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How important is surrogate consent for stroke research?

M L Flaherty1, J Karlawish, J C Khoury

  • 1Department of Neurology, University of Cincinnati Academic Health Center, 260 Stetson St., Room 2316, Cincinnati, OH 45267-0525, USA. matthew.flaherty@uc.edu

Neurology
|August 30, 2008
PubMed
Summary
This summary is machine-generated.

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Surrogate consent was crucial for the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial. Excluding patients unable to provide self-consent would have significantly delayed completion and limited generalizability.

Area of Science:

  • Neurology
  • Clinical Trials
  • Informed Consent

Background:

  • Cognitive deficits post-stroke can impair informed consent capacity.
  • Some IRBs restrict surrogate consent to legally authorized individuals.
  • The NINDS rt-PA Stroke Trial investigated a key acute ischemic stroke treatment.

Purpose of the Study:

  • To assess the importance of surrogate consent in the NINDS rt-PA Stroke Trial.
  • To determine the impact of excluding patients requiring surrogate consent on trial completion and generalizability.

Main Methods:

  • Randomized subjects with ischemic stroke to recombinant tissue plasminogen activator (rt-PA) or placebo.
  • Compared baseline characteristics and clinical outcomes between self-consent and surrogate-consent groups.

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Main Results:

  • Surrogate consent enrolled 70% (439/624) of subjects.
  • Surrogate-consent subjects were older, had more severe strokes, and poorer recovery.
  • No interaction found between consent method and rt-PA response.

Conclusions:

  • The NINDS rt-PA Stroke Trial's timely completion depended on surrogate consent.
  • Excluding patients unable to provide self-consent would have limited generalizability and trial value.