Evidence-based Synthesis Program Department of Veterans Affairs

Health Services Research & Development Service

September 2013

Prepared for:

Department of Veterans Affairs

Veterans Health Administration

Quality Enhancement Research Initiative

Health Services Research & Development Service

Washington, DC 20420

Prepared by:

Evidence-based Synthesis Program (ESP) Center

Minneapolis, MN

Timothy J. Wilt, M.D., M.P.H., Director

Investigators:

Principal Investigator: 

Hanna E. Bloomfield, M.D., M.P.H.

Co-Investigators: 

Andrew Olson, M.D.

Amy Cantor, M.D., M.H.S.

Nancy Greer, Ph.D.

Research Associates:

Roderick MacDonald, M.S.

Indulis Rutks, B.A.

Screening Pelvic Examinations

in Asymptomatic Average

Risk Adult Women

4
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Average Risk Adult Women Evidence-based Synthesis Program

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PREFACE

Quality Enhancement Research Initiative’s (QUERI) Evidence-based Synthesis Program 

(ESP) was established to provide timely and accurate syntheses of targeted healthcare topics 

of particular importance to Veterans Affairs (VA) managers and policymakers, as they work to 

improve the health and healthcare of Veterans. The ESP disseminates these reports throughout 

VA.

QUERI provides funding for four ESP Centers and each Center has an active VA affiliation. The 

ESP Centers generate evidence syntheses on important clinical practice topics, and these reports 

help:

• develop clinical policies informed by evidence,

• guide the implementation of effective services to improve patient 

outcomes and to support VA clinical practice guidelines and performance 

measures, and 

• set the direction for future research to address gaps in clinical knowledge.

In 2009, the ESP Coordinating Center was created to expand the capacity of QUERI Central 

Office and the four ESP sites by developing and maintaining program processes. In addition, 

the Center established a Steering Committee comprised of QUERI field-based investigators, 

VA Patient Care Services, Office of Quality and Performance, and Veterans Integrated Service 

Networks (VISN) Clinical Management Officers. The Steering Committee provides program 

oversight, guides strategic planning, coordinates dissemination activities, and develops 

collaborations with VA leadership to identify new ESP topics of importance to Veterans and the 

VA healthcare system.

Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP 

Coordinating Center Program Manager, at nicole.floyd@va.gov.

Recommended citation: Bloomfield H, Olson A, Cantor A, Greer N, MacDonald R, Rutks I, 

and Wilt TJ. Screening Pelvic Examinations in Asymptomatic Average Risk Adult Women. VAESP Project #09-009; 2013

This report is based on research conducted by the Evidence-based Synthesis Program 

(ESP) Center located at the Minneapolis VA Medical Center, Minneapolis, MN funded by 

the Department of Veterans Affairs, Veterans Health Administration, Office of Research and 

Development, Quality Enhancement Research Initiative. The findings and conclusions in 

this document are those of the author(s) who are responsible for its contents; the findings 

and conclusions do not necessarily represent the views of the Department of Veterans 

Affairs or the United States government. Therefore, no statement in this article should be 

construed as an official position of the Department of Veterans Affairs. No investigators 

have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, 

stock ownership or options, expert testimony, grants or patents received or pending, or 

royalties) that conflict with material presented in the report.
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EXECUTIVE SUMMARY

BACKGROUND

The routine pelvic examination has been a usual part of preventive care for women for many 

decades. In 2008, 63.4 million pelvic examinations were performed in the United States. Many 

women and providers believe that the routine pelvic exam should be included in an annual 

comprehensive well-woman visit. The exam consists of inspection of the external genitalia, 

speculum examination of the vagina and cervix, bimanual examination, and sometimes rectal 

or rectovaginal examination. Traditionally, the examination in the asymptomatic average risk 

women has been used to screen for pathology through palpation, visualization, and specimen 

collection. 

Pathology potentially detectable on the pelvic examination includes malignancies (e.g., cervical, 

ovarian, uterine, bladder, vaginal or vulvar); infections (e.g., Chlamydia, gonorrhea, warts, 

candidiasis, bacterial vaginosis); pelvic inflammatory disease (PID); or other pathology (e.g., 

atrophic vaginitis, cervical polyps, uterine prolapse, fibroids). In addition, pelvic examinations 

are often performed prior to the provision of hormonal contraception. Recent high quality 

evidence-based reviews and guidelines have concluded that pelvic examinations are not required 

for Chlamydia and gonorrhea screening or for hormonal contraception initiation and up-to-date 

evidence-based guidelines for cervical cancer screening are also available. However, we are 

unaware of any systematic reviews that have investigated the utility of the pelvic examination for 

the other indications.

