Transcript Supplemental Content - Annals of Internal Medicine

© 2015 American College of Physicians
The information contained herein should never be
used as a substitute for clinical judgment.
BEYOND THE GUIDELINES:
Screening Pelvic Examination in Adult Women
Medicine Grand Rounds
March 12, 2015
Discussants
BIDMC Series Editor
Moderator
Jennifer Potter, MD
Risa Burns, MD,
MPH
Eileen Reynolds
MD
Hope Ricciotti, MD
The Series Editors have no conflicts of interest to disclose.
CONFLICT OF INTEREST DISCLOSURE:
The speakers have no financial relationships
with a commercial entity producing
healthcare-related products and/or services.
Risa Burns, MD, MPH
Eileen Reynolds, MD
Jennifer Potter, MD
Hope Ricciotti, MD
OUR PATIENT
Medical History
• Ms C is a healthy 41 year old woman who recently
visited her primary care physician for a periodic
health exam.
• She has had mammograms performed annually
and Pap tests every 3 years.
OUR PATIENT
Past Medical and Surgical History
•
•
Past medical history
•
Gastroesophageal reflux
•
Migraine headaches
•
Scoliosis
Past surgical history
•
Multiple knee surgeries
OUR PATIENT
Social and Family History
• Social History
• Lives with her son
• Works as an administrator
• Exercises regularly
• No tobacco use
• Rare alcohol use
•
Family History
• No history of breast, cervical, ovarian or colon cancer
OUR PATIENT
Medications
•
Norethindrone 0.35mg once daily
•
Calcium and Vitamin D supplement daily
•
Ibuprofen 800mg as needed for pain
•
Acetaminophen as needed for pain
OUR PATIENT
Periodic Health Examination
• 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
• Visual inspection of the external genitalia.
• Speculum examination which allows for both a
visual inspection of the vagina and cervix and
specimen collection for cervical cancer
screening.
• Bimanual examination to palpate the uterus,
ovaries and adjacent structures.
THE GUIDELINES:
Screening Pelvic Examination in Adult Women
• The American College of Physicians, in July 2014, issued a
Guideline presenting the available evidence on screening for
pathology using pelvic examination in adult, asymptomatic,
average-risk non-pregnant women.
• The American College of Obstetrics and Gynecology
Committee on Gynecologic Practice had previously issued a
Committee Opinion in August 2012 on the need for annual
assessments and provided Guidelines on important elements
of the annual examination.
• The American College of Obstetrics and Gynecology
reaffirmed its position in a press release following publication
of the ACP Guideline.
THE ACP GUIDELINE:
Screening Pelvic Examinations in Asymptomatic, Average-Risk Adult Women:
THE ACP GUIDELINE:
Screening Pelvic Examination in Adult Women
The American College of Physicians Guideline is
based on a background article written by Bloomfield
and a systematic evidence review sponsored by the
Minneapolis Department of Veterans Affairs Health
Care System’s Evidence-based Synthesis Program
Center.
THE ACP GUIDELINE:
Key Questions
•
Evidence review was conducted to address 3 key questions:
• How accurate is the screening pelvic examination for
detection of cancer (other than cervical), pelvic inflammatory
disease, or other benign gynecologic conditions?
• What are the benefits (reduced mortality and morbidity
rates) and harms (over-diagnosis, over-treatment or
diagnostic procedure related) of the routine screening pelvic
examination?
• What are the examination-related harms and indirect benefits
of performing screening pelvic examinations in asymptomatic
women? And, do these harms vary by patient characteristics?
THE ACP GUIDELINE:
Summary of Evidence Review- Benefits of Screening
• The diagnostic accuracy of the screening pelvic examination
for detecting ovarian cancer or bacterial vaginosis is low.
• The screening pelvic examination rarely detects noncervical
cancer or other treatable conditions and was not
associated with improved health outcomes.
• There were no studies identified that addressed the
diagnostic accuracy of the pelvic examination for other
gynecologic conditions such as asymptomatic pelvic
inflammatory disease, benign conditions or gynecologic
cancers other than cervical and ovarian.
THE ACP GUIDELINE:
Summary of Evidence Review - Harms of Screening
• Many false positive findings are associated with pelvic
examination, with attendant psychological and physical
harms, including unnecessary laparoscopies or
laparotomies.
• Other harms of the pelvic examination include fear, anxiety,
embarrassment, pain and discomfort.
• Women with a history of sexual violence, especially those
with PTSD, may experience more pain, discomfort, fear,
anxiety or embarrassment.
