Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial.
OBJECTIVE
To determine whether consumer involvement would help to solve some of the ethical problems associated with research into thrombolysis for acute ischaemic stroke, with its inherent risk of fatal intracranial haemorrhage.


METHODS
Quantitative and qualitative research.


METHODS
CONSULTATION PHASE: three meetings were held to discuss the planned research, and participants completed a questionnaire. QUALITATIVE WORK: focus group meetings explored the issues raised during the consultation phase. Design of information leaflets for patients 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 patients and carers on a stroke rehabilitation unit.


RESULTS
54 people attended the consultation meetings. Four (9%) participants 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 patients 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.
Department of Clinical Neurosciences, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU.
Liedeke
L
Koops
Richard I
RI
Lindley
D000208:Acute Disease; D000368:Aged; D003256:Community Participation; D026690:Ethics, Clinical; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007255:Information Services; D007258:Informed Consent; D010174:Pamphlets; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D020521:Stroke / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D015912:Thrombolytic Therapy / Q000009:adverse effects* / Q000523:psychology
Biomedical and Behavioral Research; Empirical Approach