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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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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TABLE OF CONTENTS 

EXECUTIVE SUMMARY

Background.................................................................................................................................................... 1

Methods......................................................................................................................................................... 2

Data Synthesis............................................................................................................................................... 2

Peer Review................................................................................................................................................... 2

Results ........................................................................................................................................................... 3

Conclusion and Future Research................................................................................................................... 5

Abbreviations ................................................................................................................................................ 6

INTRODUCTION

Background.................................................................................................................................................... 7

Key Questions and Analytic Framework....................................................................................................... 8

METHODS

Search Strategy............................................................................................................................................ 10

Study Selection............................................................................................................................................ 10

Data Abstraction .......................................................................................................................................... 10

Quality Assessment ..................................................................................................................................... 11

Data Synthesis............................................................................................................................................. 11

Peer Review................................................................................................................................................. 11

RESULTS

Literature Flow ............................................................................................................................................ 12

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?.................... 13

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

over-treatment, diagnostic procedure-related) of the routine screening pelvic examination performed 

for the detection of malignancy, PID, or other gynecologic conditions? .................................................... 16

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

screening pelvic examination in asymptomatic women? ............................................................................ 17

Key Question #3a. Do these harms vary by patient or provider characteristics?....................................... 21

SUMMARY AND DISCUSSION

Introduction ................................................................................................................................................. 27

Cervical Cancer Screening .......................................................................................................................... 27

Screening for Chlamydia and Gonorrhea .................................................................................................... 28

Prior to Initiating Hormonal Contraception ................................................................................................ 28

Ovarian Cancer............................................................................................................................................ 29

Pelvic Inflammatory Disease....................................................................................................................... 29

Bacterial Vaginosis...................................................................................................................................... 30

Other Conditions ......................................................................................................................................... 30

Pelvic Examination-related Harms.............................................................................................................. 30
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Provider Attitudes, Beliefs, and Practices ................................................................................................... 31

Conclusions and Future Directions ............................................................................................................. 32

REFERENCES ................................................................................................................................................... 34

TABLES

Table 1. Prospective Cohort Studies of Diagnostic Accuracy of the Screening Pelvic Examination 

for Detection of Ovarian Cancer in Asymptomatic, Average-Risk Women................................................ 15

Table 2. Pelvic Examination-related Psychological Harms: Frequency and Impact (k=15)...................... 19

Table 3. History of Sexual Violence (SV) as a Predictor of the Pelvic Examination Experience and 

Receipt of Pap Smears (k=9)....................................................................................................................... 24

FIGURES

Figure 1. Analytic Framework...................................................................................................................... 9

Figure 2. Literature Flow............................................................................................................................ 12

APPENDIX A. Search Strategies............................................................................................................ 41

APPENDIX B. Peer Review Comments and Author Responses .................................................. 42

APPENDIX C. USPSTF Reccommendations for Screening for Sexually Transmitted

Infections in Women ....................................................................................................... 50
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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
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EVIDENCE REPORT

INTRODUCTION

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.1 Many 

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

comprehensive well-woman visit.2 The exam consists of inspection of the external genitalia, 

speculum examination of the vagina and cervix, bimanual examination (placement of two 

fingers into the vagina with simultaneous abdominal pressure provided by the examiner’s other 

hand), 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 screening3,4 or for hormonal 

contraception initiation5 and up-to-date evidence-based guidelines are also available for 

cervical cancer screening.6-8 However, we are unaware of any systematic reviews that have 

investigated the utility of the screening pelvic examination for detection of the other conditions 

in asymptomatic women.

Understanding the utility of this exam for these other conditions is important since the screening 

pelvic examination may cause anxiety, discomfort, and pain and may result in false positives, 

overdiagnosis, overtreatment, and diagnostic procedure-related harms. Moreover, fear of 

the exam could lead some women to avoid or postpone healthcare visits which might result 

in untreated sexually transmitted infections (STI), undiagnosed cervical cancer, unwanted 

pregnancy due to failure to obtain contraception, and/or failure to receive other preventive care 

such as blood pressure and cholesterol screening. Finally, 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. 

This systematic review was conducted to evaluate the benefits and harms of the routine screening 

pelvic examination in asymptomatic, average risk, non-pregnant, adult women. For cervical 

cancer and STI screening and for initiation of hormonal contraception we summarize the results 

of recent reviews and guidelines from major US healthcare organizations in the discussion 

section. For all other indications we performed a comprehensive search of the primary literature. 

This review was nominated by the VHA Center for Health Promotion and Disease Prevention 
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and will be used to inform VHA Clinical Preventive Services Guidelines Statements on 

Screening for Cervical Cancer and Ovarian Cancer.

KEY QUESTIONS AND ANALYTIC FRAMEWORK

We developed the following key questions and an analytic framework (Figure 1) with input from 

a technical expert panel.

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 (other than cervical), PID, or other 

gynecologic conditions?

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

screening pelvic examination in asymptomatic women? 

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

reening 

vic Exam

‡ BENEFITS 

Reduced mortality 

and/ or morbidity

Diagnostic accuracy for detection of cancer (uterine, ovarian, bladder, vaginal or vulvar cancer) 

KQ2 

‡ Components of the Pelvic Examination

1) Inspection of external genitalia 2) Speculum evaluation of the vagina and cervix 3) Bimanual (vaginal/abdominal) examination of the adnexa, 

uterus, ovaries and bladder 

4) Rectal/rectovaginal examination 

Diagnostic accuracy for diagnosis of other gynecologic conditions (warts, atrophic vaginitis, candidiasis, cervical polyps, uterine prolapse, fibroids, bacterial vaginosis, etc.) 

KQ1 

KQ3 

Diagnostic accuracy for detection of PID 

Treatment 

Indirect Benefit

Brings women into the healthcare system where they may then get other preventive services

Harms

Over-diagnosis False positive Diagnostic procedure induced harms 

PICOTS Population: Asymptomatic, average risk, nonpregnant adult women Intervention: Pelvic examination Control: No pelvic examination Outcomes: See harms and benefits boxes Timing: Annual or periodic exams Setting: Outpatient

‡
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METHODS

SEARCH STRATEGY

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

terms included the following Medical Subject Headings (MeSH): Gynecological Examination, 

Women’s Health, and Mass Screening. The full search strategy is presented in Appendix A. 

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

relevant to the topic (some identified in the search above, some by hand-searching). Using 

the “Related Citations” feature of PubMed, we identified an additional 826 English language 

abstracts. We also obtained additional articles 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. 

