Process / pipelineClinical / epidemiology
Pragmatic Randomized Clinical Trial — Effectiveness in Real-World Care
A pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009.
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Sources
- Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI: 10.1016/0021-9681(67)90041-0 ↗
- Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Chalkidou, K. (2009). A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology, 62(5), 464–475. DOI: 10.1016/j.jclinepi.2008.12.011 ↗
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Adaptive Randomized Clinical TrialBayesian Randomized Clinical TrialMatched Randomized Clinical TrialMulticenter Randomized Clinical TrialPragmatic case seriesPragmatic case-control studyPragmatic diagnostic accuracy studyPragmatic Dose-Response AnalysisPragmatic ecological studyPragmatic Kaplan-Meier analysisPragmatic nested case-controlPragmatic phase II clinical trialPragmatic phase IV studyPragmatic Screening Test EvaluationPragmatic survival analysisProspective Randomized Clinical Trial