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Coenrollment in a critical care trial: Characteristics and consequences
France Clarke1, Lori Hand1, Adam Deane2
1Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4L8, Canada.
Coenrollment in clinical trials is common, with one-third of participants enrolled in multiple studies. Patients with SARS-CoV-2 were more likely to be coenrolled, but this did not affect trial outcomes.
Area of Science:
- Clinical Research
- Medical Trials
- Patient Recruitment
Background:
- Coenrollment in clinical trials involves participants being enrolled in multiple studies simultaneously.
- Understanding coenrollment patterns is crucial for optimizing trial efficiency and data integrity.
- The REVISE trial investigated coenrollment in a stress ulcer prophylaxis study.
Purpose of the Study:
- To characterize patients, centers, and studies involved in coenrollment.
- To determine the association of coenrollment with trial metrics.
- To assess the impact of coenrollment on patient outcomes.
Main Methods:
- Descriptive analyses and multilevel regression were used.
- Data were collected from participants in a stress ulcer prophylaxis trial.
- Patterns and predictors of coenrollment in an intensive care unit (ICU) setting were examined.
Main Results:
- 35.7% of 4821 participants were coenrolled in 145 unique studies.
- Patients with SARS-CoV-2 infection were more likely to be coenrolled (OR 1.85).
- Coenrollment did not alter the efficacy of pantoprazole for gastrointestinal bleeding or 90-day mortality.
Conclusions:
- One-third of REVISE trial participants were coenrolled, mainly in academic randomized trials.
- Patients with SARS-CoV-2 and those managed by experienced coordinators were more frequently coenrolled.
- Coenrollment did not modify the treatment effect of pantoprazole on primary trial outcomes.
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