A Systematic Review: Screening Pelvic Exams in Average-Risk Adult Women

The routine pelvic examination has been a usual part of preventive care for years, and many women and providers believe that this exam should be included in an annual comprehensive health visit. Traditionally, the examination in asymptomatic average-risk women has been used to screen for pathology (e.g., malignancies, infections) through palpation, visualization, and specimen collection. Frequently, a primary justification for a pelvic exam is the need to collect a cervical swab for Pap tests (checks for cell changes on the cervix), and pelvic examinations are often performed prior to prescribing hormonal contraception. Because recent recommendations have suggested that annual Pap testing is not necessary for average-risk women, questions have been raised about whether pelvic exams provide additional benefits in asymptomatic women who do not need a Pap test.

Conducted by the Evidence-based Synthesis Program (ESP) in Minneapolis, MN, this systematic review sought to evaluate the benefits and harms of a routine screening pelvic examination in asymptomatic, average-risk, non-pregnant adult women. For cervical cancer and sexually transmitted infection (i.e., Chlamydia and gonorrhea) screening, and for the initiation of hormonal contraception, investigators summarize the results of recent reviews and guidelines. For all other indications, investigators report results from a comprehensive search of the medical literature from 1946 through July 2013, for a total of 52 references that met this review's inclusion criteria.

Results of this review are summarized here, and more detailed responses to specific Key Questions follow.

Summary:
No data in this review supported the effectiveness of the screening pelvic examination in the asymptomatic average-risk woman for any indication other than periodic cervical cancer screening. The procedure causes pain, discomfort, fear, anxiety, and/or embarrassment in about one-third of women, and can lead to unnecessary, invasive, and potentially harmful diagnostic procedures. Conducting a pelvic examination requires additional clinician time, especially in primary care settings, and often requires the presence of a chaperone in the examination room, thus incurring resource and opportunity costs.

Summary of Recommendations for Cervical Cancer, Chlamydia, and Gonorrhea Screening, and Initiation of Hormonal Contraception
According to the United States Preventive Services Task Force, cervical cancer screening (Pap smears) should be performed every three years in average-risk women, with a cervix, who are 21 to 65 years old. Pap smears are not recommended for women under 21, regardless of sexual activity level. In women aged 30 to 65 years, the screening interval may be lengthened to five years when simultaneous human Papillomavirus testing is performed. Pap smears should not be performed in women over 65 years of age who have had adequate and negative prior screening and are not otherwise at high risk for cervical cancer, or in women who do not have a cervix.

Pelvic examinations are not necessary prior to prescribing hormonal contraception. Only a medical history and blood pressure measurement are required to rule out contraindications. Pelvic examinations also are not required to test for Chlamydia and gonorrhea. This testing can be performed on either self-obtained vaginal swabs or urine specimens.

Key Questions and Findings

Question #1
How accurate is the screening pelvic exam for the detection of malignancy (other than cervical), pelvic inflammatory disease (PID), or other benign gynecologic conditions?

Three studies, which enrolled a total of 5,633 average-risk asymptomatic women, investigated the diagnostic accuracy of a pelvic examination for detecting ovarian cancer. Results show:

• One study did not identify any cases of ovarian cancer. In the other two studies, the positive predictive value of the pelvic examination for ovarian cancer was 1.2% to 3.6%.
• Since not all subjects underwent the gold standard test (biopsy), sensitivity and specificity could not be calculated.

One other study investigated the diagnostic accuracy of a pelvic examination for detecting bacterial vaginosis. Results reported a sensitivity of 69% and specificity of 93%; however, the clinical significance of this condition is uncertain.

There were no diagnostic accuracy studies of other malignancies or PID, in this population.

Question #2
What are the benefits (reduced mortality and morbidity) and harms (over-diagnosis, over-treatment) of the routine screening pelvic examination performed for the detection of malignancy, PID, or other benign gynecologic conditions?

• No studies evaluated the mortality and morbidity benefits of the routine pelvic examination as a screening test for ovarian cancer in asymptomatic average-risk women.
• No studies investigated the benefits of the screening pelvic examination for the diagnosis of other malignancies, PID, or other benign gynecologic conditions (e.g., ovarian cysts, fibroids).

