Care (Education) and Treatment Reviews (C(E)TRs) are intended to reduce unnecessary psychiatric hospital admission and length of stay for people with intellectual disability and autistic people. The use and impact of C(E)TRs have not been systematically evaluated since their introduction in England in 2015. The aims of this study are to describe the demographic and clinical profiles of people who receive a community C(E)TR and to investigate their effects on admission, length of hospital stay and clinical and functional change.

We will conduct a retrospective cohort study using de-identified data from electronic health records derived from two large National Health Service mental health providers in London, England, including one replication site. Data will be extracted using the Clinical Record Interactive Search (CRIS) tool for all people with recorded intellectual disability and/or autism who received mental healthcare from 2015. We will identify community C(E)TR events using keyword searches. Community C(E)TRs will be examined in two ways: (1) In a community cohort, we will capture data in the 6-month periods before and after a community C(E)TR and compare this to a matched control group and (2) In a hospital cohort, we will compare groups who did and did not receive a community C(E)TR prior to their admission. We will describe the socio-demographic and clinical profiles of each group and their health service use, and compare C(E)TR and no C(E)TR groups using t-tests (or a non-parametric equivalent). The primary outcomes are admission to a psychiatric hospital (community cohort) and length of psychiatric hospital admission and clinical change (hospital cohort). Admission to psychiatric hospital will be estimated using propensity score weighting and difference-in-differences methods. Cox’s proportional hazard model will be used for length of hospital admission and repeated-measures analysis of variance (ANOVA) will be used to assess clinical change.

Use of CRIS to examine de-identified clinical data for research purposes has overarching ethical approval. This study has been granted local approval by the South London and Maudsley CRIS Oversight Committee. Findings will be disseminated in an open-access peer-reviewed academic publication, at conference presentations, and to service users and carers in accessible formats.

Influenza is a major global health concern, responsible for up to 650 000 respiratory-related deaths annually. Although influenza is often perceived as mild in healthy adults, it can cause severe outcomes in high-risk groups, such as older adults, young children, pregnant women and those with underlying medical conditions. Various clinical, sociodemographic and environmental factors influence the progression to severe outcomes, whereas resilience factors, such as vaccination, may reduce risks. Despite growing research, the evidence base regarding risk and resilience is spread across many different aspects of the literature. This umbrella review will synthesise evidence from existing systematic reviews and meta-analyses to identify key risk and resilience factors associated with the progression of influenza to severe outcomes in the general population.

This umbrella review follows the Joanna Briggs Institute (JBI) and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include systematic reviews and meta-analyses reporting host-related risk or resilience factors for severe influenza outcomes. Four databases (EMBASE, Scopus, Medline and CINAHL) will be searched for English-language publications. Study quality will be assessed using AMSTAR 2, and the body of evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation. Due to heterogeneity, findings will be analysed narratively. Risk and resilience factors will be grouped into demographic, clinical, behavioural, social and psychological domains.

No ethical approval is required. The completed review will be shared through peer-reviewed journals and conference presentations.

CRD420250644475.

Public involvement in mental health research enhances research quality. The use of citizen science methods in mental health research has been described as a conclusion of a movement towards increased public involvement; however, this field is in its early stages of development. Our objective was to create a theory of change (ToC) for how citizen science can be used to enhance mental health research quality.

Iterative consultation with the stakeholders of an existing citizen mental health science study, that is, change for citizen science to achieve co-production at scale (C-STACS: https://www.researchintorecovery.com/research/c-stacs/)

We co-developed a ToC through an iterative consultation with C-STACS stakeholders who were (a) representatives of mental health community organisations (n=10), individuals with public involvement experience (n=2) and researchers (n=5). In keeping with established ToC practice, entities were identified, including long-term impacts, outcomes needed to create an impact, stakeholder assumptions and indicators for tracking progress.

A desired primary long-term impact of greater co-production of research was identified between researchers and members of the public, which would create a secondary impact of enhancing public capacity to engage in citizen mental health science. We proposed long-term outcomes needed to enable this impact: (1) greater co-production of research objectives and pathways between researcher and the public, (2) greater embedment of citizen mental health science into funder processes (eg, the creation of specific funding calls for citizen mental health science proposals, (3) greater clarity on the boundaries between citizen science and other participatory approaches (eg, so that there is not loss of impact due to conceptual confusion between these, (4) increased knowledge around effective frameworks to enable mass public participation and (5) greater availability of technology platforms, enabling safe and accessible engagement with citizen mental health science projects.

