Informed consent is mandatory for patients entering randomised trials in emergency situations-such as in new treatments for heart attack-but few studies have investigated the effectiveness of the consent process in such circumstances. Barbara Williams from Green Lane Hospital, Auckland, New Zealand, and colleagues assessed whether patients with acute heart attack could understand written and verbal information and whether they were competent to give independent informed consent to participate in a clinical trial.
The investigators studied around 400 patients with acute heart attack in 16 hospitals in New Zealand and Australia who were eligible for participation in a large international randomised trial (the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial) evaluating blood thinning treatments to improve survival. The readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and their competence to give consent was assessed.
Less than 20% of patients read the information sheet before giving consent to enter the trial; furthermore, the information sheet was difficult to understand for the majority (78%) of patients who had not been educated beyond secondary school level.
Barbara Williams comments: " Our study suggests that all information given to these patients should be communicated in language that is as simple and concise as possible, and that this information should be mostly verbal, supported by written information."
Contact: Barbara F Williams, Cardiovascular Research Unit, Green Lane Hospital, Private Bag 92 189, Auckland 1030, New Zealand;
T) 64-9-630-9904;
F) 64-9-630-9978;
E) barbaraw@adhb.govt.nz
The Lancet