Organization. Nutrition. Exclusive Breastfeeding. 2014. www.who.int/nutrition/topics/exclusive_breastfeeding/en/

10. Stuebe AM, Rich-Edwards JW. The reset hypothesis: lactation and maternal metabolism. Am J Perinatol. 2009; 26(1):81-88.

11. Schwartz EB, Ray RM, Stuebe AM, et al. Duration of lactation and risk factors for maternal cardiovascular disease. Obstet Gynecol. 2009;113(5):974-982.

12. Fraser A, Nelson SM, Macdonald-Wallis C, et al. Associations of pregnancy complications with calculated cardiovascular disease risk and cardiovascular risk factors in middle age: the Avon Longitudinal Study of Parents and Children. Circulation. 2012;125
(11):1367-1380.

13. Rich-Edwards J. The predictive pregnancy: what complicated pregnancies tell us about mother’s future cardiovascular risk. Circulation. 2012; 125(11):1336-1338.

14. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001;285 (19):2486-2497.

15. National Institutes of Health. National Human Genome Research Institute. December 26, 2013. www.genome.gov/25520184#al-5

16. Institute of Medicine. Weight Gain During Pregnancy: Reexamining the Guidelines. May 28, 2009.

17. Brewster S, Zinman B, Retnakaran R, Floras S. Cardiometabolic consequences of gestational dysglycemia. J Am Coll Cardiol. 2013;62(8):677-684.

It’s not just physical: The adverse psychosocial effects of polycystic ovary syndrome in adolescents

 

Management of polycystic ovary syndrome (PCOS) in adolescents entails dealing not only with the physical manifestations but also the troubling psychosocial effects related to these physical manifestations. The author conducted a literature review to ascertain the adverse psychosocial effects of PCOS in adolescents, as well as what nurse practitioners can do to mitigate these effects.

Key words: polycystic ovary syndrome, PCOS, adolescence, psychosocial effects

Polycystic ovary syndrome (PCOS) is a common endocrine disorder that affects 5%-10% of women and typically begins during adolescence.1-5 Common physical manifestations of PCOS—acne, obesity, hirsutism, and anovulation—can have adverse effects on adolescents’ self-image and mood.6,7 As a result, many of these girls may withdraw from their peers because of emotional distress or embarrassment. In addition to lowering self-esteem, obesity and the features of metabolic syndrome can increase the risk for future health complications,8,9 which in turn can provoke anxiety in adolescents who are aware of these risks. With all of these negative forces at play, adolescents with PCOS are also at increased risk for depression.10 In this article, the author shares the results of a literature search on the psychosocial concerns related to PCOS in adolescents and what nurse practitioners can do to address these concerns.

Literature review

The author searched the PubMed, Google Scholar, CINAHL, and JSTOR databases to find articles published between 2002 and 2013 that pertained to the adverse psychosocial effects of PCOS in adolescents, including management of these effects. Key words in the search were polycystic ovarian syndrome, PCOS, adolescence, teens, quality of life,
psychosocial, psychosocial issues, depression, anxiety, eating disorders, hirsutism, obesity, and metabolic syndrome. Other articles were found by hand-searching relevant studies cited in the articles initially found.

Articles met inclusion criteria if they covered psychosocial concerns related to PCOS in adolescents. Articles describing the physical effects of PCOS were included if they served to provide relevant background information. Studies focusing only on adults were excluded unless, again, they provided useful background information or they compared PCOS-related psychosocial concerns in adolescents versus adults.

Psychosocial concerns related to PCOS

Table 1 lists selected studies related to psychosocial concerns in adolescents with PCOS. These concerns include anxiety and depression,1,4 social interaction,11,12 body image,11 body weight,1,11,13,14 eating disorders,15 hirsutism,13 fertility,2,11,13 and decreased quality of life (QOL) related to sexual behavior.2,11 Health-related QOL (HQOL) scores in adolescents have been correlated with the level of PCOS symptomatology.14 A qualitative study showed that a PCOS diagnosis had an adverse impact on HQOL, with emotional and social functioning being more affected than physical health.11

Psychological problems

According to a report by Dowdy,10 adolescents with PCOS commonly use words such as nerd or freak to describe themselves; PCOS changes their bodies, which makes them feel different from other adolescents. A small study showed that adolescents with PCOS, compared with healthy adolescents, had higher anxiety scale scores.4 Dowdy10 reported that anxiety among adolescents with PCOS was related to their appearance, body-image concerns, and fear of future infertility.

Insulin resistance and increased levels of insulin in the bloodstream, which are common in patients with PCOS, have been thought to cause problems with mood.16 Insulin levels in the blood can affect serotonin levels in the brain and vice versa, so it is unclear whether insulin abnormalities initiate depressive symptoms or are the result of them.10

Body weight and body-image disturbances

Overweight/obesity (OW/O) and an elevated body mass index (BMI) are more common in adolescents with PCOS than in those without PCOS.8,14 Excess weight, among all the physical manifestations of PCOS in adolescents, has the greatest adverse impact on HQOL.17,18 One study showed that HQOL scores were inversely proportional to BMI values in teens with PCOS and high BMIs.14 PCOS-related OW/O has been linked to decreased academic achievement and lower income, even after controlling for socio­economic status and intelligence. In addition, many females with OW/O are the recipients of hurtful comments and actions from peers, family members, colleagues, strangers, and even some healthcare providers,19 which can lower their self-esteem.

Other body-image concerns in adolescents with PCOS involve male-pattern hair on the face and body and acne.10 Adolescents with hirsutism, versus those without the condition, have lower HQOL scores and self-esteem and an increased prevalence of anxiety disorders.20 Some adolescents report feeling that hirsutism has robbed them of their female identity.10 PCOS-related insulin resistance increases the risk for developing acanthosis nigricans (a brown to black, poorly defined, velvety hyperpigmentation of the skin),21 another body-image concern because of its physical visibility.

Femininity, fertility, and sexuality concerns

According to the dictionary, feminine means “having the qualities traditionally ascribed to women.”22 Menstruation is an important symbol of femininity; menarche and a normal menstrual cycle serve as rites of passage that prove that a female has the ability to reproduce.4 Adolescents with PCOS, versus their healthy peers, are more likely to have concerns about their future fertility because of their menstrual irregularities.2 Fear of potential infertility has an adverse impact on HQOL.

Adolescents with PCOS, compared with adolescents who do not have PCOS, may feel more self-conscious, less desirable, and less inclined to be outgoing with persons to whom they are attracted.10 A teen with PCOS may feel unsexy or unwomanly because her body has “let her down,” and she may have less sexual interest because of the many PCOS-related stressors with which she must cope.10Eating disorders
Results of a retrospective study showed that adolescents with menstrual disturbances were at greater risk of having an eating disorder.23 Adolescents with OW/O may develop unhealthy eating habits such as binge eating, purging, dieting, and using diuretics or laxatives to lose weight.24 Some adolescents with PCOS feel that their efforts to lose weight are not as successful as those of their peers who do not have PCOS.10

Screening for adverse psychosocial effects of PCOS

Screening for psychosocial concerns related to PCOS should start early in adolescence. Table 2 lists screening tests available for identification of psychosocial problems.25 An evaluation of the Polycystic Ovary Syndrome Questionnaire (PCOSQ) by Jones et al26 found this tool reliable for determining HQOL in women with PCOS. Validity of the tool could be improved with the addition of acne to the questionnaire because of acne’s identification as an important factor involved in HQOL. Although the PCOSQ was first developed based on research conducted on women,27 it has been used in adolescents to assess psychosocial concerns related to PCOS.13

NP role in managing psychosocial effects of PCOS

Goals of therapy for adolescents with PCOS—amelioration of psychological problems, weight loss, reduction of the manifestations of hyperandrogenism, and improvement in body image and self-esteem—are best achieved by a multidisciplinary team that includes NPs.3,4,28 The physical and psychosocial aspects of treatment go hand in hand. Meeting physical management goals (e.g., weight loss, reduction in hyperandrogenism manifestations) can lessen some of the troubling psychosocial effects, and enhancing self-esteem can motivate weight-loss efforts and perhaps even improve adherence to the pharmacotherapeutic regimen. One of the best ways that NPs can help is to supply adolescent patients with information about PCOS and its treatment that they can understand.

Mental health approaches

An open trial of weekly cognitive behavioral therapy sessions and family sessions has shown that these modalities may help treat both depressive symptoms and obesity in adolescents with PCOS.1 Participating in individual and family sessions can help patients develop positive methods of coping with PCOS and find constructive ways to manage their feelings. Support groups that meet in person or online can help motivate adolescents to make and maintain healthy lifestyle choices.29,30 NPs can recommend any or all of these psychotherapeutic approaches.

Lifestyle changes

Weight loss of 5%-10% may not only decrease cardiovascular risks and insulin resistance but also help improve HQOL.8,14,31 NPs should ascertain which weight-loss strategies have worked or not worked in the past, and identify any unsafe weight-loss strategies and eating patterns in which patients may be engaged.24,29 In these cases, NPs should offer patients safe alternatives for losing weight.24

A case–control study showed that, compared with controls, girls with PCOS engaged in physical activities less often (if they did exercise, they did so with less frequency and intensity), and they were less likely to be aware of the beneficial effects of exercise on their health.32 NPs should encourage patients to exercise regularly, which may help increase their self-esteem and overall health.13,19 Yoga may be even more beneficial; results of a recent randomized, controlled trial indicated that yoga effectuated a significantly greater increase in HQOL than did traditional exercise.33

With regard to approaches to counter the effects of hyperandrogenism, unwanted hair can be removed temporarily via shaving, waxing, and/or plucking (which unfortunately may cause other unwanted effects such as irritation, scarring, or folliculitis). Laser treatments can provide more permanent results, but many treatments may be needed and the treatments may be costly.34

Medications

Oral contraceptives (OCs) regulate menstrual cycles and treat hirsutism and acne.28,34 Insulin sensitizers such as metformin can be used to treat underlying insulin resistance.34,35 However, a randomized, placebo-controlled trial showed that adding metformin to a regimen of lifestyle changes and OC use did not lead to a significant improvement in HQOL.13 Anti-androgens such as spironolactone can help manage the hyperandrogenism effects.34,36 Statins are first-line treatments for lowering low-density lipoprotein cholesterol levels.37 Antidepressants and anxiolytics can be used to treat psychiatric disorders related to PCOS; in these cases, NPs may want to consult with a mental health specialist.

