Local government interventions for improving the health and wellbeing of tenants in private rented housing: developing initial program theory to inform evaluation in the United Kingdom.

BACKGROUND: Housing is an important wider determinant of health. Private Rented Sector (PRS) housing is generally the worst quality of housing stock across tenures. Although a wide range of interventions are available to local governments to manage and improve the quality of PRS housing and therefore the health of tenants, there is limited evidence about the extent to which these are used. This study aims to explore what drives the use of different interventions in different local governments, to better understand and inform local strategies. METHODS: As the first realist evaluation on this topic, the range of available interventions was informed by a Local Government Association toolkit. Consistent with realist approaches, retroductive analysis of intervention-context-mechanism-outcome configurations helped to develop and refine Initial Programme Theories (IPTs). Data sources included local government housing documents, a survey and eleven semi-structured interviews with housing officers. RESULTS: Using data for 22 out of the 30 local governments in the South West region of the United Kingdom, eight IPTs were developed which act on different levels from individual PRS team leaders to system wide. The IPTs include a belief in market forces, risk adverse to legal challenge, attitude to enforcement, relational approaches to partnership working, job security and renumeration, financial incentives drive action, and system-level understanding of the drivers of poor health, inequalities and opportunities for cost-savings. The findings suggest that limited objective health outcomes are being used to understand impact, which hinders interpretation of the effectiveness of all mechanisms. CONCLUSION: Interventions that bring about positive outcomes in managing PRS housing are unlikely to be universal; they depend on the context which differs across place and over time. The proposed IPTs highlight the need for strategies to be tailored considering the local context and should be evaluated in subsequent phases of study.

Mental health stigma and health-seeking behaviors amongst pregnant women in Vietnam: a mixed-method realist study.

BACKGROUND: Approximately 15% of women in low-and middle-income countries experience common perinatal mental disorders. Yet, many women, even if diagnosed with mental health conditions, are untreated due to poor quality care, limited accessibility, limited knowledge, and stigma. This paper describes how mental health-related stigma influences pregnant women's decisions not to disclose their conditions and to seek treatment in Vietnam, all of which exacerbate inequitable access to maternal mental healthcare. METHODS: A mixed-method realist study was conducted, comprising 22 in-depth interviews, four focus group discussions (total participants n = 44), and a self-administered questionnaire completed by 639 pregnant women. A parallel convergent model for mixed methods analysis was employed. Data were analyzed using the realist logic of analysis, an iterative process aimed at refining identified theories. Survey data underwent analysis using SPSS 22 and descriptive analysis. Qualitative data were analyzed using configurations of context, mechanisms, and outcomes to elucidate causal links and provide explanations for complexity. RESULTS: Nearly half of pregnant women (43.5%) would try to hide their mental health issues and 38.3% avoid having help from a mental health professional, highlighting the substantial extent of stigma affecting health-seeking and accessing care. Four key areas highlight the role of stigma in maternal mental health: fear and stigmatizing language contribute to the concealment of mental illness, rendering it unnoticed; unconsciousness, normalization, and low literacy of maternal mental health; shame, household structure and gender roles during pregnancy; and the interplay of regulations, referral pathways, and access to mental health support services further compounds the challenges. CONCLUSION: Addressing mental health-related stigma could influence the decision of disclosure and health-seeking behaviors, which could in turn improve responsiveness of the local health system to the needs of pregnant women with mental health needs, by offering prompt attention, a wide range of choices, and improved communication. Potential interventions to decrease stigma and improve access to mental healthcare for pregnant women in Vietnam should target structural and organizational levels and may include improvements in screening and referrals for perinatal mental care screening, thus preventing complications.

Realist evaluation of a community-based antiretroviral therapy (CBART) programme for key populations in Benue State in Nigeria.

