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Selection bias in clinical stroke trials depending on ability to consent.


ABSTRACT: Clinical trials are the hallmark of evidence-based medicine, but recruitment is often challenging, especially in stroke trials investigating patients not being able to give informed consent. In some nations, ethics committees will not approve of inclusion in a clinical study via consent of a legal representative. The ethical dilemma of including or excluding those patients has not been properly addressed, as there is little data on the effect of stroke characteristics on the ability to give informed consent.To examine differences between patients able and unable to consent at inclusion to an acute stroke trial, we conducted a post-hoc analysis of monitoring records from a multicentric interventional trial. These records listed patients who gave informed consent by themselves and those who needed a legal representative to do so. This exemplary STRAWINSKI trial aimed at improving stroke outcome by biomarker-guided antibiotic treatment of stroke associated pneumonia and included patients within 40 h after stroke onset, suffering from MCA infarctions with an NIHSS score?>?9 at admission. Standard descriptive and associative statistics were calculated to compare baseline characteristics and outcome measures between patients who were able to consent and those who were not.We identified the person giving consent in 228 out of 229 subjects. Patients with inability to consent were older (p?

SUBMITTER: Hotter B 

PROVIDER: S-EPMC5716230 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Selection bias in clinical stroke trials depending on ability to consent.

Hotter Benjamin B   Ulm Lena L   Hoffmann Sarah S   Katan Mira M   Montaner Joan J   Bustamante Alejandro A   Meisel Andreas A  

BMC neurology 20171204 1


<h4>Background</h4>Clinical trials are the hallmark of evidence-based medicine, but recruitment is often challenging, especially in stroke trials investigating patients not being able to give informed consent. In some nations, ethics committees will not approve of inclusion in a clinical study via consent of a legal representative. The ethical dilemma of including or excluding those patients has not been properly addressed, as there is little data on the effect of stroke characteristics on the a  ...[more]

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