Enrolment Patterns in a Probiotics Trial for Critically Ill Patients
Author Information
Author(s): Takaoka Alyson, Johnstone Jennie, Lauzier François, Heels-Ansdell Diane, Davis Megan, Zytaruk Nicole, Duan Erick, Dionne Joanna, Saunders Lois, Arabi Yaseen M., Marshall John, Thabane Lehana, Clarke France, Hand Lori, Masse Marie-Helene, Rochwerg Bram, McIntyre Lauralyn, Girard Martin, Freitag Andreas, Karachi Tim, Cook Deborah J.
Primary Institution: McMaster University
Hypothesis
What factors influence patient enrolment in multicenter randomized controlled trials?
Conclusion
The study found that early site engagement in the trial was associated with higher enrolment rates, while research coordinator experience and time to first enrolment were not significant factors.
Supporting Evidence
- 41 sites were included in the analysis, with a total of 2365 patients enrolled.
- Sites that engaged in the first quartile of the trial had significantly higher enrolment rates.
- The mean time from regulatory approval to first enrolment was 69.1 days.
Takeaway
This study looked at how different hospitals signed up patients for a trial testing probiotics. It found that hospitals that started enrolling patients earlier did a better job than those that started later.
Methodology
The study used a retrospective analysis of trial data, examining enrolment patterns across 41 sites using negative binomial regression.
Potential Biases
Potential selection bias due to inequitable trial access and socioeconomic disparities.
Limitations
The study was limited by the retrospective nature and the variables collected during the trial.
Participant Demographics
Patients were critically ill adults, with a majority from tertiary care ICUs.
Statistical Information
P-Value
0.024
Confidence Interval
(1.07, 2.47)
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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