Draft Research Plan
Enhanced Risk Assessment for Cardiovascular Disease: Coronary Artery Calcium Scoring and Ankle Brachial Index
April 25, 2024
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This document is available for Public Comments until May 22, 2024 11:59 PM EDT
In an effort to maintain a high level of transparency in our methods, we open our Draft Research Plan to a public comment period before we publish the final version.
Leave a Comment >>Abbreviations: ABI = ankle brachial index; CAC = coronary artery calcium; CVD = cardiovascular disease; KQ = key question.
1. What is the effectiveness or comparative effectiveness of enhanced cardiovascular disease risk assessment with coronary artery calcium scoring or the ankle brachial index on cardiovascular health outcomes?
1a. What is the effectiveness or comparative effectiveness of enhanced cardiovascular disease risk assessment with coronary artery calcium scoring or the ankle brachial index on physiologic outcomes or patient and provider decision-making outcomes?
2. Does the use of coronary artery calcium scoring or the ankle brachial index to predict cardiovascular disease risk improve measures of calibration, discrimination, and risk reclassification compared with the use of multivariate cardiovascular disease risk assessment without these risk markers?
3. What are the harms of using coronary artery calcium scoring or the ankle brachial index for enhanced cardiovascular disease risk assessment?
4. Does treatment guided by coronary artery calcium scoring or the ankle brachial index lead to improved health outcomes?
5. What are the harms of treatment guided by coronary artery calcium scoring or the ankle brachial index?
Contextual Questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the rate of incidental findings on computed tomography for coronary artery calcium measurement? What are the benefits and harms of detecting these incidental findings?
- What is the incidence and distribution of positive coronary artery calcium as an incidental finding in thoracic imaging?
- What are other risk markers used in enhanced cardiovascular disease risk assessment and what is their role in clinical decision making?
- What are the limitations of existing cardiovascular disease risk assessment or use of coronary artery calcium scoring or ankle brachial index in different populations?
- What is the comparative performance and agreement between PREVENT (Predicting Risk of cardiovascular disease EVENTs) and PCE (Pooled Cohort Equations)? How do 10-year risk scores compare between the two models? What are the strengths and limitations of each of the models?
Health equity will be considered throughout the review using several approaches. For Key Questions, we will describe the population characteristics of the included studies to assess the degree to which the evidence is representative of diverse populations. Further, we will characterize whether race, ethnicity, or social determinants of health were explicitly included as predictors or stratifying factors in prediction models. For risk prediction studies, we will abstract model performance outcomes by race and ethnicity and compare results. We will also analyze benefits and harms of treatment interventions by specific populations to the extent that this is reported in the included studies for selected populations of interest. These groups include racial and ethnic groups, socioeconomic and insurance status, or other social risk factors. We will also include a Contextual Question to explore the limitations of existing cardiovascular disease risk assessment or use of coronary artery calcium scoring or ankle brachial index in different populations.
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.
| Category | Included | Excluded |
|---|---|---|
| Condition definition | Atherosclerotic cardiovascular disease, including coronary heart disease, cerebrovascular disease, and peripheral artery disease | Heart failure |
| Risk Factors |
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| Populations | Adults without known cardiovascular disease
Populations being screened for lung cancer Analyses will include examination of effects by population characteristics such as sex, race, ethnicity, and comorbidities |
Populations selected exclusively based on having advanced chronic kidney disease* or chronic inflammatory disease (e.g., rheumatoid arthritis) |
| Intervention | KQs 1-3: Enhanced risk assessment:
KQs 4, 5: Interventions aimed at preventing CVD events:
|
|
| Comparisons | KQs 1-3: Base model risk assessment:
KQs 4, 5: Usual care, no treatment, or placebo |
Models predicting mortality only or heart failure only |
| Outcomes | KQs 1, 4: CVD events (e.g., myocardial infarction, stroke) and mortality KQ1a: In trials also reporting CVD events, the below outcomes will be captured:
KQ 2: Net reclassification index, discrimination (e.g., area under the curve, c-statistic, integrated discrimination improvement), calibration (e.g., agreement between observed and predicted risks), and decision curve analysis KQs 3, 5: Serious adverse events from risk factor assessment or risk factor modification resulting in unexpected or unwanted medical attention (e.g., major bleeding, development of diabetes) and exposure to radiation) |
|
| Country | Studies conducted in countries categorized as “Very High” on the 2021 Human Development Index (as defined by the United Nations Development Program) | |
| Study designs | KQs 1, 4, 5: RCTs, CCTs
KQ 2: Prognostic prediction model studies KQs 3, 5: RCTs, CCTs, large cohort studies with contemporaneous control, single-arm cohort studies for estimation of radiation exposure or incidental findings, and case-control studies for rare events |
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| Language | English language only | |
| Study Quality | “Fair” or “Good” quality only |
* eGFR <30 mL/min.
Abbreviations: ABI = ankle brachial index; CAC = coronary artery calcium; CCT = clinical controlled trial; CVD = cardiovascular disease; eGFR = estimated glomerular filtration rate; FRS = Framingham Risk Score; GLP-1 = glucagon-like peptide 1; KQ = key question; PCE = Pooled Cohort Equations; PCSK-9 = proprotein convertase subtilisin/kexin type 9; PREVENT = Predicting Risk of cardiovascular disease EVENTs; RCT = randomized controlled trial; SGLT-2 = sodium-glucose transport protein 2.