This systematic review was undertaken to evaluate the benefits and harms of the 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 initiation of hormonal contraception we summarize the results of recent reviews and 

guidelines from major US health organizations. For all other indications, we performed and 

report results from a comprehensive search of the medical literature. 

Summary of Recommendations for Cervical Cancer, Chlamydia, and Gonorrhea 

Screening and Initiation of Hormonal Contraception

According to the United States Preventive Services Task Force (USPSTF), cervical cancer 

screening (Pap smears) should be performed every 3 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 

5 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 are not required to test for Chlamydia and gonorrhea. This testing can be 

performed on either self-obtained vaginal swabs or urine specimens. 
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Key Questions

Key Question #1. How accurate is the screening pelvic exam for detection of malignancy (other 

than cervical), pelvic inflammatory disease (PID), or other benign gynecologic conditions? 

Key Question #2. What are the benefits (reduced mortality and morbidity) and harms 

(overdiagnosis, over-treatment, diagnostic procedure-related) of the routine screening pelvic 

examination performed for the detection of malignancy, PID, or other benign gynecologic 

conditions?

Key Question #3. What are the examination-related harms and indirect benefits of a screening 

pelvic examination in asymptomatic women? 

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

METHODS 

We searched MEDLINE (OVID) for articles published from 1946 through July 2013 (Appendix 

A). Our search was designed to identify studies of any design other than case series or case 

reports. We limited the search to studies involving human subjects published in the English 

language. To supplement our literature search, we selected nine references that we considered 

highly relevant to the topic and used the “Related Citations” feature of PubMed, to identify 

any additional abstracts. Additional articles were identified from hand-searching reference lists 

of existing systematic reviews and pertinent studies and from suggestions by members of the 

Technical Expert Panel and peer reviewers.

The full text of each article identified as potentially eligible was independently reviewed by two 

investigators or research associates. Study characteristics, patient characteristics, and outcomes 

data were abstracted from articles meeting inclusion criteria. We assessed the quality of the 

studies of diagnostic accuracy based on patient representativeness, quality and administration of 

the reference (gold standard) test, quality and administration of the index test, and data analysis. 

We assessed the quality of survey studies based on the population sampling method, the survey 

instrument, and the analysis methods used. 

DATA SYNTHESIS

We compared the characteristics, methods, and findings of included studies. Pooled analyses 

of data were not possible due to limited reporting and heterogeneity of methods and outcomes 

across studies. Therefore, findings were summarized in narrative form. We identified and 

highlighted findings from studies involving Veterans.

PEER REVIEW

A draft version of this report was reviewed by technical experts, as well as VA clinical 

leadership. Reviewer comments were incorporated into this report, as appropriate, and a 

summary of our responses may be found in Appendix B. 
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RESULTS

From the primary literature search, we identified 1523 abstracts. From the “Related Citations” 

literature search, we identified 826 unique abstracts for a total of 2349 abstracts. We reviewed 

the full text of 156 references and 13 met inclusion criteria. An additional 39 references were 

identified by hand-searching or from suggested references. 

Key Question #1. How accurate is the screening pelvic exam for detection of 

malignancy (other than cervical), pelvic inflammatory disease (PID), or other 

benign gynecologic conditions?

We identified three studies that investigated the diagnostic accuracy of the pelvic examination 

for detecting ovarian cancer and one for bacterial vaginosis. There were no diagnostic accuracy 

studies of other malignancies, PID, or any other benign gynecologic conditions in this 

population. 

Ovarian Cancer 

The 3 ovarian cancer studies enrolled a total of 5633 average risk asymptomatic women. Since 

not all subjects underwent the gold standard test (biopsy), sensitivity and specificity could not 

be calculated. One study did not identify any cases of ovarian cancer. In the other 2 studies the 

positive predictive value of the pelvic examination for ovarian cancer was 1.2 to 3.6%. 

Bacterial Vaginosis 

We identified one study of diagnostic accuracy of the pelvic examination for the detection of 

bacterial vaginosis that reported a sensitivity of 69% and specificity of 93%. However this study 

included both symptomatic and asymptomatic women and had a high prevalence of bacterial 

vaginosis. Furthermore, the clinical significance of this diagnosis is uncertain.

Key Question #2. What are the benefits (reduced mortality and morbidity) and 

harms (overdiagnosis, over-treatment, diagnostic procedure-related) of the 

routine screening pelvic examination performed for the detection of malignancy, 

PID, or other benign gynecologic conditions?

