Who will participate in acute stroke trials

Acute neurologic emergencies such as stroke, traumatic brain injury, status epilepticus, and others must be treated within the first few hours after onset and sometimes within the first few minutes of contact with the health care system. Few proven treatments are available, and the brief therapeutic window to initiate existing therapies poses an enormous challenge.1–5 In many centers, patients with acute neurologic emergencies are offered participation in clinical trials of novel acute therapies. Despite the substantial probability of a poor outcome and the lack of alternative proven therapy, many eligible patients (or their surrogate decision makers) choose not to participate in these trials or are unable to come to a decision during the allotted time. Consequently, trial recruitment is typically quite slow.6,7 Further, the generalizability of a trial may be called into question if only a small fraction of eligible patients actually participate in the trial.8,9 There has been relatively little research related to recruitment of patients into acute, time-sensitive clinical trials. Most existing studies addressed trials in which patients had ample time to consider their options, such as studies of disease prevention or treatment of chronic illness. None have investigated the specific issues related to acute stroke trials. When faced with the very urgent decision about participation in an acute treatment trial, patients or their surrogate decision-makers have little time to consider the many factors involved in such a decision. Moreover, patients with acute neurologic illness are often partially or completely unable to take part in the process due to their impairment.10 It is unclear which factors are most important in making decisions in this context. Gaining an understanding of how patients choose to participate or not and their attitudes toward acute stroke treatment trials may enhance patient recruitment procedures and the informed consent process with the overall goals of reaching optimal participants and improving enrollment.9