Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

Abstract:

:Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

journal_name

Clin Spine Surg

journal_title

Clinical spine surgery

authors

Merali Z,Wilson JR

doi

10.1097/BSD.0000000000000588

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

404-406

issue

9

eissn

2380-0186

issn

2380-0194

pii

01933606-201711000-00004

journal_volume

30

pub_type

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