Optimising the Conceptualisation of Context Comment on "Stakeholder Perspectives of Attributes and Features of Context Relevant to Knowledge Translation in Health Settings: A Multi-country Analysis".

Context matters. Therefore, efforts to develop greater conceptual clarity are important for science and practice. In this commentary, we outline some key issues that were prompted by Squire's et al.'s contribution. Specifically, we reinforce context as an interactive concept and therefore something that is hard to 'pin down', the problematic nature of conceptualising context in implementation and de-implementation, and a requirement for the development of culturally sensitive understandings. Finally, we suggest it is vital that continued investment into providing a more comprehensive list of determinants needs to be accompanied by an equal effort in developing practical methods and tools to support use and application.

Sleep hygiene education and children with developmental disabilities: Findings from a co-design study.

This qualitative study develops a programme theory demonstrating the complexity embedded in sleep hygiene education (SHE) as an intervention to improve sleep problems in children with developmental disabilities. In co-design workshops, eight parents and six sleep practitioners deliberated themes developed from findings of an earlier exploratory study of stakeholder perceptions of SHE. A SHE tool underpinned by programme theory was developed evidenced by mid-range theories of change. Analytical themes were developed to explain the programme theory and the complexities of a successful SHE intervention: the need to legitimize children's sleep problems and consider the nature of customization, knowledge sharing, health expectation and impact of sleep service rationing and gaming strategies on implementation success. Policy and practice implications include a need to raise the public profile of children's sleep problems and promote parental involvement in intervention implementation. Further research is needed to test out this theory-driven framework for evaluating SHE.

Brief smoking cessation in acute Welsh hospitals: a realist approach.

This implementation study sought to determine what works to support brief smoking cessation (BSC) in acute hospital settings, through exploration of organizational delivery and the role of healthcare professionals (HCPs). We used a realist approach, with embedded stakeholder engagement, within a large health organization. We conducted interviews (n = 27), a survey (n = 279) and organization documentation review (n = 44). The final programme theory suggests HCPs implement BSC when they value it as part of their role in contributing to improved patient outcomes; this is due to personal and professional influences, such as knowledge or experience. Organizational support, training and working in an environment where BSC is visible as standard care, positively influences implementation. However, the context exerts a strong influence on whether BSC is implemented, or not. HCPs make nuanced judgements on whether to implement BSC based on their assessment of the patient's responses, the patient's condition and other acute care demands. HCPs are less likely to implement BSC in dynamic and uncertain environments, as they are concerned about adversely impacting on the clinician-patient relationship and prioritize other acute care requirements. Organizations should actively promote BSC as a core function of the acute hospital setting and improve professional practice through leadership, training, feedback and visible indicators of organizational commitment. HCPs can be persuaded that implementing BSC is an acute care priority and an expectation of standard practice for improving patient outcomes.

Getting back to life after stroke: co-designing a peer-led coaching intervention to enable stroke survivors to rebuild a meaningful life after stroke.

Purpose: Rebuilding one's life after stroke is a key priority persistently identified by patients yet professionally led interventions have little impact. This co-design study constructs and tests a novel peer-led coaching intervention to improve post-stroke leisure and general social participation.Methods: This study followed the principles of co-design by actively engaging and harnessing the knowledge of stroke survivors in order to develop and test a peer-lead coaching intervention. Phase 1 assessed function, mood, and involvement in leisure and social activities 6 months following stroke (n = 79). Phase 2 involved semi-structured, in-depth interviews with 18 stroke survivors, and 10 family carers to explore experiences related to social and leisure participation. Phase 3 tested the co-designed peer-led coaching intervention. Data collected also included co-design feedback sessions and a training workshop with selected peer coaches and in addition, interviews with stroke survivors and their peer coaches at two time-points: following the training program (n = 5) and delivery of the intervention (n = 2).Results: A peer-coaching intervention was successfully co-designed and tested combining the use of lay knowledge sociocognitive and self-regulatory theories with principles of transformational leadership theory. Both peers and stroke survivors reported having benefited at a personal level.Conclusions: This study reports on an innovative community-based and peer-led intervention and its results have generated new evidence on how stroke survivors engage with and respond to peer coaching support. It further provides a theoretical platform for designing and implementing peer interventions. Hence, these results have the potential to inform the development of future peer coaching intervention not only for stroke rehabilitation but also for a wide range of chronic conditions.Implications for rehabilitationThe results of this co-design study, if replicated and extended, provide a theoretical framework to guide rehabilitation professionals about the optimal timing of peer-coaching interventions and contextual factors that need to be taken into account.Applying transformational leadership theory principles to the training of peers may prove useful at the time of the implementation of a coaching intervention.Peer-led coaching interventions, which are community-based and tailored to stroke survivors at the time of discharge, may help support re-engagement in social and leisure activities.

