Flexible bronchoscopy in pediatric lung transplantation.

Pediatric lung transplantation represents a treatment option for children with advanced lung disease or pulmonary vascular disorders who are deemed an appropriate candidate. Pediatric flexible bronchoscopy is an important and evolving field that is highly relevant in the pediatric lung transplant population. It is thus important to advance our knowledge to better understand how care for children after lung transplant can be maximally optimized using pediatric bronchoscopy. Our goals are to continually improve procedural skills when performing bronchoscopy and to decrease the complication rate while acquiring adequate samples for diagnostic evaluation. Attainment of these goals is critical since allograft assessment by bronchoscopic biopsy is required for histological diagnosis of acute cellular rejection and is an important contributor to establishing chronic lung allograft dysfunction, a common complication after lung transplant. Flexible bronchoscopy with bronchoalveolar lavage and transbronchial lung biopsy plays a key role in lung transplant graft assessment. In this article, we discuss the application of bronchoscopy in pediatric lung transplant evaluation including historical approaches, our experience, and future directions not only in bronchoscopy but also in the evolving pediatric lung transplantation field. Pediatric flexible bronchoscopy has become a vital modality for diagnosing lung transplant complications in children as well as assessing therapeutic responses. Herein, we review the value of flexible bronchoscopy in the management of children after lung transplant and discuss the application of novel techniques to improve care for this complex pediatric patient population and we provide a brief update about new diagnostic techniques applied in the growing lung transplantation field.

A comparison of social prescribing approaches across twelve high-income countries.

BACKGROUND: Social prescribing connects patients with community resources to improve their health and well-being. It is gaining momentum globally due to its potential for addressing non-medical causes of illness while building on existing resources and enhancing overall health at a relatively low cost. The COVID-19 pandemic further underscored the need for policy interventions to address health-related social issues such as loneliness and isolation. AIM: This paper presents evidence of the conceptualisation and implementation of social prescribing schemes in twelve countries: Australia, Austria, Canada, England, Finland, Germany, Portugal, the Slovak Republic, Slovenia, the Netherlands, the United States and Wales. METHODS: Twelve countries were identified through the Health Systems and Policy Monitor (HSPM) network and the EuroHealthNet Partnership. Information was collected through a twelve open-ended question survey based on a conceptual model inspired by the WHO's Health System Framework. RESULTS: We found that social prescribing can take different forms, and the scale of implementation also varies significantly. Robust evidence on impact is scarce and highly context-specific, with some indications of cost-effectiveness and positive impact on well-being. CONCLUSIONS: This paper provides insights into social prescribing in various contexts and may guide countries interested in holistically tackling health-related social factors and strengthening community-based care. Policies can support a more seamless integration of social prescribing into existing care, improve collaboration among sectors and training programs for health and social care professionals.

A systematic review of the use of the concept family resilience in interventions with families with children and young people.

OBJECTIVE: To review the evidence on using family resilience as a concept in interventions by public health nurses/health visitors with families with children and young people as part of an evaluation of the evidence base for the Family Resilience Assessment Instrument and Tool (FRAIT). FRAIT was developed by University faculty with Health Visitors and a Community of Practice in Wales, and is used by Health Visitors in Wales with families with children under 5 years to assess family resilience. METHOD: A standard Cochrane Systematic Review methodology was used to review published literature. A protocol (crd.york.ac.uk/PROSPERO/display_record.php?RecordID = 230845) was submitted to Prospero in September 2021, and reviewing began in January 2022. Title and abstract searching were undertaken 12 databases and results were captured using PRISMA and Excel spreadsheet. Second reviewers reviewed title and abstract screening, and full-text extraction. RESULTS: Initial title screening brought back 1350 papers across 12 databases. Titles and abstract screening reduced these to 106, 44 papers were considered for full-text extraction, with 25 papers included for review. DISCUSSION: Results demonstrated a focus on specific demographics, and use of family resilience with families living with specific health problems. Existing family resilience scales showed improved results in selected specific demographic groups, albeit in a reactive way. FRAIT has originality within the literature as it is used in a universal, preventative way with all families regardless of demographic or health issues. There is evidence to show that using a family resilience program in this way has originality and implications for the physical and mental health of children and young people. NO PATIENT OR PUBLIC CONTRIBUTION: This was a systematic review of existing literature so public or patient contribution would not have been appropriate.

