Comparative Effectiveness Research: A Definition.

The federal Department of Health and Human Services (DHHS) has concisely defined Comparative Effectiveness Research (CER) as research that provides evidence on the “effectiveness, benefits, and harms of different treatment options”. Research studies can generate data that compares drugs, medical devices, tests, surgeries, or ways to deliver health care two ways.

• From existing clinical trials, clinical studies, and other research, either as research reviews, that serve as systematic reviews of existing evidence, as well as epidemiologic research from large de-identified data sets
• New evidence generated from the conduct of new studies or trials that directly compare two or more effective approaches to testing, treatment, or health-care services to determine which is better (e.g., bariatric surgery vs. exercise for weight loss; cell phone vs. web-based dissemination of patient information to change cardiac outcomes)

The Need to Expand Comparative Effectiveness Research:

Comparative Effectiveness Research is rising in prominence in biomedical research for economic, research, and medical practice reasons. The Federal Coordinating Council for Comparative Effectiveness Research and the Institute of Medicine identified the need for further investigation and funding, particularly to focus on reducing health disparities and improving research dissemination. As a result, the Affordable Care Act through the Patient Centered Outcomes Research Trust Fund created a new Patient-Centered Outcomes Research Institute (PCORI) to authorize and fund research evaluating health outcomes of existing approved medical treatments.

Goals of the Program:

The program provides the infrastructure to better coordinate research and evidence into clinical practice required to compete for CER grants and mentor additional faculty to be successful in this type of research. This research, in turn, informs patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.  A secondary purpose is to improve health communications and health literacy through patient focused emphasis. The program:

• Conducts systematic reviews of the medical and healthcare literature
• Analyzes data from large data sets and randomized clinical trials that can provide insight into the most effective and safe treatments and inform further rigorous clinical studies
• Designs and conducts comparative effectiveness trials across the region to improve translation of research into practice and policy through new interventions and strategies to prevent, diagnose, treat and monitor medical conditions

Our work uses methods endorsed by the Institute of Medicine by creating a priority list for Comparative Effectiveness Research studies that includes the following:

• Process for obtaining input from and consultation with stakeholders
• Development and consideration of written priority setting criteria
• Commitment to developing a broad-based portfolio of high priority topics
• Voting process to narrow the nominated topics
• Stakeholder discussion of highest-scored topics
• Prioritization of topics should be a sustained and on-going process recognizing the dynamic state of disease, interventions and public concern
• Involvement of consumers, patients, and caregivers in key aspects of Comparative Effectiveness Research including planning, priority setting, research proposal development, peer review, and dissemination