Background Suicide is a leading cause of death worldwide, particularly in people with severe mental health problems, including schizophrenia. The development, and testing, of suicide-focused psychological interventions which can combat suicidal experiences is an unrealised necessity. However, it is vital that suicide-focused therapies are derived from robust, evidence-based mechanistic suicide theories. The Schematic Appraisals Model of Suicide is one such theory. Objective(s) The Cognitive AppRoaches to coMbatting Suicidality project had two objectives. First, based on the Schematic Appraisals Model of Suicide, to test psychological pathways underlying suicidal thoughts, plans and attempts. Second, to test the efficacy of Cognitive–Behavioural Suicide Prevention for psychosis, a suicide-focused intervention developed by our team. Design The randomised controlled trial had two groups: our suicide-focused therapy, Cognitive–Behavioural Suicide Prevention adapted Cognitive–Behavioural Suicide Prevention for psychosis, plus treatment as usual (treatment) versus treatment as usual only (control). There were three assessment time points of baseline, 6 and 12 months, with the 6-month time point being the critical point for the main primary outcome. Four qualitative methods workstreams were nested within the randomised controlled trial design. Settings Four National Health Service Trust sites in the North West of England, United Kingdom: Greater Manchester Mental Health NHS Foundation Trust, Pennine Care NHS Foundation Trust, Lancashire and South Cumbria NHS Foundation Trust, and the former North West Boroughs Healthcare NHS Foundation Trust. Participants Main inclusion criteria: (1) non-affective psychosis (e.g. schizophrenia), (2) suicidal experiences in the 3 months prior to recruitment; (3) under the care of an National Health Service mental health services team and (iv) aged 18 or over. Main outcome measures The primary outcome measure was the Adult Suicidal Ideation Questionnaire, which measures suicidal ideation severity over the past month using 25 self-report items. The 6-month follow-up assessment point was the critical time point. There were two secondary suicide measures. Mechanism measures captured six appraisals of emotional difficulties, lack of social support, interpersonal problem-solving difficulties, defeat, entrapment and hopelessness. Results Recruitment ensued from on 21 June 2017 and lasted until 25 November 2020. The last 12-month follow-up assessment was completed on 10 January 2022. Two hundred and ninety-two participants were randomly allocated to the treatment (N = 149) and control (N = 143) groups. Reductions in suicidal ideation severity were not significantly greater in the treatment compared to the control group (p = 0.07; 95% confidence interval −15.41 to 0.68) at month 6. There were, similarly, no significant treatment effects for the secondary suicide outcomes. A therapy ‘dose–response’ showed that each therapy session reduced the suicidal ideation severity score by 0.46, but this effect was also not significant (p = 0.056; 95% confidence interval −0.94 to 0.01), nor was a compliance-adjusted analysis in which only participants who attended at least one session of therapy were included (p = 0.052; 95% confidence interval −0.39 to 0.00). However, a predicted mediation pathway was statistically significant for one of the six mechanism measures, in which the therapy group relative to the control group improved social support appraisals, which, in turn, reduced suicidal ideation severity at month 6 (effect = −2.85, 95% confidence interval −7.00 to −0.23). Qualitative and mixed-methods findings showed that (1) feelings of not mattering, disconnection and irrelevance were central to suicidal thoughts, (2) it is vital to develop better ways of communicating about suicide, (3) our suicide-focused therapy was acceptable and feasible and (4) that being part of suicide work in a trial was largely a positive experience. Limitations The sample was predominantly White/Caucasian and conducted in one geographical United Kingdom location, the primary outcome measure captured only suicidal thought severity, and there were only two follow-up time points. Conclusions This suicide-focused psychological intervention did not demonstrate a treatment effect in the primary suicide outcome measure at month 6 at the 5% significance threshold. There was also no significant treatment effect for secondary suicide outcomes. Future work Research programmes founded on convergent methods, and evidenced-based psychological suicide models are needed to examine how to bolster appraisals of poor social support, disconnection, and not mattering in the context of suicidal mind-sets, and in tandem with the development of creative and inclusive communication tools to relay suicidal experiences. In addition, exploration of the role of ‘dose’ of therapy is crucial for further treatment development. Trial registration This trial is registered as ClinicalTrials.gov NCT03114917 and ISRCTN17776666. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 13/161/25) and is published in full in Efficacy and Mechanism Evaluation; Vol. 13, No. 3. See the NIHR Funding and Awards website for further award information. Plain language summary Suicidal experiences are strikingly common. They are even more common in people with severe mental health problems, such as non-affective psychosis (e.g. schizophrenia). People with psychosis experience persistent and distressing hallucinations, delusions and paranoid feelings and beliefs. In order to take action against suicide, we have to better understand the psychological mind-sets of people who have suicidal experiences. Based on that understanding, we then have to develop psychological therapies which directly target these suicidal experiences. We have developed and started to test a type of psychological talking therapy which is specifically focused on suicide. In the next stage of our research, we wanted to further our understanding of the psychological mind-sets underpinning suicide, and in addition, to determine how much our suicide-focused therapy would actually reduce the severity of suicidal thoughts in people with non-affective psychosis across 6 months. We randomly split people into two groups – treatment and control. One hundred and forty-nine participants were offered our suicide-focused therapy, together with any ongoing treatment (treatment group), and 143 carried on with their usual treatment (control group). Those in the treatment group were offered up to 24 sessions of suicide-focused therapy, with each session lasting around 50 minutes and usually occurring weekly. We asked people to complete assessments at baseline, at 6 months and at 12 months. The main analyses showed that reductions in suicidal ideation severity were not significantly greater in the treatment compared to the control group across 6 months. Analyses designed to examine compliance with the therapy also did not result in a significant treatment effect. However, we did find that the suicide-focused therapy improved social support appraisals, which in turn improved suicidal ideation severity at 6 months. This indirect pathway was significant. Our qualitative interviews expanded on the impact of social support and social connectedness. Our participants also told us in qualitative work that the suicide-focused therapy was needed, acceptable and implementable in National Health Service services. Scientific summary Background The prevalence of suicidal thoughts, suicide plans, attempts and fatalities increase markedly in people with severe mental health problems, such as non-affective psychosis (e.g. schizophrenia). Suicidal experiences, including thoughts, plans, images, compulsions/urges, often derive from immense psychological pain and distress which, in the case of people with non-affective psychosis, can be compounded by seemingly relentless hallucinations, delusions and paranoid feelings and beliefs. Yet, such suicidal experiences can be countered with psychological ‘talking therapies’, such as forms of cognitive–behavioural therapy (CBT), but only if such therapies are developed specifically to be suicide-focused and to target the psychological mechanisms which underpin suicidal experiences. This means that it is vital to advance, and test, psychological models of suicidal experiences which can then act as a foundation for suicide-focused therapy development. The Schematic Appraisals Model of Suicide (SAMS) assimilates and expands evidence that negative appraisals of (1) emotional difficulties, (2) interpersonal social problem-solving difficulties and (3) lack of social support and perceptions of defeat, entrapment and hopelessness are central in pathways to suicidal experiences. Based on the SAMS, we have developed a transdiagnostic suicide-focused CBT called ‘Cognitive–Behavioural Suicide Prevention’, which we have further evolved for people with psychosis, termed ‘Cognitive–Behavioural Suicide Prevention for psychosis’ (CBSPp). Pilot work with people in the community with psychosis and male prisoners showed that this therapy was efficacious in reducing suicidal thoughts and behaviours, and was acceptable and feasible. The next stage in our suicide prevention work required us to (1) further investigate and advance the purported underlying psychological suicide mechanisms and (2) further test the efficacy of our suicide-focused psychological therapy, specifically in people experiencing psychosis. These were the overall goals of the Cognitive AppRoaches to coMbatting Suicidality (CARMS) project, which used convergent quantitative, qualitative and mixed methods to achieve four key objectives. Objectives To determine the extent to which a suicide-focused CBSPp in addition to usual care (i.e. the treatment group) would be more efficacious in reducing suicidal ideation severity compared to usual care alone (i.e. the control group) over 6 months. To test the extent to which appraisals of lack of social support, emotional difficulties and interpersonal problem-solving difficulties, defeat, entrapment and hopelessness would (1) be reduced in the treatment relative to the control group over 6 months and (2) mediate any positive treatment effect on suicidal ideation severity at 6 months. To determine to what extent the suicide-focused therapy was considered acceptable and implementable in NHS mental health services from the perspectives of both participants and mental health professionals. To investigate the positive and negative experiences of participating in a suicide-focused randomised controlled trial (RCT) as relayed by the participants themselves. Methods Design The design followed Consolidated Standards of Reporting Trials and Standard Protocol Items: Recommendations for Interventional Trials guidelines, and the Template for Intervention Description and Replication checklist and guide. It comprised a RCT with two groups of treatment [CBSPp therapy plus treatment as usual (TAU)] versus control (TAU alone), and stratification of NHS recruitment site and the use of antidepressant medication (yes/no). There were three assessment time points of baseline, month 6 and month 12, of which the 6-month time point was critical for assessing the effect of treatment on the primary outcome measure of suicidal ideation severity. Four qualitative and mixed-methods workstreams were nested within the RCT design, which examined psychological mechanisms, acceptability, implementation and participant’s experiences of taking part in a suicide-focused RCT. Sites Four NHS Trust sites in the North West (NW) of England, UK, namely Greater Manchester Mental Health NHS Foundation Trust, Pennine Care NHS Foundation Trust, Lancashire and South Cumbria NHS Foundation Trust, and the former North West Boroughs Healthcare NHS Foundation Trust. Inclusion criteria There were six inclusion criteria, which were (1) adults, aged 18 or over; (2) able to give informed consent; (3) the presence of suicidal experiences (e.g. thoughts, plans, urges, compulsions, images, attempts) in the 3 months prior to recruitment; (4) experiences of a non-affective psychosis (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision classifications F20–F29); (5) being under the care of an NHS mental health services team with a care co-ordinator (the care co-ordinator could be the participant’s general practitioner or psychiatrist) and (6) having English as the participant’s primary language or having enough English-language fluency and abilities to take part without an interpreter. Exclusion criteria There were only two exclusion criteria of (1) dementia or organic brain disorder and (2) currently participating in a psychological intervention clinical trial. Randomised controlled trial sample sizes and attrition rate: the target sample size was 250 participants in total, with 125 in each of the treatment and control groups for the primary analyses based on a power of 80%, an alpha level of 0.05 and an effect size of 0.42. We account for clustering in the treatment group with an intraclass coefficient = 0.02, with 6 therapists seeing an average of 21 clients/participants and a variance of 21 participants. The number of clients/participants seen by each therapist is a count variable, meaning that we assume it follows a Poisson process so that the mean and variance are the same. There is no clustering in the TAU arm. An attrition rate of 25% was initially estimated across 6 months, meaning a target total of 333 was required. However, as retention levels consistently exceeded 75%, the desired target total was adjusted to 295. Therapy Our suicide-focused therapy (CBSPp) is highly collaborative, formulation-driven and based on general cognitive–behavioural principles but honed and advanced to explore evidence-based psychological mechanisms founded on the SAMS, which give rise to, and maintain, suicidal experiences. Participants allocated to the RCT treatment group were offered up to 24 sessions of therapy. Each session lasted approximately 50 minutes and usually took place weekly. Primary suicide outcome measure The Adult Suicidal Ideation Questionnaire, which is a self-report measure of suicidal ideation severity, over the past month. Secondary suicide outcome measures Two self-report questionnaires, namely the Suicide Probability Scale and the Beck Scale for Suicidal Ideation. In addition, where possible, a diary Timeline Followback method was used to document self-reported suicide attempts, serious self-harm incidents, suicide plans and suicidal thoughts. Mechanistic outcome measures Self-report questionnaires capturing six negative appraisals of emotional difficulties, interpersonal social problem-solving difficulties, lack of social support, defeat, entrapment and hopelessness. Clinical measures Structured clinical interviews were used to generate information about psychosis symptom severity, the cognitive–emotional impact of hallucinations and delusions, depression, sleep problems, general social and self-care functioning and general psychiatric symptoms. Participants in the treatment group and their therapists completed a measure of the Working Alliance Inventory at around session 4 of therapy and at therapy cessation. Statistical analysis plan Intention-to-treat principles were used across analyses. Data were presumed ‘missing at random’. Linear, mixed regression models were fitted to primary suicidal ideation severity scores at 6 and 12 months to assess efficacy, with the 6-month time point being critical. The treatment effect was the between-group adjusted mean difference between allocated groups, with 95% confidence intervals (CIs) and two-sided p-values. The same modelling procedure was applied to the secondary suicide outcomes, and mechanistic and clinical outcomes. Causal mediation analyses were based on parametric regression models, for which the primary suicidal ideation severity measure at 6 months was the outcome variable; allocated RCT group was the predictor variable; and mechanism outcomes at 6 months were mediators. Baseline scores were covariates. Indirect, direct and total effects were estimated. Two types of compliance analyses were planned, which were (1) systematic exclusion and (2) instrumental modelling of a therapy ‘dose–response’. Results Recruitment and retention Overall, CARMS recruited to target in that 252 participants completed the primary suicide outcome measure at 6 months. Attrition rates were less than expected, given that the target population had severe mental health problems of non-affective psychosis and recent suicidal experiences. Furthermore, excellent retention occurred despite the CARMS project needing to instantiate substantial procedural adjustments due to the COVID-19 pandemic. Efficacy findings There was no significant treatment effect in that across 6 months, suicidal ideation severity did not significantly decrease more in the treatment (suicide-focused therapy + TAU) group compared to the control (TAU) group {adjusted difference –7.36 [standard error (SE) 4.10]; 95% CI −15.41 to 0.68; p = 0.07}. After 12 months, suicidal ideation severity was statistically equivalent in both trial groups. This pattern of non-significance at both month 6 and month 12 extended to the secondary suicide outcome measures. Planned compliance analyses Participants had a median of 16 therapy sessions. When participants in the treatment group were excluded from the analysis if they had not attended any therapy sessions by 6 months, then the treatment effect was still not significant [adjusted difference −7.13 (SE 3.68), 95% CI −0.39 to 0.00; p = 0.052]. Using an instrumental modelling approach with randomisation as an instrument, at 6 months each additional session of therapy reduced the suicidal ideation severity score by 0.46 points, although this also failed to reach significance (95% CI −0.94 to 0.01; p = 0.056). Mediated (indirect) effects There was a significant mediated or indirect effect whereby appraisals of lack of social support (i.e. the mediator) were differentially improved in the treatment relative to the control group, which, in turn, gave rise to a reduction in suicidal ideation severity [effect = −2.85, SE 1.58 (95% CI −7.00 to −0.23)]. The direct effect was not significant. Although there were significant associations between the additional five appraisals of (1) emotional difficulties, (2) interpersonal problem-solving difficulties, (3) defeat, (4) entrapment and (5) hopelessness, and suicidal ideation severity at 6 months, the RCT allocation group did not differentially affect these five appraisals. Hence, the mediation effect was evident for only one out of six potential mediators. Qualitative thematic analyses of interview data provided an extended and expanded understanding of the significant mediated effect involving appraisals of poor social support, in that dynamics involving (1) mattering versus not mattering and (2) being connected versus becoming disconnected were fundamental to the inter-relationships between suicidal and psychotic experiences. Therapy endorsement and calls for implementation Qualitative work highlighted that while aspects of therapy could be perceived by participants as difficult and ‘hard work’, this was offset by (1) an expressed need for therapy, (2) a requirement for suicide to be a focus of therapy, (3) an increased and deepening understanding of suicide through therapy and (4) a growing confidence in using the gains of therapy outside in the ‘real world’. These sentiments were echoed when implementation of suicide-focused therapies in NHS services were discussed with both participants and mental healthcare professionals in that they emphasised that it was vital that suicide-focused therapies were readily available in NHS services, but also in a way that optimised and simplified access routes both to the therapy and also to staff training in suicide-focused therapies. Central to positive experiences of therapy and calls for implementation of suicide-focused therapies was an emphasis on the importance of creating genuine ‘safe spaces’ to talk and the need to be aware of, and open to, different ways of communicating about suicidal experiences. Experiences of being part of a randomised controlled trial about suicide Using a mixed, qualitative and quantitative methods approach, being part of CARMS was largely perceived in ways that were positive in both the shorter and longer terms. Data were collected using diverse methods of mini qualitative interviews, adjective checklists and a simple visual analogue scale mood rating at the end of every assessment/interview appointment. That the data converged provide confidence in the overall message that participation, while sometimes anxiety-provoking and/or distressing, was ‘worth it’ and of benefit. Serious adverse events Three participants died over the course of the CARMS project. However, the reports from the Coroner’s Office documented that these were not suicide-related deaths. The majority of serious adverse events (SAEs) were expected, and judged to be unrelated to the CARMS project. Furthermore, the number of participants involved in SAEs was similar across the two RCT groups. This lends reassurance to an increased impetus for the implementation of suicide-focused psychological therapies in mental health services. Conclusions and clinical implications This suicide-focused therapy intervention, CBSPp, did not demonstrate a significant treatment effect at the 5% significance threshold at month 6. Similarly, while an increasing ‘dose’ of therapy was associated with an increase in a reduction in suicidal ideation, this again did not meet statistical significance. However, there was a significant indirect (mediated) effect at 6 months, in which therapy improved participant’s appraisals of social support, which, in turn, reduced the severity of their suicidal thoughts over 6 months. Exploring appraisals of social support and social connectedness provides a pragmatic starting point for suicide-focused therapies. That said, social support appraisals were one of six different types of appraisals which were measured as part of the CARMS project, meaning that replication of the mediation effect is vital. Nevertheless, qualitative work did converge with the mediated pathway, and suggested that an important focus may be transitions from feeling disconnected to connected, and from a sense of not mattering to being of value. Although working with changing perceptions of social and interpersonal relationships might be expected to be a common aspect of therapeutic work, the CARMS qualitative work delineates how these perceptions are impacted by suicidal mind-sets. Qualitative workstreams from the CARMS project further illustrated how suicide-focused therapy was needed and desired by participants. The median number of therapy sessions attended was 16, demonstrating that people with some of the severest forms of mental health problems can engage with, and maintain, therapy attendance. Ratings of the therapeutic alliance by both participants/clients and therapists were robust, lending some reassurance to the ‘suitability’ of offering a formulation-driven, collaborative, suicide-focused therapy to people who live with both psychotic and suicidal experiences. Implications for future research The convergence between qualitative mechanism findings and the mediation analyses highlighted that we need to better understand how individuals with suicidal and psychotic experiences make transitions between (1) feeling irrelevant and inconsequential to feeling valued and appreciated, (2) feeling disconnected and an ‘outcast’ to feeling a sense of connection and belonging and (3) feeling ‘un-understandable’ to feeling ‘heard’ and worthy of being ‘heard’. Micro-longitudinal designs with both qualitative and quantitative components are needed to develop and maximise this understanding. Examining ways in which individuals fluctuate from having suicidal thoughts and urges to acting on those urges was beyond the scope of CARMS but is a research direction that is vital to advance. In the first instance, qualitative work using multimedia diary methods conjoint with experience sampling methodologies seem best suited to this research endeavour because these fluctuations seem non-linear, interactive, context-dependent and highly dynamic. CARMS investigated transdiagnostic psychological suicide mechanisms based on the SAMS. It is now essential to further develop these mechanisms so that they can explain ways in which specific mental health problems, for example, hallucinations, delusions and paranoid thoughts/beliefs, impact these mechanisms by investigating complex pathways using longitudinal and micro-longitudinal moderated mediation designs together with network analysis. A realist evaluation approach was beyond the scope of CARMS, but this approach offers the potential to better understand how multilayered contextual factors impact putative mechanisms and outcomes dependent on contextual factors. Qualitative findings revealed difficulties in navigating ‘suicide talk’. We need an improved understanding of how to communicate about suicide in ways that create genuine and trusted ‘safe spaces’, using diverse and creative channels that can be readily embraced by people with suicidal experiences, but also by health professionals, colleagues, friends, partners and family. Finally, that participants could attain high levels of formulation, experience high levels of therapeutic alliance, and that therapy ‘dose’ may confer therapy benefits suggest that these therapy process variables might be further explored. Trial registration This trial is registered as ClinicalTrials.gov NCT03114917 and ISRCTN17776666. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 13/161/25) and is published in full in Efficacy and Mechanism Evaluation; Vol. 13, No. 3. See the NIHR Funding and Awards website for further award information.

