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.
  I felt very strongly that AcademyHealth needed to contribute to this standards-making effort, and to the greatest extent possible, provide suggestions that were constructive, insightful, and represented the diversity of conceptual and technical expertise in our field. I believe we achieved a balance in the comments, and I hope you’ll agree! AcademyHealth worked closely with a subset of our Methods Council (selected based on availability and representation from quantitative, qualitative and mixed methods researchers) to identify the key messages and tone of our comments. We also worked closely with our Board of Directors and our Committee on Advocacy and Public Policy to make sure that our comments were properly representative of the field and provided helpful suggestions to strengthen the report and fill in any subject matter gaps. Our comments are available on the PCORI website here, and feel free to read the (lengthy but meaty) Draft Methodology Report here. Please let us know what you thought of the report and our statement in the comments section below. We look forward to hearing from you!
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