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 Crozier; Rob Fowler; Yaseen Arabi; Clive Woolfe; Neil Orford; Richard Hall; Neill K.J. 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 Crozier, Rob Fowler, Yaseen Arabi, Clive Woolfe, Neil Orford, Richard Hall, Neill K.J. Adhikari, Marie Clauide FerlandJohn Marshall, Maureen Meade

Medicine

Research output: Contribution to journal › Article › peer-review

25 Citations (Scopus)

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.

Original language	English
Article number	R1
Journal	Critical Care
Volume	17
Issue number	1
DOIs	https://doi.org/10.1186/cc11917
Publication status	Published - Jan 8 2013

Bibliographical note

Funding Information:
This study was funded by a North American Meeting Grant of the Canadian Institutes for Health Research which had no role in the design, conduct, analysis, interpretation or write-up of this report. D Cook, N Zytaruk and D Heels-Ansdell had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. We appreciate the interest of family members and patients in research, which enabled the main trial and this study. We thank research coordinators and physicians from all participating PROTECT centers for their collaboration. We are grateful to the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group and all participating centers for their engagement. D Cook is a Research Chair of the Canadian Institutes for Health Research. R Fowler is a Clinician Scientist of the Heart and Stroke Foundation of Canada. M Meade is an RCT Mentor of the Canadian Institutes for Health Research. We thank L Hand, K Porretta, C Wynne, D Foster and P Farias for helpful comments on earlier drafts. PROTECT Collaborators Clinical Collaborators Canadian Investigators Dr Deborah Cook (Lead), Ellen McDonald, Andrea Tkaczyk, France Clarke; Pharmacist: Christine Wallace; St Joseph’s Healthcare, Hamilton Drs Rick Hall and Graeme Rocker, Lisa Julien, Debbie Wright, Caroline Roy, Judy Theriault, Susan Pleasance; Pharmacy Technicians: Debi Snow and Shannon Herbert; Capital Health Queen Elizabeth II Health Science Center, Halifax Dr Maureen Meade, Lori Hand; Pharmacy Technician: Maya Biljan; Hamilton Health Sciences, Hamilton General Hospital, Hamilton Dr Andreas Freitag, Christine Wynne, Mark Duffett, Michelle Kho, Nicole Zytaruk; Pharmacy Technician: Karen Currie; Hamilton Health Sciences, McMaster Hospital, Hamilton Dr John Granton, Andrea Matte, Paulina Farias, Leslie Chu, Nancy Brockest, Stephanie Go, Margaret McGrath-Chong, Madison Dennis, Marc Lipkus, Emily Stern, Ryan Albert; Pharmacy: Ron Seto, Muhammad Zuberi, Jie Ming and Laura Arus-Pampin, Muhammad Walid, Robert Solek, Kim De freitas; University Health Network, Toronto General Hospital, Toronto Drs Stephan Langevin, François Lauzier and Alexis F Turgeon, Martine Blais, Maxime Beauparlant, Julie Asselin, Caroline Roy, Chantal Gagné, Marie Thibodeau; Pharmacists: Anik Rioux and Tuong-Vi Tran; Hôpital de l’Enfant-Jésus, Quebec City Dr Germain Poirier, Isabelle Neas, Sandrine Spearson; Pharmacist: Betty Ton; Charles Hôpital Charles-LeMoyne, Longueuil Drs Lauralyn McIntyre and Paul Hébert, Irene Watpool, Tracy McArdle, Claude Gaudert, Paule Marchand, Carson Davidson; Pharmacists: Anne-Marie Dugal and Susan Fetzer; Ottawa Hospital, General Campus, Ottawa Dr Joe Pagliarello, Mary-Jo Lewis, Erin Murphy, Julia Foxall; Pharmacist: Sherry Weir; Ottawa Hospital Civic Campus, Ottawa Dr Yoanna Skrobik, Johanne Harvey, Stefania Chitu; Pharmacists: Marceline Quach and Linda Pinet; Hôpital Maisonneuve-Rosemont, Montréal Dr Martin Albert, Carole