Abstract Background and aims Advance consent, where a patient at risk of incapacitation provides consent before meeting the eligibility criteria for a trial, is an innovative approach that could address the challenges of obtaining informed consent in acute stroke trials. We conducted a feasibility study assessing advance consent as a means of enrolling people at risk of stroke into acute stroke trials. Here we report qualitative outcomes of the study. Methods Patients assessed in the Stroke Prevention Clinic at The Ottawa Hospital (Ottawa, Canada) were screened for diagnoses associated with a risk of acute stroke. Eligible patients completed an initial questionnaire and a follow-up questionnaire at 1 year. In both instances, participants were invited to provide free-text comments about advance consent. Qualitative data gathered from free-text responses were analysed using inductive thematic analysis. Results Of the 157 participants who entered the study, 142 provided free-text comments. In the initial questionnaire, four main themes were identified in favour of advance consent: altruism, agency, personal impact, and trust in the health care team. At one year, respondents identified three more themes: enhancing autonomy, involving family, and ease of use of advance consent. No major concerns or objections were raised. Conclusions These qualitative findings support the acceptability of advance consent for participation in acute stroke trials, both at initial assessment and one year later. Conflict of interest Michel Shamy: Nothing to disclose; Ubong Udoh: Nothing to disclose; Brian Dewar: Nothing to disclose; Dar Dowlatshahi: Nothing to disclose
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Ubong Udoh
Brian Dewar
Dar Dowlatshahi
European Stroke Journal
University of Ottawa
Ottawa Hospital
Ottawa Hospital Research Institute
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Udoh et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7f3abfa21ec5bbf07a97 — DOI: https://doi.org/10.1093/esj/aakag023.1333