BACKGROUND: World Health Organization recommended community-based ART (CBART) approaches to improve access to antiretroviral treatment (ART) and treatment outcomes among key populations living with (KPLHIV). Key populations (KP) are female sex workers, men who have sex with men, persons who inject drugs, and transgender people. How CBART for KP (KP-CBART) worked and why, for whom and in what circumstances it worked within KP communities or at community sites, are yet to be described. The aim of this study is to describe the different KP-CBART approaches or models in Nigeria, identifying the context conditions and mechanisms that are likely to produce the desired outcomes. METHOD: Building on our previous study eliciting an initial programme theory for KP-CBART, we used a multiple case design and cross-case analysis to evaluate 3 KP-CBART approaches, namely: One Stop Shop clinic; community drop-in centre; and outreach venue. Between 2021 and 2023, we conducted a retrospective cohort study, 99 indepth interviews and 5 focused group discussions with various actors. Using realist evaluation, we synthesised context-mechanism-outcome configurations (CMOCs) and developed programme theory for each of the cases and an overall theory. RESULT: The analysis showed the central importance of decentralizing ART service delivery to a safe place within the community for KPLHIV. The provision of ART in a KP friendly environment triggered a feeling of safety and trust in the healthcare workers among KPLHIV, resulting in KP-CBART acceptance and improved ART uptake, medication adherence and retention on ART. KP community engagement in ART delivery, peer support through support group meetings, and linkages with KP-led organizations improved self-efficacy, fostered solidarity and a sense of belonging among KP. These resources encouraged and motivated clients to engage with the KP-CBART model. However, fear of disclosure of HIV and KP status, and lack of trust between KP groups, demotivated and discouraged KPLHIV from initiating ART and continuing their treatment in KP-CBART. CONCLUSION: To optimise access to ART and treatment outcomes for KPLHIV, policy makers and health practitioners should ensure the provision of a safe place for ART service delivery that can be trusted by the clients and the KP communities.

A theory building critical realist evaluation of an integrated cognitive-behavioural fluency enhancing stuttering treatment for school-age children. Part 1: Development of a preliminary program theory from expert speech-language pathologist data.

PURPOSE: This study initiated a program of research that aims to develop a program theory underlying integrated cognitive-behavioural fluency enhancing stuttering treatments for school-age children. This research asks, what in the treatment program works (or does not work), for whom, in what contexts, and why. METHODS: Using a critical realist evaluation approach, seven speech-language pathologists (SLPs) with extensive experience in treating children who stutter were asked about barriers and facilitators of optimal treatment outcomes within the context of the Comprehensive Stuttering Program - School-aged Children (CSP-SC). From these data discrete resource mechanisms, contexts, within child reasoning mechanisms, and outcomes were derived and a preliminary program theory was proposed. RESULTS: Facilitating and impeding child physiology, treatment and SLP resource mechanisms, family and school contexts, and within-child mechanisms were identified. Facilitating mechanisms included motivation, personality/psychological characteristics, understanding and trust of the treatment process, experience of speaking with less effort, and self-efficacy. Impeding mechanisms included reduced motivation, impeding personality/psychological characteristics, lack of buy-in, and, for some children, a prohibitive cost of effort in using learned strategies. CONCLUSION: A preliminary program theory was hypothesized which will be further developed in future analysis of data obtained from children and parents who participated in the CSP-SC at the same centre from which the SLPs came. Subsequent research with new cohorts of SLPs, children, and parents from other treatment programs and centres will be needed to establish the generalizability of the program theory generated in this program of research.

A realist evaluation of the implementation of a national tobacco control program and policy in India.

