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In drug development, the use of real-world data (RWD) has augmented our understanding of patients’ health care experiences and the effects of treatments beyond clinical trials. Although electronic health record (EHR) data integration at clinical trial sites is a widely adopted practice, primarily for recruitment and data capture, a challenge to data utility is the fragmentation of health data across different sources.Linking RWD sources to each other and to trial data -- while preserving patient privacy through tokenization -- aids in filling evidence gaps with outcome data and facilitates the generalization of effects from controlled trial environments to real-world settings. This paper describes the applications of RWD linkage and how they benefit both clinical development and real-world decision-making. Trial benefits include improving interpretability and generalizability (e.g., by remediating missing data or losses to follow-up), extending follow-up beyond trial closeout, and characterizing the applicability of trial results to under-represented groups.The operational aspects of linking trial data to RWD are addressed, emphasizing the importance of using privacy-preserving record linking systems with established metrics of accuracy and precision, managing consent, and providing the necessary training and resources at trial sites to inform participants about providing access to their RWD through data linkage.

Abstract Background Peer workers are people with personal experience of mental distress, employed within mental health services to support others with similar experiences. Research has identified a range of factors that might facilitate or hinder the introduction of new peer worker roles into mental health services. While there is mixed evidence for the effectiveness of peer worker delivered interventions, there are no studies exploring how implementation might be associated with effect. Methods This was a qualitative comparative case study using data from interviews with 20 peer workers and their five supervisors. Peer workers delivered peer support for discharge from inpatient to community mental health care as part of a randomised controlled trial. In the trial, level of participant engagement with peer support was associated with better outcome (hospital readmission). Study sites with higher levels of engagement also had higher scores on a measure of fidelity to peer support principles. We compared data from sites with contrasting levels of engagement and fidelity using an analytical framework derived from implementation theory. Results In high engagement-high fidelity sites, there was regular work with clinical teams preparing for working alongside peer workers, and a positive relationship between staff on inpatient wards and peer workers. The supervisor role was well resourced, and delivery of peer support was highly consistent with the intervention manual. In low engagement-low fidelity sites peer workers were employed in not-for-profit organisations to support people using public mental health services and in rural areas. Supervisors faced constrained resources and experienced barriers to joint working between organisations. In these sites, peer workers could experience challenging relationships with ward staff. Issues of geography and capacity limited opportunities for supervision and team-building, impacting consistency of delivery. Conclusions This study provides clear indication that implementation can impact delivery of peer support, with implications for engagement and, potentially, outcomes of peer worker interventions. Resourcing issues can have knock-on effects on consistency of delivery, alongside challenges of access, authority and relationship with clinical teams, especially where peer workers were employed in not-for-profit organisations. Attention needs to be paid to the impact of geography on implementation. Trial registration ISRCTN registry number ISRCTN10043328, registered 28 November 2016.

ABSTRACT Earth’s stratosphere is characterized by hypobaric conditions, low temperatures, and high intensities of ultraviolet (UV) and cosmic radiation as well as low water and nutrient availability. While it is not considered a permanent habitat for microorganisms, they can be transported to the stratosphere by storms, volcanic action, or human activity. The impact of those extreme conditions on microorganisms and their survival were tested by sending a sample gondola to the stratosphere. The sample gondola was built to allow exposure of Bacillus subtilis endospores at different angles to the sun. It moreover had holders for three environmental samples to test the effect of stratospheric conditions on complex microbial communities. The gondola attached to a stratospheric balloon was launched near Kiruna, Sweden, ascended to ~25 km, and drifted eastward for ~200 km. Samples were exposed to pressures as low as 2 kPa and temperatures as low as −50°C as well as high UV radiation. Survival rates of B. subtilis were determined by comparing the numbers of colony-forming units (CFUs) for the different exposure angles. Survival was negatively correlated with exposure angle, indicating the significant impact of UV radiation. The effect of stratospheric conditions on environmental samples was assessed by comparing most probable numbers, microbial community composition, and substrate-use profiles to controls that had stayed on the ground. Cultivation was possible from all samples with survival rates of at least 1%, and differences in community composition were observed. Survival of environmental microorganisms might have been supported by the sample matrix, which provided protection from radiation and desiccation.IMPORTANCEEarth's stratosphere is a hostile environment that has challenged microbial survival. We set out to test the effect of stratosphere exposure on survival of single species (Bacillus subtilis) and complex microbial communities from soils and sediment. B. subtilis survival was strongly impacted by sun exposure, i.e., ultraviolet (UV) radiation, with only 1% survival at full sun exposure. Complex microbial communities had high survival rates, and the soil or sediment matrix may have provided protection against radiation and desiccation, supporting the survival of environmental microorganisms.

