Randomised pilot and feasibility trial of a group intervention for men who perpetrate intimate partner violence against women.

BACKGROUND: There is a need for robust evidence on the effectiveness and cost-effectiveness of domestic abuse perpetrator programmes in reducing abusive behaviour and improving wellbeing for victim/survivors. While any randomised controlled trial can present difficulties in terms of recruitment and retention, conducting such a trial with domestic abuse perpetrators is particularly challenging. This paper reports the pilot and feasibility trial of a voluntary domestic abuse perpetrator group programme in the United Kingdom. METHODS: This was a pragmatic individually randomised pilot and feasibility trial with an integrated qualitative study in one site (covering three local-authority areas) in England. Male perpetrators were randomised to either the intervention or usual care. The intervention was a 23-week group programme for male perpetrators in heterosexual relationships, with an average of three one-to-one sessions, and one-to-one support for female current- or ex-partners delivered by third sector organisations. There was no active control treatment for men, and partners of control men were signposted towards domestic abuse support services. Data were collected at three-monthly intervals for nine months from male and female participants. The main objectives assessed were recruitment, randomisation, retention, data completeness, fidelity to the intervention model, and acceptability of the trial design. RESULTS: This study recruited 36 men (22 randomly allocated to attend the intervention group programme, 14 to usual care), and 15 current- or ex-partners (39% of eligible partners). Retention and completeness of data were high: 67% of male (24/36), and 80% (12/15) of female participants completed the self-reported questionnaire at nine months. A framework for assessing fidelity to the intervention was developed. In interviews, men who completed all or most of the intervention gave positive feedback and reported changes in their own behaviour. Partners were also largely supportive of the trial and were positive about the intervention. Participants who were not allocated to the intervention group reported feeling disappointed but understood the rationale for the trial. CONCLUSIONS: It was feasible to recruit, randomise and retain male perpetrators and female victim/survivors of abuse and collect self-reported outcome data. Participants were engaged in the intervention and reported positive benefits. The trial design was seen as acceptable. TRIAL REGISTRATION: ISRCTN71797549, submitted 03/08/2017, retrospectively registered 27/05/2022.

Improving access to general practice for and with people with severe and multiple disadvantage: a qualitative study.

BACKGROUND: People with severe and multiple disadvantage (SMD) who experience combinations of homelessness, substance misuse, violence, abuse, and poor mental health have high health needs and poor access to primary care. AIM: To improve access to general practice for people with SMD by facilitating collaborative service improvement meetings between healthcare staff, people with lived experience of SMD, and those who support them; participants were then interviewed about this work. DESIGN AND SETTING: The Bridging Gaps group is a collaboration between healthcare staff, researchers, women with lived experience of SMD, and a charity that supports them in a UK city. A project was co-produced by the Bridging Gaps group to improve access to general practice for people with SMD, which was further developed with three inner-city general practices. METHOD: Nine service improvement meetings were facilitated at three general practices, and six of these were formally observed. Nine practice staff and four women with lived experience of SMD were interviewed. Three women with lived experience of SMD and one staff member who supports them participated in a focus group. Data were analysed inductively and deductively using thematic analysis. RESULTS: By providing time and funding opportunities to motivated general practice staff and involving participants with lived experience of SMD, service changes were made in an effort to improve access for people with SMD. These included prioritising patients on an inclusion patient list with more flexible access, providing continuity for patients via a care coordinator and micro-team of clinicians, and developing an information-sharing document. The process and outcomes improved connections within and between general practices, support organisations, and people with SMD. CONCLUSION: The co-designed strategies described in this study could be adapted locally and evaluated in other areas. Investing in this focused way of working may improve accessibility to health care, health equity, and staff wellbeing.

The effectiveness and cost-effectiveness of a group domestic abuse perpetrator programme: protocol for a randomised controlled trial.

