Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

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.

Original publication

DOI

10.1186/1471-2288-10-110

Type

Journal article

Journal

BMC Med Res Methodol

Publication Date

22/12/2010

Volume

10

Keywords

Breast Neoplasms, Female, Health Education, Health Knowledge, Attitudes, Practice, Humans, Mammography, Patient Participation, Qualitative Research, Randomized Controlled Trials as Topic, Research Design