Introduction Type 2 diabetes mellitus (T2DM) is two to three times more common in people with severe mental illness (SMI) than in the general population. Supporting self-management in diabetes is fundamental to improving clinical outcomes. The DIAMONDS trial aims to evaluate the clinical and cost effectiveness of a novel, codesigned, supported diabetes self-management programme for people with T2DM and SMI.Methods and analysis This multicentre, two-armed, parallel, individually randomised controlled trial will be conducted in National Health Service mental health trusts across England. We will recruit 380 participants (≥18 years old) with a diagnosis of SMI (schizophrenia, bipolar disorder, schizoaffective disorder, psychosis and severe depression) and T2DM. Eligible and consenting participants will be randomised to the DIAMONDS intervention or treatment as usual. The intervention group will receive one-to-one sessions with a trained DIAMONDS Coach for six months. These sessions will focus on goal setting, action planning and diabetes self-management education, supported by a paper-based workbook and an optional digital application. Individuals allocated to the control group will continue to receive usual care and may be offered National Institute for Health and Care Excellence-recommended generic diabetes self-management education programmes in line with usual practice. The primary outcome is the difference in glycated haemoglobin (HbA1c) between both groups at 12 months postrandomisation. The secondary outcomes include measures of physical and mental health, diabetes complications and physical activity. Economic and process evaluations will also be performed. Outcomes will be collected at baseline and at six and 12 month post-randomisation.Ethics and dissemination This study received ethics approval by the West of Scotland Research Ethics Committee 3 (22/WS/0117). Findings will be published in peer-reviewed, academic and professional journals. We will also be producing plain language summaries, infographics and audio summaries on the website, as well as attending conferences and dissemination events. A summary of the results will be distributed to all participants and other relevant stakeholders, and we will use social media channels, websites and knowledge exchange events to communicate our findings beyond academic audiences.Trial registration number ISRCTN22275538.

Flexor tendon injuries are common and lead to over 3200 admissions for specialist surgical repair annually in England and Wales. Surgery to repair complete division of both flexor tendons in zone 2 of the hand is technically challenging. There is variation in surgical repair techniques with no high-quality evidence to support decision-making. In particular, the decision to repair both tendons or just one is contested. Surgery is followed by specialist rehabilitation, which takes at least 12 weeks. The resulting hand function can impact the patient’s income, life satisfaction, well-being, self-worth, and mental health. The FLARE trial aims to determine the clinical and cost-effectiveness of repairing the flexor digitorum profundus (FDP) alone (intervention) versus the repair of both FDP and flexor digitorum superficialis (FDS) (control) for the treatment of complete zone 2, single-digit flexor tendon injuries in adults. A multi-centre, two-arm, blinded, non-inferiority, parallel group, randomised controlled trial with an internal pilot, economic evaluation, and nested qualitative study. Participants will be randomised 1:1 to receive either repair of FDP alone or repair of both FDP and FDS. A total of 310 adults will be recruited from NHS Trusts within the UK, randomised at surgery, and followed up within 7 days, 6 weeks, 3 months, and 6 months post-randomisation. The primary outcome measure is the patient evaluation measure (PEM) administered 6 months post-randomisation. Secondary outcomes include the PEM at other timepoints, Patient Related Wrist/Hand Evaluation (PRWHE), EuroQol 5 Dimensions Score (EQ-5D-5L), complications, total range of motion, grip strength, adherence to splint and therapy regimens, work outcomes, treatment and outcome satisfaction, and healthcare resource use. FLARE is designed with sufficient power and rigour to provide evidence on the clinical and cost-effectiveness of two surgical repair methods for single-digit, complete zone 2 flexor tendon injuries in adults. If the repair of FDP alone is as beneficial to the patient as the repair of FDP and FDS, this could save the NHS £1.8 million annually through reduced time and material costs. Furthermore, the trial findings will facilitate better shared decision-making discussions between clinicians and patients. ISRCTN 10918157. Prospectively registered: 12.01.2023.