Arts-based palliative care training, education and staff development: A scoping review.

BACKGROUND: The experience of art offers an emerging field in healthcare staff development, much of which is appropriate to the practice of palliative care. The workings of aesthetic learning interventions such as interactive theatre in relation to palliative and end-of-life care staff development programmes are widely uncharted. AIM: To investigate the use of aesthetic learning interventions used in palliative and end-of-life care staff development programmes. DESIGN: Scoping review. DATA SOURCES: Published literature from 1997 to 2015, MEDLINE, CINAHL and Applied Social Sciences Index and Abstracts, key journals and citation tracking. RESULTS: The review included 138 studies containing 60 types of art. Studies explored palliative care scenarios from a safe distance. Learning from art as experience involved the amalgamation of action, emotion and meaning. Art forms were used to transport healthcare professionals into an aesthetic learning experience that could be reflected in the lived experience of healthcare practice. The proposed learning included the development of practical and technical skills; empathy and compassion; awareness of self; awareness of others and the wider narrative of illness; and personal development. CONCLUSION: Aesthetic learning interventions might be helpful in the delivery of palliative care staff development programmes by offering another dimension to the learning experience. As researchers continue to find solutions to understanding the efficacy of such interventions, we argue that evaluating the contextual factors, including the interplay between the experience of the programme and its impact on the healthcare professional, will help identify how the programmes work and thus how they can contribute to improvements in palliative care.

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

BACKGROUND: The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. METHODS/DESIGN: Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. DISCUSSION: To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

Bringing critical realism to nursing practice: Roy Bhaskar's contribution.

In the context of modern nursing practice that is embedded within complex social situations, critical discussions about the contribution of major philosophers are relevant and important. Whilst nurse theorists have advanced and shaped nursing as a discipline, other major philosophers can offer much to advance nursing enquiry. In this paper, we focus on philosopher Roy Bhaskar who, amongst others, developed critical realism, a philosophy for social science which connects with how many of us think about the world. Bhaskar's work focuses our attention on the interplay between structure and agency and on the search for the causative or generative mechanisms that explain the social world. Bhaskar was interested in human emancipation, and we suggest his work is of great importance to advance understanding of complex social situations. Critical realism has already been endorsed by a range of disciplines, especially in research which focuses on real problems and acknowledges the complexities of the social world. In recent evidence from healthcare literature, there has been a surge in research using realist methodology (realist evaluation and realist synthesis), which is underpinned by the philosophy of critical realism and which offers a different perspective to understanding nursing and healthcare problems through the realist lens. However, we suggest that sufficient attention is not always paid to the philosophical roots of this methodology. In this paper, we provide insight into Bhaskar's work and demonstrate how research positioned within critical realism and realist methodology can advance nursing and healthcare-related knowledge. Through shining a light on Bhaskar, we illustrate how critical realism philosophy is a natural fit with human and health science enquiry, including nursing.

Implementing best practice in infection prevention and control. A realist evaluation of the role of intermediaries.