BACKGROUND:Pharmacy First, a national community pharmacy service, launched in January 2024 to improve access to primary care for patients with minor conditions facing backlogs caused by the COVID-19 pandemic. Pharmacies are required to share details about their consultations with general practices. AIM:To describe how and what clinical activity was recorded in general practice during the first year of the Pharmacy First service. DESIGN AND SETTING:With the approval of NHS England, we conducted a retrospective cohort study between 31 January 2024 and 30 January 2025 using OpenSAFELY-TPP, a secure platform for analysing pseudonymised GP records from practices using TPP software. METHOD:We described patient demographics, Pharmacy First consultation trends, and the clinical conditions and medications coded with the consultations. RESULTS:A total of 402,165 Pharmacy First consultations were recorded for 340,710 patients from a general population of 26,142,380 registered patients in OpenSAFELY-TPP. Acute pharyngitis (28.9%) and uncomplicated urinary tract infection (28%) were the most frequently recorded conditions. By January 2025, 36.3% of recorded Pharmacy First consultations had a clinical condition, medication, or both. Females, younger adults and those living in more deprived areas were observed more often in Pharmacy First records compared to the general population. CONCLUSION:Increasing recording of the Pharmacy First community pharmacy service was observed in general practice records during its first year, particularly among younger and more deprived populations. However, variation in structured recording of consultation details may limit evaluation.

