Consumer involvement
This section contains the following:
Introduction
Whilst it is important that the scientific design of any randomised
trial is robust, the ultimate success of a trial depends on the
recruitment and co-operation of patients i.e. the consumers of the
trial. To achieve this, the trial has to be acceptable to
patients as well as to clinicians. Involving consumers in
designing the trial procedures can help ensure that the patients’
perspective is taken into account. Involvement of consumers
ensures that the issues which are important to the patient are
identified and prioritised e.g. the planned outcome matters to the
patient, the wording of the information leaflet addresses patients
concerns etc. To maximise the acceptability of the trial to
patients, involvement at the planning phase (i.e. when writing the
protocol) is desirable.
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Things to consider when writing a protocol
- Identify (if appropriate) which consumers will be involved in the
trial design/conduct.
- Outline the roles expected of the consumers and the areas of the
trial where they will be particularly involved.
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Additional resources
This checklist has been contributed by the Consumers in NHS Research
Support Unit who developed it for the Consumers in NHS Research Website.
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This checklist has been contributed by the Consumers in NHS Research
Support Unit and the MRC Clinical Trials Unit who developed it during a
seminar: Involving
consumers in randomized controlled trials (see below for full report)
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This checklist has been developed with help from the Consumers in
NHS Research
Support Unit.
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Involving consumers in randomized controlled trials
This a report of a seminar organised by Consumers in NHS Research
and
the Medical Research Council Clinical Trials Unit and gives a summary
of
the presentations and discussion held on 11th December 2000, when
consumers,
researchers and others with an interest in the active involvement of
consumers
in randomised controlled trials (RCTs) came together.
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Involving Consumers in Research & Development in the NHS: briefing
notes
for researchers
This booklet was contributed by the Consumers in NHS Research
Support
Unit, UK and aims to give researchers working within the NHS some
guidelines
on how best to involve consumers in their work. Although written
primarily
for researchers who receive funding through the NHS Research and
Development,
it will also be of use to other health researchers.
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Thrombolysis for acute ischaemic stroke: consumer involvement in design
of
new randomised controlled trial
Liedeke Koops, Richard I Lindley. Thrombolysis for acute ischaemic
stroke:
consumer involvement in design of new randomised controlled trial. BMJ
2002;325:415.
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Consumers in NHS Research aims to ensure that consumer involvement
in
R&D in the NHS, Public Health and Social Care improves the way that
research
is prioritised, commissioned, undertaken and disseminated.
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Further reading
Psillidis L, Flach J, Padberg RM. Participants strengthen clinical
trial
research: The vital role of participant advisors in the breast cancer
prevention
trial. Journal of Women’s Health 1997;6(2):227-232.
Editorial. How consumers can and should improve clinical
trials.
Lancet 2001; 357:1721
Thornton H. Consumers and trials [letter]. Lancet 2001;
358:763.
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This page was last updated 19th August 2003.