BACKGROUND: In contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of perpetrator programmes for reduction of abuse is uncertain. This study aims to estimate the effectiveness and cost-effectiveness of a perpetrator programme for men. METHODS: Pragmatic two-group individually randomised controlled trial (RCT) with embedded process and economic evaluation. Five centres in southwest England and South Wales aim to recruit 316 (reduced from original target of 366) male domestic abuse perpetrators. These will be randomised 2:1 to a community-based domestic abuse perpetrator programme (DAPP) or usual care comparator with 12-month follow-up. Female partners/ex-partners will be invited to join the study. The intervention for men comprises 23 weekly sessions of a group programme delivered in voluntary sector domestic abuse services. The intervention for female partners/ex-partners is one-to-one support from a safety worker. Men allocated to usual care receive no intervention; however, they are free to access other services. Their partners/ex-partners will be signposted to support services. Data is collected at baseline, and 4, 8 and 12 months' follow-up. The primary outcome is men's self-reported abusive behaviour measured by the Abusive Behaviour Inventory (ABI-29) at 12 months. Secondary measures include physical and mental health status and resource use alongside the abuse measure ABI (ABI-R) for partners/ex-partners and criminal justice contact for men. A mixed methods process evaluation and qualitative study will explore mechanisms of effectiveness, judge fidelity to the intervention model using interviews and group observations. The economic evaluation, over a 1-year time horizon from three perspectives (health and social care, public sector and society), will employ a cost-consequences framework reporting costs alongside economic outcomes (Quality-Adjusted Life Years derived from EQ-5D-5L, SF-12 and CHU-9D, and ICECAP-A) as well as the primary and other secondary outcomes. DISCUSSION: This trial will provide evidence of the (cost)effectiveness of a DAPP. The embedded process evaluation will further insights in the experiences and contexts of participants and their journey through a perpetrator programme, and the study will seek to address the omission in other studies of economic evaluations. TRIAL REGISTRATION: ISRCTN15804282, April 1, 2019.

Trauma-informed co-production: Collaborating and combining expertise to improve access to primary care with women with complex needs.

INTRODUCTION: Health, social care, charitable and justice sectors are increasingly recognising the need for trauma-informed services that seek to recognise signs of trauma, provide appropriate paths to recovery and ensure that services enable people rather than retraumatise. Foundational to the development of trauma-informed services is collaboration with people with lived experience of trauma. Co-production principles may provide a useful framework for this collaboration, due to their emphasis on lived experience, and intent to address power imbalances and promote equity. This article aims to examine trauma-informed and co-production principles to consider the extent to which they overlap and explore how to tailor co-production approaches to support people who have experienced trauma. METHODS: Bridging Gaps is a collaboration between women who have experienced complex trauma, a charity that supports them, primary care clinicians and health researchers to improve access to trauma-informed primary care. Using co-production principles, we aimed to ensure that women who have experienced trauma were key decision-makers throughout the project. Through reflective notes (n = 19), observations of meetings (n = 3), interviews with people involved in the project (n = 9) and reflective group discussions on our experiences, we share learning, successes and failures. Data analysis followed a framework approach, using trauma-informed principles. RESULTS: Co-production processes can require adaptation when working with people who have experienced trauma. We emphasise the need for close partnership working, flexibility and transparency around power dynamics, paying particular attention to aspects of power that are less readily visible. Sharing experiences can retrigger trauma. People conducting co-production work need to understand trauma and how this may impact upon an individual's sense of psychological safety. Long-term funding is vital to enable projects to have enough time for the establishment of trust and delivery of tangible results. CONCLUSIONS: Co-production principles are highly suitable when developing trauma-informed services. Greater consideration needs to be given as to whether and how people share lived experiences, the need for safe spaces, honesty and humility, difficult dynamics between empowerment and safety and whether and when blurring boundaries may be helpful. Our findings have applicability to policy-making, funding and service provision to enable co-production processes to become more trauma-informed. PUBLIC CONTRIBUTION: Bridging Gaps was started by a group of women who have experienced complex trauma, including addiction, homelessness, mental health problems, sexual exploitation, domestic and sexual violence and poverty, with a general practitioner (GP) who provides healthcare to this population, alongside a support worker from the charity One25, a charity that supports some of the most marginalised women in Bristol to heal and thrive. More GPs and healthcare researchers joined the group and they have been meeting fortnightly for a period of 4 years with the aim of improving access to trauma-informed primary care. The group uses co-production principles to work together, and we aim to ensure that women who have experienced trauma are key decision-makers throughout our work together. This article is a summary of our learning, informed by discussion, observations and interviews with members of the group.

Methodological Challenges in Group-based Randomised Controlled Trials for Intimate Partner Violence Perpetrators: A Meta-summary.

