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Original Paper

Ethical Issues of Informed Consent in Acute Stroke

Demarquay G.a · Derex L.a · Nighoghossian N.a · Adeleine P.b · Philippeau F.a · Honnorat J.a · Trouillas P.a

Author affiliations

aService d’Urgences Neurovasculaires, Hôpital Neurologique de Lyon, et bService de Biostatistique, Hospices Civils de Lyon, Lyon, France

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Cerebrovasc Dis 2005;19:65–68

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: April 05, 2004
Accepted: August 16, 2004
Published online: February 03, 2005
Issue release date: February 2005

Number of Print Pages: 4
Number of Figures: 0
Number of Tables: 3

ISSN: 1015-9770 (Print)
eISSN: 1421-9786 (Online)

For additional information: https://www.karger.com/CED

Abstract

Background: Many patients may be mentally incompetent or physically unable to give informed consent at the acute stage of stroke. Accordingly, we aimed to investigate the modalities of informed consent in urgent therapeutic stroke trials, the awareness of patients and relatives regarding stroke clinical trials and the impact of decision making on patients and relatives. Methods: We present a study of 56 acute ischemic stroke patients who were randomized in 4 trials (2 trials testing neuroprotective agents, 1 testing thrombolysis and 1 testing antithrombotic agents). A standardized questionnaire was used to assess the modalities of informed consent in this setting. Results: The mean age was 67.1 (SD 12.6) years. The mean baseline Scandinavian Stroke Scale (SSS) score was 23.8 (SD 10.5). Only 13 patients (23% of cases) gave consent while relatives gave consent for 43 patients (77%). The main reason for not getting consent from the patient was aphasia in 29 patients (67.4%). Multiple logistic regression analysis showed that the two independent factors influencing the ability to give consent are age and baseline neurological deficit as assessed by the SSS score. Concerning the psychological impact of consent, none of the 10 patients who answered our questionnaire declared feeling uncomfortable when giving consent, while 7 out of the 13 relatives who could be reached declared they felt uncomfortable, mainly because of the psychological stress induced by urgent decision making. Conclusions: Our study emphasizes the specific ethical difficulties of informed consent in the setting of acute stroke research. Only a minority of patients are able to give consent at the acute stage. Increasing age and neurological deficit are independent predictors of inability to give consent. Thus, the responsibility for consent usually relies on relatives with potential inaccuracy of decision concerning the patient’s wish or even conflict of interest. Further evaluation of the psychological impact of decision on relatives is needed in this setting of acute stroke.

© 2005 S. Karger AG, Basel


References

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  8. Schats R, Brilstra EH, Rinkel GJE, Algra A, Van Gijn J: Informed consent in trials for neurological emergencies: The example of subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry 2003;74:988–991.
  9. Bateman BT, Meyers PM, Schumacher HC, Mangla S, Pile-Spellman J: Conducting stroke research with an exception from the requirement for informed consent. Stroke 2003;34:1317–1323.

Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: April 05, 2004
Accepted: August 16, 2004
Published online: February 03, 2005
Issue release date: February 2005

Number of Print Pages: 4
Number of Figures: 0
Number of Tables: 3

ISSN: 1015-9770 (Print)
eISSN: 1421-9786 (Online)

For additional information: https://www.karger.com/CED


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