Further research

An important topic for future study is the efficacy of implementing a HQOL survey at every primary care visit for adolescents with PCOS. The purpose of this survey would be to assess for psychosocial co-morbidities common in individuals with PCOS. The studies should ascertain whether implementing such a screening would make providers more aware of the adverse psychosocial effects of PCOS, help identify psychosocial symptoms, and facilitate more comprehensive treatment when needed. Additional research should determine the outcomes of losing weight, how other PCOS-specific interventions affect overall HQOL, how to address infertility concerns, and how primary care practitioners can best manage adolescents holistically to help improve HQOL. More research is needed regarding how providers should teach and communicate with adolescents with PCOS.

Conclusion

Polycystic ovary syndrome in adolescents involves a myriad of physical manifestations that can compromise psychosocial health. These adverse psychosocial effects may have a major impact on HQOL. Early diagnosis of PCOS, screening for adverse psychosocial effects, and treatment that reduces physical manifestations of PCOS are important. Lack of attention to these problems can force adolescents to endure adverse psychosocial effects that can lead to further unhealthy behaviors. NPs have an opportunity to educate adolescents about the disease process of PCOS and to implement strategies to treat these patients’ physical and psychosocial problems to improve their HQOL for a lifetime.

Joyce S. Lee is a certified pediatric nurse practitioner who graduated from Columbia University School of Nursing in New York, New York. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

Acknowledgment

The author thanks Rita Marie John, DNP, EdD, CPNP-PC, DCC, for her help, editing, and counsel during the preparation and writing of this article.

References
1. Rofey DL, Szigethy EM, Noll RB, et al. Cognitive–behavioral therapy for physical and emotional disturbances in adolescents with polycystic ovary syndrome: a pilot study. J Pediatr Psychol. 2009;34(2):156-163.

2. Trent ME, Rich M, Austin SB, Gordon CM. Fertility concerns and sexual behavior in adolescent girls with polycystic ovary syndrome: implications for quality of life. J Pediatr Adolesc Gynecol. 2003;16(1):33-37.

3. Bekx MT, Connor EC, Allen DB. Characteristics of adolescents presenting to a multidisciplinary clinic for polycystic ovarian syndrome. J Pediatr Adolesc Gynecol. 2010;23(1):7-10.

4. Laggari V, Diareme S, Christogiorgos S, et al. Anxiety and depression in adolescents with polycystic ovary syndrome and Mayer-Rokitansky-Küster-Hauser syndrome. J Psychosom Obstet Gynaecol. 2009;30(2):83-88.

5. Rachmiel M, Kives S, Atenafu E, Hamilton J. Primary amenorrhea as a manifestation of polycystic ovarian syndrome in adolescents: a unique subgroup? Arch Pediatr Adolesc Med. 2008;162(6):521-525.

6. Perrin JM, Gnanasekaran S, Delahaye J. Psychological aspects of chronic health conditions. Pediatr Rev. 2012;33(3):99-109.

7. Leventhal H, Leventhal EA, Contrada RJ. Self-regulation, health, and behavior: a perceptual-cognitive approach. Psychol Health. 1998; 13(4):717-733.

8. Coviello AD, Legro RS, Dunaif A. Adolescent girls with polycystic ovary syndrome have an increased risk of the metabolic syndrome associated with increasing androgen levels independent of obesity and insulin resistance. J Clin Endocrinol Metab. 2006;91(2):492-497.

9. Snyder BS. Polycystic ovary syndrome (PCOS) in the adolescent patient: recommendations for practice. Pediatr Nurs. 2004;31(5):416-422.

10. Dowdy D. Emotional needs of teens with polycystic ovary syndrome. J Pediatr Nurs. 2012;27(1):55-64.

11. Jones GL, Hall JM, Lashen HL, et al. Health-related quality of life among adolescents with polycystic ovary syndrome. J Obstet Gynecol Neonatal Nurs. 2011;40(5):577-588.

12. Trent ME, Rich M, Austin SB, Gordon CM. Quality of life in adolescent girls with polycystic ovary syndrome. Arch Pediatr Adolesc Med. 2002;156(6):556-560.

13. Harris-Glocker M, Davidson K, Kochman L, et al. Improvement in quality-of-life questionnaire measures in obese adolescent females with polycystic ovary syndrome treated with lifestyle changes and oral contraceptives, with or without metformin. Fertil Steril. 2010;93(3):1016-1019.

14. Trent M, Austin SB, Rich M, Gordon CM. Overweight status of adolescent girls with polycystic ovary syndrome: body mass index as mediator of quality of life. Ambul Pediatr. 2005;5(2):107-111.

15. Wiksten-Almstromer M, Linden-Hirschberg A, Hagenfeldt K. Menstrual disorders and associated factors among adolescent girls visiting a youth clinic. Acta Obstet Gynecol Scand. 2007;86(1):65-72.

16. Weiner CL, Primeau M, Ehrmann DA. Androgens and mood dysfunction in women: comparison of women with polycystic ovarian syndrome to healthy controls. Psychosom Med. 2004;66(3):356-362.

17. Adali E, Yildizhan R, Kurdoglu M, et al. The relationship between clinico-biochemical characteristics and psychiatric distress in young women with polycystic ovary syndrome. J Int Med Res. 2008;36(6):1188-1196.

18. Hoeger KM. Obesity and lifestyle management in polycystic ovary syndrome. Clin Obstet Gynecol. 2007;50(1):277-294.

19. Zidenberg N, Wright S. Care of the overweight adolescent including polycystic ovarian syndrome. Clin Obstet Gynecol. 2008;51(2):249-256.

20. Drosdzol A, Skrzypulec V, Plinta R. Quality of life, mental health and self-esteem in hirsute adolescent females. J Psychosom Obstet Gynaecol. 2010;31(3):168-175.

21. Bhattacharya SM, Ghosh M. Insulin resistance and adolescent girls with polycystic ovary syndrome. J Pediatr Adolesc Gynecol. 2010;23(3):158-161.

22. Steinmetz S, ed. Feminine. In: Random House Webster’s Unabridged Dictionary. 2nd ed. New York, NY: Random House, Inc; 1997:708.

23. Wiksten-Almstromer M, Linden-Hirschberg A, Hagenfeldt K. Menstrual disorders and associated factors among adolescent girls visiting a youth clinic. Acta Obstet Gynecol Scand. 2007;86(1):65-72.

24. Jasik CB, Lustig RH. Adolescent obesity and puberty: the “perfect storm.” Ann N Y Acad Sci. 2008; 1135(1):265-279.

25. Jones GL, Balen AH, Ledger WL. Health-related quality of life in PCOS and related infertility: how can we assess this? Hum Fertil. 2008;11(3):173-185.

26. Jones GL, Benes K, Clark TL, et al. The polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ): a validation. Hum Reprod. 2004;19(2):371-377.

27. Cronin L, Guyatt G, Griffith L, et al. Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS). J Clin Endocrinol Metab. 1998;83(6):1976-1987.

28. Mastorakos G, Lambrinoudaki I, Creatsas G. Polycystic ovary syndrome in adolescents: Current and future treatment options. Paediatr Drugs, 2006;8(5):311-318.

29. Nicandri KF, Hoeger K. Diagnosis and treatment of polycystic ovarian syndrome in adolescents. Curr Opin Endocrinol Diabetes Obes. 2012;19(6):497-504.

30. Yii MF, Lim CED, Luo X, et al. Polycystic ovarian syndrome in adolescence. Gynecol Endocrinol. 2009;25(10):634-639.

31. Wild RA, Carmina E, Diamanti-Kandarakis E, et al. Assessment of cardiovascular risk and prevention of cardiovascular disease in women with the polycystic ovary syndrome: a consensus statement by the Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society. J Clin Endocrinol Metab. 2010;95(5):2038-2049.

32. Eleftheriadou M, Michala L, Stefanidis K, et al. Exercise and sedentary habits among adolescents with PCOS. J Pediatr Adolesc Gynecol. 2012;21(3):172-174.

33. Nidhi R, Padmalatha V, Nagarathna R, Amritanshu R. Effect of yoga program on quality of life in adolescent polycystic ovarian syndrome: a randomized control trial. Appl Res Qual Life. 2013;8(3):373-383.

34. Williams RM, Ong KK, Dunger DB. Polycystic ovarian syndrome during puberty and adolescence. Mol Cell Endocrinol. 2013;373(1-2):61-67.

35. Salmi DJ, Zisser HC, Jovanovic L. Screening for and treatment of polycystic ovary syndrome in teenagers. Exp Biol Med. 2004;229(5):369-377.

36. Arslanian S, Warren-Ulanch J. Treatment of PCOS in adolescence. Best Pract Res Clin Endocrinol Metab. 2006;20(2):311-330.

37. Wild RA. Dyslipidemia in PCOS. Steroids. 2012;77(4):295-299.

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

By Susan Kendig, JD, MSN, WHNP-BC, FAANP

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 Continue reading »

Barriers to care for sexual assault survivors of childbearing age: An integrative review

Research indicates that only a small fraction of sexual assault survivors seek comprehensive care—including physical and mental healthcare, forensic evidence collection, victim services, and legal support—after the assault. This integrative review was conducted to identify barriers that may be keeping sexual assault survivors of childbearing age from receiving such comprehensive care.

Key words: sexual assault, barriers to care, comprehensive care

For women in the United States, one of the most likely causes of severe psychological trauma is sexual assault, defined as unwanted sexual contact in any form that occurs without a person’s consent.1,2 Survivors of a completed rape have a 32%-80% incidence of posttraumatic stress disorder (PTSD), versus a rate of 9%-15% in the general population.3-6 In addition to psychological harm, sexual assault survivors may experience physical consequences such as bodily injury, sexually transmitted infections (STIs), and pregnancy. In the immediate aftermath of a sexual assault, about half of survivors show evidence of physical trauma, up to 30% contract an STI, and 5% become pregnant.7,8 Furthermore, survivors are up to 9 times more likely than the average woman to attempt suicide.9 Despite these potential health risks, a major gap exists between reported rates of sexual assault and rates of comprehensive care seeking following the assault.

