A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers

By K. Thorpe, Merrick Zwarenstein, Andrew D. Oxman, Shaun P. Treweek, C. Furberg, Douglas G. Altman, S. Tunis, E. Bergel, I. Harvey, D. Magid and 1 more. Canadian Medical Association Journal, 2009

1,448 citations recorded by the source corpus.

OBJECTIVE To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose. STUDY DESIGN AND SETTING Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, "Does this intervention work under usual conditions?," whereas explanatory trials are focused on the question, "Can this intervention work under ideal conditions?" Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory. RESULTS We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically. CONCLUSION We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial.

Subfields: Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/2ee3245cc3854359a6b09fb1dea0831c5ccb7e4e

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Citations in the corpus

Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. (2016, background): “The target trial emulated using observational data will typically be a pragmatic trial, that is, one in which treatment strategies are compared under the usual conditions in which they will be applied (9, 10).”
Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014, neutral): “Authors may find it helpful to locate their trial on the pragmatic-explanatory continuum.(14) If, for example in a”
Methods for sample size determination in cluster randomized trials (2015, background): “In a truly pragmatic trial, compliance may not be measured or actively encouraged.(68)”
A Primer on Effectiveness and Efficacy Trials (2014, background): “There are at least two tools, which can help clinicians judge where a trial may lie on the efficacy–effectiveness continuum.(18,32) Gartlehner and colleagues identified criteria to distinguish efficacy and effectiveness studies, with a sensitivity and specificity of 72% and 83%, respectively.”