Public opinion of a stroke clinical trial using ex

Authors: Joshua N Goldstein Janice A Espinola Jonathan Fisher Daniel J Pallin Carlos A Camargo

Publish Date: 2010/11/10

Volume: 3, Issue: 4, Pages: 385-389

PDF Link

Abstract

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 157 95 CI 117–210 and belief that current therapy offers a 50 chance of full recovery OR 129 95 CI 105–157 There was no difference between the proportion willing to enroll in a cardiac arrest study vs a stroke study 55 vs 55 p = 083Acute stroke is a leading cause of morbidity and mortality and few interventions have proven to improve outcome 1 Altered mental status among stroke victims limits their ability to give informed consent which excludes those patients most likely to benefit skewing the study population towards those with the least severe strokes 2 3 4 Therefore some have advocated for use of an exception from the standard informed consent procedure 5 6 While research using this exception is allowable under federal regulations the process is both logistically and ethically complex and typically applied to a narrow range of diseasesWhen stroke survivors and caregivers are involved in stroke trial development they have advocated for exception from consent 7 The only study examining patient opinion of such an exception interviewed patients after their stroke had occurred finding that 92 would be willing to participate 8 These patients may be more aware of the longterm morbidity of stroke and the limitations of current therapies and thus be more supportive of such research than the general publicTo investigate public opinion we interviewed a consecutive cohort of patients presenting to the emergency department ED for a variety of conditions 9 Since it is impossible to discuss this issue with actual patients at the time of their stroke we interviewed patients in the ED who would be more aware of the need for emergency evaluation and treatment but be cognitively intact The primary analysis examined the effect of an educational intervention on patient opinion of exception from consent in general and was published previously 9 Here we report a secondary analysis examining independent predictors of participants’ willingness to participate in a stroke trial in particular

Keywords: