BMJ Open最新文献

Introduction: Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package-DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.

Methods: This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention's outcomes.

Ethics and dissemination: This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.

Introduction: There is a recognised need to provide equity in healthcare through inclusion of ethnic minorities in research. South Asians, the largest ethnic minority group in the UK, experience high levels of mental illness, often against the backdrop of socioeconomic deprivation and discrimination. The research community recognises that South Asian communities are often excluded from health research. Efforts have been made to understand the barriers and facilitators to their participation. However, the participation of individuals at the intersection of mental ill health and South Asian ethnicity remains understudied. This is a protocol for the synthesis of qualitative evidence from mental health research studies about participation, motivation and barriers to recruitment of South Asians in high-income countries.

Methods and analysis: We will search 10 databases for qualitative evidence on participation of South Asian individuals in mental health research studies in high-income countries: MEDLINE, EMBASE, PsycINFO, Health Management Information Consortium, Social Policy and Practice, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Social Sciences Citation Index, Science Citation Index Expanded and ProQuest Dissertations and Theses Citation Index. Search terms for the following five concepts will be used: (1) South Asia, (2) ethnic minority, (3) mental health conditions, (4) barriers and facilitators to participation and (5) high-income countries. No date restriction will be applied to the search. Searches will be limited to studies in the English language. Study selection and data extraction will be performed by two researchers independently, using Covidence. Demographic data, thematic outputs and salient discussion points will be extracted from final full-text inclusions and entered into NVivo for coding. Meta-ethnographic approaches using first and second-order constructs from included studies will be used to form third-order constructs. This synthesis will generate new knowledge regarding the intersectionality of mental health and South Asian ethnicity.

Ethics and dissemination: Ethical approval is not required as this study is a synthesis of published data. This review will provide new knowledge regarding the requirements for researchers and practitioners to advance the involvement of South Asian populations in mental health research. This will undoubtedly enhance equity in the long term, reduce the burden of mental disorders and enable the provision of more effective mental health care for South Asian communities.

Prospero registration number: CRD42025626382.

Introduction: Early childhood caries (ECC) continues to be a public health problem. The application of silver diamine fluoride (SDF) is a simple, non-invasive procedure. This study aims to evaluate SDF's effectiveness, acceptability and oral health-related quality of life (OHRQoL) compared with atraumatic restorative treatment in managing ECC.

Methods and analysis: An open-label parallel superiority randomised clinical trial will be conducted involving children aged 2-5 years. Participants will include children with at least one active cavitated lesion (ICDAS 5+) of their primary teeth, with no signs of pulp involvement. The trial will occur at preschools in the La Araucanía and Metropolitan Regions of Chile from 2025 to 2027. The primary outcome variable will be the caries lesion arrest, acceptability and OHRQoL. We will also determine the presence of any adverse effects. Evaluations will be carried out at 6 and 12 months. A sample of 234 teeth with carious lesions per group is estimated. The primary inferential analysis will be performed on an intention-to-treat basis; a per-protocol analysis will be conducted for adverse effects. For caries lesion arrest, a multilevel logistic regression model adjusted for significant covariates will be used to account for within-child clustering. The acceptability will be assessed through quantitative and qualitative methods. The magnitude of change in OHRQoL between baseline and follow-up will be quantified using effect size estimates derived from the early childhood health impact scale survey data.

Ethics and dissemination: This study's implementation benefits the study population, and the ethical principles of research have been considered and approved by the Science Committee of the University, Resolution N°049_19. The results and conclusions of the clinical trial will be published in academic conferences and peer-reviewed journals.

Trial registration number: NCT06786975.

Objectives: The Trauma and Injury Severity Score (TRISS) is widely used to predict survival in patients with trauma; however, its predictive accuracy in paediatric populations remains suboptimal. In contrast, the revised Shock Index multiplied by the Glasgow Coma Scale (rSIG), a simple physiological marker, has shown potential utility in adults and children. Therefore, we aimed to compare the predictive performance of rSIG and TRISS in paediatric patients with trauma.

Design: Retrospective cohort study.

Setting: Japan Trauma Data Bank.

Participants: Paediatric patients with trauma aged ≤17 years who were registered in the Japan Trauma Data Bank between 2009 and 2021.

Primary and secondary outcome measures: The optimal cut-off value for rSIG was determined using the derivation cohort (2009-2018). In the validation cohort (2019-2021), the predictive accuracy of rSIG and TRISS for in-hospital survival was compared using the area under the receiver operating characteristic curve (AUC).

