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

Conclusions: Patients recruited by proxy consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results. Clinicaltrials.gov and Clinicaltrialsregister.eu identifiers: NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).

http://www.neurology.org/cgi/content/short/89/13/1400?rss=1

Source: Neurology - September 25, 2017 Category: Neurology Authors: Thomalla, G., Boutitie, F., Fiebach, J. B., Simonsen, C. Z., Nighoghossian, N., Pedraza, S., Lemmens, R., Roy, P., Muir, K. W., Heesen, C., Ebinger, M., Ford, I., Cheng, B., Cho, T.-H., Puig, J., Thijs, V., Endres, M., Fiehler, J., Gerloff, C. Tags: MRI, All Clinical trials, All Cerebrovascular disease/Stroke, Clinical trials Methodology/study design, All Ethics in Neurology/Legal issues ARTICLE Source Type: research