Background Transitions from hospital to home are a risky time for older people (aged 75 years and older). Unplanned and often avoidable hospital re-admissions are therefore high in this group. This research aimed to understand if increased involvement of older people in their care in hospital would improve the safety and experience of care transitions. Objectives In six work packages we set out to: understand patient and carer involvement in and experience of care transitions explore staff experiences of delivering good transitional care develop and validate a new measure (the Partners at Care Transitions Measure) to assess patient experience and safety during care transitions create a theory and logic model to inform the co-designed transitions intervention followed by a formative evaluation test the feasibility of delivering a trial to evaluate the intervention evaluate the clinical- and cost-effectiveness of the transitions intervention with a parallel process evaluation. Design Qualitative methods (1 and 2), literature reviewing, Delphi techniques and validation testing (3), co-design (4), cluster feasibility trial (5) and cluster randomised controlled trial (6). Settings National Health Service acute hospital trusts, general practices, patients and carer homes across the north of England, United Kingdom. Participants Patients aged 75 years and older and their caregivers. National Health Service staff working in acute National Health Service trusts on wards delivering the intervention. Intervention ‘Your Care Needs You’ intervention to support patient and carer involvement in hospital care in preparation for returning home. This comprised fixed components: a booklet, an advice sheet for managing at home and a film; and flexible components: ongoing staff involvement of patients through multiple approaches. Implementation included a nominated lead, staff training and posters. Main outcome measures Primary outcome was unplanned 30-day hospital re-admissions. Secondary outcomes included: unplanned 60- and 90-day hospital re-admissions; quality of transition; health-related quality of life (EuroQol-5 Dimensions, five-level version); and self-reported healthcare resource use. Data sources National Health Service Secondary Use Services data and Hospital Episodes data for work package 2 and routinely recorded National Health Service acute trust hospital data on re-admissions for work packages 5 and 6. Review methods Systematic narrative review for preparatory work on patient involvement; narrative meta review of transitions interventions; scoping review of transitions measures. Results Work package 1: Six themes relating to patient experience of care transitions. Patient involvement in hospital care found to be challenging ‘work’ that was often invisible to staff. Work package 2: National Health Service staff reported that high-quality care transitions were facilitated primarily through trust and strong relationships. Work package 3: A measure of quality and safety of care transitions (Partners at Care Transitions Measure) developed and validated with good internal reliability and internal consistency. Work package 4: An intervention called ‘Your Care Needs You’ that required revisions to support implementation. Work package 5: Primary outcome data were collected for 90% of participants. Follow-up questionnaire response rates were lower than anticipated (75% vs. 85%). Information on the acceptability, usability and implementation of the intervention informed iterations to the intervention and implementation package. Work package 6: 4947 participants from 39 hospital wards took part in the main trial. Six hundred and thirteen participants from 35 wards took part in the nested cohort. No differences were observed in the primary outcome of unplanned re-admission (Y/N) at 30 days post discharge [17% experienced re-admission within 30 days in the ‘Your Care Needs You’ group, 18% in care-as-usual, odds ratio: (0.93; 95% confidence interval, 0.78 to 1.10; p = 0.372)], and also at 60 and 90 days post discharge but all results were in favour of the intervention with a reduction in total re-admissions of 13% over 90 days [incidence rate ratio: 0.87 (0.76 to 0.99), p = 0.039]. There was a statistically significant reduction in Partners at Care Transitions Measure safety concerns at 30 days post discharge. The intervention is likely to be cost-effective. Limitations The main trial was conducted during the COVID-19 pandemic which exacerbated staffing challenges and limited opportunities to enhance and support implementation of the intervention. Participant recruitment to the nested study was challenging, resulting in fewer patients than planned and a less diverse sample than that included in the primary cohort. Therefore, while our primary cohort is representative of the patients in the hospital during the trial period, the nested cohort may suffer from some bias. Conclusions The ‘Your Care Needs You’ intervention offers a way to support staff and patients/families to facilitate greater involvement in care. This research demonstrates that increased involvement in hospital care has the potential to improve safety at transitions. Finding ways to support staff to encourage better patient involvement could lead to even more benefits being realised. Future work Hospitals could consider involving volunteers in supporting greater patient and family involvement. There was some indication that the component of the intervention most favoured was the patient advice for discharge. Trial registration This trial is registered as Current Controlled Trials ISRCTN51154948 (WP5) and ISRCTN17062524 (WP6). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20017) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 4. See the NIHR Funding and Awards website for further award information. Plain language summary Moving from hospital to home (the ‘transition’) is a risky time for older patients (75+ years). Around 18% of patients end up back in hospital as an emergency. Most of the time, these re-admissions cannot be avoided, but oftentimes they can. In this research, we wanted to understand and improve the experience and safety of care for older people as they move from hospital to home to reduce unnecessary hospital re-admissions. To do this, we conducted six pieces of research (called work packages). First, we tried to understand from patients, families and staff how they experienced care transitions. Next, we developed a tool to measure these experiences. We then worked with staff and patients and members of the public to develop an approach (called ‘Your Care Needs You’), to help involve and prepare older people for going home after a hospital stay. ‘Your Care Needs You’ included a booklet, an advice sheet for managing at home, and a film, for patients. We then ran a trial to find out if people who received ‘Your Care Needs You’ were less likely to go back into hospital. For this, we put ‘Your Care Needs You’ into 18 wards and compared hospital re-admissions there with 21 wards which delivered care as usual. We found