Results: In the derivation cohort, the optimal cut-off value for rSIG was 10.13. In the validation cohort, the overall AUC for rSIG was 0.857 (95% CI 0.796 to 0.918) compared with 0.740 (95% CI 0.661 to 0.820) for TRISS, demonstrating the significantly superior predictive accuracy of rSIG (p=0.006). Age-stratified analyses revealed that rSIG significantly outperformed TRISS in the 7-12 and 13-17 age groups.

Conclusions: The rSIG demonstrated higher predictive accuracy for in-hospital survival among paediatric patients with trauma than TRISS. These findings suggest that rSIG is a more effective prognostic tool for paediatric trauma care. Validation and the establishment of age-specific cut-off values are warranted to enhance its clinical applicability.

Objectives: To examine the emotional, cognitive and dispositional experience of children and adolescents undergoing Lokomat rehabilitation by integrating self-evaluation, therapist observations and physiological metrics across repeated sessions, with the aim of characterising how patient experience evolves throughout paediatric robot-assisted gait training.

Design: Prospective observational study using a multidimensional assessment approach combining self-report, therapist ratings and physiological measures.

Setting: Inpatients undergoing robot-assisted gait training (RAGT) with the Lokomat at the Scientific Institute Eugenio Medea in Bosisio Parini (Italy).

Participants: 42 children and adolescents (N=42; mean age 11.66±5.59 years) undergoing RAGT.

Interventions: Robot-assisted gait therapy with the Lokomat. Participants underwent 30-minute therapy sessions as per routine rehabilitation protocols, with treatment durations ranging from 15 to 20 sessions, as prescribed by their referring clinician.

Primary and secondary outcome measures: Participants completed ad-hoc questionnaires about emotional, cognitive and dispositional factors before and after therapy; therapists provided structured assessments of patient engagement and psychological states. Physiological data, such as heart rate variability (HRV) and electrodermal activity (EDA), were recorded using wearable sensors to capture physiological correlates of emotional and cognitive engagement.

Results: The results showed that by the end of Lokomat therapy, patients displayed increased cognitive engagement and better emotional regulation, along with higher vagal activity (normalised high-frequency) and increased phasic EDA responses. According to the therapists, patients appeared more confident, calm and cooperative. Sympathetic activation observed during satisfaction ratings reflected the involvement of the autonomic nervous system in positive emotional experiences.

Conclusions: This study, therefore, emphasises a multidimensional approach to rehabilitation, which involves subjective patient self-assessments, therapist observations and physiological signals in an effort to capture a more comprehensive patient experience. The findings highlight the importance of personalised, patient-centred approaches and contribute new evidence on the psychological and physiological effects of RAGT in paediatric populations. Further research is warranted to confirm these results and explore their clinical implications.

Trial registration number: NCT05767268.

Objectives: Providing peer support can benefit youth peer support workers (peers)et by supporting self-determination, recovery and resilience to self-stigma. There is a need to clarify the role of the organisation in providing benefits for peers. We aimed to identify the organisational contexts and mechanisms that result in the creation of healthy workplaces for peers.

Design: Rapid realist review guided by the Realist and Meta-Narrative Evidence Syntheses-Evolving Standards guidelines and Pawson's iterative approach.

Data sources: MEDLINE, CINAHL, PsycINFO, ERIC, SocINDEX, Google Scholar and Embase were searched from 1979 to 2025.

Eligibility criteria: We included qualitative and quantitative peer-reviewed studies and grey literature that captured characteristics of organisational practices and employment considerations in youth peer support programmes.

Data extraction and synthesis: Articles were screened independently by multiple reviewers. Inclusion criteria were adjusted to capture literature on organisational practices, and employment considerations for youth peer support programmes. Data were extracted and analysed retroductively to develop Context-Mechanism-Outcome Configurations (CMOCs).

Results: Five employment-related risks to peer well-being were identified: (1) difficulty entering the job market, (2) lack of role clarity, (3) pressure to live up to ideals, (4) retraumatisation and (5) stigma. Six CMOCs were developed; all focused on the creation of equitable employment and supporting peer development and empowerment were developed.

Conclusions: Community-based mental health organisations can facilitate equitable peer employment through strategies that reduce professional stigma, enhance peer resilience and promote professional and personal development. Policy reform that addresses precarious work conditions is needed to support healthy work environments.

Objective: This study assessed the associations between asthma, gastro-oesophageal reflux disease (GORD) and health-related quality-of-life (HRQoL) among adolescents.

Design: A cross-sectional survey.

Setting: Six randomly selected schools across all five educational zones of the Anuradhapura district in Sri Lanka.

Participants: A total of 1127 adolescents aged 13-14 years were included from six randomly selected schools representing all five educational zones in the Anuradhapura district, Sri Lanka.

