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Collaboration in practice: A framework for team-based care

Since passage of the Affordable Care Act in 2010, alternate care delivery models such as patient- centered health homes and accountable care organizations have emerged as tools for payment and healthcare delivery system reform. The intent of such clinical integration models is to drive improvement in individual and population health outcomes and in the quality and efficiency of healthcare service delivery.Although these models hold promise in moving our healthcare system from a disjointed paradigm to a seamless, value-driven standard, fragmentation persists at all levels of the healthcare continuum. Establishment of a well-functioning team is one mechanism by which healthcare providers (HCPs) can achieve the goal of patient-centric, well-coordinated, safe, and responsive healthcare.2

Healthcare providers have been challenged to respond to an evolving health policy landscape that demands movement to coordinated, value-driven care models in the face of HCP shortages and shrinking resources. In response to this changing landscape, and, reflective of his own commitment to a team approach to care, John Jennings, ACOG’s 2014 President, chose—as the priority issue of his presidential year—revision of ACOG’s Guidelines for Implementing Collaborative Practice (1995) to better reflect the demands of today’s healthcare system. To meet this charge, ACOG convened an interdisciplinary task force comprising delegates from nine different organizations representing physicians, nurse practitioners, midwives, physician assistants, clinical pharmacists, and consumers. The resulting Collaboration in Practice: Implementing Team-Based Care represents a paradigm shift for healthcare service delivery in which patients are integral participants; all team members are valued equally; and all HCPs are supported in practicing to the full extent of their education, certification, and experience and accept accountability for their practice. To date, this document has been endorsed or supported by 21 national organizations, including NPWH and our sister NP organizations AANP, GAPNA, NAPNAP, and NONPF.3 The Executive Summary of this document is available here.

Team-based care and collaboration

In crafting this document, the writing team worked with the following definitions. Team-based care is defined as the “provision of health services to individuals, families, and/or their communities by at least two healthcare providers who work collaboratively with patients and their families…to accomplish shared goals…”Effective implementation of team-based care requires interprofessional collaborationdefined as “a process involving mutually beneficial participation between autonomous individuals whose relationships are governed by shared norms and visions.”3

The terms team-based care and collaboration have sometimes been used in regulatory policies in a way that places barriers to qualified HCPs’ ability to practice to the full extent of their education, certification, and experience. However, implementing team-based care delivery models does not require team-based licensure or integrated regulatory frameworks. In some cases, linked licensure and restrictive regulations may inhibit the flexibility and innovation required for team-based, patient-centered care. Of note, the ACOG document uses the terms team-based care and collaboration in their truest forms, denoting an equitable practice environment wherein each team member’s knowledge and skills are valued contributions to the team’s work. As such, the terms team-based care and collaboration should not be construed as recommended policy constructs within the context of this document.

Core concepts: Application to women’s health practice

Collaboration in Practice identifies six principles as core components guiding team-based care, all of which are relevant to women’s healthcare and WHNP practice. First and foremost, successful team-based care recognizes the patient and family as central, actively engaged members of the healthcare team.4 In 2008, the National Priorities Partnership identified patient and family engagement as one of six priorities with the most potential to reduce harm, eliminate disparities, decrease disease burden, and remove inefficiencies in healthcare delivery.4 Given the disparities in maternal/child and women’s health outcomes across the lifespan,5 a team-based approach that supports active patient engagement and shared decision making holds merit as one strategy to improve women’s health outcomes.

The second, third, and fourth guiding principles recognize the importance of shared vision, role clarity, and accountability, respectively, as important components of team-based care. These principles underscore the value of mutual respect that recognizes the expertise of each team member. Likewise, there exists an expectation of professional accountability to one’s own practice and to the team. Maintaining competencies through continuous learning is an expectation within an accountable practice. Although regulation of scope of practice resides within the purview of each state, the document urges professional organizations to continue to provide guidance for clinical practice and promote uniform educational requirements and standards of care and conduct. The Women’s Health Nurse Practitioner: Guidelines for Practice and Education, 7th edition (2014), available hereprovides a population-focused framework for WHNPs.

Communication, the fifth guiding principle, underscores the need for clear transfer of information regarding patient status and team tasks. The document recognizes the fluid nature of teams and appreciates evolving trends in healthcare. Teams range from a typical model wherein care is provided at a discrete location by a selected team of HCPs to virtual teams wherein care is provided by multiple HCPs across a variety of settings in disparate locations—in some instances using telehealth as a tool to expand access.The sixth guiding principle recognizes the fluid and dynamic nature of patient-centered care. Team leadership is described as being situational and dynamic. Within this principle, team leadership is determined in response to patient need at any given moment in time, rather than ownership by a specific role or discipline.

Women’s healthcare providers practicing in the maternal/child healthcare field may recognize parallels between team-based care and perinatal regionalization, a concept supported by the maternal/child healthcare community for more than two decades. Perinatal regionalization, which seeks to assure that high-risk pregnant women and/or infants receive the appropriate level of care at the appropriate time in order to optimize patient outcomes in high-risk situations, can be viewed as a key example of a virtual model for team-based care. In this model, communication to facilitate seamless transitions in care among community-based HCPs and perinatal care providers must be established to achieve optimal pregnancy outcomes. In-person or virtual consultation, education, and skill building help support open communication, professional accountability, and fluid team leadership. Just as the team-based care model recognizes the important role of each member, perinatal regionalization recognizes the important role of the community-based team, the perinatal center team, and wraparound service providers, all of whom contribute to an optimal outcome.7,8 Although perinatal regionalization serves as one example of the breadth of a team-based care model, the concept is transferable across a variety of healthcare settings and specialties, within a traditional or a virtual setting.

Conclusion

Women’s healthcare has always been a team-based endeavor recognizing the important role of access to gender-focused care throughout the lifespan, with attention to the realities of women’s lives outside the hospital and clinic walls. In this regard, it is especially fitting that women’s healthcare providers led the way in bringing together a diverse group of HCPs to chart a path applicable across specialties and disciplines. Furthermore, the collaborative process used in developing this document mirrored the equitable, collaborative approach recommended as a pathway to successful implementation of team-based care. NPWH was proud to be part of the working group that helped shape the concepts put forth in this document.

The aforementioned Executive Summary of the Collaboration in Practice document provides an overview of the process and key points. All of the essential elements of the work, including recommendations for implementing an equitable, accessible, reimbursable, patient-centric model of care, are elaborated in the full report. The Collaboration in Practice team invites you to consider how the full report can be used to enhance your practice and improve patient outcomes.

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

References

1. Guterman S, Drake H. Developing innovative payment approaches: finding the path to high performanceThe Commonwealth Fund. May 2010.

2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.

3. Executive Summary: Collaboration in Practice: Implementing Team-Based Care. Report of the American College of Obstetricians and Gynecologists’ Task Force on Collaborative Practice. Obstet Gynecol. 2016;127(3):612-617.

4. National Priorities Partnership. National Priorities and Goals: Aligning Our Efforts to Transform America’s HealthcareWashington, DC: National Quality Forum; 2008.

5. Kendig S. Women’s health: more than an annual event. Womens Healthcare. 2014;2(3):36-39.

6. ACOG Task Force on Collaborative Practice. Collaboration in Practice: Implementing Team-Based CareWashington, DC: ACOG; 2016.

7. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care, 7th edition. Elk Grove Village, IL: AAP; Washington, DC: ACOG; 2012.