that the rate at which patients were re-admitted to hospital was better in the ‘Your Care Needs You’ wards but this was not significantly better. Three months after discharge, the number of people being re-admitted to the hospital was 13% less in the ‘Your Care Needs You’ wards. The approach also reduced the problems that people experienced (such as falls) around 1 month after discharge. We found that many of the wards did not deliver the approach as planned, so not all patients got ‘Your Care Needs You’. This was mainly because of staffing pressures after the COVID-19 pandemic. While some patients found the approach useful, others thought it was not for them. The approach is cheap to deliver and, on balance, is worth the cost. Scientific summary Background For older people and those with complex needs, the transition from hospital to home is risky. Approximately one in five patients experience an adverse event; two-thirds of which could be prevented or ameliorated. Rates of unplanned hospital re-admissions have increased over the last 10 years, particularly for older people. Systematic reviews of transition interventions reveal that most include multiple elements, with strategies prior to and following discharge and variable success. Knowing which of these elements represent the active ingredients is important for the management of scarce resources. There is some suggestion that interventions that seek to involve patients are most effective, but no definitive evidence. Here we address this gap in understanding. Aim To investigate whether greater involvement of patients and their families can improve patient experience and safety at transitions. Objectives Work package 1 To capture the experiences of older patients (75 years +) and their families during the transition from hospital to home. To identify opportunities for greater patient involvement in care. Work package 2 To explore how high-performing teams successfully deliver safe care to older people during transitions. Work package 3 To develop a measure of the quality-of-care transitions. Work package 4 To develop and test the acceptability of the transition intervention. Work package 5 To assess the feasibility of the ‘Your Care Needs You’ (YCNY) intervention and trial processes. Work package 6 To determine the clinical effectiveness of YCNY in a full cluster randomised controlled trial (cRCT). To determine the cost-effectiveness of YCNY compared to care as usual. Methods Work package 1: Qualitative study of patient and family experience of care transitions A longitudinal ethnographic study in two NHS Trusts exploring the involvement and experience of 32 community-dwelling older patients (75 years +) and 18 family members during their transitions from hospital to home. Semistructured interviews at up to five points from hospital admission to 3 months post discharge, supplemented with non-participant observations and go-along interviews. Data were analysed using thematic analysis. Work package 2: Qualitative study exploring how high-performing teams support care transitions A positive deviance approach to identify four wards and six general practices showing exceptionally low or reducing rates of hospital re-admissions compared to similar services. Semistructured interviews and focus groups with 157 multidisciplinary staff and observation of 9 discharge meetings. Interviews and focus groups were recorded and transcribed verbatim and data analysed using a pen-portrait approach. Work package 3: Development and testing of a care transitions measure Measure development and pilot testing A conceptual model of the transitional period developed based on findings from literature reviews and WP1 findings. A pool of items tapping into the constructs of this model was refined and simplified resulting in a two-part measure: Partners at Care Transitions Measure 1 (PACT-M1) and Partners at Care Transitions Measure 2 (PACT-M2). PACT-M1 underwent pilot testing with 15 older patients. Descriptive statistics and frequencies were calculated for each questionnaire item. Measure validation A validation study measuring internal reliability and internal consistency in the PACT-M1 and PACT-M2 within one NHS hospital trust. Eligible patients were administered the questionnaire by telephone and post. Reliability was assessed using Cronbach’s alpha and exploratory factor analysis used to evaluate dimensionality. Response rates and missing data were scrutinised and subscales refined. Work package 4: Development and refinement of a care transitions intervention Intervention development Functional resonance analysis method was used to model the transition process. This revealed the informal handover of four functional care activities to patients and families at discharge: management of medications; daily activities; health conditions; and escalation processes. The programme theory proposed that for patients to manage these activities they would need to practise them in hospital. A scoping review and stakeholder workshops supported the development of the Partners at Care Transitions (PACT) intervention. Formative evaluation and intervention refinement A formative evaluation to explore the acceptability and usability of the prototype intervention and identified implementation strategies. On 3 wards in 1 NHS trust, we recruited 25 older patients and interviewed 15 staff and 6 informal carers. Data collection using semistructured interviews and observations of intervention use. Analysis was iterative, using template analysis and group discussions leading to intervention refinement and the YCNY intervention. Work package 5: Trial feasibility study of Your Care Needs You A cRCT was conducted to test the feasibility of the YCNY intervention and trial methodology. Wards caring for older people were recruited and randomised on a 3 : 2 basis. The feasibility of accessing hospital re-admission data for our primary outcome together with other trial critical data capture was assessed. We also tested the process of data collection for our secondary outcomes, patient experience (measured by PACT-M) at 5, 30 and 90 days post discharge. We aimed to recruit 20 older patients per ward, over a 4- to 5-month period. The feasibility of conducting a full cost-effectiveness analysis was evaluated. Acceptability, usefulness and feasibility of the intervention and implementation package were assessed by observations and interviews. Work package 6: Cluster randomised controlled trial assessing the clinical effectiveness, cost-effectiveness and fidelity of Your Care Needs You with parallel process evaluation Clinical effectiveness trial data collection A cRCT of YCNY. Forty wards, covering a range of specialties and routinely caring for older people, from 11 NHS Trusts were randomly allocated equally to 1 of 2 arms: intervention or care-as-usual (control). Wards were stratified by specialty, the percentage of patients over 75 years, and NHS trust. Our primary outcome measure of 30-day unplanned hospital re-admission rates (routine data) required a sample size of 5440 based on a 10% attrition