STUDY SELECTION

Investigators and research associates trained in the critical analysis of literature assessed 

for relevance the abstracts of citations identified from the literature searches. We included 

background papers and guidelines (published within past 5 years and of high quality), clinical 

trials, cohort studies, or cross-sectional studies reporting diagnostic accuracy or outcomes related 

to the harms and benefits of pelvic examination in asymptomatic, average risk, non-pregnant 

women in outpatient settings. We excluded the following:

1. Studies that did not involve asymptomatic, average-risk non-pregnant adult women,

2. Studies that did not involve an outpatient screening pelvic examination for detection 

of malignancy, PID, or other pathology,

3. Studies that did not report harms of the pelvic exam or of avoidance of care due to 

fear of the pelvic exam; morbidity or mortality from pathology detectable from the 

pelvic exam; false positive, false negative, or over diagnosis data from the pelvic 

exam, and

4. Narrative reviews, opinion Papers, letters without data, case series, or case reports.

Full text reports of studies identified as potentially eligible (or indeterminate, e.g., title only) 

were obtained for further review using the inclusion and exclusion criteria described above. Each 

article was independently reviewed by two investigators or research associates. Reasons for 

excluding a study at full text review were noted.

DATA ABSTRACTION

Eligible studies were reviewed for outcomes of interest by investigators and research associates. 

Study characteristics, patient characteristics, and outcomes data were abstracted onto tables. 
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QUALITY ASSESSMENT

We assessed the quality of studies pertaining to key question #1 using a modification of 

the QUality Assessment of Studies of Diagnostic Accuracy included in Systematic reviews 

(QUADAS) tool.9,10 The eleven elements focus on patient representativeness, quality and 

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

and data analysis with each item evaluated as “yes,” “no,” or “unclear.” 

For key question #3, evidence was predominantly from survey studies. There is no established 

instrument for evaluating the quality of survey studies. We identified the following elements as 

critical factors in assessing study quality.

1. Population

a. Is the survey population-based or was a convenience sample used?

b. Was the sampling structure incorporated into the analysis (e.g., weighting the 

analysis for oversampling)?

2. Survey instrument – Was a validated questionnaire used or were the survey questions 

piloted with a population similar to the population of interest?

3. Analysis of findings

a. Was the method for handling missing data reported and appropriate?

b. Were the characteristics of non-responders similar to those of responders?

Response rate was also considered although a higher response rate would be expected if a 

convenience sample was used. We reviewed the included studies to determine whether these 

factors were adequately addressed and summarized our findings.

DATA SYNTHESIS

We described and qualitatively compared the characteristics, methods, and findings of included 

studies. Pooled analyses of data were not possible due to limited reporting and heterogeneity of 

diagnostic approaches and outcomes across studies. Therefore, we summarized our findings 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 addressed and our responses may be found in Appendix B.
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RESULTS

We identified 52 articles that met our inclusion criteria – 32 studies and 20 guidelines and related 

documents.

LITERATURE FLOW

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 excluded 

2193 abstracts and reviewed the full text of 156 references. We excluded 143 articles during full 

text review leaving 13 eligible for inclusion. An additional 39 references were identified by handsearching pertinent trials and related systematic reviews or were suggested by members of the 

Technical Expert Panel or peer reviewers. Figure 2 details the process. 

Figure 2. Literature Flow

Search Results

MEDLINE: 1523 Abstracts

RELATED REFERENCES: 

826 Unique Abstracts

TOTAL: 2349 Abstracts

Excluded: 

2193 Abstracts

Full Text Review:

156 Articles

Hand Search:

20 Studies

19 Guidelines and 

Related Documents 

Excluded: 143 Articles

1. Not population of interest 16

2. Not outpatient setting 42

3. No outcomes of interest 4

4. Not appropriate study 

 design 62

5. Guideline published before 2007 19

Included:

32 Studies

20 Guidelines and 

Related Documents
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KEY QUESTION #1. How accurate is the screening pelvic examination 

for the detection of malignancy (other than cervical), pelvic 

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

A diagnostic accuracy study should include an appropriate population, use a definitive gold 

standard test, and perform the screening and gold standard tests in all participants (p 275).11 For 

this review, an appropriate population is defined as asymptomatic average risk women. Ovarian 

cancer and bacterial vaginosis were the only conditions for which we found diagnostic accuracy 

studies conducted in asymptomatic average risk women. 

Accuracy of the Pelvic Examination for Detection of Ovarian Cancer 

Assessing the diagnostic accuracy of the pelvic examination for detection of ovarian cancer 

is problematic because the definitive gold standard is a pathologic diagnosis of cancer made 

on a surgical specimen and ethical concerns arise regarding performing biopsies in people 

with normal physical examinations or normal follow-up imaging studies (e.g., transvaginal or 

trans- abdominal ultrasound). The other option, employed in the 3 studies below, is to follow 

all women with normal pelvic examinations to assess the subsequent incidence of cancer and 

assume that within a given period of time (e.g., within one year) these cancers were present but 

missed at the time of the pelvic examination (false negatives). Therefore, while it is reasonable 

to expect researchers to conduct studies to assess the true and false positive rates (and positive 

predictive value) of the pelvic examination (as definitive testing is clinically indicated pursuant 

to an abnormal pelvic exam) it is unlikely that there will be any definitive studies assessing the 

true and false negative rates (and negative predictive value). 

We identified 3 cohort studies that investigated the value of the pelvic examination for the 

detection of ovarian cancer in asymptomatic average risk women (Table 1).12-14 These three 

studies assembled an appropriate population and used a definitive gold standard test (biopsy 

results) but did not perform that test in all participants. Since the gold-standard test was not 

performed in all patients, sensitivity and specificity cannot be calculated. We therefore report 

only positive predictive values.

• Grover et al. screened 2623 healthy, asymptomatic women (mean age 51 years), with 

pelvic examination and serum cancer antigen (CA)-125 measurement.12 Forty women had 

adnexal abnormalities on pelvic examination (1.5%). All abnormalities were determined 

to be benign on further investigation and no cases of ovarian cancer developed in these 

40 women during the 1 year follow-up. Therefore, the positive predictive value of the 

pelvic exam for ovarian cancer was 0%. The positive predictive value of the pelvic 

examination for benign abnormalities including dermoid cysts, endometriosis, simple 

cysts, cystadenoma, or fibromas was 22%.12

• Jacobs et al. screened 1010 healthy, asymptomatic, post-menopausal women (median 

age 54 years), with pelvic examination and serum CA-125 measurement.13 If either of 

these was abnormal a transabdominal ultrasound was performed within 4 weeks. If the 

ultrasound was normal women were followed for one year with ultrasounds and serum 

