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A pragmatic view on pragmatic trials.
1Division of Genetics, Department of Medicine, Brigham & Women's Hospital, Harvard Medical School, 77 Avenue Louis Pasteur, New Research Building (NRB) #150 Boston, MA 02115, USA. npatsopoulos@rics.bwh.harvard.edu
Pragmatic clinical trials are increasingly favored for evaluating interventions in real-world settings, offering generalizable results. This review explores the pragmatic design, its continuum with explanatory trials, and its impact on medical practice.
Area of Science:
- Clinical research methodology
- Evidence-based medicine
- Health services research
Background:
- Clinical trials are essential for evaluating health interventions.
- Trials are broadly categorized as pragmatic or explanatory.
- Explanatory trials assess interventions under optimal conditions, while pragmatic trials evaluate effectiveness in routine practice.
Purpose of the Study:
- To define the concept of pragmatism in clinical trial design.
- To elucidate the continuum between pragmatic and explanatory trial designs.
- To highlight the limitations and impact of pragmatic trials in medical practice.
Main Methods:
- Literature review and conceptual analysis.
- Exploration of the pragmatic-explanatory trial spectrum.
- Discussion of the practical implications of pragmatic trial designs.
Main Results:
- Pragmatic trials are crucial for generalizable evidence in real-world settings.
- A continuum exists between pragmatic and explanatory trials, not a strict dichotomy.
- The pragmatic design offers significant impact and importance for medical practice.
Conclusions:
- The pragmatic trial design is gaining momentum due to its generalizability.
- Understanding the pragmatic-explanatory continuum is key for appropriate trial selection.
- Pragmatic trials significantly influence and advance routine medical practice.
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