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, Endres Matthias, Fiehler Jens, Gerloff Christian
From 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.
Neurology. 2017 Sep 26;89(13):1400-1407. doi: 10.1212/WNL.0000000000004414. Epub 2017 Aug 25.
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.
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.
In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, < 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, < 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, < 0.0001) and more frequently aphasia (73.7% vs 20.0%, < 0.0001). The rate of proxy consent varied among countries ( < 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark.
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.
NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).
确定同意方式，即患者本人知情同意或代理知情同意，是否会影响纳入临床试验的急性卒中患者样本的临床特征。
我们分析了来自“唤醒”（WAKE-UP）研究的前1005例患者的知情同意获取方式，“唤醒”研究是一项由研究者发起的、随机、安慰剂对照试验，在6个欧洲国家对症状发作时间不明的卒中患者进行基于磁共振成像的溶栓治疗。将自行提供知情同意的患者与通过代理同意入组的患者进行比较。比较两组的基线临床指标。
359例（35.7%）患者通过代理获得知情同意。通过代理同意的患者年龄更大（中位数71岁对66岁，P<0.0001），动脉高血压发生率更高（58.2%对43.4%，P<0.0001）。他们的美国国立卫生研究院卒中量表得分更高（中位数11分对5分，P<0.0001），失语症发生率更高（73.7%对20.0%，P<0.0001）。代理同意率在不同国家有所差异（P<0.0001），从西班牙的77.1%到丹麦的1.2%不等。
通过代理同意招募的患者比有能力自行给予同意的患者年龄更大、卒中更严重、失语症患病率更高。各国同意方式的差异可能会影响试验结果。
NCT01525290（clinicaltrials.gov）；2011-005906-
32（clinicaltrialsregister.eu）。
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