BACKGROUND: Implementing best practice in healthcare is complex. There is evidence to suggest that certain individuals, collectively termed 'intermediaries', can contribute to implementation processes, but understanding exactly what happens and how intermediaries promote best practice is unclear. OBJECTIVES: The aim of this study was to evaluate the role of intermediaries in promoting infection prevention, and provide an explanation about what works, for whom, how, and under which conditions. METHODS: Realist methodology was used as the underpinning explanatory framework for the study. From a concept mining of the existing literature, a set of hypothetical statements about the plausible range of context-mechanism-outcome propositions that postulate how intermediaries can contribute to promoting best practice were developed and evaluated. DESIGN: Case studies were conducted consecutively to refine and test the propositions. Data included semi-structured interviews (n=32), non-participant observations (n=5) and documentation review. Data were analysed by open coding, content and pattern matching. SETTINGS: Case studies were undertaken in two hospitals within the United Kingdom. PARTICIPANTS: Purposive sampling was used to identify individuals within the organisations who had professional or organisational responsibilities for infection prevention. The inclusion criteria were; employees of the chosen organisations who would consent to take part in the study, participants with infection prevention responsibilities, adults over 18 years with the capacity to consent. The exclusion criteria were; participants outside of the chosen organisation, participants under 18 years of age, and participants who lacked the capacity to consent. RESULTS: Four context-mechanism-outcome configurations contribute to advancing our understanding about the potential of intermediaries to promote best practice. Findings showed that the ways in which intermediaries watch over practice (their human surveillance), promoted better adherence with infection control practices. Particular styles and approaches used by intermediaries led to individual staff feeling personally supported. Distinct ways of providing performance feedback for staff together with the policy discourse promoted good habitual behaviours. Practice-based teaching heightened awareness of individuals' own practice and made learning more real. CONCLUSIONS: Findings offer a new lens on the role of intermediaries in bridging the evidence to practice gap. As such they could be considered when reviewing or developing new interventions/programmes that use intermediaries to plug the gap between theory and practice. The findings could also be used to guide the design and development of new intermediary models in healthcare, to promote best practice and support the quality of patient care.

Collaboration and Co-Production of Knowledge in Healthcare: Opportunities and Challenges.

Over time there has been a shift, at least in the rhetoric, from a pipeline conceptualisation of knowledge implementation, to one that recognises the potential of more collaboration, co-productive approaches to knowledge production and use. In this editorial, which is grounded in our research and collective experience, we highlight both the potential and challenge with collaboration and co-production. This includes issues about stakeholder engagement, governance arrangements, and capacity and capability for working in a co-productive way. Finally, we reflect on the fact that this approach is not a panacea, but is accompanied by some philosophical and practical challenges.

An Occupational Therapy intervention for residents with stroke-related disabilities in UK Care Homes (OTCH): cluster randomised controlled trial with economic evaluation.

BACKGROUND: Care home residents with stroke-related disabilities have significant activity limitations. Phase II trial results suggested a potential benefit of occupational therapy (OT) in maintaining residents' capacity to engage in functional activity. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of a targeted course of OT in maintaining functional activity and reducing further health risks from inactivity for UK care home residents living with stroke-related disabilities. DESIGN: Pragmatic, parallel-group, cluster randomised controlled trial with economic evaluation. Cluster randomisation occurred at the care-home level. Homes were stratified according to trial administrative centre and type of care provided (nursing or residential), and they were randomised 1 : 1 to either the intervention or the control arm. SETTING: The setting was 228 care homes which were local to 11 trial administrative centres across England and Wales. PARTICIPANTS: Care home residents with a history of stroke or transient ischaemic attack, including residents with communication and cognitive impairments, not receiving end-of-life care. INTERVENTION: Personalised 3-month course of OT delivered by qualified therapists. Care workers participated in training workshops to support personal activities of daily living. The control condition consisted of usual care for residents. MAIN OUTCOME MEASURES: Outcome data were collected by a blinded assessor. The primary outcome at the participant level was the Barthel Index of Activities of Daily Living (BI) score at 3 months. The secondary outcomes included BI scores at 6 and 12 months post randomisation, and the Rivermead Mobility Index, Geriatric Depression Scale-15 and European Quality of Life-5 Dimensions, three levels, questionnaire scores at all time points. Economic evaluation examined the incremental cost per quality-adjusted life-year (QALY) gain. Costs were estimated from the perspective of the NHS and Personal Social Services. RESULTS: Overall, 568 residents from 114 care homes were allocated to the intervention arm and 474 residents from another 114 care homes were allocated to the control arm, giving a total of 1042 participants. Randomisation occurred between May 2010 and March 2012. The mean age of participants was 82.9 years, and 665 (64%) were female. No adverse events attributable to the intervention were recorded. Of the 1042 participants, 870 (83%) were included in the analysis of the primary outcome (intervention, n = 479; control, n = 391). The primary outcome showed no significant differences between groups. The adjusted mean difference in the BI score between groups was 0.19 points higher in the intervention arm [95% confidence interval (CI) -0.33 to 0.70, p = 0.48; adjusted intracluster correlation coefficient 0.09]. Secondary outcome measures showed no significant differences at all time points. Mean incremental cost of the Occupational Therapy intervention for residents with stroke living in UK Care Homes intervention was £438.78 (95% CI -£3360.89 to £1238.46) and the incremental QALY gain was 0.009 (95% CI -0.030 to 0.048). LIMITATIONS: A large proportion of participants with very severe activity-based limitations and cognitive impairment may have limited capacity to engage in therapy. CONCLUSION: A 3-month individualised course of OT showed no benefit in maintaining functional activity in an older care home population with stroke-related disabilities. FUTURE WORK: There is an urgent need to reduce health-related complications caused by inactivity and to provide an enabling built environment within care homes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN00757750. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 15. See the Health Technology Assessment programme website for further project information.

