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Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: Qualitative study

Forbes, Lindsay J.L., Nicholls, Carol McNaughton, Linsell, Louise, Graham, Jenny, Tompkins, Charlotte, Ramirez, Amanda J. (2010) Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: Qualitative study. Medical Research Methodology, 10 . ISSN 1471-2288. (doi:10.1186/1471-2288-10-110) (KAR id:77969)


Background: The purpose of this study was to explore women's views of the design of a large pragmatic cost-effectiveness randomised controlled trial of the policy of offering a health professional-delivered intervention to promote early presentation with breast symptoms in older women and thereby improve survival, with a view to informing protocol development. The trial will recruit over 100,000 healthy women aged 67+, and outcome data will be collected on those who develop breast cancer. The scale of the trial and the need for long-term follow-up presented a number of design challenges in relation to obtaining consent, ascertaining and contacting participants who developed breast cancer, and collecting outcome data.

Methods: Qualitative study involving 69 women participating in 7 focus groups and 17 in-depth interviews. 15 women had a previous diagnosis of breast cancer and 54 did not.

Results: The women held strong views and had a good understanding of the rationale of the design of clinical trials. The women recognised that in a very large trial with long-term follow-up it was necessary to incorporate design features to make the trial feasible and efficient. Most strikingly, they supported the idea of opt-out consent and identifying women with breast cancer using routine datasets.

Conclusions: This model of user involvement engaged women well with the design challenges of the trial and led to improvements to the protocol. The study strengthens the case for user involvement, in particular through focus groups and in-depth interviews, in the design of trials.

Item Type: Article
DOI/Identification number: 10.1186/1471-2288-10-110
Additional information: Unmapped bibliographic data: C7 - 110 [EPrints field already has value set] DB - Scopus [Field not mapped to EPrints] M3 - Article [Field not mapped to EPrints]
Uncontrolled keywords: breast cancer; focus group; National Health Service; User Involvement
Divisions: Divisions > Division for the Study of Law, Society and Social Justice > School of Social Policy, Sociology and Social Research > Centre for Health Services Studies
Depositing User: Lindsay Forbes
Date Deposited: 28 Oct 2019 13:29 UTC
Last Modified: 16 Nov 2021 10:26 UTC
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