Evidence confirms that provision of end-of-life care for infants, children and young people varies across the United Kingdom, however it is not clear how this variation impacts children and their families. This study aimed to assess parental outcomes and experiences of their infant, child or young person receiving end-of-life care in the United Kingdom through a cross-sectional mixed-methods survey. Bereaved parents were sent a survey, after their infant or child had died and had received end-of-life care in a neonatal or paediatric intensive care unit. The survey yielded qualitative and quantitative data, which were analysed using qualitative content analysis and graphical summaries of quantitative results. Data were integrated using joint display matrices. One hundred sixty nine bereaved parents completed the survey, of which 60

Abstract Objectives To evaluate the impact of continuing versus stopping biologic disease-modifying anti-rheumatic drugs (bDMARDs) during the perioperative period on surgical site infections (SSIs), delayed wound healing, and disease flares in patients with inflammatory arthritis (IA) undergoing elective non-orthopaedic surgery. Methods We conducted a systematic review of observational studies assessing the perioperative management of bDMARDs in IA patients undergoing elective non-orthopaedic surgery. Searches were conducted across seven databases and trial registries from the year 2000 onwards. Eligible studies compared outcomes in patients who continued versus stopped biologic therapy. Risk of bias was assessed using the ROBINS-I tool and due to heterogeneity data were synthesised narratively. Results Eight observational studies met the inclusion criteria. All studies were at moderate or serious risk of bias. Four studies compared infections with two suggesting higher infection rates in the stop biologic group. Two studies assessed delayed wound healing, both suggesting higher rates in the stop group. Disease flares were more common in patients who stopped biologics in all three of the studies reporting this outcome. No studies assessed health-related quality of life. Conclusions The available observational evidence does not demonstrate a consistent increase in postoperative infection or wound complications related to biologic continuation, however, confidence in these findings is limited by serious risk of bias and outcome heterogeneity. High-quality randomised controlled trials are needed to inform the perioperative management guidelines for IA patients undergoing elective non-orthopaedic procedures.

Hypertension is a leading contributor to cardiovascular disease in South Asia, affecting over 40% of adults, of whom most remain undiagnosed or poorly managed. Despite urgent healthcare needs, the already overstretched public primary care systems in low-and middle-income countries, particularly in rapidly growing urban areas, are falling short. Community pharmacies, often the first point of contact for low-income urban residents, represent an opportunity for delivering frontline chronic disease care. The Community-Pharmacies managing hypertension: intervention development and Evaluation in Bangladesh and Pakistan (COPE-BP) programme aims to investigate whether these widely accessed yet under-evaluated community pharmacists are effective and cost-effective, and assess whether the COPE-BP intervention can be successfully integrated into hypertension care pathways in Bangladesh and Pakistan. Beyond evaluating clinical and economic outcomes, COPE-BP seeks to reframe the role of semi-formal providers, including community pharmacies, which are key actors in primary care delivery. Through a stepwise programme encompassing intervention development, a multicentre clinical trial, implementation research, and policy engagement, COPE-BP aims to provide a scalable model for integrating non-traditional providers into national health strategies. In doing so, COPE-BP will help strengthen inclusive, people-centred health systems in LMICs.