8. Obstetric Care Consensus No. 2: Levels of Maternal Care. Obstet Gynecol. 2015;125(2):502-515.

Reaching postpartum women in the U.S.: Demographics and generational characteristics

The postpartum period, defined traditionally as the first 6-8 weeks after birth, is a time of rapid change for new mothers and their families. Mothers are not only recovering physically but also making psychosocial adjustments related to their family role and relationships. In addition, mothers are adding or refining skills and responsibilities such as breastfeeding and infant care. This process of becoming a mother starts with the initial transformation and continues with the growth and change of maternal identity.1

Although the postpartum period can be fraught with changes foreseen and unforeseen, most women in the United States who have given birth receive only minimal care during the critical early months after delivery.2 Unfortunately, postpartum care has not evolved along with the changing demographic and generational characteristics in this country over the past few decades, so many women’s needs are not being met. Healthcare providers (HCPs) have an opportunity to optimize the care they deliver to postpartum mothers of today.

Routine postpartum care

In the U.S., routine postpartum care consists of 2-4 days in the hospital, depending on the type of delivery, vaginal or cesarean.3 Follow-up consists of one visit to the maternity care provider, typically at 6 weeks. The focus of this office visit is on uterine involution, contraception, and management of complications. By contrast, in most northern and western European countries, HCPs make home visits to their patients after childbirth.4 According to Cawthorne and Arons,5 postpartum home visits by trained professionals/paraprofessionals can provide valuable information and practical support that family and friends may not be able to provide.

Scope of the problem

Although home visit support services are available in the U.S., many new mothers are unfamiliar with these services or they cannot afford these services. In addition, families of today are more fragmented and geographically dispersed than in previous generations, making the advice and support of grandparents or other elders less available. High-risk U.S. populations such as teenagers and certain low-income women may qualify to receive home visiting services without charge. Although these services have been shown to be helpful,6 most qualified families do not receive them. For the most part, then, after parents take their babies home from the hospital, they are left to handle their new responsibilities alone.4

The nature and extent of postpartum healthcare in the U.S. may be too limited to meet the needs of most women.7, 8 The first postpartum year is a period of vulnerability during which HCPs should be focusing on weight management,prevention of postpartum depression, breastfeeding support, promotion of healthy relationships, and postpartum morbidities such as fatigue.9 In addition, women would benefit from acquiring life skills known to support postpartum health, including mobilization of social support, development of positive coping skills, enhancement of self-efficacy, and having realistic expectations.10 A recent systematic review of postpartum interventions suggested that further research is needed to design interventions focused on health promotion, not just on treatment of adverse health conditions.11

Postpartum maternal healthcare is a neglected aspect of women’s healthcare.12 Much of the knowledge about new mothers’ role transition was developed in the 1960s to 1980s.13-16 But times have changed. The old rules no longer apply. HCPs need to remain up to date in terms of the trends and concerns that affect today’s women and provide postpartum care that is culturally competent— that is, care that is based on the demographic and generational characteristics of the population being served. In particular, the U.S. Department of Health and Human Services calls for HCPs to provide care that takes into account patients’ cultural health beliefs and practices, preferred language, health literacy, and other communication needs.17

Demographic trends

The sociocultural climate in the U.S. has changed for women giving birth in the early 21st century. Mothers of today are decidedly different from those of past generations.

First-time mothers are older.

According to the National Center for Health Statistics, the number, percentage, and rate of first births to older women have increased over the past four decades.18 In 2012, as compared with four decades ago, there were more than 9 times as many first births to women aged 35 years or older. First-birth rates of women older than 35 years have increased from 2000 to 2012 even as total births in the U.S. have declined.18

By contrast, first-birth rates for women younger than 30 years, and especially those younger than 20, have declined in the past decade.18 In 2013, there were 26.5  births for every 1,000 females aged 15-19, or 273,105 babies born to females in this age group.19 The 2013 teen birth rate was 10% lower than that in 2012 (29.4 births/1.000 females) and less than half the rate in 1991 (61.8 births/1,000 females).

In the 1960s and 1970s, new mothers were typically younger and married when they started their families. Families had more children, and many mothers stayed home to raise their children. According to a recent Pew Research Report on Social and Demographic Trends,20 in 2012, only 20% of mothers were married to a working husband and stayed home to care for their children; in 1967, 67% of mothers met these criteria. The workforce participation rate for mothers with children younger than 1 year old was 57.3% in 2013.4

Mothers are better educated and have more money. Older mothers of today, relative to their younger counterparts, are better educated and more likely to have greater resources, including higher incomes.6 As a result of new mothers having been in the workforce for some time, many of them have the means to choose the circumstances under which they want to raise a family.21 At the same time, although many older mothers could benefit from postpartum home visiting services and could afford these services, it is still not common practice to pay for them out of pocket because they are quite expensive.

Family composition has diversified.

Nowadays, it is relatively more common to see households headed by two women, two men,  an unmarried woman and man, single adults, or multiple generations.22 A recent report based on the 2006-2010 National Survey of Family Growth showed that 23% of recent births among women aged 15-44 occurred among cohabiting couples, whereas 60% of the women were married.Other newer phenomena include increases in blended families (from previously divorced couples with children who remarry or cohabit) and interracial families.9 Between 2000 and 2010, the number of unmarried-partner households increased 41%. Over this time period, opposite-sex unmarried partner households grew from 4.9 million to 6.8 million and samesex unmarried partner households grew from 358,000 to 646,000 (or from 0.3% to 0.6% of house holds).9 These trends have profoundly changed the U.S. family and, following the trends of other Western countries, are unlikely to reverse in the near future.23

Generational characteristics

Although generalizations about various age cohorts can be hotly debated, one point is undeniable: Age cohorts are affected by external events, and each generation has a unique “persona” by virtue of the fact that members occupy the same time period as they age.24 Contemporary new mothers come from Generation X (Gen X; persons born in the mid-1960s to the early 1980s) or Generation Y (Gen Y; persons born in the early 1980s to 2000); members of Gen Y are often dubbed the Millennials.

Members of Gen X have been described as family oriented, secondarily career oriented, and relatively independent. This generation is the first to grow up as latch-key children; as a consequence, many Gen-Xers did not spend a lot of time with their parents. They entertained themselves during their youth and, as adults, place high regard on entertainment and fun. They also value knowledge and expect regular feedback.25

Members of Gen Y tend to be more team oriented; they work well in groups rather than on their own. They are technologically savvy, willing to work hard, and wonder “What’s in it for me?” Gen-Yers seek balance between work and family and believe that one can successfully have it all. They multitask and respect learning. Compared with earlier generations, Gen-Yers experience a high degree of job and life satisfaction. They are constantly questioning, need immediate feedback, and believe that money buys happiness. Of interest, according to a Pew Research Center analysis of attitudinal surveys, the Millennials value parenthood far more than marriage.26

These two generations of childbearing women have had access to the Internet for much of their lives. Through the Internet, they have been able to obtain a vast quantity of information about childbearing, although it is not known whether most of them fully understand and can put into perspective what they read.27 In addition, the Internet provides opportunities for social networking and connecting with like-minded individuals. Gen X and Gen Y mothers may seek support from online groups and individuals whom they have never met in person. These two generations of women have had instant communication for much of their lives and have come to expect this type of communication from their HCPs. Email, texting, online social networking, and the many forms of social media are all modes of communication for contemporary mothers.

Healthcare has been slower to adopt the use of social media. Despite the risks, social media can bring major benefits, particularly for patient and community outreach and communication.28 In an article examining Millennial healthcare values, Rupp29 stated that Millennials are more likely than members of previous generations to participate in mobile health applications, finding these tools convenient, motivating, and empowering.

