Establishing the Definition of Patient-Centered Outcomes Research

Despite being a component of the Patient-Centered Outcomes Research Institute’s name, at the time of its creation, “patient-centered outcomes research” (PCOR) was not a commonly used term, nor had it been formally defined. One of PCORI’s foundational tasks was to clearly describe the field of patient-centered outcomes research and clarify PCORI’s focus and scope of work.

In March 2011, the PCORI Methodology Committee began an extensive, iterative, and transparent process to define patient-centered outcomes research. The committee held a series of discussions that generated multiple draft definitions, which were presented and considered at the public board meeting in St. Louis on March 8. The meeting gave Board members and the public an opportunity to provide feedback on the drafts and to articulate a vision for what the definition should include. Input was incorporated into eight subsequent hours of deliberation within the Methodology Committee to create consensus on the definition’s theme and language. A draft definition was approved by the Methodology Committee on April 26 and presented to the PCORI Board for approval at the May 2011 Board meeting. Note: This revised definition was updated on 4/20/2012 to clarify some language. See the update here.

Keeping with PCORI’s commitment to incorporate public input into every element of its work, the draft definition of PCOR was posted for a 45-day public comment period from July 20- Sept. 2, going beyond PCORI’s legislative requirements. Nearly 120 organizations and 450 individuals–representing every perspective in the medical community–responded to PCORI’s request for feedback. The comments were analyzed and a report was published publically that characterized how respondents reacted to the working definition of PCOR.

In November and December PCORI sought further public input by conducting six focus groups aimed at determining whether the PCOR definition resonated with patients, caregivers, and the general public. Fifty-nine people participated across three geographic locations--Chicago, Richmond, and Phoenix. To ensure a diversity of perspectives, one group was conducted in Spanish with Hispanic patients and caregivers and one group exclusively included African-American patients and caregivers.

Combining the analysis of the public comment period and insight from the focus groups, the Methodology Committee made several recommendations to the Board on how the PCOR definition should be adjusted to reflect the concerns of patients and other stakeholders. Each suggested edit included an explanation of the input received regarding a specific piece of the definition, and how the definition should be revised to address the feedback. The recommendations were presented at the March 5 Board meeting in Baltimore, where the Board voted to adopt the revised definition.

The process of receiving comment was thorough, providing opportunity for all healthcare stakeholders to contribute, and the incorporation of feedback was substantive and transparent. The progression of the PCOR definition was a major step in demonstrating how PCORI will uphold its commitment to be guided by the voices of patients, caregivers, and the healthcare community.

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Posted: March 13, 2012; Updated: July 15, 2014