Last week, AcademyHealth submitted comments on the Patient-Centered Outcomes Research Institute Methodology Committee’s Draft Methodology Report, which presents 60 proposed standards for conducting patient-centered outcomes research (PCOR), as well as a translation framework to help guide decisions on which methods are suitable for which questions. This landmark report describes standards for the field of PCOR in which PCORI’s Methodology Committee determined that there were “substantial deficiencies or inconsistencies in how the methods were applied in practice, or for which there was specialized knowledge in how best to conduct research that had not been effectively disseminated.” As you are likely aware, the Affordable Care Act (ACA) established the Patient-Centered Outcomes Research Institute (PCORI) as a nongovernmental entity tasked with advancing the quality and relevance of evidence-based medicine through the synthesis and dissemination of “comparative clinical effectiveness research” (Section 6301). Both the methodology report and the translation table were mandated by the ACA to begin defining standards and methods for strengthening the underlying science of patient-centered outcomes research (PCOR). The proposed standards include the following:
- Standards for formulating research questions
- Standards for patient-centeredness of research proposals and protocols (i.e., patient engagement)
- Methods for prioritizing patient-centered outcomes research
- Translation Framework and table for choosing data sources, research design, and analysis plan
- General and crosscutting methods for all PCOR, causal inference methods, studying heterogeneity of treatment effect, and preventing and handling missing data
- Use of collaborative or distributed data networks and data networks as research facilitating infrastructures
- Design-specific standards such as adaptive and Bayesian trial designs, data registries, and studies on diagnostic tests.