Evidence for treatment effects of group-based Intimate Partner Violence (IPV) perpetrators programmes remains, at best, inconclusive. In the present review, systematic/meta-analytic reviews were used to identify randomised controlled trials and a meta-summary approach was employed to identify methodological challenges in the design and conduct of these trials. Of the fifteen studies identified, seven were comparative effectiveness trials. A range of methodological challenges were also identified by the trialists; source of outcome data, treatment modality, attrition and sample characteristics were the most frequently mentioned. Although there are only a few randomised controlled trials compared to non randomised studies, the findings of both highlight the need to invest in the development of innovative and/or combined IPV treatment programmes to address co-occurring issues such as substance use and trauma. The summary of methodological challenges will provide the first step in the development of methods guidance for researchers working in this area.

La evidencia del efecto del tratamiento de los programas de intervención grupal para agresores de pareja (IPV) siguen siendo, en el mejor de los casos, no concluyentes. En la presente revisión se emplearon revisiones sistemáticas/meta-analíticas para identificar ensayos controlados aleatorizados y se empleó un enfoque de meta-resumen para identificar los desafíos metodológicos en el diseño y la realización de estos ensayos. De los quince estudios identificados, siete fueron ensayos de comparación de la efectividad. Los autores de los ensayos también identificaron una serie de desafíos metodológicos: la fuente de la que se obtienen los datos relativos a los resultados, la modalidad de tratamiento, la mortalidad de la muestra y sus características fueron los mencionados con más frecuencia. Aunque son todavía escasos los ensayos controlados aleatorizados en comparación con los estudios no aleatorizados, los resultados de ambos tipos de estudios han destacado la importancia de invertir en el desarrollo de programas de tratamiento de IPV innovadores y/o combinados para tratar problemáticas conjuntas tales como consumo de substancias y trauma. El resumen de los desafíos metodológicos proporcionará el primer paso para el desarrollo de guías metodológicas para los investigadores que trabajan en este área.

Methodological Challenges in Group-based Randomised Controlled Trials for Intimate Partner Violence Perpetrators: A Meta-summary / [Desafíos metodológicos en los ensayos controlados aleatorizados con grupos de intervención para agresores de pareja: un meta-resumen]

Evidence for treatment effects of group-based Intimate Partner Violence (IPV) perpetrators programmes remains, at best, inconclusive. In the present review, systematic/meta-analytic reviews were used to identify randomised controlled trials and a meta-summary approach was employed to identify methodological challenges in the design and conduct of these trials. Of the fifteen studies identified, seven were comparative effectiveness trials. A range of methodological challenges were also identified by the trialists; source of outcome data, treatment modality, attrition and sample characteristics were the most frequently mentioned. Although there are only a few randomised controlled trials compared to non randomised studies, the findings of both highlight the need to invest in the development of innovative and/or combined IPV treatment programmes to address co-occurring issues such as substance use and trauma. The summary of methodological challenges will provide the first step in the development of methods guidance for researchers working in this area.(AU)

La evidencia del efecto del tratamiento de los programas de intervención grupal para agresores de pareja (IPV) siguen siendo, en el mejor de los casos, no concluyentes. En la presente revisión se emplearon revisiones sistemáticas/meta-analíticas para identificar ensayos controlados aleatorizados y se empleó un enfoque de meta-resumen para identificar los desafíos metodológicos en el diseño y la realización de estos ensayos. De los quince estudios identificados, siete fueron ensayos de comparación de la efectividad. Los autores de los ensayos también identificaron una serie de desafíos metodológicos: la fuente de la que se obtienen los datos relativos a los resultados, la modalidad de tratamiento, la mortalidad de la muestra y sus características fueron los mencionados con más frecuencia. Aunque son todavía escasos los ensayos controlados aleatorizados en comparación con los estudios no aleatorizados, los resultados de ambos tipos de estudios han destacado la importancia de invertir en el desarrollo de programas de tratamiento de IPV innovadores y/o combinados para tratar problemáticas conjuntas tales como consumo de substancias y trauma. El resumen de los desafíos metodológicos proporcionará el primer paso para el desarrollo de guías metodológicas para los investigadores que trabajan en este área.(AU)

Researching Men's Violence Against Women as Feminist Women Researchers: The Tensions We Face.