rate to detect a 4.5% difference in re-admissions with 80% power. We used a nested cohort to assess the quality of transitions (PACT-M and the validated Care Transition Measure-3) as secondary outcomes. Allowing for clustering and attrition, this required a sample size of 1000 for 80% power. Clinical effectiveness analysis Analysis for the primary outcome (30-day unplanned hospital re-admissions) included treatment allocation, ward type, baseline ward re-admission rate, percentage of patients 75 + and gender as fixed effects and trust and ward as random effects to account for clustering. Two sensitivity analyses were conducted as well as a secondary complier-average causal effect analysis to assess the impact of fidelity on outcomes. The same model specifications were used for the 60- and 90-day re-admission data. A mixed-effects linear regression approach was used to analyse patient experience measures [PACT-M and Coleman’s Transition Measure-3 (CTM-3)] data and similar sensitivity analysis to those for the primary outcome were applied. All other data were summarised descriptively. Fidelity data collection and analysis We used the modified Conceptual Framework for Implementation to underpin frame fidelity assessment. Data were gathered from all intervention wards using a 26-item measure covering intervention delivery, receipt, engagement with and usefulness. An overall score from 0 to 3 was calculated, with three representing high fidelity. Health economics analysis Short-term cost-effectiveness (during the first 90 days post discharge) was calculated from the mean costs of intervention delivery (intervention group) and service utilisation (both groups) and quality-adjusted life-years (QALYs) for each group generated within the trial. Long-term (over a lifetime) cost-effectiveness was calculated using a de novo hybrid model comprising a decision-tree model and a partitioned survival model. Process evaluation data collection and analysis A process evaluation on eight intervention wards (across four trusts) to understand how the intervention was delivered, received and used by staff and patients and how this was shaped by context. We interviewed 23 staff and 19 patients (pre and post discharge) and conducted 94 hours of ward observations. Interview data in the form of recordings and detailed notes were analysed using constant comparison to identify themes/subthemes. Results Work package 1: Qualitative study of patient and family involvement and experience of care transitions We identified six themes relating to: a disappointing discharge; delivery and receipt of community care; involvement (in care), choice and decision-making; information provision; physical and social environment; and medicines. While people mostly felt safe and cared for in hospital, many ‘handed over’ their care and so were unprepared for picking this back up when they returned home. Work package 2: Qualitative study exploring how teams support care transitions Three themes were identified that demonstrate how high-performing teams support safe care transitions: building relationships with patients based on a holistic understanding of their needs; having relationships with other staff (within and across teams) based on valuing and trusting one another; and bridging gaps in care by enhanced communication, adjusting patient expectations and adapting to competing priorities. Despite being identified as high-performing, staff in these teams described that delivering exceptionally safe care was very challenging and only possible for the most complex patients. Work package 3: Development and testing of a measure of care transitions Development and pilot testing Through modelling of transitions and item generation and refinement a measure comprising two parts: PACT-M1 administered to patients shortly after discharge with eight items measuring experiences of preparedness for managing at home and seven safety items measuring post-discharge adverse events; and the PACT-M2, administered 1 month post discharge with eight items measuring the patient experience of managing care at home and the same adverse event items. Participants reported that items were easy to understand and complete. Measure validation One hundred and eighty-five patients were recruited. Response rates were 75% (n = 138) at time point 1, 59% (n = 110) at time point 2 and 50% (n = 92) at time point 3. Reliability analyses of the PACT-M1 and PACT-M2 were good (α = 0.84 and 0.92, respectively). The factor analysis revealed a single-factor solution explaining 44% of the variance for PACT-M1 and 60% for PACT-M2. All items were retained. Work package 4: Development and refinement of a transitions intervention Intervention development Guided by stakeholder workshops with patients and staff we co-designed a prototype intervention to support management of the four key functions (see above): knowing more, moving more, managing medicines and escalation. A scoping review and activities to consolidate all available evidence-supported intervention development. Formative evaluation and intervention refinement Staff and patients saw the value in, and need for, the intervention, but several challenges with the acceptability and usability of the prototype were identified. Examples include the messages within the booklet not being strong enough and the lack of time to complete the discharge template (by staff). We identified implementation strategies and key changes to the intervention. Work package 5: Trial feasibility study of the Partners at Care Transitions intervention We randomised 10 wards (6 to intervention and 4 to control) across 3 NHS Trusts. Subsequently, due to extreme staff shortages, five wards could not participate but were retained and treated according to their randomised allocation. Of 721 patients screened, 161 were recruited (95 intervention, 66 control). Routine primary outcome data were gathered for 90% of participants. Item completion within questionnaires was high. The COVID-19 pandemic meant follow-up data collection ceased early. Patient attrition rate (17.4%; n = 28) was higher than expected (10%). Data on usability, acceptability and implementation were gathered from 10 patients and 17 staff alongside 91 ward-level observations. Staff reported the need for, and value of, the intervention and patients varied in their views about its value and manner in how they engaged with it. Full implementation of the intervention was challenging because of staff shortages, lack of information technology embedding/integration (film and discharge summary), lack of buy-in from the wider ward team and organisational impediments. We responded to these challenges by modifying the intervention and enhancing the implementation strategy. Work package 6: Cluster randomised controlled trial of the Partners at Care Transitions intervention A total of 4947 patients from 39 wards were included in the primary analysis cohort. For the nested cohort, 613 participants from 35 wards were recruited. Clinical effectiveness There was no significant difference in the primary outcome