Background:Surgical wounds healing by secondary intention occur if a surgical wound is not closed or dehisces following primary closure. Surgical wounds healing by secondary intention are common and adversely affect patients' quality of life. Treatment is often prolonged, complex and expensive. Negative pressure wound therapy applies a controlled vacuum to the wound and is increasingly used to promote surgical wound healing by secondary intention despite limited rigorous evidence for the clinical and cost-effectiveness of negative pressure wound therapy to augment surgical wound healing by secondary intention. Objective:Assess the clinical and cost-effectiveness of negative pressure wound therapy versus usual care (no negative pressure wound therapy) in treating surgical wounds healing by secondary intention. Design and methods:A pragmatic, two-arm, parallel-group, randomised controlled superiority trial. Twenty-eight UK NHS Trusts randomised adult patients with a surgical wounds healing by secondary intention to receive negative pressure wound therapy or usual care (no negative pressure wound therapy). The planned sample size was 696 participants. Participants were followed up for 12 months via weekly telephone contact to collect the primary outcome (time to healing: full cover with no scab in days since randomisation) and clinical secondary outcomes: wound healing, surgical site infection, pain, hospital re-admission, current treatment and reasons for treatment change (if applicable), reoperation, amputation, antibiotic use, death. Patient-reported outcomes (pain, health-related quality of life and resource use) were collected by postal questionnaire at 3, 6 and 12 months. Validation of the Bluebelle Wound Healing Questionnaire, a patient-reported measure of surgical site infection, was also undertaken. A cost-effectiveness decision model considering all available evidence, and a within-trial cost-utility analysis, was also undertaken to evaluate the cost-effectiveness of negative pressure wound therapy against usual care. Neither participants nor the investigators were blind to treatment allocation. Results:Between 15 May 2019 and 13 January 2023, 686 participants were recruited, randomised and included in the analysis (negative pressure wound therapy n = 349; usual care n = 337). Most participants had a single surgical wound healing by secondary intention (n = 622, 90.7%), located on the foot (n = 551, 80.3%) or leg (n = 69, 10.1%) arising following vascular surgery (n = 619, 90.2%). Most participants had comorbidities; diabetes (n = 549, 80.0%), cardiovascular disease (n = 446, 65.0%) and/or peripheral vascular disease (n = 349, 50.9%). Median time to healing was 187 days (negative pressure wound therapy) versus 195 days (usual care), with no evidence that negative pressure wound therapy reduced the time to wound healing compared to usual care (hazard ratio 1.08, 95% CI 0.88 to 1.32; p = 0.47). Odds of re-admission, reoperation, surgical site infection and antibiotic use were slightly higher, and odds of amputation or death slightly lower for negative pressure wound therapy participants. These results were not clinically or statistically significant. Bluebelle Wound Healing Questionnaire, quality of life and wound pain scores were not statistically significantly different at any time point. Serious adverse events were rare (nine negative pressure wound therapy vs. five usual-care participants). Both cost-effectiveness analyses concluded that negative pressure wound therapy generates higher costs and marginally higher quality-adjusted life-years than usual care, although findings were statistically insignificant. The probability of negative pressure wound therapy being cost-effective was under the recommended National Institute for Health and Care Excellence cost-effectiveness thresholds. The Bluebelle Wound Healing Questionnaire was acceptable to participants, had low levels of missing data and demonstrated good levels of sensitivity and specificity in the detection of surgical site infection in surgical wounds healing by secondary intention. Limitations:The trial included a high proportion of diabetic participants with foot wounds, which may affect study generalisability. Negative pressure wound therapy use for 'wound management', common in certain surgical specialties, was not assessed in this study. Conclusions:Negative pressure wound therapy is not clinically or cost-effective in augmenting healing in patients with surgical wounds healing by secondary intention, particularly those with comorbidities. Future work:Evaluation of methods to treat or prevent infection of surgical wounds healing by secondary intention and evaluation of negative pressure wound therapy for 'wound management' are recommended. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/42/94.

Hypothesis: With equal numbers of adults with unreconstructable distal humerus fractures undergoing total elbow arthroplasty (TEA) and distal humerus hemiarthroplasty (DHH) a randomized trial is needed to compare the interventions. Patients have identified pain as the key outcome. There are no data on pain outcomes using a validated pain instrument to plan a trial. This study aims to use expert elicitation to produce probability distributions for the Patient Rated Elbow Evaluation (PREE) pain score at 12 months in adults undergoing TEA or DHH for trauma. Methods: Using the Sheffield Expert Elicitation Framework seven experts were recruited and provided with a summary of current knowledge on pain outcomes from a systematic review. They were asked to consider their median of the PREE pain score at 12 months after a TEA for acute trauma, their difference in the median PREE pain scores between TEA and DHH, and their standard deviation (SD) of the PREE pain score after TEA and DHH. The rational independent observer concept was used to achieve consensus. Results: The elicited median value for the PREE pain at 12 months after TEA for acute trauma was 13.6/50 (interquartile range 10.6 to 16.8). The estimated median of the difference in PREE pain scores was 3.4 (interquartile range-0.3 to 7.1). The elicited standard distribution of PREE pain scores was 9 (SD 2.2), and after DHH was 12 (SD 3.0). Conclusion: Probability distributions for pain outcomes measured using the PREE pain subscale following DHH and TEA for acute trauma in adults generated by expert elicitation indicate an expectation of small differences between interventions. A noninferiority randomized trial using the PREE pain subscale as the primary outcome at 12 months could be conducted to explore whether the possible advantages of DHH, such as lower cost and reduced adverse events, are supported.

