Final Research Plan

Ovarian Cancer: Screening

March 03, 2016

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 March 26 until April 22, 2015 at 5:00 p.m., ET.

Text Description.

The figure is an analytic framework that depicts the two Key Questions described in the Research Plan: whether screening for ovarian cancer in asymptomatic women age 45 years and older leads to changes in all-cause or disease-specific mortality and morbidity (Key Question 1) or potential harms (Key Question 2).

  1. Does screening for ovarian cancer in asymptomatic women using a single test or combined algorithm (such as, but not limited to, testing for serum cancer antigen (CA)–125 and ultrasonography) reduce all-cause or disease-specific morbidity and mortality?
  2. What are the harms of screening for ovarian cancer, including harms of the screening test and of diagnostic evaluation?
  1. Is there trial evidence that the stage or type of ovarian cancer diagnosed through screening contributes to reduced all-cause or disease-specific morbidity and mortality?
  2. Are there new screening approaches for detecting ovarian cancer that have better yield or accuracy than those evaluated in trials?

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).

  Include Exclude
Aim Screening for ovarian cancer in a primary care setting (alone or as part of a clinical examination) Screening for ovarian cancer in selected high-risk populations, such as women who are BRCA gene mutation carriers or patients of a specialty practice, such as oncology
Populations Asymptomatic, average-risk women age 45 years and older Trials enrolling only women who are selected based on an increased risk for ovarian cancer (e.g., women with a known predisposing genetic syndrome or strong family history)
Screening tests Screening tests and approaches evaluated in clinical trials, including, but not limited to: testing for serum CA–125, transvaginal ultrasonography, and combined screening approaches or algorithms Screening tests not evaluated in clinical trials
Comparisons Comparison of screening with usual care or no screening; comparison of different included screening methods or programs  
Outcomes KQ 1: Disease-specific mortality (including primary peritoneal and fallopian tube cancer) and morbidity, all-cause mortality, and quality of life

KQ 2: Surgery rate, false-positive rate, complications of diagnostic surgical procedures, and health and psychological effects of screening tests

Settings Primary care settings, including obstetrics/gynecology practices Specialty practice settings, such as oncology
Study designs Randomized, controlled trials Cohort studies, case-controls, case reports, case series, and decision analyses
Study quality Good and fair quality, according to USPSTF criteria and supplemental quality measures Poor quality, according to USPSTF criteria and supplemental quality measures
Language English Languages other than English

A draft Research Plan was posted for public comment on the USPSTF Web site from March 26, 2015 to April 22, 2015. The USPSTF received several comments about the population under consideration, particularly an interest in including women with specific genetic risk factors. Considerations for these populations are generally outside the scope of a review of a broad screening program among asymptomatic women at average risk; therefore, the included population for this topic was not changed. Several comments sought clarification on the analytic framework. In response, the USPSTF simplified the analytic framework to focus on direct evidence from screening trials. A few comments requested that specific screening interventions be evaluated. The USPSTF clarified the inclusion criteria to indicate that all screening tests and approaches evaluated in clinical trials will be included. Additionally, the USPSTF added a contextual question to address the yield or accuracy of newer screening approaches not yet evaluated by clinical trials.