Co-enrollment of critically ill patients into multiple studies : patterns, predictors and consequences
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2013 |
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| Erschienen: |
2013 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:17 |
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| Enthalten in: |
Critical care (London, England) - 17(2013), 1 vom: 08. Jan., Seite R1 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cook, Deborah [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 17.08.2015 Date Revised 10.11.2023 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/cc11917 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM223999040 |
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| 100 | 1 | |a Cook, Deborah |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Co-enrollment of critically ill patients into multiple studies |b patterns, predictors and consequences |
| 264 | 1 | |c 2013 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 17.08.2015 | ||
| 500 | |a Date Revised 10.11.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a McDonald, Ellen |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Orla |e verfasserin |4 aut | |
| 700 | 1 | |a Zytaruk, Nicole |e verfasserin |4 aut | |
| 700 | 1 | |a Heels-Ansdell, Diane |e verfasserin |4 aut | |
| 700 | 1 | |a Watpool, Irene |e verfasserin |4 aut | |
| 700 | 1 | |a McArdle, Tracy |e verfasserin |4 aut | |
| 700 | 1 | |a Matte, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Clarke, France |e verfasserin |4 aut | |
| 700 | 1 | |a Vallance, Shirley |e verfasserin |4 aut | |
| 700 | 1 | |a Finfer, Simon |e verfasserin |4 aut | |
| 700 | 1 | |a Galt, Pauline |e verfasserin |4 aut | |
| 700 | 1 | |a Crozier, Tim |e verfasserin |4 aut | |
| 700 | 1 | |a Fowler, Rob |e verfasserin |4 aut | |
| 700 | 1 | |a Arabi, Yaseen |e verfasserin |4 aut | |
| 700 | 1 | |a Woolfe, Clive |e verfasserin |4 aut | |
| 700 | 1 | |a Orford, Neil |e verfasserin |4 aut | |
| 700 | 1 | |a Hall, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Adhikari, Neill K J |e verfasserin |4 aut | |
| 700 | 1 | |a Ferland, Marie-Clauide |e verfasserin |4 aut | |
| 700 | 1 | |a Marshall, John |e verfasserin |4 aut | |
| 700 | 1 | |a Meade, Maureen |e verfasserin |4 aut | |
| 700 | 0 | |a PROTECT Research Coordinators |e verfasserin |4 aut | |
| 700 | 0 | |a PROTECT Investigators |e verfasserin |4 aut | |
| 700 | 0 | |a Canadian Critical Care Trials Group |e verfasserin |4 aut | |
| 700 | 0 | |a Australian and New Zealand Intensive Care Society Clinical Trials Group |e verfasserin |4 aut | |
| 700 | 1 | |a Cook, Deborah |e investigator |4 oth | |
| 700 | 1 | |a McDonald, Ellen |e investigator |4 oth | |
| 700 | 1 | |a Tkaczyk, Andrea |e investigator |4 oth | |
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| 700 | 1 | |a Pleasance, Susan |e investigator |4 oth | |
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