Created through the Affordable Care Act (Subtitle D), the Patient-Centered Outcomes Research Institute (PCORI) is an independent non-profit organization that will conduct research “to provide information about the best available evidence to help patients and their health care providers make more informed decisions.”

The PCORI is asking for public comments on a draft definition for Patient-Centered Outcomes Research by September 2^nd.  The definition is based on language from the ACA and PCORI’s rationale statement. For more details and the form to submit comments, see: Working Definition of Patient-Centered Outcomes Research.

The PCORI has identified eight topics for initial pilot projects and would like feedback on these topics or suggestions for other appropriate topics by August 31st. PCORI will review all of the input received and update, modify or add to this list of potential topics as appropriate to finalize the RFA. For more details and the form to submit comments, see: Topics for Tier 1 Pilot Projects.

Please help us educate the PCORI on how public health contributes to patients’ health and supports medical providers, and the value of Public Health Services & Systems Research in assuring that public health services are effectively organized, financed and delivered to benefit patient health. We have posted background information and the comments we will submit to PCORI below. Perhaps they will stimulate some additional thoughts in your field or specialty.

Working Definition of PCOR

Patient-Centered Outcomes Research (PCOR) helps people make informed health care decisions and allows their voice to be heard in assessing the value of health care options. This research answers patient-focused questions:

1. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?”
2. “What are my options and what are the benefits and harms of those options?”
3. “What can I do to improve the outcomes that are most important to me?”
   
4. “How can the health care system improve my chances of achieving the outcomes I prefer?”

To answer these questions, PCOR:

• Assesses the benefits and harms of preventive, diagnostic, therapeutic, 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 settings 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, resources, and other stakeholder perspectives.

Topics for Tier 1 Pilot Projects

PCORI plans to issue a request for applications (RFA) in late September 2011 for “Tier 1 Pilot Project” grants to:

• assist PCORI in establishing national priorities for research,
• support the development of novel methods or the collection of preliminary data that can be used to advance the field of patient-centered outcomes research (PCOR), and
• inform the development of a future PCORI research agenda. 

PCORI has identified eight topics for initial pilot projects. We would like you to provide feedback to PCORI on these topics and suggest other appropriate topics by August 31st. PCORI will review all of the input received and update, modify or add to this list of potential topics as appropriate to finalize the RFA. 

According to PCORI, all of the pilot projects will focus on methods and approaches appropriate to PCOR, including observational methodologies, systematic reviews, mixed methods and qualitative methodologies, simulations, small pragmatic pilot trials and survey methods. The pilot projects will not include clinical efficacy studies on specific conditions or interventions or randomized clinic trials.

Background

The ACA Legislative Language

COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH;
RESEARCH.—
‘‘(A) IN GENERAL.—The terms ‘comparative clinical effectiveness research’ and ‘research’ mean research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services, and items described in subparagraph (B).

‘‘(B) MEDICAL TREATMENTS, SERVICES, AND ITEMS DESCRIBED.—The medical treatments, services, and items described in this subparagraph are health care interventions, protocols for treatment, care management, and delivery, procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs and biologicals), integrative health practices, and any other strategies or items being used in the treatment, management, and diagnosis of, or prevention of illness or injury in, individuals.

 
Download a copy of Subtitle D—Patient-Centered Outcomes Research
 

The Rationale

Download a copy of "Rationale: Working Definition of Patient-Centered Outcomes Research"