Patients' preferences for enrolment into critical-care trials

Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Intensive Care Medicine (Impact Factor: 7.21). 07/2009; 35(10):1703-12. DOI: 10.1007/s00134-009-1552-y
Source: PubMed


Most critically ill patients are incapable of providing informed consent for research.
We sought to determine patients' preferences for different consent frameworks for enrolling incapable patients into critical-care trials.
Prospective observational and structured interview study.
Five university-affiliated hospitals in Ontario.
Two-hundred and forty consecutive capable and consenting survivors of critical illness.
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).
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%).
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.

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    • "Patients and families involved in emergency research report a desire for more information after enrolment (Kamarainen et al., 2012). The need to engage in ongoing assessment of patient capacity for involvement in decision-making is crucial (Bigatello et al., 2003; Chenaud et al., 2007); however, only a minority of patients pass formal capacity screens both during their ICU stay and before hospital discharge which can preclude the ability of the research coordinator to obtain first-party consent (Fan et al., 2008; Scales et al., 2009). Furthermore, there is no clear guidance in the literature, or in existing ethical frameworks , as to how long the mandate for re-consent should apply. "
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    ABSTRACT: In many countries relatives are asked to consent on behalf of ICU patients prior to inclusion in clinical trials. However, the attitudes to drug trials among relatives of unconscious ICU patients are largely unknown. We performed a prospective questionnaire survey at two university hospital ICUs of the next-of-kin to 50 unconscious adult patients. They were asked to complete a questionnaire within 48 hours of the patients' acute ICU admission. Forty-two relatives returned the questionnaire of which 41 were completed by direct family members and in one case by a friend to the patient.The majority of relatives (36/42) were positive/positive with some scepticism towards performing drug trials in unconscious ICU patients and 30/42 would most likely accept trial-participation by their relative. The majority (30/42) agreed that they should decide if their relative was to participate in a drug trial and 24 of these found that the treating clinician/ICU consultant should also consent. The majority (27/42) found that deferred consent would be acceptable if there was a limited time frame for initiation of treatment, however 8 respondents found this unacceptable when the intervention was a new drug.The majority of relatives stipulated that adherence to legislation, treatment benefit for the study patient and for future patients, no patient-risk or -discomfort and development of new drugs were important factors if their relative was to participate in an ICU drug trial. When questioned about doctors' motives for performing drug trials the wish for drug development and better patient care were highly rated among relatives. In general, relatives to unconscious ICU patients expressed positive attitudes to drug trials in the ICU and the inclusion of their relative in drug trials. Consent by next-of-kin and deferred consent was acceptable to the majority of relatives.
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