Draft Research Plan
Draft Research Plan for Cardiovascular Disease: Risk Assessment With Nontraditional Risk Factors
This opportunity for public comment expired on July 8, 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
Abbreviations: ABI = ankle brachial index; CAC = coronary artery calcium; CVD = cardiovascular disease; HDL = high-density lipoprotein; hs-CRP = high-sensitivity C-reactive protein; KQ = key question; MI = myocardial infarction.
Figure 1 is the analytic framework that depicts the five Key Questions to be addressed in the systematic review. The figure illustrates how nontraditional risk factor assessment may result in improved health outcomes, including cardiovascular morbidity and mortality (KQ1). Additionally, the figure illustrates how nontraditional risk factor assessment may improve measures of calibration, discrimination, and risk reclassification (KQ2) and how treatment based on nontraditional risk factor assessment may improve health outcomes (KQ4). Further, the figure depicts whether nontraditional risk factor assessment or treatment based on nontraditional risk factor assessment are associated with any adverse events (KQ3 and KQ5).
Draft: Proposed Key Questions to Be Systematically Reviewed
- Compared with the Pooled Cohort Equations tool or Framingham risk factors alone, does risk assessment of asymptomatic adults using nontraditional risk factors lead to reduced incidence of cardiovascular events (e.g., myocardial infarction, cerebrovascular accident) and/or mortality?
- Does use of nontraditional risk factors in addition to traditional risk factors to predict cardiovascular disease risk improve measures of calibration, discrimination, and risk reclassification?
- What are the harms of nontraditional risk factor assessment?
- Does treatment guided by nontraditional risk factors in addition to traditional risk factors lead to reduced incidence of cardiovascular events (e.g., myocardial infarction, cerebrovascular accident) and/or mortality?
- What are the harms of aggressive risk factor modification?
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).
|Condition definition||Atherosclerotic cardiovascular disease, including coronary heart disease, cerebrovascular disease, and peripheral artery disease|
|Populations||Adults without known cardiovascular disease, by sex and race/ethnicity|
|Risk factors||High-sensitivity C-reactive protein, coronary artery calcium, and ankle brachial index|
|Treatments||KQs 4, 5: Interventions aimed at preventing cardiovascular disease events, such as aspirin, HMG-CoA reductase inhibitors, lifestyle modification (e.g., diet/exercise), and aggressive risk factor modification (e.g., antihypertension medications)|
|Comparisons||KQs 1–3: Existing cardiovascular disease risk assessment models (focusing on cardiovascular disease as opposed to coronary heart disease risk assessment)
KQs 4, 5: No treatment or usual care (as defined by the study)
|Outcomes||KQs 1, 4: Cardiovascular disease events (e.g., myocardial infarction, cerebrovascular accident) and/or mortality
KQ 2: Measures of reclassification (e.g., net reclassification index, integrated discrimination improvement), discrimination (e.g., area under the curve, c-statistic), and calibration (e.g., agreement between observed and predicted risks)KQs 3, 5: Serious adverse events resulting in unexpected or unwanted medical attention (e.g., exposure to radiation, major bleeding, development of diabetes)
|Countries||Studies conducted in countries categorized as “Very High” on the 2014 Human Development Index (as defined by the United Nations Development Programme)|
|Study designs||KQs 1, 4: Systematic review of trials; randomized, controlled trials; controlled clinical trials
KQ 2: Systematic review of trials; randomized, controlled trials; controlled clinical trials; well-designed large prospective cohort studies; risk prediction studies
KQs 3, 5: Systematic reviews; randomized, controlled trials; controlled clinical trials; well-designed large prospective or retrospective cohort studies; well-designed case-control studies (only for rare events)
|Publication language||English language only|
|Study quality||Fair or good quality only|
Internet Citation: Draft Research Plan: Cardiovascular Disease: Risk Assessment With Nontraditional Risk Factors. U.S. Preventive Services Task Force. June 2015.