Abstract Background Communication interventions can facilitate communication between people with profound and multiple learning disabilities (PMLD) and familiar partners such as family and educational setting staff, including speech and language therapists. Various communication interventions are routinely used but their clinical and cost-effectiveness are unclear. Intensive Interaction (II) is one intervention that focuses on early interaction abilities. II can be delivered by staff in educational settings and/or at home. Despite many settings already implementing II, staff are sometimes untrained or have not received up to date training, potentially leading to inconsistencies in how the technique is applied and the quality of the interactions. We will provide structured training in II to educational setting staff and parents/carers with coordinated activities developed jointly for each child/young person to be delivered within the educational setting and at home. This study aims to establish whether Intensive Interaction delivered within educational settings improves communication skills of children and young people with PMLD. Methods A multi-site pragmatic cluster randomised controlled trial comparing usual care with Intensive Interaction and usual care. Clusters will be educational settings. This study will recruit 330 participants (aged 3–25 years) with PMLD from 66 educational settings within Great Britain. Each participant will have a corresponding teacher, parent/carer, and interventionist. Potential participants will be screened by their educational setting for eligibility prior to giving informed consent. Data will be collected at baseline, 32 weeks, and 52 weeks post-randomisation and will assess health and educational outcomes including participants’ communication skills, behaviour, wellbeing, and quality of life. The primary outcome is communication skills, measured by the Communication Complexity Scale (CCS) at 32 weeks post-randomisation. Setting staff will video record an interaction with each participating child/young person. Communication will be coded by members of the research team blinded to allocation using the CCS. Discussion This study addresses a much used but currently under-researched intervention and results will inform the support provided to children and young people with PMLD in their educational settings and at home. Trial registration The trial was prospectively registered on the ISRCTN registry on 3rd May 2023 (registration number: ISRCTN81099965, https://www.isrctn.com/ISRCTN81099965 ).

Background: Tobacco is consumed by two-thirds of individuals with severe mental illness (SMI). Despite a high tobacco-related disease burden, there is a lack of evidence-based cessation interventions for individuals with SMI living in low- and middle-income countries. This study aims to evaluate the feasibility and acceptability of a culturally adapted behavioural intervention for tobacco cessation (SCIMITAR-SA) delivered in mental health services in Bangladesh, India, and Pakistan. Methods: A two-arm, parallel-group, individually randomised, multi-country feasibility trial will be conducted across six mental health facilities in urban centres. All trial participants will receive Very Brief Advice (VBA) and an educational leaflet from their clinical team. Additionally, those in the intervention arm will receive up to seven structured behavioural support sessions. Salivary cotinine and anabasine will be used to biochemically verify abstinence at seven months post-randomisation. Quantitative outcomes will assess feasibility of conducting a definitive trial, including recruitment and retention rates, session attendance, completeness of baseline assessments and outcome measures at four and seven months and use of health resources. An embedded process evaluation will explore the feasibility and acceptability of trial processes, and of the delivery and receipt of the VBA and SCIMITAR-SA interventions. Economic outcomes will assess the feasibility of collecting cost and resource-use data to inform a future definitive trial. Discussion: The SCIMITAR-SA trial will provide essential evidence on the feasibility of delivering culturally adapted cessation support for people with SMI in South Asia and inform scalable integration into routine psychiatric care across low- and middle-income settings. Registration: ISRCTN registry (ISRCTN91038721)

