Current Strategies for Cancer Screening and the Well-Woman Visit Michael S. Policar, MD, MPH Professor Emeritus of Ob, Gyn, and Repro Sci UCSF School of Medicine [email protected]UCSF Essentials of Women’s Health Conference June 30, 2019 • For this lecture, I have no relevant financial relationships with any commercial interests to disclose
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Current Strategies for Cancer Screening and the Well-Woman Visit
Michael S. Policar, MD, MPHProfessor Emeritus of Ob, Gyn, and Repro SciUCSF School of [email protected]
UCSF Essentials of Women’s Health ConferenceJune 30, 2019
• For this lecture, I have no relevant financial relationships with any commercial interests to disclose
Other Disclosures• Bayer: litigation consultant • Sebela Pharmaceuticals – Investigator proctor in phase III trial of
a copper IUD (VeraCept)
Marisella
• 28 year old G2P0TAB2 established client seen for a well woman visit
• In a monogamous relationship for the past two years• Feeling well; no c/o vaginal discharge, abnormal bleeding,
dyspareunia• Last cervical cytology was 2 years ago in another city• Currently using OCs; requests a year’s supply
Which screening tests does the USPSTF recommend ?What is the most important question to ask her?
q Clinical breast examq Cervical cytologyq Bimanual pelvic examq Chlamydia + Gonorrhea NAATq HIV-1 serologyq HSV-2 serologyq Syphilis (VDRL or RPR)q Hepatitis B serologyq Fasting blood glucoseq Fasting lipid profile
Marisella: 28 Year Old Female
q Clinical breast examq Cervical cytologyq Bimanual pelvic examq Chlamydia + Gonorrhea NAAT√ HIV-1 serologyq HSV-2 serologyq Syphilis (VDRL or RPR)q Hepatitis B serologyq Fasting blood glucoseq Fasting lipid profile
Marisella: 28 Year Old Female
The Most Important Question To Ask?
• Do you have a primary care (or women’s health) provider?– When did you see her (or him)? – Which tests were performed? Results?
• Why is this so important?– Tailor the content of today’s visit
•Comprehensive well woman visit, or•GYN health screening visit
– Offer necessary services not yet performed– Avoid duplication of services already received– Minimize fragmentation of care
Historical Perspective
• “Check-ups” recommended in U.S. since the 1920s• Now antiquated terms
– Annual physical– Annual visit– Check-up visit
• Currently referred to as …– USPSTF: Periodic health screening visit– CPT: Preventive medicine visit– ACOG: Well woman visit (WWV)
The Well Woman Visit
• Major health objectives– Anticipatory guidance – Screening for asymptomatic conditions– Increase the client’s sense of well-being– Promote the clinician-client relationship– Positive action toward self-maintenance of health
• In a family planning context– Clarify her reproductive Intentions – Correct and consistent use of her contraceptive method– Optimize reproductive health
Who Defines Well Woman Services?
• US Preventive Services Taskforce–Primary care specialty societies (ACP, AAFP)–Most health plan guidelines
• ACOG: “Primary and Preventive Care” guidelines• ACS: Cancer screening guidelines• OPA/CDC: Providing Quality FP Services (QFP)• ACA: Women’s Preventive Services–Benefits without cost-sharing; not practice guidelines
USPSTF 2007: Strength of Recommendation
Comment InterventionA Recommend Net benefit is substantial Offer or provideB Recommend Net benefit is moderate Offer or provideC Recommend
against providing routinely
May be considerations that support the service in an individual patient
Offer only if other considerations to support
D Recommend against
No net benefit (or) harms outweigh benefits
Discourage the use of this service
I Evidence is insufficient
Evidence is lacking, poor quality, or conflicting
Benefits/harms can not be determined
www.uspreventiveservicestaskforce.org
http://www.acog.org/
About-ACOG/ACOG-
Departments/Annual-
Womens-Health-
Care/Well-Woman-
Recommendations
• Is a physical exam necessary with every WWV?– As needed for scheduled screening tests– Diagnostic exam when symptoms or signs– Some visits will consist solely of counseling and
education without an exam beyond a BP check • Is a yearly health screening visit advised if no tests are due?