Implementing a Systematic Voiding Program for Patients With Urinary Incontinence After Stroke.

We explored health professionals' views of implementing a systematic voiding program (SVP) in a multi-site qualitative process evaluation in stroke services recruited to the intervention arms of a cluster randomized controlled feasibility trial during 2011-2013. We conducted semi-structured group or individual interviews with 38 purposively selected nursing, managerial, and care staff involved in delivering the SVP. Content analysis of transcripts used normalization process theory (NPT) as a pre-specified organization-level exploratory framework. Barriers to implementing the SVP included perceived lack of suitability for some patient groups, patient fear of extending hospital stay, and difficulties with SVP enactment, scheduling, timing, recording, and monitoring. Enablers included the guidance provided by the SVP, patient and relative involvement, extra staff, improved nursing skill and confidence, and experience of success. Three potential mechanisms of consistency, visibility, and individualization linked the SVP process with improvements in outcome, and should be emphasized in SVP implementation.

Collective action for implementation: a realist evaluation of organisational collaboration in healthcare.

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.

Process evaluations in neurological rehabilitation: a mixed-evidence systematic review and recommendations for future research.

OBJECTIVE: To systematically review how process evaluations are currently designed, what methodologies are used and how are they developed alongside or within neurological rehabilitation trials. METHODS: This mixed-methods systematic review had two evidence streams: stream I, studies reporting process evaluations alongside neurorehabilitation trials research and stream II, methodological guidance on process evaluation design and methodology. A search strategy was designed for each evidence stream. Data regarding process evaluation core concepts and design issues were extracted using a bespoke template. Evidence from both streams was analysed separately and then synthesised in a final overarching synthesis proposing a number of recommendations for future research. RESULTS: A total of 124 process evaluation studies, reporting on 106 interventions, were included in stream I evidence. 30 studies were included as stream II evidence. Synthesis 1 produced 9 themes, and synthesis 2 identified a total of 8 recommendations for process evaluation research. The overall synthesis resulted in 57 'synthesis recommendations' about process evaluation methodology grouped into 9 research areas, including the use of theory, the investigation of context, intervention staff characteristics and the delivery of the trial intervention. CONCLUSIONS: There remains no consensus regarding process evaluation terminology within the neurological rehabilitation field. There is a need for process evaluations to address the nature and influence of context over time. Process evaluations should clearly describe what intervention staff bring to a trial, including skills and experience prior to joining the research. Process evaluations should monitor intervention staff's learning effects and the possible impact that these may have on trial outcomes.

An occupational therapy intervention for residents with stroke related disabilities in UK care homes (OTCH): cluster randomised controlled trial.