Clinical implications

Most contemporary new mothers expect to be informed and supported through digital means. The recent Listening to Mothers III survey showed that 67% of the respondents used subscription email services and 27% received short text messages to obtain pregnancy and childbirth information.30 Short online videos are also useful; when this content is culturally appropriate, it can help women develop self-efficacy as new parents.10 The greater the resemblance of the video viewers to the women in the videos, the more they will be able to sense that they, too, can achieve the skills being demonstrated.10 The Box lists websites where HCPs and patients can find culturally appropriate videos regarding pregnancy, childbirth, and motherhood.

Text4Baby is an innovative use of interactive mobile technology that provides evidence-based information for new mothers.31 This free service connects new mothers with health information on topics such as breastfeeding and infant development. Interactive features such as mobile pages, videos, appointment reminders, quizzes, and modules on specific health problems and resources have been integrated into the service.

Maternity leave is an optimal time for HCPs to provide new mothers with opportunities to learn postpartum self-care and to connect them with other new mothers in their area (if possible and if of interest). During this time, practices could offer individual and group support programs on topics such as postpartum fatigue, emotions and depression, breastfeeding continuation, mobilization of social support, expansion of social networks to include other new mothers, relationship building, community resources, and newborn and infant continuing care.

The concept of CenteringPregnancy is gaining momentum as a model to deliver pregnancy and postpartum care.32 The principle of sharing used in CenteringPregnancy helps normalize the experience, and can be applied to postpartum and infant care. The axiom that “wisdom and experience are valuable only when shared by others” is particularly true for new mothers, who are eager to learn how to integrate all the new information, experiences, doubts, tensions, and challenges into their new self-concept as mother.

As the composition of families has diversified, so, too, have the challenges of adjusting to having a newborn. New mothers in blended families tend to experience an even greater challenge in integrating their newborn into a pre-existing family environment.33 These new mothers benefit from connecting with other mothers who have similar family compositions. Social networks and social support systems can also have a beneficial effect on postpartum women’s mental health and adjustment.34, 35

Older first-time new mothers, versus their younger counterparts, demonstrate greater intensity and preparedness.36 These mothers are usually well educated and highly organized, and have a planned approach to pregnancy and new parenting. In addition, they can be quite demanding of their HCPs, and have many questions and concerns. Older first-time mothers may experience more fatigue and be less physically active than their younger counterparts. They may be at higher risk for chronic diseases such as obesity, diabetes, and hypertension.37 In the long run, HCPs benefit by spending more time with these mothers during office visits. Offering reassurance about their mothering abilities can build maternal confidence.36 Educational group sessions for older new mothers can help them feel accepted, connected, and nurtured.

Improving postpartum healthcare in the U.S. will require more funding, more research, and more dissemination of effective approaches. From the administrative side, allocation of practitioner time to group postpartum services would be money well spent. In the professional literature and at conferences, more sharing and dissemination of postpartum exemplars is needed. To move postpartum care forward, there must be more demonstrated evidence of successful and unsuccessful approaches. Without systematic reviews and meta-analyses, the pinnacles of evidence-based practice, the chances of reaching these higher levels of evidence diminish. In a sense, postpartum care in the U.S. is still in its infancy as far as improving outcomes is concerned. With increased documentation of successful outcomes with various approaches, as well as increased funding, more plentiful and effective services can be offered to postpartum women.

Conclusion

To provide optimal care for postpartum women today, HCPs need to be well informed about demographic and generational trends and apply this knowledge to their practices. Healthcare services need to be continuously updated—for example, by providing postpartum care that is tailored to individual women’s needs and not based on a set schedule, and by using digital means to communicate with patients. These recommendations are particularly important in the U.S., where postpartum services are still minimal but greatly needed.

Suzanne F. Foley, formerly an Assistant Professor of Nursing at Widener University in Chester, Pennsylvania, works as a women’s health consultant in the Philadelphia area. 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. Mercer RT. Becoming a mother versus maternal role attainment. J Nurs Schol. 2004;36(3):226-232.

2. Centers for Disease Control and Prevention. PRAMS Publications: Postpartum Care Visits. December 21, 2007.

3. Matthews TJ, Hamilton BE. First Births to Older Women Continue to Rise. Hyattsville, MD: National Center for Health Statistics; May 2014.

4. Bureau of Labor Statistics. Washington, DC: United States Department of Labor; 2014.

5. Cawthorne A, Arons J. There’s No Place Like Home. Center for American Progress; 2010.

6. Martinez GM, Daniels K, Chandra A. Fertility of Men and Women Aged 15–44 Years in the United States: National Survey of Family Growth, 2006–2010. Hyattsville, MD: United States Department of Health and Human Services. National Center for Health Statistics; 2012.

7. Albers LL. Health problems after childbirth. J Midwifery Womens Health. 2000;45:55-57.

8. Declercq ER, Sakala C, Corry MP, et al. Listening to Mothers: Report of the First National U.S. Survey of Women’s Childbearing Experiences. New York, NY: Maternity Center Association; October 2002.

9. United States Census Bureau. 2010 Census Shows Interracial and Interethnic Married Couples Grew by 28 Percent over Decade. Washington, DC; 2012.

10. Fahey J, Shenassa E. Understanding and meeting the needs of women in the postpartum period: the perinatal maternal health promotion model. J Midwifery Women’s Health. 2013;58(6):613-621.

11. Cardemil EV, Moreno O, Sanchez M. One size does not fit all: cultural considerations in evidence-based practice for depression. In: Beevers C, Springer D, Rubin A, eds. Treatment of Depression in Adolescents and Adults: Clinician’s Guide to Evidence-Based Practice. Hoboken, NJ: John Wiley and Sons; 2011:221-243.

12. Cheng C-Y, Fowles E, Walker LO. Postpartum maternal health care in the United States: a critical review. J Perin Educ. 2006;15(3):34-42.

13. Rubin R. Attainment of maternal role. Part 1: Processes. Nurs Res. 1967;16:237-245.

14. Rubin R. Attainment of the maternal role. Part ll: Models and referents. Nurs Res. 1967;16:324-346.

15. Mercer RT. A theoretical framework for studying factors that impact on the maternal role. Nurs Res. 1981;30:73-77.

16. Mercer RT. The process of maternal role attainment over the first year. Nurs Res. 1985;34:198-203.

17. Culturally Competent Nursing Care: A Cornerstone of Caring. 2012.

18. Mathews TJ, Hamilton BE. First Births to Older Women Continue to Rise. Hyattsville, MD: National Center for Health Statistics; 2014.

19. Hamilton BE, Martin JA, Osterman MJK, et al. Births: Final Data for 2013. Hyattsville, MD: National Center for Health Statistics; 2015.

20. Cohn DV, Livingston G, Wang W. After Decades of Decline, a Rise in Stay-at-Home Mothers. Washington, DC: Pew Research Center’s Social & Demographic Trends; April 2014.

21. Newitz A. Three ways that women are about to change the world. io9.com. 2010.

22. Vespa J, Lewis JM, Kreider RM. America’s Families and Living Arrangements: 2012 Current Population Reports. Washington, DC: U.S. Census Bureau; 2013.

23. Klein HS. The changing American family. Hoover Digest. July 30, 2004.

24. Hoover E. The millennial muddle: how stereotyping students became a thriving industry and a bundle of contradictions. Chronicle Higher Educ. October 11, 2009.

