The United Nations (UN) Sustainable Development Goal 6 seeks to ensure universal access to safe drinking water by 2030, but vast inequities in access exist, especially among vulnerable communities including limited resource, rural, disaster-affected areas. Flood disasters, exacerbated by the climate crisis, hinder the ability of individuals and families to meet essential drinking water needs and increase their susceptibility to waterborne illnesses. Point-of-use (POU) water treatment is an effective solution for water-insecure populations during and immediately following flood emergencies. However, an initial literature search identified knowledge gaps surrounding implementation of POU water systems. This scoping review aims to synthesise published evidence between January 2015 and July 2025 on barriers and facilitators to utilisation of POU water treatment systems during and immediately following flood-related disasters. The findings will inform efforts to promote resilience and agency among water insecure communities, specifically by equipping them with actionable knowledge on sustainable access to safe drinking water.

This scoping review will be guided by the work of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Search terms will be identified through an iterative process using the PICOT method and Boolean logic. Four databases—Scopus, PubMed, Web of Science and Google Scholar—with the addition of grey literature from UN agencies and non-governmental organisations focused on water-related issues will be searched. Two independent reviewers will apply a priori eligibility criteria to select studies. Conflicts will be resolved through discussion and a third independent reviewer absent agreement between the first two reviewers. Cohen’s kappa statistic will be calculated to assess inter-rater reliability. Data extraction will be guided by predefined data points, and the Consolidated Framework for Implementation Research will guide evidence synthesis through a solution-based approach.

Institutional research ethics review is not required because no human subjects are involved. Findings will be disseminated through a peer-reviewed publication, a policy brief, conference presentations and infographics for use by organisations serving flood disaster impacted communities.

This study aimed to assess health-related quality of life (HRQoL) and identify associated factors among patients with chronic obstructive pulmonary disease (COPD) attending selected hospitals in Addis Ababa, Ethiopia.

A hospital-based multicentre cross-sectional study was conducted among 205 patients with COPD attending the chest clinics of selected hospitals in Addis Ababa, Ethiopia, from June 2023 to December 2023.

A total of 205 patients with COPD who had follow-up at outpatient departments of the chest clinic of the selected hospitals were included in the study.

The main outcome of this study was HRQoL, which was assessed using the validated COPD Assessment Test-Amharic version (CAT-Am). Data analysis was performed using Stata version.17, and multivariable linear regression was employed to examine the relationship between HRQoL and independent variables. Variables with p-values

The mean score of the overall CAT-Am was 20.24±8.13. Older age (β=0.11, 95% CI: 0.04 to 0.17), poor social support (β=2.49, 95% CI: 0.74 to 4.24), biomass fuel exposure (β=4.57, 95% CI:3.17 to 5.97), Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages 2, 3 and 4 (β=2.12, 95% CI: 0.23 to 4.01; β=3.38, 95% CI: 1.11 to 5.66; β=5.20, 95% CI: 2.37 to 8.05, respectively), presence of comorbidity (β=4.03, 95% CI: 2.48 to 5.59), increased number of hospitalisations in the past year (β=2.78, 95% CI: 1.68 to 3.88), increased number of prescribed medications (β=0.40, 95% CI: 0.10 to 0.70), low medication adherence (β=2.79, 95% CI: 1.13 to 4.46), and moderate medication adherence (β=3.38, 95% CI: 1.65 to 5.11) were negatively associated with HRQoL.

In this study, patients with COPD had poor HRQoL, which indicates that patients need multidisciplinary interventions. Older age, poor social support, an increased number of prescribed medications, an increased number of hospitalisations in the past year, biomass fuel exposure, low and moderate medication adherence, GOLD severity stages 2, 3 and 4, and the presence of comorbidities require close follow-up to improve HRQoL. Further research should evaluate targeted strategies to address these determinants.

To evaluate the value of linked electronic health records (EHRs) for measuring stroke care quality in England before and after the COVID-19 pandemic, focusing on metrics not routinely captured: stroke incidence, dispensing of secondary prevention medications and a proxy of disability—time spent at home after stroke (‘home-time’).