Hearing loss is a prevalent condition that impacts on social, mental and physical health, and has a significant economic burden. Hearing aids can improve the quality of life for those living with hearing loss; however, low and inconsistent use remains common. Within the National Health Service (NHS), follow-up care for new hearing aid users is highly variable and often lacks structure, which may contribute to low use. The FAMOUS trial investigates whether a structured care model for follow-up, combined with evidence-based behaviour change interventions, improves hearing aid use compared to usual care. FAMOUS is a multi-centre, two-arm parallel-group cluster randomised controlled trial (CRCT) with integral internal pilot, economic, and process evaluations. The trial involves 36 NHS audiology services and compares two types of follow-up for new adult hearing aid users: structured care, which includes personalised action plans, early monitoring, and routine follow-up at 6 weeks post-fitting, to usual care, which includes the offer of a follow-up 6–12 weeks after fitting. Recruitment is conducted through participating services over 3 months, with pseudo-anonymised routine data collected from electronic medical records of all patients who attend. Consent and outcomes are then collected from patients at 12 weeks post-fitting. For patients who provide consent to future contact, the primary outcome (self-reported daily hearing aid use) is collected at 12 months post-fitting. Secondary outcomes (quality-of-life (QoL), hearing-related disability, and economic measures) are collected at both timepoints. Qualitative interviews with a subset of patients and hearing professionals in the intervention arm will assess the acceptability and implementation of the intervention. Statistical analyses, including mixed-effects regression modelling, will be conducted under an intention-to-treat framework. FAMOUS addresses a critical evidence gap regarding the potential benefits of follow-up care for new hearing aid users. If the intervention is successful, it can be rolled out nationally using existing facilities with limited impact on resources, identified in the economic analysis, and would improve hearing aid use and quality of life for those living with hearing loss. Prospectively registered with the International Standard Randomised Controlled Trial Number (ISRCTN) 10589817. Date of registration: 01/09/2022.