Statement of the problem

In this country, 1 of every 4-5 women is raped in college,10,11 and lifetime prevalence of rape is 1 in 6-10 women.1,12 Following sexual assault, women may have a need for comprehensive care provided at a rape crisis center or hospital emergency department (ED)—ideally by a specially trained sexual assault nurse examiner (SANE). Recommended comprehensive care following a sexual assault includes treatment of physical injuries and other sequelae, pregnancy prevention, STI screening and treatment, psychological support and care for potential PTSD, forensic evidence collection, victim services, and legal support.1,13-16

Many sexual assault survivors do not receive the comprehensive care they need. In one analysis of post-assault care seeking, only one-third of rape survivors sought assistance from one or more of the following: the legal system, the medical system, the mental healthcare system, a rape crisis center, and/or the religious communi­ty.17 Another report indicated that 4 million U.S. women have not received medical attention focused on preventing or treating the physical and emotional effects of rape.8

The study

The author conducted an integrative literature review to ascertain the barriers that may be keeping childbearing-age women from seeking comprehensive care following sexual assault. The review was focused on survivor, advocate, healthcare provider (HCP), police, and student perspectives.

Method—Five steps were used: problem identification, literature search, data evaluation, data analysis, and presentation.18 An integrative review was appropriate because of the mix of quantitative and qualitative data that were available.18,19Problem identification. The author analyzed empirical studies and national surveys completed between 1990 and 2012. The research question guiding the review was “What are the barriers that may prevent sexual assault survivors of childbearing age from receiving comprehensive care?”

Literature search. The review was conducted at a university library using the search terms sexual assault, rape, barriers to care, barriers, inhibitors, impede, comprehensive care, health care, and health care access. The search utilized a variety of databases. National surveys were identified separately by searching national websites. Only studies whose purpose was to identify barriers to care for sexual assault survivors of childbearing age were included. These studies had to be written in English in the form of scholarly works, dissertations, or qualitative or quantitative research. Excluded were papers unrelated to the research question, commentaries, literature reviews, and papers not written in English.

The initial search elicited 220 articles with the following distribution: Cochrane Database of Systematic Reviews (n = 3), CINAHL (n = 12), EMBASE (n = 101), ISI Web of Knowledge (n = 52), PubMed (n = 37), and PsycINFO (n = 15). Many of these 220 articles were duplicates, and only 11 met all inclusion criteria. By hand-searching the references of these 11 articles, the author found 1 additional article for inclusion, resulting in a total of 12 empirical articles. In addition, 4 national surveys described in 6 different reports met inclusion criteria.

Data evaluation and analysis. Data extraction for the 4 national surveys and 12 empirical studies was conducted with use of a table to identify key components. The author extracted data about the sample, study design, outcomes measured, instruments utilized, results related to the research question, validity, and notes. Results related to the research question were reviewed for common themes using a technique similar to the constant comparative method of analysis outlined by Glaser.20 This technique entailed reading through the results to glean general thoughts, followed by a line-by-line review to evaluate for general themes using a color-coding system. Further review elicited core themes. The data were reviewed again to find commonalities in themes among the studies. Finally, the data were compiled into over­arching themes related to the research question and assessed for the information they represented.

Whittemore and Knafl18 noted that the diverse array of primary sources in an integrative literature review increases the complexity in evaluating the quality of the literature. Also, in an integrative review with a diverse collection of studies, various threats to internal validity must be addressed.19,21 These threats were determined by assessing the studies’ methodology and data relevance.

Results—
National surveys. Four national surveys were reported in 6 different studies (Table 1).1,2,8,10,22,2Empirical studies. Table 2 lists the 12 empirical research studies that met inclusion criteria. As shown in Table 3, these studies used a cross-sectional methodology24-29 or a descriptive or exploratory qualitative method­ology.30-35 All of the studies’ research questions elicited the barriers that prevented sexual assault survivors of childbearing age from accessing community services such as police re­porting,24 mental healthcare,27 medical care,25 and sexual assault centers.26,29Themes. Several themes describing barriers to care emerged. These themes, subdivided into personal and environmental factors, are described in detail using the results from all 18 studies—that is, the 6 reports on national survey data and the 12 empirical studies.

PERSONAL FACTORS. The overarching theme of personal factors encompassed barriers to care inherent to a survivor herself. This broad theme included three subfactors: emotional states, fear of external exposure, and lack of knowledge.

Emotional states. Certain emotional states experienced by a woman after a sexual assault could preclude her from seeking physical, mental, or legal care. These emotional states were identified in 11 (61%) of the 18 studies.1,22,24,26-32,35 Emotional states most commonly cited as barriers were shame,24,28-31 embarrassment or humiliation,1,24,26-29,32,35 guilt,26,28,30,35 and self-blame.22,26Fear of external exposure. Fear of external exposure was described in 12 studies (67%).1,2,8,10,23,24,26,28,29,31,32,35 Fears cited by survivors included bad treatment by the criminal justice system,2,10,23 not being believed,24,28,29 lack of confidentiality,22,24,26,28,29,31,32 going to trial,24 the assailant,1,2,10,23,24,28,31,32,35 and public exposure.8,29 Fears related to the assailant involved fear of retaliation1,10,23,24,28,31,32,35 and, conversely, the possibility of jail for the assailant because the survivor had some type of relationship with the assailant.24 Fear of public exposure was often cited by members of groups such as immigrants, persons with disabilities, sexual minority members, and racial minority members.28 Many of these women feared that their minority status would bring them greater stigma and potentially unfair treatment.

Lack of knowledge. Lack of knowledge regarding post-assault services was identified as a barrier to care in 6 studies (33%).2,23,27,28,31,32 This knowledge deficit encompassed factors such as not knowing which services were needed,31,32 where or how to get services,2,23,28,31,32 and how to pay for services.27,31,32

ENVIRONMENTAL FACTORS. The broad theme of environmental factors captured barriers to care due to outside forces and not within a survivor’s immediate control. These factors were noted in 11 of the 18 studies and included themes of structural/organizational barriers and societal rape myths.

Structural or organizational barriers. Barriers to comprehensive care can include factors related to how these services are accessed. Structural/organization barriers were elicited from 6 studies (33%).25,31-35 For instance, many survivors cited a lack of availability or limited services as a barrier to receiving care.31-33,35 Organizational barriers reported by HCPs included inexperience in treating sexual assault survivors, inadequate time, and personal discomfort.27 Rape victim advocates noted insufficient funding resources as barriers that might compromise survivors’ ability to receive support.33,34Societal myths. Twelve studies (67%) noted the perpetuation of rape myths by society as a factor in preventing survivors from accessing care.1,10,23,24,25,27,29-32,34,35 Many of these myths are propagated through biases related to race, gender, disability, sexual orientation, and class.34 Subsumed within this category is survivors’ perception of the social stigma attached to naming the incident and the belief that the assault was not serious enough to warrant using services.1,10,23,27,29 Societal myths noted by persons in the service sector included police attitudes, including blame and insensitivity24,31,32 and doubt about the validity of the sexual assault accusations.35 Some HCPs perceived that survivors would return to partners who had perpetrated the assault.25Discussion—This review has shown that from survivor, advocate, HCP, police, and student perspectives, numerous barriers to care—encompassing both personal and environmental factors—may prohibit a woman of childbearing age from seeking care after a sexual assault. The overarching theme of personal factors comprised the survivor’s emotional state, her fear as it related to external exposure of the survivor and the assailant, and a lack of knowledge about post-assault services. These results coincide with past research, which has shown that many survivors, especially members of ethnic minorities, lack awareness about post-assault services such as rape crisis centers.17 The broad theme of environmental factors included subthemes of structural/organizational barriers and societal myths. Past research has shown that survivors needed to sit for extended periods of time while they waited to be seen by HCPs who did not have training on the physical or mental aspects of performing a forensic exam.36 In addition, rape myths are known to affect how a survivor deals with an assault, including acquisition of care.37,38 The themes subsumed under environmental factors are long-standing issues that must be addressed using a team approach to improve acquisition of comprehensive care by sexual assault survivors.

Limitations. This review could not completely separate the research articles that dealt with sexual assault and intimate partner violence. One person may be a survivor of both crimes within the same relationship; therefore, many researchers combine the topics. All data were collected via cross-sectional surveys or qualitative interviews and are thus correlational in nature. These data are subject to the possible weaknesses of responses affected by social desirability bias (wherein a respondent wishes to please a researcher) and complicated by the stigma of the topic itself and by problems of recall of traumatic events post-assault.

A limitation specific to the studies in this review was the potential for limited generalizability due to homogenous samples, small sample sizes, and failure to expound on study characteristics. However, the four studies that enrolled college students had fairly heterogeneous samples in terms of age and ethnicity,26,27,29 and most qualitative studies had heterogeneous samples as evidenced by demographic variables and identified themes consistently reported within their study samples.31,32,34

Because a validated and psychometrically sound barriers-to-care scale for sexual assault survivors does not exist, all of the cross-sectional studies used questionnaires specifically created for the purposes of their study. These surveys may not have captured the full range of barriers to care perceived by these survivors.

Strengths. This integrative review demonstrates many strengths within this body of literature. The barriers identified within each individual study, when compared as a group, were consistent. Furthermore, the studies sampled a wide range of individuals. This broad range of participants, coupled with the large geographic region they represent, provides strong evidence for the overall generalizability of the results. Finally, the exploratory and descriptive natures of the included studies have served the purpose of identifying which barriers to care exist for sexual assault survivors of childbearing age.

Implications for practice and research

For nurse practitioners (NPs) working on the front line with survivors of sexual assault, one way to begin to overcome barriers to care is to change the societal atmosphere that perpetuates rape myths. Underlying this atmosphere are patriarchal attitudes and a history of male dominance, both of which support the perpetuation of sexually violent behaviors.

Nurse practitioners need to identify and treat survivors of sexual assault, an all-too-common crime. NPs should consider using screening techniques to identify these survivors, which could simply involve asking about sexual trauma in childhood and adulthood. NPs must also be aware of potential psychological and physical manifestations of past sexual assault, including increased mental health complaints and somatic symptoms, in order to identify hidden survivors who may not freely disclose their history. Universal screening for sexual assault is controversial because of the paucity of research regarding the benefits of early identification and of treatment once a survivor is identified.39 However, NPs do have a responsibility to understand their patients’ histories and their healthcare needs.

In addition, NPs and other HCPs, mental HCPs, and members of the legal system need to know about structural barriers that may exist within their professional realm. One way to surmount these barriers is to promote and expand the use of SANE programs in all EDs. These programs, in which specially trained nurses address survivors’ emotional and medical needs while performing high-quality evidence collection, are a viable alternative to the traditional medical system.13

Nurse practitioners need to advise survivors of their options for pregnancy prevention, STI testing, care of physical injuries, and mental healthcare. And for survivors who have not yet sought post-assault care, NPs can place useful, easy-to-read brochures in public locations such as lavatories, homeless shelters, and community centers. NPs can get brochures and pamphlets from organizations such as the National Sexual Violence Resource Center or the Rape, Abuse & Incest National Network. Additional research is needed to determine the resources that survivors would find most valuable, as well as the easiest ways in which these resources could be provided. For instance, would survivors prefer to receive information about community resources at HCP visits, when they fill prescriptions (e.g., for contraceptives), or through other sources?