Prospective cohort study using national linked datasets.

England-wide health data linkage including the Sentinel Stroke National Audit Programme (SSNAP), primary and secondary care, dispensed medications and mortality records, accessed via National Health Service (NHS) England’s Secure Data Environment.

425 675 adults with a first stroke between 1 January 2020 and 31 December 2023; data were available for 304 210 in primary care, 279 825 in hospital admissions, 220 470 in SSNAP and 59 465 in death records.

Annual stroke incidence; first-year medication dispensing rates for antiplatelets, anticoagulants, antihypertensives and lipid-lowering agents (with a 1-month washout period) and home-time at 180 days post stroke.

Stroke ascertainment was highest when combining all sources, with 10.8% of non-fatal ischaemic strokes recorded exclusively in primary care and 19.4% of fatal strokes identified solely through death records. Standardised annual stroke incidence rose from 227.6 (95% CI 226.1 to 229.0) to 244.8 (95% CI 243.4 to 246.3) per 100 000 over the study period including the COVID-19 pandemic. During the COVID-19 lockdown, non-fatal stroke recordings decreased while stroke-related deaths rose, indicating that recording quality was sensitive to shifts in healthcare-seeking behaviour during the pandemic. Among people with ischaemic stroke, 89.1% received an antiplatelet or anticoagulant, 44.5% an antihypertensive and 80.5% a lipid-lowering therapy. For haemorrhagic stroke, these proportions were: for anticoagulants 13.5%, antiplatelets 13.2%, antihypertensives 46.6% and lipid lowering 41.1%. Medication dispensing for stroke prevention declined with increasing age and comorbidity, but varied little by ethnicity, region or pandemic period. Mean home-time within 180 days of stroke was 166.6 (95% CI 166.4 to 166) days, decreasing with greater age (141.4 days for 90 years or older (95% CI 140.7 to 142.1)), deprivation (166.4 days (95% CI 166.1 to 166.6) for most deprived quintile) and stroke severity (137.4 days for National Institutes of Health Stroke Scale (NIHSS) score on arrival over 22 (95% CI 135.8 to 139.1)) and increasing with years from the COVID-19 pandemic 2023 (169.3 days (95% CI 169.0 to 169.5) vs 2020 164.4 days (95% CI 164.1 to 164.7)).

Standardised stroke incidence increased significantly over the study period, highlighting a growing public health burden that persisted despite disruptions due to the pandemic although variation in case ascertainment and stroke coding practices was observed. While secondary prevention coverage for antiplatelets and lipids was high, lower rates of dispensing of antihypertensives, particularly in older and comorbid populations, potentially signal a target for improvement. Home-time represents a sensitive, person-centred outcome that exposes disparities linked to socioeconomic deprivation and clinical severity that can be used to enhance routine stroke audits. These findings justify the expansion of linked EHR infrastructure and the modernisation of governance frameworks to enable the longitudinal evaluation of care quality beyond the COVID-19 era.

For priority populations, such as Indigenous children, school-based screening programmes can increase equitable access to care. However, current traditional economic measures evaluating the effectiveness of many screening programmes in Australia do not capture the value perceived by those at the intersection of the benefits, including children and families, communities, health workers and teachers or the differences between Western-Anglo and Indigenous conceptualisations of health. This mixed-methods study aims to develop and validate a Community Reported Outcome Measure (CROM) of school health screening programmes based on concepts of value of health and healthcare and school screening programmes from the perspective of Indigenous peoples. The purpose of the tool is to provide a robustly developed and validated tool to assess the experiences of school health screening programmes from the perspective of Indigenous stakeholders including families, communities, health workers and teachers.

