Draft Research Plan
Draft Research Plan for Cervical Cancer: Screening
This opportunity for public comment expired on June 24, 2015 at 8:00 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
This figure is the proposed analytic framework that depicts the two Key Questions (KQs) to be addressed by the systematic review. The figure illustrates how cervical cancer screening programs among asymptomatic, average-risk women may improve health outcomes (KQ1) and may have possible harms (KQ2).
Draft: Proposed Key Questions to Be Systematically Reviewed
- What is the effectiveness of human papillomavirus (HPV) testing, with or without cytology, as a primary screening strategy for reducing cervical cancer mortality (1.0) and incidence (1.1)?
- Does the effectiveness of HPV testing for reducing cervical cancer outcomes vary by subpopulation (e.g., age, race/ethnicity, screening history, HPV immunization status, and socioeconomic status)?
- For each primary screening strategy, does the rescreening interval relate to future cancer incidence or progression?
- Does the appropriate rescreening interval for each primary screening strategy vary by subpopulation (e.g., age, race/ethnicity, screening history, HPV immunization status, and socioeconomic status)?
- What are the adverse effects of HPV testing, with or without cytology, as a primary screening strategy?
- Do the adverse effects vary by subpopulation (e.g., age, race/ethnicity, and HPV immunization status)?
- Do the adverse effects vary by screening strategy?
Draft: Proposed Contextual Questions
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the accuracy of and relative adherence to self-collected HPV specimens compared with clinically-collected HPV specimens?
- What are the important assay-related issues, including differences in test performance characteristics, of the different tests for HPV?
- What are the regression rates of cervical intraepithelial neoplasia (CIN)3?
- What is the current practice regarding treatment of CIN2 or CIN3?
- What are rates of colposcopy- and biopsy-related harms from diagnostic evaluation and reproductive problems associated with current treatments of precancerous or cancerous cervical lesions?
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).
|Populations||KQs 1, 2: Females age ≥18 years at risk for cervical cancer||KQs 1, 2:
|Interventions||KQs 1, 2:
||KQs 1, 2: Cytology with HPV triage (reflex HPV)|
|Comparators||KQs 1, 2:
||KQs 1, 2: Liquid-based cytology vs. conventional cytology alone|
The following hierarchy of outcomes for new cervical cancer screening methods will be used:
|Study designs||KQs 1, 2:
||KQs 1, 2:
|Timing of Outcome Assessment||KQs 1, 2: ≥12 months||KQs 1, 2: <12 months|
|Setting||KQs 1, 2: Primary care (e.g., internal medicine, family medicine, obstetrics/gynecology) or other settings generalizable to primary care (e.g., university-based health clinics, mobile clinics, sexually transmitted infection clinics, family planning clinics)||KQs 1, 2:
|Country||KQs 1, 2: Countries with cervical cancer screening programs comparable to those of the United States and categorized as “Very High” or equivalent on the 2014 Human Development Index (as defined by the United Nations Development Programme)||KQs 1, 2: Countries not categorized as “Very High” on the Human Development Index or not applicable to U.S. clinical settings or populations|
|Language||KQs 1, 2: English only||KQs 1, 2: Non-English publications|
|Quality||KQs 1, 2: Fair- or good-quality, according to USPSTF design-specific criteria||KQs 1, 2: Poor-quality, according to USPSTF design-specific criteria|
*Surrogates may need to suffice for purposes of health policy, followed by modeling.
Internet Citation: Draft Research Plan: Cervical Cancer: Screening. U.S. Preventive Services Task Force. June 2015.