Conclusion

Educating women about available resources and recommended care after a sexual assault can help remove personal barriers to care. However, NPs must keep in mind that the community is responsible for minimizing structural barriers. Community members must work together to prevent the occurrence of sexual assault; to provide resources on care, social support, and legal advocacy for instances in which sexual assault has occurred; and to continue to speak with community allies and survivors to determine their needs.

Michelle L. Munro is a research fellow at the University of Michigan School of Nursing in Ann Arbor. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

Acknowledgment

The author thanks Dr. Julia Seng and Dr. Kimberlee Gretebeck for the comments and support they provided on this manuscript. The author also gratefully acknowledges grant support by the National Institutes of Health and National Institute of Nursing Research, 5 T32 NR007073-19.

References
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2. Wolitzky-Taylor KB, Resnick HS, McCauley JL, et al. Is reporting of rape on the rise? A comparison of women with reported versus unreported rape experiences in the National Women’s Study – replication. J Interpers Violence. 2011;26(4):807-832.

3. Breslau N, Peterson EL, Schultz LR. A second look at prior trauma and the posttraumatic stress disorder effects of subsequent trauma: a pro­spect­ive epidemiological study. Arch Gen Psychiatry. 2008;65(4):431-437.

4. Foa EB, Rothbaum BO. Treating the Trauma of Rape: Cognitive Behavioral Therapy for PTSD. New York, NY: The Guilford Press; 1998.

5. Kilpatrick DG, Saunders BE, Amick-McMullan A, et al. Victim and crime factors associated with the development of crime-related post-traumatic stress disorder. Behav Ther. 1998;20:199-214.

6. Resnick HS, Kilpatrick DG, Dansky BS, et al. Prevalence of civilian trauma and posttraumatic stress disorder in a representative national sample of women. J Consult Clin Psychol. 1993;61(6):984-991.

7. Holmes MM, Resnick HS, Kilpatrick DG, Best CL. Rape-related pregnancy: estimates and descriptive characteristics from a national sample of women. Am J Obstet Gynecol. 1996;175(2):320-325.

8. Resnick HS, Holmes MM, Kilpatrick DG, et al. Predictors of post-rape medical care in a national sample of women. Am J Prev Med. 2000;19(4):214-219.

9. Goodman LA, Koss MP, Russo NF. Violence against women: physical and mental health effects. Part I: research findings. Appl Prevent Psychol. 1993;2(2):79-89.

10. Fisher BS, Cullen FT, Turner MG. The Sexual Victimization of College Women. (No. NCJ 182369). Washington, DC: U.S. Department of Justice, Bureau of Justice Statistics; 2000.

11. Koss MP, Gidycz CA, Wisniewski N. The scope of rape: incidence and prevalence of sexual aggression and victimization in a national sample of higher education students. J Consult Clin Psychol. 1987;55(2):162-170.

12. Basile KC, Chen J, Black MC, Saltzman LE. Prevalence and characteristics of sexual violence victimization among U.S. adults, 2001-2003. Violence Vict. 2007;22(4):437-338.

13. Ahrens CE, Campbell R, Wasco SM, et al. Sexual assault nurse examiner (SANE) programs: alternative systems for service delivery for sexual assault victims. J Interpers Violence. 2000;15:921-943.

14. Campbell R, Bybee D, Ford K, Patterson D. Systems Change Analysis of SANE Programs: Identifying the Mediating Mechanisms of Criminal Justice System Impact. (No. 226497). Washington, DC: U.S. Department of Justice; 2008.

15. Campbell R, Patterson D, Lichty LF. The effectiveness of sexual assault nurse examiner (SANE) programs: a review of psychological, medical, legal, and community outcomes. Trauma Violence Abuse. 2005;6:313-329.

16. U.S. Department of Justice, Office on Violence Against Women. A National Protocol for Sexual Assault Medical Forensic Examinations: Adults/Adolescents. (NCJ 206554); 2004. http://www.ncjrs.gov/pdffiles1/ovw/206554.pdf

17. Campbell R, Wasco SM, Ahrens CE, et al. Preventing the “second rape”: Rape survivors’ experience with community service providers. J Interpers Violence. 2001;16(12):1239-1259.

18. Whittemore R, Knafl K. The integrative review: updated methodology. J Adv Nurs. 2005;52(5):546-553.

19. Cooper HM. Synthesizing Research: A Guide for Literature Reviews. 3rd ed. Thousand Oaks, CA: Sage Publications; 1998.

20. Glaser BG. Advances in the Methodology of Grounded Theory: Theoretical Sensitivity. Mill Valley, CA: Sociology Press; 1978.

21. Kirkevold M. Integrative nursing research—an important strategy to further the development of nursing science and nursing practice. J Adv Nurs. 1997;25:977-984.

22. Kilpatrick DG, Edmunds C, Seymour A. Rape in America: A Report to the Nation. Charleston, SC: National Victim Center & the Crime Victims Research and Treatment Center, Medical University of South Carolina; 1992.

23. Kilpatrick DG, Resnick HS, Ruggiero KJ, et al. Drug-Facilitated, Incapacitated, and Forcible Rape: A National Study. (Document No. 219181); 2007. https://www.ncjrs.gov/pdffiles1/nij/grants/219181.pdf

24. Jones JS, Alexander C, Wynn BN, et al. Why women don’t report sexual assault to the police: The influence of psychosocial variables and traumatic injury. J Emerg Med. 2009;36(4):417-424.

25. McGrath ME, Bettacchi A, Duffy SJ, et al. Violence against women: provider barriers to intervention in emergency departments. Acad Emerg Med. 1997;4(4):297-300.

26. Nasta A, Shah B, Brahmanandam S, et al. Sexual victimization: incidence, knowledge and resource use among a population of college women. J Pediatr Adolesc Gynecol. 2005;18(2):91-96.

27. Prospero M, Vohra-Gupta S. The use of mental health services among victims of partner violence on college campuses. J Aggression Maltreat Trauma. 2008;16(4):376-390.

28. Sable MR, Danis F, Mauzy DL, Gallagher SK. Barriers to reporting sexual assault for women and men: Perspectives of college students. J Am Coll Health. 2006;55(3):157-162.

29. Walsh W, Banyard V, Moynihan M, et al. Disclosure and service use on a college campus after an unwanted sexual experience. J Trauma Dissociation. 2010;11(2):134-151.

30. Kelleher C, McGilloway S. ‘Nobody ever chooses this …’: a qualitative study of service providers working in the sexual violence sector – key issues and challenges. Health Soc Care Community. 2009;17(3):295-303.

31. Logan TK, Evans L, Stevenson E, Jordan C. Barriers to services for rural and urban survivors of rape. J Interpers Violence. 2005;20(5):591-616.

32. Logan TK, Stevenson E, Evans L, Leukefeld C. Rural and urban wom­en’s perceptions of barriers to health, mental health, and criminal justice services: implications for victim services. Violence Vict. 2004;19(1):37-62.

33. Muganyizi PS, Nyström L, Axemo P, Emmelin M. Managing in the contemporary world: Rape victims’ and supporters’ experiences of barriers within the police and the health care system in Tanzania. J Interpers Violence. 2011;26(16):3187-3209.

34. Ullman S, Townsend S. Barriers to working with sexual assault survivors: a qualitative study of rape crisis center workers. Violence Against Women. 2007;13(4):412-443.

35. Young CL. Barriers to reporting sexual assault as identified by sexual assault service providers: a qualitative study. Unpublished Doctor of Nursing Science Dissertation. Memphis, TN: University of Tennessee Health Science Center; 2002.

36. Ledray LE. Sexual Assault Nurse Examiner Development & Operation Guide. NCJ 170609; 1999. http://www.ojp.usdoj.gov/ovc/publications/infores/sane/saneguide.pdf

37. DuMont J, Miller KL, Myhr TL. The role of “real rape” and “real victim” stereotypes in the police reporting practices of sexually assaulted women. Violence Against Women. 2003;9(4):466-486.

38. McGee H, O’Higgins M. Garavan R, Conroy R. Rape and child sexual abuse: what beliefs persist about motives, perpetrators, and survivors? J Interpers Violence. 2011;26(17):3580-3593.

39. Basile KC, Smith SG. Sexual violence victimization of women: prevalence, characteristics, and the role of public health prevention. Am J Lifestyle Med. 2011;5:407-417.

A disease you just caught: Low-income African American mothers’ cultural beliefs about postpartum depression

By McClain Sampson, PhD, MSSW; Jacquelynn F. Duron, LCSW, PhD; Melissa Irene Maldonado Torres, MSW; and Michele R. Davidson, PhD, CNM, CFN, RN, CPS

Postpartum depression (PPD), the most common complication of childbirth, can have many adverse effects on a mother and an infant and interfere with family functioning. Continue reading »

Editor-in-chief’s message

Dear Colleagues,

What a great first year for Women’s Healthcare: A Clinical Journal for NPs! Gay Johnson, our NPWH CEO, established the journal to provide you, our readers, with comprehensive, timely, useful information to empower you to set a new standard for women’s healthcare. Continue reading »

Motivational interviewing and adherence to osteoporosis regimens

Osteoporosis is associated with increased morbidity, mortality, and healthcare costs—billions of dollars annually. Although many types of pharmacotherapy are available to prevent or treat the disease, many patients, for various reasons, do not adhere to their prevention or treatment regimen. In this article the authors show how motivational interviewing, initially created for patients with substance abuse problems, can be used to help patients with osteoporosis overcome their ambivalence toward positive behavior change and better adhere to their prevention or treatment plan.

