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Background: Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-researched. Cutting edge perspectives advocate exploring the whole system rather than individual influences on patient safety. Ethnography (the study of people and cultures) has been acknowledged as a suitable method for identifying health care issues as they occur within the natural context. In this paper we compare multiple methods used in a multi-site, qualitative study that aimed to identify system influences on decision making.Methods: The study was conducted in three NHS Ambulance Trusts in England and involved researchers from each Trust working alongside academic researchers. Exploratory interviews with key informants e.g. managers (n = 16) and document review provided contextual information. Between October 2012 and July 2013 researchers observed 34 paramedic shifts and ten paramedics provided additional accounts via audio-recorded 'digital diaries' (155 events). Three staff focus groups (total n = 21) and three service user focus groups (total n = 23) explored a range of experiences and perceptions. Data collection and analysis was carried out by academic and ambulance service researchers as well as service users. Workshops were held at each site to elicit feedback on the findings and facilitate prioritisation of issues identified.Results: The use of a multi-method qualitative approach allowed cross-validation of important issues for ambulance service staff and service users. A key factor in successful implementation of the study was establishing good working relationships with academic and ambulance service teams. Enrolling at least one research lead at each site facilitated the recruitment process as well as study progress. Active involvement with the study allowed ambulance service researchers and service users to gain a better understanding of the research process. Feedback workshops allowed stakeholders to discuss and prioritise findings as well as identify new research areas.Conclusion: Combining multiple qualitative methods with a collaborative research approach can facilitate exploration of system influences on patient safety in under-researched settings. The paper highlights empirical issues, strengths and limitations for this approach. Feedback workshops were effective for verifying findings and prioritising areas for future intervention and research. [ABSTRACT FROM AUTHOR]

Background: The English health system experienced a large-scale reorganisation in April 2013. A national tri-partite delivery framework involving the Department of Health, NHS England and Public Health England was agreed and a new local operational model applied. Evidence about how health system re-organisations affect constituent public health programmes is sparse and focused on low and middle income countries. We conducted an in-depth analysis of how the English immunisation programme adapted to the April 2013 health system reorganisation, and what facilitated or hindered the delivery of immunisation services in this context.Methods: A qualitative case study methodology involving interviews and observations at national and local level was applied. Three sites were selected to represent different localities, varying levels of immunisation coverage and a range of changes in governance. Study participants included 19 national decision-makers and 56 local implementers. Two rounds of interviews and observations (immunisation board/committee meetings) occurred between December 2014 and June 2015, and September and December 2015. Interviews were audio recorded and transcribed verbatim and written accounts of observed events compiled. Data was imported into NVIVO 10 and analysed thematically.Results: The new immunisation programme in the new health system was described as fragmented, and significant effort was expended to regroup. National tripartite arrangements required joint working and accountability; a shift from the simpler hierarchical pre-reform structure, typical of many public health programmes. New local inter-organisational arrangements resulted in ambiguity about organisational responsibilities and hindered data-sharing. Whilst making immunisation managers responsible for larger areas supported equitable resource distribution and strengthened service commissioning, it also reduced their ability to apply clinical expertise, support and evaluate immunisation providers' performance. Partnership working helped staff adapt, but the complexity of the health system hindered the development of consistent approaches for training and service evaluation.Conclusion: The April 2013 health system reorganisation in England resulted in significant fragmentation in the way the immunisation programme was delivered. Some of this was a temporary by-product of organisational change, other more persistent challenges were intrinsic to the complex architecture of the new health system. Partnership working helped immunisation leaders and implementers reconnect and now the challenge is to assess how inter-agency collaboration can be strengthened. [ABSTRACT FROM AUTHOR]