There is a growing interest in studying and unpacking implementation of policies and programmes as it provides an opportunity to reduce the policy translation time lag taken for research findings to translate to policies and get implemented and understand why policies may fail. Realist evaluation is a theory-driven approach that embraces complexity and helps to identify the mechanisms generating the observed policy outcomes in given context. We aimed to study facilitators and barriers while implementing the Cigarettes and Other Tobacco Products Act, 2003 (COTPA) a comprehensive national tobacco control policy, and the National Tobacco Control Programme (NTCP), 2008 using realist evaluation. We developed an initial program theory (IPT) based on a realist literature review of tobacco control policies in Low- and Middle-Income Countries (LMICs). Three diverse states -Kerala, West Bengal, and Arunachal Pradesh- with varying degree of implementation of tobacco control law and program were chosen as case studies. Within the three selected states, we conducted in-depth interviews with 48 state and district-level stakeholders and undertook non-participant observations to refine the IPT. Following this, we organized two regional consultations covering stakeholders from 20 Indian states for a second iteration to further refine the program theory. A total of 300 Intervention-Context-Actor-Mechanism-Outcome (ICAMO) configurations were developed from the interview data, which were later synthesized into state-specific narrative program theories for Kerala, West Bengal and Arunachal Pradesh. We identified five mechanisms: collective action, felt accountability, individual motivation, fear, and prioritization that were (or were not) triggered leading to diverse implementation outcomes. We identified facilitators and barriers to implementing the COTPA and the NTCP, which have important research and practical implications for furthering the implementation of these policies as well as implementation research in India. In the future, researchers could build on the refined program theory proposed in this study to develop a middle-range theory to explain tobacco control policy implementation in India and other LMICs.

A Realist Evaluation of a "Whole Health" Response to Domestic Violence and Abuse in the UK.

Health Pathfinder is a multilevel system change intervention initiated to transform the health response to domestic violence and abuse in eight sites in England. The current study drew upon interviews with health professionals (n = 27) and victim-survivors (n = 20) to provide a realist account of how this intervention achieved its goals. Findings show that five change mechanisms explain why Health Pathfinder was effective as an ecological intervention: awareness, expertise, relationships, empowerment, and evidence. Positive progress in respect of each mechanism had meaningful impacts on victim-survivor experiences of enquiry, disclosure, and uptake of services and had the potential to meaningfully impact health inequities.

A realist evaluation protocol: assessing the effectiveness of a rapid response team model for mental state deterioration in acute hospitals.

Background: Mental state deterioration poses significant challenges in healthcare, impacting patients and providers. Symptoms like confusion and agitation can lead to prolonged hospital stays, increased costs, and the use of restrictive interventions. Despite its prevalence, there's a lack of consensus on effective practices for managing mental state deterioration in acute hospital settings. To address this gap, a rapid response team model has been proposed as a potential intervention, aiming to provide early identification and targeted interventions. Methods: Based on realist evaluation steps, first, initial program theories are formulated to understand the logic behind the intervention. Second, literature synthesis identifies empirical evidence on contexts, mechanisms, and outcomes elements, refining initial theories. During the third step, data will be collected using qualitative methods such as field observations and interviews, as well as quantitative methods such as surveys of the staff, audits of electronic medical records, and analysis of incident records of mental state deterioration. Analysing this data informs configurations of contexts, mechanisms, and outcomes. In the fifth step, the configurations are synthesised, presenting refined, evidence-informed program theories. Conclusion: This study addresses the knowledge gap by evaluating the rapid response model's effectiveness in managing mental state deterioration in acute hospital settings. Realist principles guide the exploration of causal mechanisms and their interaction with specific implementation contexts. The objective is to identify what works, for whom, and under what circumstances, aiming to manage deterioration, reduce restrictive interventions, and enhance the experience for patients and staff by implementing a proactive model of care. The findings contribute to evidence-based approaches for managing mental state deterioration in hospital settings, informing policy and practice in this crucial area of healthcare.

Social participation in the promoting activity, independence and stability in early dementia (PrAISED), a home-based therapy intervention for people living with dementia: a realist evaluation.

