Document Detail

Brain lesion volume and capacity for consent in stroke trials: potential regulatory barriers to the use of surrogate markers.
MedLine Citation:
PMID:  18535280     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND PURPOSE: European directives and legislation in some countries forbid inclusion of subjects incapable of consent in research if recruitment of patients capable of consent will yield similar results. We compared brain lesion volumes in stroke patients deemed to have capacity to consent with those defined as incapacitated. METHODS: Data were obtained from 3 trials recruiting patients primarily with cortical stroke syndromes. Patients were recruited within 24 hours of onset and used MRI based selection or outcome criteria. Method of recruitment was recorded with stroke severity, age, and brain lesion volumes on Diffusion Weighted Imaging. RESULTS: Of the 56 subjects included, 38 (68%) were recruited by assent and 18 (32%) by consent. The assent group had a median lesion volume of 18.35 cubic centimetres (cc) (interquartile range [IQR] 8.27-110.31 cc), compared to 2.79 cc (IQR 1.31-12.33 cc) when patients consented (P=0.0004). Lesions were smaller than 5 cc in 7/38 (18%) in the assent group and 11/18 (61%) in the consent group (P=0.0024). There was good correlation between neurological deficit by NIH stroke scale score and lesion volume (r=0.584, P<0.0001). Logistic regression demonstrated NIHSS or lesion volume predicted capacity to consent. CONCLUSIONS: Patients with acute stroke who retain capacity to consent have significantly smaller infarct volumes than those incapable of consent, and these are frequently below the limits where measurement error significantly compromises valid use of volumetric end points. Only a small proportion of patients with capacity to consent would be eligible for, and contribute usefully to, most acute stroke trial protocols.
Krishna A Dani; Michael T McCormick; Keith W Muir
Publication Detail:
Type:  Journal Article     Date:  2008-06-05
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  39     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-07-29     Completed Date:  2008-08-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2336-40     Citation Subset:  IM    
Division of Clinical Neurosciences, University of Glasgow, Institute of Neurological Sciences, Southern General Hospital, Glasgow G51 4TF, Scotland, UK.
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MeSH Terms
Acute Disease
Aged, 80 and over
Biological Markers
Brain / pathology
Clinical Trials as Topic / ethics*
Diffusion Magnetic Resonance Imaging*
Informed Consent / ethics*,  standards
Logistic Models
Predictive Value of Tests
Severity of Illness Index
Stroke / pathology*,  therapy*
Reg. No./Substance:
0/Biological Markers

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