Qualitative and feminist researchers aim to build rapport, show empathy, be non-judgemental, and equalise power imbalances. A crucial challenge researchers face is how to navigate and balance competing aims and values when interacting with and interviewing participants who have perpetrated intimate partner violence and abuse towards women. In this article, four female researchers evaluating perpetrator programmes for abusive men use reflexive analysis to identify the tensions encountered in such research. We outline how these tensions affected us and the data produced, and end with recommendations, which we hope will help prepare researchers, particularly women, for conducting interviews with violent/abusive men.

Domestic violence and injuries: prevalence and patterns-a pilot database study to identify suspected cases in a UK major trauma centre.

BACKGROUND: Victim-survivors of domestic violence and abuse (DVA) present to secondary care with isolated injuries to the head, limb or face. In the UK, there are no published studies looking at the relationship of significant traumatic injuries in adults and the relationship to DVA.The primary objective was to assess the feasibility of using a tailored search method to identify cases of suspected DVA in the national audit database for trauma. The secondary objective was to assess the association of DVA with clinical characteristics. METHODS: We undertook a single-centre retrospective observational cohort pilot study. Data were analysed from the local Trauma and Audit Research Network (TARN) database. The 'Scene Description' field in the database was searched using a tailored search strategy. Feasibility was evaluated with notes review and assessed by the PPV and prevalence. Secondary objectives used a logistic regression in Excel. RESULTS: This method of identifying suspected cases of DVA from the TARN database is feasible. The PPV was 100%, and the prevalence of suspected DVA in the study period was 3.6 per 1000 trauma discharges. Of those who had experienced DVA, 52.7% were male, median age 43 (IQR: 33-52) and mortality 5.5%. Subgroup analysis of older people demonstrated longer hospital stay (p=0.17) and greater likelihood of admission to intensive care (OR 2.60, 95% CI 0.48 to 14.24). CONCLUSION: We have created a feasible methodology to identify suspected DVA-related injuries within the TARN database. Future work is needed to further understand this relationship on a national level.

Shared decision making in consultations for hypertension: Qualitative study in general practice.

BACKGROUND: Hypertension is mainly managed in primary care. Shared decision making is widely recommended as an approach to treatment decision making. However, no studies have investigated; in detail, what happens during primary care consultations for hypertension. AIM: To understand patients' and clinicians' experience of shared decision making for hypertension in primary care, in order to propose how it might be better supported. DESIGN: Longitudinal qualitative study. SETTING: Five general practices in south-west England. METHOD: Interviews with a purposive sample of patients with hypertension, and with the health-care practitioners they consulted, along with observations of clinical consultations, for up to 6 appointments. Interviews and consultations were audio-recorded and observational field notes taken. Data were analysed thematically. RESULTS: Forty-six interviews and 18 consultations were observed, with 11 patients and nine health-care practitioners (five GPs, one pharmacist and three nurses). Little shared decision making was described by participants or observed. Often patients' understanding of their hypertension was limited, and they were not aware there were treatment choices. Consultations provided few opportunities for patients and clinicians to reach a shared understanding of their treatment choices. Opportunities for patients to engage in choices were limited by structured consultations and the distribution of decisions across consultations. CONCLUSION: For shared decision making to be better supported, consultations need to provide opportunities for patients to learn about their condition, to understand that there are treatment choices, and to discuss these choices with clinicians. PATIENT OR PUBLIC CONTRIBUTION: A patient group contributed to the design of this study.

Continuity of care as a predictor of ongoing frequent attendance in primary care: a retrospective cohort study.

BACKGROUND: Frequent attenders (FAs) in primary care receive considerable resources with uncertain benefit. Only some FAs attend persistently. Modestly successful models have been built to predict persistent attendance. Nevertheless, an association between relational continuity of care and persistent frequent attendance remains unclear, and could be important considering both the UK government and Royal College of General Practitioner's (RCGP) aim of improving continuity. AIM: To identify predictive measures (including continuity) for persistent frequent attendance that may be modified in future interventions. DESIGN & SETTING: This is a retrospective cohort study sampling 35 926 adult patients registered in seven Bristol practices. METHOD: The top 3% (1227) of patients by frequency of GP consultations over 6 months were classed as FAs. Individual relational continuity was measured over the same period using the Usual Provider Continuity (UPC) index. Attendance change was calculated for the following 6 months. Multivariable logistic regression analysis was used to determine variables that predicted attendance change. RESULTS: FAs were on average 8.41 years older (difference 95% confidence interval [CI] = 7.33 to 9.50, P<0.001) and more likely to be female (65.36% versus 57.88%) than non-FAs. In total, 79.30% of FAs decreased attendance over the subsequent 6 months. No association was found between continuity and subsequent attendance. Increasing age was associated with maintained frequent attendance. CONCLUSION: Continuity does not predict change in frequent attendance. In addition to improving continuity, recent government policy is focused on increasing primary care access. If both aims are achieved it will be interesting to observe any effect on frequent attendance.