Speaking the same language - a scoping review to identify the terminology associated with social prescribing.

AIM: To identify the social prescribing-related terminology within the peer-reviewed literature of the UK and the grey literature from Wales. BACKGROUND: Social prescribing has seen a period of development that has been accompanied by a proliferation of related terminology and a lack of standardisation in the manner in which it is employed. This creates barriers to engagement and impairs communication, both between professionals and members of the public. The Wales School for Social Prescribing Research and Public Health Wales committed to the development of a glossary of terms for social prescribing, to facilitate the clarification and standardisation of the associated terminology. Here, we describe the first step in that process. METHOD: A scoping review of the peer-reviewed UK literature and Welsh grey literature was conducted. The titles and abstracts of 46,242 documents and the full text of 738 documents were screened. Data were charted from 205 documents. Data capture included terminology, the location within the UK of the research or intervention described in the article, and the perspective from which the article was authored. A general inductive approach was used to categorise the terms by theme. FINDINGS: This research serves to highlight the breadth and diversity of the terminology associated with social prescribing. Results demonstrate aspects of shared commonality and clear distinction between the terminology from the two literature sources. The greatest contributions of terms were from articles that examined research and/or interventions in England and that were authored from the perspective of health or health and social care. The research indicates that nation- and sector-specific terms may not be adequately represented in the literature at large. Looking forward, it will be important to ensure that social prescribing terminology within the UK literature is culturally relevant and accurately reflects the terminology used by the workforce who encounter and deliver social prescribing.

Enhancing Student Wellbeing Through Social Prescribing: A Rapid Realist Review.

Objectives: A Rapid Realist Review of social prescribing in Higher Education (HE) was undertaken to determine what works, for whom, how, why, and within what circumstances. The review resulted in the development of a Realist Programme Theory articulating the way in which social prescribing can be implemented within the HE environment. Methods: Searches of 12 electronic databases were supplemented by citation chaining and grey literature surfaced by the Project Advisory Group. The RAMESES Quality Standards for Realist Review were followed, and the retrieved articles were systematically screened and iteratively analysed to develop Context-Mechanism-Outcome Configurations (CMOCs) and an overarching Realist Programme Theory. Results: A total of 57 documents were included. The overarching programme theory was developed from the analysis of these documents and comprised of a social prescribing pathway with the following components: (1) An Accessible Gateway, (2) A Skilled Peer, (3) Trusted-Safe-Credible Resources, and (4) A Healthy Setting. Conclusion: A Realist Programme Theory was developed-this model and associated principles will provide a theoretical basis for the implementation of social prescribing pathways within higher education. Whilst the direct project outputs are of particular significance to the UK HE audience, the underpinning principles can support practice within the global arena.

Identifying barriers and facilitators to the inclusion of older adults living in UK care homes in research: a scoping review.

BACKGROUND: With an ageing population, older adults will have more complex health and social care needs and many of these older adults will be living in care homes. Despite the growth in care home populations, care home residents are often excluded from research that could potentially benefit their care. The purpose of this scoping review is to explore resident-related barriers and facilitators to including older people living in UK care homes in research and to identify potential approaches to modify such barriers. METHOD: The 6-stage scoping review methodology framework proposed by Arksey and O'Malley guided this review. Five electronic databases (MedLine, PsychINFO, Scopus, Web of Science, CINAHL) and grey literature were searched. Identified articles went through two levels of screening, and those deemed relevant were collated, summarised and reported using a thematic analysis approach. RESULTS: 90 reports were eligible for inclusion and were synthesised into 7 themes and related subthemes: (1) research design; (2) understanding and beliefs about research (resident and care home staff); (3) communication; (4) relationships; (5) eligibility criteria (resident and care home); (6) preference-based decisions; and (7) care home staff and environment. Given the complex interplay of the factors identified, both direct and indirect factors were included. CONCLUSIONS: A number of recurring barriers and facilitators to the inclusion of care home residents in research are reported. However, isolating resident-related barriers was complex as both direct and indirect factors must be considered as influential. Understanding the barriers and facilitators to inclusion will enable these factors to be addressed and increase the evidence-base for care provided to older people living in care homes.

