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A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers
Kevin E Thorpe1, Merrick Zwarenstein, Andrew D Oxman
1Dalla Lana School of Public Health, University of Toronto, Ontario, Canada. kevin.thorpe@utoronto.ca
Journal of Clinical Epidemiology
|April 8, 2009
Summary
A new tool, PRECIS, helps researchers align clinical trial design with their goals. It assesses how pragmatic or explanatory a trial is, ensuring design choices match the trial's purpose for better outcomes.
Area of Science:
- Clinical Trial Design
- Health Services Research
Background:
- Randomized trials are categorized as pragmatic (real-world effectiveness) or explanatory (ideal-condition efficacy).
- Design choices significantly influence a trial's pragmatic or explanatory nature.
- No existing tool aids researchers in aligning trial design with its primary objective.
Purpose of the Study:
- To propose a novel tool to assist trialists in making design decisions consistent with their trial's stated purpose.
- To provide a structured approach for evaluating the pragmatic or explanatory nature of clinical trials.
Main Methods:
- International meetings involving experts in clinical care, research commissioning, health care financing, trial methodology, and reporting.
- Definition and refinement of trial design aspects differentiating pragmatic and explanatory attitudes.
Main Results:
- Development of the PRECIS tool, comprising 10 key domains.
- PRECIS provides criteria to assess a trial's degree of pragmatism or explanation.
- Trial assessment is visually summarized graphically.
Conclusions:
- PRECIS serves as a valuable initial step in developing a comprehensive tool for trial design.
- The tool aims to help trialists ensure design decisions align with the trial's intended purpose.
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