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• Well appearing
• BP 124/81
• BMI 25.2
• Normal external and vaginal exam
• Pap test and HPV co-testing performed
• Bimanual examination was not performed
BACKGROUND
• Pelvic examinations have historically been a part of regular
preventive care with 62.8 million performed in the US in 2010.
• Historically the examination was conducted in conjunction with
annual cervical cancer screening.
• As cervical cancer screening can now be performed at intervals up
to every 5 years, depending on the patient, there are questions
about whether women need to be seen annually for a routine
pelvic examination.
• Many women and providers continue to believe that routine pelvic
examination should be a part of the well woman visit.
• And yet, performing routine pelvic examinations adds direct and
indirect costs to the health care system as well as opportunity costs.
THE PELVIC EXAMINATION - 3 parts
• Well-woman visit. Committee Opinion No. 534. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2012;120:421–4.
ACOG OPINION:
Well-Woman Annual Visit
• Jennifer Potter, MD
Associate Professor of Medicine, HMS
Director of Women’s Health Program at BIDMC and Fenway Health
• Hope Ricciotti, MD
Associate Professor of Medicine, HMS
Chair and Residency Program Director in the Department of
Obstetrics and Gynecology at BIDMC
Dr. Potter
Primary Care Viewpoint
Routine Pelvic Examination:
An Evidence-Based Appraisal
CHOOSING WISELY:
Questions to Ask and Discuss with Patients
Adnexal Mass ≥ 5 cm 0.28 (0.13, 0.46) 0.93 (0.83, 0.96) 0.64 (0.35, 0.74)
Abnormal Uterine Size 0.64 (0.45, 0.83) 0.80 (0.67, 0.87) 0.57 (0.37, 0.72)
Abnormal Uterine Contour 0.62 (0.43, 0.80) 0.78 (0.64, 0.85) 0.55 (0.37, 0.66)
• No specific studies.
• Given the biology of endometrial CA, would not expect
BME to detect disease until late in the course.
• High proportion of patients present with symptoms
(abnormal bleeding).
• Patient education, rather than pelvic exam, a key early
detection strategy.
• Trimble CL, Method M, Leitao M, Lu K, Ioffe O, Hampton M, et • Modesitt S. Missed opportunities for primary endometrial
al. Management of endometrial precancers. Obstet Gynecol. cancer prevention: how to optimize early identification and
2012;120:1160-75. treatment of high-risk women. Obstet Gynecol. 2012;120:989-
91.
DIAGNOSTIC ACCURACY FOR DETECTION
OF UPPER GENITAL TRACT INFECTIONS
• Retrospective cohort study (n=2169) of asymptomatic
women presenting to an STI clinic:
• 26/2169 (1.2%) had upper genital tract findings; infection
was confirmed in only 7/26.
• CDC recommends presumptive treatment for PID only
if patients have both signs and symptoms.
• Patient-collected vaginal swabs are the specimens of
choice when screening at-risk women for STIs.
• Singh RH, Erbelding EJ, Zenilman JM, Ghanem KG. The role of speculum and bimanual • Schachter J, Chernesky MA, Willis DE, Fine PM, Martin DH, Fuller D, et al. Vaginal swabs are the
examinations when evaluating attendees at a sexually transmitted diseases clinic. Sex specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results
Transm Infect. 2007;83:206-10. from a multicenter evaluation of the APTIMA assays for both infections. Sex Transm Dis.
• Chernesky MA, Hook EW 3rd, Martin DH, Lane J, Johnson R, Jordan JA, et al. Women find 2005;32:725-8.
it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis • Workowski KA, Berman S, Centers for Disease Control and Prevention (CDC). Sexually transmitted
or Neisseria gonorrhoeae infections. Sex Transm Dis. 2005;32:729-33. diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010;59:1-110.
DIAGNOSTIC ACCURACY IN DETECTING
PELVIC FLOOR DYSFUNCTION
• No studies on the role of vaginal palpation in screening
asymptomatic women.
• Literature has focused on identification and treatment
of symptomatic women.
• Emerging data suggest that preemptive pelvic floor
muscle training (PFMT) at strategic points across the
reproductive continuum may have preventive value.
• Boyle R, Hay-Smith EJ, Cody JD, Mørkved S. Pelvic floor muscle training for prevention and treatment
of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev.
