Abstract
Background SPOTLIGHT was a Canadian multicentre, placebo-controlled, randomized trial of emergency treatment with recombinant Factor VIIa for patients with acute intracerebral hemorrhage that enrolled a subset of eligible patients via deferral of consent. We investigated attitudes towards deferral of consent among participants and their legally-authorized representatives (LARs). Methods All participants or LARs approached for enrolment in SPOTLIGHT were invited to complete an 11-item questionnaire within the first 4 days of enrolment, and again at 90 days. Results Eight out of 50 participants in SPOTLIGHT (16%) were enrolled via deferral of consent. Ten LARs for participants (20%) completed the initial survey and 6 completed the 90 day follow-up survey. Ninety percent of respondents agreed with the process of deferral of consent both in principle and specifically for the SPOTLIGHT trial. Participants were more likely to support deferral of consent for low-risk or time-sensitive interventions, or in situations with no alternative treatment options. Conclusions The majority of respondents were supportive of using deferral of consent to enrol participants into SPOTLIGHT and acute stroke trials.
Cost effectiveness of recombinant factor VIIa for treatment of intracerebral hemorrhage