This mixed-methods study will be conducted in three stages in accordance with regulatory and international consensus guidance: (1) concept elicitation to construct a conceptual framework of value in school screening; (2) item generation and mapping to the conceptual framework and (3) a psychometric evaluation of the CROM. Phase 1 concept elicitation: this involves an umbrella review (phase 1.1); yarning circles with communities in New South Wales (phase 1.2); concept integration of the umbrella review and yarning circles data (phase 1.3) and an online e-Delphi study to ensure the framework of value is nationally representative (phase 1.4). Phase 2 item generation and mapping: this involves item generation (phase 2.1) and cognitive testing of the item pool (phase 2.2). Phase 3 psychometric evaluation: this involves field testing (phase 3.1) and assessing the structural validity of the CROM via Rasch analysis (phase 3.2).

This study was reviewed and approved by the Australian Institute of Aboriginal and Torres Strait Islander Studies (Ref: REC-0397) and State Education Research and Partnerships (Ref: SERAP 6500). The results of this study will be presented at relevant academic and non-scientific conferences and meetings and published in high-impact peer-reviewed journals.

Primary hyperparathyroidism (PHPT) increases the risk of renal stones and progressive renal dysfunction. Parathyroidectomy is recommended for patients with renal involvement, yet whether surgery improves renal outcomes compared with non-surgical management remains unclear. Prior reviews have focused mainly on biochemical or skeletal outcomes, included few renal events and largely predate recent large cohort studies using contemporary methods to evaluate renal stones, chronic kidney disease (CKD) progression and long-term estimated glomerular filtration rate (eGFR) decline. A contemporary renal-focused synthesis is needed to clarify the true renal benefits of parathyroidectomy. We aim to evaluate the effect of parathyroidectomy versus non-surgical management on renal stones and broader renal outcomes in adults with PHPT.

This Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P)-aligned protocol describes a systematic review and meta-analysis comparing parathyroidectomy with non-surgical management in adults (≥18 years) with PHPT. MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials will be searched from inception to 5 November 2025. Eligible studies include randomised trials, non-randomised interventional studies and observational comparative designs. Studies without a comparator, those focused exclusively on secondary or normocalcaemic hyperparathyroidism and case reports or series will be excluded. Primary outcomes are renal stones and renal functional outcomes (eg, CKD progression, ≥30% decline in eGFR, dialysis initiation). Secondary outcomes include health-related quality of life and adverse events. Two reviewers will independently screen records, extract data and assess risk of bias (Cochrane Risk-of-Bias 2 and Risk Of Bias In Non-randomised Studies of Interventions). Random-effects models will be used where appropriate, and heterogeneity assessed using I². Publication bias will be assessed using appropriate quantitative or qualitative methods based on the available evidence.

Ethics approval is not required as only published data will be used. Findings will be disseminated through peer-reviewed publication and conference presentations.

CRD420251240480.

To study the association between job demands and distress among working adults and to test whether perceived supervisor support moderates this relationship.

Mixed-effects analysis of repeated measures from a population-based cohort study, estimating overall (combined within-person and between-person) associations.

The Netherlands Longitudinal Study on Hearing (NL-SH), an ongoing Dutch cohort with nationwide recruitment and follow-up including four measurement waves.

A total of 989 employed individuals (≥12 hours/week) with 1858 observations had complete data on distress, job demands, supervisor support and covariates.

The dependent variable was distress, measured using the 16-item distress subscale (range 0–32) of the Four-Dimensional Symptom Questionnaire. Job demands and supervisor support were assessed with subscales from the Job Content Questionnaire. Multilevel linear models were used to estimate main and interaction effects, adjusted for age, sex, educational level, hearing impairment, contract type and chronic diseases.

Higher job demands were associated with greater distress (B=0.22, 95% CI (0.17 to 0.27)). Higher supervisor support was associated with lower distress (B=–0.26, 95% CI (–0.38 to –0.15)). The interaction between job demands and supervisor support was statistically significant (B=-0.02, 95% CI (-0.04 to 0.001), p=0.042). Stratified analyses showed that the association between job demands and distress was stronger among employees with low supervisor support (B=0.27, p

Job demands and supervisor support were independently associated with distress. Supervisor support appeared to buffer the impact of job demands, as the association between job demands and distress was stronger among employees reporting low levels of supervisor support. These findings underscore the importance of strengthening supportive supervisor practices, alongside addressing excessive job demands, as integral components of workplace mental health strategies.