2012;10:CD007471.
IMPACT OF BME ON QOL & MORTALITY
• No RCTs have evaluated the impact of either BME or
combined speculum/BME on morbidity or mortality from any
gynecological condition.
• BME was dropped from the screening protocol of the Prostate
Lung Colorectal Ovarian (PLCO) trial (n=78,216) after 5 years
because no ovarian cancer cases were detected solely by
adnexal palpation.
• PLCO results: no significant differences in number of ovarian
cancer cases detected by CA-125/TVUS (212 vs. 176 cases; RR
1.21 [95% CI, 0.99-1.48]), stage of disease, or ovarian cancer
mortality (118 vs. 100 deaths; RR 1.18 [95% CI, 0.82-1.71]).
• Buys SS, Patridge E, Black A, Johnson CC, Lamerato L, Isaacs C, et al. Effect of screening on ovarian cancer
mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled
Trial. JAMA. 2011;305:2295-303.
PELVIC EXAM IS ASSOCIATED WITH
PSYCHOLOGICAL / PHYSICAL DISTRESS
• Data from 14 low quality survey studies and 1 cohort
study (median n=409; range 40-7168).
• Fear, embarrassment, or anxiety endorsed by 10-
80% (median = 34%).
• Pain or discomfort endorsed by 11-60% (median =
35%).
• No studies have examined the degree of distress
attributable to different pelvic exam components.
• Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutkus I, et al. Screening pelvic examinations in
asymptomatic, average-risk adult women: an evidence report for a clinical practice guideline from the
American College of Physicians. Ann Intern Med. 2014;161:46-53.
PATIENT-CENTERED CARE PARAMOUNT
• Low patient acceptability reduces adherence:
• Women reporting pelvic exam-related pain or
discomfort less likely to follow-up (5/5 studies).
• High patient acceptability increases adherence:
• Increased utilization of hormonal contraceptives
when receipt is uncoupled from pelvic exam.
• Patient preference for (and better performance of)
self-collected vaginal swabs for STI screening.
• Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutkus I, et al. Screening pelvic examinations • Chernesky MA, Hook EW 3rd, Martin DH, Lane J, Johnson R, Jordan JA, et al. Women
in asymptomatic, average-risk adult women: an evidence report for a clinical practice guideline from the find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia
American College of Physicians. Ann Intern Med. 2014;161:46-53 trachomatis or Neisseria gonorrhoeae infections. Sex Transm Dis. 2005;32:729-33.
• Harper C, Balistreri E, Boggess J, Leon K, Darney P. Provision of hormonal contraceptives without a • Schachter J, Chernesky MA, Willis DE, Fine PM, Martin DH, Fuller D, et al. Vaginal swabs
mandatory pelvic examination: the first stop demonstration project. Fam Plann Perspect. 2001;33:13-8. are the specimens of choice when screening for Chlamydia trachomatis and Neisseria
gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both
infections. Sex Transm Dis. 2005;32:725-8.
DIAGNO STIC PRO CEDURES AFTER SCREENING -
RELATED FINDINGS MAY ALSO INCUR HARM
• False reassurance patient ignores or delays
evaluation for new symptoms.
• Overdetection (diagnosis of a clinically irrelevant
abnormality).
• Overtreatment (treatment for a clinically irrelevant
abnormality that would never have adversely affected
QOL or survival).
• Diagnostic procedure-related complications.
• No studies have directly assessed any of these
potential harms. • Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutkus I, et al. Screening pelvic
examinations in asymptomatic, average-risk adult women: an evidence report for a
clinical practice guideline from the American College of Physicians. Ann Intern Med.
2014;161:46-53.
FALSE POSITIVE BME F INDINGS LEAD TO
UNNECESSARY SURGERIES ( I N D I R E C T E V I D E N C E )
In 1 prospective cohort
study, 174/2000 (8.7%) Performance of
asymptomatic, 2/31 (6.5%) screening BME
31/174 (18%)
average-risk women were found to led to
underwent
aged 45-80 had have ovarian unnecessary
surgery
abnormal adnexal cancer surgery in 1.5%
findings on BME and a (29/2000)
normal serum CA-125
62.8 million screening pelvic exams were performed in the US in 2010 (NAMCS
and NHAMCS data); therefore, the number of false positive tests
occurring nationwide is likely substantial.
