Journal of clinical epidemiology
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To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose. ⋯ 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.
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Methodologists have traditionally categorized randomized controlled trials (RCTs) as explanatory (representing the ideal setting) and pragmatic (representing the real-world setting). Although this framework has greatly advanced the design and interpretation of RCTs, current interpretations of the explanatory-pragmatic framework suffer from two major limitations. First, they confound purpose with structure. ⋯ This revised framework facilitates investigators' choice of optimal trial design, and clinicians' optimal interpretation of RCT results. If our goal is clinical trials most relevant to individual patient decision making, we will eschew the use of trials that enroll patients unlikely to benefit (e.g., those with uncertain diagnosis); those likely to be noncompliant; treated by practitioners whose differing expertise is likely to result in differing outcomes; and permitting cointerventions that are likely to influence treatment effectiveness-i.e., the conventional pragmatic trial. Instead we will design, implement, and apply the results of practical trials to our patients.