The proposed ToC is grounded in the C-STACS project, but intended to be broadly applicable. It allows the continued formation of a community of practice around citizen mental health science and should be reviewed, as greater knowledge is developed on how citizen mental health science creates change.

To identify the factors influencing professionals’ implementation of the National Institute for Health and Care Excellence (NICE) guidelines on self-harm.

A rapid review evidence synthesis

Five electronic databases (ASSIA, CINAHL, EMBASE, MEDLINE, PsycINFO) and five indexing databases (Science Citation Index Expanded (SCIE), Social Sciences Citation Index (SSCI), Arts and Humanities Citation Index (AHCI), Emerging Sources Citation Index (ESCI) and Conference Proceedings Citation Index (CPCI)), using the Web of Science platform, were searched in December 2023 and repeated in July 2024.

We included quantitative and qualitative studies that investigated professionals’ knowledge and implementation of NICE guidelines on self-harm, that were in English language and published between 2004 and July 2024.

One reviewer used standardised methods to search, screen, select, quality assess and synthesise the included studies, to accelerate the review. Quality assessment was conducted using the Mixed Methods Appraisal Tool. Data were extracted and synthesised thematically using NICE guidance implementation priorities.

The review included 10 studies. Six were conducted in accident and emergency (A&E) settings, two in general practice, one in a burns and plastic surgery hospital department and one involved cross-sectoral health professionals. Key findings indicate that awareness and implementation of self-harm guidelines is low among health professionals. Systemic barriers include lack of staff training, negative staff attitudes towards people who self-harm and lack of resources.

There is a need to develop and implement regular training on self-harm, incorporating NICE guidance and measures, to integrate knowledge and mobilise practice changes. Further research into the implementation of NICE guidelines in children who self-harm is needed, and in a wider variety of health and social care settings. The absence of studies from the social care sector into professionals’ awareness and implementation of NICE guidelines on self-harm is a key limitation.

Cohort studies of ageing and cognitive decline typically do not begin fielding comprehensive cognitive assessments until older adulthood. However, for identifying preventable dementia risk factors, there is strong value in beginning at earlier ages. The case is especially compelling in sub-Saharan Africa, where the number of older individuals is expected to triple in the next three decades, and where risk factors may operate more intensively at earlier ages. This study reports on the adaptation and validity of the Harmonised Cognitive Assessment Protocol (HCAP) approach in the Kenya Life Panel Survey (KLPS), collected among middle-aged respondents.

To evaluate the validity of the HCAP approach in Kenya, this study assesses model fit statistics from confirmatory factor analyses (CFA) and tests measurement invariance by respondent characteristics.

Both rural and urban areas in Kenya.

A sample of n=5878 individuals from the KLPS, who have been surveyed regularly since they were schoolchildren in the 1990s. The HCAP assessment was administered in 2023 at an average age of 37 years (10–90 range 34 to 41).

For each individual, the CFA generates a general cognitive performance score, and cognitive performance scores for five distinct domains, including memory, executive functioning, language, orientation to time and place, and visuospatial functioning.

Fit of the models to the data was adequate for general cognitive performance (root mean squared error of approximation (RMSEA)=0.03; comparative fit index (CFI)=0.94; standardised root mean residual (SRMR)=0.05), language (RMSEA=0.02; CFI=0.95; SRMR=0.05) and good for memory (RMSEA=0.05; CFI=0.99; SRMR=0.02) and executive functioning (RMSEA=0.03; CFI=0.98; SRMR=0.03). The CFA indicate that the factor structure is consistent with findings from other countries and that reliability for the general cognitive performance score was high. Statistical models also suggest invariance at the scalar level for leading demographic (gender, age) and socioeconomic (education, occupational complexity) characteristics.

This study demonstrates that the cognitive functioning of mid-age Kenyans appears to be well captured by the adapted protocol. While there is a moderate decline in cognitive performance among older individuals, this relationship appears to be mediated by education, indicating that this KLPS HCAP provides a valuable baseline for studying future cognitive decline.

To investigate the sociocultural and epidemiological factors associated with non-alcoholic beer (NAB) consumption in Poland, including motivations for use, consumption context, and its reported impact on alcohol consumption patterns.

