Journal
CLINICAL SPINE SURGERY
Volume 30, Issue 9, Pages 404-406Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/BSD.0000000000000588
Keywords
spine surgery; lumbar spine; lumbar degenerative spondylolisthesis; clinical trial design; research methodology; pragmatic trial; efficacy trial
Categories
Ask authors/readers for more resources
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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available