25. Wallis L. Born to be different. Nurs Stand. 2009;23(33):62-63.

26. Wang W, Taylor P. For Millennials, Parenthood Trumps Marriage. Washington, DC: Pew Research Center; March 9, 2011.

27. Carolan M. Health literacy and the information needs and dilemmas of first-time mothers over 35 years. J Clin Nurs. 2007;16(6):1162-1172.

28. Institute E. Social Media in Healthcare: Executive Summary. November 2011.

29. Rupp SE. Millennials are reshaping healthcare. Multibriefs: Exclusive. January 26, 2015.

30. Declercq ER, Sakala C, Corry MP, et al. Listening to Mothers III: Pregnancy and Birth. New York, NY: Childbirth Connection; May 2013.

31. Jordan ET, Bushar J, Ingersoll S, Goodman A. Text4baby: an innovative example of utilizing interactive mobile health to provide evidence-based information.J Obstet Gynecol Neonat Nurs. 2014;43(suppl 1):S55-S56.

32. Reid J. Centering pregnancy: a model for group prenatal care. Nurs Womens Health. 2007;11(4):382-388.

33. Bernstein AC, ed. Remarriage: Redesigning Couplehood. New York, NY: Guilford Press; 2000.

34. Surkan PJ, Peterson KE, Hughes MD, Gottlieb BR. The role of social networks and support in postpartum women’s depression: a multiethnic urban sample. Matern Child Health J. 2006;10(4):375-383.

35. Haga SM, Lynne A, Slinning K, Kraft P. A qualitative study of depressive symptoms and wellbeing among first-time mothers. Scand J Caring Sci. 2012;26(3):458-466.

36. Nelson AM. A qualitative study of older first-time mothering in the first year. J Pediatr Healthcare. 2004;18(6): 284-291.

37. University of Eastern Finland. New evidence on risks of advanced maternal age. Science Daily. February 11, 2015.

Dyspareunia for a dozen years in a young woman

A 30-year-old woman named CL presents to the office as a new patient. Her health history is notable for dysmenorrhea; irritable bowel syndrome (IBS), diarrhea dominant; and dyspareunia since the onset of sexual activity at age 18. CL has never been pregnant.

CL tells the nurse practitioner (NP) that her dysmenorrhea has been well managed since age 15 with combination oral contraceptives (COCs) and an occasional NSAID on day 1 of her period. She does not take any medication for her IBS, and she avoids foods that might cause bouts of diarrhea. CL tells the NP she is seeking relief of the pain she experiences during sex, which has worsened over the past 6 months and which she fears might ruin her current relationship. She tearfully tells the NP that three prior relationships ended badly because she was unable to have comfortable, enjoyable sex. Although she said she was able to tolerate sexual touching and intercourse in the past, her symptoms have been gradually getting worse.

She goes on to tell the NP that she has been dating her current partner for 6 months and that they have had sex 3 times, which caused great discomfort. She says she tried various over-the-counter (OTC) lubricants and different positions, to no avail. Although CL says she enjoys cuddling and kissing with her partner, she has been avoiding this type of contact for the past 2 months because of fear that it would lead to intercourse. At the same time, she wants to enjoy intercourse and please her partner.

What else would be helpful to know about CL’s symptoms and health history?

CL tells the NP she feels she is “a mess down there.” She reports experiencing itching and burning in the vulvar area. The symptoms are present on most days and worsen with her period. She ascribes the symptoms to yeast infections (3-4 in the past year), which she treats with OTC antifungal creams. She also reports that, in the past year, she has been treated by another healthcare provider (HCP) for bacterial vaginosis with a vaginal gel. In addition, she has gone to an urgent care center twice for treatment of urinary tract infections— even though she is unsure whether the urine culture findings were positive or negative.

A year ago, at the suggestion of a friend to whom she mentioned the painful sex, CL went to a clinic for sexually transmitted disease testing and a Pap smear with a human papillomavirus (HPV) co-test. She reports that all findings were negative but adds that she hesitates to “go through that again” because the speculum examination was very painful. She says, “I don’t even use tampons because they hurt too much.” She tells the NP that she wears a panty liner every day because she does not take her COC consistently; when she forgets to take a pill or takes it late, she has some spotting. She remarks that she never feels really clean because of the frequent diarrhea, and uses feminine wipes daily.

As she tears up again, CL tells the NP that, over the past few months, she has felt more stressed than usual because of worries about her relationship and because of work pressures with a new boss. She laughs a little as she says, “I don’t drink, use drugs, or smoke, but when I get home from work, all I want to do is take a long hot bath with some scented oils to help me relax and feel clean.”

The NP seeks more details about the dyspareunia, and asks CL to rate the pain she experiences during and after sexual intercourse using a Likert scale, with 0 = no pain and 10 = maximum pain. CL rates the pain she feels in the vestibule area when her partner’s penis enters the vagina as an 8, and describes it as burning or a “razor blade” sensation. During penile thrusting, she experiences vaginal pain rated as a 6. After sexual touching, she has heightened burning pain in the vestibule area rated as a 4; the pain lasts 12-24 hours.

Which differential diagnoses would you consider at this point?

CL describes chronic vulvar itching and burning, significant vestibular pain during and after sex, and vaginal pain with thrusting. These symptoms may have similar or overlapping causes such as:

• Vulvitis;

• Vulvar dermatoses (e.g., lichen sclerosus);

• Vulvar cancer (pruritus is the most common early symptom);

• Vulvovaginal atrophy (associated with the patient’s prolonged COC use);

• Vaginismus; and

• Vulvodynia.

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

The NP begins with inspection of the vulva and vestibule to assess for anatomic changes or variations, pigmentation changes, lesions, and integrity of vulvar tissues. The inspection reveals normal vulvar structures and mildly erythematous, dry labia majora with no other pigmentation changes or lesions. The labia minora are moist and pink. Vulvar hair is absent; CL reports that she has been removing this hair with a razor and shaving cream for years.

In the absence of abnormal visible findings other than mild erythema of the labia majora, the NP performs a cotton-swab test to specifically localize any areas of altered sensation in the vulvar area. The test is done prior to digital palpation and an attempt at insertion of a speculum. A standard cotton tip applicator is used to apply light touch starting on the upper inner thigh and following in a clockwise fashion in a manner that includes the labia majora, the vestibular duct openings for Skene’s and Bartolin glands, the clitoris/hood, and the perineum. The patient is asked to rate her pain on a scale of 0-10 at each location (Figure). CL’s cotton-swab test produces scores of 0 on the inner thighs and labia majora, 2 at the clitoris, and 2 at the perineal body. Pain at the vestibular gland duct openings is rated at 6-7 for the Skene’s glands and 7-8 for the Bartholin glands.

Because CL has high vestibular pain scores, the NP does not perform a speculum exam. The NP uses a cotton swab to obtain a vaginal specimen for pH and microscopic wet mount evaluation.

The pH is 4.0. A whiff test is negative. Mature squamous epithelial cells are present, with no pseudohyphae, clue cells, or motile trichomonads seen on the wet mount. A vaginal specimen is sent for fungal culture to assess for infection caused by atypical Candida species. The culture results are negative.

Pelvic floor muscle (PFM) assessment is done using one finger inserted into the vagina without touching the vestibule. The Oxford Grading System uses a 6-point scale to measure PFM strength: 0 = no contraction; 1 = flicker; 2 = weak; 3 = moderate; 4 = good (with lift); and 5 = strong. CL’s PFM strength is rated a 4. Palpation of the levator ani group and obturator internus muscles reveals hypertonicity and tenderness.

Based on the history and exam findings, what is the diagnosis?

