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 |
Liedeke Koops
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.
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What is already known on this topic Consumer involvement in trial design has been successful in some medical specialties but not previously reported in stroke research What this study adds 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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