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No more breast exams and annual exams? Update on recommendations from ACOG’s Gyn Practice committee Peggy A. Norton, M.D. Chief of Female Pelvic Medicine.

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Presentation on theme: "No more breast exams and annual exams? Update on recommendations from ACOG’s Gyn Practice committee Peggy A. Norton, M.D. Chief of Female Pelvic Medicine."— Presentation transcript:

1 No more breast exams and annual exams? Update on recommendations from ACOG’s Gyn Practice committee Peggy A. Norton, M.D. Chief of Female Pelvic Medicine and Reconstructive Pelvic Surgery University of Utah School of Medicine

2 Learning Objectives Describe the source of committee opinions and practice bulletins in ACOG Describe the history of changes in basic gyn services in the U.S. over the past five years Know if there are to be no more breast exams! Or no more annual exams!

3 ..dedicated to the advancement of women’s health care through continuing medical education, practice, and research

4 Structure of ACOG ACOG executive Board Gynecologic Practice Committee Subcommittees on REI, FPMRS, Gyn Oncology Gyn Practice Bulletins Committee Clinical Document Review Panel Obstetric Practice Committee Subcommittee on MFM Obstetric Practice Bulletins

5 Types of ACOG practice documents Practice Bulletin: high quality data exists from which to recommend practice. Committee Opinion: important issue to gynecologists and their patients, but insufficient data exists to generate a Bulletin. Technology Assessment: technologic assessment, usually for new technology, for which members need guidance on use in the absence of extensive data.

6 Types of ACOG practice documents Practice Bulletin: high quality data exists from which to recommend practice. Committees of Gyn Practice and Practice Bulletins consider initial data. An expert is selected who writes the bulletin under the direction of the Practice Bulletins Committee

7 Types of ACOG practice documents Committee Opinion: important issue to gynecologists and their patients, but insufficient data exists to generate a Bulletin. Decision is made between PB and GP committees. COs demand absence of bias in committee members, who write and edit the documents

8 The way it was… Annual exam by Ob/Gyn Breast exam, pap and pelvic Annual prior to any treatment including OCPs Aggressive screening for cervical and breast CA Primary care issues for women beginning in the 1980s

9 Shift in thinking about cervical cancer screening 2009-2011 ASCCP issues new guidelines in cervical cancer screening – Prevent morbidity and mortality from cervical cancer – Prevent overzealous mgmt of precurser lesions that most likely will regress or disappear and for which and for which the risks of management outweigh the benefits.

10 ACS, ASCCP, ASCP No screening prior to age 21 years 21-29 years, cytology every three years. HPV testing should not be used as a screening test 30-65 years, cytology plus HPV co-testing every five years, or cytology every three years Stop screening after hysterectomy unless there is a history of CIN2 or greater Screening should not resume after 65 years, even if there is a new partner If h/o CIN 2, 3, or AIS, continue screening for 20 years thereafter.

11 Management of Abnormal Cervical Cancer Screening Test Results and Cervical Cancer Precursors PB 140 2013 The following recommendations are based on good and consistent scientific evidence (Level A): For women with ASC-US cytology test results, reflex HPV testing is preferred. For women with HPV-positive ASC-US, whether from reflex HPV testing or co-testing, colposcopy is recommended. For women with LSIL cytology test results and no HPV test or a positive HPV test result, colposcopy is recommended. For women with a histologic diagnosis of CIN 2, CIN 3, or CIN 2,3 and adequate colposcopic examination, both excision and ablation are acceptable treatment modalities, except in pregnant women and young women.

12 The Well Woman Visit CO 534, August 2012 reaffirmed 2014 The annual health assessment should include screening, evaluation and counseling, and immunizations based on age and risk factors. The interval for specific individual services and the scope of services provided may vary in different ambulatory care settings. The performance of a physical examination is a key part of an annual visit, and the components of that examination may vary depending on the patient’s age, risk factors, and physician preference. In general, the physical examination will include obtaining standard vital signs, determining body mass index, palpating the abdomen and inguinal lymph nodes, and making an assessment of the patient’s overall health. Many, but not all, women will have a pelvic examination and a clinical breast examination as a part of the physical examination. Information on these core elements of the physical examination is provided in the following sections.