CA-125s every 3 months. If the ultrasound was abnormal the woman was referred to 

her primary care physician for further consultation. Adnexal abnormalities were present 
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on pelvic examination in 28 women (2.8%). In these 28 women, 1 case of ovarian 

cancer was diagnosed at laparotomy resulting in a positive predictive value of 3.6% for 

the pelvic examination alone. The addition of the CA-125 did not change the positive 

predictive value of the pelvic examination alone because among the 28 women with 

abnormal pelvic examination, the CA-125 was elevated in only the one case of ovarian 

cancer.13 

• Adonakis et al. screened 2000 healthy, asymptomatic women aged 45 years or older 

(mean age 58.1 years), with pelvic examination and CA-125 measurement.14 If either 

of these was abnormal a transvaginal ultrasound was performed. If the ultrasound 

was normal the women were followed for one year with ultrasound and CA-125 

every 3 months. Women who had an abnormal ultrasound were referred for “further 

management.” One hundred and seventy four women had abnormal or ambiguous 

pelvic examinations. In these 174 women, 2 cases of ovarian cancer were diagnosed at 

laparotomy resulting in a positive predictive value of 1.2% for the pelvic examination 

alone. The positive predictive value of an abnormal or ambiguous pelvic exam PLUS an 

elevated CA-125 was 2/12 (17%).14

Accuracy of the Pelvic Examination for Detection of Bacterial Vaginosis

We identified one study of bacterial vaginosis that included asymptomatic women, used 

a definitive gold standard test, and performed the screening and gold standard tests in all 

participants.15 The screening test evaluated, known as the Amsel criteria, were the following 

characteristics of vaginal secretions obtained by swab during the pelvic examination: thin, 

homogeneous consistency; pH greater than 4.5; presence of clue cells on microscopic evaluation; 

and release of amine odor following the addition of a base (whiff test). The presence of 3/4 of 

these criteria is generally considered diagnostic of bacterial vaginosis.16 The gold standard was 

Gram’s stain. The study was a prospective observational study of 269 women undergoing a 

pelvic examination at a University-based clinic in Rhode Island. Sixty seven percent of women 

were asymptomatic. The prevalence of bacterial vaginosis by Gram’s stain was 39%. The 

sensitivity and specificity of the Amsel criteria were 69% and 93% respectively. 

Since this study included both symptomatic and asymptomatic women in whom the prevalence 

of bacterial vaginosis was higher than generally reported, the results may not be applicable to the 

average risk asymptomatic population that is the focus of this review.
15

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udies of Diagnostic Accuracy of the Screening Pelvic Examination for Detection of Ovarian Cancer in Asymptomatic, 

Population Findings

One Year 

Incidence 

of Ovarian 

Cancer n/N (%)

Positive 

Predictive 

Value

Harms Study Quality

(# of QUADAS 

Elements Met*)

Abnormal 

Pelvic Exams

Laparoscopic 

or Open 

Surgery

0

5 and older 

o evidence of 

xal pathology

age: 58 years 

 80) 

Abnormal pelvic exam: 59/2000 

(3.0%)

Ovarian cancer if abnormal exam: 

1/59 (1.7%)

Ambiguous pelvic exam: 115/2000 

(5.8%)

Ovarian cancer if ambiguous exam: 

1/115 (0.9%)

2/2000

(0.10%) 1.2% 174 31 8

3 

y, asymptomatic

age: 51 years 

 92)

Abnormal adnexa on pelvic exam: 

40/2623 (1.5%)

Ovarian disease: 9/40 (PPV=22%) 

(all benign)

One cancer case reported at 12 

month follow-up†

1/2623

(0.04%) 0%‡ 40 NR 8

0

y, age 45 and 

 amenorrheic 

2 months

n age: 54 years 

 83)

Abnormal pelvic exam: 28/1010 

(2.8%)

Ovarian cancer if abnormal exam: 

1/28 (3.6%)

No additional cancer cases at 12 

month follow-up||

1/1010

(0.10%) 3.6% 28 NR§ 8

 the 11 QUADAS elements.(Reitsma 2009)9 1) Representativeness: Yes; 2) Acceptable reference standard: Yes; 3) Acceptable delay between 

ple verification: No; 5) Same reference standard: No; 6) Reference test independent of index: Yes; 7) Index test results blinded: No; 8) Reference 

clinical information available: Yes; 10) Uninterpretable results reported: Yes; 11) Withdrawals explained: Yes

re at 1 year follow-up; the response rate was 83%

etected in women with an abnormal pelvic examination

d findings were advised to consult their general practitioner for possible referral to a gynecologist

asound if initial testing was abnormal or a postal questionnaire if initial testing was normal
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Summary

We identified no studies of diagnostic accuracy of the pelvic examination for ovarian cancer 

that applied the gold standard test to all patients; thus, true sensitivity and specificity cannot 

be determined. However, the positive predictive value of the pelvic examination alone for the 

detection of ovarian cancer in asymptomatic women in the reviewed studies was low (1.2-3.6%). 

We identified one study that evaluated the accuracy of the Amsel criteria for diagnosing bacterial 

vaginosis. The sensitivity and specificity were 69% and 93%, respectively. Since this study 

included both symptomatic and asymptomatic women in whom the prevalence of bacterial 

vaginosis was higher than generally reported, the results may not be applicable to the average 

risk asymptomatic population that is the focus of this review.

We identified no studies that assessed the diagnostic accuracy of the pelvic examination for PID, 

other gynecologic cancers, or benign conditions. 

KEY QUESTION #2. What are the benefits (reduced mortality and 

morbidity) and harms (over-diagnosis, 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 found no studies that assessed the benefits (reduced mortality or morbidity) of routine pelvic 

examinations for the detection of ovarian cancer in asymptomatic average risk women. Although 

labeled as screening studies, the three year-long cohort studies discussed under Key Question#1 

were not designed to evaluate the effect of screening on ovarian cancer-related morbidity or 

mortality outcomes.12-14

In 2012 the USPSTF stated that there is “at least moderate certainty that harms of screening for 

ovarian cancer outweigh the benefits.” The screening modalities evaluated were transvaginal 

ultrasonography and testing for the serum tumor marker CA-125. The report comments that there 

are no randomized clinical trials assessing the role of the pelvic exam for cancer screening and 

that the pelvic examination was not a focus of its review.17 A complete discussion of screening 

for ovarian cancer with modalities other than the pelvic examination is included in the discussion 

section, below. 

Other Malignancies 

We found no studies that assessed the benefits of routine pelvic examinations for the detection of 

uterine, bladder, vaginal or vulvar cancer in asymptomatic average risk women.

PID and Other Benign Gynecologic Conditions 

We found no studies that assessed the benefits of screening asymptomatic women with routine 
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pelvic exams for PID, fibroids, warts, atrophic vaginitis, or any other gynecological condition. 