of unplanned 30-day re-admissions or 60 or 90 days (as odds ratios) between intervention and control. However, at all time points, the rate was lower in the intervention group. Total number of re-admissions was also lower in the intervention group at all time points and this reached statistical significance across 90 days post discharge with 13% fewer re-admissions. At 30 days post discharge, significant differences were observed in PACT-M adverse event items and in the CTM-3 in favour of the intervention but not at other times. Fidelity Twenty-three per cent of patients reported receiving booklets and 77% found them useful or very useful. Further, 29% of patients reported receiving the advice sheet for managing at home and 86% found them useful or very useful. Overall fidelity to the intervention was moderate for majority of wards (n = 11, 68.75%) and low for the remaining five (31.25%). Fidelity to the intervention had no impact on re-admissions at 30 days. Cost-effectiveness In the short term, differences in costs and QALYs were in favour of the intervention, suggesting that the intervention could be cost-effective. Similarly in the longer term (over a lifetime), the intervention is likely to be cost-effective. Process evaluation While the core values of the intervention appeared to be understood and valued by the staff, translating this into practice was oftentimes challenging and the patients interviewed felt they already had the knowledge in the booklet. Conclusion We developed a novel intervention called YCNY to support safety and experience for older people leaving hospital and going home. We also developed and validated (PACT-M) to measure patient experience and safety during care transitions. A randomised controlled trial of YCNY found some evidence of clinical benefit with the majority of results in favour of YCNY, although only secondary outcomes were statistically significant (total number of unplanned re-admissions after 3 months and the number of patient-reported adverse events after 30 days). YCNY is likely to be cost-effective in both the short term and long term. Staff valued YCNY intervention, but they struggled to fully implement it in the challenging post-COVID era. Implications for health care There is some promise for promoting safety at transitions from hospital to home through greater involvement of patients and their relatives in their care. To optimise the potential gains, staff need to engage differently with patients, and this was not always possible in the current depleted healthcare system. The intervention is freely available to all NHS hospitals. Recommendations for research Further research is needed to explore opportunities for developing and delivering an intervention to support patient involvement in care before hospital admission. Patients found the advice sheet for managing at home (a component of the YCNY intervention) to be the most useful. Further research is needed to develop a systems-integrated patient-friendly discharge summary. The methodology of fidelity assessments for complex healthcare interventions requires further development. Trial registration This trial is registered as Current Controlled Trials ISRCTN51154948 (WP5) and ISRCTN17062524 (WP6). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20017) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 4. See the NIHR Funding and Awards website for further award information.

BackgroundAutistic children can experience mental health, social and emotional difficulties. Carol Gray's Social Stories (TM) are a highly personalised intervention that provide social information in a short individually tailored story.MethodsA multi-site pragmatic cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of Social Stories (TM) alongside care as usual in autistic children aged 4-11 years. The primary outcome was the Social Responsiveness Scale-2 completed by teachers 6 months post-randomisation, analysed on an intention-to-treat basis. Trial Registration: ISRCTN11634810.ResultsEighty-seven schools, including 249 children, were randomised (intervention 44 schools with 129 children, and usual care 43 schools with 120 children). After 6 months, a reduction of 1.61 points was found on the Social Responsiveness Scale-2 in the intervention group (95% CI -4.18 to 0.96, p = .220) and for those who attended at least six sessions a reduction of 3.37 points (CACE 95% CI -6.65 to -0.10, p = .043). Children in the intervention group met their individual socio-emotional goal more frequently than children receiving usual care alone and this was statistically significant. No statistically significant differences were found in other secondary outcomes including anxiety, depression, general health or parental stress.ConclusionsSocial Stories (TM) represent a low-cost, low-burden intervention. Benefits are seen in individual socio-emotional goals but without clinically evident impact on social responsiveness, anxiety, depression, parental stress or general health.

Background Transitions from hospital to home are risky for older people. The role of patient involvement in supporting safe transitions is unclear. Objective To assess the clinical effectiveness of an intervention to improve the safety and experience of care transitions for older people. Trial design Cluster randomised controlled trial. Participants Eleven National Health Service acute hospital trusts and 42 wards (clusters) routinely providing care for older people (aged 75 years and older) planning to transition back home. Intervention Patient involvement ward-level intervention—Your Care Needs You (YCNY). Outcomes Unplanned hospital readmission rates within 30 days of discharge (primary outcome). Secondary outcomes included readmissions at 60 and 90 days post-discharge, experience of transitions and safety events. Randomisation Ward as the unit of randomisation from varying medical specialities randomised to YCNY or care-as-usual on a 1:1 basis. Blinding Ward staff, research nurses and researchers were unblinded. Patients were unaware of treatment allocation. Statisticians were blinded to the primary outcome data until statistical analysis plan sign-off. Results Using a mixed effects logistic regression we saw no significant difference in unplanned 30-day readmission rates (OR 0.93; 95% CI, 0.78 to 1.10; P = .372) between intervention (17%) and control (19%). At all timepoints, rates were lower in the intervention group. The total number of readmissions was lower in the intervention group (all timepoints) reaching statistical significance across 90-days with 13% fewer readmissions (IRR: 0.87; 95% CI 0.76 to 0.99) than the control. At 30-days only, intervention group patients reported better experiences of transitions and significantly fewer safety events. Serious adverse events were similarly observed in both groups [YCNY: 26 (52.0%), Care-as-usual: 24 (48.0%)]. None related to treatment. Conclusions YCNY did not significantly impact on unplanned hospital readmissions at 30 days but in some secondary outcomes we did find evidence of clinical benefit.