13 Age-based ACOG recommendations Patients under 21 do not need internal pelvic exams unless there are symptoms that warrant such exam. Patients over 21: The decision whether or not to perform a complete pelvic examination at the time of the periodic health examination for the asymptomatic patient should be a shared decision after a discussion between the patient and her health care provider.

14 Well woman visit: pelvic exam The pelvic examination includes three elements: – inspection of the external genitalia, urethral meatus, vaginal introitus, and perianal region (external examination); – speculum examination of the vagina and cervix; and – bimanual examination of the uterus, cervix, and adnexa (the latter two elements constitute the internal examination). When indicated, a rectovaginal examination also should be performed. – Additionally, cultures for STIs can be obtained from the cervix during an internal pelvic examination. However, current evidence shows that screening for STIs also can be performed without an internal pelvic examination using nucleic acid amplification testing from urine samples or vaginal swab specimens.

15 Shared Communication and Decision Making The decision to perform an internal pelvic examination, breast examination, or both should be made by the physician and the patient after shared communication and decision making. Concerns, such as individual risk factors, patient expectations, or medical–legal concerns may influence the decision to perform an internal pelvic examination or clinical breast examination. In these situations, the medical record should reflect the pertinent details of the patient’s medical and family history and overall condition, documentation of the physical examination, and the issues discussed between the patient and physician.

16 January 2013 American Academy of Family Practice: “Time not well spent” Breast CA: In contrast to ACOG's recommendations, the USPSTF has found insufficient evidence to assess the benefits and harms of clinical breast examination, and recommends against teaching breast self- examination Ovarian CA: Routine screening for ovarian cancer with bimanual examination, transvaginal ultrasonography, or cancer antigen 125 testing is not recommended. It does not reduce ovarian cancer mortality, and leads to complications from diagnostic evaluation of false- positive results.

17 “Preventative time not well spent” editorial Nguyen et al 2014 Primary care physicians need to make the best use of their limited time to deal effectively with patients' medical concerns, address preventive care, and nurture the doctor-patient relationship. It has been suggested that to address every preventive service recommended by the U.S. Preventive Services Task Force (USPSTF), a typical physician with a standard patient panel would need to spend 7.4 hours per working day providing these services. Consequently, when considering the health maintenance examination, we must think carefully about which tasks are supported by evidence and which are being performed merely out of habit. Given the lack of evidence to support annual pelvic examinations, it would be better for patients if we spend that time addressing screening, counseling, and other preventive services for which strong evidence exists.

18 Response to AAFP The College continues to firmly believe in the clinical value of pelvic examinations, through which gynecologists can recognize issues such as incontinence and sexual dysfunction. While not evidence- based, the use of pelvic exams is supported by the clinical experiences of gynecologists treating their patients. Pelvic examinations also allow gynecologists to explain a patient’s anatomy, reassure her of normalcy, and answer her specific questions, thus establishing open communication between patient and physician. Of course, pelvic examinations represent just one part of the annual well-woman visit, which can help to identify health risks for women and which can also feature clinical breast examinations, immunizations, contraceptive care discussions, and health care counseling. Importantly, annual well-woman visits help to strengthen the patient-physician relationship.

19 Over-the-Counter Access to Oral Contraceptives CO 544: December 2012 Unintended pregnancy remains a major public health problem in the United States. Access and cost issues are common reasons why women either do not use contraception or have gaps in use. A potential way to improve contraceptive access and use, and possibly decrease unintended pregnancy rates, is to allow over-the-counter access to oral contraceptives (OCs). Screening for cervical cancer or sexually transmitted infections is not medically required to provide hormonal contraception. Weighing the risks versus the benefits based on currently available data, OCs should be available over-the-counter. Women should self-screen for most contraindications to OCs using checklists.

