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

Thomalla, G. et al. (2017) Effect of informed consent on patient characteristics in a stroke thrombolysis trial. Neurology, 89(13), pp. 1400-1407. (doi: 10.1212/WNL.0000000000004414) (PMID:28842449)

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. Clinicaltrials.gov and Clinicaltrialsregister.eu identifiers: NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).

• Item Type: Articles
• Additional Information: WAKE-UP receives funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement no. 278276 (WAKE-UP).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Muir, Professor Keith and Ford, Professor Ian
• Authors: 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., and Gerloff, C.
• Subjects: R Medicine > R Medicine (General)
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Psychology & Neuroscience
• Journal Name: Neurology
• Publisher: Lippincott, Williams and Wilkins
• ISSN: 0028-3878
• ISSN (Online): 1526-632X
• Published Online: 25 August 2017
• Copyright Holders: Copyright © 2017 The Authors
• First Published: First published in Neurology 89(13): 1400-1407
• Publisher Policy: Reproduced under a Creative Commons license