Introduction Diabetic foot ulceration represents a prevalent, persistent and resource-intensive complication of diabetes. These ulcers are slow to heal, prone to recurrence and impose a substantial burden on both patients and healthcare providers. The reducing the impact of diabetic foot ulcers (REDUCE) intervention has been designed as a multifaceted approach targeting psychological and behavioural determinants linked to diabetic foot ulcer (DFU) outcomes. Following a successful pilot trial, the REDUCE trial has been designed as a pragmatic, multicentre randomised trial to compare the effectiveness and cost-effectiveness of the REDUCE intervention plus usual care versus usual care alone in reducing recurrence in people with healed DFUs. Additionally, there is an embedded process evaluation and two sub-studies which will be carried out alongside the main trial.Methods and analysis Adults over 18 years of age, with a recently healed DFU and two lower limbs, will be identified from around 30 specialist multidisciplinary diabetic foot clinics at participating National Health Service Trusts in the UK. Patients with active Charcot neuro-osteoarthropathy, active DFU or ulcers healed for more than 12 weeks will be excluded. We will aim to recruit 544 participants (1:1 randomisation). The primary outcome for this trial will be total ulcer-free days with limbs intact (ie, without amputation) between randomisation and the end of follow-up (18 months post-randomisation). Secondary outcomes include time to re-ulceration, total number of ulcers, amputation, quality of life (EQ-5D-5L), Patient Health Questionnaire-9, Nottingham Assessment of Functional Footcare, ICEpop capability measure for adults and resource use. As part of the process evaluation, up to 20 REDUCE intervention patient-participants will be interviewed, and the healthcare professionals delivering the intervention will also be interviewed. An assessment of intervention fidelity will also be carried out.Ethics and dissemination Ethics approval was granted by Wales 3 Research Ethics Committee (REC reference 22/WA/0053) on 16 March 2022. The findings will be presented at relevant conferences and disseminated via peer-reviewed research publications and to relevant stakeholders.Trial registration number ISRCTN15570706.

AIMS:This study assessed the feasibility and acceptability of a new theory- and evidence-based intervention designed to prevent return to pre-admission smoking behaviours after discharge from a smokefree mental health in-patient setting in the United Kingdom (UK). DESIGN:A multi-centre individually randomised controlled feasibility trial with follow-up at 3 and 4-6 months. SETTING:Acute adult mental health wards of six National Health Service Mental Health Trusts in England. PARTICIPANTS:Thirty-eight (17 intervention, 21 usual care) adults who smoked on or after admission to an acute adult mental health in-patient ward and wished to continue reducing or quitting smoking after discharge, enrolled between February and November 2024. INTERVENTION:The intervention comprised usual care and a 12-week, theory- and evidence-informed support programme including a bespoke resource kit, personalised behavioural support including phone calls and text messages, and access to a digital smoking cessation app with 24/7 live support. It was delivered by trained mental health workers. The comparator group received usual care as per UK national guidance, typically involving brief behavioural support, offers of nicotine replacement therapy and sometimes electronic cigarettes. MEASUREMENT:Primary outcomes included recruitment and retention, intervention acceptability and feasibility of collecting smoking, mental health and economic data. Success criteria for progression to trial were set a priori at a minimum of 60% of the n = 64 target for both recruitment and retention, i.e. at n = 38. Secondary outcomes included measures of smoking, quitting, reduction of cigarette consumption. Acceptability data were collected through exploratory interviews with participants, mental health staff and interventionists. FINDINGS:We recruited n = 38 (60%) participants and retained n = 20 (52.6%) at 3 months, and n = 13 (34.2%) at second follow-up. As such, criteria agreed to determine progression to full trial were marginally met for recruitment and not met for retention. Two intervention participants reported maintaining abstinence. Motivation to quit remained higher in the intervention than the usual care group over time, and use of e-cigarettes was overall common (76.9% n = 10 across groups at 4-6 month follow up). Intervention group participants reported valuing the tailored and personalised behavioural support options but engaged little with tailored digital tools. Health economic data collection was feasible, though refinement is needed for future research. CONCLUSIONS:A new intervention delivering smoking cessation support to individuals discharged from smoke-free mental health settings was discontinued because key feasibility criteria were not met, highlighting the need for focused reconsideration of recruitment and retention strategies, intervention design and delivery in mental health in-patient populations. Design implications are discussed, taking into account individual patient-level and systemic challenges.

