Thrombolysis for acute XXXX : consumer involvement in design of new randomised controlled trial.

@entity1 @entity64 @entity932
OBJECTIVES: To determine whether consumer involvement would help to solve some of the ethical problems associated with research into thrombolysis for acute @entity64 , with its inherent risk of fatal @entity932 . DESIGN: Quantitative and qualitative research. SETTING AND @entity1 : CONSULTATION PHASE: three meetings were held to discuss the planned research, and @entity1 completed a questionnaire. QUALITATIVE WORK: focus group meetings explored the issues raised during the consultation phase. Design of information leaflets for @entity1 and relatives: trial materials were drafted during the consultation phase and revised in the light of feedback from the focus group meetings and review by @entity1 and carers on a @entity64 rehabilitation unit. RESULTS: 54 @entity1 attended the consultation meetings. Four (9%) @entity1 considered the risks of thrombolysis too great, but most (89%) were prepared to accept the treatment in a clinical trial. Nearly all would accept treatment if it was shown to be effective. Most (85%) would give their consent to enter the planned trial. The focus group meetings and feedback from @entity1 and carers led to significant changes in the information leaflets. The revised trial materials were considered ethical by a national multicentre research ethics committee. CONCLUSIONS: Consumers generally supported a planned trial, and their involvement helped to refine trial consent procedures and led to an ethically acceptable trial design.
