title: Patients' preferences for enrolment into critical-care trials.
abstract: BACKGROUND
  Most critically ill patients are incapable of providing informed consent for research.
  
  
  OBJECTIVE
  We sought to determine patients' preferences for different consent frameworks for enrolling incapable patients into critical-care trials.
  
  
  METHODS
  Prospective observational and structured interview study.
  
  
  METHODS
  Five university-affiliated hospitals in Ontario.
  
  
  METHODS
  Two-hundred and forty consecutive capable and consenting survivors of critical illness.
  
  
  METHODS
  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).
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
authors: Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
authors: Damon C
authors: DC
authors: Scales
authors: Orla M
authors: OM
authors: Smith
authors: Ruxandra
authors: R
authors: Pinto
authors: Kali A
authors: KA
authors: Barrett
authors: Jan O
authors: JO
authors: Friedrich
authors: Neil M
authors: NM
authors: Lazar
authors: Deborah J
authors: DJ
authors: Cook
authors: Niall D
authors: ND
authors: Ferguson
mesh_terms: D002986:Clinical Trials as Topic; D003422:Critical Care; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D011446:Prospective Studies