BACKGROUND: Interventions promoting social activity may reduce behavioural psychological symptoms and improve quality of life in people living with dementia. This study aimed to identify social benefits for participants living with dementia in the context of Promoting Activity, Independence and Stability in Early Dementia (PrAISED), an exercise intervention programme promoting physical activity and independence in participants living with dementia in England. METHODS: This was a multi-method realist evaluation undertaking secondary analysis of data collected during the PrAISED process evaluation, including qualitative interviews with participants with dementia, caregivers and therapists, personal notes of researchers, and video recordings of therapy sessions. The study consisted of four phases: (1) Setting operational definition of social outcomes in PrAISED; (2) Developing Context, Mechanisms, Outcome (CMO) configurations; (3) Testing and refining CMOs; and (4) Synthesising definitive CMOs into a middle range theory. RESULTS: Two CMOs were identified. (1) When therapists were able to make therapy sessions engaging and had the caregivers' support, the participants experienced therapy sessions as an opportunity to achieve goals in areas they were interested in. They also found the sessions enjoyable. This all led to the participants being highly engaged in their social interactions with the therapists. (2) When the participants realised that they were gaining benefits and progress through the PrAISED intervention, such as increased balance, this boosted their confidence in physical ability. It might also reduce caregivers' risk-aversion/gatekeeping attitude, which in turn would lead to participants' increased participation in social activities. CONCLUSION: The PrAISED intervention supported social participation in participants living with dementia. Under certain circumstances, home-based therapy interventions can be beneficial for social health (regardless of physical health gains). Given the limitations of currently available outcome measures to assess social participation, qualitative methods should be used to explore social health outcomes.

Women's engagement with community perinatal mental health services: a realist evaluation.

BACKGROUND: In recognition of the burden of Perinatal Mental Health problems, NHS England invested £365 million to transform women's access to mental health care, including investment in Community Perinatal Mental Health Services. This study examined how elements of provider care affected women's engagement with these services. METHODS: Semi-structured interviews were conducted with 139 women and explored their experiences of care from 10 different Community Perinatal Mental Health Teams; including which service components participants believed made a difference to their initial and continued engagement. Realist analysis was used to create context-mechanism-outcome configurations (CMOCs) across interviews, since not all parts of the configurations were always articulated within singular interviews. RESULTS: Four key pillars for engagement were identified: perinatal competence, relationship building, accurate reassurance, and reliability. The way perinatal competencies were relayed to women mattered; compassion, understanding and consistency were critical interactional styles. The extent to which these factors affected women's engagement varied by their context and personal characteristics. CONCLUSIONS: As mental health problems increase, disproportionately affecting vulnerable populations, it is critical to continue to ensure support is not only available, but appropriately meets the needs of those individuals. Our findings suggest that key staff behaviours applied at the right time can support women's engagement and potentially contribute to better treatment outcomes.

Using PURPOSE-T in clinical practice: A realist evaluation.

AIM: To explain how the clinical and organisational context influenced the way the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE-T) is used by nursing staff to support their clinical judgement and decision making about care planning and delivery. METHODS: A realist process evaluation was undertaken in a large acute hospital trust using mixed methods incorporating organisational policy review, staff semi-structured, ethnographic observation of clinical care and patient record review. Approximately 75 h of ethnographic field work involving 72 patients, 15 patient record reviews and 16 staff interviews were undertaken on 4 wards. FINDINGS: Findings suggest PURPOSE-T assisted nurses differently depending on their level of experience. Those with less experience use it as an educational guide, while those with more experience made an initial clinical judgement and used PURPOSE-T as a safety net to ensure they hadn't missed anything. Nurses were concerned about demonstrating good documentation of assessment, care planning and delivery in order to underpin consistent communication about care and because they had an underlying fear of being blamed if things went wrong. There is an array of other contextual features that impact the planning and delivery of pressure area care that go beyond the use of PURPOSE-T alone, including systematic equipment provision, competing patient safety initiatives and rehabilitation requirements. CONCLUSION: The findings reinforce the assertion that PU-RAIs are complex interventions and could inform the development of a more integrated system of care which takes into account the contextual features associated with PU prevention in modern hospitals.

Community case management to accelerate access to healthcare in Mali: a realist process evaluation nested within a cluster randomized trial.

