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Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation
Zamir Merali1, Jefferson R Wilson
1St. Michael's Hospital, Division of Neurosurgery, University of Toronto, Toronto, ON, Canada.
Clinical Spine Surgery
|October 20, 2017
Summary
Understanding the explanatory-pragmatic continuum in clinical trials is crucial. This framework helps assess how well trial results, like those for spinal surgery, generalize to real-world patient populations.
Area of Science:
- Clinical research methodology
- Evidence-based medicine
- Surgical innovation evaluation
Background:
- Randomized clinical trials (RCTs) are key for evaluating medical interventions.
- Internal validity of RCTs is enhanced by randomization.
- External validity (generalizability) depends on trial design elements like eligibility criteria and setting.
Purpose of the Study:
- To detail the explanatory-pragmatic continuum for clinical trials.
- To introduce a tool for grading trials on this continuum.
- To apply this grading tool to recent trials on lumbar degenerative spondylolisthesis surgery.
Main Methods:
- Description of the explanatory-pragmatic continuum.
- Introduction and application of a trial grading tool.
- Analysis of two surgical trials for lumbar degenerative spondylolisthesis.
Main Results:
- Explanatory trials prioritize internal validity, potentially limiting generalizability.
- Pragmatic trials prioritize external validity for real-world applicability.
- The grading tool was applied to assess the continuum position of two specific surgical trials.
Conclusions:
- The explanatory-pragmatic continuum provides a framework for understanding trial generalizability.
- Distinguishing between explanatory and pragmatic trial designs is essential for interpreting results.
- This continuum aids in evaluating the clinical applicability of surgical interventions for spinal conditions.
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