OBJECTIVES:In response to high levels of demand for primary medical services in England, characterized by longer appointment waiting times and delayed referrals, the Government developed its National Health Service (NHS) Primary Care Recovery Plan. A key component of the plan is Pharmacy First (PF), which involves participating community pharmacies supplying prescription-only medicine after consultation with a pharmacist for seven common conditions: earache, uncomplicated urinary tract infections in women, sore throat, sinusitis, impetigo, shingles, and infected insect bites. The study aims to evaluate the implementation of the PF service and its impact on the volume of prescribing, case mix of General Practitioner consultations, accident and emergency department and other hospital use, equity of access, and cost for different groups of patients in different contexts, as well as its acceptability and fidelity. METHODS:A 36-month, mixed methods evaluation with five elements, namely evidence synthesis, semi-structured interviews, focus groups, quantitative analysis of impacts before and after implementation (e.g. using interrupted time series analysis) using routine data, and an economic evaluation. Findings will be synthesized and interpreted using the Consolidated Framework for Implementation Research supplemented by Proctor's Implementation Outcomes Framework. CONCLUSIONS:The evaluation should have service level, policy, professional, and research impact both in England and beyond. This includes generating evidence to show: whether PF contributes to improving primary healthcare access, assessing the quality of antimicrobial use, identifying the scope for refinements to PF, and, overall, informing better implementation of PF. The findings will also provide robust evidence to enable policymakers to determine how to enhance the role of community pharmacy in England in the future. Furthermore, the evaluation will develop a data dashboard, and the methods and codes used to interrogate it (though not the patient data), will be made publicly available that could support other similar evaluations in England and internationally.

Liaison psychiatry services play a central role in self-harm care and suicide prevention by providing specialist mental health input in general hospitals. Psychosocial interventions, including brief contact approaches (e.g., safety plans) and longer-term structured therapies (e.g., cognitive-behaviour therapy [CBT], dialectical behaviour therapy [CBT]), may reduce self-harm and suicide risk but their relevance and effectiveness within liaison psychiatry settings remains unclear. To synthesise systematic evidence review on psychosocial interventions for preventing self-harm and suicide in liaison psychiatry settings through an umbrella review. We searched Medline, Embase, CINAHL, PsycInfo, and CDSR (2013–2023) for systematic reviews evaluating interventions in liaison psychiatry contexts (including emergency departments, wards in general hospitals, outpatient/follow-up clinics for acute care patients receiving treatment for self-harm/suicidal behaviour), in adults or mixed adult/adolescent populations. Review quality (AMSTAR-2), primary study overlap in reviews, and evidence certainty (adapted GRADE) were assessed. Findings were narratively synthesised and tabulated, with input from experts-by-experience throughout. PROSPERO: CRD42023442639. Twenty-three systematic reviews (including 12 meta-analyses; >450,000 participants), were included. Person-centred brief contact interventions, particularly those incorporating safety planning and follow-up, were most consistently associated with reduced suicide attempt rates. However, methodological limitations including heterogeneity, limited generalisability, lack of self-harm specific outcomes, and mixed findings for remote only contact interventions warrant cautious interpretation. For longer-term psychological therapies, CBT was associated with reduced repeat self-harm, particularly with longer follow-up, whereas DBT reduced the rate of repetition. Evidence was limited by the lack of setting-specific trials, limited patient involvement, and suboptimal quality trials. Review quality varied. Primary trial overlap was slight overall, but high for some pairs of reviews of brief interventions. Current evidence for self-harm and suicide prevention interventions in liaison psychiatry services is methodologically suboptimal. Given widescale implementation of psychosocial interventions, there is an urgent priority to ensure they are safe, effective, and acceptable within liaison psychiatry services.