– USPSTF: every 1-3 years, depending upon health status and risk behaviors of the client
– ACOG: perform annually
Well Woman Visits
Exams and Tests Needed Before Contraceptive Method Initiation
• If hrHPV testing alone– Screening should not be initiated before 25 years of age– Screen no sooner than every 3 years
• Advantages– Better sensitivity than cytology alone– Less expensive than co-testing (since no cytology for most)– Highly adaptable to low-resource countries
• Disadvantages– Less specificity than cytology alone…more colposcopies
Huh WK. et al. Obstet Gynecol 2015;125:330–7
Cervical Cancer ScreeningFinal Recommendation
[ A ] Three options for women 30-65 years of age….either– Primary hrHPV (only) every 5 years, OR– Co-testing every 5 years, OR– Cervical cytology alone every 3 years
[ A ] Women 21-29 years of age: cytology every 3 years[ D ] Women < 21 years of age: do not screen[ D ] Women > 65, adequately screened in prior 10 yrs, no history of treatment or NED >20 years: do not screen
2018
Recommends that females discuss options with clinician
2018 Cervical Cancer Screening Guidelines
< 21 y.o.
21-29 y.o. 30-65 y.o.
USPSTF2018
[D] Cytology every 3 yrs hrHPV alone: every 5 yrs orCo-test: every 5 years orCytology: every 3 yrs
Triple A2012
None Cytology every 3 yrs Co-test: every 5 orCytology: every 3 yrs
ACOG2016
“Avoid” Cytology every 3 yrs Co-test: every 5 orCytology: every 3 yrs
Co-test: cervical cytology plus high risk HPV test (hrHPV)Cytology: cervical cytology (Pap smear) alone
Implications: 2018 USPSTF Cervical Cancer Screening Recommendations
• ACOG, ACS & ASCCP haven’t changed recommendations yet, but may do so
• Fewer cervical cytology tests, since 1o hr-HPV screening option added in women > 30 years of age
• More colposcopies, as women >30 years of age move away from cytology alone and toward 1o HPV screening
• Health plans may consider limiting the use of co-tests to surveillance after abnormal cytology or treatment
1. Reproductive goals counseling2. Cervical cancer screening3. Screening clinical breast exam (SCBE)4. Screening pelvic exam (SPE)
40-49: offer and initiate50-74: recommend every 1-2 yrs>75: shared decision
40-49: discuss50-74: offer every 2 yrs> 75: life expectancy < 10 years: discontinue
Screening Clinical Breast Exam
The ACS does not recommend clinical breast
examination for breast cancer screening among
average-risk women at any age (Q)
2015
Screening Clinical Breast Exam
• No evidence of any benefit of a CBE alone or in conjunction with screening mammography
– No data on whether outcomes are improved
• Moderate-quality evidence that adding CBE to mammography increases the false-positive rate
• CBE detects a small number of additional breast cancers (2%-6%) missed by mammography alone
2015
Screening Clinical Breast Exam
2015
“Recognizing the time constraints in a typical clinic
visit, clinicians should use this time instead for
ascertaining family history and counseling women
regarding the importance of being alert to breast
changes and the potential benefits, limitations, and
harms of screening mammography”
Screening Clinical Breast ExamACOG Practice Bulletin #179
Screening clinical breast exam may be offered…
• To women in the context of shared decision making that recognizes the additional benefits and harms of CBE beyond screening mammography (Q)
– To women ages 19–39 years every 1–3 years (Q)
– Annually to women aged 40 years and older (Q)
Q: “Qualified” recommendations rely primarily on expert consensus
2017
The Evolving Screening Pelvic
Examination Debate
The SPE Debate: Terms
• Screening Pelvic Exam (SPE)
– External inspection, speculum and bimanual exam at the time of a WWV in an asymptomatic patient
• Diagnostic Pelvic Exam
– Pelvic exam for the purpose of evaluating symptoms, signs, or other abnormal findings (lab, imaging)
• Cervical cytology sampling
– Speculum used for the purpose cervical sampling
SPE: What’s the Fuss About?
Potential benefits• Find an asymptomatic condition that is a health risk
– Ovarian cancer– Benign neoplasm that could torse
• Find a symptomatic condition that the patient is unwilling to disclose or does not recognize as a problem– Urinary incontinence, pelvic organ prolapse– Sexual issues (GSM?)– HSIL of the vulva (VIN)
Ovarian Cancer Screening
• Recommends against screening for ovarian cancer in asymptomatic women Grade [D]
• Applies to asymptomatic women who are not known to have a high-risk hereditary cancer syndrome
February 2018
Other Potential Benefits: What Does the Evidence Say?
• Asymptomatic BV not recommended CDC• Asymptomatic trichomoniasis targeted screening only• VIN/vulvar cancer no studies• Fibroids no studies• Urinary incontinence determine by history• GU syndrome of menopause determine by history
SPE: American College of PhysiciansQaseem A et al, Ann Intern Med. 2014;161:67-72
• ACP recommends against performing SPE in asymptomatic, non-pregnant adult women
• Many clinicians include SPE as part of the WWV, and because it is low-value care, it should be omitted
2014
Why Recommend Against SPE?
