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

published online 28 November 2011.

Abstract 

Objectives

To describe the literature search strategies and results to inform development of health outcomes of interest (HOI) definitions studied within the Observational Medical Outcomes Partnership (OMOP) research program. These HOIs represent the safety and benefit endpoints that may be associated with the use of particular medications.

Methods

Two organizations implemented search strategies to identify articles that described the validation of various HOI definition algorithms and produced systematic reviews of the published literature for the OMOP HOIs; reviews of 5 HOIs were available from each organization. Search results were summarized descriptively.

Results

Based on the differences in publications identified by each organization, neither search strategy captured all the relevant literature across 5 HOIs. A composite search strategy developed by the OMOP research team failed to effectively capture all relevant publications as well. Among publications in observational databases, a large proportion did not report actual codes used to identify HOIs in administrative claims databases, nor did they provide substantive detail of any validation studies.

Conclusion

No single search strategy or literature database captured all relevant articles efficiently. The lack of specific search terms hampered identification of relevant articles. Due to limited details about positive predictive value of various HOI definitions, information culled from available literature was insufficient to identify one best definition for each HOI. Researchers seeking to capture and understand prior published work that defined relevant outcomes of interest need to be aware of the shortcomings of this approach and the lack of detail of validation studies available in published literature.

Keywords: Claims database, Drug safety surveillance, Electronic health record database, Literature search, Health outcome, Health outcome of interest, Outcome definition, Outcomes Research, Outcomes Studies, Surveillance

 

 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

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