Despite a decade of initiatives in the UK to raise awareness of acute kidney injury (AKI) and isolated reports of progress through improvement work in some regions, concerns remain that people who have had AKI do not receive adequate follow-up and care after transitioning from hospital back into the community. People discharged from hospital after AKI often have complex health needs and multiple long-term conditions, are at high risk of multiple poor outcomes and have high rates of unplanned readmissions. There is therefore a need to examine factors that are associated with variations in post-discharge AKI care. As part of the AsterAKI study, a mixed methods study aiming to develop interventions to improve post-discharge AKI care in primary care, we performed a cohort study to describe variations in the implementation of recommended post-discharge AKI care. Using admission data in England from Hospital Episode Statistics, we delineated a cohort of adult patients (≥18 years) with a hospital diagnostic code of AKI discharged between 1 January 2017 and 31 March 2021. Using linked primary care data from the Clinical Practice Research Datalink Aurum, we measured adherence to indicators of good care covering domains of (1) recording of AKI in primary care, (2) timeliness of post-discharge clinical reviews, (3) recommendations to monitoring of recovery at 90 days, and (4) guideline indicated prescribing. We evaluated care quality both overall, and within subgroups based on demographic, socioeconomic, and clinical characteristics. A total of 209,222 patients (48.0% females; mean age 74.1 years, SD 15.6) were included in the study cohort, representing 279,187 AKI hospital inpatient episodes. While some form of clinical contact (either in person or remotely) was made within 30 days of discharge for 72.5% of episodes, only 19.5% had a diagnosis of AKI hospitalisation recorded in the primary care notes. These percentages rose to 88.1% and 22.0% respectively at 90 days. Variations by demographic and socioeconomic factors were observed. At around 90 days post-discharge, measurement of serum creatinine for kidney recovery occurred in 34.2% of episodes, blood pressure was recorded in 34.6%, and urine albuminuria testing in only 3.8%. Of people with a guideline indication for a renin-angiotensin system inhibitor (RAASi) based on diabetes/hypertension and proteinuria levels, only 42.1% received a prescription. Across all subgroups of people with a hospital diagnostic code of AKI in this analysis, AKI was rarely documented in the patient's primary care records, and only a minority received the recommended post-AKI monitoring of blood and urine testing or blood pressure measurement, despite relatively high levels of contact with health care professionals. Rates of measuring albuminuria were particularly low, despite its strong association with subsequent kidney and cardiovascular events. Further, rates of prescribing of RAASi were low in patients who could benefit from these medications. Recommendations to improve this include provision of clear, case-specific guidance on post-discharge management to primary care professionals, and development of concerted implementation strategies between secondary and primary care.

Personal narratives describing recovery from mental health problems are widely available to the public. We developed theory on the characteristics and impact of recovery narratives, developed curation procedures for the NEON Collection of 659 recovery narratives and developed and evaluated the NEON Intervention, a theory-informed web application providing access to the NEON Collection. To evaluate the effectiveness and cost-effectiveness of the NEON Intervention as compared to usual care and whether this varies by prior health service usage. Three pragmatic parallel-group randomised controlled trials of the NEON Intervention. Intervention arm participants received immediate access. Control arm participants received access after a 52-week follow-up. The effectiveness analysis was a linear regression model of outcome at 52 weeks. The cost-effectiveness analysis compared the incremental cost-effectiveness ratio to the £20,000–30,000 threshold defined in the National Institute for Health and Care Excellence reference case. All analyses were intention-to-treat and baseline-adjusted, with multiple imputation for missing data. England. All trials recruited people who were aged 18+ years, resident in England, capable of accessing or being supported to access the internet, able to understand written and spoken English and capable of providing online informed consent. NEON Trial participants also had experience of mental health-related distress in the last 6 months, and psychosis in the previous 5 years. NEON-O (i.e. non-psychosis) Trial participants also had experience of mental health-related distress in the last 6 months, but with no psychosis in the previous 5 years. People identifying as informal carers for people affected by mental health problems but not eligible for the NEON Trial or NEON-O Trial were recruited to the NEON-C feasibility trial. All inclusion criteria were self-rated. Recruitment was from March 2020 to March 2021, through public communications by the central study team, and the work of clinical support officers at 11 secondary care research sites. The NEON Intervention has four narrative access mechanisms: theory-informed algorithmic recommendation, random selection, self-selection by narrative category and return to impactful narratives. Participants used the NEON Intervention as much as they wished. Primary outcome: quality of life (Manchester Short Assessment). Secondary outcomes: distress, hope, self-efficacy, meaning in life and health status. For the NEON-O (i.e. non-psychosis) Trial, we found a significant baseline-adjusted difference of 0.13 (95% confidence interval 0.01 to 0.26, p = 0.041) in the Manchester Short Assessment score between intervention and control, and a significant baseline-adjusted difference of 0.22 (95% confidence interval 0.05 to 0.40, p = 0.014) in the presence subscale of the Meaning in Life Questionnaire. The incremental cost-effectiveness ratio was £12,526 per quality-adjusted life-year, lower than a threshold of £30,000 per quality-adjusted life-year used for health service commissioning in England. For participants who had used specialist mental health services at baseline, the intervention appeared to reduce cost, although confidence intervals were wide and results were not statistically significant (–£98, 95% credible interval –£606 to £309). It also improved quality-adjusted life-years (0.0165, 95% credible interval 0.0057 to 0.0273) per participant. Hence, for this subgroup of participants, it dominated usual care. For the NEON Trial, no significant baseline-adjusted differences in outcome were found. An incremental cost-effectiveness ratio of £110,501 was found for the NEON Intervention. A subgroup analysis provided preliminary evidence for greater cost-effectiveness for current mental health service users, with an incremental cost-effectiveness ratio of £35,013. The NEON-C Trial showed acceptability and feasibility for informal carers. It recommended integration of carer narratives and creation of an online carer community. Participants were recruited during a period in which movement and social interaction were widely affected by the COVID-19 pandemic, with the potential to influence generalisability. For the NEON-O Trial, we had an unrepresentative proportion of female-gendered participants (79.3%). Therefore, our NEON-O Trial findings cannot be generalised. This research programme has shown promising findings from the testing of the NEON Intervention. There is further research to do before implementation can be suggested. The NEON Intervention should be evaluated through a randomised controlled trial with people experiencing psychosis and using mental health services. The NEON Intervention should be refined to suit the needs of carers and then evaluated through a randomised controlled trial. The NEON-O Trial should be repeated with narrower mental health populations (e.g. mood disorders, eating disorders) to refine knowledge on effectiveness and cost-effectiveness. This may include refining the narrative collection used with these populations. If the NEON Intervention is implemented on a larger scale for people with non-psychosis mental health problems, then studies should be conducted to monitor benefits, continuously assess safety and documentation implementation processes. Future studies should consider alternative forms for presenting recovery narratives, including through multilanguage or multiculture support, and addressing digital exclusion by providing access through widely available technologies, such as smartphones and text messaging. Longitudinal designs are needed to document the short-term, medium-term and long-term impacts of recovery narratives. This trial is registered as NEON Trial ISRCTN11152837, NEON-O Trial ISRCTN63197153 and NEON-C Trial ISRCTN76355273. 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-0615-20016) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 9. See the NIHR Funding and Awards website for further award information.