PURPOSE:This study aimed to compare implant survivorship and patient-relevant outcomes associated with the constraint level used at first-time aseptic revision total knee arthroplasty (rTKA). METHODS:This retrospective cohort study used data from the National Joint Registry for England, Wales, Northern Ireland, the Isle of Man, Guernsey and Jersey, linked to Hospital Episode Statistics and national patient-reported outcome measures (PROMs). Patients undergoing first-time aseptic rTKA between 1 January 2009 and 30 September 2023 were included. Constraint was categorized as unconstrained, posterior-stabilized (PS), condylar-constrained (CCK) or hinge. The primary outcome was 10-year cumulative incidence of re-revision. Prespecified subgroups included patients at high risk of re-revision and those revised for aseptic loosening or instability. Secondary outcomes included 6-month PROMs; 90-day mortality and medical complications; and length of stay. Competing risk regression was used to estimate re-revision risk, treating death as a competing event. RESULTS:After exclusions, 12,950 cases were analysed (median follow-up 7.4 years [95% confidence interval, CI 7.3-7.5]. CCK prostheses were associated with the lowest unadjusted 10-year cumulative incidence of re-revision overall (9.2% [95% CI 8.4-10.1]) and in all subgroups. In the primary adjusted analysis, unconstrained (subdistribution hazard ratio [sHR] 1.46 [1.23-1.74], p < 0.001), PS (sHR 1.23 [1.04-1.44], p = 0.013) and hinged prostheses (sHR 1.66 [1.38-2.01], p < 0.001) were associated with higher re-revision risk than CCK constructs. There was weak evidence that the association between PS implants and re-revision was greater among low-volume than high-volume surgeons (interaction sHR 1.30 [1.00-1.70], p = 0.053). After further adjustment for implant-related factors, re-revision risk was similar for unconstrained (sHR 0.97 [0.78-1.21], p = 0.792) and PS implants (sHR 1.00 [0.83-1.19], p = 0.972) versus CCK, whilst increased risk associated with hinges persisted (sHR 1.67 [1.36-2.05], p < 0.001). CONCLUSION:CCK constructs were consistently associated with favourable implant survivorship across a range of clinical scenarios. These findings provide reassurance that clinically indicated use of CCK constraint is not associated with compromised implant survival. LEVEL OF EVIDENCE:Level III.

BACKGROUND:This study aimed to characterise the patterns and severity of bone loss at elective aseptic revision of a primary total knee arthroplasty (pTKA) and to identify factors associated with major bone loss. METHODS:A national multi-centre prospective service evaluation was undertaken across NHS hospitals in England and Wales. Patients undergoing elective aseptic tibiofemoral revision of a pTKA were included. Baseline characteristics and the anticipated (pre-operative) and encountered (intraoperative) degree of bone loss were recorded, using the Anderson Orthopaedic Research Institute (AORI) classification. Reconstruction techniques were also captured. Logistic regression identified factors associated with intraoperative AORI type ≥2B bone loss. RESULTS:Analyses comprised 157 cases undertaken by 35 surgeons across 12 hospitals. The majority of cases were associated with intraoperative AORI type ≤2A bone loss (tibia = 73.2%; femur = 72.0%). Surgeons reported more bone loss than anticipated in 23.5% of cases, less frequently among patients with a pre-operative CT scan (17.0% vs 26.9%, p = 0.165). Metaphyseal fixation devices were used in 40.4% of tibial and 15.9% of femoral reconstructions. Tibial AORI ≥ 2B bone loss was associated with an indication of aseptic loosening/lysis (other indications OR 0.11-0.28), while femoral AORI ≥ 2B was associated with increased time from primary to revision (OR 1.07 (1.00, 1.14) per year, p = 0.037). CONCLUSION:Major bone loss at elective aseptic revision of a primary total knee replacement is uncommon, but intraoperative defects are frequently underestimated pre-operatively. Surgeons should ensure appropriate revision implants and bone-loss solutions are available. Future research should determine whether metaphyseal fixation devices improve patient-relevant outcomes in this setting.