Global developments in social prescribing.

Social prescribing is an approach that aims to improve health and well-being. It connects individuals to non-clinical services and supports that address social needs, such as those related to loneliness, housing instability and mental health. At the person level, social prescribing can give individuals the knowledge, skills, motivation and confidence to manage their own health and well-being. At the society level, it can facilitate greater collaboration across health, social, and community sectors to promote integrated care and move beyond the traditional biomedical model of health. While the term social prescribing was first popularised in the UK, this practice has become more prevalent and widely publicised internationally over the last decade. This paper aims to illuminate the ways social prescribing has been conceptualised and implemented across 17 countries in Europe, Asia, Australia and North America. We draw from the 'Beyond the Building Blocks' framework to describe the essential inputs for adopting social prescribing into policy and practice, related to service delivery; social determinants and household production of health; workforce; leadership and governance; financing, community organisations and societal partnerships; health technology; and information, learning and accountability. Cross-cutting lessons can inform country and regional efforts to tailor social prescribing models to best support local needs.

Exploring how and why social prescribing evaluations work: a realist review.

OBJECTIVE: The evidence base for social prescribing is inconclusive, and evaluations have been criticised for lacking rigour. This realist review sought to understand how and why social prescribing evaluations work or do not work. Findings from this review will contribute to the development of an evidence-based evaluation framework and reporting standards for social prescribing. DESIGN: A realist review. DATA SOURCES: ASSIA, CINAHL, Embase, Medline, PsycINFO, PubMed, Scopus Online, Social Care Online, Web of Science and grey literature. ELIGIBILITY CRITERIA: Documents reporting on social prescribing evaluations using any methods, published between 1998 and 2020 were included. Documents not reporting findings or lacking detail on methods for data collection and outcomes were excluded. ANALYSIS: Included documents were segregated into subcases based on methodology. Data relating to context, mechanisms and outcomes and the programme theory were extracted and context-mechanism-outcome configurations were developed. Meta-inferences were drawn from all subcases to refine the programme theory. RESULTS: 83 documents contributed to analysis. Generally, studies lacked in-depth descriptions of the methods and evaluation processes employed. A cyclical process of social prescribing evaluation was identified, involving preparation, conducting the study and interpretation. The analysis found that coproduction, alignment, research agency, sequential mixed-methods design and integration of findings all contributed to the development of an acceptable, high-quality social prescribing evaluation design. Context-mechanism-outcome configurations relating to these themes are reported. CONCLUSIONS: To develop the social prescribing evidence base and address gaps in our knowledge about the impact of social prescribing and how it works, evaluations must be high quality and acceptable to stakeholders. Development of an evaluation framework and reporting standards drawing on the findings of this realist review will support this aim. PROSPERO REGISTRATION NUMBER: CRD42020183065.

Using an integrated competence model to evaluate a health visitor cascade training programme for the Family Resilience Assessment Instrument and Tool (FRAIT).

This paper reports on an evaluation of health visitor trainers' experience of a cascade training programme delivered in Wales, UK. Health visitors used Driscoll's model (What, So What, Now What) to organise their feedback and an integrated competence model developed by Weeks et al. was used to analyse the feedback via category analysis of free text. As well as feedback on the logistics of running the training, the evaluation allowed for cognitive and functional competence to be identified along with personal and meta competence. There was limited scope for identifying ethical competence in the Health Visitor cascade trainer feedback. Suggestions are made for how this may be addressed.

Enhancing higher education student well-being through social prescribing: a realist evaluation protocol.

