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

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

Agency, Transgression and the Causation of Homelessness: A Contextualised Rational Action Analysis

Academic accounts of the causation of homelessness consistently refer to social structural factors. There is no engagement in these accounts with the possibility that 'agency' (individually taken actions) also has a role. The transgressive nature of factors associated with homelessness-substance misuse, poor mental health, and so on-and a desire to avoid pathologising people experiencing homelessness, may explain this lack of engagement. Transgression refers to acts that challenge boundaries of normative social behaviour. Yet, it is demonstrated in this article that agency has to be 'written back in' if adequate theories of homelessness and causation are to develop. Contextualised rational action theory provides a critical realist conceptual framework from which to do so, without losing sight of the importance of social structures. Drawing on three case studies, it is demonstrated that what may be considered transgressive acts that lead to homelessness-refusal to engage with support services, alcohol misuse, street sex work-can be identified as having a 'thin' rationality, when the context they occur within is incorporated into the analysis. This approach therefore takes agency into proper account, whilst also acknowledging the importance of structural constraints in the generation of transgressive acts and homelessness. The intention here is not to apportion 'blame' or to 'pathologise', but to take people experiencing homelessness and their circumstances, motivations and actions seriously.Edgework, critical realism, case studies,

User involvement in designing a survey of people directly employing care and support workers

User involvement in social care research has generally been the preserve of qualitative methodologies, while user involvement in quantitative research has tended to be limited by the assumed inflexibility of statistical designs and concerns that lay people may require specialist training to engage with quantitative methods. Using the example of the Care and Caring study, a survey about the direct employment of care and support workers in England commissioned and funded by Skills for Care, this paper explores the benefits and difficulties of involving service users in the development and design of survey processes and instruments