| Title: |
Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences |
| Authors: |
Cook, Deborah; McDonald, Ellen; Smith, Orla; Zytaruk, Nicole; Heels-Ansdell, Diane; Watpool, Irene; McArdle, Tracy; Matte, Andrea; Clarke, France; Vallance, Shirley; Finfer, Simon; Galt, Pauline; Crozier, Tim; Fowler, Rob; Arabi, Yaseen; Woolfe, Clive; Orford, Neil; Hall, Richard; Adhikari, Neill KJ; Ferland, Marie-Clauide; Marshall, John; Meade, Maureen |
| Source: |
Critical Care ; volume 17, issue 1 ; ISSN 1364-8535 |
| Publisher Information: |
Springer Science and Business Media LLC |
| Publication Year: |
2013 |
| Description: |
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 ( Pro phylaxis for T hrombo E mbolism in C ritical Care T rial), 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1186/cc11917 |
| DOI: |
10.1186/cc11917.pdf |
| DOI: |
10.1186/cc11917/fulltext.html |
| Availability: |
https://doi.org/10.1186/cc11917; https://link.springer.com/content/pdf/10.1186/cc11917.pdf; https://link.springer.com/article/10.1186/cc11917/fulltext.html |
| Rights: |
http://creativecommons.org/licenses/by/2.0/ ; http://creativecommons.org/licenses/by/2.0/ |
| Accession Number: |
edsbas.96E275F2 |
| Database: |
BASE |