INTRODUCTION: UK higher education (HE) student numbers are increasing and students report higher levels of mental health and well-being issues. Social prescribing links individuals to community-based, non-medical support. It is widely implemented throughout the UK, and is supported by the Welsh Government. This protocol presents an evaluation of a new social prescribing service to enhance student well-being, a first for UK HE students. METHODS AND ANALYSIS: A realist evaluation to articulate why, how and to what extent and circumstances social prescribing works for students, using a mixed-methods sequential design of four cycles. Cycle 1 informs the model and programme theory development of how the model works; activities include a Realist Review, Group Concept Mapping and producing bilingual short films about the evaluation and model. Cycle 2 involves secondary analysis of routine service data, and outcome measurements from students receiving a social prescription. Cycle 3 uses reflective diaries and qualitative realist interviews with stakeholders to understand the process and outcome of the model. Cycle 4 concludes with a world café workshop with stakeholders to agree and finalise the framework specification of 'how, why, when and to what extent' the model works. A meta-matrix construction will determine convergence, complementarity or discrepancy across the cycles. An advisory group of key stakeholders informs each cycle. ETHICS AND DISSEMINATION: University of South Wales Life Sciences and Education Ethics Committee and Wrexham Glyndwr University (WGU) Research Ethics Sub-Committee approved secondary data analysis of participant demographics (200 805LRL:USW, id441:WGU), outcome measurement tools (200 902LR:USW, id441:WGU) and qualitative data collection (200 804LR:USW, id449:WGU). The authors will publish findings in peer-reviewed journals, produce an evaluation report to the funder and a short film for dissemination via stakeholders, university networks, United Nations Regional Centre of Expertise in Wales, PRIME Centre Wales, Wales School for Social Prescribing Research, conferences and social media.

Primary health care in the Amazon and its potential impact on health inequities: a scoping review.

INTRODUCTION: Health studies of the Amazon often focus on diseases and infections prevalent in the region, and few studies address health organizations and services. In this sense, this study fills a gap by reviewing the studies aimed at primary healthcare (PHC) implementation in the nine Amazonian countries. This review addresses a need to explore the forms in which PHC is implemented in the Amazon areas outside the urban centers and its potential to reduce health inequities. This study contributes to improvements in the practices of managers and health professionals and research on the topic. METHODS: Scoping review methodology was applied to peer-reviewed articles. The databases searched were PubMed, Scopus, Lilacs, Embase and Web of Science. Selected studies included peer-reviewed publications, published between January 2000 and November 2019, that focused on PHC or one of its components in the Amazon, and were published in English, Spanish and Portuguese. The study used Arksey and O'Malley's scoping review guidelines, supported by Levac, and included five steps: (i) identification phase, where search queries were applied to the databases followed by the removal of duplicates; (ii) screening phase, where titles and abstracts of articles were screened to exclude irrelevant articles; (iii) eligibility phase, where the full texts of articles were read to assess their relevancy to this study; (iv) data extraction, using a spreadsheet designed to capture relevant information required in this review, using an iterative process; (v) summarizing and classification of each article according to content. The second and third phases were conducted independently by two reviewers. If a disagreement arose between the reviewers, a third reviewer was consulted to help decide whether to include or exclude a study. RESULTS: This review included 25 studies. Of these, 11 presented promising results regarding PHC functioning in the Amazon region, and 14 presented challenges and difficulties in its functioning. Some PHC strategies implemented in the Amazon showed the potential to reduce inequities, mostly when they involved actions that increased access to PHC in the region when they developed a culturally adapted role and engaged community members in the decision-making and in the collaborative construction of health services. Actions that exposed challenges and difficulties were related to ill-prepared healthcare professionals, inadequate service approach and the inability to adapt to cultural issues. CONCLUSION: The findings reveal information about PHC implementations that have had promising results in the Amazon region and, at the same time, show the challenges and difficulties of the PHC actions. The findings also highlight and synthesize knowledge about the potential that PHC strategies have to affect existing inequities in the Amazon region and gaps in the studies that have been undertaken, or at least published, including a lack of studies of PHC implementation and examination of strategies aimed at health determinants.

Training in health coaching skills for health professionals who work with people with progressive neurological conditions: A realist evaluation.