BACKGROUND:Strong compression is a recommended first line venous leg ulcer treatment. With limited research comparing the clinical effectiveness of compression wraps (CW) and two-layer compression bandage treatments with evidence-based compression (EBC) (four-layer compression bandages and two-layer compression hosiery), this study aimed to evaluate their clinical effectiveness on time to venous leg ulcer healing. METHODS AND FINDINGS:A pragmatic, three-arm, randomised controlled trial in 33 United Kingdom primary, community and hospital sites between 03.02.2021 and 31.08.2024. Adults with a venous leg ulcer appropriate for compression therapy were randomised 1:1:1 to be offered CW, two-layer bandage, or EBC (two-layer hosiery or four-layer bandage). Participants and clinical staff were not blinded. The primary outcome was time to blind assessed ulcer healing (date of ulcer healing: date of earliest photograph showing healing). Analyses included a noninferiority comparison of two-layer bandage and EBC (handling key intercurrent events under hypothetical and treatment policy strategies), and superiority comparisons of CW with both EBC and two-layer bandage (handling key intercurrent events under a treatment policy strategy). Healing times were analysed using Cox proportional hazards regression adjusted for fixed effects (treatment allocation, baseline ulcer area and duration, participant age, and mobility status), and shared frailties (recruitment site). The trial was pre-registered: ISRCTN67321719. 637 participants were randomised to be offered CW (n = 213), two-layer bandage (n = 211) or EBC (n = 213). Mean age was 70.3 (range 24.6 to 97.0) years, 55% (n = 351) were male, and the majority (n = 606, 95%) were white. 633 participants contributed time at risk of healing and were included in the analysis. Using a treatment policy strategy to handle key intercurrent events (modified intention-to-treat analysis), the estimated hazard ratio (HR) for the noninferiority comparison (EBC and two-layer bandage) was 1.01 (95% CI [0.79, 1.28]), meeting the pre-specified noninferiority margin of 1.33. The corresponding hypothetical strategy analysis gave a HR of 1.16 (95% CI [0.86, 1.58]), which did not demonstrate noninferiority. For the superiority comparisons, healing was slower in the CW group than in the EBC group (HR 0.78, 95% CI [0.61, 1.00]; p = 0.046). Results were similar for the two-layer bandage group (HR 0.79, 95% CI [0.61, 1.01]; p = 0.056), although this did not reach statistical significance. Both comparisons showed considerable statistical uncertainty, with confidence intervals ranging from a 39% reduction in the hazard of healing to little or no difference between groups. Nine serious adverse events occurred; one potentially related to treatment (cause of death could not be ascertained). Departures from allocated compression treatment were common, which limits generalisability to settings with different adherence patterns. These departures, lower than expected ulcer healing incidence rates and slight under-recruitment, resulted in the number of healing events being smaller than the number required for 80% power. CONCLUSION:CW is unlikely to reduce the time to venous leg ulcer healing compared to two-layer bandage or EBC, although confidence intervals included treatment effects indicating little or no difference between groups. Despite remaining uncertainty, these findings may not support CW as a first line strong compression treatment for venous leg ulcers. TRIAL REGISTRATION:ISRCTN - reference 67321719.

Emotional disorders in young people have been increasing, leading to a high demand for support and long waiting times for UK child and adolescent mental health services (CAMHS). Consequently, access to evidence-based psychological therapy is limited; in addition, many young people do not respond to existing treatments. Blended delivery of therapy, which combines face-to-face and digital interventions, offers a promising solution to improve the reach and effectiveness of mental health support. However, the efficacy of blended behavioural activation (BA) for young people with depression is not yet established. This randomised controlled trial will investigate the clinical and cost effectiveness of blended behavioural activation intervention for adolescents aged 11–17 years with moderate to severe depression. We will recruit 446 participants from CAMHS across 6 sites in the UK. Participants will be randomised to receive either BA with psychoeducation (PE) and treatment as usual (TAU) or PE and TAU. The primary outcome measure will be depressive symptoms, assessed using the child-completed Mood and Feelings Questionnaire (MFQ-C) at 6 months. A range of secondary outcome measures will be collected to estimate the clinical and cost effectiveness and acceptability of the intervention. A nested qualitative investigation exploring provider and young people/carer perspectives will be included. The findings from this trial will provide crucial evidence on the effectiveness of blended BA for young people with moderate to severe depression. If effective, this intervention could offer a scalable and accessible treatment option, potentially transforming the delivery of mental health services for adolescents. The large sample size and pragmatic approach will enhance the generalisability of the results, informing future clinical practice and policy. ISCRTN12315118. Registered on August 29, 2023.

