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Screening for Gynecologic Conditions with Pelvic Examination: a Systematic Review for the U.S

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Screening for Gynecologic Conditions with Pelvic Examination: a Systematic Review for the U.S Evidence Synthesis Number 147 Screening for Gynecologic Conditions With Pelvic Examination: A Systematic Review for the U.S. Preventive Services Task Force Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. HHSA-290-2012-00015-I-EPC4, Task Order No. 4 Prepared by: Kaiser Permanente Research Affiliates Evidence-based Practice Center Kaiser Permanente Center for Health Research Portland, OR Investigators: Janelle M. Guirguis-Blake, MD Jillian T. Henderson, PhD, MPH Leslie A. Perdue, MPH Evelyn P. Whitlock, MD, MPH AHRQ Publication No. 15-05220-EF-1 March 2017 This report is based on research conducted by the Kaiser Permanente Research Affiliates Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2012-00015-I-EPC4, Task Order No. 4). The findings and conclusions in this document are those of the authors, who are responsible for its contents; and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients). This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report. Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Smyth Lai, MLS, for creating and conducting the literature searches; Kevin Lutz, MFA, for editorial assistance; Nadia Redmond, MSPH, for assistance with data abstraction; Jennifer S. Lin, MD, for review of the final report; Tina Fan, MD, MPH, at AHRQ; current and former members of the U.S. Preventive Services Task Force who contributed to topic deliberations; and Hanna Bloomfield, MD, MPH, Melinda A. Cavicchia, MD, MPH, David Chelmow, MD, Esther Eisenberg, MD, MPH, Tara Jatlaoui, MD, MPH, Barnett Kramer, MD, MPH, Giang Nguyen, MD, MPH, Mary Roary, PhD, Mona Saraiya, MD, MPH, Sherri Stewart, PhD, and Naomi Tepper, MD, MPH, for their expert feedback on this report. The authors thank Barnett Kramer, MD, MPH, Paul Pinsky, PhD, and Maryam Doroudi, PhD, for providing unpublished data from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial for participants undergoing ovarian palpation. Suggested Citation Guirguis-Blake JM, Henderson JT, Perdue LA, Whitlock EP. Screening for Gynecologic Conditions With Pelvic Examination: A Systematic Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 147. AHRQ Publication No. 15-05220-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2017. Screening With Pelvic Examination ii Kaiser Permanente Research Affiliates EPC Structured Abstract Background: In light of recent guideline changes in the periodicity of cervical cancer screening, there is uncertainty surrounding the role of the routine screening pelvic examination during annual prevention visits. Purpose: We conducted this systematic review to support the U.S. Preventive Services Task Force in creating its recommendation on the periodic screening pelvic examination. Our review addresses three questions: 1) What is the direct evidence for the effectiveness of the pelvic examination in reducing all-cause mortality, cancer- and disease- specific morbidity and mortality, and improving quality of life? 2) What are the test performance characteristics of the pelvic examination in screening for gynecologic cancers and other gynecologic conditions? 3) What are the adverse effects of screening using the pelvic examination? Data Sources: We searched MEDLINE, PubMed (publisher-supplied references only), and the Cochrane Central Register of Controlled Trials to identify literature that was published from the earliest date indexed (1946 for MEDLINE) to January 13, 2016. We supplemented our searches with reference lists from relevant existing systematic reviews, suggestions from experts, and ClinicalTrials.gov to identify ongoing trials. Study Selection: Two investigators independently reviewed identified abstracts and full-text articles against a set of a priori inclusion and quality criteria. Data Analysis: One investigator abstracted data into an evidence table and a second investigator confirmed these data. We qualitatively synthesized the data for each key question; quantitative synthesis was not appropriate due to heterogeneity and the low number of trials for any given intervention and outcome. Results: We found no studies that assessed the effectiveness of the pelvic examination in reducing all-cause mortality, reducing cancer- and disease-specific morbidity and mortality, or improving quality of life. For four conditions, we identified a total of eight diagnostic accuracy studies that examined test characteristics for the screening pelvic examination: ovarian cancer (k=4), bacterial vaginosis (k=2), trichomoniasis (k=1), and genital herpes (k=1). These eight studies also provided information on the harms of screening using the pelvic examination (false- positive and false-negative results). One large good-quality randomized, controlled trial reported additional diagnostic workup, surgeries, and any complications occurring 1 year after abnormal ovarian palpation. An additional cohort study also assessed harms (urinary symptoms). The low prevalence of ovarian cancer in the general population consistently resulted in low positive predictive values. In these four ovarian cancer screening studies, with more than 26,000 screened patients, more than 98 percent of the positive test results were false positives, depending on the study design and management protocols. Surgery rates resulting from an abnormal pelvic examination ranged from 5 to 36 percent at 1 year, with the largest study reporting an 11 percent surgery rate and 1 percent complication rate within 1 year of an abnormal screening pelvic examination. Each diagnostic accuracy study for bacterial vaginosis, trichomoniasis, and genital herpes was performed in a high-prevalence population with high proportions of symptomatic patients and reported accuracy characteristics for individual physical examination findings, Screening With Pelvic Examination iii Kaiser Permanente Research Affiliates EPC thereby limiting any conclusions that could be made regarding the screening accuracy or adverse effects of the pelvic examination in asymptomatic primary care populations. Conclusions: There is no direct evidence on the overall benefits and harms of the pelvic examination as a one-time or periodic screening test. In addition, there is limited evidence regarding the diagnostic accuracy and harms of the routine screening pelvic examination to guide practice in asymptomatic primary care populations. Research is needed to illuminate how recent changes in cervical cancer screening periodicity may influence women’s access to other evidence-based preventive services in the primary care setting and to create best practices for achieving high rates of uptake for these recommended services. Screening With Pelvic Examination iv Kaiser Permanente Research Affiliates EPC Table of Contents Chapter 1. Introduction ............................................................................................................... 1 Background ................................................................................................................................. 1 Current Clinical Practice in the United States ............................................................................ 2 Recommendations of Other Groups............................................................................................ 3 Previous Related USPSTF Topics .............................................................................................. 4 Chapter 2. Methods ...................................................................................................................... 5 Scope and Purpose ...................................................................................................................... 5 Key Questions and Analytic Framework .................................................................................... 5 Key Questions ......................................................................................................................... 5 Data Sources and Searches ......................................................................................................... 6 Study Selection ..........................................................................................................................
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