Evidence Library

Title: Patient and clinician collaboration in the design of a national randomized breast cancer trial.
Author: Marsden, J. & Bradburn, J.
Date Published: 2004
Reference: Health Expectations, 7, 6-17.
Are service users or carers authors: No/Not Known


Aim: To find out if breast cancer patient involvement in the design of a randomised controlled trial of hormone replacement therapy in symptomatic patients will increase recruitment rates.

Methods: Nine focus groups were held with breast cancer patients to identify the issues they thought relevant to the trial. A consensus on the focus group recommendations was reached at a one-day workshop with focus group representatives and research stakeholders. Patient representatives joined the trial steering committee and commented on the resulting trial design.
Findings/recommendations: There was some concern about this trial because of the potential for HRT to have an adverse effect on breast cancer survival. However, the issues relating to trial participation raised by the women in the focus groups were much broader than just the research topic. They also commented on more complex aspects of the trial design and the significance of the trial. This led fo further negotiation between the patients and the clinicans to agree priorities for the final trial protocol.
The patients also highlighted the lack of information available about breast cancer and HRT in general which led to the production of an information booklet. This was written with the input of patients. Given the need to give more background information to trial participants, consent interviews were extended. This may have reduced recruitment rates, but overall the quality of the consent process was greatly improved. The authors conclude that measuring recruitment rates is too simple a measure to assess the impact of patient involvement.

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Related entry: none currently available

Categories: health
Designing research
impact on research
impact on research ethics
impact on implementation and change
impact of public involvement
journal article
Implementation and change

Date Entered: 2007/02/22

Date Edited: 2012/11/21

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