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Challenges conducting comparative effectiveness research: the Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) experience

Authors Friedly J, Bauer Z, Comstock B, DiMango E, Ferrara A, Huang S, Israel E, Jarvik J, Nierenberg A, Ong M, Penson D, Smith-Bindman R, Stillman A, Vollmer W, Warren S, Zhan C, Hsia D, Trontell A

Received 13 December 2013

Accepted for publication 17 January 2014

Published 3 May 2014 Volume 2014:4 Pages 1—12


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Janna L Friedly,1,4 Zoya Bauer,2,4 Bryan A Comstock,3,4 Emily DiMango,5 Assiamira Ferrara,6 Susan S Huang,7 Elliot Israel,8 Jeffrey G Jarvik,2,4 Andrew A Nierenberg,9 Michael K Ong,10 David F Penson,11 Rebecca Smith-Bindman,12 Arthur E Stillman,13 William M Vollmer,6 Stephen M Warren,14 Chunliu Zhan,15 David Chu-Wen Hsia,15 Anne Trontell15

1Department of Rehabilitation Medicine, 2Department of Radiology, 3Department of Biostatistics, 4Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA, 5Columbia University Medical Center, New York, NY, 6Kaiser Foundation Research Institute, Oakland, 7Division of Infectious Diseases and Health Policy Research Institute, University of California Irvine School of Medicine, Irvine, CA, 8Harvard Medical School, Pulmonary and Critical Care, Allergy and Immunology, Brigham and Women's Hospital, 9Massachusetts General Hospital, Boston, MA, 10Division of General Internal Medicine & Health Services Research, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, 11Vanderbilt University and Tennessee Valley VAHCC, Nashville, TN, 12Departments of Radiology and Biomedical Imaging, Health Policy, Epidemiology and Biostatistics, University of California, San Francisco, SF, 13Emory University, Atlanta, GA, 14Department of Plastic Surgery, Division of Clinical and Translational Research, NYU Langone Medical Center, New York, NY, 15Agency for Healthcare Research and Quality, Rockville, MD, USA

Abstract: The Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) program, which includes 12 ongoing comparative effectiveness research (CER) trials funded by the Agency for Healthcare Research and Quality under the American Recovery and Reinvestment Act of 2009, has had firsthand experience in dealing with the unique challenges of conducting CER since the trials started in the fall of 2010. This paper will explore the collective experience of the CHOICE program and discuss common challenges and successes the CHOICE investigators have experienced conducting CER research in the United States. The specific aims of this paper are to describe the common features of the CHOICE award studies (observational studies and trials), to summarize the strategies undertaken to address the challenges in conducting comparative effectiveness pragmatic trials and observational studies from the patient, physician, and administrative perspective, and to provide recommendations for improving the efficiency and feasibility of conducting prospective CER studies in the future.

Keywords: comparative effectiveness research, underserved patients, pragmatic clinical trials

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