Who will consent to emergency treatment trials for subarachnoid hemorrhage?

Acad Emerg Med. 2009 Apr;16(4):309-15. doi: 10.1111/j.1553-2712.2009.00367.x. Epub 2009 Mar 6.


Objectives: 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.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Blood Transfusion / psychology*
  • Blood Transfusion / statistics & numerical data
  • Choice Behavior*
  • Cross-Sectional Studies
  • Emergency Treatment
  • Family
  • Female
  • Health Personnel
  • Hospitals, University
  • Humans
  • Informed Consent
  • Male
  • Mental Competency
  • Middle Aged
  • Philadelphia
  • Randomized Controlled Trials as Topic / psychology*
  • Research Subjects / psychology*
  • Subarachnoid Hemorrhage / psychology*
  • Subarachnoid Hemorrhage / therapy
  • Surveys and Questionnaires
  • Third-Party Consent
  • Young Adult