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- Title
Patients' preferences for enrolment into critical-care trials.
- Authors
Scales DC; Smith OM; Pinto R; Barrett KA; Friedrich JO; Lazar NM; Cook DJ; Ferguson ND; Scales, Damon C; Smith, Orla M; Pinto, Ruxandra; Barrett, Kali A; Friedrich, Jan O; Lazar, Neil M; Cook, Deborah J; Ferguson, Niall D
- Abstract
<bold>Background: </bold>Most critically ill patients are incapable of providing informed consent for research.<bold>Objective: </bold>We sought to determine patients' preferences for different consent frameworks for enrolling incapable patients into critical-care trials.<bold>Design: </bold>Prospective observational and structured interview study.<bold>Setting: </bold>Five university-affiliated hospitals in Ontario.<bold>Patients: </bold>Two-hundred and forty consecutive capable and consenting survivors of critical illness.<bold>Intervention: </bold>Participants 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).<bold>Measurements and Main Results: </bold>For 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%).<bold>Conclusions: </bold>Most 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.
- Publication
Intensive Care Medicine, 2009, Vol 35, Issue 10, p1703
- ISSN
0342-4642
- Publication type
journal article
- DOI
10.1007/s00134-009-1552-y