Cross-sectional survey study.

Community setting across Poland; data were collected in December 2024.

A total of 1114 adults aged 18–84 years (mean age: 47.1±14.4 years; 54.3% female) completed the questionnaire. Participants were recruited through an online panel using stratified quota sampling to approximate national population distributions by age, sex and region. Inclusion criteria were age ≥18 years and residence in Poland. No exclusion criteria beyond informed consent were applied.

Not applicable.

The primary outcome was current NAB use, defined as self-reported consumption of NAB. Secondary outcomes included sociodemographic correlates, reasons for use, consumption contexts and self-reported changes in alcoholic beer consumption following NAB adoption.

70.6% of respondents reported current NAB use. Multivariable logistic regression showed that age 18–49 years (p

NAB consumption in Poland is associated with identifiable sociodemographic characteristics and motivated by practical and health-related considerations. While nearly half of current users report reduced or substituted alcohol intake, a substantial proportion incorporate NAB into existing drinking routines without change or with increased alcohol use. These findings suggest a heterogeneous behavioural impact, underlining the need for nuanced public health messaging and further research into the long-term effects of NAB use on alcohol-related outcomes.

Paediatric vulval lichen sclerosus (VLS) is a chronic disease with distressing symptoms and severe consequences when left untreated. Majority of existing data on pathophysiology and treatment is based on studies conducted among adult patients. Whereas the course of VLS, its symptomatology and prognosis are distinct to some extent in paediatric and adolescent patients as compared with adults. The purpose of this scoping review is to systematically examine what symptoms of VLS are typical of paediatric and adolescent patients, how often specific signs and symptoms are reported in the literature, if there are differences between paediatric and adolescent patients and what could be the implication of such differences.

This scoping review will adopt the methodology for Joanna Briggs Institute scoping reviews and will consider studies that include female patients aged 1–18, with VLS symptoms and signs with no exclusion based on ethnicity, comorbidity or previous history of treatment. Studies on any aspect of paediatric VLS, including pathogenesis, diagnosis and treatment, which included patients and reported patients’ symptoms and signs, will be considered eligible. There will be no geographical or cultural limitation applied in relation to this scoping review. The search will include Embase, Academic Search Premier, CINAHL, Cochrane Library, Google Scholar, Health Source, Ovid Embase, Ovid Medline, PubMed, Scopus and Web of Science Principal Collection. A critical synthesis and results will be presented in the final review as tables and accompanying narrative summary.

Ethical approval is not required for this review. To date, no systematic approaches were undertaken to classify symptoms of the VLS that would aid in formulating disease severity criteria adequate for the paediatric population. We believe that the results of this review will facilitate the development of disease severity scales that could aid in intraindividual and interindividual comparability, both in real-life settings and clinical trials.

https://doi.org/10.17605/OSF.IO/FB9EG

Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).

It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy.

Cluster randomised trial.

320 000 women from up to 80 hospital maternity units.

Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design.

The primary outcome is all-cause early (

The trial received a favourable opinion from Derby Research Ethics Committee on 16 September 2019 (19/EM/0253). The allocated testing strategy will be adopted as standard clinical practice by the site. Women in the routine testing sites will give verbal consent for the test. The trial will use routinely collected data retrieved from National Health Service databases, supplemented with limited participant-level collection of process outcomes. Individual written consent will not be sought. The trial results, and parallel economic, qualitative, implementation and methodological results, will be published in the journal Health Technology Assessment.

ISRCTN49639731.

The combination of a reduction in the Danish hospital bed count, the shortage of hospital staff and demographic changes challenges the Danish hospital capacity. This was further highlighted during the COVID-19 pandemic when hospitals worldwide were overwhelmed by infected patients requiring acute hospital care. To address these challenges, a hospital-at-home (HaH) programme offers an alternative to conventional in-hospital admission. Furthermore, HaH has the potential to improve patient outcomes, reduce costs and increase patient satisfaction. However, few studies have evaluated HaH in a Scandinavian setting, and this article describes the protocol for a randomised controlled trial (RCT) comparing an HaH model with continued conventional in-hospital admission. The main aim of the trial is to evaluate physical activity level and mental wellbeing in patients admitted at home compared with conventionally admitted patients.