The Proactive Community Case Management (ProCCM) trial in Mali reinforced the health system across both arms with user fee removal, professional community health workers (CHWs) and upgraded primary health centres (PHCs)-and randomized village-clusters to receive proactive home visits by CHWs (intervention) or fixed site-based services by passive CHWs (control). Across both arms, sick children's 24-hour treatment and pregnant women's four or more antenatal visits doubled, and under-5 mortality halved, over 3 years compared with baseline. In the intervention arm, proactive CHW home visits had modest effects on children's curative and women's antenatal care utilization, but no effect on under-5 mortality, compared with the control arm. We aimed to explain these results by examining implementation, mechanisms and context in both arms We conducted a process evaluation with a mixed method convergent design that included 79 in-depth interviews with providers and participants over two time-points, surveys with 195 providers and secondary analyses of clinical data. We embedded realist approaches in novel ways to test, refine and consolidate theories about how ProCCM worked, generating three context-intervention-actor-mechanism-outcome nodes that unfolded in a cascade. First, removing user fees and deploying professional CHWs in every cluster enabled participants to seek health sector care promptly and created a context of facilitated access. Second, health systems support to all CHWs and PHCs enabled equitable, respectful, quality healthcare, which motivated increased, rapid utilization. Third, proactive CHW home visits facilitated CHWs and participants to deliver and seek care, and build relationships, trust and expectations, but these mechanisms were also activated in both arms. Addressing multiple structural barriers to care, user fee removal, professional CHWs and upgraded clinics interacted with providers' and patients' agency to achieve rapid care and child survival in both arms. Proactive home visits expedited or compounded mechanisms that were activated and changed the context across arms.

How does mentoring occupational therapists improve intervention fidelity in a randomised controlled trial? A realist evaluation.

BACKGROUND: Integrating complex interventions within healthcare settings can be challenging. Mentoring can be embedded within a randomised controlled trial (RCT) to upskill and support those delivering the intervention. This study aimed to understand, from a realist perspective, how mentoring worked to support implementation fidelity for occupational therapists (OTs) delivering a vocational rehabilitation (VR) intervention within the context of an RCT. METHODS: A realist evaluation using secondary data (emails, mentoring record forms, interviews) collected as part of an RCT. Three researchers coded the data following content analysis, focused on refining or refuting an initial programme theory by exploring the interactions between context, mechanisms, and outcomes. The research team met to further refine the programme theories. RESULTS: Data from 584 emails, 184 mentoring record forms, and 25 interviews were analysed following a realist approach. We developed a programme theory consisting of two contexts (trial set-up, ongoing mentoring), nine mechanisms (collective understanding, monitoring, timely support, positive reinforcement, reflective practice, support data completeness, facilitation strategy, shared learning experience, management of research and clinical duties), and three outcomes (improved confidence, improved fidelity, reduced contamination). CONCLUSIONS: Offering mentoring support to OTs delivering a VR intervention as part of an RCT improves intervention fidelity and reduces the risk of contamination. It improves OTs' understanding of the differences between their clinical and research roles and increases their confidence and competence in trial paperwork completion and identification of potential contamination issues.

'For Want of a Nail': developing a transparent approach to retroduction and early initial programme theory development in a realist evaluation of community end of life care services.

A crucial part of theory-driven realist thinking is retroduction, the process of looking backwards for explanation of how and why things may be. Conducted early in the realist evaluation process, it provides a foundation for evidenced 'theory gleaning'. Despite retroduction being an inherent part of the realist process, it is often 'hidden' in realist reports. This paper explains the thinking behind, alongside an example of, a framework created by the authors to make transparent the retroductive process as used in a realist evaluation of two community End of Life Care services. The approach makes visible the application of the 'sociological imagination' and lends robustness to hypotheses by establishing how the authors utilised: wide-ranging potential generative causation; stakeholder and Patient and Public Involvement feedback; literature scoping; and substantive theories at the middle range, specifically Transitions Theory. These stages led to the development of Initial Programme Theories, with a clear history of genesis.

A realist evaluation of community champion and participatory action approaches during the COVID-19 pandemic.

