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Who Will Consent to Emergency Treatment Trials for Subarachnoid Hemorrhage?
Author(s) -
Del Giudice Angela,
Plaum Justin,
Maloney Eileen,
Kasner Scott E.,
Le Roux Peter D.,
Baren Jill M.
Publication year - 2009
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1111/j.1553-2712.2009.00367.x
Subject(s) - medicine , emergency department , randomized controlled trial , subarachnoid hemorrhage , informed consent , clinical trial , confidence interval , family medicine , emergency medicine , alternative medicine , psychiatry , pathology
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.