Background: Hospital discharge is a vulnerable transitional stage in patient care. This qualitative study investigated the views of healthcare professionals and patients about the threats to safe hospital discharge with aim of identifying contributory and latent factors. The study was undertaken in two regional health and social care systems in the English National Health Service, each comprising three acute hospitals, community and primary care providers and municipal social care services. The study focused on the threats to safe discharge for hip fracture and stroke patients as exemplars of complex care transitions.Methods: A qualitative study involving narrative interviews with 213 representative stakeholders and professionals involved in discharge planning and care transition activities. Narratives were analysed in line with 'systems' thinking to identify proximal (active) and distal (latent) factors, and the relationships between them.Results: Three linked categories of commonly and consistently identified threat to safe discharge were identified: (1) 'direct' patient harms comprising falls, infection, sores and ulceration, medicines-related issues, and relapse; (2) proximal 'contributing' factors including completion of tests, assessment of patient, management of equipment and medicines, care plan, follow-up care and patient education; and distal 'latent' factors including discharge planning, referral processes, discharge timing, resources constraints, and organisational demands.Conclusion: From the perspective of stakeholders, the study elaborates the relationship between patient harms and systemic factors in the context of hospital discharge. It supports the importance of communication and collaboration across occupational and organisational boundaries, but also the challenges to supporting such communication with the inherent complexity of the care system. [ABSTRACT FROM AUTHOR]

Background: Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties.Methods: Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently.Results: Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner.Conclusions: This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs.Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN): ISRCTN89052791 . [ABSTRACT FROM AUTHOR]

Background: Self-management of inflammatory arthritis (IA) requires patients to address the impact of symptoms, treatment, and the psychosocial consequences of a long term condition. There are several possible mechanisms for facilitating self-management, including patient-clinician interactions in routine consultations. This requires patients to collaborate in their healthcare, and clinicians to specifically encourage and help patients to do so. To design training that enables clinicians to support patients to be actively involved and self-manage requires understanding both patients' and clinicians' perspectives about what is important and feasible. Previous research explored the perspectives of clinicians who had undertaken brief training which they were putting into practice in their routine consultations. This study explored the perspectives of patients attending those routine consultations to identify aspects of the interaction that influenced collaboration and self-management.Methods: Nineteen patients with IA who had attended a routine consultation with a rheumatology clinician at one of four hospitals in England took part in semi-structured interviews. Interviews were transcribed, anonymised and analysed using inductive thematic analysis.Results: Three themes encompass participants' thoughts about interactions that facilitated collaboration in consultations and their ability to self-manage their IA: first, patients and clinicians viewing care as a shared endeavour, including patients responding actively to their IA and clinicians exploring and negotiating with patients; second, the need for clinicians to understand the challenges faced by patients, appreciate the impact of IA and focus on patients' priorities; and third, clinicians using an open communication style, including the use of non-didactic, patient-centred approaches. A fourth theme was perceived benefits of actively engaging in consultations, including increased confidence to deal with the impact of IA and greater acceptance of a long term condition.Conclusions: Patients perceive that self-management can be facilitated when clinicians and patients view healthcare as a shared responsibility, underpinned by clinicians as experts in the disease and patients as experts in living with it. Clinicians can support patients' self-management by using non-didactic communication skills to identify patients' priorities, and to prompt patients to problem-solve and share in setting the consultation agenda. This should inform skills-training for rheumatology clinicians. [ABSTRACT FROM AUTHOR]