Introduction Effective management of type 2 diabetes mellitus (T2DM) consists of lifestyle modification and therapy optimisation. While glycaemic monitoring can be used as a tool to guide these changes, this can be challenging with self-monitoring of blood glucose (SMBG). The FreeStyle Libre 3 (FSL3) is a real-time continuous glucose monitoring (CGM) system designed to replace SMBG. The evidence for the benefit of CGM in people with T2DM on non-intensive insulin regimens is limited. This study aims primarily to assess the glycaemic impact of FSL3 in people with suboptimally controlled T2DM treated with basal-only insulin regimens plus sodium-glucose cotransporter-2 (SGLT-2) inhibitor and/or glucagon-like peptide (GLP)-1 agonist.Methods and analysis This is an open-label, multicentre, parallel design, randomised (2:1) controlled trial. Recruitment has been offered across 24 clinical centres in the UK and nationally through self-referral. Adults with T2DM treated with basal-only insulin regimens plus SGLT-2 inhibitor and/or GLP-1 agonist and with screening HbA1c from ≥59 mmol/mol to ≤97 mmol/mol are included. Eligible participants will be randomised to either FSL3 (intervention) for 32 weeks or continuation of SMBG (control). The study is split into two phases, each of 16 weeks duration: phase 1 consisting of self-management with basal-insulin self-titration and phase 2 where additional therapies may be initiated. Control group participants may subsequently enter an optional extension phase to receive FSL3. The primary endpoint is the difference between treatment groups in mean change from baseline in HbA1c at 16 weeks. Secondary outcomes include HbA1c at 32 weeks, CGM-based metrics, therapy changes, physical activity levels and psychosocial measures. An economic evaluation for costs and patient outcomes will be undertaken.Ethics and dissemination The study was approved by the Health Research Authority, Health and Care Research Wales and the West Midlands-Edgbaston Research Ethics Committee (reference: 23/WM/0092). Study results will be disseminated in peer-reviewed journals.Trial registration number NCT05944432.Secondary identifying number Identifier assigned by the sponsor: ADC-UK-PMS-22057.Protocol version Revision D. Dated, 13 December 2024.

Objective: We previously showed that intermittently scanned continuous glucose monitoring (isCGM) reduces HbA1c at 24 weeks compared with self-monitoring of blood glucose with finger pricking (SMBG) in adults with type 1 diabetes and high HbA1c levels (58-97 mmol/mol [7.5%-11%]). We aim to assess the economic impact of isCGM compared with SMBG.Methods: Participant-level baseline and follow-up health status (EQ-5D-5L) and within-trial healthcare resource-use data were collected. Quality-adjusted life-years (QALYs) were derived at 24 weeks, adjusting for baseline EQ-5D-5L. Participant-level costs were generated. Using the IQVIA CORE Diabetes Model, economic analysis was performed from the National Health Service perspective over a lifetime horizon, discounted at 3.5%.Results: Within-trial EQ-5D-5L showed non-significant adjusted incremental QALY gain of 0.006 (95% CI: -0.007 to 0.019) for isCGM compared with SMBG and an adjusted cost increase of 548 pound (95% CI: 381-714) per participant. The lifetime projected incremental cost (95% CI) of isCGM was 1954 pound (-5108 to 8904) with an incremental QALY (95% CI) gain of 0.436 (0.195-0.652) resulting in an incremental cost-per-QALY of 4477 pound. In all subgroups, isCGM had an incremental cost-per-QALY better than 20,000 pound compared with SMBG; for people with baseline HbA1c >75 mmol/mol (9.0%), it was cost-saving. Sensitivity analysis suggested that isCGM remains cost-effective if its effectiveness lasts for at least 7 years.Conclusion: While isCGM is associated with increased short-term costs, compared with SMBG, its benefits in lowering HbA1c will lead to sufficient long-term health-gains and cost-savings to justify costs, so long as the effect lasts into the medium term.

OBJECTIVE:To investigate risks of multiple adverse outcomes associated with use of antipsychotics in people with dementia. DESIGN:Population based matched cohort study. SETTING:Linked primary care, hospital and mortality data from Clinical Practice Research Datalink (CPRD), England. POPULATION:Adults (≥50 years) with a diagnosis of dementia between 1 January 1998 and 31 May 2018 (n=173 910, 63.0% women). Each new antipsychotic user (n=35 339, 62.5% women) was matched with up to 15 non-users using incidence density sampling. MAIN OUTCOME MEASURES:The main outcomes were stroke, venous thromboembolism, myocardial infarction, heart failure, ventricular arrhythmia, fracture, pneumonia, and acute kidney injury, stratified by periods of antipsychotic use, with absolute risks calculated using cumulative incidence in antipsychotic users versus matched comparators. An unrelated (negative control) outcome of appendicitis and cholecystitis combined was also investigated to detect potential unmeasured confounding. RESULTS:Compared with non-use, any antipsychotic use was associated with increased risks of all outcomes, except ventricular arrhythmia. Current use (90 days after a prescription) was associated with elevated risks of pneumonia (hazard ratio 2.19, 95% confidence interval (CI) 2.10 to 2.28), acute kidney injury (1.72, 1.61 to 1.84), venous thromboembolism (1.62, 1.46 to 1.80), stroke (1.61, 1.52 to 1.71), fracture (1.43, 1.35 to 1.52), myocardial infarction (1.28, 1.15 to 1.42), and heart failure (1.27, 1.18 to 1.37). No increased risks were observed for the negative control outcome (appendicitis and cholecystitis). In the 90 days after drug initiation, the cumulative incidence of pneumonia among antipsychotic users was 4.48% (4.26% to 4.71%) versus 1.49% (1.45% to 1.53%) in the matched cohort of non-users (difference 2.99%, 95% CI 2.77% to 3.22%). CONCLUSIONS:Antipsychotic use compared with non-use in adults with dementia was associated with increased risks of stroke, venous thromboembolism, myocardial infarction, heart failure, fracture, pneumonia, and acute kidney injury, but not ventricular arrhythmia. The range of adverse outcomes was wider than previously highlighted in regulatory alerts, with the highest risks soon after initiation of treatment.

