Federal agencies are busy implementing the new program for comparative effectiveness research. The Federal Coordinating Council for Comparative Effectiveness Research (CER) has released, for public comment, a draft definition of CER and draft prioritization criteria for making research selections. The definition and criteria are intended to help guide, albeit at a high level, federal use of the $1.1 billion appropriated for comparative effectiveness research in FY 2009 and FY 2010 in the American Recovery and Reinvestment Act (ARRA).
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):
- Included within statutory limits of Recovery Act and FCC definition of CER.
- Responsiveness to expressed needs and preferences of patients, clinicians, and other stakeholders, including community engagement in research.
- Feasibility of research topic (including time necessary for research).
The criteria for scientifically meritorious research and investments are:
- Potential Impact (based on prevalence of condition, burden of disease, variability in outcomes, and costs of care).
- Potential to evaluate comparative effectiveness in diverse populations and patient sub-populations.
- Uncertainty within the clinical and public health communities regarding management decisions.
- Addresses need or gap unlikely to be addressed through other funding mechanisms.
- Potential for multiplicative effect (e.g. lays foundation for future CER or generates additional investment outside government).
To comment on the draft definition and criteria, click here.
Plans for Implementing Comparative Effectiveness Research:
Of the $1.1 billion Congress appropriated for comparative effectiveness research, the Agency for Healthcare Research and Quality (AHRQ) received $300 million, the National Institutes of Health (NIH) received $400 million, and the HHS Office of the Secretary (OS) received $400 million. They have each developed plans for implementing their parts of the federal CER initiative:
- AHRQ Implementation Plan for Comparative Effectiveness Research.
- NIH Implementation Plan for Comparative Effectiveness Research.
- Office of the Secretary Implementation Plan for Comparative Effectiveness Research.
Lessons from Comparative Effectiveness Research in Other Countries:
Meanwhile, an interesting new report from the Deloitte Center for Health Solutions profiles comparative effectiveness programs in the United Kingdom, Australia, Canada, and Germany. The report nicely lays out the complexity, challenges, and usefulness of comparative effectiveness. It also gives a helpful history of CER in the U.S. To read the report, click here (PDF).