IntroductionBiological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT).Methods and analysisPERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients’ and clinicians’ acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively.Ethics and disseminationEthical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period.Trial registration numberISRCTN17691638.

Background Differences in the way autistic children experience the world can contribute to anxiety and stress. Carol Gray’s Social Stories™ are a highly personalised intervention to support children by providing social information about specific situations in an individual story. Objectives This randomised controlled trial aimed to establish whether Social Stories are clinically effective and cost-effective in improving social responsiveness and social and emotional health in children on the autism spectrum in schools. Design A multisite pragmatic cluster randomised controlled trial comparing Social Stories with care as usual. Setting Eighty-seven schools (clusters) across Yorkshire and the Humber. Participants Two hundred and forty-nine children were randomised via a bespoke system hosted at York Trials Unit (129 Social Stories and 120 care as usual). Recruitment was completed in May 2021. Participants were children aged 4–11 years with a diagnosis of autism, alongside teachers, interventionists and caregivers. Recruitment was via schools, NHS trusts, support groups and local publicity. Intervention The intervention included training for educational professionals and caregivers covering psychoeducation and implementation of Social Stories. Stories were written around contextualised goals around the child’s need for social information. Interventionists read the Social Story™ with the child at least six times over 4 weeks during school. Main outcome measure The primary outcome was the Social Responsiveness Scale-2 completed by teachers at 6 months (the primary end point), which measures social awareness, cognition, communication and behaviour. Data were collected from caregivers and educational professionals at 6 weeks and 6 months through questionnaires. Blinding of participants was not possible. Results At 6 months, the estimated difference in expected teacher-reported Social Responsiveness Scale-2 T-score (the primary end point) was −1.61 (95% confidence interval −4.18 to 0.96, p = 0.220), slightly favouring the intervention group. The estimated differences for the parent-reported secondary outcomes at 6 months were small and generally favoured the control group except the measure of children’s quality-adjusted life-year (+ 0.001, 95% confidence interval −0.032 to 0.035) and parental stress (−1.49, 95% confidence interval −5.43 to 2.46, p = 0.460), which favoured the intervention group. Children in the intervention group met their individual goals more frequently than children who received usual care alone (0.97 confidence interval 0.21 to 1.73, p = 0.012). The intervention is likely to save small costs (−£191 per child, 95% confidence interval −767.7 to 337.7) and maintain a similar quality of life compared to usual care. The probability of Social Stories being a preferred option is 75% if the society is willing to pay £20,000 per quality-adjusted life-year gained. Limitations include considerable disruptions during the coronavirus disease 2019 pandemic. Conclusion Social Stories are used in schools and represent a low-cost intervention. There is no clinically evident impact on social responsiveness, anxiety and/or depression, parental stress or general health. Benefits were observed for specific behavioural goals as assessed by the teacher, and Social Stories may serve as a useful tool for facilitating dialogue between children and school staff to address specific behavioural challenges. Usage should be at the school’s discretion. Future work Given the uncertainty of the results in light of coronavirus disease 2019, further work to establish the impact of Social Stories is merited. Trial registration This trial is registered as ISRCTN11634810. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/91) and is published in full in Health Technology Assessment ; Vol. 28, No. 39. See the NIHR Funding and Awards website for further award information.

Background One in 57 children are diagnosed with autism in the UK, and the estimated cost for supporting these children in education is substantial. Social Stories™ is a promising and widely used intervention for supporting children with autism in schools and families. It is believed that Social Stories™ can provide meaningful social information to children that can improve social understanding and may reduce anxiety. However, no economic evaluation of Social Stories has been conducted. Aims To assess the cost-effectiveness of Social Stories through Autism Spectrum Social Stories in Schools Trial 2, a multi-site, pragmatic, cluster-randomised controlled trial. Method Children with autism who were aged 4–11 years were recruited and randomised (N = 249). Costs measured from the societal perspective and quality-adjusted life-years (QALYs) measured by the EQ-5D-Y-3L proxy were collected at baseline and at 6-month follow-up for primary analysis. The incremental cost-effectiveness ratio was calculated, and the uncertainty around incremental cost-effectiveness ratios was captured by non-parametric bootstrapping. Sensitivity analyses were performed to evaluate the robustness of the primary findings. Results Social Stories is likely to result in a small cost savings (–£191 per child, 95% CI −767.7 to 337.7) and maintain similar QALY improvements compared with usual care. The probability of Social Stories being a preferred option is 75% if society is willing to pay £20 000 per QALY gained. The sensitivity analysis results aligned with the main study outcomes. Conclusions Compared with usual care, Social Stories did not lead to an increase in costs and maintained similar QALY improvements for primary-aged children with autism.