Benefits

Ovarian Cancer 

We identified no studies that evaluated the mortality and morbidity benefits of the routine pelvic 

examination (specifically the bimanual examination) as a screening test for ovarian cancer in 

asymptomatic average risk women. Indeed the bimanual examination was not included as a 

screening modality in either of the 2 large contemporary trials of ovarian cancer screening. In 

the Prostate Lung Colorectal and Ovarian cancer (PLCO) study, a randomized controlled trial 

of over 78,000 women aged 55 to 74 years followed for a median of 12.4 years, the bimanual 

exam was initially included in the screening protocol but was dropped after 5 years because 

no cancers were detected solely by this examination. The second screening trial, the United 

Kingdom Collaborative Trial for Ovarian Cancer Screening (UKCTOCS), does not include 

pelvic examination in its screening protocol. This study of 202,638 post-menopausal women 
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ages 50 to 74 years is comparing no screening, screening with annual CA-125 with transvaginal 

ultrasound as a second-line test, or transvaginal ultrasound and is expected to report mortality 

results in 2015. 

Other Conditions 

We identified no studies investigating the benefits of the screening pelvic examination for the 

diagnosis of other malignancies, PID, or other benign gynecologic conditions (e.g., ovarian cysts, 

fibroids)

Harms 

Direct harms of the pelvic examination itself (e.g., pain, discomfort, embarrassment) are 

discussed under Key Questions #3. We include here harms related to false reassurance, overdiagnosis, over-treatment, or diagnostic procedure-related harms that result from findings on the 

pelvic examination performed in asymptomatic women. We identified no studies that directly 

investigated any of these harms. However, one of the studies on diagnostic accuracy of the pelvic 

examination for detection of ovarian cancer in asymptomatic average risk women provides 

some indirect evidence. In this study there were 174 abnormal screening pelvic examinations 

in 2000 women (8.7%). These 174 women received follow-up with either a transvaginal or 

transabdominal ultrasound plus a serum CA-125. Based on the results of these follow-up tests, 

31 women (18%) underwent either open or laparoscopic surgery which revealed ovarian cancer 

in 2 women (6.5%). Thus screening pelvic examination led to unnecessary surgery in 29/2000 or 

1.5% of women. 

Key Question #3. What are the examination-related harms and indirect benefits of 

a screening pelvic examination in asymptomatic women?

Examination-related Harms 

We identified 15 studies that examined women’s attitudes towards and/or experiences of the 

routine pelvic examination: 14 surveys and 1 longitudinal cohort study. These studies included 

more than 13,000 women. 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 respondents 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 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 care system and thereby receive recommended evidence-based 

preventive care. Our literature search did not identify any studies that tested this hypothesis. 
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Key Question #3a. Do these harms vary by patient or provider characteristics?

We looked for studies investigating factors that might moderate the association between pelvic 

examinations and psychological harms. Patient factors include demographics and physical 

traits, history of sexual trauma and/or post-traumatic stress disorder, and veteran status. Provider 

factors include gender and specialty. 

Patient Factors

Obesity 

We identified only one study that 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. 

History of Sexual Violence (SV) 

We identified nine studies that investigated the association between a history of SV and 

experience of the pelvic examination or receipt of gynecologic services. Two of four studies 

found significantly higher rates of pelvic examination related pain and discomfort in women 

with a history of SV compared to women without a history of SV. Two of three studies found a 

significant association between history of SV and fear, anxiety, or embarrassment during a pelvic 

examination. Women with a history of SV who also had a diagnosis of PTSD had significantly 

more distress, fear, and embarrassment than either SV+ or SV- women without PTSD.

Provider Factors 

Although studies have reported patient preferences for provider characteristics (especially 

gender), we identified no studies that investigated the association between provider 

characteristics and psychological harms. 

CONCLUSION AND FUTURE RESEARCH

In conclusion, there are no data supporting the effectiveness of the screening pelvic examination 

(including speculum and bimanual examinations) 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 a 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. 

The most important area for future research is development and testing of strategies to reduce 

inappropriate use of the pelvic examination. The implementation literature suggests that passive 

education alone is unlikely to be effective; a variety of strategies employed at multiple levels 

within the healthcare system will likely be required.
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ABBREVIATIONS 

ACOG American College of Obstetricians and Gynecologists

ACS American Cancer Society

ASCP American Society for Clinical Pathology

ASCCP American Society for Colposcopy and Cervical Pathology

BMI Body mass index

CA-125 Cancer antigen-125

CDC Centers for Disease Control and Prevention

CI Confidence interval

HMO Health maintenance organization

HPV Human Papilloma virus

NAA(T) Nucleic acid amplification (test)

PID Pelvic inflammatory disease

STI Sexually transmitted infection

SV Sexual violence

USPSTF United States Preventive Services Task Force

UTI Urinary tract infection

VA Veterans Affairs

VHA Veterans Health Administration

WHO World Health Organization