Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial

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http://bmj.com/cgi/content/abstract/325/7361/415

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Collections under which this article appears:
Other geriatric medicine
Sociology
Randomized Controlled Trials: descriptions
Qualitative Research: examples
Drugs: cardiovascular system
Stroke
Informed Consent
Patient safety / Clinical risk / Medical error
Patient - caregiver communication (including Patient education)
Patients' views

BMJ 2002;325:415 ( 24 August )
 

Papers

Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial

Liedeke Koops, visiting research associate,  Richard I Lindley, part time senior lecturer. 

Department of Clinical Neurosciences, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU

Correspondence to: R I Lindley richard.lindley@ed.ac.uk

Objectives: 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.
Design: Quantitative and qualitative research.
Setting and participants: 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.

 

What is already known on this topic
Obtaining informed consent for emergency stroke treatment is difficult and presents many ethical dilemmas

Consumer involvement in trial design has been successful in some medical specialties but not previously reported in stroke research

What this study adds
Involvement of consumers in the design of trials on stroke is valuable

Comments from people who have not yet had a stroke and from carers of those who have can enable substantial improvement of trial information leaflets

Consumers support different consent approaches depending on the clinical state of the patient

Consumer involvement can be a very important part of the development of new randomised controlled trials

 



 


 

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