A resurgent methamphetamine epidemic is a major driver of HIV incidence in the USA. Although daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition, its effectiveness depends on achieving and maintaining prevention-effective adherence (ie, four or more doses per week). Digital health interventions offer a scalable method to extend the reach of behavioural approaches to HIV prevention, but evidence of their efficacy in improving objectively measured adherence remains limited. Addressing this gap is critical to maximising the clinical and public health benefits of PrEP.

From 26 January 2022 through 17 January 2025, this single-blind, parallel-group randomised controlled trial (RCT) enrolled 239 men taking PrEP who reported problematic stimulant use and who resided in California or Florida. Participants were randomised to receive five individually delivered telehealth sessions of a positive psychological intervention (n=119) or an attention-control condition (n=120), both delivered alongside remote contingency management for directly observed PrEP doses using the Spotlight mobile health application. Participants received US$20 per session and up to US$360 for uploading videos of at least four PrEP doses per week over 3 months. Follow-up assessments at 3, 6 and 12 months included surveys and dried blood spot specimens to quantify tenofovir diphosphate (TFV-DP). The primary outcome is biobehavioural HIV acquisition risk, defined as any recent condomless anal sex in the absence of TFV-DP concentrations consistent with prevention-effective adherence.

This RCT was approved by the University of Miami Institutional Review Board and registered prior to initiation of enrolment. Analyses of primary and secondary outcomes using intent-to-treat principles will be conducted after the completion of TFV-DP assays in June 2026, with results disseminated shortly thereafter through peer-reviewed publications.

This RCT was registered on www.clinicaltrials.gov (NCT04899024) prior to launching enrolment.

While improvements have been made across the HIV care continuum in South Africa, gaps remain. Relationship-focused couples-based approaches may be one avenue to improve HIV-related outcomes for men and women. Prior couples-based studies have been found to improve several HIV care and treatment outcomes in this context, but few have considered viral suppression as the primary outcome. We aimed to compare a couples-based motivational-interviewing intervention delivered to couples to similar content delivered to men and women in couples separately. We will test the efficacy of this approach in a randomised controlled trial.

Our goal is to enrol 270 heterosexual couples for this trial, with at least one partner living with HIV. Couples will be randomised into one of two arms, stratified by couples’ HIV status. The intervention arm, Simunye (‘We are one’ in isiZulu), will provide two sessions of motivational information and skills regarding HIV-related behaviours to couples together, along with relationship-focused content and skills. The content is based on Partner Steps (P-steps), a couples-focused adaptation of Life Steps, an evidence-based programme shown to improve adherence and viral suppression. The control group will receive two sessions as individuals, with similar HIV-related information but without relationship-focused content. Participants will be followed up at 6, 12 and 18 months postrandomisation. The baseline questionnaire will include measures of relationship domains such as satisfaction and communication, and measures pertaining to HIV and reproductive health (eg, fertility intentions, HIV knowledge and risk perception, and sexual behaviour), and mental health (eg, depression symptoms). The primary outcome is viral suppression, based on dried blood spots. Secondary outcomes will include other aspects of treatment engagement. We will also examine hypothesised mediators of intervention participation, for example, relationship dynamics. Primary analyses will use a multilevel modelling approach, which will feature planned time-averaged comparisons of postbaseline measurements across the intervention and control groups to test the primary hypothesis. The analysis will account for the dyadic nature of the data, for example, participants nested within couples.

This trial was approved by the Institutional Review Board (IRB) at the Human Sciences Research Council in South Africa, protocol number 2/27/01/21, and the IRB at the University of Michigan (HUM 00203672). Human subjects’ concerns or adverse events will be reported to both IRBs and the Data Safety and Monitoring Board. We will disseminate findings to community members and stakeholders via community meetings, as well as by conference presentations and publications in peer-reviewed journals.

Clinicaltrials.gov Protocol Registration NCT05231707 registered on 8 February 2022. Protocol version 2.0, 31 October 2025.

