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

ABSTRACT:

Background

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.

Methods

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 c

SUBMITTER: Hotter B 

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

REPOSITORIES: biostudies-literature