Acceptability of the BATHE technique amongst GPs and frequently attending patients in primary care: a nested qualitative study.

BACKGROUND: BATHE is a brief psychosocial intervention designed for physician use in patient consultations. The technique has gained some international recognition, but there is currently limited research evidence to demonstrate its acceptability and benefits to patient care. We conducted a pilot cluster randomised controlled trial and feasibility study to explore the use of BATHE as a key component of a person-focused intervention to improve the care of frequent attending patients in UK primary care. METHODS: A nested qualitative interview study conducted within a pilot trial. The trial took place in six general practices in the South West of England. Eligible patients had been identified as being in the top 3% of attenders in the previous 12 months. General practitioners (GPs) were trained to use BATHE during a one-hour initial training session, and two top-up trainings which included feedback on implementation fidelity. GPs were asked to use BATHE with their study patients for a period of 12 months. 34 GPs were trained and documented using BATHE in a total of 577 consultations with eligible patients during the intervention period. At the end of the intervention period, GPs and study patients from the intervention practices were invited to take part in an interview. Interviews were semi-structured, audio-recorded and transcribed. Thematic analysis was used. RESULTS: Eleven GPs and 16 patients took part in post-intervention interviews. Benefits of using BATHE included making consultations more person-centred, challenging assumptions that the GP knew what was going on for the patient and their main concerns, and supporting self-management. Difficulties reported included changing existing consultation habits, identifying appropriate consultations in which to use BATHE, and organisational constraints. CONCLUSIONS: The study suggests that using BATHE is both acceptable and beneficial but also highlighted some of the difficulties GPs had incorporating BATHE into routine practice. Strategies to reduce these difficulties are needed before the extent of the potential benefits of BATHE can be fully assessed. TRIAL REGISTRATION: ISRCTN62939408 Prospectively registered on 24/06/2015.

A consultation-level intervention to improve care of frequently attending patients: a cluster randomised controlled feasibility trial.

BACKGROUND: Frequent attenders (FAs) to primary care receive considerable NHS resources without necessarily gaining benefit, and may even be harmed. AIM: To assess the feasibility of a consultation-level intervention to improve care and address service use of FAs. DESIGN & SETTING: A cluster randomised controlled feasibility trial was undertaken. The study used a mixed-methods process evaluation and took place in six practices in England. METHOD: All practices screened the top 3% of all attending patients over the previous 12 months for eligibility. Following randomisation, intervention patients were matched with named GPs, trained to use the Background, Affect, Trouble, Handling, Empathy (BATHE) technique during consultations. Telephone consultations were encouraged. Feasibility outcomes assessed were recruitment, retention, data collection and completeness, implementation fidelity, and acceptability. RESULTS: A total of 599/1328 (45.1%) FAs were eligible. Four practices were randomised to the intervention (n = 451) and two to usual care (n = 148). A total of 96 (23.7%) patients were recruited to complete questionnaires. Retention and completeness of data were good; for example, 76% of those agreeing to complete questionnaires did so at the 12-month assessment point. Thirty-four GPs were trained and delivered BATHE ≥1 times to 50.1% of patients (n = 577 consultations). There were minimal increases in continuity and telephone consultations. Patients were positive about the intervention, but noticed little change in their care. Despite valuing BATHE, low adherence to training was indicated and GPs used it less than anticipated. CONCLUSION: It was feasible to identify FAs and collect trial data. GPs were keen to engage and there was evidence that the BATHE technique was taken into practice. Optimising training is likely to improve fidelity. The intervention was low cost and low risk.

Addressing the challenges of knowledge co-production in quality improvement: learning from the implementation of the researcher-in-residence model.

