Patients’ preferences for enrolment into critical-care trials View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2009-06-24

AUTHORS

Damon C. Scales, Orla M. Smith, Ruxandra Pinto, Kali A. Barrett, Jan O. Friedrich, Neil M. Lazar, Deborah J. Cook, Niall D. Ferguson

ABSTRACT

BackgroundMost critically ill patients are incapable of providing informed consent for research.ObjectiveWe sought to determine patients’ preferences for different consent frameworks for enrolling incapable patients into critical-care trials.DesignProspective observational and structured interview study.SettingFive university-affiliated hospitals in Ontario.PatientsTwo-hundred and forty consecutive capable and consenting survivors of critical illness.InterventionParticipants considered four frameworks for enrolling incapable patients into clinical trials using a baseline scenario and three permutations for: risk (very low vs. high), treatment type (new vs. currently available), and availability of substitute decision-maker (yes vs. no).Measurements and main resultsFor each scenario, patients chose their preferred framework and rated the acceptability of each framework using a seven-point Likert scale. Most (180/240; 76%) patients selected “consent by substitute prior to enrolment” as their preferred framework; this also received the highest baseline acceptability ratings (“acceptable” or “highly acceptable” 207/240; 87%). Modifying risk or treatment type did not substantially change these ratings. A minority of patients rated delayed consent as unacceptable or highly unacceptable in both the baseline scenario (48/240, 20% delayed to substitute; 57/240, 24% delayed to patient) and when a substitute was unavailable (34/240; 15%).ConclusionsMost survivors of critical illness found the usual practice of obtaining informed consent from a substitute decision-maker prior to enrolment in a clinical trial to be acceptable. Nearly half of patients considered foregoing informed consent to be unacceptable, whereas a minority considered enrolment followed by delayed consent to be unacceptable even when a substitute was unavailable. These approaches should, therefore, only be considered when deviating from the usual practice of obtaining consent from a substitute decision-maker is truly justified, such as where treatments being tested need to be delivered as soon as possible in order to be effective. More... »

PAGES

1703-1712

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00134-009-1552-y

DOI

http://dx.doi.org/10.1007/s00134-009-1552-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1045782771

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/19551372


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