The Patient-Centered Outcomes Research Institute (PCORI) has issued a Request for Information concerning its proposed framework for assessing the design of research that examines the safety and effectiveness of health interventions, including research on behavioral therapies and health promotion. This framework is expected to guide PCORI’s future decisions for soliciting and funding comparative effectiveness studies.

PCORI’s proposed framework incorporates such factors as: internal and external validity, precision, heterogeneity of risks/benefits across subgroups, ethical considerations, time urgency, logistical constraints and data availability. 

The Institute seeks comments on the adequacy of these factors, suggestions for alternative factors or frameworks, and discussion of how these factors apply in different research domains. Respondents are encouraged to provide examples or case studies of how designs are selected for particular research questions, including considerations of trade-offs among factors.

PCORI was established by the Patient Protection and Affordable Care Act of 2010 (the health care reform law) as an independent, nonprofit organization to support research on how to most effectively prevent, treat and manage diseases and disorders. 

The Request for Information contains instructions for submitting comments. The deadline is February 17, 2012. 

Previous coverage of PCORI:

• Behavior change research highlighted at first PCORI board meeting (December 2010) 

• PCORI solicits public input on its research funding priorities (August 2011) 

• PCORI issues first funding announcement (October 2011)