BACKGROUND: Supporting people to self-manage their long-term conditions is a UK policy priority. Health coaching is one approach health professionals can use to provide such support. There has been little research done on how to train clinicians in health coaching or how to target training to settings where it may be most effective. OBJECTIVE: To develop theories to describe how training health professionals in health coaching works, for whom and in what circumstances, with a focus on those working with people with progressive neurological conditions. DESIGN: Realist evaluation using mixed methods (participant observation, pre- and post-training questionnaires, and telephone interviews with participants and trainers). Realist data analysis used to develop and refine theories. INTERVENTION: Two 1-day face-to-face training sessions in health coaching with 11 weeks between first and second days. SETTING AND PARTICIPANTS: Twenty health-care professionals who work with people with neurological conditions in the UK, two training facilitators. RESULTS: Four theories were developed using context-mechanism-outcome configurations to describe how training triggers critical reflection; builds knowledge, skills and confidence; how participants evaluate the relevance of the training; and their experiences of implementing the training. Some participants reported a major shift in practice, and others implemented the training in more limited ways. DISCUSSION: Fully embracing the role of coach is difficult for health professionals working in positions and settings where their clinical expertise appears most highly valued. CONCLUSIONS: Training should address the practicality of using coaching approaches within existing roles, while organizations should consider their role in facilitating implementation.

Collaboration with community connectors to improve primary care access for hardly reached people: a case comparison of rural Ireland and Australia.

BACKGROUND: This study presents a way for health services to improve service access for hardly reached people through an exploration of how staff can find and collaborate with citizens (referred to as connectors) who span socio-cultural boundaries in their community. The study explored the local socio-cultural contexts of connectors' boundary spanning activities and if they are health related; boundary spanning occurring between connectors and health professionals at the interface of health systems and community; and the opportunities and barriers to actively seeking out and collaborating with community connectors to access marginalised and hardly reached people. METHODS: We conducted a qualitative case comparison from rural Ireland and Australia. Following purposive snow-ball sampling techniques to recruit participants, semi-structured interviews were conducted with 34 community informants, 21 healthcare staff and 32 connectors. Transcripts were coded and analysed using an inductive approach to ascertain categories and overall themes. RESULTS: We found a diverse sample of connectors relating to heterogenous, small and locally distinct groups of hardly reached people. Overall 26 connectors were active at the interface between health services and the community, with variation in how this occurred between cases. The majority (21) described one or more health related activities with hardly reached people. All connectors expressed a willingness to develop a relationship with local health services on issues they identified as relevant. Barriers to collaborations between connectors and health services related to bureaucracy, workload, and burnout. CONCLUSIONS: Collaborating with connectors has potential as one strategy to improve access to health services for hardly reached people. To enact this, health staff need to identify local socio-cultural boundaries and associated connectors, facilitate two-way connections at the boundary between health services and community and enable collaboration by attending to activities in the community, at the interface between health services and community, and within the health system.

Using group concept mapping to explore the complexities of managing children's care.

BACKGROUND: Children whose assessed health needs cannot be met by statutory and universal services may require bespoke packages of continuing care. A project management group was set up to design a study that would explore the complexities for a children's community nurse (CCN) of managing such packages. METHODOLOGY: Group concept mapping (GCM), a mixed quantitative/qualitative participant-centred methodology, was used to obtain consensus from 20 CCNs about the complexities inherent in managing such packages and to develop a concept map that illustrated the emerging conceptual framework. DISCUSSION: The participants' ideas were written as statements and analysed. Core analysis of a square symmetrical matrix through multidimensional scaling and hierarchical cluster analysis was undertaken to produce a set of maps and reports. The final concept map was interpreted. It contained 99 statements organised into five conceptual clusters: 'education and training' (17 statements), 'risk and safety' (15 statements), 'continuing care process' (17 statements), 'relationships and boundaries' (22 statements) and 'working with families' (28 statements). CONCLUSION: CCNs used GCM to explore their roles and responsibilities when managing children's continuing care. Their resulting ideas were developed into a five-cluster conceptual framework that illustrated their views about the complexities of managing such care. IMPLICATIONS FOR PRACTICE: The emergent conceptual framework enables CCNs to explore their practice in relation to managing packages of care. Additionally, the framework will be used to design a CCN workforce planning instrument that will be useful to measure complexity in CCN caseloads. The GCM methodology could be used by other nursing teams who wish to develop their practice.