Sirois, Carole Nadon, Stéphanie Dolle, Audrey-Anne Gosselin, Patrice Deroy; Pharmacists: Anne Julie Frenette and David Williamson; Hôpital du Sacré-Coeur de Montréal, Montréal Dr Sangeeta Mehta, Cheryl Ethier, Sam Tirgari, Lindsay Steinberg, Rod McDonald, Vidhya Sivanantham, Kristofer Bandayrel, Friederike Quittnat Pelletier, Marnie Kramer-Kile, Maedean Brown, Scott Kim; Pharmacist Holly Leung; Mount Sinai Hospital, Toronto Dr Robert Fowler, Nicole Marinoff, Karen Code, Boris Bojilov, Derek Parsotam; Pharmacist: John Iazzetta; Sunnybrook Hospital, Toronto Dr John Marshall, Orla Smith, Beth Fry, Kerri Porretta, Yoon Lee, Jeanna Morrissey, Victoria Wen; Pharmacy Technicians: Laura Parsons and Ann Kosinski; St Michael’s Hospital, Toronto Dr John Muscedere, Susan Fleury, Nicole Godfrey, Sharlene Hammond, Elizabeth Mann, Monica Myers, Amber Robinson; Pharmacist: Chris Grey; Kingston General Hospital, Kingston Drs Sean Keenan and Steven Reynolds, Miroslav Svetik, Mary Van Osch; Pharmacist: Anne-Marie Liberman; Royal Columbian Hospital, Westminster Drs Dean Chittock and Vinay Dhingra, Maureen Gardner, Susan Logie, Denise Foster, Roger Autio, Dara Davies, Pia Ganz, Laurie Smith; Pharmacy: Jane Day, Kaldip Mattu and Judy Yip; Vancouver General Hospital, Vancouver Dr Peter Dodek, Betty Jean Ashley, Sheilagh Mans; Pharmacist: Mara Pavan; St. Paul’s Hospital, Vancouver Dr Chip Doig, Linda Knox, Crystal Wilson, Kevin Champagne; Pharmacist: Angela Kayall Peters; Calgary University Foothills Hospital, Calgary Dr Niall Ferguson, Andrea Matte, James Stevenson, Joel Elman, Madison Dennis; Pharmacist: Jenn Tung, Robert Solek, Kim De Freitas, Nga Pham; University Health Network, Toronto Western Hospital, Toronto Dr Jim Kutsogiannis, Patrica Thompson, Norine Whalen; Pharmacist: Liz Helboe; Royal Alexandra Hospital, Edmonton Dr François Lellouche, Marie-Claude Ferland, Patrick Dussault, Caroline Jacob, Marie-Ève Morneau, Nancy Laberge; Pharmacist: Nathalie Chateauvert; Institut Universtaire de Cardiologie et de Pneumologie de Québec, Québec Dr Tim Karachi, Andrea Tkaczyk; Pharmacy Technician: Diane Lourenco; Hamilton Health Sciences, Juravinski Hospital, Hamilton Dr Michael Jacka, Marleen Irwin, Carmen Chan, Leeca Sonnema, Kelly Marsh, Jennifer Maurer, Tamara Kreidl, Candice Varden, Carey Kinjerski; Pharmacist: Noelle Carey; University of Alberta, Edmonton Dr Chip Doig, Linda Knox, Crystal Wilson, Kevin Champagne; Pharmacist: Angela Kayall Peters; Calgary University Peter Lougheed Hospital, Calgary Dr Kosar Khwaja, Laura Banici, Carole Sirois, Lena Havell; Pharmacists: Gilbert Matte and Kathleen Normandin; Montreal General Hospital, Montréal Dr Gordon Wood, Fiona Auld, Leslie Atkins; Pharmacist: John Foster-Coull; Vancouver Island Health Authority, Vancouver Drs Olivier Lesur and François Lamontagne, Sandra Proulx; Pharmacist: Sylvie Cloutier, Brigitte Bolduc, Marie-Pierre Rousseau, Julie Leblond; Centre Hospitalier Universitaire de Sherbrooke and Centre de Recherche Clinique Étienne-Le Bel, Sherbrooke Dr Kosar Khwaja, Laura Banici, Carole Sirois, Lena Havell; Pharmacists: Gilbert Matte and Kathleen Normandin; Royal Victoria Hospital, Montreal

ASJC Scopus Subject Areas

Critical Care and Intensive Care Medicine

Access to Document

10.1186/cc11917

Cite this

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., Fowler, R., Arabi, Y., Woolfe, C., Orford, N., Hall, R., Adhikari, N. K. J., ... Meade, M. (2013). Co-enrollment of critically ill patients into multiple studies: Patterns, predictors and consequences. Critical Care, 17(1), Article R1. https://doi.org/10.1186/cc11917