The concept of knowledge co-production is used in health services research to describe partnerships (which can involve researchers, practitioners, managers, commissioners or service users) with the purpose of creating, sharing and negotiating different knowledge types used to make improvements in health services. Several knowledge co-production models have been proposed to date, some involving intermediary roles. This paper explores one such model, researchers-in-residence (also known as 'embedded researchers').In this model, researchers work inside healthcare organisations, operating as staff members while also maintaining an affiliation with academic institutions. As part of the local team, researchers negotiate the meaning and use of research-based knowledge to co-produce knowledge, which is sensitive to the local context. Even though this model is spreading and appears to have potential for using co-produced knowledge to make changes in practice, a number of challenges with its use are emerging. These include challenges experienced by the researchers in embedding themselves within the practice environment, preserving a clear focus within their host organisations and maintaining academic professional identity.In this paper, we provide an exploration of these challenges by examining three independent case studies implemented in the UK, each of which attempted to co-produce relevant research projects to improve the quality of care. We explore how these played out in practice and the strategies used by the researchers-in-residence to address them. In describing and analysing these strategies, we hope that participatory approaches to knowledge co-production can be used more effectively in the future.

Interventions to support shared decision making for hypertension: A systematic review of controlled studies.

BACKGROUND: Hypertension (high blood pressure) is a common long-term health condition. Patient involvement in treating and monitoring hypertension is essential. Control of hypertension improves population cardiovascular outcomes. However, for an individual, potential benefits and harms of treatment are finely balanced. Shared decision making has the potential to align decisions with the preferences and values of patients. OBJECTIVE: Determine the effectiveness of interventions to support shared decision making in hypertension. SEARCH STRATEGY: Searches in MEDLINE, EMBASE, CINAHL, Web of Science and PsycINFO up to 30 September 2017. ELIGIBILITY CRITERIA: Controlled studies evaluating the effects of shared decision-making interventions for adults with hypertension compared with any comparator in any setting and reporting any outcome measures. RESULTS: Six studies (five randomized controlled trials) in European primary care were included. Main intervention components were as follows: training for health-care professionals, decision aids, patient coaching and a patient leaflet. Four studies, none at low risk of bias, reported a measure of shared decision making; the intervention increased shared decision making in one study. Four studies reported blood pressure between 6 months and 3 years after the intervention; there was no difference in blood pressure between intervention and control groups in any study. Lack of comparability between studies prevented meta-analysis. CONCLUSIONS: Despite widespread calls for shared decision making to be embedded in health care, there is little evidence to inform shared decision making for hypertension, one of the most common conditions managed in primary care.

'Who does this patient belong to?' boundary work and the re/making of (NSTEMI) heart attack patients.

This ethnography within ten English and Welsh hospitals explores the significance of boundary work and the impacts of this work on the quality of care experienced by heart attack patients who have suspected non-ST segment elevation myocardial infarction (NSTEMI) /non-ST elevation acute coronary syndrome. Beginning with the initial identification and prioritisation of patients, boundary work informed negotiations over responsibility for patients, their transfer and admission to different wards, and their access to specific domains in order to receive diagnostic tests and treatment. In order to navigate boundaries successfully and for their clinical needs to be more easily recognised by staff, a patient needed to become a stable boundary object. Ongoing uncertainty in fixing their clinical classification, was a key reason why many NSTEMI patients faltered as boundary objects. Viewing NSTEMI patients as boundary objects helps to articulate the critical and ongoing process of classification and categorisation in the creation and maintenance of boundary objects. We show the essential, but hidden, role of boundary actors in making and re-making patients into boundary objects. Physical location was critical and the parallel processes of exclusion and restriction of boundary object status can lead to marginalisation of some patients and inequalities of care (A virtual abstract of this paper can be viewed at: https://www.youtube.com/channel/UC_979cmCmR9rLrKuD7z0ycA).

Using conversation analytic methods to assess fidelity to a talk-based healthcare intervention for frequently attending patients.