• Accuracy for detecting ovarian cancer is low– PLCO Trial: Ovarian cancer screening with ultrasound,
CA-125, SPE: more harms than benefits• No studies have assessed benefit for other conditions
(PID, benign conditions, or other gyn cancers)• Outcomes are not improved• Harms: unnecessary laparoscopies or laparotomies, fear,
ACOG Well Woman Task Force Obstet Gynecol 2015;126:697–701
For women age 21 years and older (Qualified)
• External exam may be performed annually
• Inclusion of speculum exam, bimanual exam, or both, in otherwise healthy women should be a shared, informed decision between patient and provider
“Qualified” recommendations rely primarily on expert consensus
20152018
Screening Pelvic Exam
• [ I ] Recommendation
• Current evidence is insufficient to assess the balance of benefits and harms of performing SPE
• “…clinicians are encouraged to consider risk factors for various gynecologic conditions and the patient’s values and preferences, and engage in shared decision making to determine whether to perform a pelvic exam”
March 2017
The Utility of and Indications for Routine Pelvic Examination
Obstet Gynecol. 2018 Oct;132(4):e174-e180
• ObGyns and other providers should counsel asymptomatic women about the benefits, harms, and lack of data
• After reviewing risks and benefits, SPE may be performed if a woman expresses a preference for it
• Regardless of whether SPE is performed, a woman should see her ObGyn at least once a year for well-woman care
2018
Should I Do a Screening Pelvic Exam…
• ACP, AAFP (2014): We know…don’t do it• ACOG (2015) : We think we know….do it. But
discuss it first• USPSTF (2017): We don’t know, but you may want
to discuss it• ACOG (2018): We don’t know, but you should
discuss it
SPE: What Do We Tell Patients?
Active• “3 national guidelines: each one is different”• All 3 agree that there is no evidence of benefit
• Evidence of harms: “false alarms” and complicationsPassive• It is reasonable to say nothing about the SPE, and
only respond to questions or to a request for an exam
How Can My Practice Prepare?
• Ask every patient if she sees a PCP/ women’s HC provider• Determine the screening policies for your practice
– Seek consistency among your providers– Make sure that all staff are aware of your policy
• Inform your patients of changes that apply to them– During transition, leave decisions to patient– Inform patients with a personal letter or newsletter
• Keep track of benefit changes made by your payers– Few have changed screening benefits yet
• ACOG Committee Opinion No. 754: The Utility of and Indications for Routine Pelvic Examination. Obstet Gynecol. 2018 Oct;132(4):e174-e180
• Brown HL, Warner JJ, et al. Promoting risk identification and reduction of cardiovascular disease in women through collaboration with obstetricians and gynecologists: a presidential advisory from the AHA and ACOG. Circulation. 2018;137:e843–e852.
References
• Miller WB, Barber JS, Gatny HH. The effects of ambivalent fertility desires on pregnancy risk in young women in the USA. Popul Stud (Camb). 2013;67(1):25-38
• Callegari LS, Aiken AR, Dehlendorf C, Cason P, Borrero S. Addressing potential pitfalls of reproductive life planning with patient-centered counseling. Am J Obstet Gynecol. 2017 216(2):129-134.
• Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S SPR for Contraceptive Use, 2016. MMWR 2016 Jul 29;65(4):1-66
References
• ACOG Practice Bulletin No. 168 Cervical Cancer Screening and Prevention. Obstet Gynecol 2016 Oct;128(4):e112-130
• Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol 2015;125:330–7
• USPSTF Final Recommendation Statement Cervical Cancer: Screening. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2
References
• Wentzensen N, Schiffman M, et al. Triage of HPV positive women in cervical cancer screening. J Clin Virol. 2016 Mar; 76(Suppl 1): S49–S55.
• Sawaya GF, Smith-McCune K. Clinical Expert Series. Cervical Cancer Screening. Obstet Gynecol 2016;127:459–67
• Conry JA, Brown H. Well-Woman Task Force: Components of the Well-Woman Visit. Obstet Gynecol 2015;126:697–701
• USPSTF, Bibbins-Domingo K, Grossman DC, et al. Screening for Gynecologic Conditions with Pelvic Examination: US Preventive Services Task Force Recommendation Statement. JAMA 2017;317:947–953.
References
• Qaseem A, et. al. Clinical Guidelines Committee of the American College of Physicians. Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2014;161:67–72.
• Qaseem A, et. al. Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the ACP. Ann Intern Med. 2019;170:547-560
• Sawaya GF. Screening Pelvic examinations: the emperor’s new clothes, now in 3 sizes? JAMA Intern Med 2017; 177:467–46