Objective To collect data on content/face validity and interobserver agreement for a Neonatal Coma Score (NCS) in well full-term neonates and on construct validity in unwell and preterm babies, specifically how the NCS changed with gestational age and illness. Design Prospective cohort studies. Setting Two UK tertiary neonatal units (Sheffield and Leeds). Patients 151 well full-term (≥37 weeks gestational age) newborn babies recruited between January and February 2020 in Sheffield and April and May 2021 in Leeds; 101 sick preterm and full-term babies admitted to Sheffield neonatal unit between January 2021 and May 2022. Intervention A new NCS. Main outcome measures Determination of normal values in well babies born ≥37 weeks gestational age; data on how the NCS changes with gestational age and illness. Results Face validity was demonstrated during development of the NCS. The median NCS of well, full-term newborn babies was 15 and the intraclass correlation coefficient was 0.78 (95% CI 0.70 to 0.84). In the ‘well’ preterm population, 95% <28 weeks had a score ≥11; 28–31 weeks ≥11; 32–36 weeks ≥13 and 37–44 weeks 14–15. The NCS dropped during periods of deterioration, demonstrating evidence of construct validity. Criterion validity was not assessed. Conclusions The NCS has good intraobserver agreement in well full-term babies, with a normal NCS 14–15. The NCS in preterm neonates depended on gestational age, and deterioration from baseline was associated with illness. Further work is needed to determine normal scores each gestational age, reliability at lower levels, how early the NCS identifies deterioration and comparison with other assessment tools to demonstrate criterion validity.

Results of a randomized controlled trial in English elementary schools of Lexia Core5 Reading are presented here. The research assessed whether a computer-assisted learning program designed to improve reading outcomes for all readers, when delivered as a targeted intervention to struggling readers improves reading outcomes for these First Grade students. The program was delivered successfully across one school year. Analysis was undertaken for 620 students, from 57 participating schools with a mean average of socio-economic disadvantage above the national average. Positive Effect Sizes were observed of +0.08 overall and of +0.18 for low socio-economic status (SES) students. A larger study is warranted to ascertain generalizability to a larger population including in other grades.

BACKGROUND:Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home.METHODS:A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards.DISCUSSION:This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts.TRIAL REGISTRATION:UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020.

Background The ‘Your Care Needs You’ (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. Methods A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. Results Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% ( n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients’ health, capacity, and preferences. Conclusions If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. Trial registration ISRCTN: 51154948.

Introduction Recurrent pulmonary exacerbations lead to progressive lung damage in cystic fibrosis (CF). Inhaled medications (mucoactive agents and antibiotics) help prevent exacerbations, but objectively measured adherence is low. We investigated whether a multi-component (complex) self-management intervention to support adherence would reduce exacerbation rates over 12 months. Methods Between October 2017 and May 2018, adults with CF (aged >= 16 years; 19 UK centres) were randomised to the intervention (data-logging nebulisers, a digital platform and behavioural change sessions with trained clinical interventionists) or usual care (data-logging nebulisers). Outcomes included pulmonary exacerbations (primary outcome), objectively measured adherence, body mass index (BMI), lung function (FEV1) and Cystic Fibrosis Questionnaire-Revised (CFQ-R). Analyses were by intent to treat over 12 months. Results Among intervention (n=304) and usual care (n=303) participants (51% female, median age 31 years), 88% completed 12-month follow-up. Mean exacerbation rate was 1.63/year with intervention and 1.77/year with usual care (adjusted ratio 0.96; 95% CI 0.83 to 1.12; p=0.64). Adjusted mean differences (95% CI) were in favour of the intervention versus usual care for objectively measured adherence (9.5% (8.6% to 10.4%)) and BMI (0.3 (0.1 to 0.6) kg/m(2)), with no difference for %FEV1 (1.4 (-0.2 to 3.0)). Seven CFQ-R subscales showed no between-group difference, but treatment burden reduced for the intervention (3.9 (1.2 to 6.7) points). No intervention-related serious adverse events occurred. Conclusions While pulmonary exacerbations and FEV1 did not show statistically significant differences, the intervention achieved higher objectively measured adherence versus usual care. The adherence difference might be inadequate to influence exacerbations, though higher BMI and lower perceived CF treatment burden were observed.

Post-kala-azar dermal leishmaniasis (PKDL) is a chronic, stigmatizing skin condition occurring frequently after apparent clinical cure from visceral leishmaniasis. Given an urgent need for new treatments, we conducted a phase IIa safety and immunogenicity trial of ChAd63-KH vaccine in Sudanese patients with persistent PKDL. LEISH2a (ClinicalTrials.gov: NCT02894008) was an open-label three-phase clinical trial involving sixteen adult and eight adolescent patients with persistent PKDL (median duration, 30 months; range, 6-180 months). Patients received a single intramuscular vaccination of 1 x 10(10) viral particles (v.p.; adults only) or 7.5 x 10(10) v.p. (adults and adolescents), with primary (safety) and secondary (clinical response and immunogenicity) endpoints evaluated over 42-120 days follow-up. AmBisome was provided to patients with significant remaining disease at their last visit. ChAd63-KH vaccine showed minimal adverse reactions in PKDL patients and induced potent innate and cell-mediated immune responses measured by whole-blood transcriptomics and ELISpot. 7/23 patients (30.4%) monitored to study completion showed >90% clinical improvement, and 5/23 (21.7%) showed partial improvement. A logistic regression model applied to blood transcriptomic data identified immune modules predictive of patients with >90% clinical improvement. A randomized controlled trial to determine whether these clinical responses were vaccine-related and whether ChAd63-KH vaccine has clinical utility is underway.