Background: During the COVID-19 pandemic, public health teams tried several approaches to circulate accurate health information and engage with community members to understand what they need from public health services. Two such approaches were community champions and community participatory action research (CPAR). This study evaluates two champion programmes and a CPAR programme in terms of what worked, for whom, and in what contexts, including the funding and resourcing associated with implementation. Methods: Between June 2022 and June 2023, a realist evaluation of three distinct case studies (COVID-19 champions, Vaccine Champions, and CPAR programmes) in the city of Southampton in England was conducted in three stages: development of initial programme theories and collection of additional contextual information, including funding and resources associated with delivering each programme; initial programme theory testing; synthesis of final programme theories. Data was collected primarily through semi-structured interviews (n = 29) across programme and training leads, voluntary services, community organisations, volunteers, and local community members, and one focus group with local community members (n = 8). Results: The City Council used £642 k from two funding awards to deliver the programmes: COVID-19 Champions £41 k; Vaccine Champions £485 k; and CPAR programmes £115 k. Twenty-eight initial programme theories were generated, which were "tested" to support, refine, or refute context-mechanism-outcome relationships, resulting finally in a set of 22 programme theories across the three programmes. Six demi-regularities were generated, each featuring in multiple programme theories, and providing data on how and why these programmes can work, and in which contexts: (1) building trust through community connections; (2) fostering relationships and collaboration; (3) provision of training and resources; (4) local community knowledge and expertise; (5) community representation and leadership; (6) appropriate communication and information sharing. Conclusion: This study provides new knowledge and understanding of the factors affecting the implementation of community champion and CPAR approaches during public health emergencies. These findings suggest that representation and involvement of community members, establishing and building on trust, adequate training and resources, and clear communication from trusted community members and organisations are catalysts for meaningful engagement with communities.Evaluation registration: Research Registry identifier: researchregistry8094.

Realist process evaluation of the knowledge translation programme of a patient-oriented research network.

RATIONALE: The Knowledge Translation (KT) Programme of a pan-Canadian strategic patient-oriented research network focused on brain-based developmental disabilities aimed to mobilize knowledge relevant to the network members. The programme also promotes and studies integrated Knowledge Translation (iKT) approaches involving different interested parties, such as researchers, patient-partners and decision-makers, in all parts of the knowledge creation process. AIMS AND OBJECTIVES: The objective of this study is to advance research programme evaluation methods through a realist evaluation of the process of implementing iKT activities. METHODS: Realist process evaluation included: (1) development of initial programme theories (using the partnership synergy theory); (2) data collection and analysis; (3) synthesis and refinement of theories through engagement with literature; and (4) presentation of findings in context-mechanism-outcome (C-M-O) configurations. A range of project documentation records were reviewed for analysis, and three co-leads, a programme coordinator, and a senior research associate were consulted to contextualize the implementation process of relevant KT activities. RESULTS: Based on the developed C-M-O configurations, we identified five key mechanisms of generating synergy in the iKT processes: (1) Visible shared leadership that embodies what iKT looks like; (2) Researchers' readiness for iKT; (3) Adaptation and flexible allocation of resources to emerging needs; (4) Power sharing to create practical and creative knowledge; and (5) Collective voice for potential transformative impacts at the policy level. CONCLUSIONS: The current realist evaluation demonstrated how partnerships between researchers, patient-partners and other interested parties can synergistically generate new ways of thinking among all interested parties, actionable strategies to integrate users in research, and solutions to disseminate knowledge. In particular, we identified a pivotal role for patient-partners to act as equal decision-maker helps building and maintaining partnerships and consolidating KT strategies.

How do oilcloth sessions work? A realist evaluation approach to exploring ripple effects in an implementation strategy.

