Résumé
Background: Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. Objective: The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Design: Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. Setting: The trial was conducted in 67 centers in 6 countries. Measurements and main results: A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with > 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, < 0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Conclusions: Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial.
| Langue d'origine | English |
|---|---|
| Pages (de-à) | 28-39 |
| Nombre de pages | 12 |
| Journal | Journal of Critical Care |
| Volume | 28 |
| Numéro de publication | 1 |
| DOI | |
| Statut de publication | Published - févr. 2013 |
Note bibliographique
Funding Information:This consent study was funded by the St Joseph's Healthcare Research Foundation. The original PROTECT trial was funded by the Canadian Institute Health Research, Heart & Stroke Foundation of Canada and the Australian and New Zealand College of Anesthetists Research Foundation; study drug was provided for international use by Pfizer, Inc, and Eisai, Inc, provided study drug in the United States. These agencies played no role in the design, conduct, analysis, interpretation or write-up of this trial. None of the authors have any conflicts of interest to declare.
Funding Information:
The authors thank the research coordinators for their thoughtful input into this analysis, particularly Christine Wynne, Katie Krause, Lori Hand, Marie-Claude Ferland, and Chantal Cagne. We are grateful to the Canadian Critical Care Trials Group, the Australian and New Zealand Intensive Care Society Clinical Trials Group, and all participating centers for their collaboration. O Smith is supported by a Doctoral Research Award from the Canadian Institutes of Health Research. R Fowler is a Clinician Scientist of the Heart and Stroke Foundation of Canada. N Ferguson is supported by a New Investigator Award from the Canadian Institutes of Health Research. K Burns holds a Clinician Scientist Award from the Canadian Institutes of Health Research. D Cook is a Research Chair of the Canadian Institutes for Health Research.
ASJC Scopus Subject Areas
- Critical Care and Intensive Care Medicine