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HHS Releases CER Definition/Criteria Print E-mail

Draft Definition of Comparative Effectiveness Research for the Federal Coordinating Council

Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, behavioral change strategies, and delivery system interventions. This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness.

Draft Prioritization Criteria for Comparative Effectiveness Research

Threshold Minimal Criteria (i.e. must meet these to be considered)

1. Included within statutory limits of Recovery Act and FCC definition of CER 

2. Responsiveness to expressed needs and preferences of patients, clinicians, and other stakeholders, including community engagement in research

3. Feasibility of research topic (including time necessary for research)

Prioritization Criteria

The criteria for scientifically meritorious research and investments are:

1. Potential Impact (based on prevalence of condition, burden of disease, variability in outcomes, and costs of care)

2. Potential to evaluate comparative effectiveness in diverse populations and patient sub-populations

3. Uncertainty within the clinical and public health communities regarding management decisions

4. Addresses need or gap unlikely to be addressed through other funding mechanisms

5. Potential for multiplicative effect (e.g. lays foundation for future CER or generates additional investment outside government)