110 clinically stable patients from two internal medical wards at Nordsjaellands Hospital in Denmark will be included and randomised in a ratio of 1:1 to either continued conventional in-hospital admission (control group) or virtual HaH model (intervention group). The control group will receive standard hospital treatment, and the intervention group will be transferred home for continued treatment (eg, intravenous antibiotics or oxygen treatment). The primary outcome measures are physical activity assessed using daily step count (during the first 24 hours after inclusion, as an intermediary indicator of the risk of adverse events) and treatment satisfaction (assessed using a patient satisfaction survey). Secondary outcome measures are adverse events of special interest, escalation of care, readmission rate postdischarge (30 days and 90 days), mortality (associated and 7 days, 30 days and 90 days postdischarge), process data (eg, the number of teleconsultations) and a health economic evaluation.

The study was approved by the Danish Research Ethics Committees (no. 2303051) and the Danish Medicines Agency (CIV-23-03-042542) and will be monitored by the Copenhagen University Hospital Good Clinical Practice unit. Results will be published in peer-reviewed journals and presented at relevant national and international conferences. We also plan to communicate the results to relevant stakeholders in the Danish healthcare system.

NCT05920304.

The multifaceted impact of dementia means that people living with dementia require multidisciplinary care across different services and settings; however, these care transitions pose a risk of fragmented care. Models that improve integration and coordination of care in the community are needed.

This randomised control trial will test the effectiveness and cost effectiveness of a dementia nurse-led intervention to: (1) increase days lived in the community at 12-month follow-up (primary outcome) among people living with dementia and (2) improve quality of life for people living with dementia and their carers, compared with usual care. Participants are recruited from several sources including private and public geriatric medicine clinics, carer support groups and self-referral. People living with dementia and their carers are randomised as a dyad to (1) usual care or (2) dementia nurse-led care-coordination. The dementia nurse will provide care coordination and direct support through a tailored, integrated and patient-centred approach. The needs of people living with dementia will be identified and addressed, with a focus on improving the management of comorbidities, risk reduction and symptoms. Carers will also receive support. The model for people living with dementia will focus on days lived in their community as the outcome variable. Differences between groups in quality of life at 12-month follow-up will be assessed using linear mixed effects regression. Analysis will follow the intention to treat principles. People living with dementia and carers’ data will be analysed separately and collectively for the economic study.

The trial has been approved by the Hunter New England Research Ethics Committee (2023/ETH01221) and the University of Newcastle Ethics Committee (R-2024–0021). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team aims to further implement the intervention as usual care within the participating services and beyond.

The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12624000235505. Registration date: 11 March 2024.

To explore trial participants’ experience of long-term catheters (LTC), the acceptability of washout policies, their experience of the CATHETER II trial (a randomised controlled trial comparing the clinical effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters) and their satisfaction with the outcomes. The objectives of the healthcare professionals (HCPs) focus group and interview were to explore their attitudes towards weekly prophylactic catheter washout, views on the provision of training and participants’ ability to enact washout behaviours.

A longitudinal qualitative study embedded within the CATHETER II randomised controlled trial, which included semi-structured interviews and focus groups with participants from multiple trial sites. Data were analysed using the Theoretical Framework of Acceptability and Theoretical Domains Framework. This UK community-based study included 50 (24 female, 26 male) CATHETER II trial participants, aged between 23 and 100 years, with LTC and able to self-manage the washout and study documentation either independently or with the help of a carer. Seven HCPs (five female, two male) also participated.

The participants had positive attitudes towards weekly prophylactic saline or acidic catheter washouts and other trial elements, such as washout training, catheter calendar and monthly phone calls. Participants and HCPs found the ‘ask’ of the CATHETER II trial and the weekly self-administered prophylactic washout policies to be feasible. The participants reported that the catheter washout training provided during the trial enhanced their self-efficacy, skills and self-reported capability to carry out the washouts. Participants reported having positive outcomes from the weekly washout. These included reduced blockage, pain or infection, reduced need for HCP support and greater psychological reassurance. HCPs attested to the participants’ understanding of and adherence to the weekly washouts and other elements of the trial.

This study shows acceptability, feasibility and self-reported fidelity of the CATHETER II trial on a behavioural level. Self-management for prophylactic catheter washouts is both feasible and, following training, achievable without any need for additional support.

ISRCTN17116445.