Draft Research Plan

Gynecological Conditions: Periodic Screening With the Pelvic Examination

December 04, 2014

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.

Women’s health is an important issue to the USPSTF. In response to a topic nomination from the public, the Task Force is commissioning 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 review because pelvic examinations performed in these populations are often for a different indication than those outlined above. The review will focus on 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; and 3) bimanual examination of the uterus, cervix, and adnexa. 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 asymptomatic women at average risk for these conditions. Women with symptoms of disease and women 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. The USPSTF welcomes your comments on this proposed research approach.

Text Description.

Figure 1 is the proposed analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how screening 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 the early detection of gynecological conditions or cancers. Additionally, the figure depicts whether there are any adverse events resulting from the pelvic examination (KQ3).

1. a. What is the effectiveness of screening with the pelvic examination in reducing all-cause mortality?
    b. What is the effectiveness of screening with the pelvic examination in reducing cancer- and disease-specific morbidity and     mortality?
    c. What is the effectiveness of screening with the pelvic examination in improving quality of life?
2. What is the accuracy of the pelvic examination (i.e., sensitivity, specificity, positive and negative predictive values) in screening for gynecological cancers and other gynecological conditions?
3. What are the adverse effects of screening for gynecological conditions with the pelvic examination?

The proposed 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).

  Included Excluded
Populations Asymptomatic, nonpregnant females age ≥18 years at average risk; includes women with and without hysterectomy and postmenopausal women Children and adolescents age <18 years; pregnant adolescents and women
Settings Countries categorized as “Very High” on the 2014 Human Development Index (as defined by the United Nations Development Programme)

Primary care outpatient settings (or similar settings that are applicable to primary care)

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
Interventions Screening pelvic examination (external inspection, internal speculum examination, or bimanual examination)

Entire pelvic examination or components of pelvic examination

Pelvic examination for diagnostic purposes; digital rectal examination; speculum examination to collect a Papanicolaou or human papillomavirus test sample
Comparisons KQ 1: No pelvic examination

KQ 2: Reference standard

KQ 2: No reference standard or reference standard applied to a nonrandom subset
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, treatment, and surgery; 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

Narrative reviews; editorials; case series; case reports

Poor-quality studies