• Adonakis GL, Paraskevaidis E, Tsiga S, Seferiadis K, Lolis DE. A combined approach for the early detection of ovarian
cancer in asymptomatic women. Eur J Obstet Gynecol Reprod Biol. 1996;65:221-25.
http://www.cdc.gov/nchs/data/ahcd/namcs_summary/2010_namcs_web_tables.pdf
UNNECESSARY SURGERIES CAN CAUSE
S ERIOUS COMPLICAT IO NS ( I N D I R E C T E V I D E N C E )
• Buys SS, Patridge E, Black A, Johnson CC, Lamerato L, Isaacs C, et al. Effect of screening on
ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer
Screening Randomized Controlled Trial. JAMA. 2011;305:2295-303.
REDUCING UNNECESSARY PELVIC EXAMS
WOULD RESULT IN SIGNIFICANT SAVINGS
• Annual cost of preventive GYN exams was $2.6 billion
in 2002-2004 (NAMCS & NHAMCS data).
• Average per-visit laboratory and radiology costs
were $136.
• Current costs likely substantial due to inflation and
performance of pelvic exams more often than
recommended by current cervical cancer screening
guidelines.
• Mehrotra A, Zaslavsky AM, Ayanian JZ. Preventive health examinations and preventive
gynecological examinations in the United States. Arch Intern Med. 2007;167:1876-83.
CURRENT PRACTICE: NOT EVIDENCE -BASED
• Paps still being done on women < 21 years of age and after
hysterectomy for benign disease.
• 2010 survey of US physicians and APRNs (n=1196; response
rate 65%): 1/3 still required pelvic exam prior to provision of
OCs.
• 2009 survey of US physicians (n=2825; response rate 44%):
30-95% routinely performed pelvic exams to screen for
ovarian cancer, 41-96% to screen for other GYN cancers, and
40-92% to screen for STIs.
• Morioka-Douglas N, Hillard PJ. No Papanicolaou tests in women younger than • Stormo AR, Hawkins NA, Cooper CP, Saraiya M. The pelvic
21 years or after hysterectomy for benign disease. JAMA Intern Med. examination as a screening tool: practices of US physicians. Arch
2013;173:855-6. Intern Med. 2011;171:2053-4.
• Henderson JT, Harper CC, Gutin S, Saraiya M, Chapman J, Sawaya GF. Routine
bimanual pelvic examinations: practices and beliefs of US obstetrcian-
gynecologists. Am J Obstet Gynecol. 2013;208:109.e1-7.
EVIDENCE-BASED PREVENTIVE HEALTH
INTERVENTIONS ARE UNDERUTILIZED
• In 2012, HPV vaccine uptake among US females aged 19-26 (≥ 1
dose, ever) was 34.5%.
• In 2001, 7% of women aged ≥ 18 in a nationally representative
sample (n=4821) reported ever being asked about domestic
violence.
• Between 1999-2010, chlamydia screening coverage among
eligible US females ranged from 40-60%.
• In 2009, the proportion of contraceptors using long-acting
reversible contraception (LARC) was 8.5%.
• Williams WW, Lu PJ, O'Halloran A, Bridges CB, Pilishvili T, Hales CM, et al. • Hoover KW, Leichliter JS, Torrone EA, Loosier PS, Gift TL, Tao G, et al.
Noninfluenza vaccination coverage amoung adults - United States, 2012. MMWR Chlamydia screening amoung females aged 15-21 years--multiple data
Morb Mortal Wkly Rep. 2014;63:95-102. sources, United States, 1999-2010. MMSW Surveill Summ. 2014;63:80-8.
• Klap R, Tang L, Wells K, Starks SL, Rodriguez M. Screening for domestic violence • Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contrceptive
amoung adult women in the United States. J Gen Intern Med. 2007;22:579-84. methods in the United States, 2007-2009. Fertil Steril. 2012;98:893-7.
‘ASYMPTOMATIC ’ AND ‘AVERAGE -RISK’ ARE
OPERATIVE WORDS, BUT…
• Only 40% of US OB GYNs routinely ask about sexual function
(2012 survey, n=1154, response rate 66%).