Objectives: The primary aim of this study was to assess the feasibility of delivering an adapted problem-solving skills (PSS) intervention by quantifying the recruitment, follow-up and completion rates using a brief problem-solving intervention for people with a mental health diagnosis in two Polish prisons. Design: IAPPS is an open, multi-centred, parallel group feasibility randomised controlled trial (RCT). Setting: Two prisons in Poland. Participants: Men in custody aged 18 years and older, having a mental illness and living within the prison therapeutic unit. Interventions: The intervention consisted of an adapted PSS skills intervention plus care as usual (CAU) or care as usual only. Delivered in groups of up to five people in 1.5-hour sessions over the course of two weeks. Main outcome measures: Primary outcomes - rate of recruitment, follow-up, and feasibility to deliver the intervention. Secondary outcomes included measures of depression, general mental health, and coping strategies. Results: 129 male prisoners were screened, 64 were randomly allocated, with a mean age of 53.5 years (SD 14, range 23-84). 59 (95%) prisoners were of Polish origin. Our recruitment rate was 48%. There was differential follow up with those in the intervention group less likely to complete the post-test battery versus those who received care as usual. Outcome measures were successfully collected at both time points. Conclusions We were able to recruit, retain and deliver the intervention within the prison setting; some logistical challenges limited our assessment of intervention engagement. Our data helps to demonstrate how use of the RCT study design can be implemented and delivered within the complex prison environment. Trial registration number [ISRCTN 70138247][1], protocol registration date May 2021 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN70138247 ### Clinical Protocols ### Funding Statement The study is funded by the Centre for Future Health at the University of York in the UK. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The trial received ethical approval from the Department of Health Sciences; University of York; Research Governance Committee on 13th May 2021; from the Governor at each prison site and the Polish equivalent of the GDPR expert (RODO) within Poland. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN70138247

Background Horizon scanning is an exploratory research method used to identify, select, and analyse information to detect signals and trends related to new and emerging innovations using pre-defined and explicit methods. It has the potential to play a role in anticipating methodological research trends and innovations, helping to deliver therapies to patients faster. However, the extent to which horizon scanning has been applied to identify emerging research methods is unclear. Objectives This scoping review explores if and how horizon scanning has been used to identify research methods in any field, setting or location. Methods Eligibility was based on the Population, Concept and Context framework: Any information source that used horizon scanning to identify research methods was eligible for inclusion. Two reviewers independently screened titles/abstracts and then full texts. Following a pilot phase, one reviewer extracted data, and three others performed data accuracy checks. Results Five studies published between 2017 and 2024 met the eligibility criteria, and a further 13 partially met the eligibility criteria and are summarised separately. The five fully included studies belonged to the environmental, ecological, and earth science disciplines. Using the horizon scanning system defined by the EuroScan network, the most reported was signal detection. A literature review was the most common method used to identify signals, other approaches included a combination of literature reviews with interviews and expert opinion. A range of methods were identified as priority areas for the future, including digitisation, computational techniques, genomics and statistical methods. There was heterogeneity in horizon scanning approaches and reporting. Conclusions This scoping review found limited systematic research using horizon scanning to identify research methods, which hinders preparation for evaluation and implementation. This highlights the need for further research to establish optimal horizon scanning approaches to identify research methods in health and social care.