BACKGROUND:There is currently a dearth of psychological support available to clients who self-harm in the NHS and there is a need to develop brief, targeted interventions to better fill this treatment gap. Cognitive analytic therapy (CAT) is a relational psychotherapy that holds promise for helping people who self-harm. A brief version of CAT has been developed and now requires evaluation. AIMS:To evaluate the feasibility of evaluating 8-session CAT to adult outpatients accessing community services who self-harm in a subsequent definitive trial. METHOD:A feasibility randomised controlled trial evaluating 8-session CAT for self-harm in adult outpatients. Participants were randomly allocated (1:1) to brief CAT plus treatment as usual (TAU) or TAU alone. Rater-blind assessments occurred at baseline, 12-weeks and 18-weeks. RESULTS:Pre-specified study progression criteria concerning recruitment (n = 60 recruited over 12 months), retention (92 %), missing data on clinical outcomes (< 7 %) and engagement with therapy (90 % attended ≥ 4 sessions within a 10-week window) were all met. Urges to self-harm and psychological distress declined in the CAT arm and to a greater extent than the TAU arm (self-harm urges: 80 % CI:6.22 -1.68; psychological distress: 80 % CI:5.95, -2.22). CONCLUSIONS:The results support the feasibility of evaluating brief CAT for self-harm and so progression to larger-scale definitive efficacy trial is warranted. CAT shows initial promise as a treatment for self-harm in adults but this now requires evaluation within a definitive trial. TRIAL REGISTRATION:The trial was pre-registered (21/10/22) on ISRCTN (ISRCTN code: ISRCTN75661422).

OBJECTIVES:To quantify prevalence, harms, and NHS costs in England of problematic oral non-steroidal anti-inflammatory drug (NSAID) prescribing in high risk groups. DESIGN:Population based cohort and economic modelling study. SETTING:Economic models estimating patient harm associated with NSAID specific hazardous prescribing events, and cost to the English NHS, over a 10 year period, were combined with trends of hazardous prescribing event to estimate national levels of patient harm and NHS costs. PARTICIPANTS:Eligible participants were prescribed oral NSAIDs and were in five high risk groups: older adults (≥65 years) with no gastroprotection; people who concurrently took oral anticoagulants; or those with heart failure, chronic kidney disease, or a history of peptic ulcer. MAIN OUTCOME MEASURES:Prevalence of hazardous prescribing events, by each event and overall, discounted quality adjusted life years (QALYs) lost, and cost to the NHS in England of managing harm. RESULTS:QALY losses and cost increases were observed for each hazardous prescribing event (v no hazardous prescribing event). Mean QALYs per person were between 0.01 (95% credibility interval (CI) 0.01 to 0.02) lower with history of peptic ulcer, to 0.11 (0.04 to 0.19) lower with chronic kidney disease. Mean cost increases ranged from a non-statistically significant £14 (€17; $18) (95% CI -£71 to £98) in heart failure, to a statistically significant £1097 (£236 to £2542) in people concurrently taking anticoagulants. Prevalence of hazardous prescribing events per 1000 patients ranged from 0.11 in people who have had a peptic ulcer to 1.70 in older adults. Nationally, the most common hazardous prescribing event (older adults with no gastroprotection) resulted in 1929 (1416 to 2452) QALYs lost, costing £2.46m (£0.65m to £4.68m). The greatest impact was in people concurrently taking oral anticoagulants: 2143 (894 to 4073) QALYs lost, costing £25.41m (£5.25m to £60.01m). Over 10 years, total QALYs lost were estimated to be 6335 (4471 to 8658) and an NHS cost for England of £31.43m (£9.28m to £67.11m). CONCLUSIONS:NSAIDs continue to be a source of avoidable harm and healthcare cost in these five high risk populations, especially in inducing an acute event in people with chronic condition and people taking oral anticoagulants.

BACKGROUND:The effect of hearing and vision difficulties on the risk of developing dementia and worsening outcomes in people already living with dementia is well established. We evaluated the clinical impact of a hearing and vision rehabilitation and support programme on quality of life in people with mild-to-moderate dementia and concurrent sensory difficulties. METHODS:We conducted a parallel-group, multicentre, observer-blind, superiority randomised controlled trial in seven older adult clinics in five European countries (Cyprus, France, Greece, Ireland, and the UK). People with mild-to-moderate dementia with adult-acquired hearing difficulties, vision difficulties, or both were randomly assigned (1:1) along with their care partner to an 18-week home-basedsensory support intervention (SSI) of tailored hearing and vision rehabilitation and support, or to care as usual. Randomisation was blocked (block size of four, six, or eight) and stratified by country, with allocation assigned via a remote web-based system. The SSI included: full hearing assessment, vision assessment, or both; fitting of hearing aids, glasses, or other sensory aids; and home-based support from a sensory support therapist to assist adherence and uptake of sensory aids, foster social networking, and optimise the home sensory environment. Care as usual involved no additional intervention beyond services normally available to people with dementia at the respective sites. The primary outcome was health-related quality of life (Dementia Quality of Life Instrument [DEMQoL]) score at 36 weeks, reported as an adjusted mean difference. Analyses were done according to the intention-to-treat principle. This trial is registered with the ISRCTN Registry, ISRCTN17056211. FINDINGS:Between May 4, 2018, and May 6, 2021, 252 people with mild-to-moderate dementia were randomly assigned, of whom 251 (n=126 in the SSI group and n=125 in the care as usual group) were included in the analysis. The mean age of participants was 79·6 years (SD 5·8), and 132 (53%) were women. After a median follow-up time of 37·7 weeks (IQR 36·2-39·0), the mean DEMQoL score was 92·8 (SD 15·2) in the SSI group and 92·8 (14·0) in the care as usual group (adjusted difference 0·18, 95% CI -2·13 to 2·30, p=0·87). Among 114 adverse events reported for 56 (44%) participants in the SSI group, ten events in nine participants were related or possibly related to the intervention (medical device pain or discomfort n=6, ear pain n=1, scratch to the ear n=1, sore eye n=1, redness n=1; all of grade 1). Serious adverse events were reported for 25 (20%) participants in the SSI group and 16 (13%) in the care as usual group. Six (5%) participants in the SSI group and five (4%) in the care as usual group died. None of the serious adverse events or deaths were related to the study intervention or procedures. INTERPRETATION:This study showed no improvement in quality in life in participants who received the intervention in the longer term. Sensory difficulties are common in people with dementia and interventions aimed at improving sensory-cognitive health should be explored further. FUNDING:EU Horizon 2020.