Harms

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

discussed under Key Question #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, as shown in Table 1.14 In this study there were 174 abnormal screening pelvic 

examinations in 2000 average risk asymptomatic 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 women or 1.5% of women.

Summary

We identified no studies that evaluated the benefits and harms of the routine pelvic examination 

as a screening test for ovarian cancer in asymptomatic average risk women. Indirect data 

suggest that such screening would lead to unnecessary surgery for 1.5% of women screened. 

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

diagnosis of other malignancies, PID, or other benign gynecologic conditions.

KEY QUESTION #3. What are the examination-related harms and 

indirect benefits of performing a screening pelvic examination in 

asymptomatic women?

Harms

The pelvic examination includes insertion of a speculum and examiner fingers (for a bi-manual 

examination) into the vagina. Anticipating and undergoing such an examination may cause 

psychological harms (fear, anxiety, embarrassment, pain, discomfort). 

Although physical harms (urinary tract infections and symptoms such as dysuria, and frequency) 

have been reported by one investigator group, these results should be interpreted with caution 

given substantial methodological weaknesses including inadequate control for confounding and 

incomplete follow-up.18,19 Hypothesized mechanisms include microtrauma, alteration of normal 

flora, or inoculation of the urinary tract with vaginal flora from insertion of the speculum and 

examiner fingers and use of lubricant. 

Psychological Harms (Fear, Anxiety, Embarrassment, Pain or Discomfort)

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

routine pelvic examination; 14 surveys20-33 and 1 longitudinal cohort study (Table 2). 34 Nine 

were conducted in the US, two in Sweden, and one each in Jamaica, England, Scotland, and 

New Zealand. Median sample size was 409 (range: 40 to 7168). Generally the studies included 
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only women in their reproductive years. In three of the nine US studies, ethnic and racial 

minorities were well represented.27,28,34 Reported outcomes were diverse, including 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. Five 

studies reported the association between psychological harms and self-reported adherence to 

return gynecologic visits or Pap smears.21,23,27,28,34 Three of these used multivariable analysis.27,28,34

The overall quality of the studies was low. Most studies enrolled a convenience sample 

(i.e., women attending family planning, primary care or other clinics). Five were population 

based22-24,27,28 and three of these recruited a random sample of the population.22,24,28 One study 

developed the survey instrument based on focus group responses;27 three studies reported pretesting or piloting the instrument.25,28,29 Although the cohort study compared characteristics of 

participants who stayed in the study with those who were lost to follow-up,34 none of the survey 

studies provided a comparison of responders and non-responders.
19

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lated Psychological Harms: Frequency and Impact (k=15)

tion/Setting/N 

ponse Rate) Psychological Harms Impact on Return Visits Fear, Anxiety, Embarrassment Pain, Discomfort Global Assessment

reported)

 US

years

Anxiety: 32/40 (80%)

%)

sed in Sweden

 to mass screening

years

25% said “exam was not at all unpleasant”

74% said exam “not at all painful”

MVA: NoParticipants in screening were less likely than non-participants to endorse “unpleasantness” of the exam although it is unclear if this finding was statistically significant

t reported)

 in New York 

0 to over 60” years

34% endorsed moderate or severe anxiety before a visit to the gynecologist; a similar % endorsed these same feelings about general medical check-ups.

t reported)

ah

ions, median age 

45% “felt comfortable during a pelvic examination”

87%)

ode Island

er

86% reported that pelvic examinations are “not all that bad”

R 80%)

g clinic in New 

7 to 30” years

60% reported some pain or discomfort during the examination

R 67%)

sed in Sweden

years

Among women who were ≤19 years old at first pelvic exam, 71% reported that it was painful

75% rated the pelvic examination as > 46 on a scale of 0 (very negative) to 100 (very positive)

t reported)

mear 

23)

 a Pap smear 

27)

ed clinics in London

years

Pap +: 15% embarrassingPap -: 13% embarrassed

Pap +: 11% painfulPap -: 4% painful 

Pap +: 3% troublesomePap -: 12% troublesome; 13% scared
20

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tion/Setting/N 

ponse Rate) Psychological Harms Impact on Return Visits Fear, Anxiety, Embarrassment Pain, Discomfort Global Assessment

t reported)

sidents of California

years

75% endorsed fear and embarrassment

No statistical analysis done31% said feelings of fear and embarrassment had prevented them from getting a pelvic exam at some time

RR 69%)

g or sexual health 

and

 50% 21-40, 42% 

10% feel anxious or distressed at the prospect of a pelvic examination

Older women and women who had been pregnant were significantly and independently less likely to “feel negative towards pelvic examination”

 in Cincinnati

(44% < 18 years)

% hispanic

61% believed Pap would not be painful

MVA: yesLack of pain associated with return visit (OR 1.73, 95% CI: 1.08 to 2.83)Embarrassment not significantly associated with return visitThese outcomes did not differ by race/ethnicity.

R 82%)

sed in Seattle

years

e-American

31% endorsed pain MVA: yes 

Concern about pain and discomfort was NOT a significant barrier to Pap testing (OR 0.5, 95% CI: 0.3 to 1.1)

R 84%)

sed, Durham, NC

years

24% endorsed pain MVA: yes

Pain associated with Pap nonadherence (OR 4.8, 95% CI: 1.7 to 13.7)

sed, Jamaica

years

Among the 57% who had never had a pelvic exam, 0.5% endorsed embarrassment as the reason

Among the 57% who had never had a pelvic exam, 1.4% said the reason was they did “not like the process”0.1% did “not like the environment”

R 23%)

nthood Clinic in 

years

17% endorsed fear16% endorsed embarrassment

iable analysis; OR = odds ratio; CI = confidence interval
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The percentage of women endorsing pain or discomfort during the pelvic exam ranged from 

11 to 60% (median 35%; 8 studies, N=4576). The percentage endorsing fear, embarrassment, 

or anxiety ranged from 10 to 80% (median 34%; 7 studies, N=10,702). One study reported 

that women were more likely to report pain at their first (71%) compared to their last (33%) 

examination.24 Similarly, another study reported that older age and previous pregnancy were both 

independently associated with less negative feelings towards the pelvic examination.22

All five studies that examined the relationship between pelvic-examination pain or discomfort 

and return visits, reported that women who endorsed pain or discomfort were less likely to return 

for another visit. The three studies that used multivariable statistical analysis are described here. 

