Greg Simon, MD, MPH
Kaiser Permanente Washington Health Research Institute
Laura Dember, MD
Professor of Medicine
University of Pennsylvania
Perelman School of Medicine
Who to Include in a Pragmatic Trial? It Depends
Pragmatic clinical trial; Clinical research; Clinical research; PRECIS-2, inclusion criteria
- Compared with traditional explanatory trials, the inclusion criteria for pragmatic clinical trials are relevant not only to patients, but also to healthcare providers and systems.
- PRECIS-2, the Pragmatic-Explanatory Continuum Indicator Summary tool, asks trialists to think about how closely the care delivery of their intervention resembles usual care.
- Another view of generalizability is how well will findings of this trial predict what will occur if this treatment or program is implemented.
- The Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Demonstration Project, includes health systems with the necessary support, capacity, and staff familiar with suicide risk assessment tools in order to maximize feasibility.
- The Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial showed that balancing feasibility and generalizability is key to having both the necessary infrastructure and essential diversity.
- Eligibility criteria increase the likelihood of answering the trial question but can reduce generalizability. Sometimes it is pragmatic to be less pragmatic.
Through its Demonstration Projects, the NIH Health Care Systems Research Collaboratory has aimed to answer questions about the best ways to design and conduct PCTs.
Prediction is difficult, and it can be hard to know what challenges will occur when a treatment or program is implemented in the future. There need to be explicit steps documented around implementation in a dynamic environment.
The process of developing trials must be iterative; it’s critical to design trials to ask the harder questions.
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