Background Rates of readmission are high following discharge from psychiatric inpatient care. Evidence suggests that transitional interventions incorporating peer support might improve outcomes. Peer support is rapidly being introduced into mental health services, typically delivered by peer workers (people with experiences of mental health problems trained to support others with similar problems). Evidence for the effectiveness of peer support remains equivocal, and the quality of randomised controlled trials to date is often poor. There is an absence of formal cost-effectiveness studies of peer support in mental health services. Objectives This programme aimed to develop, pilot and trial a peer support intervention to reduce readmission to inpatient psychiatric care in the year post-discharge. The programme also developed a peer support fidelity index and evaluated the impact of peer support on peer workers. Design Linked work packages comprised: (1) systematic review and stakeholder consensus work to develop a peer support for discharge intervention; (2) development and psychometric testing of a peer support fidelity index; (3) pilot trial; (4) individually randomised controlled trial of the intervention, including mixed methods process evaluation and economic evaluation; (5) mixed method cohort study to evaluate the impact of peer support on peer workers. The research team included: two experienced service user researchers who oversaw patient and public involvement; service user researchers employed to develop and undertake data collection and analysis; a Lived Experience Advisory Group that informed all stages of the research. Setting The programme took place in inpatient and community mental health services in seven mental health National Health Service trusts in England. Participants Participants included 590 psychiatric inpatients who had had at least one previous admission in the preceding 2 years; 32 peer workers who delivered the intervention; and 8 peer workers’ supervisors. Intervention Participants randomised to peer support were offered at least one session of manualised peer support for discharge prior to discharge and then approximately weekly for 4 months post-discharge. Main outcome measures The primary outcome for the trial was readmission (formal or informal) to psychiatric inpatient care (readmitted or not) within 1 year of discharge from the index admission. Secondary outcomes included inpatient and emergency mental health service use at 1 year post discharge, plus standardised measures of psychiatric symptom severity and psychosocial outcomes, measured at end of intervention (4 months post discharge). Data sources Service use data were collected from electronic patient records, standardised measures of outcome and qualitative data were collected by interview. Review methods We produced two systematic reviews of one-to-one peer support for adults in mental health services. The first included studies of all designs and identified components of peer support interventions; the second was restricted to randomised controlled trials and pooled data from multiple studies to conduct meta-analyses of the effects of peer support. Results Our systematic review indicated that one-to-one peer support improved individual recovery and empowerment but did not reduce hospitalisation. The main trial demonstrated that one-to-one peer support did not have a significant effect on readmission. There was no significant reduction in secondary service use outcomes at 1-year, or improvement in clinical or psychosocial outcomes at 4 months. Participants who received a pre-defined minimal amount of peer support were less likely to be readmitted than patients in the control group who might also have received the minimal amount if offered. Compared to care as usual, black participants in the intervention group were significantly less likely to be readmitted than patients of any other ethnicity (odds ratio 0.40, 95% confidence interval 0.17 to 0.94; p = 0.0305). The economic evaluation indicated a likelihood that peer support offered a reduction in cost in excess of £2500 per participant compared to care as usual (95% confidence interval −£21,546 to £3845). The process evaluation indicated that length and quality of first session of peer support predicted ongoing engagement, and that peer support offered a unique relationship that enables social connection. The impact study indicated that peer workers found their work rewarding and offering opportunities for personal growth but could find the work emotionally and practically challenging while expressing a need for ongoing training and career development. Limitations In the trial, follow-up rates at 4 months were poor, reducing confidence in some of our analyses of secondary outcome and in a wider societal perspective on our health economic evaluation. Conclusions One-to-one peer support for discharge from inpatient psychiatric care, offered in addition to care as usual to participants at risk of readmission, is not superior to care as usual alone in the 12 months post-discharge. Future work Further research is needed to optimise engagement with peer support and better understand experiences and outcomes for people from black and other ethnic communities. Study registration The systematic review is registered as PROSPERO CRD42015025621. The trial is registered with the ISRCTN clinical trial register, number ISRCTN 10043328. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1212-20019) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. Plain language summary When people share similar experiences of mental health problems and provide each other with emotional or practical support this can be called peer support. In recent years peer support has been introduced into mental health services. The months after discharge from psychiatric hospital can be difficult for some people. There is research that suggests that peer support might be helpful for people at discharge. There is a lack of good quality trials of peer support in mental health services. There are no studies that tell us if peer support provides value for money. We developed new training for peer workers and a handbook guiding peer support for discharge. We tried this out in two mental health National Health Service trusts to check that we could deliver the peer support and collect the information we needed for our trial. We recruited 590 people from seven mental health National Health Service trusts while they were staying on psychiatric wards. Half of those people were randomly selected to receive peer support for discharge, and half to receive community mental health care only. We found that people offered peer support were just as likely to be readmitted to hospital in the year after they were discharged as people offered usual care only. We found that people who met their peer worker at least twice were less likely to be readmitted in the next year. Black people offered peer support were much less likely to be readmitted compared to people offered usual care than other people in the study (although numbers were small). Our results also suggested that cost of care could be slightly less for people receiving peer support. We interviewed some people who had been offered peer support who told us what they valued about peer support. We interviewed peer workers who told us the work was rewarding but could be challenging. Scientific summary Background Risk of self-harm, suicide and readmission is high in the months immediately following discharge from psychiatric inpatient care. There is some evidence that transitional interventions incorporating peer support improve outcomes, including reduced readmission rates. Peer support is rapidly being introduced into mental health services internationally, typically delivered by peer workers (PWs) (people with their own experiences of mental health problems trained to support others with similar problems). Evidence for the effectiveness of peer support in mental health services remains equivocal, and the quality of randomised controlled trials to date is often poor, with trials at risk of bias because of unclear randomisation and masking procedures and incomplete reporting of outcomes. Peer support interventions are often poorly described, including the support provided for PWs, and the mechanisms of peer support unclear. Health economic evaluations are absent from the literature. Objectives The aim of the programme is to manualise, pilot and trial a peer support intervention to enhance discharge from inpatient to community mental health care, significantly reducing readmissions and the associated cost of care. The detailed research objectives of the programme are: to refine an empirically and theoretically grounded model that explains how peer support impacts on outcomes for service users post-discharge to develop and manualise a peer support intervention to enhance discharge to develop an index to assess the fidelity of peer support interventions to conduct a high-quality randomised controlled trial of the intervention to establish the effectiveness and cost-effectiveness of a peer support intervention to enhance discharge to explore the impact on PWs of working in a peer support role. Methods A training manual for PWs and intervention handbook were developed in work package 1 (months 1–15). We produced two systematic reviews of one-to-one peer support for adults in mental health services. The first, until April 2015, included studies of all designs and was used to identify components of peer support interventions; the second, until June 2019, was restricted to randomised controlled trials and pooled data from multiple studies to conduct meta-analyses of the effects of peer support. In both searches we searched MEDLINE, PsycINFO, Embase, CINAHL and Cochrane databases (as well as grey literature for the review of components), using ‘peer’, ‘consumer’, ‘survivor’ or ‘prosumer’ adjacent to ‘support’, ‘supporter’, ‘provider’, ‘worker’, ‘specialist’, ‘consultant’, ‘tutor’, ‘educator’, ‘mentor’, ‘intervention’, ‘listener’, ‘mediator’, ‘counsellor’, ‘befriender’ or ‘therapist’ as search terms for peer support. Paper selection at both title and abstract, and full text stage was undertaken independently by two researchers, with data extracted to spreadsheets relevant to each review. Results for the first review were combined with consensus workshops with stakeholder panels to develop and refine the peer support for discharge intervention. We also developed and tested the appropriateness, inter-rated reliability and internal consistency of a peer support fidelity index (work package 2, months 7–24). The index was first tested in 20 peer support projects not involved in the trial, before being retested and then implemented at three timepoints in each trial site. We conducted an internal pilot of the intervention and trial procedures in two sites (work package 3, year 2 of the programme) before proceeding to full trial in seven sites (work package 4, years 3–5). Sites were inpatient and community mental health services in seven mental health National Health Service trusts in England. Participants were people admitted to psychiatric inpatient care who had at least one previous admission in the preceding 2 years (i.e. who were at increased risk of readmission), the PWs who were employed and trained at each site to deliver the intervention, and the PW co-ordinators (PWCs) who supervised PWs at each site. Participants randomised to peer support were offered a manualised peer support for discharge intervention and care as usual (CAU). Participants in the control group received CAU only (discharge summary sent to community or primary care mental health team who contacted participant within 1 week of discharge to plan ongoing care). The primary outcome for the trial was readmission (formal or informal) to psychiatric inpatient care (readmitted or not) within 1 year of discharge from the