In the largest and most methodologically rigorous of these, Kahn et al. found that women who 

had not experienced pain were 73% more likely to return for another examination than those who 

had experienced pain (OR 1.73, 95% CI 1.08 to 2.83, N=490).34 In the smallest study conducted 

in middle-aged African American women, the perception of pain on a Pap test was significantly 

associated with non-adherence to future tests (OR 4.8, 95% CI 1.7 to 13.7, N= 144).27 The third 

study of exclusively Vietnamese American women (N=370) reported that only 55% of women 

who endorsed pain or discomfort had a Pap smear in the previous 3 years compared with 74% of 

those who did not endorse pain or discomfort (P<0.001). This association remained significant 

in multivariable analysis (OR and 95 % CI not reported).28 One of these studies also examined 

the association between embarrassment and return visits and found that embarrassment was not 

significantly associated with likelihood of return visit.34

Summary of Psychological Harms

We identified 15 studies of more than 13,000 women conducted in 6 countries that reported 

psychological harms. The percentage endorsing fear, embarrassment, or anxiety ranged from 10 

to 80% (median 34%, 7 studies). The percentage of women endorsing pain or discomfort during 

the pelvic exam ranged from 11 to 60% (median 35%, 8 studies). Women who endorsed pain or 

discomfort were less likely to return for another visit than those who did not experience pain or 

discomfort.

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 gynecologic services such 

as contraception, screening for STIs and cervical cancer and other non-gynecologic preventive 

care including immunizations, blood pressure, weight and cholesterol measurement, colon cancer 

screening, and risk factor assessment and counseling.35 Our literature search did not identify any 

studies that tested this hypothesis. Indeed, as discussed above, fear or anxiety about the pelvic 

exam is associated with lower compliance with visits for Pap smears. 

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 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. The only harms for which we found data were psychological harms 
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Patient Factors

Obesity 

We identified one study that reported pelvic examination-associated psychological harms in 

women of varying body weights36 and one that evaluated weight as a predictor of return visits.37

The quality of both studies was low. Both enrolled a convenience sample and in one study36 there 

was no adjustment for oversampling. One study used a survey instrument developed based on 

focus group data;36 the other study provided no information about the development of the survey 

instrument.37 Neither study provided information on whether non-responders were similar to 

responders. 

A community-based study of attitudes and behavior related to gynecologic care in California 

surveyed 498 overweight women (response rate not reported) purposefully selected to include 

a high percentage of African Americans (32%).36 Ages ranged from 21 to 80 years, BMI from 

25 to 122 kg/m2. Over 90% had health insurance. Overall, 41% reported delaying seeking 

healthcare because of their weight and 52% considered their weight to be a barrier to getting 

appropriate healthcare. BMI was an independent and significant predictor of the patient 

perception that weight was a “barrier to health care” and a factor in “delay of care.” Women 

in the highest BMI category also had a significantly lower rate of Pap test completion in the 

previous 2 years compared to women with lower BMIs, after controlling for age and race. 

Furthermore, heavier women were significantly more likely than thinner women to endorse 

feelings of disrespect and embarrassment during a gynecology visit.36

A community-based study in Connecticut surveyed 303 women between the ages of 40 and 65 

years (response rate 96%) to determine rates and predictors of screening pelvic examinations in 

overweight and non-overweight women.37 Sixty-six percent of the respondents were classified 

as average weight, 20% as moderately overweight, and 14% as very overweight. Significantly 

fewer very overweight women (48%) reported annual pelvic examinations than average weight 

(68%) or moderately overweight (67%) women. The only “attitude” investigated in this study 

was intention to get an exam (“reluctant”, “they are routine”, and “I schedule them annually”) 

which was highly correlated with actual behavior.37 This study did not investigate possible harms 

of the pelvic examination such as fear, embarrassment, anxiety, pain or discomfort. 

History of Sexual Violence (Table 3)

We identified nine studies (eight with a control group), that focused on women with a history 

of sexual violence (SV). Two were from Europe and seven from the US. Five of the US studies 

were conducted in the VA, three of these at a single VA medical center.38-40 Outcomes included 

psychological harms only (k=6), self-reported utilization of gynecologic care only (k=3), or both 

(k=2).41,42 Eight of the nine studies were cross-sectional survey studies38-40,42-46 and one was a 

case-control study.41 The two studies by Weitlauf also evaluated the effect of PTSD on the pelvic 

examination experience.39,40

Overall, the studies were of low quality. Most enrolled a convenience sample with only two 

being population-based and studying a random sample of the population.43,44 In six studies, 

the survey or interview tool was either validated (five studies)38,39,43-45 or piloted (1 study).42

One study reported using only complete surveys;41 no other study commented on missing data. 
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Characteristics of responders and non-responders were reported in one study.40 Another study 

compared responders to the general clinic population.46

In the 8 studies that included a control group, outcomes included pain and discomfort (k=4), fear, 

anxiety, or embarrassment (k=3), and receipt of gynecologic services (k=5). Two of the 4 studies 

reporting pain and discomfort found significantly higher rates in women with a history of SV

compared to women without a history of SV; in the other 2 studies there was no difference. Two 

of the 3 studies reporting fear anxiety or embarrassment found that women with a history of SV 

were significantly more likely to endorse these emotions than women without a history of SV. 

A survey study of 94 women (response rate 72%) from a single VA medical center, reported that 

women with a history of SV who also had symptoms of PTSD reported significantly more pelvic 

examination-related distress than women without PTSD.39 A second study from the same group 

(N=165, response rate 55%) reported significantly higher median scores for fear, embarrassment, 

and distress in women who had a history of SV and a diagnosis of PTSD than in women without 

PTSD, irrespective of their SV history.40 In both studies, levels of reported pain did not differ 

between women with and without a history of SV. 

Five studies assessed receipt of gynecological services.41-44,46 Three were population-based,42-44

one enrolled primary care patients at a VA,46 and one was a case-control study from Germany.41

The findings in these five studies were inconsistent, with two finding decreased utilization in 

women with a history of SV, two finding no difference, and one finding increased utilization in 

women with a history of SV. The methodologically strongest of these studies was the analysis of 

data from the Behavioral Risk Factor Surveillance System, a population-based telephone survey 

of a nationally representative US sample.44 In this study of 35,048 women the prevalence of selfreported sexual violence was 15%. The percentage of women 18 or older reporting a Pap test 

within the prior 3 years did not differ between women with and without a history of SV (85.6% 

v. 84.3%, P=0.32)

Provider Factors

We identified no studies that investigated the association between provider characteristics and 

psychological harms.
24

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ence (SV) as a Predictor of the Pelvic Examination Experience and Receipt of Pap Smears (k=9)

Population/Setting Predictors Outcomes Findings

esponse Rate 67%)

 veterans 

PTSD Anticipated PE-related distress No association between PTSD symptom severity and 

anticipated PE-related distress

esponse Rate 72%)

erans

+

SD

ars

SVPTSD (current)