The study aim was to assess implementation fidelity (i.e., adherence) to a talk-based primary care intervention using Conversation Analytic (CA) methods. The context was a UK feasibility trial where General Practitioners (GPs) were trained to use "BATHE" (Background,Affect,Trouble,Handling,Empathy) - a technique to screen for psychosocial issues during consultations - with frequently attending patients. 35 GPs received BATHE training between July-October 2015. 15 GPs across six practices self-selected to record a sample of their consultations with study patients at three and six months. 31 consultations were recorded. 21/26 patients in four intervention practices gave permission for analysis. The recordings were transcribed and initially coded for the presence or absence of the five BATHE components. CA methods were applied to assess delivery, focusing on position and composition of each component, and patients' responses. Initial coding showed most of the BATHE components to be present in most contacts. However the CA analysis revealed unplanned deviations in position and adaptations in composition. Frequently the intervention was initiated too early in the consultation, and the BATHE questions misunderstood by patients as pertaining to their presenting problems rather than the psychosocial context for their problems. Often these deviations resulted in reducing theoretical fidelity of the intervention as a whole. A CA approach enabled a dynamic assessment of the delivery and receipt of BATHE in situ revealing common pitfalls in delivery and provided valuable examples of more and less efficacious implementations. During the trial this evidence was used in top-up trainings to address problems in delivery and to improve GP engagement. Using CA methods enabled a more accurate assessment of implementation fidelity, a fuller description of the intervention itself, and enhanced resources for future training. When positioned appropriately, BATHE can be a useful tool for eliciting information about the wider context of the medical visit.

Community case management and unplanned hospital admissions in patients with heart failure: A systematic review and qualitative evidence synthesis.

AIMS: The aim of this study was to describe case management as experienced by patients with heart failure and their health professionals with the aim of understanding why case management might contribute in reducing hospital admissions. BACKGROUND: Heart failure is a common cause of unplanned hospital admission. The evidence for case management in patients with heart failure for reducing admissions is promising. DESIGN: Systematic review and qualitative evidence synthesis. DATA SOURCE: Searches were conducted in Medline, Psychinfo, Kings Fund database and Cinahl from inception of each database to 16 February 2017. REVIEW METHODS: Robust systematic review methodology was used to identify qualitative studies describing the experiences of patients with heart failure and healthcare providers of case management. Data were synthesized thematically, and analytic themes were developed. FINDINGS: Five studies (six papers) from which nine descriptive themes were used to determine three analytic themes. This synthesis showed that case management provides positive quality of care for patients, increases perceived access to services and creates more time to ask questions and develop trusted relationships. For health professionals, case management enhanced care by improved relationships with both patients and colleagues although concerns remained around resources, training and inter-professional conflict. CONCLUSIONS: This synthesis emphasizes the importance of the quality of being cared for as a patient and caring as a health professional. Case management enhances communication between patients and health professionals, supports patient self-care and self-management and can be an important contributing factor in reducing unplanned admissions for patients with heart failure.

Left behind and left out: The impact of the school environment on young people with continence problems.

OBJECTIVES: To explore the impact of the secondary school environment on young people with continence problems. DESIGN: In-depth qualitative semi-structured interviews. METHODS: We interviewed 20 young people aged 11-19 years (11 female and nine male) with continence problems (daytime wetting, bedwetting, and/or soiling). Interviews were conducted by Skype (n = 11) and telephone (n = 9). Transcripts were analysed using inductive thematic analysis. RESULTS: We generated five main themes: (1) Boundaries of disclosure: friends and teachers; (2) Social consequences of avoidance and deceit; (3) Strict and oblivious gatekeepers; (4) Intimate actions in public spaces; and (5) Interrupted learning. CONCLUSION: Disclosure of continence problems at school to both friends and teachers was rare, due to the perceived stigma and fears of bullying and social isolation. The lack of disclosure to teachers and other school staff, such as pastoral care staff, creates challenges in how best to support these young people. Young people with continence problems require unrestricted access to private and adequate toilet facilities during the school day. There is a need for inclusive toilet access policies and improved toilet standards in schools. Addressing the challenges faced by young people with continence problems at school could help to remove the barriers to successful self-management of their symptoms. It is particularly concerning that young people with continence problems are at higher risk of academic underachievement. Increased support at school is needed to enable young people with continence problems to achieve their academic potential. Statement of Contribution What is already known on this subject? Continence problems are among the most common paediatric health problems Self-management of continence problems requires a structured schedule of fluid intake and bladder emptying Inadequate toilet facilities and restricted access make it difficult for young people to manage their incontinence What does this study add? Improvement is needed in teacher understanding of the needs of young people with continence problems Young people are reluctant to disclose continence problems due to perceived stigma and fear of social isolation Young people with continence problems may be at increased risk of academic underachievement.

'We all want to succeed, but we've also got to be realistic about what is happening': an ethnographic study of relationships in trial oversight and their impact.

BACKGROUND: The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines. METHODS: Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials' TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK. RESULTS: Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders' priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring that relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor and funder. Stakeholders' perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight. CONCLUSIONS: Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines.