New report names best practices in patient-centered outcomes research

By Diana Manos
09:15 AM

The Patient-Centered Outcomes Research Institute (PCORI) has released its latest report – an update of the draft it released in 2012.

PCORI's Methodology Report now reflects input from public feedback and offers minimal requirements for following best practices in the conduct of scientifically valid patient-centered outcomes research (PCOR), the group announced in a news release.

The Nov. 18 Patient-Centered Outcomes Research Institute (PCORI)  Methodology Report is intended to help researchers develop comparative clinical effectiveness research (CER) studies that focus on questions and information that matter most to patients, their clinicians, and other end-users of research findings. 

The report serves as a roadmap for conducting studies that are likely to provide trustworthy, useful information for real-world clinical problems, a spokesman for the group says. Its methodology standards provide specific guidance for the design and conduct of research projects.

PCORI is embarking on an intensive outreach and dissemination plan for the report that focuses on adherence, training, and engagement with the broader health care community.

During its latest public meeting in Atlanta on Nov. 18, PCORI’s Board of Governors accepted the report presented by PCORI’s Methodology Committee, which was revised to address extensive feedback received from the healthcare community during a public comment period that followed the July 2012 release of a draft.

The report provides context for PCORI’s Methodology Standards, which set forth baseline requirements for clinical comparative effectiveness research centered on questions and results that matter most to patients, clinicians, and other end-users of research findings. The report includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.

PCORI's Board also approved minor editorial revisions to the standards, which had previously been revised in response to the public comments and published in December 2012. Applicants for PCORI funding have been required to follow the standards starting with the August 2013 cycle of PCORI Funding Announcements.

Joe Selby, MD, PCORI executive director said that the report is a vlauable resource for "not just the research community but the healthcare system as a whole."

Both PCORI and its 17-member Methodology Committee expect the Methodology Standards to evolve over time based on ongoing input from the healthcare community.

"We encourage all who support, develop, and conduct health research to adopt them as their own," said committee chair Robin Newhouse, professor and chair of Organizational Systems and Adult Health at the University of Maryland School of Nursing. "We are committed to efforts to expand and refine the standards over time to address the full spectrum of patient-centered research inquiries and approaches.”

As part of that effort, Committee members and PCORI staff will start working with organizations and institutions across the healthcare community to seek input on how to most effectively promote wider use of the standards through the development of training, implementation tools, and other resources. The hope is that the community, as it makes use of the report and standards, will regularly suggest ways to improve them. At the same time, the Committee and PCORI staff will continue working to identify areas where new standards might be needed or where current standards need revision.

The standards provide a common set of expectations about the characteristics of high-quality PCOR. The 47 standards include several that guide researchers on the inclusion of relevant patients and other stakeholders in the research process and the use of outcomes that are meaningful to these end-users of study results.

Development of the standards and Methodology Report drew on the expertise of dozens of individuals and organizations, including the National Institutes of Health and the Agency for Healthcare Research and Quality, both of which have representatives on the Methodology Committee and whose directors serve on PCORI’s Board of Governors.


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