As applied research designed to inform decision makers (patients, providers, and policy makers), comparative effectiveness research (CER) poses unique challenges for research design and implementation. Unlike in traditional health services research, outcomes research, or clinical research, in CER tradeoffs of validity, relevance, feasibility, and timeliness must be considered in the context of specific health care decisions. Despite significant interest and current and future planned investment in CER, there is little information on how best to select a particular methodology to answer a particular CER question facing decision-makers.
For these reasons, in a parallel effort intended to inform the work of the Patient Centered Outcomes and Research Institute (PCORI), the goal of this project is to develop a framework to guide the selection of appropriate study designs and methods to address specific types of CER questions. To achieve this goal, CMTP has partnered with Outcomes Sciences and the National Pharmaceutical Council (NPC). Together, we have:
- conducted a literature review describing the full range of existing clinical research methods that are applicable to CER, including experimental, non-experimental, and combined approaches;
- commissioned two white papers by distinguished teams led by Dr. Sheldon Greenfield (UC Irvine) and Dr. Victor Montori (Mayo Clinic) which discuss the selection and application of methods to four specific CER research questions; and
- convened a multi-stakeholder meeting of key decision-makers and methodology experts in December 2011 to review and discuss the white papers, collectively considering a set of guiding principles for method selection for CER questions and the role of diverse stakeholders in articulating principles for designing CER.
To disseminate the conclusions from this effort, in collaboration with Drs. Greenfield and Montori, CMTP, Outcome, and NPC are preparing a series of papers to appear in the Journal of Comparative Effectiveness Research.