THE ACP GUIDELINE:
ACP Recommendations
• Based on the evidence review the ACP recommends
against performing routine screening pelvic examination
in asymptomatic, non-pregnant, adult women. (strong
recommendation, moderate quality evidence)
• The current evidence suggests that the harms of
performing routine screening pelvic examination
outweigh any demonstrated benefit .
• Indirect evidence shows that routine screening pelvic
examination does not reduce morbidity or mortality in
asymptomatic adult women.
THE ACP GUIDELINE:
ACP Recommendations
• As pelvic examination is low-value care it should be
omitted from the well-woman visit.
• Cervical cancer screening should be limited to visual
inspection of the cervix and cervical swabs for cancer
and human papillomavirus.
• Screening for chlamydia and gonorrhea should be done
with self-collected vaginal swabs.
• Pelvic examination should not be required before
prescribing hormonal contraception.
THE ACOG Opinion:
The Well-Woman Visit
ACOG Committee Opinion
Well-Woman Visit
August 2012
•
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
•
•
Annual visit fundamental part of medical care and provides:
• An opportunity to promote prevention practices
• An opportunity to recognize risk factors for disease
• An opportunity to identify medical conditions
• An opportunity to establish the clinician-patient
relationship
Annual visit should include:
• Screening, evaluation, counseling and immunizations
based on risk factors and age
• Performance of a physical examination is a key part of an
annual visit though the components may vary depending
on patient age, risk factors, and physician preferences
ACOG OPINION:
Well-Woman Annual Visit - Pelvic Examination
• The ACOG opinion is that a pelvic examination should
be performed on an annual basis in all patients aged
21 years and older.
• Acknowledge, no evidence supports or refutes the
annual pelvic examination for the asymptomatic, lowrisk patient.
• An annual pelvic examination seems logical but also
lacks data to support a specific time frame or
frequency of such examinations.
ACOG OPINION:
Well-Woman Annual Visit - Shared Decision Making
• The decision whether or not to perform a routine pelvic
examination at the time of the periodic health examination for
the asymptomatic patient should be a shared discussion
between the patient and her health care provider.
• The decision to receive an exam can be left to the patient if
she is asymptomatic and has undergone a TAH-BSO for benign
indications, has no history of vulvar or cervical neoplasia, is
HIV negative, is not immunocompromised and was not
exposed to DES.
• It is reasonable to stop performing pelvic examinations when a
woman’s age or other health issues reach a point where the
woman would choose not to intervene on conditions detected
during the examination.
QUESTIONS
For Dr. Potter and Ricciotti
To help us decide how to apply these divergent recommendations
in Ms C’s case we asked our discussants the following questions:
1. Would you recommend a pelvic examination for this patient
on an annual basis and if so, why or why not?
2. What do you think the impact will be on the care of this
patient and other patients if physicians stop routinely
performing routine pelvic examinations?
3. What do you think are the pros and cons of performing a
routine pelvic examination on this patient?
OUR MODERATOR & DISCUSSANTS
• Eileen Reynolds, MD (Moderator)
Associate Professor of Medicine, HMS
Vice Chair for Education in the Department of Medicine at BIDMC
General Medicine and Primary Care, BIDMC
• 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
•
•
•
•
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?
• Or should other services be considered that are of
definitive value?
BURDEN OF PROOF
• To meet effectiveness criteria for a screening test,
conclusive evidence must show that bimanual
examination (BME):
• Accurately detects disease at an early stage
• Is acceptable to patients
• Is cost effective
• Reduces morbidity and mortality in a large-scale,
randomized, controlled trial.
DIAGNO STIC ACCURACY O F BME: DETEC TIO N
O F UPPER GENITAL TRAC T ABNO RMALITIES
Experienced gynecologists (n=52) examining anesthetized
patients (n=84; average age 37.7 years) with known upper
genital tract abnormalities undergoing surgery
Outcome
Sensitivity
Specificity
Positive Predictive
Value (PPV)*
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)
*PPV = True positives/All positives
•
Padilla LA, Radosevich DM, Milad MP. Limitations of the pelvic examination for
evaluation of the female pelvic organs. Int J Gynaecol Obstet. 2005;88:84-88.
DIAGNOSTIC ACCURACY OF SCREENING
BME FOR DETECTION OF OVARIAN CANCER
Prospective
Cohort Study*
(Year)
Study
Population
Jacobs et al.
(1988)
N=1010
Mean age 54
Grover et al.
(1995)
Adonakis et al.
(1996)
Positive
1 Year Incidence Predictive Value
of Ovarian Cancer
(PPV) of
Abnormal BME
Abnormal or
Ambiguous
BME
28 (2.7%)
1/1010 (0.1%)
3.6% (1/28)
N=2623
Mean age 51
40 (1.5%)
1/2623 (0.04%)**
0% (0/40)
N=2000
Mean age 58
174 (8.7%)
2/2000 (0.1%)
1.2% (2/174)
*None designed/powered to detect morbidity/mortality benefits.
