• Open Access

A CTSA Agenda to Advance Methods for Comparative Effectiveness Research

Authors

  • Mark Helfand M.D., M.S., M.P.H.,

    1. Oregon Clinical & Translational Research Center, Oregon Health & Sciences University and Department of Hospital and Specialty Medicine, The Portland VA Medical Center, Portland, Oregon, USA
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  • Sean Tunis M.D., M.Sc.,

    1. Department of Medicine, John Hopkins School of Medicine, Baltimore, Maryland, USA
    2. Center for Medical Technology Policy, Baltimore, Maryland, USA
    3. Department of Surgery and Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, USA
    4. Center for Health Policy, Stanford University, Stanford, California, USA
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  • Evelyn P. Whitlock M.D., M.P.H.,

    1. The Center for Health Research, Kaiser Permanente Center for Health Research, Portland, Oregon, USA
    2. Oregon Evidence-Based Practice Center, Oregon Health & Sciences University, Portland, Oregon, USA
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  • Stephen G. Pauker M.D.,

    1. Tufts Clinical and Translational Science Institute and Department of Medicine Division of Clinical Decision Making, Informatics and Telemedicine, Department of Medicine, Institute of Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA
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  • Anirban Basu Ph.D.,

    1. Departments of Health Services and Pharmacy, University of Washington, Seattle, Washington, USA and The National Bureau of Economic Research, Cambridge, Massachusetts, USA
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  • Jon Chilingerian Ph.D.,

    1. School for Social Policy and Management, The Heller School, Brandeis University, Waltham, Massachusetts, USA
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  • Frank E. Harrell Jr. Ph.D.,

    1. Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA
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  • David O. Meltzer M.D., Ph.D.,

    1. Center for Health and the Social Sciences and Hospital Medicine, The University of Chicago, Chicago, Illinois, USA
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  • Victor M. Montori M.D.,

    1. Healthcare Delivery Research Program, Translating CER Core, Mayo CTSA and Department of Health Sciences Research, Division of Healthcare and Policy Research, Mayo Clinic, Rochester, Minnesota, USA
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  • Donald S. Shepard Ph.D.,

    1. Schneider Institute of Health Policy, The Heller School, Brandeis University, Waltham, Massachusetts, USA
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  • David M. Kent M.D.,

    1. Tufts Clinical and Translational Science Institute, Department of Medicine, Institute of Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA.
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  • The Methods Work Group of the National CTSA Strategic Goal Committee on Comparative Effectiveness Research


Mark Helfand (helfand@ohsu.edu)

Abstract

Clinical research needs to be more useful to patients, clinicians, and other decision makers. To meet this need, more research should focus on patient-centered outcomes, compare viable alternatives, and be responsive to individual patients’ preferences, needs, pathobiology, settings, and values. These features, which make comparative effectiveness research (CER) fundamentally patient-centered, challenge researchers to adopt or develop methods that improve the timeliness, relevance, and practical application of clinical studies.

In this paper, we describe 10 priority areas that address 3 critical needs for research on patient-centered outcomes (PCOR): (1) developing and testing trustworthy methods to identify and prioritize important questions for research; (2) improving the design, conduct, and analysis of clinical research studies; and (3) linking the process and outcomes of actual practice to priorities for research on patient-centered outcomes. We argue that the National Institutes of Health, through its clinical and translational research program, should accelerate the development and refinement of methods for CER by linking a program of methods research to the broader portfolio of large, prospective clinical and health system studies it supports. Insights generated by this work should be of enormous value to PCORI and to the broad range of organizations that will be funding and implementing CER. Clin Trans Sci 2011; Volume 4: 188–198

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