CL has three interconnected diagnoses contributing to the dyspareunia: contact vulvitis, vulvodynia, and vaginismus.

Vulvitis may be caused by chronic or recurrent infection by pathogens such as Candida, herpes simplex virus, or HPV; contact with allergens or irritants; or injury/trauma. CL has reported regular use of vulvar contact irritantsuch as panty liners, feminine wipes, shaving cream, and scented bath oils. Pubic hair shaving may heighten one’s sensitivity to contact irritants. CL’s physical exam and wet mount findings tend to rule out infection as the cause of the vulvitis. The labia majora dryness may be related to prolonged use of COCs.

Vulvodynia is defined as vulvar discomfort (usually described as burning pain) occurring in the absence of relevant visible findings or a specific, clinically identifiable, neurologic disorder.1 It is a diagnosis of exclusion when all other potential causes have been ruled out and when symptoms persist longer than 3 months.1 The etiology of vulvodynia is unknown but may be related to genetic susceptibility,chronic inflammation,3 a combination of factors (e.g., PFM abnormalities, neuropathic pain, anxiety, primary/secondary sexual dysfunction),4 regionally elevated cytokines produced by vulvar vestibule-specific fibroblasts,hormonal changes,6 or dietary oxalates.7, 8 Chronic inflammation related to the contact irritants, recurrent infections, hormonal changes, or chronic skin conditions acts as a trigger. Normal sensations are perceived as abnormal, resulting in heightened sensitivity.

Estimates of vulvodynia prevalence range from 3% to 18%.9 Onset is most likely to occur between the ages of 18 and 25. Among symptomatic women, 60% see an average of three HCPs before receiving the correct diagnosis and 40% remain undiagnosed.9

Vulvodynia is classified as localized or generalized. Localized vulvodynia is subdivided into primary, in which vestibular pain begins during the first attempt at vaginal penetration, or secondary, in which pain occurs after a period of pain-free sex. Generalized vulvodynia may include all of the vulva or be limited to one side, with pain occurring in the absence of a triggering event. Of note, about 10% of women with generalized vulvodynia have a co-existing pain syndrome such as interstitial cystitis/painful bladder syndrome, IBS, fibromyalgia, or chronic fatigue syndrome.10

Prolonged use of COCs as a risk factor for vulvodynia is controversial. Several studies have supported the theory that use of COCs or progesterone-only contraceptives in females younger than age 18 causes down-regulation of estrogen receptors, leading the vestibular epithelium to become thin and fragile.11, 12 Although some women with vulvodynia have increased perception of pain when taking COCs, stopping COCs does not necessarily lead to resolution of the symptoms.12

Vaginismus is defined as recurrent or persistent involuntary spasm of the musculature of the outer third of the vagina that interferes with vaginal penetration and that causes personal distress or interpersonal difficulties.13

What can the NP offer CL as first-line treatment?

Because studies on the cause and treatment of vulvodynia are limited, the American College [now Congress] of Obstetricians and Gynecologists recommends that therapy be based on evidence from descriptive studies, expert reports, and clinical experience— with the understanding that the condition is difficult to treat and that no single approach is successful for all women.14

Individualized treatment usually involves multiple therapies over time.Treatment is considered in a step-wise progression, starting with self-management and moving upward on the scale of complexity. Total symptom resolution can be unrealistic. Primary goals are symptom reduction, return of satisfactory sexual function, and improved quality of life. Patient education concerning the manageability yet chronicity of this neuropathic condition is essential in setting realistic goals and in instituting a treatment plan that leads to improvement and satisfaction.

Mental health counseling is an important component. Approximately 50% of women with vulvodynia have a concordant diagnosis of anxiety.15 An increased occurrence of childhood physical/sexual abuse in women with vulvodynia has been reported.16 Referral to a mental health specialist with expertise in women’s sexual health and chronic pain conditions can be helpful.

Self-management is essential in CL’s case. She is educated to avoid use of feminine hygiene wipes/washes, panty liners (at times other than menses), and repetitive use of OTC antifungals.She is encouraged to stop removing her vulvar hair, which provides a protective barrier for sensitized vestibular tissues. She is advised to avoid exposure to very hot water in bathtubs and hot tubs, which can exacerbate vestibular discomfort. Application of unscented, hypoallergenic emollients to the vulvar skin and sitz baths in lukewarm water can be soothing, however.

CL and her partner should explore alternatives to penetrative sex (e.g., light physical contact with her genitalia). As pain diminishes with treatment over time, CL can consider restarting penetrative sex. The NP advises her to implement strategies for PFM relaxation, to adopt positions during intercourse that minimize pressure on sensitive areas, and to use liberal amounts of water-soluble lubrication.

A low-oxalate diet has been suggested to reduce high levels of oxalate in urine. However, little evidence supports the efficacy of this dietary modification in reducing vulvar pain.7, 8

What types of pharmacologic agents are appropriate?

Topical medications can be used on a short-term basis.17 Options include lidocaine 5% ointment, doxepin 5% cream in water-soluble base, gabapentin 2%-6% in watersoluble base, and amitriptyline 2% with baclofen 2% in water-soluble base. When topicals are used, those with an ointment base, rather than a cream base, are preferred.17 Cream bases contain more preservatives and stabilizers, which can act as contact irritants and cause burning upon application.

The next line of treatment is the use of oral neuropathic pain modulators, either antidepressants (e.g., amitriptyline, desipramine, venlafaxine) or anticonvulsants (e.g., gabapentin, pregabalin, lamotrigine, topiramate).17 Side-effect profiles and patient tolerance drive dosing regimens. Pruritus can be managed with an antihistamine such as hydroxyzine or cetirizine. In addition, nerve blocks, topical nitroglycerin, topical capsaicin, interferon injection, and trigger point injections have shown some efficacy in treating vulvodynia.17 Vaginal valium, injectable botulinum toxin, and topical baclofen have been used in the treatment of vaginismus.

What role does physical therapy play in CL’s treatment?

Pelvic floor physical therapy (PT) is an essential component of treatment for CL once she can withstand cotton-swab touch with lowered vestibular pain scores. A person with expertise in pelvic floor PT may use a combination of interventions to decrease CL’s dyspareunia and to improve her sexual function.17, 18 Interventions include (1) bio-feedback, which can help CL learn to relax her PFMs; (2) external soft tissue mobilization and myofascial release techniques; (3) trigger point pressure; and (4) transcutaneous electrical stimulation applied to the sacral nerve. The physical therapist or NP may teach CL how to use vaginal dilators to gradually overcome the tension in the PFMs. When CL is ready to resume sexual activity, she can use the dilator to prepare herself for and facilitate penetration.

When is surgery an option?

For women who continue to experience intractable symptoms after all other treatments have been tried, vestibulectomy—excision of the vestibule with vaginal advancement— is an option. Patient selection is critical for success; women can consider this option only if symptoms are confined to the vestibule. Success rates range from 60% to 85%.19, 20 Referral to a pelvic and reconstructive surgeon is advised in these cases.

Reflection for practice

Vulvodynia is a complex chronic pain condition. The interrelated physical, psychological, and psychosexual components make management challenging for both clinician and patient. CL has sought an NP’s help in seeking relief of her dyspareunia. The treatment plan focuses on symptom reduction to allow for sexual functioning that provides intimacy and satisfaction. Total relief of pain may not be achievable. A multidisciplinary approach to treatment may produce the best results. In fact, when available, referral to vulvovaginal disease specialists can facilitate an individualized, coordinated, comprehensive approach to treatment.

