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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, 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.
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