index admission. Secondary outcomes were number of voluntary admissions, involuntary admissions and total number of admissions, total number of days in hospital, time to first readmission, use of accident and emergency services for a psychiatric emergency (measured as number of episodes of liaison psychiatry contact) and number of contacts with crisis resolution and home treatment teams in the year post discharge, plus standardised measures of psychiatric symptom levels, subjective quality of life, social inclusion, hope for the future and strength of social network, measured at end of intervention (4 months post discharge). Analyses were conducted on an intention-to-treat (ITT) basis. We carried out a Complier Average Casual Effect (CACE) analysis of the primary outcome (where compliers were participants who had at least two PW meetings, at least one of which was in the community following discharge). The CACE was estimated with a two-stage estimation procedure. In the first stage, a logistic regression of treatment receipt regressed on randomisation was conducted. In the second stage, a Poisson regression of the outcome on treatment receipt was conducted. The analysis was adjusted for the same covariates as the ITT analysis. A bootstrap (1000 samples) was used to obtain bias corrected and accelerated confidence intervals (CIs). Subgroup analyses for the primary outcome were pre-specified: ethnicity (any black ethnicity, all other ethnicities); primary diagnosis at index admission (psychotic disorders, personality disorders, other eligible disorders); first language (English, other). Service use data were collected from electronic patient records (EPRs) at study site, standardised measures of outcome and qualitative data were collected by face-to-face interview by a member of the study team. Our primary economic analysis of total costs over 12 months (using EPR of mental health service use), allowing for cost of peer support, and the secondary cost-effectiveness analysis at 4 months [using self-reported quality of life to derive quality-adjusted life-years (QALYs)] were carried out from an NHS mental health service perspective. A wider ‘societal’ perspective was taken when analysing non-NHS mental health care costs over 4 months (using self-reported service use outside of mental health NHS care). All analyses were conducted on an ITT basis using generalised linear modelling (GLM) with a logarithmic link function. We conducted a mixed methods process evaluation as part of work package 4, alongside the trial. Quantitative analyses used regression models to explore pre- and post-randomisation predictors of engagement with the peer support intervention. In-depth qualitative interviews with a subsample of 39 trial participants and all 32 PWs who were involved in delivering the intervention explored their experiences of peer support and sought to elucidate and refine the change model underpinning the intervention. Interviews were undertaken by service user researchers and data analysed using a ‘co-production’ approach to integrate the full range of perspectives on the research team – clinical, academic and experiential – in interpretive workshops, producing an analytical framework that was then used to code the full set of qualitative interviews. Work package 5 was a mixed method, longitudinal cohort study which explored the impact of providing peer support on PWs (from month 31 until the end of year 5). PWs completed standardised measures of well-being and employment outcomes, and in-depth interviews at three timepoints. All data were collected by service user researchers, who played a key role in developing interview schedules, refining rating procedures for the fidelity index, and analysis and interpretation of qualitative interview data. Development of the intervention and all research procedures were informed by a Lived Experience Advisory Panel (LEAP), as well as the experiential knowledge brought by service user researchers and PWs on the research team. Results In the first (2015) systematic review we identified 97 studies (including 12 from grey literature) that contributed 44 potential components to the intervention development process. A total of 66 potential components were identified when combined with outputs of our stakeholder workshops. Through iterative rounds of consensus building and testing we developed and refined our peer support intervention, comprising a bespoke PW training programme and a detailed handbook guiding implementation. In the second (2019) review we identified 23 studies reporting 19 trials. We found that one-to-one peer support in mental health services has a small but statistically significant benefit for individual recovery [standardised mean difference (SMD) 0.22, 95% CI 0.01 to 0.42; p = 0.042] and empowerment (SMD 0.23, 95% CI 0.04 to 0.42; p = 0.020). There was no effect on clinical outcomes such as symptoms or hospitalisation; the risk of being hospitalised was reduced by 14% for those receiving peer support but was non-significant [risk ratio (RR) 0.86, 95% CI 0.66 to 1.13]. We developed a principles-based fidelity index that had good acceptability and psychometric properties. The index measures set-up, delivery and overall fidelity of peer support against four domains (principles): building trusting relationships based on shared lived experience; reciprocity and mutuality; leadership, choice and control; building strengths and making connections to community. In the trial, fidelity was good at set-up in all sites, while fidelity of delivery of peer support was lower in sites where PWs were employed in voluntary sector organisations outside of the NHS. The pilot trial indicated that progression criteria were met subject to a small number of actions to improve the rate of recruitment of participants. In the main trial we successfully recruited our target of 590 participants, and participant characteristics were well-balanced between groups. In the PW group, 136 (47.4%) participants were readmitted to psychiatric inpatient care within 12 months post-index admission, and 146 (50.2%) in the CAU group. The adjusted relative risk of readmission in the ITT analysis was 0.97 (95% CI 0.82 to 1.14; p = 0.6777), and the adjusted odds ratio (OR) was 0.93 (95% CI 0.66 to 1.30). In the CACE analysis, the relative risk of readmission according to the natural indirect effect (RR 0.88, 95% CI 0.76 to 0.99) was lower than from the ITT analysis and was significant. In subgroup analyses (see Table 6), for patients of any black ethnicity the adjusted OR of readmission was 0.40 (95% CI 0.17 to 0.94), while for any other ethnicity the OR was 1.12 (95% CI 0.77 to 1.63; interaction p = 0.0305). There were no statistically significant differences between the groups in any of the secondary outcomes assessed at 4 or 12 months. Adherence to the intervention was assessable in 268 (91.2%) participants with a mean of 1.8 [standard deviation (SD) = 2.9] face-to-face contacts with a PW in hospital, 4.4 (SD = 4.6) post discharge. There was a total of 67 serious adverse events (SAE) reported in the trial (34 in the peer support group, 33 in the CAU group) from 51 participants (26 in the peer support group, 25 in the CAU group). One SAE in the peer support group, an incident of self-harm, was reported as related to the intervention. Number and type of SAE included 12 deaths, none of which were reported as related to the study. A cost analysis of mental health service contacts over a 12-month period following discharge from inpatient care showed that, adjusting for baseline covariates, exposure to peer support was associated with a reduction in mean total costs of £2631 (95% CI −£21,546 to £3845): this amounted to a 10% reduction in mean total costs over 12-month post hospital discharge compared to usual care (95% CI −31% to 15%). Given sampling uncertainty there was an estimated 82% probability that peer support was associated with lower total costs over 12 months (or a 18% chance that usual care was the lower cost alternative). Most of the cost advantage over follow-up was due to reductions in the cost of bed day utilisation. Over 4 months, and considering patient quality of life outcomes as well as cost, peer support was also found to be cost-effective from an NHS mental health service perspective. The expected QALY gains associated with peer support were marginal: a 0.002 QALY improvement per participant, equivalent to less than a single day in full health. Participants who were heterosexual were less likely to engage with peer support than gay, lesbian or bisexual participants, OR 0.3 (95% CI 0.08 to 0.87; p = 0.029). We found that length of first contact (in minutes) was positively associated with engaging with peer support, OR 1.02 (95% CI 1.00 to 1.04; p = 0.010), and participants who went on to engage with peer support experienced more relationship building activity in that first contact. A shorter period between allocation to peer support and discharge (in days) was also associated with engagement in the intervention, OR 0.99 (95% CI 0.98 to 1.00; p = 0.002). Our qualitative process evaluation largely supports our original change model, further elucidating the distinctive nature of the peer-to-peer relationship while indicating the role that PWs played in enabling people to build relationships and make connection to community. Choice and control over how people engaged with peer support was identified as an important mediator of good experience and outcomes of peer support. Peer worker well-being, job satisfaction, team working and burn out scores were close to or better than scores for appropriate norm populations throughout the study. There were small but significant drops in well-being, personal satisfaction and satisfaction with workload after 4 months in post, and a similar small increase in burn out, but these changes were not maintained at 12 months. Satisfaction with training and job prospects were lower at 12 months. Qualitative data largely confirmed these findings with PWs indicating that they found that peer support work could be emotionally and practically challenging for the first few months but was rewarding and offered opportunities for personal growth. Conclusions We conclude that peer support for discharge, offered to participants at risk of readmission, was not superior to CAU. Peer support should not be commissioned with the expectation that it reduces readmissions for this group, although some cost-saving based on fewer days in hospital is likely. Our trial findings reflect those of our systematic review, suggesting that one-to-one peer support in mental health services is unlikely to improve clinical outcomes or reduce hospitalisation. Further research is needed to: improve implementation in order to optimise engagement with peer support establish the impact of peer support on psychosocial outcomes understand and evaluate the impacts of peer support for people from different ethnic communities (and especially to optimise benefits for black people using mental health services) understand and evaluate the impacts of peer support for people from different clinical populations establish the construct validity of our fidelity index through use with larger samples better understand the ongoing training and support needs, and career development pathway for PWs. Study registration The systematic review is registered as PROSPERO CRD42015025621. The trial is registered with the ISRCTN clinical trial register, number ISRCTN 10043328. Funding This award was funded by the UK National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1212-20019) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 8. See the NIHR Funding and Awards website for further award information. This paper presents independent research funded by NIHR. The views expressed are those of the authors and not necessarily those of the UK National Health Service (NHS), the NIHR or the Department of Health and Social Care.