• Only 38% of women with urinary incontinence asked about
symptoms (2006 study, n=321 patients presenting to a UK
general GYN clinic).
• Patient-reported family histories of ovarian and uterine cancer
are often unreliable:
• Negative likelihood ratios 0.51 [95% C, 0.13-2.10] and 0.68 [95% CI, 0.31-
1.52], respectively.
• Dyer K, das Nair R. Why don't healthcare professionals talk about sex? A • Murff HJ, Spigel DR, Syngal S. Does this patient have a family history
systematic review of recent qualitative studies conducted in the United of cancer? An evidence-based analysis of the accuracy of family
Kingdom. J Sex Med. 2013;10:2658-70. cancer history. JAMA. 2004;292:1480-9.
• Griffiths AN, Makam A, Edwards GJ. Should we actively screen for urinary and
anal incontinence in the general gynaecology outpatients setting? - A
prospective observational study. J Obstet Gynaecol. 2006;26:442-4.
WHAT WILL HAPPEN IF WE STOP ROUTINELY
PERFORMING PELVIC EXAMS?
• Improve care by refocusing efforts on:
• Communicating more effectively with patients.
• Optimizing delivery of evidence-based preventive
health interventions.
• Redirect resources toward:
• Developing novel research, policy, and
educational strategies to enhance female sexual
and reproductive health outcomes.
WHAT TO SAY TO OUR PATIENT
Choosing Wisely Questions, Revisited
• What benefits do we hope to achieve?
• Is there evidence that these benefits are attainable?
• Is there evidence for harm?
• Is the service a rational way to utilize available
resources?
Screening BME should not be done as it has no
demonstrable benefits and may cause harm.
Services with proven benefits should be offered.
WHAT TO SAY TO OUR PATIENT
• For a woman of Ms C’s age, comorbidities, and stated risks, the
periodic health visit provides an appropriate context to:
Elicit symptoms (incl. taking a thorough sexual and
urological history) and respond to concerns;
Identify risk factors (incl. updating her family history);
Screen for domestic violence;
Screen for STIs (if at-risk; patient-collected vaginal swab);
Discuss ‘alarm’ symptoms (e.g., abnormal bleeding);
Provide counseling re: highly effective contraception,
healthy lifestyle behaviors; and
Offer same-day access to LARC insertion (if desired).
Dr. Ricciotti
Gynecology Viewpoint
HOPE RICCIOTTI’S VIEWPOINT
I recommend annual pelvic examination
(speculum and bimanual examination) for
women over 21 years (as recommended by
the American College of Obstetricians and
Gynecologists)
ACOG RECOMMENDATIONS
Population Annual Pelvic Examination Cervical Cancer Screening
Women younger than Only when indicated by No screening
21 years medical history
Women aged 21-29 Yes Cytology alone every 3 years
Women aged 30-65 Yes Human papillomavirus and cytology
Co-testing (preferred) every 5 years
Cytology alone
(acceptable) every 3 years
• No studies done
• All women in studies on ovarian cancer were
older than 45 or postmenopausal
• Deciding when sufficient quality evidence to
make a broadly applied practice
recommendation is a complex task
MORE STUDY NEEDED TO ANSWER:
• Women may not come in for care and would miss regular
screening.
• Agreement:
• GC and chlamydia screening can be self-collected
• No need for pelvic examination before providing birth
control
• Disagreement:
• Need for performing a bimanual examination when
doing Pap test
• Need for routine annual pelvic examination
EDITOR’S SUMMARY
Unanswered Questions
• Ms C asked us - Are you able to provide proof?
• Deciding when there is sufficient quality evidence to conclude that a
broadly applied practice should be stopped is a difficult task.
• Future Research
• What is the value of pelvic examination in detecting benign
conditions?
• Do pelvic examinations improve quality of life for women?
• What is the optimal method and timing for sensitive
conversations?
• Do we have enough evidence to stop performing routine pelvic
examination or should there be a discussion with shared decision
making between a patient and her physician until more evidence is
available.
We would like to thank…
Our Patient
Discussants
Hope Ricciotti, MD
Jennifer Potter, MD
Video Production
Last Minute Productions
We would like to thank…
Series Coordinator
Lizzie Williamson
© 2015 American College of Physicians