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, Fowler, R, Arabi, Y, Woolfe, C, Orford, N, Hall, R, Adhikari, NKJ, Ferland, MC, Marshall, J & Meade, M 2013, 'Co-enrollment of critically ill patients into multiple studies: Patterns, predictors and consequences', Critical Care, vol. 17, no. 1, R1. https://doi.org/10.1186/cc11917

@article{e2db8a86f9754a7896b3fadbc90d4b2c,

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

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.",

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 Tim Crozier and Rob Fowler and Yaseen Arabi and Clive Woolfe and Neil Orford and Richard Hall and Adhikari, {Neill K.J.} and Ferland, {Marie Clauide} and John Marshall and Maureen Meade",

note = "Funding Information: This study was funded by a North American Meeting Grant of the Canadian Institutes for Health Research which had no role in the design, conduct, analysis, interpretation or write-up of this report. D Cook, N Zytaruk and D Heels-Ansdell had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. We appreciate the interest of family members and patients in research, which enabled the main trial and this study. We thank research coordinators and physicians from all participating PROTECT centers for their collaboration. We are grateful to the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group and all participating centers for their engagement. D Cook is a Research Chair of the Canadian Institutes for Health Research. R Fowler is a Clinician Scientist of the Heart and Stroke Foundation of Canada. M Meade is an RCT Mentor of the Canadian Institutes for Health Research. We thank L Hand, K Porretta, C Wynne, D Foster and P Farias for helpful comments on earlier drafts. PROTECT Collaborators Clinical Collaborators Canadian Investigators Dr Deborah Cook (Lead), Ellen McDonald, Andrea Tkaczyk, France Clarke; Pharmacist: Christine Wallace; St Joseph{\textquoteright}s Healthcare, Hamilton Drs Rick Hall and Graeme Rocker, Lisa Julien, Debbie Wright, Caroline Roy, Judy Theriault, Susan Pleasance; Pharmacy Technicians: Debi Snow and Shannon Herbert; Capital Health Queen Elizabeth II Health Science Center, Halifax Dr Maureen Meade, Lori Hand; Pharmacy Technician: Maya Biljan; Hamilton Health Sciences, Hamilton General Hospital, Hamilton Dr Andreas Freitag, Christine Wynne, Mark Duffett, Michelle Kho, Nicole Zytaruk; Pharmacy Technician: Karen Currie; Hamilton Health Sciences, McMaster Hospital, Hamilton Dr John Granton, Andrea Matte, Paulina Farias, Leslie Chu, Nancy Brockest, Stephanie Go, Margaret McGrath-Chong, Madison Dennis, Marc Lipkus, Emily Stern, Ryan Albert; Pharmacy: Ron Seto, Muhammad Zuberi, Jie Ming and Laura Arus-Pampin, Muhammad Walid, Robert Solek, Kim De freitas; University Health Network, Toronto General Hospital, Toronto Drs Stephan Langevin, Fran{\c c}ois Lauzier and Alexis F Turgeon, Martine Blais, Maxime Beauparlant, Julie Asselin, Caroline Roy, Chantal Gagn{\'e}, Marie Thibodeau; Pharmacists: Anik Rioux and Tuong-Vi Tran; H{\^o}pital de l{\textquoteright}Enfant-J{\'e}sus, Quebec City Dr Germain Poirier, Isabelle Neas, Sandrine Spearson; Pharmacist: Betty Ton; Charles H{\^o}pital Charles-LeMoyne, Longueuil Drs Lauralyn McIntyre and Paul H{\'e}bert, Irene Watpool, Tracy McArdle, Claude Gaudert, Paule Marchand, Carson Davidson; Pharmacists: Anne-Marie Dugal and Susan Fetzer; Ottawa Hospital, General Campus, Ottawa Dr Joe Pagliarello, Mary-Jo Lewis, Erin Murphy, Julia Foxall; Pharmacist: Sherry Weir; Ottawa Hospital Civic Campus, Ottawa Dr Yoanna Skrobik, Johanne Harvey, Stefania Chitu; Pharmacists: Marceline Quach and Linda Pinet; H{\^o}pital Maisonneuve-Rosemont, Montr{\'e}al Dr Martin Albert, Carole Sirois, Carole