The Patient-Centered Outcomes Research Institute’s mission is not only to fund comparative clinical effectiveness research, but to create widely accepted standards for how this research should be conducted to provide the greatest benefit to patients and those who care for them. The law establishing PCORI specifically called for the creation of a Methodology Committee that “shall work to develop and improve the science and methods of comparative clinical effectiveness research.”
The PCORI Methodology Committee is comprised of 17 of the nation’s leading researchers and methodology experts, appointed by the Government Accountability Office (GAO). They are important members of the PCORI team. They have taken the lead, for example, on defining “patient-centered outcomes research.” They continue to review public input on the working definition and will present a revised draft for the PCORI Board to consider in early 2012.
Importantly, they are called upon in the Affordable Care Act to create and publish a methodology report that includes a “translation table” for identifying optimal research methods for studying various kinds of patient-centered, comparative clinical effectiveness research questions, as well as developing new methods to address gaps in how we can answer the questions patients and their caregivers have about how best to make personalized healthcare decisions.
The Methodology Committee will present to PCORI’s Board of Governors in May 2012 its first report, including the translation table and a strong standard for the patient-centered outcomes research that PCORI will fund. The Committee has authored a draft framework of the translation table and is now seeking input from stakeholders to inform the development of the report before it is presented to the Board and subsequently issued for formal public comment. This early request for stakeholder input is reflective of PCORI’s commitment to incorporate public feedback throughout its work, from beginning to end.
PCORI is specifically requesting:
- suggestions for enhancing the draft framework components,
- thoughts on alternate components or frameworks,
- discussion of how these components apply to different research domains, and
- comments on the limitations of the proposed framework.
Decisions about the design and methods used in patient-centered outcomes research require consideration of the tradeoffs in applying each translation framework component. Respondents are invited to discuss these decisions or tradeoffs from the perspective of at least one potential stakeholder, which could be patients, clinicians, researchers, payers, policymakers or others. We’re looking for specific examples or case studies – based on patient-centered research questions – that describe the research question of interest and demonstrate application of the translation framework.
Responses to this Request for Information (RFI) will be considered for inclusion in the May 2012 draft Methodology report. Consenting authors of case studies or suggestions that are included in the report will be acknowledged. To be considered, responses to this RFI must be submitted electronically no later than February 17, 2012, at 5:00 p.m. ET.
We’re excited to receive your input in this process and your continued interest in our work.