Final Research Plan
Gynecological Conditions: Periodic Screening With the Pelvic Examination
March 05, 2015
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from December 4, 2014 until January 7, 2015.
Women's health is an important issue to the USPSTF. In response to a topic nomination from the public, the USPSTF has commissioned a review of the evidence on the benefits and harms of performing routine, periodic pelvic examinations to screen for gynecological conditions. The research approach that will guide this evidence review is described below. To focus the review on information that will be most helpful to primary care clinicians, the USPSTF will concentrate on the following: conditions identified by clinicians as a reason for performing the screening pelvic examination; conditions for which detection of early-stage disease in asymptomatic patients is biologically and clinically plausible; and conditions for which there is not already another method of screening addressed by a current USPSTF recommendation. This review will focus on nonpregnant women age 18 years and older. Adolescents and pregnant women will not be included in the current review because pelvic examinations performed in these populations are often for a different indication than those outlined above. The review will include the following components of the pelvic examination: 1) inspection of the external genitalia, urethral meatus, vaginal introitus, and perianal region; 2) speculum examination of the vagina and cervix; 3) bimanual examination of the uterus, cervix, and adnexa; and 4) rectovaginal examination of the posterior wall of the vagina. Congenital malformations, such as Müllerian duct anomalies, will be excluded because they are often detected upon initial examination and are not the focus of periodic pelvic examinations. Lastly, the review will focus on the general, unselected population of women who are asymptomatic for the gynecological conditions being evaluated. Women with symptoms of disease and women who are at increased risk for disease (such as BRCA mutation carriers, who are at increased risk for ovarian cancer) will be excluded, as these women may need a diagnostic examination or more intensive surveillance than a routine, periodic pelvic examination.
Figure 1 is the analytic framework that depicts the three key questions to be addressed in the systematic review. The figure illustrates how screening unselected, asymptomatic, nonpregnant adult females with the pelvic examination could lead to reductions in all-cause mortality, disease-specific morbidity and mortality, and improved quality of life (KQ1). The figure also shows how the pelvic examination could detect an abnormal finding (KQ2) that leads to early detection of gynecological conditions or cancers. Additionally, the figure depicts that there are adverse events that could result from the pelvic examination (KQ3).
- What is the direct evidence for the effectiveness of screening with the pelvic examination in:
- Reducing all-cause mortality?
- Reducing cancer- and disease-specific morbidity and mortality?
- Improving quality of life?
- What are the test performance characteristics of the pelvic examination (i.e., sensitivity, specificity, positive and negative predictive values) in screening for gynecological cancers and other gynecological conditions?
- What are the adverse effects of screening with the pelvic examination?
The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).
|Populations||General unselected, asymptomatic, nonpregnant female adults age ≥18 years; includes women with and without a hysterectomy and women who are postmenopausal||Children and adolescents age <18 years; pregnant female adolescents and women|
||Settings not applicable to primary care|
|Conditions||Gynecological cancers (e.g., ovarian, vulvar, vaginal, and endometrial cancer) and other gynecological conditions (e.g., candidiasis, human papillomavirus, herpes simplex virus, trichomoniasis, bacterial vaginosis, atrophic vaginitis, pelvic organ prolapse, pelvic floor dysfunction, pelvic inflammatory disease, cervical polyps, ovarian cysts, uterine fibroids, and endometriosis) not listed as excluded||Cervical cancer; gonorrhea; chlamydia|
||Pelvic examination for diagnostic purposes; digital rectal examination; Papanicolaou or human papillomavirus testing|
|Comparisons||KQ 1: No pelvic examination
KQ 2: Reference standard
|KQ 2: No reference standard or reference standard is applied to a nonrandom subset of the study population|
|Outcomes||KQ 1: All-cause mortality; cancer-specific mortality and morbidity for included cancers; disease-specific morbidity for included conditions (including but not limited to abnormal bleeding, pelvic pain, incontinence, and infertility); quality of life
KQ 2: Sensitivity, specificity, likelihood ratios, positive and negative predictive values
KQ 3: Unnecessary diagnostic workup; unnecessary treatment; physical pain/discomfort; barriers to obtaining hormonal contraception; psychological harms
|Study Design||KQ 1: Systematic reviews; randomized, controlled trials
KQ 2: Systematic reviews of diagnostic accuracy studies; diagnostic accuracy studies
KQ 3: Observational studies (not listed as excluded); randomized, controlled trials; controlled clinical trials
|All KQs: Narrative reviews; editorials; case series; case reports; statistical models that extrapolate beyond direct clinical evidence; poor-quality studies|
The draft Research Plan was posted for public comment on the USPSTF Web site from December 4, 2014 to January 7, 2015. The USPSTF received comments requesting that average-risk patients be more clearly defined; the Research Approach now defines the population as general unselected, asymptomatic, nonpregnant female adults. The USPSTF received comments asking it to include the rectovaginal examination or to provide a justification for its exclusion. In response, the USPSTF added the rectovaginal examination to the included interventions. The USPSTF also made minor clarifications to the inclusion and exclusion criteria in response to various comments. Public comments indicated that clear communication regarding the scope and context of the evidence review for this topic is important, and the research team will strive to clearly present its final findings.