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PCORI Releases Preliminary Draft Methodology Report

Erin Hertzog

Emily Stopa

12 June 2012

The Patient Centered Outcomes Research Institute (PCORI) released its Preliminary Draft Methodology Report, entitled “Our Questions, Our Decisions: Standards for Patient-centered Outcomes Research” on June 4, 2012.   Among other things, the report sets forth 60 standards to guide the process of patient-centered outcomes research.  This initial list of standards, set forth in Appendix A of the report, was selected to reflect areas in which PCORI’s Methodology Committee believed that there were “either substantial deficiencies or inconsistencies in how the methods were applied in practice, or for which there was specialized knowledge in how to conduct research that had not been effectively disseminated.”  These standards fall into the following 11 categories:

  • Standards for formulating research questions
  • Patient-centeredness
  • Research prioritization
  • General and cross-cutting methods for all patient-centered outcomes research
  • Causal inference
  • Heterogeneity of Treatment Effects
  • Missing data
  • Data networks
  • Adaptive trials
  • Data registries
  • Diagnostic tests

The report is provided as a resource for applicants for PCORI Funding Announcements issued May 22, 2012, although applications will not be scored on adherence to the report’s recommendations, as the report has not yet been subject to public comment. 

PCORI will release an updated version of the draft report for public comment in July 2012.  PCORI’s Methodology Committee will then provide a revised version of the report to PCORI’s Board of Governors in November, 2012.  PCORI plans to periodically update the report in accordance with its mandate under section 6301 of PPACA.

Erin Hertzog

Emily Stopa

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