**Single case occurred in a woman with a normal exam.
•
•
Jacobs I, Stabile I, Bridges J, Kemsley P, Reynolds C, Grudzinskas J, et
al. Multimodal approach to screening for ovarian cancer. Lancet.
1988;1:268-71.
Grover SR, Quinn MA. Is there any value in bimanual pelvic
examination as a screening test. Med J Aust. 1995;162:408-410.
•
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;65:221-5.
DIAGNOSTIC ACCURACY OF BME FOR
DETECTION OF ENDOMETRIAL CANCER
• 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
al. Management of endometrial precancers. Obstet Gynecol.
2012;120:1160-75.
•
Modesitt S. Missed opportunities for primary endometrial
cancer prevention: how to optimize early identification and
treatment of high-risk women. Obstet Gynecol. 2012;120:98991.
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
examinations when evaluating attendees at a sexually transmitted diseases clinic. Sex
Transm Infect. 2007;83:206-10.
Chernesky MA, Hook EW 3rd, Martin DH, Lane J, Johnson R, Jordan JA, et al. Women find
it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis
or Neisseria gonorrhoeae infections. Sex Transm Dis. 2005;32:729-33.
•
•
Schachter J, Chernesky MA, Willis DE, Fine PM, Martin DH, Fuller D, et al. Vaginal swabs 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.
Workowski KA, Berman S, Centers for Disease Control and Prevention (CDC). Sexually transmitted
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 1080% (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
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
Harper C, Balistreri E, Boggess J, Leon K, Darney P. Provision of hormonal contraceptives without a
mandatory pelvic examination: the first stop demonstration project. Fam Plann Perspect. 2001;33:13-8.
•
•
Chernesky MA, Hook EW 3rd, Martin DH, Lane J, Johnson R, Jordan JA, et al. Women
find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia
trachomatis or Neisseria gonorrhoeae infections. Sex Transm Dis. 2005;32:729-33.
Schachter J, Chernesky MA, Willis DE, Fine PM, Martin DH, Fuller D, et al. Vaginal swabs
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%)
asymptomatic,
average-risk women
aged 45-80 had
abnormal adnexal
findings on BME and a
normal serum CA-125
31/174 (18%)
underwent
surgery
2/31 (6.5%)
were found to
have ovarian
cancer
Performance of
screening BME
led to
unnecessary
surgery in 1.5%
(29/2000)
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
SERIO US CO MPLICATIO NS ( I N D I R E C T E V I D E N C E )
In the PLCO trial, 1080/3285 women
(33%) with false positive screening
tests (serum CA-125 and TVUS) for
ovarian cancer underwent surgery
•
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.
15% (163/1080)
experienced at least one
serious complication
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
21 years or after hysterectomy for benign disease. JAMA Intern Med.
2013;173:855-6.
Henderson JT, Harper CC, Gutin S, Saraiya M, Chapman J, Sawaya GF. Routine
bimanual pelvic examinations: practices and beliefs of US obstetrciangynecologists. Am J Obstet Gynecol. 2013;208:109.e1-7.
•
Stormo AR, Hawkins NA, Cooper CP, Saraiya M. The pelvic
examination as a screening tool: practices of US physicians. Arch
Intern Med. 2011;171:2053-4.
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.
Noninfluenza vaccination coverage amoung adults - United States, 2012. MMWR
Morb Mortal Wkly Rep. 2014;63:95-102.
Klap R, Tang L, Wells K, Starks SL, Rodriguez M. Screening for domestic violence
amoung adult women in the United States. J Gen Intern Med. 2007;22:579-84.
•
•
Hoover KW, Leichliter JS, Torrone EA, Loosier PS, Gift TL, Tao G, et al.
Chlamydia screening amoung females aged 15-21 years--multiple data
sources, United States, 1999-2010. MMSW Surveill Summ. 2014;63:80-8.
Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contrceptive
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, 0.311.52], respectively.
•
•
Dyer K, das Nair R. Why don't healthcare professionals talk about sex? A
systematic review of recent qualitative studies conducted in the United
Kingdom. J Sex Med. 2013;10:2658-70.
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.
•
Murff HJ, Spigel DR, Syngal S. Does this patient have a family history
of cancer? An evidence-based analysis of the accuracy of family
cancer history. JAMA. 2004;292:1480-9.