Distress PainBoth measured on Likert scales, 0-10

Distress (median)SV+ 4.27 SV- 0P=0.03Pain (median)SV+ 2.5 SV- 0P=0.04SV+ women with PTSD had significantly increased distress (but not pain) compared to women without PTSD (either SV+ or SV-) (P=0.02)

Response Rate 55%)

PTSD: 17

PTSD: 48 PTSD: 22

erans

ars

SVPTSD (current)

FearEmbarrassmentDistressPainEach measured on Likert scales 

Median scores for fear, embarrassment, and distress were significantly higher in the SV+ plus PTSD group than the SV-, no PTSD group (Ps <0.005) and the SV+ no PTSD group (Ps <0.001)

1 (Response Rate 80%)

ars

ospital clinic

SV Discomfort On multivariate analysis, SV+ women were significantly more 

likely to report discomfort than SV- women (OR 1.85, 95% CI: 1.19 to 2.87)

ponse Rate: NR)

based, small mid-western 

SV Distress

Physical pain, discomfortReceipt of gynecological careEmbarrassment, shame, fear

Distress: significantly higher in SV+ than SV- (P<0.01)Physical pain or discomfort: no significant differenceSV+ significantly less likely to seek regular gyn care (P<0.05)All 3 significantly higher in SV+ than SV- (P<0.05, 0.01. 0.05, respectively)

sponse Rate: NR)

SV % endorsing assumption “that a 

visit to the GYN would cause an important psychological strain”Receipt of gynecologic services 

SV+ 37.7 SV- 3.5 P<0.0001No significant difference in self-reported receipt of GYN services
25

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Population/Setting Predictors Outcomes Findings

14 w/ Pap test in prior 2 yrs; 

ithout (Response Rate 17%)

4 years

ifornia

SV Receipt of Pap test in past 2 years On multivariate analysis, SV was associated with a 

significantly lower odds of Pap smear receipt in past 2 years (OR 0.56, 95% CI: 0.34 to 0.91)

 (Response Rate 56%)

46.6

e clinic at San Diego VA

SV Mean number of Pap tests in past 

5 years

SV+ 4.5 (SD 2.5)SV- 3.8 (SD 2.0)P<0.05

women (Response Rate: NA)

4

44

on based

SV % of women age > 18 with Pap 

test within prior 3 yrs 

SV+ 85.6 (SE 1.2)SV- 84.3 (SE 0.5)P=0.32

umatic stress disorder; PE = pelvic examination; SV = sexual violence; VA = Veterans Affairs; OR = odds ratio; CI = confidence interval; SD = 

aintenance organization
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Summary

Women who are very overweight may be less likely than other women to get Pap tests, possibly 

due to feelings of embarrassment (2 studies). 

We identified nine studies that investigated the association between a history of sexual violence 

(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 SV+ 

women compared to SV- women. Two of three studies found a significant association between 

history of SV and fear, anxiety, or embarrassment during a pelvic examination. Among the five 

studies reporting receipt of gynecologic services, two found increased utilization, two found 

decreased utilization, and one (the methodologically strongest) found no difference in utilization 

between women with and without a history of SV. Women with a history of SV who also have a 

diagnosis of PTSD have significantly more distress, fear, and embarrassment than either SV+ or 

SV- women without PTSD (2 studies).
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SUMMARY AND DISCUSSION 

INTRODUCTION

This systematic review was conducted to evaluate the benefits and harms of the routine 

screening pelvic examination in asymptomatic average risk non-pregnant adult women. Our 

primary conclusion is that there are no data indicating that the performance of the routine 

pelvic examination in asymptomatic average risk women reduces morbidity or mortality from 

any condition other than cervical cancer. For cervical cancer the recommended examination 

is visual inspection of the cervix and cervical swabs for cancer and HPV. Nevertheless pelvic 

examinations in asymptomatic women are often performed even when cervical cancer screening 

is not required. Commonly cited indications are to screen for ovarian cancer, prior to prescribing 

hormonal contraception, to detect sexually transmitted infections or other pathology, or simply as 

part of the well-woman exam.2,47

In this review we summarize the results of recent reviews and guidelines from major US health 

organizations for cervical cancer and sexually transmitted infections (i.e., Chlamydia and 

gonorrhea) screening and for initiation of hormonal contraception. For all other indications we 

performed and report results from a comprehensive search of the medical literature. 

CERVICAL CANCER SCREENING

During the speculum examination, cervical swabs for human Papillomavirus infection and 

for cervical cancer (Pap smears) may be obtained. According to the United States Preventive 

Services Task Force (USPSTF), Pap smears should be performed every 3 years in average risk 

women with a cervix who are 21 to 65 years old; or every 5 years in women age 30 to 65 years 

if co-testing for human Papillomavirus testing is performed (Grade A Recommendation, i.e., 

USPSTF recommends the service; high certainty that the net benefit is substantial). Average risk 

is defined as absence of personal history of cervical cancer or high-grade precancerous cervical 

lesion, in utero exposure to diethylstilbestrol, or immunocompromised status.6

Pap smears should not be performed in the following circumstances (all Grade D 

recommendations, i.e. USPSTF recommends against the service; moderate or high certainty 

that the service has no net benefit or that the harms outweigh the benefits): women under 21 

years of age, even if sexually active; women over 65 years of age who have had adequate and 

negative prior screening and are not otherwise at high risk for cervical cancer; women who have 

had a hysterectomy with removal of the cervix and who do not have a history of a high-grade 

precancerous lesion (cervical intraepithelial neoplasia, grade 2 or 3) or cervical cancer.6

Similar recommendations have been issued by the Centers for Disease Control and Prevention, 

American College of Obstetricians and Gynecologists (ACOG), the American Cancer Society 

(ACS), the American Society for Clinical Pathology (ASCP), and the American Society for 

Colposcopy and Cervical Pathology (ASCCP).7,8.48
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SCREENING FOR CHLAMYDIA AND GONORRHEA

Chlamydia and gonorrhea are common sexually transmitted infections (STIs) that are often 

asymptomatic. These infections can cause serious complications in women including PID, 

infertility, and increased risk of ectopic pregnancy. Clinical trials have demonstrated that screening 

of high risk populations for Chlamydia reduces incidence of PID49,50 and many professional 

organizations, and the USPSTF, endorse such screening for all sexually active, non-pregnant women 

24 years of age or younger and older women at increased risk.3,51-53 Sexually active pregnant or 

non-pregnant women of any age who are at increased risk should be screened for gonorrhea.53 The 

USPSTF is currently in the process of updating its recommendations for screening for gonorrhea 

and Chlamydia (http://www.uspreventiveservicestaskforce.org/uspstf/uspschlm.htm#update).

