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Draft Research Plan

Draft Research Plan for Breast Cancer: Medications for Risk Reduction

This opportunity for public comment expired on April 19, 2017 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 is below the image.

Text Description.

Figure 1 is a flow diagram of selection of candidates for medications to reduce the risk for primary breast cancer. Women without preexisting breast cancer are screened and sorted into either appropriate or inappropriate candidates for therapy. Women who are appropriate candidates for therapy receive medications to reduce the risk for primary breast cancer. Women may experience adverse effects due to these medications. Women who are treated with these medications may have reduced incidence of invasive or noninvasive breast cancer, which may lead to improved breast cancer-related mortality and all-cause mortality.

Draft: Proposed Key Questions to Be Systematically Reviewed

  1.  a.  In adult women without preexisting breast cancer, what is the accuracy of methods used to identify women who could benefit from medications to reduce risk for primary breast cancer (e.g., clinical risk assessment models)?
    1. What is the optimal age at which to begin risk assessment to identify women who could benefit from medications to reduce risk for primary breast cancer?
    2. What is the optimal frequency of risk assessment to identify women who could benefit from medications to reduce risk for primary breast cancer?
  2. In adult women without preexisting breast cancer, what is the effectiveness and comparative effectiveness of using medications to reduce risk for primary breast cancer on improvement in short- and long-term health outcomes, including invasive breast cancer, noninvasive breast cancer (including ductal carcinoma in situ), breast cancer–specific mortality, and all-cause mortality?
    1. Does the effectiveness of risk-reducing medications vary by timing of initiation or duration of use?
    2. Does the effectiveness of risk-reducing medications persist beyond discontinuation of use?
  3. What are the harms of using medications to reduce risk for primary breast cancer?
    1. Do the harms of risk-reducing medications vary by timing of initiation, duration of use, or both?
    2. Do the harms of risk-reducing medications persist beyond discontinuation of use?
  4. How do the outcomes of using medications to reduce risk for primary breast cancer vary by population subgroups?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What are current clinician and patient attitudes and practices regarding use of medications to reduce risk for primary breast cancer?
  2. How well do decision analysis models inform the practice of identifying and treating women with medications to reduce risk for primary breast cancer?

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).

Proposed KQs 1a, 2, 3, and 4 will be similar to those in the previous evidence review. Two additional questions about the use of risk assessment to identify women who could benefit from medications to reduce risk for primary breast cancer focus on optimal ages (KQ 1b) and intervals (KQ 1c). In the previous evidence review, the question “How do benefits and harms affect decisions to use medications to reduce risk for primary breast cancer, concordance, adherence, and persistence?” did not yield findings useful or applicable to clinical practice. This KQ was replaced with a contextual question about current clinician and patient attitudes and practices regarding use of risk-reducing medications.

Category Included Excluded
Populations Women without preexisting breast cancer, including women who are known BRCA mutation carriers and women with a previous nonmalignant breast biopsy (e.g., atypical hyperplasia) Women with preexisting breast cancer (invasive or ductal carcinoma in situ); men; populations not similar to those in the United States
Interventions KQ 1: Risk assessment

KQs 2–4: Tamoxifen, raloxifene, and aromatase inhibitors
KQs 2–4: Medications not used or available in the United States; other medications not listed as included
Comparisons KQ 1: Risk assessment vs. usual care or an alternate method of risk assessment

KQs 2–4: Medications vs. placebo; tamoxifen vs. raloxifene, tamoxifen vs. aromatase inhibitors, and raloxifene vs. aromatase inhibitors
Comparisons with other types of medications
Outcomes KQ 1a: Measures of risk assessment test performance (sensitivity, specificity, positive and negative likelihood ratios, and c-statistic)

KQs 2–4: Incidence of invasive and noninvasive breast cancer; breast cancer–specific and all-cause mortality; harms (including, but not limited to, thromboembolic events, cardiovascular events, metabolic disorders, musculoskeletal symptoms, mental health, genitourinary outcomes, adverse breast outcomes, other malignancies, ophthalmologic disorders, gastrointestinal/hepatobiliary disorders, and other adverse events affecting quality of life)
Other outcomes
Setting Primary care settings; settings comparable to U.S. practice Practice settings not similar to those in the United States
Study Design KQ 1a: Discriminatory accuracy studies

KQs 1b, 1c, 2–4: Randomized, controlled trials; observational studies, with or without comparison groups, except for efficacy (KQ 2)
Other study designs
Study Quality Good- and fair-quality studies for meta-analyses Poor-quality studies
Current as of: March 2017

Internet Citation: Draft Research Plan: Breast Cancer: Medications for Risk Reduction. U.S. Preventive Services Task Force. April 2017.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/breast-cancer-medications-for-risk-reduction1

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