Regarding harms, the investigators included those related to false reassurance, over-diagnosis, over-treatment, or diagnostic procedure-related harms that resulted from findings on the pelvic examination performed in asymptomatic women.

• No studies were identified that directly investigated any of these harms. However, one of the studies on diagnostic accuracy of the pelvic examination for detection of ovarian cancer provides some indirect evidence. In this study, screening pelvic examination led to unnecessary surgery in 29 out of 2,000 women or 1.5% of the women in this study.

Question #3
What are the examination-related harms and indirect benefits of a screening pelvic examination in asymptomatic women?

Investigators identified 15 studies, with more than 13,000 women, that examined women's attitudes towards and/or experiences of the routine pelvic examination. Outcomes included fear, anxiety, embarrassment, pain, discomfort, and global assessment of the pelvic examination experience. Since all the studies used different outcome measures, it was not possible to pool the data.

• The percentage of women endorsing fear, embarrassment, or anxiety during or in advance of the pelvic examination ranged from 10% to 80% (median 34%, 7 studies, N=10,702).
• The percentage of women endorsing pain or discomfort during the pelvic exam ranged from 11% to 60% (median 35%, 8 studies, N=4,576).
• Women who endorsed pain or discomfort were less likely to return for another visit.

Indirect Benefits
It has been suggested that the annual pelvic examination might serve as an incentive for women to access the healthcare system, and thereby receive recommended evidence-based preventive care. This literature search did not identify any studies that tested this hypothesis.

Question #3a
Do these harms vary by patient or provider characteristics?

Investigators looked for studies that examined factors that might moderate the association between pelvic examinations and psychological harms. Patient factors included: demographics and physical traits (i.e., obesity); history of sexual trauma/violence, and/or post-traumatic stress disorder (PTSD); and Veteran status. Provider factors included gender and specialty.

Patient Factors

• Only one study reported pelvic examination-associated psychological harms in women of varying body weights. In this study, heavier women were significantly more likely than thinner women to endorse feelings of disrespect and embarrassment during a gynecology visit.
• Nine studies were identified that investigated the association between a history of sexual violence (SV) and experience of the pelvic examination or receipt of gynecologic services. About half of these studies found a significantly higher incidence of pelvic examination-related pain, discomfort, anxiety, fear, and/or embarrassment in women who had a history of SV compared to those who did not. PTSD was found to be significantly associated with pelvic examination-related fear, embarrassment, and distress in the two studies that investigated this association.

Provider Factors
Although studies have reported patient preferences for provider characteristics (especially gender), no studies were identified that investigated the association between provider characteristics and psychological harms.

Future Research
The most important area for future research is the development and testing of strategies to reduce the inappropriate use of a pelvic examination. The implementation literature suggests that passive education alone is unlikely to be effective; thus, a variety of strategies employed at multiple levels within the healthcare system may be required.

Comment from Operational Partner
"This report will be very helpful to primary care and women's health providers in our system (and outside VA, too). As healthcare systems begin to look closely at the value of services provided, this report makes clear that doing screening pelvic examinations in asymptomatic average-risk adult women is a low-value service; routinely providing these exams needs to be reconsidered." Linda Kinsinger, M.D., M.P.H., VA Chief Consultant for Preventive Medicine.

The date and time for a cyberseminar session on this ESP Report is TBD. Please check the HSR&D Upcoming Cyberseminars web page to register.

This report is a product of VA/HSR&D's Quality Enhancement Research Initiative's (QUERI) Evidence-Based Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers — and to disseminate these reports throughout VA.

Reference

Bloomfield H, Olson A, Cantor A, Greer N, MacDonald R, Rutks I, and Wilt TJ. Screening Pelvic Examinations in Asymptomatic Average Risk Adult Women. VA-ESP Project #09-009; 2013.

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This report is a product of the HSR&D Evidence-Based Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers - and to disseminate these reports throughout VA.

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