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Title: Effect of informed consent on patient characteristics in a stroke thrombolysis trial
Austin Authors: Thomalla, Götz;Boutitie, Florent;Fiebach, Jochen B;Simonsen, Claus Z;Nighoghossian, Norbert;Pedraza, Salvador;Lemmens, Robin;Roy, Pascal;Muir, Keith W;Heesen, Christoph;Ebinger, Martin;Ford, Ian;Cheng, Bastian;Cho, Tae-Hee;Puig, Josep;Thijs, Vincent N ;Endres, Matthias;Fiehler, Jens;Gerloff, Christian
Affiliation: Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
Service de Biostatistique, Hospices Civils de Lyon, Lyon, France
Department of Neurology, Hospices Civils de Lyon, Lyon, France
Université Lyon 1, Villeurbanne, France
CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France
Centrum für Schlaganfallforschung Berlin (CSB), Charité-Universitätsmedizin Berlin, Germany
Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin, Germany
Department of Neurology, Aarhus University Hospital, Denmark
Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d’Investgació Biomèdica de Girona (IDIBGI), Girona, Spain
Department of Neurosciences, Experimental Neurology, and Leuven Research Institute for Neuroscience and Disease (LIND) , KU Leuven-University of Leuven, Leuven, Belgium
VIB, Laboratory of Neurobiology, Center for Brain & Disease Research, Leuven, Belgium
Department of Neurology, University Hospitals Leuven, Leuven, Belgium
Institute of Neuroscience & Psychology, University of Glasgow, UK
Robertson Centre for Biostatistics, University of Glasgow, UK
Stroke Division, Florey Institute of Neuroscience and Mental Health, Austin Health, Heidelberg, Australia
Department of Neurology, Austin Health, Heidelberg, Australia
Issue Date: 26-Sep-2017
Date: 2017-08-27
Publication information: Neurology 2017; 89(13): 1400-1407
Abstract: Objective: To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials. Methods: We analyzed the manner of obtaining informed consent in the first 1,005 patients from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset running in 6 European countries. Patients providing informed consent by themselves were compared with patients enrolled by proxy consent. Baseline clinical measures were compared between groups. Results: In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, p < 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, p < 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, p < 0.0001) and more frequently aphasia (73.7% vs 20.0%, p < 0.0001). The rate of proxy consent varied among countries (p < 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark. Conclusions: Patients recruited by proxy consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results. and identifiers: NCT01525290 (; 2011-005906-32 (
DOI: 10.1212/WNL.0000000000004414
ORCID: 0000-0002-6614-8417
Journal: Neurology
PubMed URL:
Type: Journal Article
Appears in Collections:Journal articles

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