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Background/aims: The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University's Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration. Methods: We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper. Results: Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies. Conclusions: Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit's experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations. [ABSTRACT FROM AUTHOR]

Aims: Aim of this study is to better understand the role of nurses' professional judgment in nurse staffing systems. Design: Qualitative comparative case study design of nurse staffing systems in England and Wales. Methods: Data will be collected through a variety of sources: individual interviews, observations of relevant meetings and analysis of key documents. Ethical approval for the study was granted in August 2020 from The Healthcare Research Ethics Committee (SREC reference: REC741). Data generation will be informed by science and technology studies and practice theories. Discussion: Ensuring adequate numbers of nurses are available to care for patients in response to shifting demand is an international policy priority. Emerging evidence on the use of formal workforce planning methodologies across the developed world highlights both the centrality of nurses' professional judgement in nurse staffing methodologies and the urgent need for theoretically informed research to better understand and conceptualise its contribution to decision‐making. This study is designed to address this gap in understanding. It takes advantage of nurses' experiences of managing the service and staffing impacts of the Covid‐19 pandemic and differences in strategic approaches to nurse staffing systems between England and Wales. Impact: The research will: make visible the knowledge and skills that underpin professional judgement in nurse staffing decisions and provide a conceptual language with which to articulate this;lay the foundations for evidence‐based programmes of nurse education and continuing professional development;furnish the evidence to inform the development of nurse‐led decision support tools to augment professional judgement; andgenerate wider insights into the effectiveness of nurse staffing systems in practice. [ABSTRACT FROM AUTHOR]

Objective: Research is needed to understand how Shared Decision-Making (SDM) is enacted in routine clinical settings. We aimed to 1) describe the process of SDM between clinicians and patients; 2) examine how well the SDM process compares to a prescriptive model of SDM, and 3) propose a descriptive model based on observed SDM in routine practice.Methods: Patients with chronic kidney disease and early stage breast cancer were recruited consecutively via Cardiff and Vale University Health Board (UK) teams. Consultations were audio-recorded, transcribed and thematically analysed.Results: Seventy-six consultations were observed: 26 pre-dialysis consultations and two consultations each for 25 breast cancer patients. Key stages of the 'Three Talk Model' were observed. However, we also observed more elements and greater complexity: a distinct preparation phase; tailored and evolving integrative option conversation; patients and clinicians developing 'informed preferences'; distributed and multi-stage decisions; and a more open-ended planning discussion. Use of decision aids was limited.Conclusion: A more complex picture was observed compared with previous portrayals in current theoretical models.Practice Iimplications: The model can provide a basis for future training and initiatives to promote SDM, and tackle the gap between what is advocated in policy, but rarely achieved in practice. [ABSTRACT FROM AUTHOR]