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September 26, 2017; 89 (13) ArticleOpen Access

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

Götz Thomalla, Florent Boutitie, Jochen B. Fiebach, Claus Z. Simonsen, Norbert Nighoghossian, Salvador Pedraza, Robin Lemmens, Pascal Roy, Keith W. Muir, Christoph Heesen, Martin Ebinger, Ian Ford, Bastian Cheng, Tae-Hee Cho, Josep Puig, Vincent Thijs, Matthias Endres, Jens Fiehler, Christian Gerloff
First published August 25, 2017, DOI: https://doi.org/10.1212/WNL.0000000000004414
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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).

GLOSSARY

DWI=
diffusion-weighted imaging;
FLAIR=
fluid-attenuated inversion recovery;
IQR=
interquartile range;
NIHSS=
NIH Stroke Scale

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article. The Article Processing Charge was funded by the European Commission.

  • Received December 21, 2016.
  • Accepted in final form June 19, 2017.

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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