Nadon, St{\'e}phanie Dolle, Audrey-Anne Gosselin, Patrice Deroy; Pharmacists: Anne Julie Frenette and David Williamson; H{\^o}pital du Sacr{\'e}-Coeur de Montr{\'e}al, Montr{\'e}al Dr Sangeeta Mehta, Cheryl Ethier, Sam Tirgari, Lindsay Steinberg, Rod McDonald, Vidhya Sivanantham, Kristofer Bandayrel, Friederike Quittnat Pelletier, Marnie Kramer-Kile, Maedean Brown, Scott Kim; Pharmacist Holly Leung; Mount Sinai Hospital, Toronto Dr Robert Fowler, Nicole Marinoff, Karen Code, Boris Bojilov, Derek Parsotam; Pharmacist: John Iazzetta; Sunnybrook Hospital, Toronto Dr John Marshall, Orla Smith, Beth Fry, Kerri Porretta, Yoon Lee, Jeanna Morrissey, Victoria Wen; Pharmacy Technicians: Laura Parsons and Ann Kosinski; St Michael{\textquoteright}s Hospital, Toronto Dr John Muscedere, Susan Fleury, Nicole Godfrey, Sharlene Hammond, Elizabeth Mann, Monica Myers, Amber Robinson; Pharmacist: Chris Grey; Kingston General Hospital, Kingston Drs Sean Keenan and Steven Reynolds, Miroslav Svetik, Mary Van Osch; Pharmacist: Anne-Marie Liberman; Royal Columbian Hospital, Westminster Drs Dean Chittock and Vinay Dhingra, Maureen Gardner, Susan Logie, Denise Foster, Roger Autio, Dara Davies, Pia Ganz, Laurie Smith; Pharmacy: Jane Day, Kaldip Mattu and Judy Yip; Vancouver General Hospital, Vancouver Dr Peter Dodek, Betty Jean Ashley, Sheilagh Mans; Pharmacist: Mara Pavan; St. Paul{\textquoteright}s Hospital, Vancouver Dr Chip Doig, Linda Knox, Crystal Wilson, Kevin Champagne; Pharmacist: Angela Kayall Peters; Calgary University Foothills Hospital, Calgary Dr Niall Ferguson, Andrea Matte, James Stevenson, Joel Elman, Madison Dennis; Pharmacist: Jenn Tung, Robert Solek, Kim De Freitas, Nga Pham; University Health Network, Toronto Western Hospital, Toronto Dr Jim Kutsogiannis, Patrica Thompson, Norine Whalen; Pharmacist: Liz Helboe; Royal Alexandra Hospital, Edmonton Dr Fran{\c c}ois Lellouche, Marie-Claude Ferland, Patrick Dussault, Caroline Jacob, Marie-{\`E}ve Morneau, Nancy Laberge; Pharmacist: Nathalie Chateauvert; Institut Universtaire de Cardiologie et de Pneumologie de Qu{\'e}bec, Qu{\'e}bec Dr Tim Karachi, Andrea Tkaczyk; Pharmacy Technician: Diane Lourenco; Hamilton Health Sciences, Juravinski Hospital, Hamilton Dr Michael Jacka, Marleen Irwin, Carmen Chan, Leeca Sonnema, Kelly Marsh, Jennifer Maurer, Tamara Kreidl, Candice Varden, Carey Kinjerski; Pharmacist: Noelle Carey; University of Alberta, Edmonton Dr Chip Doig, Linda Knox, Crystal Wilson, Kevin Champagne; Pharmacist: Angela Kayall Peters; Calgary University Peter Lougheed Hospital, Calgary Dr Kosar Khwaja, Laura Banici, Carole Sirois, Lena Havell; Pharmacists: Gilbert Matte and Kathleen Normandin; Montreal General Hospital, Montr{\'e}al Dr Gordon Wood, Fiona Auld, Leslie Atkins; Pharmacist: John Foster-Coull; Vancouver Island Health Authority, Vancouver Drs Olivier Lesur and Fran{\c c}ois Lamontagne, Sandra Proulx; Pharmacist: Sylvie Cloutier, Brigitte Bolduc, Marie-Pierre Rousseau, Julie Leblond; Centre Hospitalier Universitaire de Sherbrooke and Centre de Recherche Clinique {\'E}tienne-Le Bel, Sherbrooke Dr Kosar Khwaja, Laura Banici, Carole Sirois, Lena Havell; Pharmacists: Gilbert Matte and Kathleen Normandin; Royal Victoria Hospital, Montreal",

year = "2013",

month = jan,

day = "8",

doi = "10.1186/cc11917",

language = "English",

volume = "17",

journal = "Critical Care",

issn = "1364-8535",

publisher = "Springer Science + Business Media",

number = "1",

}

TY - JOUR

T1 - Co-enrollment of critically ill patients into multiple studies

T2 - 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

AU - Fowler, Rob

AU - Arabi, Yaseen

AU - Woolfe, Clive

AU - Orford, Neil

AU - Hall, Richard

AU - Adhikari, Neill K.J.

