Title |
Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences
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Published in |
Critical Care, January 2013
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DOI | 10.1186/cc11917 |
Pubmed ID | |
Authors |
Deborah Cook, Ellen McDonald, Orla Smith, Nicole Zytaruk, Diane Heels-Ansdell, Irene Watpool, Tracy McArdle, Andrea Matte, France Clarke, Shirley Vallance, Simon Finfer, Pauline Galt, Tim Crozier, Rob Fowler, Yaseen Arabi, Clive Woolfe, Neil Orford, Richard Hall, Neill KJ Adhikari, Marie-Clauide Ferland, John Marshall, Maureen Meade, The PROTECT Research Coordinators, PROTECT Investigators, Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group |
Abstract |
ABSTRACT: INTRODUCTION: Research on co-enrollment practices and their impact are limited in the ICU setting. The objectives of this study were: 1) to describe patterns and predictors of co-enrollment of patients in a thromboprophylaxis trial, and 2) to examine the consequences of co-enrollment on clinical and trial outcomes. METHODS: In an observational analysis of an international thromboprophylaxis trial in 67 ICUs, we examined the co-enrollment of critically ill medical-surgical patients into more than one study, and examined the clinical and trial outcomes among co-enrolled and non-co-enrolled patients. RESULTS: Among 3,746 patients enrolled in PROTECT (Prophylaxis for ThromboEmbolism in Critical Care Trial), 713 (19.0%) were co-enrolled in at least one other study (53.6% in a randomized trial, 37.0% in an observational study and 9.4% in both). Six factors independently associated with co-enrollment (all P < 0.001) were illness severity (odds ratio (OR) 1.35, 95% confidence interval (CI) 1.19 to 1.53 for each 10-point Acute Physiology and Chronic Health Evaluation (APACHE) II score increase), substitute decision-makers providing consent, rather than patients (OR 3.31, 2.03 to 5.41), experience of persons inviting consent (OR 2.67, 1.74 to 4.11 for persons with > 10 years' experience compared to persons with none), center size (all ORs > 10 for ICUs with > 15 beds), affiliation with trials groups (OR 5.59, 3.49 to 8.95), and main trial rather than pilot phase (all ORs > 8 for recruitment year beyond the pilot). Co-enrollment did not influence clinical or trial outcomes or risk of adverse events. CONCLUSIONS: Co-enrollment was strongly associated with features of the patients, research personnel, setting and study. Co-enrollment had no impact on trial results, and appeared safe, acceptable and feasible. Transparent reporting, scholarly discourse, ethical analysis and further research are needed on the complex topic of co-enrollment during critical illness. |
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United States | 1 | 100% |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Portugal | 1 | 2% |
France | 1 | 2% |
Unknown | 56 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 8 | 14% |
Student > Master | 8 | 14% |
Student > Ph. D. Student | 7 | 12% |
Student > Bachelor | 6 | 10% |
Professor > Associate Professor | 5 | 9% |
Other | 16 | 28% |
Unknown | 8 | 14% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 26 | 45% |
Nursing and Health Professions | 7 | 12% |
Agricultural and Biological Sciences | 3 | 5% |
Arts and Humanities | 2 | 3% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 3% |
Other | 9 | 16% |
Unknown | 9 | 16% |