title: Who will consent to emergency treatment trials for subarachnoid hemorrhage?
abstract: OBJECTIVE
  Aneurysmal subarachnoid hemorrhage (SAH) is a devastating disorder that still requires much clinical study. However, the decision to participate in a randomized clinical trial, particularly a neuroemergency trial, is a complex one. The purposes of this survey were to determine who would participate in a randomized clinical trial that intended to examine transfusion practices after SAH, to identify who could serve as potential proxy decision-makers, and to find which patient characteristics were associated with the decision to participate.
  
  
  METHODS
  This was a cross-sectional study using a self-administered questionnaire, composed of a brief description of the proposed trial followed by questions about participation using a 5-point Likert scale. Information sought included potential decision-maker, demographic data, setting and reason for current health care access, and personal or family history of neurologic injury.
  
  
  RESULTS
  Nine-hundred five subjects were enrolled during emergency department (ED) visits, office visits, hospital admissions, or online, during a 1-month period: 63% were women and 46% were white. Nonneurologic problems were the leading reason (90%) for health care access, but 45% had a personal or family history of neurologic injury. Overall, 54% (95% confidence interval [CI] = 51% to 57%) of subjects stated they would definitely or probably consent to participate. No subject characteristics were associated with this decision: age (p = 0.28), sex (p = 0.16), race/ethnicity (p = 0.07), education (p = 0.44), religion (p = 0.42), clinical setting (p = 0.14), reason for visit (p = 0.58), and/or history of neurologic injury (p = 0.33). The vast majority (88%) identified a family member as the proxy decision-maker, again without differences among groups.
  
  
  CONCLUSIONS
  Greater than half of respondents stated they would participate in a proposed emergency treatment trial for SAH. Our survey suggests that the decision to participate is highly individualized, because no demographic, pathologic, historical, or access-related predictors of choice were found. Educational materials designed for this type of trial would need to be broad-based. Family members should be considered as proxy decision-makers where permitted by federal and local regulations.
authors.affiliation: Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: Del Giudice
authors.forename: Justin
authors.initials: J
authors.lastname: Plaum
authors.forename: Eileen
authors.initials: E
authors.lastname: Maloney
authors.forename: Scott E
authors.initials: SE
authors.lastname: Kasner
authors.forename: Peter D
authors.initials: PD
authors.lastname: Le Roux
authors.forename: Jill M
authors.initials: JM
authors.lastname: Baren
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001803:Blood Transfusion / Q000523:psychology* / Q000706:statistics & numerical data; D002755:Choice Behavior; D003430:Cross-Sectional Studies; D004638:Emergency Treatment; D005190:Family; D005260:Female; D006282:Health Personnel; D006785:Hospitals, University; D006801:Humans; D007258:Informed Consent; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D015143:Philadelphia; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D035842:Research Subjects / Q000523:psychology*; D013345:Subarachnoid Hemorrhage / Q000523:psychology* / Q000628:therapy; D011795:Surveys and Questionnaires; D020458:Third-Party Consent; D055815:Young Adult