Susan Hoffstetter is a Fellow in the International Society of the Study of Vulvovaginal Diseases and an Associate Professor at Saint Louis University School of Medicine in St. Louis, Missouri. 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. Haefner HK. Report of the International Society for the Study of Vulvovaginal Disease terminology and classification of vulvodynia. J Low Genit Tract Dis. 2007;11(1):48-49.

2. Goldstein AT, Kim N, Burrows LJ, Goldstein I. Genetic differences may reflect differences in susceptibility to vulvodynia in general or in spontaneous remission propensity: a response. J Sex Med. 2015;12(2):578-579.

3. Akopians AL, Rapkin AJ. Vulvodynia: the role of inflammation in the etiology of localized provoked pain of the vulvar vestibule (vestibulodynia). Semin Reprod Med. 2015;33(4):239-245.

4. Edwards L. Vulvodynia. Clin Obstet Gynecol. 2015;58(1):143-152.

5. Foster DC, Piekarz KH, Murant TI, et al. Enhanced synthesis of proinflammatory cytokines by vulvar vestibular fibroblasts: implications for vulvar vestibulitis. Am J Obstet Gynecol. 2007;196(4):346e1-8.

6. Eva LJ, MacLean AB, Reid WM, et al. Estrogen receptor expression. Am J Obstet Gynecol. 2003;189(2):458-461.

7. Greenstein A, Militscher I, Chen J, et al. Hyperoxaluria in women with vulvar vestibulitis syndrome. J Reprod Med. 2006;51(6):500-502.

8. Harlow BL, Abenhaim HA, Vitonis AF, Harnack L. Influence of dietary oxalates on the risk of adult onset vulvodynia. J Reprod Med. 2008; 53(3):171-178.

9. Harlow BL, Stewart EG. A population based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc. 2003;58(2):82-88.

10. Reed BD, Harlow SD, Sen A, et al. Relationship between vulvodynia and chronic comorbid pain conditions. Obstet Gynecol. 2012;120(1):145-151.

11. Bohm-Starke N, Johannesson U, Hilliges M, et al. Decreased mechanical pain threshold in the vestibular mucosa of women using oral contraceptives: a contributing factor in vulvar vestibulitis? J Reprod Med. 2004;49(11):888-892.

12. Goldstein AT, Krapf J, Belken Z. Do oral contraceptive pills cause vulvodynia? Time to finally end the controversy. International Pelvic Pain Society Blog. October 2015.

13. Curtis M, Linares S, Antoniewicz L. Glass’ Office Gynecology. 7th ed. Philadelphia, PA: Wolters Kluwer Health; 2014.

14. American College of Obstetricians and Gynecologists. 2006. Committee Opinion Number 345. Vulvodynia. Washington, DC: American College of Obstetricians and Gynecologists; 2006.

15. Tribo MJ, Andio O, Ros S et al. Clinical characteristics and psycho-pathological profile of patients with vulvodynia: an observational and descriptive study. Dermatology. 2008; 216(1):24-30.

16. Harlow BJ, Stewart EG. Adult onset vulvodynia in relation to childhood violence victimization. Am J Epidemiol. 2005;161(9):871-880.

17. Haefner HK, Collins ME, Davis GD, et al. The vulvodynia guideline. J Low Genit Tract Dis. 2005;9(1):40-51.

18. DeBevoise TM, Dobinsky AF, McCurdy Robinson CB, et al. Pelvic floor physical therapy: more than Kegels. Womens Healthcare. 2015;3(2):34-41.

19. McCormack WM, Spence MR. Evaluation of surgical treatment of vulvar vestibulitis. Eur J Obstet Gynecol Reprod Biol. 1999;86(2):135-138.

20. Haefner HK. Critique of new gynecologic surgical procedures: surgery for vulvar vestibulitis. Clin Obstet Gynecol. 2000;43(3):689-700.

The cervical cancer screening dilemma: Choosing the optimal screening strategy

Faculty

Kim Choma, DNP, APN, WHNP-BC, is a Part-time Lecturer at Rutgers University School of Nursing in Camden, New Jersey.

Charles F. Dubin, MD, is a Assistant Clinical Professor at the UCLA David Geffen School of Medicine, University of California at Los Angeles in Los Angeles, California.

Intended audience

This continuing education (CE) activity has been designed to meet the educational needs of women’s health nurse practitioners (NPs), adult NPs, family NPs, and certified nurse midwives (CNMs) involved in women’s health.

CE approval period

Now through March 31, 2017

Estimated time to complete this activity

1 hour

CE approval hours

1.0 contact hour of CE credit

Needs assessment

The essence of the cervical cancer screening (CCS) dilemma is which screening test(s) to use and how frequently to screen. Major national health organizations may differ somewhat in terms of their specific recommendations, but their

general objectives are to prevent morbidity and mortality from cervical cancer (Saslow et al, 2012 [this article presents recommendations from the American Cancer Society, the American Society of Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology]; U.S. Preventive Services Task Force, 2012; American College of Obstetrics and Gynecology, 2012) and to prevent overzealous management of precursor lesions that most likely will regress or disappear.

Educational objectives

At the conclusion of this educational activity, participants should be able to:

1.Understand the importance of maximizing the benefits of cervical cancer prevention while minimizing the harms associated with overtreatment.

2. Evaluate current available options for CCS: cervical cytology, primary HPV testing, and co-testing.

3.Determine the optimal interval for CCS for each patient.

Accreditation statement

This activity has been evaluated and approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women’s Health (NPWH), and has been approved for 1.0 contact hour of CE credit.

Faculty disclosures

NPWH policy requires all faculty to disclose any affiliation or relationship with a commercial interest that may cause a potential, real, or apparent conflict of interest with the content of a CE program. NPWH does not imply that the affiliation or relationship will affect the content of the CE program. Disclosure provides participants with information that may be important to their evaluation of an activity. Faculty are also asked to identify any unlabeled/unapproved uses of drugs or devices made in their presentation.

Kim Choma, DNP, APN, WHNP-BC, has disclosed that she serves on the Speakers’ Bureau and advisory board of Hologic.

Charles Dubin, MD, reports that he serves on the Speakers’ Bureau of Hologic, Myriad Genetics, and Phenogen Sciences.

Disclosure of unlabeled use

NPWH policy requires authors to disclose to participants when they are presenting information about unlabeled use of a commercial product or device or an investigational use of a drug or device not yet approved for any use.

Disclaimer

Participating faculty members determine the editorial content of the CE activity; this content does not necessarily represent the views of NPWH or Hologic. This content has undergone a blinded peer review process for validation of clinical content. Although every effort has been made to ensure that the information is accurate, clinicians are responsible for evaluating this information in relation to generally accepted standards in their own communities and integrating the information in this activity with that of established recommendations of other authorities, national guidelines, FDA-approved package inserts, and individual patient characteristics.

Successful completion of this activity

Successful completion of this activity, J-16-01, requires participants to:

1. “Sign In” at the top right-hand corner of the page (npwh.org/courses/home/details/559) if you have an NPWH account. You must be signed in to receive credit for this course. If you do not remember your username or password, please follow the “Forgot Password” link and instructions on the sign-in page. If you do not have an account, please click on “Create an Account.”

2.Read the learning objectives, disclosures, and disclaimers on the next page.

3.Check “Agree to Terms” on the next page and then click the “Continue” button.

4. Study the material in the learning activity during the approval period (now through March 31, 2017).

5.Complete the posttest and evaluation. You must earn a score of 70% or better on the posttest to receive CE credit.

6.Print out the CE certificate if successfully completed.