Environmental enteropathy (EE) is a syndrome affecting the gut characterised by villus blunting, reduced nutrient absorption and microbial translocation in children and adults experiencing a high burden of enteric infection due to inadequate access to clean water and sanitation.

We will conduct coordinated randomised controlled trials in six countries to determine if supplementation with indispensable amino acids (IAAs) can improve intestinal barrier dysfunction in six geographically diverse populations of 18–36 months old children with stunting or severe stunting. All trials will measure the same primary outcomes while secondary outcomes will be measured on a per-trial basis using standardised protocols across the project. The primary endpoint will be change in gut permeability as assessed by the lactulose/rhamnose ratio. Secondary endpoints include changes in amino acid and carbohydrate absorption using novel, isotope tracer tests. Other prespecified outcome measures include changes in EE biomarkers and child weight. IAA supplementation will be given daily for 28 days and evaluation of the major endpoints will be at baseline and after 28 days of supplementation.

Ethical approval will be obtained from the Research Ethics Committee at each participating site. Caregivers will provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and face-to-face meetings with participant caregivers.

CTRI: CTRI/2024/06/069187 (India); ClinicalTrials.gov (NCT06617130, Malawi; NCT06676215, Philippines and NCT07256028, Morocco); Ongoing (Zambia); Ongoing (Morocco); PACTR: (PACTR202311714091884, Ghana).

Trichomonas vaginalis is estimated to be the most common non-viral sexually transmitted infection (STI) worldwide with 156 million new cases each year. In 2021, the United States Centres for Disease Control and Prevention (CDC) updated their STI Treatment Guidelines to recommend multi-dose oral metronidazole (MTZ) for all T. vaginalis-infected women. Although multi-dose oral MTZ 500 mg twice daily was found to be superior to single-dose 2 g oral MTZ in multiple trials in women, multi-dose oral MTZ still had unacceptably high rates of breakthrough infection (9%–11%) at test-of-cure. With approximately 156 million cases of T. vaginalis worldwide per year, over 17 million persons per year are estimated to be insufficiently treated with multi-dose oral MTZ. Moreover, past trials only included women, and single-dose 2 g oral MTZ remains the recommended treatment for men. Thus, there is a critical need to further refine T. vaginalis treatment in women and men. A single dose of 2 g of oral secnidazole (SEC), a next generation 5-nitroimidazole with a longer half-life than oral MTZ and improved tolerability, may be a good option. This study will examine the effectiveness of multi-dose oral MTZ versus single-dose oral SEC in both men and women infected with T. vaginalis.

This is a multi-centred open-label effectiveness trial comparing oral multi-dose MTZ (500 mg twice daily for 7 days) to 2 g of single-dose oral SEC. This trial aims to enrol 1200 T. vaginalis-infected women and men aged 18 years and older at four clinical sites: the University of Alabama at Birmingham (UAB) Sexual Health Clinic and the UAB Gynaecology Clinics in Birmingham, AL, LSU-CrescentCare Sexual Health Centre (LSUHSC-NO) in New Orleans, LA, and HealthCare Clinical Data, Inc. in Miami, FL. Those who are pregnant/lactating, have been treated with a 5-nitroimidazole within the last 28 days, used intra-vaginal boric acid or any other intra-vaginal treatment for T. vaginalis within the last 14 days, have a history of a type 1 hypersensitivity reaction to 5-nitroimidazoles, are taking phenytoin and/or warfarin, use any medications which may alter the metabolism of oral MTZ, or have previously been enrolled will be excluded from the study. Participants will be randomised in a 1:1 fashion to either multi-dose oral MTZ or single-dose oral SEC. A test-of-cure (TOC) visit will be performed 4 weeks after completion of treatment (window 1 week before and 2 weeks after scheduled TOC visit).