AU - Ferland, Marie Clauide

AU - Marshall, John

AU - Meade, Maureen

N1 - Funding Information: This study was funded by a North American Meeting Grant of the Canadian Institutes for Health Research which had no role in the design, conduct, analysis, interpretation or write-up of this report. D Cook, N Zytaruk and D Heels-Ansdell had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. We appreciate the interest of family members and patients in research, which enabled the main trial and this study. We thank research coordinators and physicians from all participating PROTECT centers for their collaboration. We are grateful to the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group and all participating centers for their engagement. D Cook is a Research Chair of the Canadian Institutes for Health Research. R Fowler is a Clinician Scientist of the Heart and Stroke Foundation of Canada. M Meade is an RCT Mentor of the Canadian Institutes for Health Research. We thank L Hand, K Porretta, C Wynne, D Foster and P Farias for helpful comments on earlier drafts. PROTECT Collaborators Clinical Collaborators Canadian Investigators Dr Deborah Cook (Lead), Ellen McDonald, Andrea Tkaczyk, France Clarke; Pharmacist: Christine Wallace; St Joseph’s Healthcare, Hamilton Drs Rick Hall and Graeme Rocker, Lisa Julien, Debbie Wright, Caroline Roy, Judy Theriault, Susan Pleasance; Pharmacy Technicians: Debi Snow and Shannon Herbert; Capital Health Queen Elizabeth II Health Science Center, Halifax Dr Maureen Meade, Lori Hand; Pharmacy Technician: Maya Biljan; Hamilton Health Sciences, Hamilton General Hospital, Hamilton Dr Andreas Freitag, Christine Wynne, Mark Duffett, Michelle Kho, Nicole Zytaruk; Pharmacy Technician: Karen Currie; Hamilton Health Sciences, McMaster Hospital, Hamilton Dr John Granton, Andrea Matte, Paulina Farias, Leslie Chu, Nancy Brockest, Stephanie Go, Margaret McGrath-Chong, Madison Dennis, Marc Lipkus, Emily Stern, Ryan Albert; Pharmacy: Ron Seto, Muhammad Zuberi, Jie Ming and Laura Arus-Pampin, Muhammad Walid, Robert Solek, Kim De freitas; University Health Network, Toronto General Hospital, Toronto Drs Stephan Langevin, François Lauzier and Alexis F Turgeon, Martine Blais, Maxime Beauparlant, Julie Asselin, Caroline Roy, Chantal Gagné, Marie Thibodeau; Pharmacists: Anik Rioux and Tuong-Vi Tran; Hôpital de l’Enfant-Jésus, Quebec City Dr Germain Poirier, Isabelle Neas, Sandrine Spearson; Pharmacist: Betty Ton; Charles Hôpital Charles-LeMoyne, Longueuil Drs Lauralyn McIntyre and Paul Hébert, Irene Watpool, Tracy McArdle, Claude Gaudert, Paule Marchand, Carson Davidson; Pharmacists: Anne-Marie Dugal and Susan Fetzer; Ottawa Hospital, General Campus, Ottawa Dr Joe Pagliarello, Mary-Jo Lewis, Erin Murphy, Julia Foxall; Pharmacist: Sherry Weir; Ottawa Hospital Civic Campus, Ottawa Dr Yoanna Skrobik, Johanne Harvey, Stefania Chitu; Pharmacists: Marceline Quach and Linda Pinet; Hôpital Maisonneuve-Rosemont, Montréal Dr Martin Albert, Carole Sirois, Carole Nadon, Stéphanie Dolle, Audrey-Anne Gosselin, Patrice Deroy; Pharmacists: Anne Julie Frenette and David Williamson; Hôpital du Sacré-Coeur de Montréal, Montréal Dr Sangeeta Mehta, Cheryl Ethier, Sam Tirgari, Lindsay Steinberg, Rod McDonald, Vidhya Sivanantham, Kristofer Bandayrel, Friederike Quittnat