Introduction People living with HIV/AIDS (PLWHA) have complex physical, psychological, social and spiritual needs following diagnosis and poorer health-related quality of life than the general population. Holistic assessment and care delivery incorporating person-centred principles is required to address these needs. This protocol describes a cluster randomised controlled trial (cRCT) and process evaluation to evaluate the effectiveness of the extra community-based enhanced care intervention (ExtraCECI) to improve the quality of life and person-centred outcomes for PLWHA in Ghana.Methods and analysis This cRCT will randomly assign 26 recruited HIV clinics using 1:1 allocation to either ExtraCECI intervention or standard HIV care, with each clinic recruiting an average of 25 participants, that is, 650 in total. Eligible participants are adult PLWHA aged at least 18 years and in HIV care for at least 6 months, with cognitive ability to consent as guided by the Mental Capacity Act, clinically well to participate, attending an outpatient clinic. Healthcare professionals (HCP) at clinics randomised to the ExtraCECI intervention arm will receive training on person-centred care and holistic assessment of PLWHA in the domains of physical, psychological, social and spiritual well-being. PLWHA will be empowered to contribute to their care decisions including HCP using telehealth for ExtraCECI delivery with ongoing mentorship, while participants in the Standard HIV Care arm continue with usual care. The primary outcome is quality of life measured at the individual level using Medical Outcomes Study-HIV (MOS-HIV). The primary analysis will compare MOS-HIV total scores between groups using repeated measure linear mixed model and adjusting for important baseline characteristics (including stratification factors) and random effect of clinic. The incremental cost-effectiveness ratio will be used to estimate the cost-effectiveness of the ExtraCECI intervention, and a process evaluation will be conducted.Ethics and dissemination This protocol was approved by Edinburgh Napier University School of Health and Social Care Research Integrity Committee (REF: SHSC3681836) and the Ghana Health Service Ethics Review Committee (GHS-ERC:010/07/24). Results from this study whether positive or negative will be presented to participating sites, communities, at scientific conferences and published in peer-reviewed journals.Trial registration number ISRCTN77405303.

Background There are increasing numbers of children living with conditions that may threaten or shorten their lives. While child mortality has decreased in recent decades, it is estimated 4500 infants, children and young people (0–19 years) die in the United Kingdom every year. Despite a growing increase in clinical provision, there is a clear paucity in research evidence underpinning paediatric palliative care. To support research delivery, a United Kingdom-wide network composed of paediatric palliative care-sector organisations and academics with expertise in the area was developed. The network had a clear vision of establishing partnerships between academia and services delivering paediatric palliative care that would support increased research capacity and delivery in the sector. Objective(s) The overarching aim of the network was to deliver national high-quality research studies, education and materials, and build research capacity. Specific objectives included working closely with seven paediatric palliative care sites to develop guidance on the appropriate methods for undertaking research, the delivery of information and educational resources including a webinar series, offering of mentor opportunities, and the development of a minimum of two bids to National Institute for Health and Care Research related funding pathways. Design A collaborative design underpinned the network. Network activity included continued partner engagement through online meetings and newsletters, scoping activity to identify research priorities, establishment of research themes, and active engagement and support from national organisations. Patient and public involvement was core to all network activity. Setting Network engagement largely took place online. The network has a web page hosted on the website of the organisation Together for Short Lives. Partners Seven paediatric palliative care sites in England and Scotland (six hospices and one National Health Service hospital site) formed the network with input from several academic partners. Results The network achieved several outputs related to objectives including the submission of two National Institute for Health and Care Research applications for funding, the delivery of five educational webinars, the establishment of an online research toolkit and the development of a research nurse group. Conclusions Prior to the establishment of the network, there was no national mechanism for co-ordination for research in paediatric palliative care. In bringing together seven partner organisations and clinical and research expertise, the network has supported the foundations upon which to deliver high-quality research in the sector. Future work Future work is required to support the sustainability of the network including obtaining necessary funding. Key learning from the network can be transferred and replicated across other contexts, including internationally. Grant applications and research themes developed as a result of the network will continue to develop and mature. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR135304.

Introduction Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.Methods and analysis This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.Ethics and dissemination Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.Trial registration number ISRCTN77855199.