Background: People with cystic fibrosis frequently have low levels of adherence to inhaled medications. Objectives: The objectives were to develop and evaluate an intervention for adults with cystic fibrosis to improve adherence to their inhaled medication. Design: We used agile software methods to develop an online platform. We used mixed methods to develop a behaviour change intervention for delivery by an interventionist. These were integrated to become the CFHealthHub intervention. We undertook a feasibility study consisting of a pilot randomised controlled trial and process evaluation in two cystic fibrosis centres. We evaluated the intervention using an open-label, parallel-group randomised controlled trial with usual care as the control. Participants were randomised in a 1 : 1 ratio to intervention or usual care. Usual care consisted of clinic visits every 3 months. We undertook a process evaluation alongside the randomised controlled trial, including a fidelity study, a qualitative interview study and a mediation analysis. We undertook a health economic analysis using both a within-trial and model-based analysis. Setting: The randomised controlled trial took place in 19 UK cystic fibrosis centres. Participants: Participants were people aged ≥ 16 years with cystic fibrosis, on the cystic fibrosis registry, not post lung transplant or on the active transplant list, who were able to consent and not using dry-powder inhalers. Intervention: People with cystic fibrosis used a nebuliser with electronic monitoring capabilities. This transferred data automatically to a digital platform. People with cystic fibrosis and clinicians could monitor adherence using these data, including through a mobile application (app). CFHealthHub displayed graphs of adherence data as well as educational and problem-solving information. A trained interventionist helped people with cystic fibrosis to address their adherence. Main outcome measures: Randomised controlled trial – adjusted incidence rate ratio of pulmonary exacerbations meeting the modified Fuchs criteria over a 12-month follow-up period (primary outcome); change in percentage adherence; and per cent predicted forced expiratory volume in 1 second (key secondary outcomes). Process evaluation – percentage fidelity to intervention delivery, and participant and interventionist perceptions of the intervention. Economic modelling – incremental cost per quality-adjusted life-year gained. Results: Randomised controlled trial – 608 participants were randomised to the intervention (n = 305) or usual care (n = 303). To our knowledge, this was the largest randomised controlled trial in cystic fibrosis undertaken in the UK. The adjusted rate of exacerbations per year (primary outcome) was 1.63 in the intervention and 1.77 in the usual-care arm (incidence rate ratio 0.96, 95% confidence interval 0.83 to 1.12; p = 0.638) after adjustment for covariates. The adjusted difference in mean weekly normative adherence was 9.5% (95% confidence interval 8.6% to 10.4%) across 1 year, favouring the intervention. Adjusted mean difference in forced expiratory volume in 1 second (per cent) predicted at 12 months was 1.4% (95% confidence interval –0.2% to 3.0%). No adverse events were related to the intervention. Process evaluation – fidelity of intervention delivery was high, the intervention was acceptable to people with cystic fibrosis, participants engaged with the intervention [287/305 (94%) attended the first intervention visit], expected mechanisms of action were identified and contextual factors varied between randomised controlled trial sites. Qualitative interviews with 22 people with cystic fibrosis and 26 interventionists identified that people with cystic fibrosis welcomed the objective adherence data as proof of actions to self and others, and valued the relationship that they built with the interventionists. Economic modelling – the within-trial analysis suggests that the intervention generated 0.01 additional quality-adjusted life-years at an additional cost of £865.91 per patient, leading to an incremental cost-effectiveness ratio of £71,136 per quality-adjusted life-year gained. This should be interpreted with caution owing to the short time horizon. The health economic model suggests that the intervention is expected to generate 0.17 additional quality-adjusted life-years and cost savings of £1790 over a lifetime (70-year) horizon; hence, the intervention is expected to dominate usual care. Assuming a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, the probability that the intervention generates more net benefit than usual care is 0.89. The model results are dependent on assumptions regarding the duration over which costs and effects of the intervention apply, the impact of the intervention on forced expiratory volume in 1 second (per cent) predicted and the relationship between increased adherence and drug-prescribing levels. Limitations: Number of exacerbations is a sensitive and valid measure of clinical change used in many trials. However, data collection of this outcome in this context was challenging and could have been subject to bias. It was not possible to measure baseline adherence accurately. It was not possible to quantify the impact of the intervention on the number of packs of medicines prescribed. Conclusions: We developed a feasible and acceptable intervention that was delivered to fidelity in the randomised controlled trial. We observed no statistically significant difference in the primary outcome of exacerbation rates over 12 months. We observed an increase in normative adherence levels in a disease where adherence levels are low. The magnitude of the increase in adherence may not have been large enough to affect exacerbations. Future work: Given the non-significant difference in the primary outcome, further research is required to explore why an increase in objective normative adherence did not reduce exacerbations and to develop interventions that reduce exacerbations. Trial registration: Work package 3.1: Current Controlled Trials ISRCTN13076797. Work packages 3.2 and 3.3: Current Controlled Trials ISRCTN55504164. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 11. See the NIHR Journals Library website for further project information.