Draft Research Plan
Draft Research Plan for Ovarian Cancer: Screening
This opportunity for public comment expired on April 22, 2015 at 5:00 PM EST
Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. 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.
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.
Draft: Proposed Analytic Framework
*Harms of screening include the downstream harms of surgical evaluation, the outcomes of which are expressed as excess surgeries per cancer detected. With regard to “evaluation/treatment,” only the harms of diagnostic surgery will be reviewed.
The figure is an analytic framework that depicts three Key Questions described in the Research Plan. In general, it illustrates the overarching questions of whether screening for ovarian cancer in asymptomatic women who are age 45 years and older or peri- or post-menopausal leads to improved health outcomes or potential harms (including downstream harms of surgical evaluation). The analytic framework also illustrates the intermediate step and Key Question related to the yield and accuracy of screening approaches and methods for early detection of ovarian cancer.
Draft: Proposed Key Questions to Be Systematically Reviewed
- Does screening for ovarian cancer in asymptomatic women reduce morbidity and mortality?
- What is the yield and accuracy of screening approaches and methods for detection of ovarian cancer?
- What are the harms of screening (including downstream harms of surgical evaluation) for ovarian cancer in asymptomatic women? Do these harms vary by screening approach or method?
Draft: Proposed Contextual Questions
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Are the type* (type I vs. type II) and stage of screen-detected ovarian cancer associated with reduced mortality compared with no screening?
- What is current medical practice concerning the method of surgical diagnosis of ovarian cancer (i.e., what proportion of patients receive laparoscopy vs. laparotomy)? How often is laparoscopy changed to laparotomy during surgery? What patient and/or risk characteristics are associated with the recommendation and final use of either procedure?
* Newer evidence suggests that high-grade serous type II ovarian cancer may originate in the fallopian tubes and seed the ovaries and other sites early in disease progression, which means early-stage diagnosis and screening may have less of an effect on mortality for this type of cancer. Screening may have more of an effect on type I ovarian cancer, which is more amenable to treatment.
Draft: Proposed Research Approach
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).
|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 mutation carriers or patients of a specialty practice, such as oncology|
|Populations||Asymptomatic women who are age ≥45 years or peri- or post-menopausal||Women who are selected for increased risk for ovarian cancer due to known predisposing genetic mutations, family history, or race/ethnicity (e.g., Ashkenazi Jewish women)|
|Screening tests||Initial screening tests such as, but not limited to: testing for serum cancer antigen (CA)–125, transvaginal ultrasonography (alone or in combination), and algorithms, such as the risk of ovarian cancer algorithm (ROCA)||Tests without validation in screening populations|
|Comparisons||Comparison of screening with usual care; comparison of different included screening methods|
|Outcomes||KQ 1: Ovarian cancer–specific mortality (including primary peritoneal and fallopian tube cancer), all-cause mortality, and cancer-related morbidity
KQ 2: Diagnostic accuracy of screening tests for ovarian cancer
KQ 3: Number of surgeries performed to detect 1 case of ovarian cancer, rates of false-positive screening results, complications of unnecessary surgery (laparoscopy vs. laparotomy), and psychological effects of screening
|Settings||KQs 1–3: U.S. primary care settings, including obstetrics/gynecology practices
KQ 2: In addition, radiology practices and studies conducted in countries categorized as “High” on the Human Development Index (as defined by the United Nations Development Programme)
|Specialty practice settings, such as oncology|
|Study designs||KQ 1: Randomized, controlled trials
KQ 2: Randomized, controlled trials; well-designed large prospective cohort studies
KQ 3: Randomized, controlled trials; large cohort studies
|Case-controls, case reports, case series, and decision analyses|
|Study quality||Good and fair quality according to USPSTF criteria and supplemented by recognized quality measures, as applicable (e.g., Newcastle-Ottawa Scale for observational studies)||Poor quality according to USPSTF criteria and supplemental quality measures|
Internet Citation: Draft Research Plan: Ovarian Cancer: Screening. U.S. Preventive Services Task Force. June 2015.