Patient-Centered Outcomes Research – Why Methods Matter

July 25, 2012 by Sherine Gabriel, MD, MSc and Sharon-Lise Normand, PhD

Sherine Gabriel and Sharon-Lise NormandPatients today have more health-related options than ever before, with a dramatic increase in the number and types of treatment choices available for the same condition. The healthcare delivery systems of today differ markedly from those of the past, and the way care is delivered can have a profound impact on outcomes.

These factors combine to make it difficult, but critical, for patients and their care providers to understand and use the research information most relevant to the health decisions they make. Selecting the right prevention, diagnostic, or treatment options requires a serious examination of their potential benefits and harms, while considering a person’s unique characteristics, health status, and preferences.

Patient-centered outcomes research (PCOR) is designed to help people, together with their families and care providers, better assess these options. But there’s so much research out there, and results often conflict, so finding information that can be trusted to make important health decisions is challenging.

It’s become clear that knowing how a research study is conducted determines how useful its results will be. In other words, it’s important to understand the methods behind the research in order to know whether or not the results are useful to you. If the wrong methods are used or if the right methods are misused, research results won’t lead to better decisions but instead could cause greater confusion.

Getting the methods right matters. It’s this theme that drives the work of the Methodology Committee of the Patient Centered Outcomes Research Institute, or PCORI, which has drafted standards for conducting this research. These standards, developed with input from experts from around the country, will help people identify trustworthy information that can lead to better health decisions.

PCORI, and especially the PCORI Methodology Committee, were created to address these challenges. The draft of the first Methodology Report, made public this week, is an important step towards that goal.

The report includes a set of methodological standards and recommendations for the conduct of PCOR — standards and recommendations that PCORI will incorporate into its funding process and encourage the broader community to adopt and use.  In addition, PCORI will fund research to develop better methods and to improve existing methods. A key goal is to connect the results of research to patients’ health care needs and make study findings accessible to all.

Issuing this draft report is just the start of a process. We hope to transform this document into meaningful guidance for the entire community. That will take ongoing public comment, engagement, and revision.

Through that effort, we hope everyone will come to understand what many of us have learned:

  • For research to be meaningful, the methods upon which it is based must be scientifically sound and patient-centered.
  • All members of the healthcare community should be able to gauge the quality and usefulness of research for their health decisions

In short, if medical research is to realize the promise of improving health, getting the methods right matters.

Sherine Gabriel, MD, MSc, is Chair of the PCORI Methodology Committee and Professor of Medicine and of Epidemiology and the William J. and Charles H. Mayo Professor at the Mayo Clinic. Co-author Sharon-Lise Normand, PhD, is Vice Chair of the Committee, Professor of Health Care Policy at Harvard Medical School and Professor of Biostatistics at the Harvard School of Public Health. They wrote this blog post on behalf of the Methodology Committee

One Response to“Patient-Centered Outcomes Research – Why Methods Matter”

  1. Bernard A.Yablin(MD)

    It is very hard to determine which efforts including(NEJM,AHRQ,NYSDOH,NCI,NIH,NIMH,various clinics) are most useful to eveluate standards of care..


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