PURPOSE: To explore the mechanisms of the implementation strategy, "oilcloth sessions" and understand and explain the ripple effects of oilcloth sessions as a strategy to implement a new emergency department. DESIGN/METHODOLOGY/APPROACH: A qualitative design was used whereby data were collected using field notes from an ethnographic study of the oilcloth sessions and follow-up semi-structured interviews with staff, managers and key employees who participated in the oilcloth sessions. The data analysis was inspired by the realist evaluation approach of generative causality proposed by Pawson and Tilley. FINDINGS: The primary ripple effect was that the oilcloth sessions were used for different purposes than the proposed program theory, including being used as: (1) a stage, (2) a battlefield, (3) a space for imagination and (4) a strategic management tool influencing the implementation outcomes. The results bring essential knowledge that may help to explain why and how a well-defined implementation strategy has unplanned outcomes. ORIGINALITY/VALUE: Unintended outcomes of implementation strategies are an underexplored issue. This study may help implementation researchers rethink the activities required to reduce unintended negative outcomes or explore potential unplanned outcomes and, in this way, hinder or enhance outcomes, effectiveness and sustainability. Future studies within implementation research should incorporate attention to unintended outcomes to fully understand the impact of implementation strategies.

Translating global evidence into local implementation through technical assistance: a realist evaluation of the Bloomberg philanthropies initiative for global Road safety.

BACKGROUND: Traffic-related crashes are a leading cause of premature death and disability. The safe systems approach is an evidence-informed set of innovations to reduce traffic-related injuries and deaths. First developed in Sweden, global health actors are adapting the model to improve road safety in low- and middle-income countries via technical assistance (TA) programs; however, there is little evidence on road safety TA across contexts. This study investigated how, why, and under what conditions technical assistance influenced evidence-informed road safety in Accra (Ghana), Bogotá (Colombia), and Mumbai (India), using a case study of the Bloomberg Philanthropies Initiative for Global Road Safety (BIGRS). METHODS: We conducted a realist evaluation with a multiple case study design to construct a program theory. Key informant interviews were conducted with 68 government officials, program staff, and other stakeholders. Documents were utilized to trace the evolution of the program. We used a retroductive analysis approach, drawing on the diffusion of innovation theory and guided by the context-mechanism-outcome approach to realist evaluation. RESULTS: TA can improve road safety capabilities and increase the uptake of evidence-informed interventions. Hands-on capacity building tailored to specific implementation needs improved implementers' understanding of new approaches. BIGRS generated novel, city-specific analytics that shifted the focus toward vulnerable road users. BIGRS and city officials launched pilots that brought evidence-informed approaches. This built confidence by demonstrating successful implementation and allowing government officials to gauge public perception. But pilots had to scale within existing city and national contexts. City champions, governance structures, existing political prioritization, and socio-cultural norms influenced scale-up. CONCLUSION: The program theory emphasizes the interaction of trust, credibility, champions and their authority, governance structures, political prioritization, and the implement-ability of international evidence in creating the conditions for road safety change. BIGRS continues to be a vehicle for improving road safety at scale and developing coalitions that assist governments in fulfilling their role as stewards of population well-being. Our findings improve understanding of the complex role of TA in translating evidence-informed interventions to country-level implementation and emphasize the importance of context-sensitive TA to increase impact.

Tracking the Development of Community Engagement Over Time: Realist Qualitative Study.

BACKGROUND: A growing interest in engaging communities in the development of health care services and communities has not automatically led to progress or consensus as to how to engage communities successfully, despite the evidence base showing how to leverage enablers and alleviate barriers. OBJECTIVE: To bridge the gap between the evidence base and which community engagement (CE) approaches have actually been applied in practice over time, this study aims to investigate how CE approaches have changed over the past 4 years in 6 different regions in the Netherlands and citizens' and professionals' experiences underlying these changes. METHODS: For the last stage of a multiple case study following the development of CE approaches in 6 different regions in the Netherlands, a realist qualitative case study was conducted. To investigate how CE approaches had changed over the past 4 years, data from the entire 4 years of the study were used, including documents, interview transcripts, and observations. To examine citizens' and professionals' experiences underlying these changes, new interviews were conducted. The latest interview results were discussed with a panel to ensure the results had face validity. RESULTS: The regions had implemented different types of CE approaches over the past 4 years and were adapting these approaches over time. Many of the (remaining) approaches may be operating on a smaller scale. The study identified the following overarching themes along which CE had been adapted: fewer region-wide approaches and more community-focused approaches, more focus on building relationships with (already engaged) citizens and community-led initiatives, and more focus on practical and tangible health promotion and social cohesion activities and less focus on complex "abstract" programs. The study identified a further 4 overarching themes highlighting citizens' and professionals' experiences underlying these changes in the CE approaches: a lack of engagement environment, need for facilitative leadership from organizations, need for a clear and shared vision underscoring the importance of CE, and misalignment between citizens' and professionals' perspectives and motivations for CE. All participants had experienced the engagement environment as insufficient. To support CE, professionals experienced the need to develop and receive more facilitative leadership and to develop approaches better equipped to involve citizens in the decision-making process. Citizens experienced the need to better align citizens' and professionals' motivations and aims for CE approaches and to receive longer-term financial support for their community-led initiatives. CONCLUSIONS: This study suggests that CE has not yet been embedded within organizational cultures. This has arguably meant that the (remaining) CE approaches are operating on a smaller scale. To enable the further development of CE approaches, an investment in the engagement environment and a shared vision is required. Only then could CE within the regions move beyond the more seemingly smaller-scale CE approaches.

