On July 23, the Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee released for public comment a draft of its first methodology report, which puts forth 60 recommended standards to guide patient-centered outcomes research (PCOR). PCORI is an independent, nonprofit organization that was established by Congress through the 2010 Patient Protection and Affordable Care Act (PPACA), and was created to conduct research to provide information about the best available evidence to help patients and their healthcare providers make more informed decisions.
According to the report, the standards offer an approach to align the research agenda with questions that underlie patients’ and clinicians’ uncertainty about what works best, for whom, and under what conditions. Methodological standards aim to do this by improving the way research questions are selected, formulated, and addressed, and findings reported. They can also help prevent the research agenda from employing flawed, out-of-date, or inappropriate methods to answer research questions, and may raise the bar for researchers, publishers, and industry as they try to inform decision-making.
Among others, the recommended standards for patient-centered outcomes research include standards for formulating research questions, patient-centeredness, research prioritization, data networks, adaptive trials, and data registries.
The draft report is available for public comment through September 14. It can be accessed at the PCORI website.
After incorporating public input, the draft methodology report will be considered for adoption by the PCORI Board of Governors at its November public meeting. Further, as new methods are implemented and verified, the report will continue to be revised and improved.