Key words: osteoporosis, adherence, motivational interviewing, osteoporosis management, osteoporosis drug regimen

Osteoporosis is a chronic metabolic disease of the skeletal system wherein bone resorption exceeds bone formation, leading to low bone mass, marked skeletal fragility, and an increased risk for fracture.1,2 In postmenopausal wo­men, bone loss is related to the effects of aging and the low estrogen state, but it can be exacerbated by immobilization, use of medications such as corticosteroids or gonadotropin-releasing hormones, overexposure to alcohol or tobacco, or nutritional deficiencies related to diet or caused by various malabsorption syndromes.3

In 2010, 10 million persons in the United States and 75 million persons in the Americas, Europe, and Japan were estimated to have osteoporosis.4 Worldwide, the presence of osteoporosis contributes to 9 million fractures annually.4 Osteoporosis-related fractures, particularly those of the hip, are associated with major increases in morbidity, mortality, and healthcare costs.2,5 Risk for such a fracture rises dramatically in women aged 70 years or older.5

Sequelae of hip fracture include declines in physical, mental, and functional health. In many cases, a hip fracture signals the downward spiral of an otherwise healthy and independent elder. In fact, fractures are considered life-threatening events in the elderly.5 In the U.S., osteoporosis-related fractures lead to approximately 4 million days of hospitalization and more than 3 million outpatient and emergency department visits per year.6 About one-half of women who develop a hip fracture rely on others for help with daily activities, one-fifth need long-term care, and one-fifth die within a year.1 The economic burden of osteoporosis in the U.S. is $13-$17 billion a year,1,4,6,7 a figure that is expected to rise to $25 billion by 2025.4,7

Osteoporosis management approaches

Although these statistics provide a grim outlook on the future of osteoporosis, recent scientific advances in the management of patients with osteoporosis may be able to prevent fractures. A wide array of pharmacologic and nonpharmacologic options is already available.6

Pharmacologic interventions work either by accelerating bone regeneration or decreasing bone resorption, resulting in a decreased risk for fracture.1,2 Teriparatide (parathyroid hormone) is the only agent that increases bone mineral density (BMD) anabolically by enhancing bone formation via the osteoblasts. Other osteoporosis medications decrease bone resorption; these antiresorptive agents include the bisphosphonates, the selective estrogen receptor modulators, and denosumab, a monoclonal antibody that limits activation of nuclear factor kappa B ligands, a component of osteoclasts that is important to their formation, function, and survival.4,5 Calcitonin, another antiresorptive agent, is mildly effective in improving BMD of the spine.4

In addition to drug therapy, patients with osteoporosis need to ingest adequate amounts of calcium and vitamin D. Obtaining the recommended 1200-1500 mg of elemental calcium and 1000 IU of vitamin D is difficult for persons following a typical Western diet, so calcium and vitamin D supplementation is often required.3

An important nonpharmacologic intervention for patients with osteoporosis is exercise. Exercise improves muscle efficiency, flexibility, and balance, which results in a decreased risk for falls and, ultimately a decreased risk for fall-related fractures.8 In a randomized controlled trial (RCT), researchers tested the effects of a 44-week exercise program on bone mass, bone quality, and functional capacity in subjects with low BMD.8 The exercise program included a combination of land (weight-bearing) and water (non–weight-bearing) exercises aimed at improving muscle strength, endurance, balance, and joint mobility. Pre- and post-treatment testing showed that bone quality and BMD in the intervention group remained the same and functional capacity improved. Results for the controls, who did not participate in the exercise program, showed a significant decline in bone quality and a decrease in physical function capacity. A meta-analysis of four RCTs on the effects of exercise in postmenopausal women with osteoporosis or osteopenia showed improvements in quality of life, physical function, vitality, and pain.9

Both pharmacologic and nonpharmacologic treatments for osteoporosis have been shown to be effective in reducing bone loss and fracture risk. However, efficacy can be realized only if patients adhere to their management regimen.9 Based on reports in the literature, only about 60% of patients with osteoporosis adhere to their drug regimens.1,2,7 To improve this low rate, nurse practitioners (NPs) first need to understand the reasons for lack of adherence in osteoporosis management.

Adherence in osteoporosis management

Adherence involves a combination of compliance and persistence.2 Compliance refers to the use of medications or other treatments exactly as instructed by a healthcare provider (HCP).1,2,10 With regard to medications, this process includes taking the proper dose at the prescribed frequency and time of day and following specific instructions (eg, taking the medication with food).2 Persistence is defined as following a treatment regimen for as long as it is prescribed.1,2,10 Nonadherence is the failure to comply with precise instructions and/or the premature discontinuation of treatment.

A review of the literature shows various reasons for nonadherence to osteoporosis regimens. A main reason is that osteoporosis is asymptomatic until a fracture occurs; patients are less likely to adhere to a regimen that prevents something from occurring than to a regimen that relieves acute symptoms. In addition, a belief that one’s illness is not serious or life-threatening may result in poor adherence.1,6 Other reasons cited for low adherence among patients with osteoporosis include complexity of the regimen, high frequency of dosing, high cost of medications, adverse side effects, poor understanding about osteoporosis and its chronic nature, and a poor patient–HCP relationship.1,2,6,7,11-13

Nonadherence to osteoporosis regimens results in a significant increase in fracture risk.13 By contrast, even a slight improvement in adherence may result in reduced fracture rates, hospitalization, and general costs of care and lost productivity.1,2,12 In light of the forecast on the personal and financial implications of osteoporosis-related fractures, HCPs must develop strategies that increase adherence to osteoporosis regimens.1,7

Interventions to improve adherence

A post hoc analysis of the results of an RCT was done to ascertain whether patient adherence to osteoporosis regimens would be improved with the use of educational interventions.12 Patients were randomized to an intervention group, who received physician-directed education and additional information about osteoporosis, or a control group, who received usual care without the additional education. Results showed that the additional education on osteoporosis did not improve adherence in the intervention group versus the control group.

A systematic literature review of seven studies focused on various interventions to improve adherence to osteoporosis regimens.7 In two of the studies, the intervention was to provide feedback to subjects regarding their bone turnover markers in response to treatment. Participants in the other five studies received educational material either in person or by brochures, letters, or telephone calls. In the seven studies, the intervention resulting in the greatest improvement in patient adherence was a patient-centered telephonic counseling style used in a nonrandomized investigation by Cook et al.6 This counseling style is similar to motivational interviewing (MI), a technique that facilitates patient self-motivation for treatment and equips patients with information and insight to overcome their own barriers to adherence so that they may improve their ability to manage their condition. Results of the study by Cook et al6 showed that participants who received the intervention had better adherence rates than did those who did not participate. These results suggest the need for further investigation; a blinded RCT is now testing the use of MI to improve adherence to osteoporosis regimens.13

Motivational interviewing

Background—MI was initially developed in the 1980s to help patients reduce substance abuse behaviors (click here for more information).14,15 This patient-centered method of communication aims to evoke one’s own intrinsic motivation for behavior change.16 The philosophy behind the use of MI is that behavior change is complex, and that simply advising patients or prescribing orders to make a change results in temporary change or no change at all.14 Instead, patients are recognized as having the answers they seek and as being experts about their own being.17,18 What impedes motivation, a necessary ingredient for behavior change, is unrecognized ambivalence.17,19 The role of the HCP is to facilitate identification and resolution of this ambivalence,14,16-19 which oftentimes leads to the desired behavior change.

Since its inception, MI has become increasingly used to modify behavior in healthcare domains such as intimate partner violence, smoking cessation during pregnancy, and dialysis adherence in chronic kidney disease.6,18,20,21 MI has a strong theoretical foundation.19 In a review of four meta-analyses on MI, Lundahl and Burke19 concluded that this technique builds on cognitive dissonance theory and self-perception theory to reduce ambivalence and increase motivation needed for change. The patient-centered focus of MI, evident in its therapeutic approach of reflective listening and empathy, is said to be derived from Carl Rogers’ patient-centered therapy.17 MI has been hailed as the clinical application of self-determination theory,18 which states that individuals are innately motivated to improve their own condition and that they are much more likely to adhere to a proposed behavior change if they believe that change is necessary and has personal significance.15 In addition, the self-determination theory suggests that autonomy is ingrained, and that individuals tend to succeed at change when the motivation to do so is of their own volition, as opposed to being influenced from elsewhere.18Learning the MI technique—Successful use of MI in clinical practice requires a certain level of training, but HCPs need not have a background in psychology or counseling.14,22 In a review of meta-analyses on the clinical applicability of MI, Lundahl and Burke19 concluded that the credentials and specific profession of the practitioner had no noteworthy impact on MI outcomes.

Training for MI includes practical exercises in a format wherein MI responses can be checked and modified if needed.22 In a pilot study, researchers aimed to teach a brief version of MI (brief MI) to third-year medical students.23 The researchers first developed a curriculum called CHANGE, a mnemonic that captures the essentials of brief MI: Check patients’ perspective regarding their health and health behaviors; Hear what patients say by using reflective listening skills; Avoid behaviors that are not in alignment with MI; Note patients’ priorities with regard to behavior change; Give feedback to patients only when requested or after permission has been granted; and End the interview by summarizing patients’ own plan for behavior change and healthcare follow-up. These researchers taught six instructors in two 4-hour sessions how to teach CHANGE. The instructors then taught CHANGE to the medical students during one 2-hour session. During the teaching session, students had an opportunity to practice brief MI skills and receive immediate feedback from the instructors, who had been “acting” as patients. In a posttest given right after the training, students showed an increase in their use of brief MI skills, a positive change that held true at a 4-week follow-up.23Applying MI to clinical practice—Practitioners of MI must embrace four key principles and acquire certain therapeutic skills. If properly applied, these principles and skills can help achieve the goal of MI, which is the identification and eradication of patients’ ambivalence toward the desired change.15

Key principles. The first principle of MI is to express empathy for patients’ challenges. In doing so, HCPs show respect for and a nonjudgmental attitude toward patients’ concerns, which fosters a collaborative relationship.15,24 Patients and HCPs work together as equal partners, with HCPs giving direction and support14 while patients supply expertise on their own being.17

The second principle is to develop a discrepancy between patients’ behavior and their personal goals.15,24 To develop this discrepancy, patients are encouraged to outline their own reasons for behavior change. Once this change talk develops, inconsistencies between patients’ current behavior and their stated goal can be identified. It is crucial that patients speak of the inconsistencies; HCPs merely guide them toward recognizing the difference between current action and desire.23 The greater and more obvious the discrepancy, the stronger the motivation to initiate a change.14,15

The third principle is to roll with resistance.24 Patients’ expressions of resistance, whether overt or covert, are indications of ambivalence about change.15 If their ambivalence is ignored or undermined, and HCPs push harder toward change, patients will defend themselves and resist.14 Instead, HCPs must remain nonjudgmental and gently suggest new perspectives for patients to ponder,15,24 which avoids conflict and keeps the lines of communication open.15

