Trial reportNeurology2017
Effect of informed consent on patient characteristics in a stroke thrombolysis trial.
Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01525290 (Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke: a Randomised, Double-blind, Placebo-controlled Trial
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Views on consent approaches used in emergency and critical care research: a rapid, systematic review.Trials · 2026Pooled it
- Pooled it
- Trial
- Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT.Health technology assessment (Winchester, England) · 2020Trial
- Development and Reliability Test of the Intravenous Thrombolysis Intention Scale for Patients With Acute Ischemic Stroke.Nursing open · 2026Article
- Emergency consent pathways in acute ischemic stroke trials: determinants, consequences, and stakeholder attitudes-an evidence-mapping study.BMC medical ethics · 2026Article
- Clinical equipoise and ethical challenges in expanding endovascular stroke thrombectomy practice.Frontiers in surgery · 2026Review
- The relationship between state anxiety of surrogate decision-makers and decision-making duration in acute ischemic stroke thrombolysis.Scientific reports · 2025Article
- Review
- Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study.European stroke journal · 2023Observational
- Article
- Introducing the Tele-OCS: Preliminary evidence of validity for a remotely administered version of The Oxford Cognitive Screen.Health open research · 2023Article
- Decision-making psychological state and characteristic of proxies of thrombolytic patients: a pilot study.Scientific reports · 2022Article
Corrections and comments
- Commented on by
Authors and funding
19 authors at 1 institution in 2 countries.
Götz ThomallaFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia. thomalla@uke.de.
Florent BoutitieFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Jochen B FiebachFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Claus Z SimonsenFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Norbert NighoghossianFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Salvador PedrazaFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Robin LemmensFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Pascal RoyFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Keith W MuirFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Christoph HeesenFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Martin EbingerFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Ian FordFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Bastian ChengFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Tae-Hee ChoFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Josep PuigFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Vincent ThijsFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Matthias EndresFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Jens FiehlerFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Christian GerloffFrom Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), 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) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia.
Université Claude Bernard Lyon 1 · FR
Funding
Medical Research Council MR/N003403/1
Abstract
objectiveTo 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.
methodsWe 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.
resultsIn 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years,
conclusionsPatients 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. CLINICALTRIALSGOV AND CLINICALTRIALSREGISTEREU IDENTIFIERS: NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).
Indexed as
Informed ConsentThrombolytic TherapyAgedAge FactorsAphasiaBrainDouble-Blind MethodEuropeFemaleHumansHypertensionMagnetic Resonance ImagingMaleMiddle AgedPrevalenceProxy
Identifiers
What OpenQuestion holds
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LicenceCC BY-NC-ND
Read underepoch 390
Registered trials
NCT01525290ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.