A Realist Evaluation of Social Care Practitioners' Experiences With and Understanding of Applied Healthcare Research.

Social care practitioners are often under-represented in research activity and output. Evidence-based practice enables social care practitioners to develop/engage the skills to evaluate evidence and be more actively involved in research. REalist Synthesis Of non-pharmacologicaL interVEntions for antipsychotic-induced weight gain (RESOLVE) is a NIHR-funded study where realist synthesis is used to understand and explain how, why, for whom, and in what contexts non-pharmacological interventions help service users, with severe mental illness, to manage antipsychotic-induced weight gain. Social care practitioners are a key part of the team providing care for people living with severe mental illness and therefore supporting antipsychotic-induced weight gain. The current study, RESOLVE 2, uses realist evaluation and RESOLVE as an illustrative example to help understand why and how social care practitioners engage (or not) with research. Semi-structured, audio-recorded interviews will be undertaken with a purposive sample of approximately 20 social care practitioners working with people who have severe mental illness, are treated with antipsychotics, and have experienced weight gain. Participants will be recruited from NHS Trusts and recruitment avenues such as social media and personal networks. Topics discussed during interviews will include barriers and facilitators to engagement in research, current, and past engagement as well as recommendations for researchers and other practitioners. Interview recordings will be transcribed verbatim and analyzed using realist evaluation which will allow in-depth causal explanations for research engagement. Better understanding of research engagement by social care practitioners will allow for evidence-based practice and better patient outcomes within these settings.

A realist evaluation of devices used for the prevention of heel pressure ulcers: An ethnographic study of clinical practice.

BACKGROUND: It is known that heel offloading devices are widely used in clinical practice for the prevention of heel pressure ulcers, even though there is a lack of robust, good quality evidence to inform their use. OBJECTIVE: To explore how and why heel offloading devices are used (or not used) and reasoning behind their use in population at high risk of developing heel pressure ulcers. METHODS: An ethnographic study was conducted as part of a realist evaluation in three orthopaedic wards in a large English hospital. Twelve observations took place, with 49 h and 35 min of patient care observed. A total of 32 patients were observed and 19 members of the nursing team were interviewed and in-depth interviews with the three ward managers were conducted. RESULTS: Although the focus of the study was on offloading devices, constant low pressure heel specific devices were also observed in use for pressure ulcer prevention, whilst offloading devices were perceived to be for higher risk patients or those already with a heel pressure ulcer. Nursing staff viewed leadership from the ward manager and the influence of the Tissue Viability Nurse Specialists as key mechanisms for the proactive use of devices. CONCLUSIONS: This study informs trial design as it has identified that a controlled clinical trial of both types of heel specific devices is required to inform evidence-based practice. Involving the ward managers and Tissue Viability Nurse Specialists during set up phase for clinical equipoise could improve recruitment. Tweetable abstract How, for whom, and in what circumstances do devices work to prevent heel pressure ulcers? Observations of clinical practice.