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
21 years
Only when indicated by
medical history
No screening
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
Women over 65
Yes
No screening necessary after
adequate negative prior screening
results
Women who
underwent total
hysterectomy
Decision to receive an
internal examination can be
left to the patient if she is
asymptomatic
No screening necessary in low-risk
women
CERVICAL CANCER SCREENING IS NOT
PART OF DEBATE
• Pap testing very effective in prevention and
early detection of cervical cancer
• Intervals have been lengthened to every three
to five years
• May prompt women to question coming in to
see health provider in years test not indicated
PELVIC EXAMINATION IS
NOT NECESSARY
• To screen for sexually transmitted infections
(STIs) - Urine or vaginal swab samples can be
tested using nucleic acid amplification, and do
not require a pelvic examination
• Before initiating contraception in healthy,
asymptomatic individuals; does not help
identify contraindications to hormonal
contraception
OVARIAN CANCER AND
PELVIC EXAMINATION
• Consensus - no evidence for effectiveness of
pelvic examination in early detection of ovarian
cancer
• No effective test for early detection of ovarian
cancer in asymptomatic low-risk women – not
pelvic examination, ultrasound, or Ca125 blood
testing
PELVIC EXAMINATION FOR BENIGN
CONDITIONS OR CANCERS OTHER THAN
CERVIX OR OVARY
• 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:
• Does pelvic examination have effect on benign
conditions?
• Does pelvic examination improve quality of life
among women of all ages, especially
reproductive aged women?
PROS OF PELVIC EXAMINATION
• Enhances informed decision-making, provider
judgment (difficult outcomes to measure)
• Prolapse, vaginal discharge, atrophic changes,
and fixed organs might prompt health care
provider to ask additional pointed questions
• Basing decision to do pelvic examination on
report of abnormal symptoms or risk factors
may not be universally effective
CONS OF PELVIC EXAMINATION
• Potential harms of over-diagnosis and overtreatment, increased health care costs
• Patient fear, anxiety, embarrassment and pain
• May prompt patients to avoid care
IMPLICATIONS OF NOT DOING
ROUTINE PELVIC EXAMINATIONS
• Women may stop coming for preventive
reproductive care health care
• Could limit health insurance coverage for well
women examinations
• Provider skill decline, especially in obese or
challenging patients
• Resident training decline
WHY MORE SCRUTINY OF PELVIC
EXAMINATION THAN OTHER PARTS
OF PHYSICAL EXAMINATION?
• Is pelvic examination being held to higher
standard?
• Consider prostate screening “shared decision
making” model
• Pelvic examination should not be stigmatized
PATIENT-CENTERED APPROACH
• Allow the patient to be final arbiter of what
tradeoffs they are willing to make to decrease
their risk of developing a condition
• Gone are days when physicians are final arbiter
of what tradeoffs patients are willing to make to
decrease their risk of developing a condition
EDITOR’S SUMMARY
Ms C’s request
“ I want to see proof. I respect the
professionals, so if you are able to provide
proof over whatever studies have been
done, then I think I would be more
comfortable with it.”
EDITOR’S SUMMARY
Would you recommend a pelvic examination for Ms C?
• Dr Potter agrees with the ACP Guideline. She would not
recommend a pelvic examination based on the currently available
scientific evidence.
• Dr Ricciotti concurs with the ACOG Opinion. She would
recommend a pelvic examination though she acknowledges that
there is no current scientific evidence that supports or refutes an
annual pelvic examination for an asymptomatic, average-risk
woman.
• They both agree that there are potential harms of performing
pelvic examinations including over-diagnosis and over-treatment
as well as patient fear, anxiety, embarrassment and pain.
EDITOR’S SUMMARY
Impact of the Recommendation - Dr Potter
• Providers could refocus their efforts on communicating more
effectively with patients and increasing receipt of evidence-based
care.
• Messaging to patients could be changed to highlight services of
proven value that should be offered during a periodic health visit.
• Medical education programs could supplement opportunities to
practice examination techniques with actual patients by using
simulation and genital teaching associates.
EDITOR’S SUMMARY
Impact of the Recommendation - Dr Ricciotti
• The pelvic examination provides an opportunity to start a
conversation about symptoms and this would be lost.
• Women may not come in for care and would miss regular
screening.
• Insurance coverage may become limited for routine care.
• Providers are at risk of losing skills and training opportunities.
EDITOR’S SUMMARY
High Value Care Considerations
• 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
Beyond the Guidelines Editors
Risa Burns, MD, MPH
Deborah Cotton, MD, MPH
Eileen Reynolds, MD
Gerald Smetana, MD
Video Production
Last Minute Productions
We would like to thank…
BIDMC Media Services
Series Coordinator
Lizzie Williamson
© 2015 American College of Physicians
The information contained herein should never be
used as a substitute for clinical judgment.