Public opinion of a stroke clinical trial using exception from informed consent.

BACKGROUND

Acute stroke is a leading cause of morbidity and mortality. Clinical trials in stroke are challenging because victims often do not have the capacity to provide informed consent, excluding those patients most likely to benefit from the research.

AIM

We evaluated patient willingness to participate in a hypothetical acute stroke trial using an exception from informed consent.

METHODS

Consecutive patients presenting to four emergency departments (EDs) underwent structured interviews regarding a hypothetical stroke trial using an exception from informed consent.

RESULTS

Of 461 (72% of eligible) participants, 55% (95% CI, 50%-59%) were willing to be enrolled in the hypothetical study without giving informed consent. After multivariable analysis, independent predictors of willingness to enroll included Catholic religion (OR 1.57, 95% CI 1.17-2.10) and belief that current therapy offers a >50% chance of full recovery (OR 1.29, 95% CI 1.05-1.57). There was no difference between the proportion willing to enroll in a cardiac arrest study vs. a stroke study (55% vs. 55%, p = 0.83)

CONCLUSIONS

Fifty-five percent of ED patients would be willing to be enrolled in a stroke trial using exception from informed consent.