20 Over the counter OCPs: What were they thinking? They were thinking that the consequences of unintended pregnancy outweighed the benefits of being screened for contraindications to OCPs.

21 ACOG Practice Advisory on Annual Pelvic Examination Recommendations: June 30, 2014 The College’s guidelines, which were detailed in this year’s Committee Opinion on the Well- Woman Visit, acknowledge that no current scientific evidence supports or refutes an annual pelvic exam for an asymptomatic, low-risk patient, instead suggesting that the decision about whether to perform a pelvic examination be a shared decision between health care provider and patient, based on her own individual needs, requests, and preferences.Committee Opinion on the Well- Woman Visit

22 CO #615, Access to Contraception January 2015 Common medical practices prevent easy initiation of contraception. There is no medical or safety benefit to requiring routine pelvic examination or cervical cytology before initiating hormonal contraception. The prospect of such an examination may deter a woman, especially an adolescent, from having a clinical visit that could facilitate her use of a more effective contraceptive method than those available over the counter.

23 Another common practice is requiring one medical appointment to discuss initiation of a LARC method and a second for placement of the device or requiring two visits to perform and obtain results from sexually transmitted infection testing. Clinicians are encouraged to initiate and place LARC in a single visit as long as pregnancy may be reasonably excluded. Sexually transmitted infection testing can occur on the same day as LARC placement, and women do not require cervical preparation for insertion. Insurer payment policies should support same-day provision by providing appropriate payment and reimbursement for multiple services performed during a single visit. Similarly, health care providers should encourage patients initiating combined hormonal contraceptives to start on the day of the medical visit.

24 The Initial Reproductive Health Visit CO #598, May 2014 The initial visit for screening and the provision of reproductive preventive health care services and guidance should take place between the ages of 13 years and 15 years. The initial reproductive health visit provides an excellent opportunity for the OB/GYN to start a patient–physician relationship, build trust, and counsel patients and parents regarding healthy behavior while dispelling myths and fears. …A general exam, a visual breast exam, and external pelvic examination may be indicated. However, an internal pelvic examination generally is unnecessary during the initial reproductive health visit, but may be appropriate if issues or problems are discovered in the medical history.

25 Well woman: breast Although the value of a screening clinical breast examination for women with a low prevalence of breast cancer (eg, women aged 20–39 years) is not clear, the College, ACS, and the National Comprehensive Cancer Network continue to recommend clinical breast examination for these women every 1–3 years. All three organizations also recommend the teaching of breast self-awareness and inquiry into medical history and family history of risk factors for breast disease.

26 No more breast exams? Probably continue every 1-3 years unless there is new evidence of benefit Self- exam? Self-awareness Mammography debates

27 No more pap smears? Not as many Definitely fewer, probably better Start later, stop earlier No paps after hyst in most cases Why didn’t we study this sooner?

28 No more pelvic exams? Wrong. Sound clinical judgment always must be the guiding factor in determining when a pelvic examination is indicated. The decision to receive an internal examination can be left to the patient if she is asymptomatic and has undergone a total hysterectomy and BSO for benign indications and has no history of CIN 2 +

29 Who are Ob/Gyns and whom does ACOG serve?

30 ACOG Is ACOG the advocate for women’s health providers? Or is ACOG the advocate for women’s health?

31 COs and PBs are available at Practice bulletins: – Management of Abnormal Cervical Cancer Screening Test Results and Cervical Cancer Precursors PB 140 2013 Committee opinions: – The Well Woman Visit.CO 534, August 2012 reaffirmed 2014 – Over-the-Counter Access to Oral Contraceptives CO 544: December 2012 Riley et al. Health maintenance in women. Am Fam Physician. 2013 Jan 1;87(1):30-37. Nguyen et al. The Annual Pelvic Examination: Preventive Time Not Well Spent. Am Fam physician. 2013 Jan 1;87(1):8-9

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