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A tool for assessing the feasibility of comparative effectiveness research

DOI: http://dx.doi.org/10.2147/CER.S40357

Keywords: equipoise, observational CER, methodology, community-acquired pneumonia, heart failure

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Abstract:

tool for assessing the feasibility of comparative effectiveness research Methodology (1320) Total Article Views Authors: Walker AM, Patrick AR, Lauer MS, Hornbrook MC, Marin MG, Platt R, Roger VL, Stang P, Schneeweiss S Video abstract presented by Alexander M Walker Views: 92 Published Date January 2013 Volume 2013:3 Pages 11 - 20 DOI: http://dx.doi.org/10.2147/CER.S40357 Received: 15 November 2012 Accepted: 20 December 2012 Published: 30 January 2013 Alexander M Walker,1 Amanda R Patrick,2 Michael S Lauer,3 Mark C Hornbrook,4 Matthew G Marin,5 Richard Platt,6 Véronique L Roger,7 Paul Stang,8 Sebastian Schneeweiss2 1World Health Information Science Consultants, Newton, MA; 2Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA; 3National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD; 4The Center for Health Research, Kaiser Permanente Northwest, Portland, OR; 5Department of Medicine, New Jersey Medical School, Newark, NJ; 6Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA; 7Department of Health Sciences Research, Mayo Clinic, Rochester, MN; 8Johnson and Johnson Pharmaceutical Research and Development, Titusville, NJ, USA Background: Comparative effectiveness research (CER) provides actionable information for health care decision-making. Randomized clinical trials cannot provide the patients, time horizons, or practice settings needed for all required CER. The need for comparative assessments and the infeasibility of conducting randomized clinical trials in all relevant areas is leading researchers and policy makers to non-randomized, retrospective CER. Such studies are possible when rich data exist on large populations receiving alternative therapies that are used as-if interchangeably in clinical practice. This setting we call “empirical equipoise.” Objectives: This study sought to provide a method for the systematic identification of settings it in which it is empirical equipoise that offers promised non-randomized CER. Methods: We used a standardizing transformation of the propensity score called “preference” to assess pairs of common treatments for uncomplicated community-acquired pneumonia and new-onset heart failure in a population of low-income elderly people in Pennsylvania, for whom we had access to de-identified insurance records. Treatment pairs were considered suitable for CER if at least half of the dispensings of each treatment-pair member fell within a preference range of 30% to 70%. Results: Among 3889 community-acquired pneumonia patients, insurance claims histories were sufficiently similar in seven drug pairs to suggest that observational CER might be effective. Relapse appears to have been less common in levofloxacin recipients than in similar patients given other products. In 6035 heart failure patients, metoprolol, carvedilol, and atenolol were employed in patients with similar claims histor

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