Impact of restricting enrollment in stroke genetics research to adults able to provide informed consent

Donna T. Chen, L. Douglas Case, Thomas G. Brott, Robert D. Brown, Scott L. Silliman, James F. Meschia, Bradford B. Worrall

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

BACKGROUND AND PURPOSE - The extent of potential consent bias in observational studies elucidating genetic and environmental contributions to ischemic stroke is largely unknown. The purpose of this study was to assess differences in stroke cohort characteristics between those who provided informed consent and those whose enrollment was authorized by surrogate decision makers. METHODS - The Ischemic Stroke Genetics Study (ISGS) is a prospective, 5-center, case-control study of first-ever ischemic stroke. Demographic, clinical, and stroke characteristics were compared between cases enrolled by self versus by surrogate. Data from one site that limits enrollment only to those able to self-consent were also analyzed to compare those who enrolled with those not able to consent. RESULTS - Overall, 10% (54 of 517) were enrolled using surrogate authorization. Self-consented and surrogate-authorized cases did not differ significantly in age, sex, or conventional risk factors. Surrogate-authorized cases had significantly more severe stroke deficits, larger infarcts, and infarcts localizing to left supratentorial regions. Similarly, at the site restricting enrollment, stroke severity and characteristics differed between self-consented individuals and those otherwise eligible but unable to provide consent. CONCLUSIONS - Failure to permit surrogate authorization in genetic studies of ischemic stroke may skew enrollment toward less severe strokes caused by smaller infarcts. This potential consent bias may undermine the ability to identify genetic determinants of risk and severity and suggests that surrogate enrollment in these studies can be ethically justifiable.

Original languageEnglish (US)
Pages (from-to)831-837
Number of pages7
JournalStroke
Volume39
Issue number3
DOIs
StatePublished - Mar 2008

Keywords

  • Consent bias
  • Ischemia
  • Research ethics
  • Stroke

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Fingerprint Dive into the research topics of 'Impact of restricting enrollment in stroke genetics research to adults able to provide informed consent'. Together they form a unique fingerprint.

Cite this