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    Effect of informed consent on patient characteristics in a stroke thrombolysis trial

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    Author
    Thomalla, G; Boutitie, F; Fiebach, JB; Simonsen, CZ; Nighoghossian, N; Pedraza, S; Lemmens, R; Roy, P; Muir, KW; Heesen, C; ...
    Date
    2017-09-26
    Source Title
    Neurology
    Publisher
    LIPPINCOTT WILLIAMS & WILKINS
    University of Melbourne Author/s
    Thijs, Vincent
    Affiliation
    Florey Department of Neuroscience and Mental Health
    Metadata
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    Document Type
    Journal Article
    Citations
    Thomalla, G., Boutitie, F., Fiebach, J. B., Simonsen, C. Z., Nighoghossian, N., Pedraza, S., Lemmens, R., Roy, P., Muir, K. W., Heesen, C., Ebinger, M., Ford, I., Cheng, B., Cho, T. -H., Puig, J., Thijs, V., Endres, M., Fiehler, J. & Gerloff, C. (2017). Effect of informed consent on patient characteristics in a stroke thrombolysis trial. NEUROLOGY, 89 (13), pp.1400-1407. https://doi.org/10.1212/WNL.0000000000004414.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/256854
    DOI
    10.1212/WNL.0000000000004414
    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. CLINICALTRIALSGOV AND CLINICALTRIALSREGISTEREU IDENTIFIERS: NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).

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