The final principle is to support self-efficacy. To achieve this goal, HCPs express belief in patients and their ability to plan and execute change.24 HCPs’ encouragement and positive reinforcement are ongoing. Continued support for self-efficacy empowers patients to believe that they are in control of their own behavior change.15Basic therapeutic skills. To carry out the key principles of MI, certain basic therapeutic skills are utilized.24 An important skill is avoidance of the righting reflex.15 Although HCPs may have certain goals for their patients, accompanied by a powerful drive to see these goals come to fruition,22 they must resist their natural knee-jerk reaction to right or fix things.14,15,22 Instead, they should encourage patients to search within themselves for their own ideas on how to create a change.15

Another important skill to hone is reflective listening,15 which entails summarizing patients’ statements in order to allow patients to correct any misunderstanding. This process enhances understanding between the two parties. In addition, HCPs can selectively reflect on patients’ own statements in favor of change, which encourages further discussion and elicits further change talk by patients.24

Another important therapeutic skill required in MI is asking open-ended questions.15,24 This type of questioning allows patients to do most of the talking while HCPs listen. This practice is especially important in the early stages of communication.24 Responses from open-ended questions can shed light on patients’ goals and values and guide HCPs regarding where to take the conversation next.17,24

The ask-provide-ask approach is yet another useful MI skill. Using this technique, HCPs ask patients to explain what they already know about their behavior or condition. If HCPs deem that additional information is needed, they ask patients for permission to present the information (providing unwanted information can build resistance).14,15 The information is prefaced with permission for patients to disregard it, and is provided in a neutral manner.14 Following the provision of information, patients are given an opportunity to discuss their interpretation of it.14,15

The final therapeutic skill, affirming and summarizing, is used throughout the MI process. Affirmations allow for acknowledgment and compliments for any success, recognition of difficulties, and support and encouragement for positive change. Summaries are used to reiterate statements made by patients during the interview, including those made regarding desire for change and HCPs’ support for fostering this change.14,24

Use of MI precludes HCPs from expressing their own ideas regarding desirable outcomes for patients. This approach does not equate to a lack of care on HCPs’ part, but, rather, represents a realization that within patients is the intrinsic motivation to change their lives.17 Three distinct styles of communication are evident in MI: (1) guiding rather than badgering, (2) encouraging rather than shaming, and (3) negotiating rather than dictating. According to MI’s founding fathers, “it is within the spirit of motivational interviewing that these three styles of communication come together.”22 With adequate MI training and inclusion of key principles and therapeutic skills, HCPs can help patients achieve positive behavior change.

Implications for NPs

With the aging of the U.S. population, the incidence of osteoporosis will increase rapidly in the coming years. Many of these patients will be seen by NPs in primary care and women’s health practices. Ample effective medications are available, along with well-studied exercise regimens. Use of a combination of pharmacologic and nonpharmacologic interventions can help re­duce the risk for osteoporosis-related falls and fractures. However, adherence rates among patients with osteoporosis are historically low. MI has been shown to be effective in helping patients implement favorable behavioral changes, including improved adherence to osteoporosis regimens. The versatility and nearly universal applicability of MI makes this technique fairly easy for NPs to learn and implement in practice, which may significantly alter the course of osteoporosis and osteoporotic fractures in this country.

Conclusion

The foundations of MI are deeply rooted in sound evidence-based theories such as cognitive dissonance theory, self-perception theory, and self-determination theory. This decade-old, patient-centered therapeutic style of communication has been assisting patients in overcoming their ambivalence toward behavior change. MI is not a clever set of tricks used to manipulate patients but, rather, a respectful appreciation of the fact that patients have tools within themselves to create their own change. HCPs’ only objective is to evoke change talk from patients, which then creates a discrepancy between current and desired actions. Finally, gentle guidance toward recognition of the discrepancy heightens patients’ own innate motivation for the sought-after change.

Racquel S. Maccagno is a nurse practitioner at the MinuteClinic in Tampa, Florida. Cathy R. Kessenich is a professor of nursing at the University of Tampa in Tampa, Florida. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

Note to readers: An older version of this article was published in the January/February 2013 issue of AJNP Online.

References

1. Papaioannou A, Kennedy CC, Dolovich L, et al. Patient adherence to osteoporosis medications: problems, consequences, and management strategies. Drugs Aging. 2007;24(1):37-55.

2. Badamgarav E, Fitzpatrick LA. A new look at osteoporosis outcomes: the influence of treatment, compliance, persistence, and adherence. Mayo Clin Proc. 2006;81(8):1009-1012.

3. Binkley N, Krueger D. Current osteoporosis prevention and management. Topics Geriatr Rehabil. 2005; 21(1):17-29.

4. McBane S. Osteoporosis: a review of current recommendations and emerging treatment options. Formulary. 2011;46:432-446.

5. Reginster JY. Antifracture efficacy of currently available therapies for postmenopausal osteoporosis. Drugs. 2011;71(1):65-78.

6. Cook PF, Emiliozzi S, McCabe MM. Telephone counseling to improve osteoporosis treatment adherence: an effectiveness study in community practice settings. Am J Med Qual. 2007;22(6):445-456.

7. Gleeson T, Iversen MD, Avorn J, et al. Interventions to improve adherence and persistence with osteoporosis medications: a systematic literature review. Osteoporosis Int. 2009;20(12):2127-2134.

8. Tolomio S, Ermolao A, Alberto L, Marco Z. The effect of a multicomponent dual-modality exercise program targeting osteoporosis on bone health status and physical function capacity of postmenopausal women. J Women Aging. 2010;22(4):241-254.

9. Wei-Chun L, Yi-Chan C, Rong-Sen Y, Jau-Yih T. Effects of exercise programmes on quality of life in osteoporotic and osteopenic postmenopausal women: a systematic review and meta-analysis. Clin Rehabil. 2009;28:888-896.

10. Hiligsmann M, Gathon HJ, Bru­yère O, et al. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010;13(4):394-401.

11. Sanfelix-Genovés J, Gil-Guillén VF, Orozco-Beltran D, et al. Determining factors for osteoporosis patients’ reported therapeutic adherence to calcium and/or vitamin D supplements: a cross-sectional, observational study of postmenopausal women. Drugs Aging. 2009;26(10):861-869.

12. Shu AD, Stedman MR, Polinski JM, et al. Adherence to osteoporosis medications after patient and physician brief education: post hoc analysis of a randomized controlled trial. Am J Manag Care. 2009;15(7):417-424.

13. Solomon DH, Gleeson T, Iversen M, et al. A blinded randomized controlled trial of motivational interviewing to improve adherence osteoporosis medication: design of the OPTIMA trial. Osteoporosis Int. 2010;21(1):137-144.

14. Shannon R, Hillsdon M. Motivational interviewing and musculoskeletal care. Musculoskeletal Care. 2007; 5(4):206-215.

15. McCarley P. Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. Nephrol Nurs J. 2009;36(4):409-413.

16. Apodaca TR, Longbaugh R. Mechanisms of change in motivational interviewing: a review and preliminary evaluation of the evidence. Addiction. 2009;104(5):705-715.

17. Croston M. Motivational interviewing: an overview. HIV Nurs. Autumn 2010;15-18.

18. Neighbors C, Walker DD, Roffman RA, et al. Self-determination theory and motivational interviewing: complementary models to elicit voluntary engagement by partner-abusive men. Am J Fam Ther. 2008;36(2):126-136.

19. Lundahl B, Burke BL. The effectiveness and applicability of motivational interviewing: a practice-friendly review of four meta-analyses. J Clin Psychol. 2009;65(11):1232-1245.

20. Karatay G, Kublay G, Emiroglu ON. Effect of motivational interviewing on smoking cessation and pregnant wo­m­en. J Adv Nurs. 2010;66(6):1328-1337.

21. Russell CL, Cronk NJ, Herron M. Motivational interviewing and dialysis adherence study (MIDAS). Nephrol Nurs J. 2011;38(3):229-236.

22. Wilson H. Implementing motivational interviewing in practice: issues and challenges. HIV Nurs. Autumn 2010;19-21.

23. Martino S, Haeseler F, Belitsky R, et al. Teaching brief motivational interviewing to year three medical students. Med Educ. 2007;41(2):160-167.

24. Levensky ER, Forcehimes A, O’Donohue WT, Beitz K. Motivational interviewing: anevidence-based approach to counseling helps patients follow treatment recommendations. Am J Nurs. 2007;107(10):50-58.

Women’s health: More than an annual event

By Susan Kendig, JD, MSN, WHNP-BC, FAANP

As I write this column in mid-May, we are a 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. Continue reading »

Treating women with osteoporosis: Review and NPWH survey results

The author reviews osteoporosis, including basic facts about the disease, risk factors, prevention, diagnosis, and treatment. In addition, the author presents findings of a National Association of Nurse Practitioners in Women’s Health (NPWH) survey* in which 361 nurse practitioners answered questions about different aspects of caring for their patients with osteoporosis, particularly with regard to treatment options and their benefits and risks.

*This survey was conducted with funding from Mission Pharmacal.

In the United States, 40-52 million adults have either osteoporosis or the low bone mass (LBM) that puts them at increased risk for developing osteoporosis.1,2 Among the 10 million U.S. adults with osteoporosis, about 8 million (80%) are wom­en.3 Data from the 2005-2008 National Health and Nutrition Examination Survey showed that 16% of wom­en aged 50 or older have osteoporosis, and that an additional 61% have LBM at the femur neck or lumbar spine.4 According to the National Osteoporosis Foundation (NOF), osteoporosis is responsible for 2 million broken bones and $19 billion in related costs each year.2 The NOF predicts that the number of osteoporosis-related fractures will rise to about 3 million by 2025, at an annual cost of more than $25 billion.2

Nurse practitioners who care for women are key to helping change the course of osteoporosis-related fractures in the future. By gaining up-to-date knowledge about osteoporosis and its prevention and treatment, NPs can teach patients at risk for LBM and osteoporosis how to protect their bones. And if either LBM or osteoporosis is identified in any of their patients, NPs can implement optimal treatment to prevent further bone loss and avert fractures. This article not only covers the basics about osteoporosis, but it also provides the results of NPWH’s survey of NPs who are already treating women with osteoporosis. The aims of the survey were to…
• Gain additional insight into how NPs treat osteoporosis in their practice;
• Identify NPs’ educational needs with regard to treatment of patients with osteoporosis; and
• Gather feedback that can be used to design or improve the education provided by NPWH about the care of patients with osteoporosis.

