Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences

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 M E Crozier; Rob Fowler; Yaseen Arabi; Clive Woolfe; Neil Orford; Richard Hall; Neill KJ Adhikari; Marie-Clauide Ferland; John Marshall; Maureen Meade

doi:10.1186/cc11917

Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences

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 M E Crozier, Rob Fowler, Yaseen Arabi, Clive Woolfe, Neil Orford, Richard Hall, Neill KJ Adhikari, Marie-Clauide FerlandJohn Marshall, Maureen Meade

Epidemiology and Preventive Medicine Alfred Hospital

Research output: Contribution to journal › Article › Other

19 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	1 - 11
Number of pages	11
Journal	Critical Care
Volume	17
Issue number	1 (Art. No.: R1)
DOIs	https://doi.org/10.1186/cc11917
Publication status	Published - 2013

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10.1186/cc11917

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Cook, D., McDonald, E., Smith, O., Zytaruk, N., Heels-Ansdell, D., Watpool, I., McArdle, T., Matte, A., Clarke, F., Vallance, S., Finfer, S., Galt, P., Crozier, T. M. E., Fowler, R., Arabi, Y., Woolfe, C., Orford, N., Hall, R., Adhikari, N. KJ., ... Meade, M. (2013). Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences. Critical Care, 17(1 (Art. No.: R1)), 1 - 11. https://doi.org/10.1186/cc11917

@article{e673cb7a7cee4704a7152916f692ea09,

title = "Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences",

abstract = "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.",

author = "Deborah Cook and Ellen McDonald and Orla Smith and Nicole Zytaruk and Diane Heels-Ansdell and Irene Watpool and Tracy McArdle and Andrea Matte and France Clarke and Shirley Vallance and Simon Finfer and Pauline Galt and Crozier, {Tim M E} and Rob Fowler and Yaseen Arabi and Clive Woolfe and Neil Orford and Richard Hall and Adhikari, {Neill KJ} and Marie-Clauide Ferland and John Marshall and Maureen Meade",

year = "2013",

doi = "10.1186/cc11917",

language = "English",

volume = "17",

pages = "1 -- 11",

journal = "Critical Care",

issn = "1364-8535",

publisher = "BioMed Central",

number = "1 (Art. No.: R1)",

}

Cook, D, McDonald, E, Smith, O, Zytaruk, N, Heels-Ansdell, D, Watpool, I, McArdle, T, Matte, A, Clarke, F, Vallance, S, Finfer, S, Galt, P, Crozier, TME, Fowler, R, Arabi, Y, Woolfe, C, Orford, N, Hall, R, Adhikari, NKJ, Ferland, M-C, Marshall, J & Meade, M 2013, 'Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences', Critical Care, vol. 17, no. 1 (Art. No.: R1), pp. 1 - 11. https://doi.org/10.1186/cc11917

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 -

Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences

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