OBJECTIVE: To evaluate the clinical efficacy of an established programme of occupational therapy in maintaining functional activity and reducing further health risks from inactivity in care home residents living with stroke sequelae. DESIGN: Pragmatic, parallel group, cluster randomised controlled trial. SETTING: 228 care homes (>10 beds each), both with and without the provision of nursing care, local to 11 trial administrative centres across the United Kingdom. PARTICIPANTS: 1042 care home residents with a history of stroke or transient ischaemic attack, including those with language and cognitive impairments, not receiving end of life care. 114 homes (n=568 residents, 64% from homes providing nursing care) were allocated to the intervention arm and 114 homes (n=474 residents, 65% from homes providing nursing care) to standard care (control arm). Participating care homes were randomised between May 2010 and March 2012. INTERVENTION: Targeted three month programme of occupational therapy, delivered by qualified occupational therapists and assistants, involving patient centred goal setting, education of care home staff, and adaptations to the environment. MAIN OUTCOME MEASURES: Primary outcome at the participant level: scores on the Barthel index of activities of daily living at three months post-randomisation. Secondary outcome measures at the participant level: Barthel index scores at six and 12 months post-randomisation, and scores on the Rivermead mobility index, geriatric depression scale-15, and EuroQol EQ-5D-3L questionnaire, at all time points. RESULTS: 64% of the participants were women and 93% were white, with a mean age of 82.9 years. Baseline characteristics were similar between groups for all measures, personal characteristics, and diagnostic tests. Overall, 2538 occupational therapy visits were made to 498 participants in the intervention arm (mean 5.1 visits per participant). No adverse events attributable to the intervention were recorded. 162 (11%) died before the primary outcome time point, and 313 (30%) died over the 12 months of the trial. The primary outcome measure did not differ significantly between the treatment arms. The adjusted mean difference in Barthel index score at three months was 0.19 points higher in the intervention arm (95% confidence interval -0.33 to 0.70, P=0.48). Secondary outcome measures also showed no significant differences at all time points. CONCLUSIONS: This large phase III study provided no evidence of benefit for the provision of a routine occupational therapy service, including staff training, for care home residents living with stroke related disabilities. The established three month individualised course of occupational therapy targeting stroke related disabilities did not have an impact on measures of functional activity, mobility, mood, or health related quality of life, at all observational time points. Providing and targeting ameliorative care in this clinically complex population requires alternative strategies.Trial registration Current Controlled Trials ISRCTN00757750.

What is rehabilitation potential? Development of a theoretical model through the accounts of healthcare professionals working in stroke rehabilitation services.

INTRODUCTION: Multi-disciplinary team members predict each patient's rehabilitation potential to maximise best use of resources. A lack of underpinning theory about rehabilitation potential makes it difficult to apply this concept in clinical practice. This study theorises about rehabilitation potential drawing on everyday decision-making by Health Care Professionals (HCPs) working in stroke rehabilitation services. METHODS: A clinical scenario, checked for face validity, was used in two focus groups to explore meaning and practice around rehabilitation potential. Participants were 12 HCPs working across the stroke pathway. Groups were co-facilitated, audio-recorded and fully transcribed. Analysis paid attention to data grounded in first-hand experience, convergence within and across groups and constructed a conceptual overview of HCPs' judgements about rehabilitation potential. RESULTS: Rehabilitation potential is predicted by observations of "carry-over" and functional gain and managed differently across recovery trajectories. HCPs' responses to rehabilitation potential judgements include prioritising workload, working around the system and balancing optimism and realism. Impacts for patients are streaming of rehabilitation intensity, rationing access to rehabilitation and a shifting emphasis between management and active rehabilitation. For staff, the emotional burden of judging rehabilitation potential is significant. Current service organisation restricts opportunities for feedback on the accuracy of previous judgements. CONCLUSION: Patients should have the opportunity to demonstrate rehabilitation potential by participation in therapy. As therapy resources are limited and responses to therapy may be context-dependent, early decisions about a lack of potential should not limit longer-term opportunities for rehabilitation. Services should develop strategies to enhance the quality of judgements through feedback to HCPs of longer-term patient outcomes. Implications for Rehabilitation Rehabilitation potential is judged at the level of individual patients (rather than population-based predictive models of rehabilitation outcome), draws on different sources of often experiential knowledge, and may be less than reliable. Decisions about rehabilitation potential may have far reaching consequences for individual patients, including the withdrawal of active rehabilitation in hospital or in the community and eventual care placement. A better understanding of what people mean by rehabilitation potential by all team members, and by patients and carers, may improve the quality of joint decision making and communication.

Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial.

BACKGROUND: Urinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients. METHODS: We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death. RESULTS: It was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence. CONCLUSIONS: The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.

Resource based view of the firm as a theoretical lens on the organisational consequences of quality improvement.

Evaluating the investment that healthcare organisations make in quality improvement requires knowledge of impact at multiple levels, including patient care, workforce and other organisational resources. The degree to which these resources help organisations to survive and thrive in the challenging contexts in which healthcare is designed and delivered is unknown. Investigating this question from the perspective of the Resource Based View (RBV) of the Firm may provide insights, although is not without challenge.

Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm.

