Rates and determinants of informed consent

A case study of an international thromboprophylaxis trial

Orla M. Smith, Ellen McDonald, Nicole Zytaruk, Denise Foster, Andrea Matte, France Clarke, Laurie Meade, Nicole O'Callaghan, Shirley Vallance, Pauline Galt, Dorrilyn Rajbhandari, Marcelo Rocha, Sangeeta Mehta, Niall D. Ferguson, Richard Hall, Robert Fowler, Karen Burns, Ismael Qushmaq, Marlies Ostermann, Diane Heels-Ansdell & 1 others Deborah Cook

Research output: Contribution to journalArticleResearchpeer-review

14 Citations (Scopus)

Abstract

Background: Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. Objective: The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Design: Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. Setting: The trial was conducted in 67 centers in 6 countries. Measurements and main results: A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with > 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, < 0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Conclusions: Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial.

Original languageEnglish
Pages (from-to)28-39
Number of pages12
JournalJournal of Critical Care
Volume28
Issue number1
DOIs
Publication statusPublished - Feb 2013
Externally publishedYes

Keywords

  • Clinical research
  • Critical care
  • Informed consent
  • Intensive care
  • Randomized trials
  • Studies

Cite this

Smith, O. M., McDonald, E., Zytaruk, N., Foster, D., Matte, A., Clarke, F., ... Cook, D. (2013). Rates and determinants of informed consent: A case study of an international thromboprophylaxis trial. Journal of Critical Care, 28(1), 28-39. https://doi.org/10.1016/j.jcrc.2012.08.005
Smith, Orla M. ; McDonald, Ellen ; Zytaruk, Nicole ; Foster, Denise ; Matte, Andrea ; Clarke, France ; Meade, Laurie ; O'Callaghan, Nicole ; Vallance, Shirley ; Galt, Pauline ; Rajbhandari, Dorrilyn ; Rocha, Marcelo ; Mehta, Sangeeta ; Ferguson, Niall D. ; Hall, Richard ; Fowler, Robert ; Burns, Karen ; Qushmaq, Ismael ; Ostermann, Marlies ; Heels-Ansdell, Diane ; Cook, Deborah. / Rates and determinants of informed consent : A case study of an international thromboprophylaxis trial. In: Journal of Critical Care. 2013 ; Vol. 28, No. 1. pp. 28-39.
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abstract = "Background: Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. Objective: The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Design: Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. Setting: The trial was conducted in 67 centers in 6 countries. Measurements and main results: A total of 3764 patients were randomized. The overall consent rate was 82.2{\%} (range, 50{\%}-100{\%}) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1{\%} and 9.9{\%} of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95{\%} confidence interval, 2.42-4.86; P < .001 for those with > 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, < 0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95{\%} confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95{\%} confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Conclusions: Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial.",
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author = "Smith, {Orla M.} and Ellen McDonald and Nicole Zytaruk and Denise Foster and Andrea Matte and France Clarke and Laurie Meade and Nicole O'Callaghan and Shirley Vallance and Pauline Galt and Dorrilyn Rajbhandari and Marcelo Rocha and Sangeeta Mehta and Ferguson, {Niall D.} and Richard Hall and Robert Fowler and Karen Burns and Ismael Qushmaq and Marlies Ostermann and Diane Heels-Ansdell and Deborah Cook",
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Smith, OM, McDonald, E, Zytaruk, N, Foster, D, Matte, A, Clarke, F, Meade, L, O'Callaghan, N, Vallance, S, Galt, P, Rajbhandari, D, Rocha, M, Mehta, S, Ferguson, ND, Hall, R, Fowler, R, Burns, K, Qushmaq, I, Ostermann, M, Heels-Ansdell, D & Cook, D 2013, 'Rates and determinants of informed consent: A case study of an international thromboprophylaxis trial', Journal of Critical Care, vol. 28, no. 1, pp. 28-39. https://doi.org/10.1016/j.jcrc.2012.08.005

Rates and determinants of informed consent : A case study of an international thromboprophylaxis trial. / Smith, Orla M.; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D.; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah.

In: Journal of Critical Care, Vol. 28, No. 1, 02.2013, p. 28-39.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Rates and determinants of informed consent

T2 - A case study of an international thromboprophylaxis trial

AU - Smith, Orla M.

AU - McDonald, Ellen

AU - Zytaruk, Nicole

AU - Foster, Denise

AU - Matte, Andrea

AU - Clarke, France

AU - Meade, Laurie

AU - O'Callaghan, Nicole

AU - Vallance, Shirley

AU - Galt, Pauline

AU - Rajbhandari, Dorrilyn

AU - Rocha, Marcelo

AU - Mehta, Sangeeta

AU - Ferguson, Niall D.

AU - Hall, Richard

AU - Fowler, Robert

AU - Burns, Karen

AU - Qushmaq, Ismael

AU - Ostermann, Marlies

AU - Heels-Ansdell, Diane

AU - Cook, Deborah

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N2 - Background: Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. Objective: The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Design: Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. Setting: The trial was conducted in 67 centers in 6 countries. Measurements and main results: A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with > 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, < 0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Conclusions: Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial.

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