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Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context?

Overview of attention for article published in BMC Medical Ethics, April 2015
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Title
Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context?
Published in
BMC Medical Ethics, April 2015
DOI 10.1186/s12910-015-0018-8
Pubmed ID
Authors

Anne-Marie Mendyk, Julien Labreuche, Hilde Henon, Marie Girot, Charlotte Cordonnier, Alain Duhamel, Didier Leys, Régis Bordet

Abstract

The provision of informed consent is a prerequisite for inclusion of a patient in a clinical research project. In some countries, the legislation on clinical research authorizes a third person to provide informed consent if the patient is unable to do so directly (i.e. surrogate consent). This is the case during acute stroke, when the symptoms may prevent the patient from providing informed consent and thus require a third party to be approached. Identification of factors associated with the medical team's decision to resort to surrogate consent may (i) help the care team during the inclusion process and (ii) enable the patient's family circle to be better informed (and thus feel less guilty) about providing surrogate consent. Patients included in the BIOSTROKE cohort (initially dedicated to the analysis of factors influencing stroke severity) were divided into two groups: those having provided informed consent directly and those for whom a third party (such as a family member) had provided surrogate consent. We compared the groups in terms of the initial clinical characteristics (age, gender, type of stroke, severity on the National Institutes of Health Stroke Scale (NIHSS), pre-stroke cognitive status according to the Informant Questionnaire on Cognitive Decline in the Elderly, and the stroke's aetiology) and the functional and cognitive impairments (according to the NIHSS, the modified Rankin score (mRS) and the Mini Mental State Examination) on post-stroke days 8 and 90. Three hundred and ninety five patients were included (mean ± SD age: 67 ± 15 years; 53% males). Surrogate consent had been obtained in 228 cases, and 167 patients had provided consent themselves. The patients included with surrogate consent were likely to be older and more aphasic, with a pre-existing cognitive disorder and more severe stroke (relative to the patients having provided consent). In terms of recovery, the patients included with surrogate consent had a worse functional prognosis (day 90 mRS ≥3: 57.6%, compared with 16.8% in patients having provided consent themselves; p < 0.0001) and a worse cognitive prognosis (day 90 MMS < 24: 15.4% and 4.8%, respectively; p < 0.002). The mortality rate was significantly higher in the surrogate consent group. We found that in addition to age, aphasia and stroke severity, pre-stroke cognitive status is a factor that should prompt the care team to consider requesting surrogate consent for participation in a clinical study. Given that the unfavourable outcome in patients with surrogate consent is often due to their initial clinical state (rather than inclusion in a trial per se), the issue of the family's feelings of guilt (and how to avoid these feelings) should be further addressed.

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Mendeley readers

The data shown below were compiled from readership statistics for 42 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 42 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 7 17%
Student > Ph. D. Student 7 17%
Researcher 6 14%
Professor 5 12%
Student > Bachelor 4 10%
Other 10 24%
Unknown 3 7%
Readers by discipline Count As %
Medicine and Dentistry 12 29%
Psychology 6 14%
Nursing and Health Professions 6 14%
Neuroscience 4 10%
Social Sciences 2 5%
Other 6 14%
Unknown 6 14%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 May 2015.
All research outputs
#9,906,435
of 12,373,815 outputs
Outputs from BMC Medical Ethics
#479
of 526 outputs
Outputs of similar age
#158,026
of 226,365 outputs
Outputs of similar age from BMC Medical Ethics
#1
of 1 outputs
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