Skip to navigation bar Skip to breadcrumbs Skip to page content Skip to comments area
clear place holder
Envelope icon E-mail Updates Teal square Text size:  a A A
You are here: HomePublic Comments and NominationsOpportunity for Public CommentDraft Research Plan : Draft Research Plan

Draft Research Plan

Draft Research Plan for Cardiovascular Disease: Risk Assessment Using 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.

Send Us Your Comments

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.

Comment period is not open at this time.

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.

Text Description.

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

  1. 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?
  2. 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?
  3. What are the harms of nontraditional risk factor assessment?
  4. 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?
  5. 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).

  Include
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
Current as of: June 2015

Internet Citation: Draft Research Plan: Cardiovascular Disease: Risk Assessment Using Nontraditional Risk Factors. U.S. Preventive Services Task Force. June 2015.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan180/coronary-heart-disease-screening-using-non-traditional-risk-assessment

USPSTF Program Office   5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857