Commercial support: This activity is supported by educational grants from Hologic.

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

The authors evaluate current available options for cervical cancer screening (CCS), with an emphasis on the importance of maximizing the benefits of cancer prevention while minimizing the harms associated with overtreatment. Two major dilemmas are addressed: Which CCS method is recommended for women aged 30-65? and What is the optimal interval between screenings for women in any age group?

Cervical cancer screening (CCS) has been one of the most successful screening programs in United States history, reducing cervical cancer-related incidence and mortality by 45% and 49%, respectively, since 1980.1 Until fairly recently, yearly cytology testing was recommended to maximize detection of pre-cancerous lesions. The discovery that infection with the human papillomavirus (HPV) underlies the pathophysiology of nearly all cervical cancers led to the incorporation of HPV testing in general screenings of women aged 30 years or older, starting in 2003.2, 3

Unlike few other forms of cancer, cervical cancer is nearly always

preventable.4 Under optimal circumstances, each potential case of cervical cancer can be forestalled by identifying and treating

disease that progresses, at most, to the high-grade cancer precursor stage.5, 6 At the same time, healthcare professionals (HCPs) want to minimize the harms associated with overtreatment of benign

lesions not destined to become cancerous.6

The cervical cancer screening dilemma

The essence of the CCS dilemma is which screening test(s) to use and how frequently to screen. Major national health organizations may differ somewhat in their specific recommendations, but their general objectives are to prevent morbidity and mortality from cervical cancer and to prevent overzealous management of precursor lesions that most likely will regress or disappear.6, 7

Which cervical cancer screening tests are available?

Two tests, cervical cytology and the HPV test, are used to screen for cervical cancer. In essence, though, HCPs have three CCS options: cytology alone, the HPV test alone (known as the primary HPV test), and co-testing with both methods.

Cervical cytology

A sample of cervical cells is examined under a microscope to screen for premalignant cells that could signal the presence of cancer precursors.8 Cervical cells collected by an HCP are smeared on a glass slide (traditional or conventional cytology—that is, the Pap test) or added to a preservative fluid (liquid-based thin-layer test). Liquid-based cytology, because of its greater sensitivity than conventional cytology in detecting disease, enables extension of the screening interval from 1 year to up to 3 years—without significantly diminishing CCS effectiveness.9

HPV testing

The causal role of persistent HPV infection in the development of cervical cancer and its precursors has been well documented.10 A landmark 2010 study showed that, over a 60-year study period, the 8 most common HPV types identified were (in descending order of frequency) 16, 18, 45, 33, 31, 52, 58, and 35.11 Together, these genotypes account for 91% of all cases of cervical cancer. HPV 16, 18, and 45 were found in 75% of the most common type of cervical cancer (squamous cell) and in 94% of the second most common form (adenocarcinoma). A study of more than 20,000 women showed that those infected with HPV types 16 and/or 18, versus those infected with other high-risk types, had a 10 times greater risk of developing cervical cancer.12 Because HPV cannot be cultured, in most cases its accurate identification relies on molecular biology techniques.13 Molecular assays use primers and probes that identify a region of HPV DNA or HPV mRNA. Of note, HPV tests used in clinical practice need to be FDA approved for validity.6

Co-testing

Recent incorporation of HPV DNA testing into CCS strategies offers the benefits of increasing early disease detection (up to 100% sensitivity) 14 and increasing the length of the interval between screenings—thereby lessening harms such as the adverse psychosocial impact of screening positive, the need for additional visits and procedures, and the treatment of lesions that would have resolved on their own.6 Even more recently, HPV infection can be identified by HPV mRNA testing, which, like standard HPV DNA testing, has up to 100% sensitivity15 but also offers improved specificity, with a 24% reduction in false-positive results.16

Which approaches to screening are recommended for women aged 21-29?

According to guidelines issued in 2012 by the American Cancer Society (ACS), the American Society of Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP), CCS should begin at age 21.6 Women aged 21-29 should undergo cervical cytology every 3 years.6 The same year, the U.S. Preventive Services Task Force (USPSTF) and the American Congress of Obstetricians and Gynecologists (ACOG) issued similar recommendations.17, 18 These organizations all advised against HPV co-testing in women younger than 30; although HPV is commonly present in women in this age group, most of them successfully fight off the infection within a few years.19 An updated Practice Bulletin from ACOG published in January 2016 reinforces the recommendations for women aged 21-29 based on level A evidence: Co-testing in these women and annual cytology should not be performed.20 Until more longterm, level A evidence studies are available to support future updates to the 21-29 age group, HCPs are encouraged to follow the consensus guidelines.6 Although primary HPV testing was not recommended at the time of the ACS/ASCCP/ASCP, USPSTF, and ACOG updates in 2012—in fact, its use was specifically discouraged in women in their 20s—the body of evidence supporting this CCS approach has grown. Findings from the Addressing the Need for Advanced HPV Diagnostics (ATHENA) study (2008-2012) supported the safety and effectiveness of primary HPV testing.21, 22 In 2014, the FDA approved the use of the cobas HPV test as a primary screen for cervical cancer in women aged 25 years or older.23 As a result, interim clinical guidance issued by the Society of Gynecologic Oncology (SGO) and the ASCCP in 2015 supported primary HPV testing as a possible alternative to cytology-based screening and co-testing, but starting no sooner than age 25.24

Which approaches to screening are recommended for women aged 30-65?

Again, HCPs have three CCS options: cervical cytology, primary HPV testing, and co-testing. The ACS/ASCCP/ASCP recommends cytology alone every 3 years or cotesting every 5 years.6 The USPSTF endorses cytology every 3 years, with co-testing as an option in women who want to extend their screening interval to 5 years.17 ACOG supports the options of cytology at 3-year intervals and co-testing at 5-year intervals, with the latter preferred.18 None of these organizations advocates the use of primary HPV testing as an alternative to cytology or co-testing.

Co-testing for women aged 30 or older was approved by the FDA in 2006. But how does co-testing compare with primary HPV testing— as advocated in the interim guidance report—and with cervical cytology alone in predicting outcomes in women in the 30- to 65-year age group?

Studies supporting co-testing 

Blatt et al25 conducted a retrospective study to assess the sensitivity of various testing options for biopsy-proven cervical intraepithelial neoplasia grade 3 or worse (CIN3+). The authors evaluated 256,648 cervical biopsies from women aged 30-65 who had undergone a co-test and colposcopy within 1 year of each other (colposcopy was performed a mean of 54 days after the co-testing result). Among the samples, 4,090 (1.6%) exhibited CIN3+. A positive co-test result was 98.8% sensitive for diagnosing CIN3+, compared with the 94% sensitivity of a positive HPV test result and the 91.3% sensitivity of a positive cytology result. Looked at another way, in this group of women, use of cytology alone would have missed 8.7% of the CIN3+ cases and use of the HPV test alone would have failed to catch 6% of the CIN3+ cases, whereas co-testing would have missed only 1.2% of these cases. Therefore, co-testing identified 80% of the CIN3+ cases that would have been missed by screening with the primary HPV test. Of the 526 confirmed cases of cervical cancer in this study, 98 (18.6%) were HPV test negative and 64 (12.2%) were cytology negative, whereas only 29 (5.5%) were cotest negative. Co-testing identified 70% of cervical cancers that would have been missed by screening with the HPV test alone.