Background Sexual assault referral centres have been established to provide an integrated service that includes forensic examination, health interventions and emotional support. However, it is unclear how the mental health and substance use needs are being addressed. Aim To identify what works for whom under what circumstances for people with mental health or substance use issues who attend sexual assault referral centres. Setting and sample Staff and adult survivors in English sexual assault referral centres and partner agency staff. Design A mixed-method multistage study using realist methodology comprising five work packages. This consisted of a systematic review and realist synthesis (work package 1); a national audit of sexual assault referral centres (work package 2); a cross-sectional prevalence study of mental health and drug and alcohol needs (work package 3); case studies in six sexual assault referral centre settings (work package 4), partner agencies and survivors; and secondary data analysis of outcomes of therapy for sexual assault survivors (work package 5). Findings There is a paucity of evidence identified in the review to support specific ways of addressing mental health and substance use. There is limited mental health expertise in sexual assault referral centres and limited use of screening tools based on the audit. In the prevalence study, participants (n = 78) reported high levels of psychological distress one to six weeks after sexual assault referral centre attendance (94% of people had symptoms of post-traumatic stress disorder). From work package 4 qualitative analysis, survivors identified how trauma-informed care potentially reduced risk of re-traumatisation. Sexual assault referral centre staff found having someone with mental health expertise in the team helpful not only in helping plan onward referrals but also in supporting staff. Both sexual assault referral centre staff and survivors highlighted challenges in onward referral, particularly to NHS mental health care, including gaps in provision and long waiting times. Work package 5 analysis demonstrated that people with recorded sexual assault had higher levels of baseline psychological distress and received more therapy but their average change scores at end point were similar to those without sexual trauma. Limitations The study was adversely affected by the pandemic. The data were collected during successive lockdowns when services were not operating as usual, as well as the overlay of anxiety and isolation due to the pandemic. Conclusions People who attend sexual assault centres have significant mental health and substance use needs. However, sexual assault referral centres vary in how they address these issues. Access to follow-up support from mental health services needs to be improved (especially for those deemed to have ‘complex’ needs) and there is some indication that co-located psychological therapies provision improves the survivor experience. Routine data analysis demonstrated that those with sexual assault can benefit from therapy but require more intensity than those without sexual assault. Future work Further research is needed to evaluate the effectiveness and cost-effectiveness of providing co-located psychological therapy in the sexual assault referral centres, as well as evaluating the long-term needs and outcomes of people who attend these centres. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (16/117/03) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 21. Trial registration This trial is registered as PROSPERO 2018 CRD42018119706 and ISRCTN 18208347. Plain language summary A sexual assault referral centre provides a service for people who have experienced a sexual assault. It offers emotional support, health checks, forensic examination (to collect physical evidence of assault) and advice. Many who experience sexual assault experience distress for some weeks and months afterwards, and some already have mental health problems. The aim of the study was to understand: What was the level of mental distress and substance use issues? How were mental health, drug and alcohol concerns picked up? What therapy or other support is available as part of the sexual assault referral centre service? How do sexual assault referral centres work with other agencies to ensure that people access the right help? What we did We undertook several studies including: Searching and examining published research (review). A survey that asked sexual assault referral centres how mental health and substance use are addressed. Questionnaires: survivors who had recently attended a sexual assault referral centre completed questionnaires on mental health, alcohol and drugs, and quality of life. Interviews with staff at sexual assault referral centres and survivors of assualts. Routine data: we analysed anonymous data from mental health services to compare how those with sexual assault benefit from psychological therapy. What we learnt We combined the findings from all the aspects of the study to conclude that most people who attend sexual assault referral centres have significant mental health needs; however, the response to these needs is variable within sexual assault referral centres. Survivors report that the sexual assault referral centres offer a caring and supportive service, but many also reported difficulties in accessing the right support afterwards. Where there was co-located psychological therapy, there were benefits for both survivors and the wider team. We also showed that, despite high needs, people surviving sexual assault can benefit from therapies but may need more therapy than those who have not experienced sexual assault. Scientific summary Background Sexual assault is a common but under-reported crime; the consequences can be devastating and wide-reaching, impacting on a person’s health, mental health, use of substances, as well as impacting on work, education and relationships. Sexual assault referral centres (SARCs) were established to provide an integrated service, offering forensic examination, sexual health, emergency contraception, pregnancy tests, and post-exposure prophylaxis to prevent HIV. SARC service specifications state that mental health problems should be identified and referrals made to address these needs. However, it is not clear how and when that assessment should happen, or by whom, and how best to offer mental health aftercare. Many people who attend a SARC had prior contact with mental health services (40%), so it is important to consider the needs of those with pre-existing mental ill health and those at risk of developing mental health problems as a result of the assault. An acute trauma response is a normal psychological reaction to sexual assault and many survivors will not require mental health care. However, it is important to identify and offer appropriate support to those with significant needs. Research aims To undertake a mixed-methods study using realist methodology to identify programme theories that will seek to identify the contexts and mechanisms involved in the identification, assessment and the pathways to care (outcomes): to undertake evidence reviews of global SARC provision for health outcomes (including mental health and substance use) (work package (WP) 1) to identify what models of SARCs currently exist in England (WP2) to identify the mental health and substance use needs of attendees of SARCs in England (WP3) to identify what services are available in SARCs in England, and to explore satisfaction with care, barriers to access and gaps in provision (WPs 2, 3 and 4) to understand from the perspective of the SARC workforce and their current practice, skills and training needs in terms of recognition of, and referral for, mental health and substance use issues (WP4) to obtain the survivor view on how they felt their emotional well-being was addressed by the SARC as well as by external services (WP4) to compare health outcomes for people who experience sexual assault and access bespoke SARC psychological therapies provision compared to those who experience sexual assault and are in mainstream mental health services (WP5) to produce a range of lay and academic outputs that will aim to identify and share good practice in SARC services related to identifying and supporting substance use and mental health among people who experience sexual assault to have an impact on care delivery. Setting and participants Staff who work in SARCs, representatives from relevant partner agencies, and survivors. Methods WP1 consisted of a systematic review that sought to address three questions: (1) how mental health and drug/alcohol issues were identified and assessed; (2) evidence for interventions that aimed to improve mental health and/or drug/alcohol issues following an attendance at a SARC; and (3) stakeholder views (including survivors) of how SARCs can promote and support mental health. WP2 was a national audit of SARCs in England, which collected information about skill mix, assessment, what mental health support was available, and partnerships with other agencies. A cluster analysis was performed to group SARCs by their similar responses to these key variables. WP3 was a prevalence study. The sample included people who had recently attended a SARC (data were collected between one and six weeks of attendance). Outcome measures Outcomes were measured using the following tools: Clinical Outcomes in Routine Evaluation 10 (CORE-10) Alcohol Use Disorders Identification Test (AUDIT-C) Primary Care PTSD Screen for DSM-5 (PC-PTSC-5) Recovering Quality of Life (ReQoL) Drug Abuse Screen Test (DAST) Structured Assessment of Personality Abbreviated Scale (SAPAS). Procedure Following informed consent, participants were sent an online questionnaire containing the outcome measures. The online responses were checked by a researcher to pick up any safeguarding issues. If there were any present, the researcher would contact the participant and assess their safety and well-being. Work package 4 case studies Documentary analysis was undertaken on policies and local documents including the SARC website and used to create a localised journey map for each SARC, which informed the interviews. Interviews and focus groups were conducted in the six case study sites and involved survivors, SARC staff and partner agencies (mental health services, drug and alcohol services, and third sector counselling and support services, e.g. rape counselling). Interviews were transcribed verbatim and contexts mechanisms and outcomes were coded in NVivo (Lumivero, Denver, CO). Within-SARC and between-SARC case study analyses were performed and programme theories were refined. Work package 5 secondary data analysis WP5 involved secondary data analysis of two separate datasets. The first used anonymised data on the outcomes of co-located psychological therapy services within one SARC. The second dataset was extracted from the anonymised Clinical Research Interactive Search (CRIS) anonymised routine data base from one NHS mental health organisation in England. A sample of people was selected who had a sexual assault identified in their notes and a comparison group of people who did not have that experience documented, who also had baseline and follow-up CORE-10 data following psychological therapy. Results Review: the most commonly reported method of assessing mental health and alcohol and/or drug use was using an unstructured and often unspecified assessment. Use of validated screening tools was rarely reported and where they were mentioned, this tended to be screening for post-traumatic stress disorder (PTSD) specifically. The most common support offered was ‘counselling’ but this was poorly described. There was limited mention of evidence-based therapies such as eye movement desensitisation reprocessing or cognitive behaviour therapy. There were five randomised controlled trials (RCTs) which evaluated psychoeducation tools. Overall, there was a lack of robust evidence to inform how best to address mental health and substance use in SARCs. A realist synthesis was undertaken to identify initial programme theories. WP2: In the audit, a 77% response rate was achieved. Few SARCs had mental health expertise in the team and 7% of SARCs had in-house or co-located psychosocial support. There were limited formal care pathways to partner agencies and respondents were less satisfied with level of integration with local mental health and alcohol/drug services compared with rape counselling and domestic violence services. WP3: Prevalence study – of the 275 people who gave consent to contact, successful contact was made with 157 (43%) and, of these, 78 were enrolled on the study; 76% scored moderate/severe distress on CORE-10; 94% of scores indicated PTSD; 63% of scores indicated a possible personality disorder; 12% were drinking at ‘risky’ alcohol levels (AUDIT-C) and 26% had a moderate to severe drug problem according to the DAST. In terms of quality of life, most (87%) had low quality of life from ReQoL scores. WP4: Case studies – SARC staff identified that the lack of having mental health expertise alongside fragmented care pathways meant that people who were identified as having continuing mental health needs were not able to efficiently get those needs met. In SARCs where there was in-house or co-located psychological support, this seemed to improve the speed and quality in which people received the right care at the right time. In addition, there were wider benefits to having a mental health professional in the team in terms of contributing to team discussions on care planning and referrals, as well as supporting staff in terms of informal support and reflection on practice. Survivors found the experience of the SARCs very helpful, specifically around the trauma-informed practices that helped them reframe their experiences, seeing themselves as survivors rather than victims. The survivors’ experiences of past and current mental health services was less positive owing to long waiting lists, limited sessions being offered due to resource issues, or not quite fitting into a service remit. WP5: In SARC 5, there was a stepped care model for counselling and therapy. Between April 2020 and December 2020, 467 people referred to counselling and 229 to psychological therapies. Those on the higher-intensity therapy track had higher needs at baseline and received more sessions than those referred for counselling. Despite this, the average change scores for both groups were similar at end of therapy. Reasons for disengagement with counselling were mainly about difficulty travelling to sessions (SARC 5 covers a large mainly rural area). There was less textual information regarding the therapy service but this information indicated that some referrals were not accepted because the person’s needs were too complex and were stepped up to other mental health provision. In the CRIS data analysis, the cohort identified as having been sexually assaulted compared with a control group had higher needs and complexity at baseline. They also had more sessions of therapy than those without a history of sexual assault. However, despite the baseline differences the sexual assault cohort has similar average change scores in the CORE-10 outcome data compared with the control group. Discussion There are high levels of mental health and alcohol/drug use needs in people who attend SARC, certainly as measured in the immediate period after SARC attendance, and many had pre-existing mental health or alcohol/drug use issues. However, there was limited evidence of integration of mental health and substance use interventions following SARC attendance, and few SARC staff has expertise in mental health. Most operated referral system to external agencies but this was deemed to be less than ideal as reported by all stakeholders. Survivors valued the support they received at the SARC from staff who used a trauma-informed approach. In comparison, survivors spoke less favourably about mainstream NHS mental health provision, citing a limited number of sessions, long waiting lists and unhelpful attitudes towards people who have been sexually assaulted. The quality of the local care pathways was hampered by complexity of local service providers, a lack of a single point of contact and perceived high threshold to access mental health and psychological therapies. Analysis of outcome data comparing people who had been sexually assaulted and those who had not (WP5) found that average change scores at follow-up were the same for both groups. This is an important finding, as it offers therapeutic optimism that therapy is beneficial for survivors of sexual assault, but also has resource implications that need to be addressed. Limitations The study was impacted by the COVID-19 pandemic, especially WP3. The target of 360 people was not achieved and, even after extending recruitment period by three months, only 78 were recruited from four of the six sites. This had a knock-on effect for recruitment for the survivor qualitative interviews. All the data were collected using remote methods, which worked well, and there were no issues related to this method in terms of people declining to participate. Implications for health care There is a need to for detailed specification for SARCs with regard to mental health and substance use. This would help address inconsistency in how this service is operationalised nationally. The specification should include raising awareness of SARCs to mental health and alcohol/drug services. The SARC would benefit from having access someone with a mental health background who can support the integration of standard practice in mental health identification and assessment, management of crisis and distress, as well as either providing in-house support or formalising pathways to local mental health, alcohol/drug services, and other relevant services. The implications for mental health services include improving routine enquiry about sexual violence, addressing the gaps in accessing support for those who have experienced sexual violence who may already be in mental health care, as well as being able to provide timely access to evidence based therapies for people who have multiple needs. Recommendations for research Further research should investigate whether routine screening improves access to mental health care and outcomes for survivors. There is a need for research to evaluate co-located bespoke therapy using a RCT to establish clinical and cost-effectiveness. In addition, there is a need to investigate how gaps in therapy provision can be addressed and evaluated, specifically for those who are perceived to have more ‘complex’ needs. Further research should investigate how to improve routine enquiry and recording of sexual violence in mental health and substance use. Conclusion People who attend SARCs have high levels of need in relation to mental health and alcohol/drug use, and clarity is required as to how these needs should identified and addressed by SARCs and partner agencies. The trauma-informed approach adopted by SARCs aids in survivor recovery and mental well-being. However, some survivors have multiple needs that may require intensive evidence-based therapies delivered by people who understand sexual trauma. There is a clear imperative for SARCs and partner agencies to develop closer relationships and agreed pathways so that survivors have their needs accurately identified and are referred to the right service for those needs. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (16/117/03) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 21. Trial registration This trial is registered as PROSPERO 2018 CRD42018119706 and ISRCTN 18208347.

