Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1 - 11 |
| Number of pages | 11 |
| Journal | Critical Care |
| Volume | 17 |
| Issue number | 1 (Art. No.: R1) |
| DOIs | |
| Publication status | Published - 2013 |
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Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences. / 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 M E; Fowler, Rob; Arabi, Yaseen; Woolfe, Clive; Orford, Neil; Hall, Richard; Adhikari, Neill KJ; Ferland, Marie-Clauide; Marshall, John; Meade, Maureen.
In: Critical Care, Vol. 17, No. 1 (Art. No.: R1), 2013, p. 1 - 11.Research output: Contribution to journal › Article › Other
TY - JOUR
T1 - Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences
AU - Cook, Deborah
AU - McDonald, Ellen
AU - Smith, Orla
AU - Zytaruk, Nicole
AU - Heels-Ansdell, Diane
AU - Watpool, Irene
AU - McArdle, Tracy
AU - Matte, Andrea
AU - Clarke, France
AU - Vallance, Shirley
AU - Finfer, Simon
AU - Galt, Pauline
AU - Crozier, Tim M E
AU - Fowler, Rob
AU - Arabi, Yaseen
AU - Woolfe, Clive
AU - Orford, Neil
AU - Hall, Richard
AU - Adhikari, Neill KJ
AU - Ferland, Marie-Clauide
AU - Marshall, John
AU - Meade, Maureen
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
UR - http://ccforum.com/content/pdf/cc11917.pdf
U2 - 10.1186/cc11917
DO - 10.1186/cc11917
M3 - Article
VL - 17
SP - 1
EP - 11
JO - Critical Care
JF - Critical Care
SN - 1364-8535
IS - 1 (Art. No.: R1)
ER -