Main outcome measures: Prevalence of asthma and GORD, the associations between asthma, GORD and HRQoL among adolescents in Sri Lanka.

Results: This study of 1127 adolescents (44.8% male, mean age 13.66±0.56 years) found that 16.1% (n=181) had current asthma and 17.9% (n=202) exhibited symptoms of GORD. A significant association was observed between current asthma and GORD (OR 2.30, 95% CI 1.59 to 3.31, p=0.0005). Comorbidity of asthma and GORD was observed in 4.8% of participants (n=54). The total HRQoL score was not associated with asthma, GORD or those having both asthma and GORD. However, the presence of GORD was associated with poor emotional functioning (unstandardized regression coefficient ± standard error = -4.7±1.7, p=0.008).

Conclusion: Asthma and GORD were significantly associated among early adolescents in Sri Lanka. While overall HRQoL did not differ by disease status, the presence of GORD was associated with poorer emotional functioning.

Objectives: To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.

Design: Pilot cluster randomised controlled trial (c-RCT).

Setting: Community-based healthcare services across six UK sites representing primary and secondary care settings.

Participants: 31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.

Interventions: The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.

Primary and secondary outcome measures: Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.

Results: Recruitment occurred over an 8-month period (September 2023-April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.

Conclusions: The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.

Trial registration number: ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).

Objective: To explore experiences of healthcare providers, stroke survivors and caregivers on stroke transitional care delivery at a tertiary hospital in Tanzania.

Design: A qualitative descriptive design with a phenomenological approach was used. Colaizzi's thematic analysis was conducted using Dedoose software to identify significant information that describes the transitional care experiences of the study participants.

Setting: This study was conducted in the internal medicine and outpatient departments of a tertiary hospital in Tanzania.

Participants: 15 triads of healthcare providers, stroke survivors and caregivers were purposively recruited to participate in semi-structured in-depth interviews between June and September 2024.

Results: The analysis identified four themes: communication and exchange of information, involvement of patients and caregivers in transitional care, coordination of transitional care and experiences with changing care setting. Effective communication and information exchange among healthcare providers, survivors and caregivers ensured that survivors and their caregivers were well informed about the care process, clinical condition, prognosis and transitional care needs. A collaborative care approach enabled survivors and caregivers to actively participate in care, decision-making and discharge planning during hospital-to-home transition. Coordination of care was equally important during hospital-to-home transition as it provided survivors with home-care instructions and opportunities for follow-up care. However, miscommunication among the healthcare team, insufficient information exchange, inadequate discharge planning, poor social support and lack of care coordination prevented smooth hospital-to-home transition leading to a crisis at home.

Conclusions: The experiences of healthcare providers, patients and caregivers during stroke transitional care in Tanzania highlight achievements and key areas for improvement. Hospital-to-home transition is often characterised by uncertainty and emotional strain, emphasising the need for effective communication, involving patients and caregivers in care, as well as coordinating transitional care to address medical and psychosocial needs of survivors and their caregivers during and after discharge.

Objective: This study aims to investigate whether oral fluoroquinolone use is associated with an increased risk of aortic and mitral valve regurgitation.

Design: A nationwide cohort study based on linked healthcare register data encompassing patient characteristics, prescription data and cases of aortic and mitral valve regurgitation.

Setting: Sweden, 2006-2018.

Participants: Study participants were adults aged 18-75 years. 794 588 courses of fluoroquinolones (88% ciprofloxacin) propensity score-matched (1:1) to an equal number of courses of penicillin V.

Main outcome measures: Aortic or mitral valve regurgitation leading to ED visit, hospitalisation or death. Cox regression was used to estimate HRs for the first incident of valve regurgitation within 120 days of treatment initiation. Subgroup and supplementary analyses included sex, age, first episode, surgery or death only, 356-day follow-up and analysis using amoxicillin as comparator drug.

Results: There were 29 (incidence rate 0.5 per 1000 person-years) cases in the fluoroquinolone group compared with 43 (0.7 per 1000 person-years) cases in the penicillin V group during the main (1-30 days) follow-up period; corresponding to a HR 0.70 (95% CI 0.43 to 1.11). Analyses of subsequent time periods yielded results consistent with the main period: HR 1.06 (0.63-1.78) for days 31-60 and 0.90 (0.59-1.36) days 61-120. No significant differences were found in any of the subgroup- or supplementary analyses. The absolute risk difference was -17 (95% CI -33 to 6) cases of valve regurgitation per 1 000 000 courses of fluoroquinolones.

Conclusion: In a nationwide cohort study, there was no statistical support for an increase in the risk of mitral or aortic valve regurgitation associated with oral fluoroquinolone use.