Bone and osteoporosis—the basics

Bone consists primarily of collagen, a tough, elastic protein that forms its framework, and calcium phosphate deposits, which harden and strengthen that framework. As a dynamic tissue, bone is constantly being remodeled; new bone is continuously being formed by osteoblasts and old bone is removed by osteoclasts.5 Most people attain their peak bone mass at about age 30, after which the resorption of existing bone slowly begins to exceed the formation of new bone, leading to a decrease in bone mass.1

Osteoporosis literally means porous bone, which describes the LBM and deterioration that characterize this disease.1 Risk for osteoporosis and its related fractures becomes much higher in women at about age 50, when the level of estrogen, which protects against excessive bone loss, declines and bone loss accelerates.3 Osteoporosis is frequently undetected until one or more vertebrae collapse or a fragility fracture occurs.5

Risk factors

Nonmodifiable risk factors for osteoporosis include female gender, increasing age, and having a small, thin-boned body type.1 Caucasian and Asian women are at higher risk than African American and Hispanic women, although the risk is substantial for all women. Heredity may partially account for an increased risk of LBM and a tendency for fractures.

Modifiable risk factors for osteoporosis include having a treatable condition that raises osteoporosis risk, including amenorrhea in younger women, hypoestrogenemia in older women, anorexia nervosa, and a long history of low calcium and vitamin D intake. Long-term use of glucocorticoids or certain anticonvulsants leads to a loss of bone mineral density (BMD). Other risk factors for osteoporosis that can be altered include physical inactivity, extended bed rest, smoking, and excessive alcohol intake.1

Prevention

Preventive measures against osteoporosis must be taken across a lifetime. Women need to build optimal peak bone mass by getting enough calcium and vitamin D and exercising when they are young, while avoiding cigarette smoking and excessive alcohol consumption. NPs need to be aware of medications that can decrease BMD and contribute to increased fracture risk.1 These medications include
• Glucocorticoids: used to treat arthritis, asthma, Crohn’s disease, lupus, and other diseases of the lungs, kidneys, and liver;
• Antiseizure drugs, such as phenytoin and barbiturates;
• Gonadotropin-releasing hormone agents used to treat
endometriosis;
• Excessive use of aluminum-containing antacids;
• Certain cancer treatments; and
• Excessive thyroid hormone treatment.

Following a healthful diet and performing regular exercise remain important even after LBM or osteoporosis has developed. NPs need to assess patients’ daily intake of calcium and vitamin D.6 NPs should recommend that women older than 50 receive calcium 1,200 mg/day and vitamin D 800-1,000 IU/day from food, and supplement their diet only as needed to make up for any shortfall. Every precaution must be taken to keep living and working areas safe so as to prevent falls, a major cause of fractures.1

Diagnosis

Several factors in a woman’s health history are key in terms of ultimately identifying LBM and osteoporosis. In addition to basic information such as age and menopausal status, NPs should check for a personal history of broken bones during adulthood, a family history of osteoporosis and fractures, an adequate intake of calcium and vitamin D, regular exercise and physical activity, smoking and/or drinking alcohol, a history of eating disorders or irregular periods, and any health conditions and/or medications that might affect bone mass. Regular thorough physical examinations can document any height loss and identify spinal changes.7

If osteoporosis is suspected, NPs can order a central dual-energy x-ray absorptiometry (DXA) scan to measure a patient’s BMD. Diagnosis of osteoporosis is made if a woman aged 50 or older has a T-score less than or equal to –2.5 or if a woman has a history of fragility fractures—regardless of BMD. The T-score represents a way of comparing a patient’s BMD with that of a normal reference person aged 30. Low bone mass is defined as a T-score between –1.0 and –2.5; BMD is considered normal if it is –1.0 or higher. In premenopausal wom­en and younger men, a Z-score is used to evaluate BMD; this score compares the person’s BMD to a reference matched for age. Either score is given as a standard deviation from the BMD used as the norm.6 Medicare covers the cost of a DXA scan every 2 years, or more often if deemed necessary.8

A tool to aid practitioners in developing a treatment plan is the World Health Organization fracture risk assessment, or FRAX®, which helps estimate 10-year fracture risk.9 The tool uses an established set of clinical risk factors to compute 10-year fracture risk. FRAX can be used with or without BMD scores. In the U.S., FRAX is especially helpful when determining the best treatment plan for women with LBM but not established osteoporosis. Treatment should be considered for women with low BMD and a 10-year risk of hip fracture of at least 3%, as assessed by FRAX, or a 10-year risk of a major osteoporosis-related fracture of at least 20%, as assessed by FRAX.10

Treatment

Medications prescribed for prevention and/or treatment of osteoporosis include bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, parathyroid hormone (PTH), estrogen, other types of hormone therapy, and an osteoclast or RANK ligand (RANKL) inhibitor.1 Some bisphosphonates, the RANKL inhibitor denosumab, and teriparatide, the PTH agent, have indications for both women and men, whereas calcitonin, estrogen and other hormone therapies, SERMs, and certain bisphosphonates are approved only for use in women.11 Bisphosphonates are the most common type of anti-osteoporosis medication currently being prescribed.6

Because many of the NPWH survey questions dealt specifically with bisphosphonate therapy, the remaining discussion of medications focuses on this class. Bisphosphonates have a great affinity for bone mineral, which helps increase BMD. These agents also inhibit osteoclast activity, thereby slowing bone turnover.12 Bisphosphonates have proven efficacy in reducing the risk of fractures of the spine, hip, and other nonvertebral sites. In addition, use of these agents has been associated with a significant reduction in morbidity and an increase in survival.13

Bisphosphonate products with an FDA indication include alendronate (Fosamax®, Binosto®),14,15 risedronate (Actonel®, Atelvia®),16,17 ibandronate (Boniva®),18,19 and zoledronic acid (Reclast®).20 Alendronate, ibandronate, zoledronic acid, and risedronate as Actonel® are approved for both prevention and treatment of osteoporosis14-16,18-20; delayed-release risedronate (Atelvia®) is approved only for treatment.17 Ibandronate and delayed-release risedronate have indications for women only17-19; alendronate, risedronate in Actonel®, and zoledronic acid are approved for both women and men.14-16,20 Both formulations of alendronate are taken orally on a weekly basis.14,15 Risedronate is an oral agent that can be taken weekly, monthly, or on 2 consecutive days each month; dosing differs by product.16,17 Ibandronate is taken orally on a monthly basis or given intra­ve­nous­ly (IV) every 3 months.18,19 Zoledronic acid is given IV once a year.20

Oral bisphosphonates are poorly absorbed and, when taken with food, form complexes that cannot be absorbed. Because of this problem, oral bisphosphonates usually must be taken on an empty stomach with plain water,21 followed by a 30- to 60-minute delay before ingestion of any food or beverage.14-16,18 Because of this inconvenient routine, some patients eat and/or drink too soon, thereby negating some or all of the medication effect, or they abandon treatment altogether. Use of IV bisphosphonates can be associated with short-term flu-like symptoms, which occur more often with zoledronic acid than with ibandronate.22

Two newer bisphosphonate products were developed to avoid or minimize the original problems associated with oral dosing. For patients who do not want to wait to eat or drink, delayed-release risedronate (Atelvia),17 which also contains a calcium chelator,21 is taken immediately after breakfast. For patients who do not want to swallow a pill, an alendronate sodium effervescent tablet (Binosto) has been developed15; the tablet is dropped into a small glass of water to create a strawberry-flavored oral solution.

Rare adverse effects of the bisphosphonates

Over the past several years, a growing body of research has identified an increased risk for atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ) in bisphosphonate users. It is important for NPs prescribing these medications—or hesitating to do so because of the headlines—to know the facts.

Atypical femoral fracture—Most fractures of the femoral shaft are caused by a major trauma. However, a 2005 report initially raised concern about unusual fractures associated with bisphosphonate use.23 A task force of the American Society for Bone and Mineral research established a list of major features that must be present to classify a femoral fracture as atypical:
• Location anywhere along the femur from just distal to the lesser trochanter to just proximal to the supracondylar flare;
• Association with no or minimal trauma (e.g., a fall from a standing height or less);
• Transverse or short oblique configuration;
• Noncomminuted (not crushed or broken into small pieces); and
• Complete fractures that extend through both cortices and that may be associated with a medial spike; incomplete fractures that involve only the lateral cortex.24

Minor features that are not required for this diagnosis but are sometimes present include bilateral fractures and symptoms, delayed healing, co-morbid conditions (e.g., vitamin D deficiency, rheumatoid arthritis, hypophosphatasia), and use of agents such as bisphosphonates, glucocorticoids, and proton-pump inhibitors, among others.24

Data from a population-based nationwide analysis in Sweden found that the age-adjusted relative risk for AFF in bisphosphonate users was 47.3 and the multivariable-adjusted odds ratio was 33.3.25 However, absolute risk was increased by only 5 cases/10,000 patient-years. A 12-year study showed that although AFF incidence was low, it increased with longer bisphosphonate use.26 A systematic review from the Research on Adverse Drug Events And Reports (RADAR) Project showed that up to 26% of the published cases of AFF in bisphosphonate users had delayed healing or did not heal.27

As a rule, bisphosphonate therapy is considered safe when used for the length of time in the original trials—less than 5 years. Risk for AFFs is increased in patients who have used bisphosphonates for more than 5 years.28 A systematic review of clinical studies of bisphosphonate use in postmenopausal women with osteoporosis found persistent anti-fracture efficacy and increases in BMD beyond 3 years of treatment.29 Some studies in the review showed continuing fracture benefits when patients who had used alendronate or zoledronic acid for 3-5 years discontinued treatment for 3-5 years.

Bisphosphonates are incorporated into bone, allowing them to exert an effect for a time after treatment is discontinued.13 Although there is no formal recommendation for patients at low risk of fracture to take a drug holiday from bisphosphonate therapy, some clinicians think that treatment suspension is appropriate after 5 years.30 However, the benefits of continuing therapy probably outweigh any risk of harm in patients at high risk for fracture—that is, in those with BMD indicating osteoporosis or in those who have sustained a previous fragility fracture.13 Once a patient has been identified as having an AFF, bisphosphonate therapy should be discontinued. Initiating teriparatide therapy may help enhance healing of the fractures.28Osteonecrosis of the jaw—Bisphosphonate-related ONJ occurs when the jaw bone is exposed and begins to die because of a lack of a blood supply.31 One proposed mechanism has to do with the antiangiogenic effect of bisphosphonates. These agents may limit the angiogenesis that is vital to the development of blood vessels in bone, which has a high turnover rate.32 Prevalence of bisphosphonate-related ONJ is between 1/1000 and 1/100,000 for each year of exposure.31 Risk may depend on the bisphosphonate dose, the length of time it has been taken, and the condition for which it has been prescribed. For example, patients with cancer who take IV bisphosphonates are at higher risk for this adverse effect than are patients with osteoporosis taking oral bisphosphonates.31

NPWH survey results

In 2013, NPWH surveyed 411 NPs about different aspects of caring for their patients with osteoporosis. These NPs were located in many different areas of the country, including Western (23.8%), Northeastern (21.9%), Great Lakes (20.0%), Southeastern (16.3%), South Central (14.6%), and North Atlantic (3.4%) regions. Among NPs surveyed, almost two-thirds (63.6%) reported working in an obstetrics/gynecology practice. The group had a great deal of experience; 31.9% had been in practice 11-20 years and 26.8% had been in practice more than 20 years. A total of 361 NPs (87.8%) who replied that they treat patients with osteoporosis completed the survey.