Public involvement and engagement in primary and emergency care research: the story from PRIME Centre Wales.

BACKGROUND: Policy throughout the United Kingdom promotes involvement of patients and public members in research to benefit patient care and health outcomes. PRIME Centre Wales is a national research centre, developing and coordinating research about primary and emergency care which forms 90% of health service encounters. In this paper, we describe our approach to public involvement and engagement in PRIME Centre Wales (hereafter called PRIME), in particular: how this approach has developed; ways in which public members contribute to PRIME activity; the strengths and limitations of our approach, challenges and future opportunities. PRIME ensures work is relevant to service users, carers, the public and policy makers by incorporating comprehensive patient and public involvement in every phase of our work. APPROACH: PRIME has policies and processes to enable and promote successful public involvement and engagement across research activities. This ensures public perspectives and patient experiences are integrated throughout research development, implementation and dissemination and in managing and delivering PRIME strategy over a 10 year timescale. A public/patient group called SUPER is a key resource providing wide-ranging perspectives via email and face-to-face discussion. We collect information on processes and experiences to assess value and impact, to guide ongoing involvement and engagement. A funded post provides leadership and support to staff and to public/patient contributors to facilitate collaborations. DISCUSSION: A stable, well-resourced structure has provided the timescales to build strong relationships and embed diverse approaches to public involvement and engagement within PRIME. Researchers and public contributors have committed to collaborations, developed knowledge and skills and sustained relationships. Effective approaches incorporate values and actions which, when operating together, strengthen processes and outcomes of public involvement and engagement. CONCLUSION: Supportive context, motivation and time are necessary to foster values and practices that enable effective public involvement and engagement. PRIME has embedded public involvement and engagement across research activities and structures. Central is the public/patient group SUPER offering experience-based expertise to add value to the research cycle. This innovative model, aligned with best practice, enhances relevance and quality of primary and emergency care research to benefit patients and the general population.

Developing a family resilience assessment tool for health visiting/public health nursing practice using virtual commissioning, high-fidelity simulation and focus groups.

UK public health nurse assessment of family resilience is a necessary component of monitoring family health and children's development and identifying areas for change. This research was part of an exploration of Welsh public health nurses' understanding of 'family resilience' as a concept underpinning their practice. From it, the Family Resilience Assessment Instrument Tool (FRAITTM www.frait.wales/) was developed for public health nurses use. We report on a virtual commissioning process using focus groups and an immersive simulation suite to test a FRAIT prototype in a safe environment before field testing. Virtual commissioning design: Hydra-Minerva Immersive Simulation Suite - individual public health nurses presented with a multi-media scenario as they used the prototype FRAIT. Follow-up focus groups for usability insights before field testing. Virtual commissioning raised real-world issues which public health nurses discussed in focus groups. Issues were scoring, absence of information, focusing on family resilience, identifying adults caring for children, potential for use, identifying need and monitoring change, potential impact of using FRAIT and fitting it to everyday practice. Prototype testing like this allowed us to fine tune the FRAIT for field testing.

Engaging Individuals with Neurological Conditions and Caregivers in Rural Communities in a Health Research Team.

