Health Outcomes Research in Medicine
Volume 3, Issue 1 , Pages e37-e44 , February 2012

Health Outcomes of Interest in Observational Data: Issues in Identifying Definitions in the Literature

  • Paul E. Stang, PhD

      Affiliations

    • Johnson & Johnson Pharmaceutical Research and Development LLC, Titusville, NJ
    • Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD
    • Corresponding Author InformationCorresponding Author: Paul E. Stang, PhD, Johnson & Johnson, 1125 Trenton-Harbourton Road, PO Box 200, MS K304, Titusville, NJ 08560.
  • ,
  • Patrick B. Ryan, PhD

      Affiliations

    • Johnson & Johnson Pharmaceutical Research and Development LLC, Titusville, NJ
    • Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD
  • ,
  • Stacie B. Dusetzina, PhD

      Affiliations

    • Department of Health Care Policy, Harvard Medical School, Boston, Mass
  • ,
  • Abraham G. Hartzema, PharmD, MSPH, PhD

      Affiliations

    • Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD
    • College of Pharmacy, University of Florida, Gainesville
    • At the time of this work Dr Hartzema was on sabbatical with the Office of Critical Path Programs at the US Food and Drug Administration, Silver Spring, MD.
  • ,
  • Christian Reich, MD, PhD

      Affiliations

    • Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD
  • ,
  • J. Marc Overhage, MD, PhD

      Affiliations

    • Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD
    • Siemens Health Services, Malvern, PA
  • ,
  • Judith A. Racoosin, MD, MPH

      Affiliations

    • Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD
    • Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

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 This article expresses the views of the authors and does not necessarily represent those of their affiliated organizations. We gratefully acknowledge the work of RTI and UBC in the generation of the evidence tables used in this manuscript. Their work was funded via contracts from the Foundation for the National Institutes of Health.

 The Observational Medical Outcomes Partnership is funded by the Foundation for the National Institutes of Health through generous contributions from the following: Abbott, Amgen Inc., AstraZeneca, Bayer Healthcare Pharmaceuticals, Inc., Bristol-Myers Squibb, Eli Lilly & Company, GlaxoSmithKline, Johnson & Johnson, Lundbeck, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Pharmaceutical Research Manufacturers of America (PhRMA), Roche, sanofi-aventis, Schering-Plough Corporation, and Takeda. Patrick Ryan and Paul Stang are employees of Johnson & Johnson Pharmaceutical Research and Development. Abraham Hartzema is funded by NIH, Pfizer, and Florida AHCA. No person was compensated for the production of or editing of this manuscript.

PII: S1877-1319(11)00048-6

doi: 10.1016/j.ehrm.2011.11.003

Health Outcomes Research in Medicine
Volume 3, Issue 1 , Pages e37-e44 , February 2012