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JAMA Guide to Statistics and Methods |

Pragmatic Trials Practical Answers to “Real World” Questions

Harold C. Sox, MD1,2; Roger J. Lewis, MD, PhD3,4,5
[+] Author Affiliations
1Patient Centered Outcomes Research Institute (PCORI), Washington, DC
2Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
3Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California
4Department of Emergency Medicine, David Geffen School of Medicine at the University of California-Los Angeles
5Berry Consultants, LLC, Austin, Texas
JAMA. 2016;316(11):1205-1206. doi:10.1001/jama.2016.11409.
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This Guide to Statistics article compares pragmatic randomized controlled trials, which focus on important challenges that patients, physicians, and policy makers face in day-to-day life with explanatory trials that seek to test a hypothesis.

The concept of a “pragmatic” clinical trial was first proposed nearly 50 years ago as a study design philosophy that emphasizes answering questions of most interest to decision makers.1 Decision makers, whether patients, physicians, or policy makers, need to know what they can expect from the available diagnostic or therapeutic options when applied in day-to-day clinical practice. This focus on addressing real-world effectiveness questions influences choices about trial design, patient population, interventions, outcomes, and analysis. In this issue of JAMA, Gottenberg et al2 report the results of a trial designed to answer the question “If a biologic agent for rheumatoid arthritis is no longer effective for an individual patient, should the clinician recommend another drug with the same mechanism of action or switch to a biologic with a different mechanism of action?” Because the authors included some pragmatic elements in the trial design, this study illustrates the issues that clinicians should consider in deciding whether a trial result is likely to apply to their patients.

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