INTRODUCTION: Little is understood about the role of quality improvement in enabling health organisations to survive and thrive in the contemporary context of financial and economic challenges. We will draw on the theoretical foundations of the 'Resource Based View of the Firm' (RBV) to develop insights into why health organisations engage in improvement work, how impacts are conceptualised, and 'what works' in delivering these impacts. Specifically, RBV theorises that the mix and use of resources across different organisations may explain differences in performance. Whether improvement work influences these resources is unclear. METHODS AND ANALYSIS: Case study research will be conducted across health organisations participating in four approaches to improvement, including: a national improvement programme; a multiorganisational partnership around implementation; an organisational strategy for quality improvement; and a coproduction project designed to enhance the experience of a clinical service from the perspective of patients. Data will comprise in-depth interviews with key informants, observation of key events and documents; analysed within and then across cases. Adopting a realist perspective, the core tenets of RBV will be evaluated as a programme theory, focusing on the interplay between organisational conditions and behavioural or resource responses that are reported through engagement in improvement. ETHICS AND DISSEMINATION: The study has been approved by Bangor University Ethics Committee. The investigation will not judge the relative merits of different approaches to healthcare quality improvement. Rather, we will develop unique insights into the organisational consequences, and dependencies of quality improvement, providing an opportunity to add to the explanatory potential of RBV in this and other contexts. In addition to scientific and lay reports of the study findings, research outputs will include a framework for constructing the economic impacts of quality improvement and practical guidance for health service managers that maximises the impacts of investment in quality improvement.

Towards a programme theory for fidelity in the evaluation of complex interventions.

RATIONALE, AIMS AND OBJECTIVES: This paper addresses the challenge of investigating fidelity in the implementation of a complex rehabilitation intervention designed to increase the level of independence in personal activities of daily living of stroke patients living in UK care homes. A programme theory of intervention fidelity was constructed to underpin a process evaluation running alongside a cluster randomized trial of the rehabilitation intervention. METHODS: The programme theory has been constructed drawing on principles of realist evaluation. Using data from in-depth semi-structured interviews (n = 17) with all occupational therapists (OTs) and critical incident reports from the trial (n = 20), and drawing from frameworks for implementation, the programme theory was developed. RESULTS: The programme theory incorporates four potential mechanisms through which fidelity within the trial can be investigated. These four programme theory areas are (1) the balancing of research and professional requirements that therapists performed in a number of areas while delivering the study interventions; (2) the OTs rapport building with care home staff; (3) the work focused on re-engineering the personal environments of care home patients; and (4) the learning about the intervention within the context of the trial and its impacts over time. CONCLUSIONS: These findings characterize the real-world nature of fidelity within intervention research, and specifically the negotiated nature of implementation within clinical settings, including individual patients' needs. This research adds to the evidence base because current frameworks for fidelity neglect the importance of learning over time of individuals and across the time span of a trial.

Does self-efficacy influence recovery and well-being in osteoarthritis patients undergoing joint replacement? A systematic review.

OBJECTIVE: To investigate the role of self-efficacy in functional recovery and well-being outcomes in osteoarthritis patients, undergoing hip or knee replacement surgery. DATA SOURCES: Studies were identified using MEDLINE via PUB med, PsycINFO and CINAHL from inception to July 2013. METHODS: Three search strategies that combined key terms of 'self-efficacy', 'functional recovery', 'well-being' and 'joint replacement' were applied. Titles and abstracts were screened for eligibility and, accordingly, potentially eligible studies were retrieved for review. Included studies were assessed in terms of their quality, and data were extracted by two independent reviewers. A narrative synthesis of results was conducted. RESULTS: In total, 836 articles were identified and after electronic de-duplication, 708 articles remained. After screening 15 articles were retrieved as potentially eligible and eight articles were included in the review. Of the eight studies (n = 967 patients), seven had a prospective design and all studies were considered of good quality. No fully conclusive evidence for the influence of self-efficacy upon functional recovery outcomes was found. When the timing of self-efficacy measurement was examined, post-operative self-efficacy was found to be related to functional recovery outcomes. CONCLUSION: Presurgical self-efficacy was the least consistent predictor of functional outcomes while postoperative self-efficacy was more consistently associated with recovery outcomes such as longer distance ambulation, exercise repetition and frequency, walking speed and disability.