Evidence Library
Title: Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial.
Author: Koops, L., Lindley, R.
Date Published: 2002
Reference: BMJ, 325, 415-418.
Are service users or carers authors: No/Not Known
Abstract:
Aim: To determine whether consumer involvement could help to address some of the ethical issues associated with research into thrombolysis for acute ischaemic stroke.
Methods used: One of the researchers attended three meetings of older people in Edinburgh to discuss stroke and thrombolysis. Older people who attended these meetings were also asked to complete a questionnaire. Two focus groups were then held to explore the issues raised in the discussions and questionnaires. This led to a revision of patient information leaflets. These leaflets were then tested with six patients and carers in a stroke rehabilitation unit.
Findings/recommendations: Most people who completed the questionnaire were prepared to accept the risks of thrombolytic treatment in a clinical trial. Participants in the focus groups were comfortable with the concept of risk, and recognised the ethical dilemmas involved in obtaining valid consent. They suggested some solutions to these dilemmas.
The researchers made many changes to their information leaflet as a result of this consultation process. They report that "despite the potential ethical bariers to our planned trial, our trial material was accepted after only one cycle of amendments with the national ethics committee, an important achievement". They call for consumer involvement in trial development to become the norm.
External link: The following links will take you to information on this entry on an external website. INVOLVE is not responsible for the content or the reliability of the external websites. Link to journal article
Related entry: none currently available
Categories: health
Designing research
impact on research
impact on research ethics
impact of public involvement
journal article
Date Entered: 2007/02/21
Date Edited: 2012/11/20
Additional Info: