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Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory
Joost B Nieuwenhuis1, Elaine Irving2, Katrien Oude Rengerink1
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, 3584 CG, the Netherlands.
Journal of Clinical Epidemiology
|May 11, 2016
Summary
Incorporating pragmatic or explanatory elements into clinical trials impacts validity, generalizability, precision, and feasibility. Careful consideration is needed to balance these design choices for optimal trial outcomes.
Area of Science:
- Clinical trial design
- Health services research
Background:
- Pragmatic trials balance real-world applicability with scientific rigor.
- Understanding the impact of design choices on trial outcomes is crucial.
Purpose of the Study:
- To illustrate how pragmatic and explanatory trial design elements affect validity, generalizability, precision, and operational feasibility.
- To analyze trade-offs between different design choices in clinical trials.
Main Methods:
- Review of randomized drug trials with pragmatic design features from the IMI Get Real Consortium.
- Analysis of trial publications to identify effects of design elements on key trial domains.
Main Results:
- Incorporating pragmatic elements can affect generalizability, precision, and validity, potentially introducing operational challenges.
- Adding explanatory elements to pragmatic trials can impact validity, generalizability, and feasibility, especially if applied to a single arm.
- Design choices optimizing one domain may negatively influence others, such as generalizability versus feasibility.
Conclusions:
- Explicit consideration and balancing of consequences for validity, generalizability, precision, and feasibility are essential when incorporating pragmatic or explanatory elements.
- Development of tools to enhance transparency regarding these design consequences is needed.
Keywords:
Explanatory trialGeneralizabilityOperational feasibilityPragmatic clinical trialsPrecisionReal-world evidenceTrial designValidityMore Related Videos
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