Abstract Background Peer workers are increasingly employed in mental health services to use their own experiences of mental distress in supporting others with similar experiences. While evidence is emerging of the benefits of peer support for people using services, the impact on peer workers is less clear. There is a lack of research that takes a longitudinal approach to exploring impact on both employment outcomes for peer workers, and their experiences of working in the peer worker role. Methods In a longitudinal mixed methods study, 32 peer workers providing peer support for discharge from inpatient to community mental health care - as part of a randomised controlled trial - undertook in-depth qualitative interviews conducted by service user researchers, and completed measures of wellbeing, burnout, job satisfaction and multi-disciplinary team working after completing training, and four and 12 months into the role. Questionnaire data were summarised and compared to outcomes for relevant population norms, and changes in outcomes were analysed using paired t-tests. Thematic analysis and interpretive workshops involving service user researchers were used to analysis interview transcripts. A critical interpretive synthesis approach was used to synthesise analyses of both datasets. Results For the duration of the study, all questionnaire outcomes were comparable with population norms for health professionals or for the general population. There were small-to-medium decreases in wellbeing and aspects of job satisfaction, and increase in burnout after 4 months, but these changes were largely not maintained at 12 months. Peer workers felt valued, empowered and connected in the role, but could find it challenging to adjust to the demands of the job after initial optimism. Supervision and being part of a standalone peer worker team was supportive, although communication with clinical teams could be improved. Conclusions Peer workers seem no more likely to experience negative impacts of working than other healthcare professionals but should be well supported as they settle into post, provided with in-work training and support around job insecurity. Research is needed to optimise working arrangements for peer workers alongside clinical teams.