Pelletier, Marnie Kramer-Kile, Maedean Brown, Scott Kim; Pharmacist Holly Leung; Mount Sinai Hospital, Toronto Dr Robert Fowler, Nicole Marinoff, Karen Code, Boris Bojilov, Derek Parsotam; Pharmacist: John Iazzetta; Sunnybrook Hospital, Toronto Dr John Marshall, Orla Smith, Beth Fry, Kerri Porretta, Yoon Lee, Jeanna Morrissey, Victoria Wen; Pharmacy Technicians: Laura Parsons and Ann Kosinski; St Michael’s Hospital, Toronto Dr John Muscedere, Susan Fleury, Nicole Godfrey, Sharlene Hammond, Elizabeth Mann, Monica Myers, Amber Robinson; Pharmacist: Chris Grey; Kingston General Hospital, Kingston Drs Sean Keenan and Steven Reynolds, Miroslav Svetik, Mary Van Osch; Pharmacist: Anne-Marie Liberman; Royal Columbian Hospital, Westminster Drs Dean Chittock and Vinay Dhingra, Maureen Gardner, Susan Logie, Denise Foster, Roger Autio, Dara Davies, Pia Ganz, Laurie Smith; Pharmacy: Jane Day, Kaldip Mattu and Judy Yip; Vancouver General Hospital, Vancouver Dr Peter Dodek, Betty Jean Ashley, Sheilagh Mans; Pharmacist: Mara Pavan; St. Paul’s Hospital, Vancouver Dr Chip Doig, Linda Knox, Crystal Wilson, Kevin Champagne; Pharmacist: Angela Kayall Peters; Calgary University Foothills Hospital, Calgary Dr Niall Ferguson, Andrea Matte, James Stevenson, Joel Elman, Madison Dennis; Pharmacist: Jenn Tung, Robert Solek, Kim De Freitas, Nga Pham; University Health Network, Toronto Western Hospital, Toronto Dr Jim Kutsogiannis, Patrica Thompson, Norine Whalen; Pharmacist: Liz Helboe; Royal Alexandra Hospital, Edmonton Dr François Lellouche, Marie-Claude Ferland, Patrick Dussault, Caroline Jacob, Marie-Ève Morneau, Nancy Laberge; Pharmacist: Nathalie Chateauvert; Institut Universtaire de Cardiologie et de Pneumologie de Québec, Québec Dr Tim Karachi, Andrea Tkaczyk; Pharmacy Technician: Diane Lourenco; Hamilton Health Sciences, Juravinski Hospital, Hamilton Dr Michael Jacka, Marleen Irwin, Carmen Chan, Leeca Sonnema, Kelly Marsh, Jennifer Maurer, Tamara Kreidl, Candice Varden, Carey Kinjerski; Pharmacist: Noelle Carey; University of Alberta, Edmonton Dr Chip Doig, Linda Knox, Crystal Wilson, Kevin Champagne; Pharmacist: Angela Kayall Peters; Calgary University Peter Lougheed Hospital, Calgary Dr Kosar Khwaja, Laura Banici, Carole Sirois, Lena Havell; Pharmacists: Gilbert Matte and Kathleen Normandin; Montreal General Hospital, Montréal Dr Gordon Wood, Fiona Auld, Leslie Atkins; Pharmacist: John Foster-Coull; Vancouver Island Health Authority, Vancouver Drs Olivier Lesur and François Lamontagne, Sandra Proulx; Pharmacist: Sylvie Cloutier, Brigitte Bolduc, Marie-Pierre Rousseau, Julie Leblond; Centre Hospitalier Universitaire de Sherbrooke and Centre de Recherche Clinique Étienne-Le Bel, Sherbrooke Dr Kosar Khwaja, Laura Banici, Carole Sirois, Lena Havell; Pharmacists: Gilbert Matte and Kathleen Normandin; Royal Victoria Hospital, Montreal

PY - 2013/1/8

Y1 - 2013/1/8

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84871998024&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84871998024&partnerID=8YFLogxK

U2 - 10.1186/cc11917

DO - 10.1186/cc11917

M3 - Article

AN - SCOPUS:84871998024

SN - 1364-8535

VL - 17

JO - Critical Care

JF - Critical Care

IS - 1

M1 - R1

ER -

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

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