BACKGROUND: In rural communities, individuals living with neurological conditions, such as stroke, traumatic brain injury (TBI), or spinal cord injury (SCI) and their caregivers face limited resources, decreased support, and a lack of access to health information and research. Little information exists on how to engage these individuals in community-based research. OBJECTIVES: We sought to 1) determine the most effective method(s) for engaging individuals with stroke, TBI, or SCI, and their caregivers in rural communities; 2) determine the perceived value of patient-centered outcomes research (PCOR) in their health care and clinical decision making; 3) to determine their health needs and related research priorities; and 4) to establish a community-based research team to support the development of relevant questions. METHODS: Targeting a population of individuals with stroke, TBI, or SCI and their caregivers, as well as health care providers, 17 in-depth interviews were conducted, followed by seven focus groups, and two half-day meetings to establish a community-based research team and develop a research agenda. RESULTS: Recruitment through trusted community networks was found to be the most beneficial for engaging participants. Participants placed high value on health research, but reported difficulties in accessing health information and in finding the information most relevant to them. A research team was established and research priorities centered on access to care and education. CONCLUSIONS: It is imperative to involve those living with a diagnosis or in an under-resourced community to develop the solutions that will work for them in their settings.

Boundary spanning practices of community connectors for engaging 'hardly reached' people in health services.

Global health policies direct health services to improve access and health outcomes of people who are 'hardly reached' by services. The institutionalised nature of health services with associated professional and organisational boundaries create ongoing challenges to achieving this policy aim. We present an approach to this challenge by exploring how health services can tap into the existing boundary spanning activities of community members we term as 'community connectors' who undertake valuable boundary work within the community to include people who are hardly reached. We address the research questions: what are the behaviours and characteristics of community connectors?; to what extent are they motivated to help out with health?; and how can health service personnel identify community connectors? We conducted an instrumental case study during 2017 in Victoria, Australia in the catchment area of a rural health service. Interviews with 17 key informants and eight staff members led to a further 15 interviews with community connectors. We identified the three key roles of 'noticer and responder', 'connector' and 'provider' that make connectors a valuable asset for health services. Community connectors seek opportunities to negotiate new boundaries with health services that support their boundary spanning with people hardly reached and also enable health services to transgress their own boundaries and access people who are hardly reached. We conclude that by paying attention to their own production, maintenance and transgression of boundaries, health services can apply this approach, noting that the local and iterative nature of identifying community connectors means that each cohort of community connectors will be unique as determined by local boundaries and relationships.

Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting.

BACKGROUND: Although adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. We describe our approach to reporting and categorising medical and other AE reports, using a case study trial. We explore predictors of medical and social AEs, and develop a model for conceptualising safety monitoring. METHODS: The Building Blocks randomised controlled trial of specialist home visiting recruited 1618 first-time mothers aged 19 years or under at 18 English sites. Event reports collected during follow-up were independently reviewed and categorised as either Medical (standard Good Clinical Practice definition), or Social (trial-specific definition). A retrospectively developed system was created to classify AEs. Univariate analyses explored the association between baseline participant and study characteristics and the subsequent reporting of events. Factors significantly associated at this stage were progressed to binary logistic regressions to assess independent predictors. RESULTS: A classification system was derived for reported AEs that distinguished between Medical or Social AEs. One thousand, three hundred and fifteen event reports were obtained for mothers or their babies (1033 Medical, 257 Social). Allocation to the trial intervention arm was associated with increased likelihood of Medical rather than Social AE reporting. Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events. Baseline predictors of Social AEs included being younger at recruitment (OR = 0.78 (CI = 0.67 to 0.90), p = 0.001), receiving benefits (OR = 1.60 (CI = 1.09 to 2.35), p = 0.016), and having a higher antisocial behaviour score (OR = 1.22 (CI = 1.09 to 1.36), p < 0.001). Baseline predictors of Medical AEs included having a limiting long-term illness (OR = 1.37 (CI = 1.01 to 1.88), p = 0.046), poorer mental health (OR = 1.03 (CI = 1.01 to 1.05), p = 0.004), and being in the intervention arm of the trial (OR = 1.34 (CI = 1.07 to 1.70), p = 0.012). CONCLUSIONS: Continuity between baseline and subsequent adverse experiences was expected despite potentially beneficial intervention impact. We hypothesise that excess events reported for intervention-arm participants is likely attributable to surveillance bias. We interpreted our findings against a new model that explicates processes that may drive event occurrence, presentation and reporting. Focussing only upon Medical events may miss the well-being and social circumstances that are important for interpreting intervention safety and participant management. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN23019866. Registered on 20 April 2009.