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

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 (medi

SUBMITTER: Thomalla G 

PROVIDER: S-EPMC5649757 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature