Informed consent practical during trials involving life-threatening conditions

Last Updated: 2007-11-13 16:19:52 -0400 (Reuters Health)

NEW YORK (Reuters Health) – Informed consent for participation in a trial of decompressive surgery for space occupying hemispheric infarction is feasible and acceptable to the family of affected patients, according to a report in the October issue of the Journal of Neurology, Neurosurgery, and Psychiatry.

The Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial (HAMLET) is an ongoing study of the effect of decompressive surgery on functional outcome in patients with middle cerebral artery infarction and life-threatening edema formation.

"Obtaining informed consent is possible even in a trial like HAMLET, and deferred consent or consent waiver is unnecessary and inappropriate in most situations," Dr. J. Hofmeijer from University Medical Center Utrecht, The Netherlands told Reuters Health.

Dr. Hofmeijer and colleagues investigated whether the life-threatening condition and time pressure compromised the ability of relatives to perceive the details of the trial and whether they considered the randomization itself to be unethical or unacceptable because of the purported reduction in mortality attributed to the treatment under study.

Relatives of HAMLET patients remembered significantly more trial details than did relatives of patients in a study in which less vital issues were at stake, the authors report.

There were no differences in negative feelings between representatives of patients who received surgical or best medical treatment or between representatives of patients who died or survived.

"Moreover, the majority of HAMLET representatives considered themselves in retrospect capable of deciding about participation," Dr. Hofmeijer said. "In addition, only a small minority would have preferred the doctor to have taken the responsibility for study participation."

"This dispelled some of the concerns about the applicability of obtaining informed consent in a trial like HAMLET," Dr. Hofmeijer concluded.

"Hofmeijer and colleagues should be applauded for investigating introspective aspects of informed consent in a contemporary stroke trial," writes Dr. David S. Liebeskind from UCLA Stroke Center, Los Angeles, California in a related editorial. "Perhaps such insight will be used to enhance the way we tackle medical decisions in concert with our patients."

J Neurol Neurosurg Psychiatry 2007;78:1124-1128,1040.