BackgroundPeople with serious mental illness experience worse physical health and greater mortality than the general population. Crude rates of A&E attendance and acute hospital admission are higher in people with serious mental illness than other hospital users. We aimed to further these findings by undertaking a standardised comparison of urgent and emergency care pathway use among users of mental health services and the general population.MethodsRetrospective cohort analysis using routine data from 2013-2016 from the CUREd dataset for urgent and emergency care contacts (NHS 111, ambulance, A&E and acute admissions) and linked mental health trust data for Sheffield, England. We compared annual age- and sex-standardised usage rates for each urgent and emergency care service between users of mental health services and those without a recent history of mental health service use.ResultsWe found marked differences in usage rates for all four urgent and emergency care services between the general population and users of mental health services. Usage rates and the proportion of users were 5-6 times and 3-4 times higher in users of mental health services, respectively, for all urgent and emergency care services. Users of mental health services were often more likely to experience the highest or lowest acuity usage characteristics.ConclusionsCurrent users of mental health services were heavily over-represented among urgent and emergency care users, and they made more contacts per-person. Higher service use among users of mental health services could be addressed by improved community care, more integrated physical and mental health support, and more proactive primary care. A complex pattern of service use among users of mental health services suggests this will need careful targeting to reduce avoidable contacts and optimise patient outcomes.

