Читать книгу Randomised Clinical Trials - David Machin - Страница 130

Haussen, Doppelheuer, Schindler, et al. (2017) describe the use of an electronic consent (e‐Consent) tool to facilitate the informed consent process in trials involving patients with acute ischemic stroke. Because of impairment of language and cognitive status in these patients, the requirement of a physical signature of a legally authorised representative during the consent taking process hinders patient enrolment. The use of e‐Consent was first piloted in a trial of patients, with large vessel occlusion stroke. Eligible patients, who presented within 6–24 hours of last seen as normal, were randomised to either stent‐retriever thrombectomy or best medical therapy. Although the trial commenced recruitment in January 2015, the process of e‐Consent was only approved by the institutional review board in December 2016, 2 months before enrolment to the trial ended in February 2017.