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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.

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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

Text Description.

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

  1. 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)?
    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)?
    2. For each primary screening strategy, does the rescreening interval relate to future cancer incidence or progression?
    3. 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)?
  2. What are the adverse effects of HPV testing, with or without cytology, as a primary screening strategy?
    1. Do the adverse effects vary by subpopulation (e.g., age, race/ethnicity, and HPV immunization status)?
    2. 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.

  1. What is the accuracy of and relative adherence to self-collected HPV specimens compared with clinically-collected HPV specimens?
  2. What are the important assay-related issues, including differences in test performance characteristics, of the different tests for HPV?
  3. What are the regression rates of cervical intraepithelial neoplasia (CIN)3?
  4. What is the current practice regarding treatment of CIN2 or CIN3?
  5. 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).

  Included Excluded
Populations KQs 1, 2: Females age ≥18 years at risk for cervical cancer KQs 1, 2:
  • High-risk populations (e.g., females who are HIV-positive)
  • Women without a cervix
  • Women who have had a hysterectomy
Interventions KQs 1, 2:
  • HPV testing, alone or in combination (co-testing) with cytology
  • HPV testing with cytology triage of positive HPV (reflex cytology)
  • Self- or clinician-collected specimens
KQs 1, 2: Cytology with HPV triage (reflex HPV)
Comparators KQs 1, 2:
  • No screening
  • Waitlist
  • Comparative effectiveness (i.e., cytology-based or other primary HPV screening strategies)
KQs 1, 2: Liquid-based cytology vs. conventional cytology alone
Outcomes KQ 1:
  • Early detection of disease (CIN3+)
  • Invasive cancer
  • Mortality (all-cause or cervical cancer)
  • Improved quality of life

The following hierarchy of outcomes for new cervical cancer screening methods will be used:

Rank 1: Cervical cancer mortality (quality-adjusted life-years gained)
Rank 2: Cervical cancer morbidity/Stage IB+ incidence
Rank 3: Cervical cancer incidence (including microinvasive)
Rank 4: Reduced CIN3+ incidence*
Rank 5: Increased detection of CIN3+ (or CIN2+)*

  • More CIN3+ detection overall (cumulative CIN3+)
  • More CIN2+ detection followed by less CIN3+ detection at subsequent screening (Note: CIN2+ detection may include overdiagnosis)
Rank 6: Increased test positivity with increased, similar, or minimally reduced positive predictive value

KQ 2:

  • Consequences of false-positive and false-negative screening test results (e.g., harms of colposcopy, unnecessary biopsy, biopsy-related harms, overtreatment)
  • Rates of colposcopy
  • Treatment-related reproductive harms
  • Unnecessary labeling/stigma
  • Partner discord
  • Psychological distress (e.g., anxiety)
  • Reduced quality of life
Study designs KQs 1, 2:
  • Systematic reviews and meta-analyses
  • Randomized, controlled trials; controlled clinical trials
  • Cohort studies
KQs 1, 2:
  • Case-control studies
  • Case reports
  • Case series
  • Narrative reviews
  • Editorials
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:
  • Community/university research laboratories or other nonmedical centers
  • Correctional facilities
  • Worksites
  • Inpatient/residential facilities
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.

Current as of: May 2015

Internet Citation: Draft Research Plan: Cervical Cancer: Screening. U.S. Preventive Services Task Force. June 2015.

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