Narratives describing first‐hand experiences of recovery from mental health problems are widely available. Emerging evidence suggests that engaging with mental health recovery narratives can benefit people experiencing mental health problems, but no randomized controlled trial has been conducted as yet. We developed the Narrative Experiences Online (NEON) Intervention, a web application providing self‐guided and recommender systems access to a collection of recorded mental health recovery narratives (n=659). We investigated whether NEON Intervention access benefited adults experiencing non‐psychotic mental health problems by conducting a pragmatic parallel‐group randomized trial, with usual care as control condition. The primary endpoint was quality of life at week 52 assessed by the Manchester Short Assessment (MANSA). Secondary outcomes were psychological distress, hope, self‐efficacy, and meaning in life at week 52. Between March 9, 2020 and March 26, 2021, we recruited 1,023 participants from across England (the target based on power analysis was 994), of whom 827 (80.8%) identified as White British, 811 (79.3%) were female, 586 (57.3%) were employed, and 272 (26.6%) were unemployed. Their mean age was 38.4±13.6 years. Mood and/or anxiety disorders (N=626, 61.2%) and stress‐related disorders (N=152, 14.9%) were the most common mental health problems. At week 52, our intention‐to‐treat analysis found a significant baseline‐adjusted difference of 0.13 (95% CI: 0.01‐0.26, p=0.041) in the MANSA score between the intervention and control groups, corresponding to a mean change of 1.56 scale points per participant, which indicates that the intervention increased quality of life. We also detected a significant baseline‐adjusted difference of 0.22 (95% CI: 0.05‐0.40, p=0.014) between the groups in the score on the “presence of meaning” subscale of the Meaning in Life Questionnaire, corresponding to a mean change of 1.1 scale points per participant. We found an incremental gain of 0.0142 quality‐adjusted life years (QALYs) (95% credible interval: 0.0059 to 0.0226) and a £178 incremental increase in cost (95% credible interval: –£154 to £455) per participant, generating an incremental cost‐effectiveness ratio of £12,526 per QALY compared with usual care. This was lower than the £20,000 per QALY threshold used by the National Health Service in England, indicating that the intervention would be a cost‐effective use of health service resources. In the subgroup analysis including participants who had used specialist mental health services at baseline, the intervention both reduced cost (–£98, 95% credible interval: –£606 to £309) and improved QALYs (0.0165, 95% credible interval: 0.0057 to 0.0273) per participant as compared to usual care. We conclude that the NEON Intervention is an effective and cost‐effective new intervention for people experiencing non‐psychotic mental health problems.

ObjectivesTo estimate the number and burden of medication errors associated with prescription information transfer within the National Health Service (NHS) in England and the impact of implementing an interoperable prescription information system (a single digital prescribing record shared across NHS settings) in reducing these errors.MethodsWe constructed a probabilistic mathematical model. We estimated the number of transition medication errors that would be undetected by standard medicines reconciliation, based on published literature, and scaled this up based on the annual number of hospital admissions. We used published literature to estimate the proportion of errors that lead to harm and applied this to the number of errors to estimate the associated burden (healthcare resource use and deaths). Finally, we used reported effect sizes for electronic prescription information sharing interventions to estimate the impact of implementing an interoperable prescription information system on number of errors and resulting harm.ResultsAnnually, around 1.8 million (95% credibility interval (CrI) 1.3 to 2.6 million) medication errors were estimated to occur at hospital transitions in England, affecting approximately 380 000 (95% CrI 260 397 to 539 876) patient episodes. Harm from these errors affects around 31 500 (95% CrI 22 407 to 42 906) patients, with 36 500 (95% CrI 25 093 to 52 019) additional bed days of inpatient care (costing around £17.8 million (95% CrI £12.4 to £24.9 million)) and >40 (95% CrI 9 to 146) deaths. Assuming the implementation of an interoperable prescription information system could reduce errors by 10% and 50%, there could be 180 000–913 000 fewer errors, 3000–15 800 fewer people who experience harm and 4–22 lives saved annually.ConclusionsAn interoperable prescription information system could provide major benefits for patient safety. Likely additional benefits include healthcare professional time saved, improved patient experience and care quality, quicker discharge and enhanced cross-organisational medicines optimisation. Our findings provide vital safety and economic evidence for the case to adopt interoperable prescription information systems.

Background:The Narrative Experiences Online (NEON) Intervention provides self-managed web-based access to mental health recovery narratives (n = 659). We evaluated effectiveness and cost-effectiveness in improving quality of life for adults resident in England with mental health problems and recent psychosis experience. Methods:Prospectively registered pragmatic parallel-group randomised trial controlling for usual care, recruiting from statutory mental health services and through community engagement activities, with a 52-week primary endpoint (ISRCTN11152837). All trial procedures and the NEON Intervention were delivered by an integrated web-application. Randomisation was through an independently generated list (no stratification). Allocation was masked for statistical staff and the Chief Investigator but not participants. Intervention arm participants received immediate NEON Intervention access. Control arm participants received access after completing primary endpoint questionnaires. The primary outcome was quality of life through the Manchester Short Assessment (MANSA). Serious Adverse Events (SAEs) were collected through web-based safety report forms and identified from health service usage data. The primary analysis was by a prospectively described Intention To Treat principle excluding participants who had registered multiple times, with multiple imputation for missing data. Findings:Between 9 March 2020 and 1 March 2021, 739 participants were randomised (intervention:370; control: 369), providing more than 90% power to detect a baseline-adjusted difference of 0.25 in the MANSA score. Mean age was 34.8 years (standard deviation (SD) 12.0), 561 (75.9%) were white British, 443 (59.9%) were female, 609 (82.4%) had accessed specialist care mental health services, and 698 (94.5%) had accessed primary care mental health services. Mean baseline MANSA score was 3.7 for control and intervention arms (SD 0.9 and 1.0). 565 (76.5%) participants provided primary endpoint MANSA data with a mean score of 4.1 (SD 1.0) for both arms. We found no significant difference in Quality of Life between the two arms at the primary endpoint (baseline-adjusted difference 0.07, 95% CI -0.07 to 0.21, p = 0.35). The incremental cost-effectiveness ratio (£110,501 per quality-adjusted life-year (QALY)) exceeded the prospectively defined cost-effectiveness threshold (£30,000 per QALY). 158 (42.8%) control arm and 194 (52.4%) intervention arm participants accessed narratives outside of the NEON Intervention. There were no related serious adverse events (SAEs). 116 unrelated SAEs were reported by control arm participants, and 107 by intervention arm participants. Interpretation:Our findings do not indicate NEON Intervention access for all people with psychosis experience. Future research should consider a) evaluation with current mental health services users; b) optimisation to enable users to find hope-promoting narratives. Funding:National Institute for Health and Care Research (NIHR).

BackgroundAdherence to preventative inhaled therapies in people with cystic fibrosis (CF) is low, resulting in potentially avoidable health losses and the need for costly rescue therapies.ObjectivesTo estimate the cost-effectiveness of the CFHealthHub (CFHH) intervention to support adherence to inhaled medications. MethodsA state transition model was developed to assess the cost-effectiveness of the CFHH intervention versus usual care from the perspective of the UK National Health Service and Personal Social Services over a lifetime horizon. Costs and health outcomes were discounted at a rate of 3.5 percent per annum. Costs were valued at 2021/22 prices. The model structure includes health states defined by survival status, level of lung function, and transplant history. Treatment effects were modeled by changing the probabilities of transitioning between lung function states and reducing exacerbation rates. Model parameters were informed by the CFHH trial, CF Registry data, routine cost databases, literature, and expert opinion. Deterministic and probabilistic sensitivity analyses were undertaken to assess uncertainty. ResultsThe CFHH intervention is expected to generate additional health gains and cost savings compared with usual care. Assuming that it is delivered for 10 years, the CFHH intervention is expected to generate 0.17 additional quality-adjusted life years and cost savings of GBP 1,600 (EUR 1,662) per patient. ConclusionsThe CFHH intervention is expected to dominate usual care, irrespective of the duration over which the intervention is delivered. The modeled benefits and cost savings are smaller than initially expected and are sensitive to relative treatment effects on lung function.