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Published 8 October 2009, doi:10.1136/bmj.b3911
Cite this as: BMJ 2009;339:b3911
The ACRE Trial Collaborators
Correspondence to: D Young, Intensive Care Society Clinical Trials Group, Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, Oxford OX3 9DU duncan.young{at}nda.ox.ac.uk
Design Unblinded multicentre randomised controlled trial using a sequential design. Centralised 24 hour telephone randomisation based on randomised permuted blocks of 10.
Setting 79 general, neuroscience, and paediatric intensive care units in the United Kingdom.
Participants 201 relatives of patients meeting criteria for brain stem death. Relatives were blind to the intervention and to the trial; all other participants were necessarily unblinded.
Interventions Collaborative requesting for consent for organ donation by the potential donors clinician and a donor transplant coordinator (organ procurement officer) compared with routine requesting by the clinical team alone.
Main outcome measure Proportion of relatives consenting to organ donation.
Results 101 relatives were randomised to routine requesting and 100 to collaborative requesting. All were analysed on an intention to treat basis. In the routine requesting group, 62 relatives consented to organ donation. In the collaborative requesting group, 57 relatives consented. After correction for the ethnicity, age, and sex of the potential donors the risk adjusted ratio of the odds of consent in the collaborative requesting group relative to the routine group was 0.80 (95% confidence interval 0.43 to 1.53), with a P value of 0.49 adjusted for interim analysis and trial over-running. The conversion rate (donors with consent from whom any organs were retrieved) was 92% (57/62) in the routine requesting group and 79% (45/57) in the collaborative requesting group (P=0.043). There were 140 approaches to relatives in the per protocol analysis, leading to 60.3% (44/73) consent after routine and 67.2% (45/67) after collaborative requesting (risk adjusted odds ratio of consent 1.47, 0.67 to 3.20, P=0.33).
Conclusion There is no increase in consent rates for organ donation when collaborative requesting is used in place of routine requesting by the patients clinician.
Trial registration ISRCTN01169903
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
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