Additional studies conducted over the past 11 years showed that primary HPV testing missed a substantial proportion of cervical cancers, and were in concordance with the landmark study by Blatt and colleagues.11, 26-29

Studies supporting primary HPV testing

The aforementioned interim guidance from the SGO/ASCCP was based, in large part, on the results of several large trials demonstrating that a negative HPV test result provides greater reassurance of low CIN3+ risk than does a negative cytology result. For example, Dillner et al30 evaluated primary data from seven HPV screening studies in six European Union countries, each investigating the predictive value of primary HPV testing for future CIN3+. The cumulative incidence rate of CIN3+ after 6 years was considerably lower among women negative for HPV at baseline (0.27%) than among women with negative results on cytology (0.97%). The cumulative incidence rate among women who were cytology-negative/HPV-positive rose continuously over time, reaching 10% at 6 years, whereas the rate among women who were cytologypositive/HPV-negative remained below 3%.

Other recent studies provided evidence that a negative HPV test result, as compared with a negative cytology result, offers greater reassurance that a woman will be free of CIN3+ over time.31-33 In these studies, participants underwent co-testing. In essence, the investigators found that the HPV test results, relative to the cytology results, were more predictive of outcomes over 3-5 years. That is, the cytology portion of the cotest did not add much information to the HPV portion, suggesting, to some at least, that HPV testing could be used by itself.

The first dilemma: Which CCS method is recommended for women aged 30-65?

The findings of the studies supporting primary HPV testing are open to interpretation. For example, Gage et al32 compared the risks of CIN3+ and of cervical cancer alone for HPV testing every 3 years, cytology testing every 3 years, and co-testing every 5 years among more than 1 million women in the Kaiser Permanente population who were aged 30-64 years and who tested HPV-negative and/or cytology-negative in routine screening. Investigators found that 3-year risks following an HPV-negative result were lower than 3-year risks following a cytology-negative result (CIN3+, 0.069% vs. 0.19%; P <.0001; cancer, 0.011% vs. 0.020%; P<.0001) and 5-year risks following an HPV-negative/Pap-negative co-test result (CIN3+, 0.069% vs. 0.11%; P <.0001; cancer, 0.011% vs. 0.014%; P = .21). That is, the 3- year safety (i.e., reassurance against future risk of pre-cancer and cancer) conferred by a negative HPV test result exceeded the 3-year safety conferred by a negative cytology result or the 5-year safety conferred by a negative cotest result. However, a closer look at the data shows that if HPV testing had been compared with cotesting at the 3-year checkpoint instead of the 5-year checkpoint (the recommended interval), negative co-testing results at baseline were slightly more reassuring than negative HPV results at baseline for CIN3+ and for cancer.

In addition, as HPV-infected cervical cells progress toward cervical cancer, HPV DNA levels decline.34 Depending on the age at which CCS begins and the frequency with which it is performed, relying initially, solely, or mainly on the results of HPV DNA screening tests might miss fastgrowing cancers. Although as HPV integrates itself into the human genome and HPV DNA levels decrease, HPV E6/E7 mRNA levels increase, suggesting that the assay that particularly targets this protein, as compared with the HPV DNA assays, is more specific in indicating lesion severity.35 

Furthermore, with cytology alone, adenocarcinoma and its precursors are difficult to identify— simply because of the cervical anatomy and the detection methods used. Cervical adenocarcinoma is usually farther away from the transformation zone, the area targeted most readily with the use of cervical sampling devices. Cytology alone has been relatively ineffective in identifying glandular lesions associated with adenocarcinoma. Addition of HPV testing to cytology—that is, co-testing—should enhance identification of adenocarcinoma and its precursor, adenocarcinoma in situ (ACIS).18

At this point in time, co-testing seems a reasonable option in women aged 30-65 years because it offers optimal sensitivity and specificity in identifying cervical cancer precursors.

What is the optimal screening interval for cervical cancer screening?

The 2012 ACS/ASCCP/ASCP and ACOG guidelines’ recommended screening intervals are 3 years for liquid-based cytology testing and 5 years for co-testing.6, 18 The updated Practice Bulletin from ACOG states that co-testing every 5 years is preferred, but that screening with cytology alone every 3 years is acceptable.20 ACOG recommends against annual testing. The USPSTF recommends cytology every 3 years for women younger than 30.17 For women aged 30-65 who want to extend their screening interval to 5 years, adding HPV testing is advised. The interim guidance provided by the SGO/ASCCP recommends that re-screening after a negative primary HPV test result occur no sooner than every 3 years—but only in women aged 25 years or older.24

For decades in the past, women underwent conventional Pap testing every year—their single best option for identifying cervical cancer precursors in a timely fashion. But there was a distinct downside to this yearly testing, which often yielded results—atypical squamous cells of undetermined significance (ASCUS) or a higher-grade lesion—that would lead to colposcopy and, depending on the results of the cervical biopsies, a loop electrosurgical excision procedure or conization. Most of these cytologic abnormalities, as well as the HPV infections underlying them, resolve on their own. Screening women every year, then, is bound to lead to unnecessary diagnostic and therapeutic procedures. These procedures are, at the very least, unpleasant and worrisome and at worst, harmful.36-41

The second dilemma: What is the optimal interval between screenings for women in any age group? 

Since the CCS guidelines were published in 2012 and the interim guidance was published last year, a different perspective on the CCS interval has been offered. According to a commentary by Kinney et al,42 which was based on a modeling study for the USPSTF that was published in 2013,43 women who comply with the CCS recommendations and increase the co-testing interval from 3 years to 5 years are increasing their risk for unfavorable consequences, with an additional 1/369 diagnosed with cancer in her lifetime and 1/1,639 dying of cancer. Adoption of a 3-year co-testing interval instead of a 5-year co-testing interval between screenings would “cost” 409 additional colposcopies and 14.3 additional women treated for each cancer death prevented. Many women and their HCPs might argue that the extra screenings, tests, treatments, and related harms are worth it to save even a small number of lives. In  addition, as noted in the discussion of the first CCS dilemma, results of the study by Gage et al32 suggest that the optimal interval for co-testing may be 3 years, not 5 years. Finally, there is considerable clinician resistance to the 5-year screening interval recommended for a negative co-test result.42

Based on what is known to date, HCPs should consider the optimal CCS screening interval to be 3 years, both for cytologic testing in women aged 21-29 or older and for co-testing in women aged 30-65. 

At what age can cervical cancer screening safely be stopped?

According to the ACS/ASCCP/ASCP, CCS can safely be stopped in women older than 65 who have had adequate negative prior screening (three consecutive negative cytology results or two negative co-test results within the previous 10 years, with the most recent test performed within the past 5 years) and no history of CIN2+ within the past 20 years.6 The USPSTF and ACOG are in general agreement with these criteria.17, 18 For women older than 65 with a history of CIN2, CIN3, or ACIS, routine screening should continue for at least 20 years.6, 18 According to the USPSTF, women older than 65 who have never been screened, women who do not meet the criteria for adequate prior screening, or women for whom the adequacy of prior screening cannot be accurately accessed or documented should undergo routine CCS.17 Likewise, routine screening should continue for at least 20 years after spontaneous regression or appropriate management of a highgrade pre-cancerous lesion, even if this extends screening past age 65.

Conclusion

The best approach to prevent cervical cancer entails screening and vaccination. The goals of maximizing benefits and minimizing harms for patients are guiding principles at the forefront of CCS. To this end, using the evidence to date, which includes the 2012 guidelines, the interim guidance published last year, and the updated ACOG practice bulletin, cytology screening every 3 years in women aged 21-29 and co-testing every 3 years in women aged 30-65 are reasonable recommendations to balance patient harms and clinician resistance to 5- year screening intervals.

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