Background: In 2008, the National Institute for Health Research (NIHR) began funding a major 5-year pilot research programme of translational research in England, establishing nine 'Collaborations for Leadership in Applied Health Research and Care' (CLAHRCs). A number of evaluations were carried out to examine whether or not the various collaborations worked as intended and why. In this paper, we examine what the theory of co-production adds to understanding of processes of knowledge creation and translation we observed in one of the CLAHRCs.Methods: A case study of a successful knowledge translation project was identified from our wider realist evaluation of the mechanisms of closer collaboration at play in the CLAHRC. In the project, a computer simulation model of an emergency pathway for acute ischaemic stroke was built to explore if and how the time between the onset and treatment of the condition could be minimised by redesigning the pathway. The aim of the case study was to improve our understanding of the nature and workings of the mechanisms of closer collaboration that were associated with the more successful projects by examining the relevance of the theory of co-production. Qualitative methods of analysis were used to explore the fit between the mechanisms of closer collaboration we observed in the realist evaluation and the principles of co-production we identified from the literature.Results: We found a close fit between the nine mechanisms of closer collaboration at work in the project and the principles of co-production (active agents; equality of partners; reciprocity and mutuality; transformative; and facilitated). The successful style of collaborative working exemplified by the project was consistent with a strong form of co-production.Conclusions: In our view, the theory of co-production provides useful insights into what it is about the qualities of collaborative working that inspire the requisite mechanisms for generating knowledge that is translated into practice. The theory provides a potentially useful basis for future knowledge translation programmes and projects in applied health research in a range of contexts. [ABSTRACT FROM AUTHOR]

Background: Increasingly, it is being suggested that translational gaps might be eradicated or narrowed by bringing research users and producers closer together, a theory that is largely untested. This paper reports a national study to fill a gap in the evidence about the conditions, processes and outcomes related to collaboration and implementation.Methods: A longitudinal realist evaluation using multiple qualitative methods case studies was conducted with three Collaborations for Leadership in Applied Health Research in Care (England). Data were collected over four rounds of theory development, refinement and testing. Over 200 participants were involved in semi-structured interviews, non-participant observations of events and meetings, and stakeholder engagement. A combined inductive and deductive data analysis process was focused on proposition refinement and testing iteratively over data collection rounds.Results: The quality of existing relationships between higher education and local health service, and views about whether implementation was a collaborative act, created a path dependency. Where implementation was perceived to be removed from service and there was a lack of organisational connections, this resulted in a focus on knowledge production and transfer, rather than co-production. The collaborations' architectures were counterproductive because they did not facilitate connectivity and had emphasised professional and epistemic boundaries. More distributed leadership was associated with greater potential for engagement. The creation of boundary spanning roles was the most visible investment in implementation, and credible individuals in these roles resulted in cross-boundary work, in facilitation and in direct impacts. The academic-practice divide played out strongly as a context for motivation to engage, in that 'what's in it for me' resulted in variable levels of engagement along a co-operation-collaboration continuum. Learning within and across collaborations was patchy depending on attention to evaluation.Conclusions: These collaborations did not emerge from a vacuum, and they needed time to learn and develop. Their life cycle started with their position on collaboration, knowledge and implementation. More impactful attempts at collective action in implementation might be determined by the deliberate alignment of a number of features, including foundational relationships, vision, values, structures and processes and views about the nature of the collaboration and implementation. [ABSTRACT FROM AUTHOR]

Background: Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.Methods: In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.Results: We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.Conclusion: Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.Trial Registration: Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of font size and paper thickness on the response to, and completion of, a self-completion postal questionnaire among older people with joint pain.Study Design and Setting: Randomized trial. People aged 50 years and older with joint pain who consulted a general practitioner at one of five general practices in Central Cheshire were sent a postal questionnaire. Questionnaire format (large or small font size, thick or thin paper) was randomly allocated using a 2 x 2 factorial design.Results: Questionnaires were received from 502 out of 650 participants (crude response 77%). Response was significantly higher for participants receiving questionnaires with a larger font size (79.3% vs. 75.2%; hazard ratio 1.26, 95% confidence interval: 1.02, 1.56). Paper thickness had no significant effect on response. Completion (measure by assessing double-page turnover error) was increased in participants receiving questionnaires printed on thicker paper (3.2% vs. 7.1%; P=0.049) but was not affected by font size.Conclusion: This study demonstrates that questionnaires in larger font and on thicker paper may produce higher and more complete responses than surveys using standard size font and standard thickness paper, and should therefore be considered in studies among older people. [ABSTRACT FROM AUTHOR]