Abstract Objectives Peer support is rapidly being introduced into mental health services internationally, yet peer support interventions are often poorly described, limiting the usefulness of research in informing policy and practice. This paper reports the development of a peer support intervention that aims to improve outcomes of discharge from inpatient to community mental health care. People with experiential knowledge of using mental health services—peer workers and service user researchers—were involved in all stages of developing the intervention: generating intervention components; producing the intervention handbook; piloting the intervention. Results Systematic review and expert panels, including our Lived Experience Advisory Panel, identified 66 candidate intervention components in five domains: Recruitment and Role Description of Peer Workers; Training for Peer Workers; Delivery of Peer Support; Supervision and Support for Peer Workers; Organisation and Team. A series of Local Advisory Groups were used to prioritise components and explore implementation issues using consensus methods, refining an intervention blueprint. A peer support handbook and peer worker training programme were produced by the study team and piloted in two study sites. Feedback workshops were held with peer workers and their supervisors to produce a final handbook and training programme. The ENRICH trial is registered with the ISRCTN clinical trial register, number ISRCTN 10043328, and was overseen by an independent steering committee and a data monitoring committee.

Higher education students’ mental health has been a growing concern in recent years even before the COVID-19 pandemic. The stresses and restrictions associated with the pandemic have put university students at greater risk of developing mental health issues, which may significantly impair their academic success, social interactions and their future career and personal opportunities. This paper aimed to understand the mental health status of University students at an early stage in the pandemic and to investigate factors associated with higher levels of distress. An online survey including demographics, lifestyle/living situations, brief mental well-being history, questions relating to COVID-19 and standardised measures of depression, anxiety, resilience and quality of life was completed by 1173 students at one University in the North of England. We found high levels of anxiety and depression, with more than 50% experiencing levels above the clinical cut offs, and females scoring significantly higher than males. The survey also suggested relatively low levels of resilience which we attribute to restrictions and isolation which reduced the opportunities to engage in helpful coping strategies and activities rather than enduring personality characteristics. Higher levels of distress were associated with lower levels of exercising, higher levels of tobacco use, and a number of life events associated with the pandemic and lockdown, such as cancelled events, worsening in personal relationships and financial concerns. We discuss the importance of longer-term monitoring and mental health support for university students.

Antimicrobial resistance (AMR) is an emerging challenge to global public health. The use of antibiotics in the veterinary field is one of the contributing factors to AMR mostly due to poor knowledge, attitudes, and practices (KAP) of dispensers. Veterinary drug dispensers are expected to guide clients on indications, contraindications, and withdrawal periods of veterinary drugs. This study assessed veterinary drug dispensers’ KAP toward AMR and associated potential contributing factors. A cross-sectional study, using a structured questionnaire, was conducted in three main cities of Malawi, namely Mzuzu, Lilongwe, and Blantyre. A total of 68 agrovet shops were selected using a simple random sampling technique. The KAP level was presented descriptively. Bivariate and multivariable analyses were run to investigate the relationships between the independent and outcome variable. Overall, the KAP score for knowledge, attitude, and practices was 46.7%, 49.2%, and 41.6%, respectively. The significant determinants of the knowledge were the practice of asking for a written prescription (OR: 16.291, 95% CI: 11.6–24.2) (p = 0.024), female (OR: 0.609, 95% CI: 0.3–0.9) (p = 0.001), and old age (≥35) (OR: 0.227, 95% CI: 0.1–0.5) (p = 0.04). Poor knowledge, negative attitude, and poor practices were observed among most of the participants. Sensitization and training on AMR and antimicrobial stewardship are recommended to address the KAP score gaps and the observed determinants among veterinary drug dispensers.

Abstract Background and aims Diabetes is highly prevalent among individuals with serious mental illness. Managing diabetes in forensic mental health settings presents unique challenges which are under‐reported and poorly understood. This study aimed to explore diabetes care in a medium‐secure setting and identify key areas for improvement. Methods A single case study design used a retrospective chart review. Qualitative interviews and a focus group were analyzed using thematic analysis. Results Prevalence of diabetes was over twice that of the general population and highest in female service users. Evidence suggests limited understanding and lack of diabetes education for staff and service users, and difficulties in accessing external diabetes recourses. Conclusion Constraints inherent to forensic mental health settings contribute to difficulties in accessing external resources and adequate diabetes education. Secure mental health services should adopt a collaborative approach to diabetes care and provide appropriate specialist training to both staff and service users.

