Trial Consent Form not Appropriate

AUCKLAND, New Zealand (Ivanhoe Newswire) -- A new study shows most patients in emergencies do not understand the consent form to be part of a clinical trial. Even though the information forms meet regulatory requirements, authors of the study say they are inappropriate for most patients' needs.

In order for a patient to be part of clinical trial, informed consent is mandatory. In an emergency, such as receiving a new treatment after a heart attack, the consent is done quickly. Researchers from Green Lane Hospital in Auckland, New Zealand, conducted a study to assess whether patients in an emergency understood the consent form.

Investigators studied about 400 patients who had suffered an acute heart attack. The patients were treated in 16 hospitals in New Zealand and Australia. All of the patients were asked to be part of a large trial evaluating blood-thinning treatments to improve survival. Researchers assessed the patient's readability of the information sheets, patients' education status, their views on the consent process, comprehension of the verbal and written information and their competence to give consent.

Researchers found only 18 percent of the patients read the patient information sheet before giving or refusing consent to participate. Patients who agreed to be part of the study were more likely to report good or partial comprehension of the information compared to those who refused to be part of the trial. Furthermore, researchers say the patient information sheet was hard to understand for nearly 80 percent of those who had not been educated beyond a secondary school level.

Lead author Barbara Williams, from Green Lane Hospital, says, "Our study suggests that all information given to these patients should be communicated in language that is as simple and as concise as possible, and that this information should be mostly verbal, supported by written information."

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SOURCE: The Lancet, 2003;361:918-922