Although screening for Chlamydia and gonorrhea traditionally required a speculum examination 

to obtain endocervical samples, newer assays achieve high diagnostic accuracy with selfobtained specimens. For Chlamydia, nucleic acid amplification tests (NAATs) perform well 

(i.e., high specificity and sensitivity) on either self-collected vaginal swabs or urine54 and are 

endorsed by the USPSTF.3,55 For gonorrhea, NAA testing of self-collected vulvovaginal swabs 

is equivalent to NAA testing of clinician obtained endocervical samples;56 this test may not have 

adequate sensitivity for gonorrhea detection when performed on urine samples.55

Studies have shown that women of all ages, of varying education levels, and of diverse ethnic 

and racial groups are easily able to self-collect vaginal samples. Furthermore, these self-obtained 

samples are comparable to those obtained by clinicians and, most importantly, women prefer 

this to the more invasive speculum examination.57-59 Reflecting the widespread acceptance of 

this non-invasive screening strategy for sexually transmitted infections, ACOG recently issued 

an opinion stating that “NAA testing on urine samples or vaginal swab specimens is now an 

acceptable form of screening for gonorrhea and chlamydial infection.”2

Current screening recommendations for Chlamydia and gonorrhea as well as for other sexually 

transmitted infections diagnosed by blood tests (human immunodeficiency virus, syphilis, and 

hepatitis B) are shown in Appendix C.

PRIOR TO INITIATING HORMONAL CONTRACEPTION

In the mid 1990’s several professional organizations, including the World Health Organization 

and ACOG, published recommendations stating that routine pelvic examinations were not 

required prior to prescribing hormonal contraception for healthy asymptomatic women 

(summarized in Stewart, 2001).5 These women require only a medical history and a blood 

pressure measurement to rule out contraindications to birth control pills.5 Nevertheless, according 

to a recent survey of obstetrician-gynecologists and primary care providers in the US, about a 

third require a pelvic examination prior to provision of oral contraceptives.60 Other, somewhat 

older data indicate that fewer than 5% of practicing obstetrician-gynecologists in the US would 

fill a prescription for hormonal contraception unless a woman was up-to-date on cervical cancer 

screening.61 Requiring a pelvic examination prior to prescribing hormonal contraception may 

cause women, especially teen age women, to avoid or delay obtaining contraception due to fear 

of the exam,21,25 thus increasing their risk of unwanted pregnancy. 
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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. Even under ideal circumstances (i.e., examination under 

anesthesia by an experienced gynecologist) and in a population with a high pre-test probability 

of disease (i.e., women undergoing gynecologic surgery), the bimanual examination has a 

sensitivity of only 28% and a positive predictive value of 64% for detection of adnexal masses.62

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.63 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 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 2015.64

Results from the PLCO screening trial were disappointing. The screening tests included serum 

CA-125 (offered annually for 6 years) and transvaginal ultrasonography (offered annually for 

4 years). Despite an increase in ovarian cancer detection rates in the screened group, mortality 

from ovarian cancer was not reduced.63 If these 2 tests, which have greater diagnostic accuracy 

than the bimanual examination, are not associated with decreased mortality from ovarian cancer, 

it is difficult to make the case that the less specific and sensitive bimanual examination should be 

used for ovarian cancer screening. 

In the absence of evidence, most major professional and government groups recommend against 

screening for ovarian cancer in asymptomatic average risk women.65,66 For example, the Australian 

National Breast and Ovarian Cancer Centre stated there is no evidence that supports any form of 

screening for ovarian cancer, including the pelvic examination.67 A joint statement from ACOG 

and the Society of Gynecologic Oncologists states that there is “no effective strategy for ovarian 

cancer screening”.68 The American Cancer Society states that there is “no proven effective 

screening strategy for the early detection of ovarian cancer” and does not recommend screening 

asymptomatic women at average risk.69 In 2012, the United States Preventive Services Task Force 

(p 903) noted that “no randomized trial has assessed the role of the bimanual pelvic examination 

for cancer screening.”17 Further, it concluded that there is “at least moderate certainty that harms 

of screening for ovarian cancer [with transvaginal ultrasonography and serum tumor marker CA125] outweigh the benefits”.17 Nevertheless, recent data indicate that about a third of US physicians 

continue to order these tests to screen for ovarian cancer.65

PELVIC INFLAMMATORY DISEASE

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

the diagnosis of pelvic inflammatory disease. PID is a condition often presenting with vague 
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or minimal symptoms70 which if left untreated can lead to infertility, ectopic pregnancy, or 

chronic pelvic pain.71-74 Nevertheless, the Centers for Disease Control and Prevention states 

that “the optimal treatment regimen and long-term outcome of early treatment of women with 

asymptomatic or subclinical PID are unknown” and recommends treatment only when a woman 

with some symptoms (e.g., lower abdominal or pelvic pain) has physical exam findings (e.g., 

cervical motion, uterine or adnexal tenderness) suggestive of PID.75 Symptom questionnaires 

are available to help determine which patients require a bi-manual examination for diagnosis of 

PID.76

BACTERIAL VAGINOSIS

We identified one study of bacterial vaginosis that included both symptomatic and asymptomatic 

women (N=269, 67% asymptomatic), used a definitive gold standard test (Gram’s stain), and 

performed the screening and gold standard tests in all participants.15 The screening test evaluated, 

known as the Amsel criteria, are characteristics of vaginal secretions obtained by swab during 

the pelvic examination.16 The prevalence of bacterial vaginosis (39%) was higher than usually 

reported. The sensitivity and specificity of the Amsel criteria were 69% and 93% respectively 

and were not reported separately for the subgroup of asymptomatic women.

Since this study included both symptomatic and asymptomatic women in whom the prevalence 

of bacterial vaginosis was high, the results may not be applicable to the average risk 

asymptomatic population that is the focus of this review. Furthermore the clinical significance of 

a diagnosis of bacterial vaginosis in asymptomatic women is unclear; many of these cases may 

represent overdiagnosis.77

OTHER CONDITIONS 

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

diagnosis of other malignancies or other benign gynecologic conditions. Although several 

studies have documented a 2-4% prevalence of pelvic-examination-detected abnormalities in 

asymptomatic women, these studies did not determine if detection in the asymptomatic phase 

had any impact on patient outcomes.78,79

PELVIC EXAMINATION-RELATED HARMS

We identified no studies that specifically investigated over-diagnosis, over-treatment, or 

diagnostic procedure-related harms resulting from findings on the pelvic examination performed 

in asymptomatic women. However data from one of the older screening studies indicated 

that screening pelvic examinations led to unnecessary surgery in 1.5% of women screened,14

exposing them to a major surgical complication risk that may be as high as 15%.63

Other harms include psychological distress in anticipation of, and during, the pelvic examination. 