Of these 361 survey respondents, 75.6% first counseled their patients about osteoporosis risk as a routine part of well-woman visits, and 18.0% first addressed this risk when a woman became perimenopausal. Of the 361 NPs, more than three-fourths (75.9%) used a BMD test to make the diagnosis of osteoporosis and 23.5% treated patients who had been diagnosed by another healthcare practitioner. In addition to prescribing medication to reduce their patients’ fracture risk, the NPs recommended adequate calcium and vitamin D intake (97.2%), regular weight-bearing exercise (95.3%), cessation of tobacco use (84.2%), and avoidance of excessive alcohol intake (70.9%). The vast majority of the respondents (90.3%) stated that they wanted to receive more education about the diagnosis and treatment of this disease.

As reflected in the literature, most of these NPs (84.8%) prescribed a bisphosphonate as first-line treatment for osteoporosis. The group was almost evenly split between those who felt oral bisphosphonates were of great value as a treatment option (50.4%) and those who felt these agents were of moderate value (47.9%). Although 53.7% of the NPs have maintained their previous level of prescribing bisphosphonates in the past 2 years, 28.3% had decreased their level. Common concerns about prescribing oral bisphosphonates included patient noncompliance (33.8%), gastrointestinal (GI) problems (28.0%), rare side effects such as ONJ (14.4%), and patients’ failure to fill their prescriptions (10.5%). Only 4.7% of the NPs had no concerns about prescribing these agents. About half of the survey group (51.0%) planned to keep patients on bisphosphonate therapy for 3-5 years; 32.4% of the group were not sure.

The NPs were asked to compare different aspects of alendronate, ibandronate, and rised­ronate. Most respondents (73.1%) thought that all three agents had equal efficacy, whereas 18.6% favored alendronate, 6.1% chose risedronate, and 2.2% selected ibandronate as being more efficacious. When asked to compare the agents with respect to the incidence of GI side effects, 76.7% thought that the agents did not differ in this regard and 11.4%, 9.1%, and 2.8% of the group identified alendronate, rised­ronate, and ibandronate, respectively, as having the lowest incidence of GI side effects. Most respondents (80.6%) thought that branded and generic bisphosphonates did not differ in tolerability, whereas 19.4% favored branded products.

The NPs reported several common patient complaints about oral bisphosphonate therapy. The main problems were having to take the pill in the morning on an empty stomach (35.5%), GI side effects (26.3%), dislike of needing to stay upright after taking the tablet (13.0%), difficulty remembering to take the tablets (12.5%), and feeling that the drug was having no impact (5%).

Almost two-thirds of the respondents (63.4%) said that a monthly tablet would likely improve their patient’s adherence to an oral bisphosphonate regimen; 17.5% suggested a weekly tablet and 11.1% chose a daily tablet. Among respondents who favored weekly dosing, 40% preferred a weekly tablet and 60%, a weekly tablet that dissolves into a drinkable strawberry-flavored solution. When asked specifically about the value of this bisphosphonate solution as a treatment option, 61.5% thought that it would be of moderate value, 27.1% felt it would be of great value, and 11.4% saw it has having no value. Among the 361 NPs surveyed, 79.2% were aware of Binosto alendronate sodium effervescent tablets; however, 93.8% of the 145 NPs who replied to this question had never prescribed this product.

Conclusion

Nurse practitioners who treat women with osteoporosis need to be aware of all the treatment options available. Bisphosphonates are still the first-line choice for patients with low BMD and osteoporosis. New formulations have been developed to address concerns that affect adherence to the regimen. Although NPs need to be aware of the rare adverse effects associated with bisphosphonate use, they also need to keep the low absolute risk in mind when deciding whether or not to prescribe these medications.

Susan Rawlins is Director of Education at the National Association of Nurse Practitioners in Women’s Health and practices at the Greater Texoma Health Clinic in Denison, Texas. Ms. Rawlins is a consultant to Mission Pharmacal.

References
1. NIH Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis overview. www.niams.nih.gov/Health_Info/Bone/osteoporosis/overview.pdf

2. National Osteoporosis Foundation. What is osteoporosis? http://nof.org/articles/7

3. National Osteoporosis Foundation. What women need to know. http://nof.org/articles/235

4. Looker AC, Borrud LG, Dawson-Hughes B, et al. Osteoporosis or low bone mass at the femur neck or lumbar spine in older adults: United States, 2005-2008. NCHS Data Brief. 2012(93):1-8.

5. NIH Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis handout on health. www.niams.nih.gov/Health_Info/Bone/Osteoporosis/osteoporosis
_hoh.asp

6. Warriner AH, Saag KG. Osteoporosis diagnosis and medical treatment. Orthop Clin North Am. 2013;44(2):125-135.

7. National Osteoporosis Foundation. Making a diagnosis. http://nof.org/
articles/8

8. Medicare & You 2014. Centers for Medicare & Medicaid Services: Baltimore, MD. www.medicare.gov/Pubs/pdf/10050.pdf

9. FRAX® WHO Fracture Risk Assessment Tool. www.shef.ac.uk/FRAX/tool.jsp

10. Unnanuntana A, Gladnick BP, Donnelly E, Lane JM. The assessment of fracture risk. J Bone Joint Surg Am. 2010;92(3):743-753.

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Healthy bones for women*

 

Osteoporosis is a disease known for slow, silent loss of bone. (In this case, the word “silent” means that you won’t feel anything as the disease starts or worsens.) Bones become thinner and weaker, so they are more likely to fracture—that is, to break. Women are more likely than men to get osteoporosis. Your risk is also higher if someone in your family has had osteoporosis or if at least one of your parents has had a broken hip. More than 1.5 million fractures each year are related, at least in part, to osteoporosis.

Your healthcare professional (HCP) can help you assess your bone health at routine visits by…

Measuring your height.
A loss in height may mean that you have had silent spine fractures. Any loss in height from year to year should be checked further.
Using your height and weight measures together to compute your body mass index (BMI).
A low BMI or a weight less than 127 pounds (thinner women) is a risk factor for osteoporosis.
Reviewing all the medicines you are taking, including prescription and over-the-counter medicines and supplements.
Medicines such as prednisone, some anti depressants, some heartburn/ulcer drugs, and others may increase bone loss.
Discussing whether you should have a blood test to measure your vitamin D level.
Vitamin D is needed to absorb calcium in your bones. A normal blood level of vitamin D is 30 ng/mL or higher. Risk factors for having a low vitamin D level include being older than 60, being obese, having a disease of the kidney or bowel, getting too little sun, having very
dark skin, having had gastric bypass surgery, and using certain medicines. If your vitamin D level is too low, your HCP will prescribe vitamin D supplements and retest your vitamin D level in a few months.
Discussing whether you should have a bone density test.
A bone density test measures bone mass in places such as the lower spine, hip, and forearm. The most common bone density test done is a DXA (dual energy x-ray absorptiometry) scan. You should have this test if you are 65 or older, if you are older
than 50 and have risk factors for osteoporosis, if you broke a bone after age 50, or if you are past menopause and are stopping the use of estrogen. Depending on your test results and your risk factors, and whether you’ve had any osteoporosis treatment, you may need another DXA scan every 2 or more years.

Using a tool called FRAX to see whether you should have a bone density test (if
you are past menopause but not yet 65).
Your HCP may also use FRAX if your bone density test shows low bone mass (but not osteoporosis) to see if you need to be on an osteoporosis prevention medicine. FRAX shows your risk of having a bone fracture in the next 10 years by looking at your risk factors and, if done, your bone density test scores.

You can maintain or improve your bone health by…

Eating the right foods and taking supplements if needed.
You need calcium to make and keep your bones strong. Adult women up to age 50 need 1,000 mg/day and women older than 50 need 1,200 mg/day. Good food sources of calcium are low-fat dairy products, calcium-fortified foods (e.g., cereals, orange juice),
kale, bok choy, halibut, and sardines with bones. Know your usual dietary intake of calcium to decide how much supplement is needed to meet daily requirements. If you take a supplement, it’s best to divide your dose so you take no more than 500 mg of calcium at one time. Calcium carbonate costs the least and is taken with meals to work best. Calcium citrate need not be taken with meals.  You need vitamin D for calcium to be absorbed by your bones. Women younger than 50 need 400-800 IU/day and women older than 50 need 800-1,000 IU/day. Most women do not stay out in the sun long enough for their bodies to make vitamin D. Good food sources of vitamin D are wild salmon, halibut, trout, sardines, and vitamin Dfortified foods (e.g., milk, yogurt, cereals, orange juice). Know your usual dietaryintake of vitamin D to decide how much supplement is needed to meet daily requirements.
Limiting your intake of sodium, which reduces calcium absorption.
Look for sodium content on food labels. Avoid processed and canned foods and
salted snack foods and nuts. Eat fresh or frozen fruits and vegetables and fresh
lean meats, poultry, and fish.
Getting regular exercise, which helps make your bones strong.
Plan to get at least 30 minutes of moderate weight-bearing exercise on most
days of the week. Weight-bearing exercises include brisk walking, running/jogging, dancing, stair climbing, tennis, and use of exercise equipment such as elliptical training and stair-step machines and treadmills. Plan to do muscle strengthening exercises 2 or 3 days each week. You can lift weights, use weight machines, or use elastic exercise bands. Yoga and Pilates can improve strength, flexibility, and balance.
Not smoking.
Smoking decreases calcium absorption and speeds up bone breakdown.
Drinking alcohol in moderation.
For women, this is no more than 2 drinks each day. One drink = 10 ounces of beer, 4 ounces of wine,or 1 ounce of liquor. Drinking heavily can lead to bone loss.

Resources for more information

National Osteoporosis Foundation
4BoneHealth
FRAX calculator

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