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PCORI Finalizes “Patient-Centered Outcomes Research” Definition

Stuart M. Langbein

Stuart M. Langbein,

Washington, D.C.

Erin Hertzog

12 April 2012
Section 6301 of the Patient Protection and Affordable Care Act established the Patient-Centered Outcomes Research Institute (PCORI), an independent nonprofit organization charged with conducting and disseminating comparative clinical-effectiveness research to help patients, providers, purchasers, and policy-makers reach more informed decisions. On March 5, 2012, the PCORI board of governors voted to finalize a revised definition of “patient-centered outcomes research.”  This was an important step for PCORI, as potential grantees will have to ensure that their work falls within this definition.  The board had released a draft definition for public comment in July 2011, and had solicited feedback directly from stakeholders. 
PCORI Finalizes “Patient-Centered Outcomes Research” Definition

The revised definition incorporates comments the board received during that process, and includes several changes vis-à-vis the draft definition (changes are underlined):

Patient-Centered Outcomes Research (PCOR) helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options.  This research answers patient-centered research questions, such as:

  1. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?”
  2. “What are my options about the potential benefits and harms of those options?”
  3. “What can I do to improve the outcomes that are most important to me?”
  4. “How can clinicians and the care delivery systems the work in help me make the best decisions about my health and health care?”[1]

 To answer these questions, PCOR:

  •  Assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative¸ or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people;
  • Is inclusive of an individual’s preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life;
  • Incorporates a wide variety of setting and diversity of participants to address individual differences and barriers to implementation and dissemination; and
  • Investigates (or may investigate) optimizing outcomes while addressing burden to individuals, resource availability, and other stakeholder perspectives.

For additional information about other recent work of PCORI, including opportunities to provide comment, please see our related client alerts dated January 26, 2012 and January 23, 2012.


[1] Question number four was previously drafted as: “How can the health care system improve my chances of achieving the outcomes I prefer?”

Stuart M. Langbein

Stuart M. Langbein,

Washington, D.C.

Erin Hertzog

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