In the 15 studies (N>13,000) that examined these outcomes, 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). 
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Women who endorsed pain or discomfort were less likely to return for another visit than those 

who did not experience pain or discomfort. 

It has been hypothesized that women who have been victims of sexual violence (SV) are more 

likely to experience psychological harms from the pelvic examination. Our review however 

indicates that the data are mixed. Pain and discomfort were significantly more common in 

SV + compared to SV- women in only 2 of 4 studies39,45 and 2 of 3 studies found a significant 

association between history of SV and fear, anxiety, or embarrassment.40,42 Post traumatic stress 

disorder was evaluated as a co-variate in 2 controlled studies and was found to be significantly 

associated with pelvic examination-related fear, embarrassment, and distress, independent of SV 

history.39,40

Although our review focused on adult women it is worth noting that several groups have reported 

that younger women (e.g., age < 25 years) are more likely than older women to experience pelvic 

examination-associated embarrassment and pain.29,30

Finally, it has been suggested that the opportunity for an annual pelvic examination might 

serve as an incentive for women to access the healthcare care system and thereby receive 

recommended gynecologic services such as contraception, screening for sexually transmitted 

infections and cervical cancer, and other non-gynecologic preventive care including 

immunizations, blood pressure, weight and cholesterol measurement, colon cancer screening, 

and risk factor assessment and counseling.35 Our literature search did not identify any studies 

that tested this hypothesis. Indeed, as discussed above, fear or anxiety about the pelvic exam is 

associated with reduced compliance with visits for Pap smears. 

PROVIDER ATTITUDES, BELIEFS AND PRACTICES

As documented in this report, the evidence does not support performance of the routine pelvic 

examination in asymptomatic women to screen for any condition other than cervical cancer. 

Nevertheless providers continue to perform this exam for a variety of reasons including prior 

to prescribing hormonal contraception, to diagnose sexually transmitted infections, or to screen 

for benign conditions or malignancies other than cervical cancer. A recent study, for example, 

reported that 33% of providers (obstetric-gynecology and family physicians and advanced 

practice nurses) said that they always and 44% said they usually require a pelvic exam prior to 

prescribing oral contraceptives.60

In addition, many providers perform the examination to obtain Pap tests for women in whom 

the test is not indicated (e.g., those who have had a hysterectomy for benign conditions or are 

younger than 21 years of age80 or at more frequent intervals than recommended (Perkins 2013). 

A recent study showed that primary care provider adherence to recommended screening intervals 

for cervical cancer screening was poor, with 67 to 94% of respondents stating they would 

perform subsequent screening sooner than recommended by contemporary guidelines.81 This 

overuse was recently high-lighted by the American Board of Internal Medicine Foundation’s 

Choosing Wisely Campaign.80

Finally, many providers continue to include a pelvic examination as part of the well woman visit. 

Indeed, ACOG recommends annual routine pelvic examinations while acknowledging (p 422) 
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that “this recommendation is based on expert opinion.”2 In a survey study of 1250 physicians in 

the US, 54% of internists, 90% of family practitioners and 98 % of obstetrician-gynecologists 

indicated that they perform pelvic examinations “as part of a well-woman exam.”1,82 In a clinicalvignette survey study of 521 obstetrician-gynecologists, over 95% indicated that they would 

perform a bimanual examination in asymptomatic women not due for a Pap test.47

Reasons for performing routine pelvic examinations include clinician preference, legal concerns, 

financial incentives and reimbursement, and the influence of medical training.2,35,82 In a small 

(n=27) study of US general practitioners, clinicians cited “patient reassurance, documenting the 

norm, ‘because I was taught to,’ for legal reasons, and for completeness” as a few of the reasons 

they continue the exam annually.35 In a recent survey of 521 US obstetrician-gynecologists, 

performing a routine pelvic examination was considered very important for adherence to 

standard medical practice (45% of respondents), patient reassurance (49%), detection of ovarian 

cancer (47%), and identification of benign conditions (54-59%). The authors of this study 

concluded that more provider education is required, particularly with regard to ovarian cancer 

screening.47

CONCLUSIONS AND FUTURE DIRECTIONS

There are no data indicating that the performance of the routine pelvic examination in 

asymptomatic average risk women reduces morbidity or mortality from any condition other 

than cervical cancer. For cervical cancer screening, the pelvic examination only needs to 

include visual inspection of the cervix and collection of a cervical specimen for Pap testing 

and, if indicated, for human papillomavirus testing. A bimanual examination is not indicated for 

cervical cancer screening. Although the pelvic examination may detect abnormalities in about 

2-4% of asymptomatic women, the vast majority of these conditions are of minimal clinical 

importance.78,79,83

Harms of the screening pelvic examination include unnecessary laparoscopies or laparotomies 

performed because of abnormalities detected on the speculum or bimanual examination. This 

occurs at a rate of about 1.5% and may expose these women to a 15% risk of one or more major 

surgical complications. Other harms of the examination include fear, embarrassment, or anxiety 

(in 10 to 80%, median 34%) and pain or discomfort (in 11 to 60%, median 35%). Victims of 

sexual violence may be more likely than other women to experience pelvic examination-related 

distress, fear and embarrassment. Women who endorse pain or discomfort are less likely to return 

for another visit than those who don’t. We did not identify any studies that evaluated possible 

indirect benefits of the pelvic examination (e.g., as an incentive to women to seek healthcare). 

Conducting a pelvic examination incurs substantial costs. It has been estimated that the total 

annual cost of preventive gynecologic exams and associated laboratory and radiologic services 

in the US is $2.6 billion.84 Medicare “National Payment Amount” values for 2013 are $38.11 

for a screening pelvic examination and $45.93 for collection of a Pap smear specimen (www.

cma.gov/apps/physician-fee-schedule/overview/aspx). It is likely that a substantial percentage 

of the annual cost represents unnecessary care, given that a majority of clinicians report 

performing routine pelvic examinations in asymptomatic women even if they are not due for a 

Pap smear and a substantial proportion report doing Pap smears more often than recommended. 
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Unnecessary pelvic examinations incur opportunity costs as well, including the time required for 

the examination and its preparation (patient disrobing and putting on a gown, clinician finding a 

chaperone, chaperone taking time away from other duties).

In conclusion, we found no data supporting the use 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. It is time and resource 

intensive, and can lead to unnecessary, invasive, and potentially harmful diagnostic procedures.85

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

high rate of inappropriate use of the pelvic examination.86 Because the implementation literature 

suggests that passive education alone is unlikely to be effective87 a variety of strategies employed 

at multiple levels within the healthcare system will likely be required.88
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