Future directions for cardiovascular disease comparative effectiveness research: report of a workshop sponsored by the National Heart, Lung, and Blood Institute

Abstract

Comparative effectiveness research (CER) aims to provide decision makers with the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart, Lung, and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address 8 clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER.

Figure 1. Conceptual framework for comparative effectiveness research (CER)

CVD = cardiovascular disease. IOM = Institute of Medicine.

Figure 2. Evidence and data portfolio management for AF

The general framework for CER (Figure 1) is applied to atrial fibrillation. Examples of registries might include an AF clinical care registry, or registry of individuals screened but not randomized to a clinical trial, or individuals followed after completion of a clinical trial. An example of an ongoing AF clinical trial is the Catheter Ablation Versus Anti-Arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA, NCT00911508). AF = atrial fibrillation AFI = atrial flutter CER = comparative effectiveness research CHF = congestive heart failure CVD = cardiovascular disease QOL = quality of life SES = socioeconomic status

Figure 3. Proposed cluster randomized trial for the management of heart failure

DC = discharge DM = disease management QOL = quality of life