BackgroundSpecialist sexual assault services, which collect forensic evidence and offer holistic healthcare to people following sexual assault, have been established internationally. In England, these services are called sexual assault referral centres (SARCs). Mental health and substance misuse problems are common among SARC attendees, but little is known about how SARCs should address these needs. This review aims to seek and synthesise evidence regarding approaches to identification and support for mental health and substance misuse problems in SARCs and corresponding services internationally; empirical evidence regarding effective service models; and stakeholders' views and policy recommendations about optimal SARC practice.MethodsA systematic review was undertaken. PsycINFO, MEDLINE, IBSS and CINAHL were searched from 1975 to August 2018. A web-based search up to December 2018 was also conducted to identify government and expert guidelines on SARCs. Quality assessment and narrative synthesis were conducted.ResultsWe included 107 papers. We found that identification based on clinical judgement, supportive counselling and referral to other services without active follow-up were the most common approaches. Evaluations of interventions for post-rape psychopathology in attendees of sexual assault services provided mixed evidence of moderate quality. Very little evidence was found regarding interventions or support for substance misuse. Stakeholders emphasised the importance of accessibility, flexibility, continuity of care, in-house psychological support, staff trained in mental health as well as specialist support for LGBT groups and people with learning difficulties. Guidelines suggested that SARCs should assess for mental health and substance misuse and provide in-house emotional support, but the extent and nature of support were not clarified. Both stakeholders and guidelines recommended close partnership between sexual assault services and local counselling services.ConclusionsThis review suggests that there is big variation in the mental health and substance misuse provision both across and within different sexual assault service models. We found no robust evidence about how sexual assault services can achieve good mental health and substance misuse outcomes for service users. Clearer guidance for service planners and commissioners, informed by robust evidence about optimal service organisations and pathways, is required. PROSPERO registration number: CRD42018119706.

Abstract Odorant molecules stimulate olfactory receptor neurons, and axons of these neurons project into the main olfactory bulb where they synapse onto mitral and tufted cells. These project to the primary olfactory cortex including the anterior olfactory nucleus (AON), the piriform cortex, amygdala, and the entorhinal cortex. The properties of mitral cells have been investigated extensively, but how odor information is processed in subsequent brain regions is less well known. In the present study, we recorded the electrical activity of AON neurons in anesthetized rats. Most AON cells fired in bursts of 2–10 spikes separated by very short intervals (

In the light of the declaration “Nothing about us without us” (Charlton, 2000), interest in co-production, and coproduced research is expanding. Good work has been done establishing principles for co-production (Hickey et al., 2018) and for good quality involvement (Involve, 2013; 4Pi, 2015) and describing how this works in practice in mental health research (Gillard et al., 2012a,b, 2013). In the published literature, co-production has worked well in qualitative research projects in which there is often methodological flexibility. However, to change treatment guidelines in the UK, e.g., the National Institute for Health and Care Excellence guidelines, and influence service commissioning, high quality quantitative research is also needed. This type of research is characterized by formal methodological rules, which pose challenges for the scope of co-production. In this paper we describe the significant challenges and solutions we adopted to design and deliver a coproduced randomized controlled trial of mental health peer support. Given the methodological rigidity of a randomized controlled trial, establishing clearly which methodological and practical decisions and processes can be coproduced, by whom, and how, has been vital to our ongoing co-production as the project has progressed and the team has expanded. Creating and maintaining space for the supported dialogue, reflection, and culture that co-production requires has been vital. This paper aims to make our learning accessible to a wide audience of people developing co-production of knowledge in this field.

Magnocellular neurons of the supraoptic nucleus (SON) secrete oxytocin and vasopressin from axon terminals in the neurohypophysis, but they also release large amounts of peptide from their somata and dendrites, and this can be regulated both by activity-dependent Ca(2+) influx and by mobilization of intracellular Ca(2+). This somato-dendritic release can also be primed by agents that mobilise intracellular Ca(2+), meaning that the extent to which it is activity-dependent, is physiologically labile. We investigated the role of different Ca(2+) channels in somato-dendritic release; blocking N-type channels reduced depolarisation-induced oxytocin release from SONs in vitro from adult and post-natal day 8 (PND-8) rats, blocking L-type only had effect in PND-8 rats, while blocking other channel types had no significant effect. When oxytocin release was primed by prior exposure to thapsigargin, both N- and L-type channel blockers reduced release, while P/Q and R-type blockers were ineffective. Using confocal microscopy, we found immunoreactivity for Ca(v)1.2 and 1.3 channel subunits (which both form L-type channels), 2.1 (P/Q type), 2.2 (N-type) and 2.3 (R-type) in the somata and dendrites of both oxytocin and vasopressin neurons, and the intensity of the immunofluorescence signal for different subunits differed between PND-8, adult and lactating rats. Using patch-clamp electrophysiology, the N-type Ca(2+) current density increased after thapsigargin treatment, but did not alter the voltage sensitivity of the channel. These results suggest that the expression, location or availability of N-type Ca(2+) channels is altered when required for high rates of somato-dendritic peptide release.

Abstract Background Supporting self-care is being explored across health care systems internationally as an approach to improving care for long term conditions in the context of ageing populations and economic constraint. UK health policy advocates a range of approaches to supporting self-care, including the application of generic self-management type programmes across conditions. Within mental health, the scope of self-care remains poorly conceptualised and the existing evidence base for supporting self-care is correspondingly disparate. This paper aims to inform the development of support for self-care in mental health by considering how generic self-care policy guidance is implemented in the context of services supporting people with severe, long term mental health problems. Methods A mixed method study was undertaken comprising standardised psychosocial measures, questionnaires about health service use and qualitative interviews with 120 new referrals to three contrasting community based initiatives supporting self-care for severe, long term mental health problems, repeated nine months later. A framework approach was taken to qualitative analysis, an exploratory statistical analysis sought to identify possible associations between a range of independent variables and self-care outcomes, and a narrative synthesis brought these analyses together. Results Participants reported improvement in self-care outcomes (e.g. greater empowerment; less use of Accident and Emergency services). These changes were not associated with level of engagement with self-care support. Level of engagement was associated with positive collaboration with support staff. Qualitative data described the value of different models of supporting self-care and considered challenges. Synthesis of analyses suggested that timing support for self-care, giving service users control over when and how they accessed support, quality of service user-staff relationships and decision making around medication are important issues in supporting self-care in mental health. Conclusions Service delivery components – e.g. peer support groups, personal planning – advocated in generic self-care policy have value when implemented in a mental health context. Support for self-care in mental health should focus on core, mental health specific qualities; issues of control, enabling staff-service user relationships and shared decision making. The broad empirical basis of our research indicates the wider relevance of our findings across mental health settings.