This protocol is approved through a single Institutional Review Board (IRB) mechanism by the Tulane Human Research Protection Programme (Protocol # 2024–101 SPHTM). External relying sites are the UAB IRB (including both the UAB Sexual Health Research Clinic and Gynaecology Clinics; Protocol ID IRB-300012617), the LSUHSC-NO IRB (LSU-CrescentCare Sexual Health Centre; Protocol ID 6979) and the Advarra IRB (Healthcare Clinical Data Inc; Protocol ID Pro00085531). This study is also approved for referral purposes only by the Research Review Committee at the Jefferson County Department of Health (JCDH) Sexual Health Clinic in Birmingham, AL (JCDH Research Number 2024–03). Study findings will be presented in scientific conferences and peer-reviewed journals, shared with treatment advisory boards, as well as disseminated to providers and patients in communities of interest. The study Data Safety and Monitoring Board (DSMB) will meet twice a year to review patient safety data and study progress and provide recommendations on the study’s continuation or modification.

NCT06261840.

Overweight and obesity are a growing global public health problem. Eating behaviours of adults and children are largely influenced by the home food environment (HFE). The lack of access to nutritious food in homes contributes to unhealthy dietary habits and, consequently, overweight and obesity among adults and children, as well as chronic diseases associated with poor diets. The present systematic review aims to identify existing HFE and household food security interventions and to determine the effects of these interventions in improving the availability of healthy food in the home, household access to food, diet quality and nutritional status of adults.

This systematic review protocol was developed according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis protocols guidelines. Electronic databases including PubMed, Web of Science, Scopus, Science Direct and CINAHL (EBSCOhost) will be searched for relevant articles using keywords and MeSH terms. Risk of bias will be assessed using the adapted Cochrane effective practice and organisation of Care risk of bias tool for studies with a separate control group and Risk of Bias in non-randomised studies of interventions. The overall strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation tool. Two reviewers will independently screen the identified records and assess the eligible full texts for inclusion. Any discrepancies will be resolved through consensus or consultation with a third reviewer. Where sufficient homogeneous data are available, subgroup analysis will be conducted to explore heterogeneity. A thematic synthesis will be performed for qualitative studies.

This study has a systematic review and meta-analysis design, which will assess published data and does not require ethical approval. Findings of the systematic review will be disseminated through peer-reviewed publications and conference presentations.

CRD420251030896.

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

Guided parent-delivered cognitive behavioural therapy (GPD-CBT) is an evidence-based, low-burden treatment programme for childhood anxiety disorders with demonstrated efficacy, cost-effectiveness and accessibility. However, it has been tested primarily in Western countries, and the efficacy and cost-effectiveness have not been evaluated in Japanese families. The current study aims to examine GPD-CBT’s efficacy and cost-effectiveness in Japanese samples and explore potential cultural adaptations of the programme.

This study is designed as a Bayesian single-blind randomised controlled trial with two parallel groups: GPD-CBT (intervention group) and a waitlist control group. The primary outcome is remission of primary anxiety disorders evaluated through diagnostic interviews by independent evaluators. Secondary outcomes include child and parent-reported child anxiety symptoms, depressive symptoms and life interference. Additionally, measures of parental psychological characteristics, programme acceptability and quality of life are collected. We will conduct qualitative interviews with parents who participated in the programme and therapists who delivered the intervention to explore potential cultural adaptations. We aim to recruit 54–170 families, depending on the results of sequential Bayesian analyses. GPD-CBT consists of seven weekly 20 min sessions and a 1-month follow-up session. Assessments will be conducted at baseline, 13 weeks post randomisation (primary endpoint for between-group comparison), with an additional 25 weeks post randomisation. The waitlist control group will receive GPD-CBT after the 13-week assessment.

This study has been approved by the Ethics Review Committees of Chiba University and the University of Tokyo. We will disseminate results through academic conference presentations and peer-reviewed journal publications. If the GPD-CBT intervention proves efficacious, we will promote wider implementation in Japan through the development of training programmes for mental health professionals and key stakeholders.

jRCT1032250421 (https://jrct.mhlw.go.jp/latest-detail/jRCT1032250421) and jRCT1030250422 (https://jrct.mhlw.go.jp/latest-detail/jRCT1030250422) registered on 9 October 2025.

Cerebral amyloid angiopathy (CAA) is caused by the accumulation of amyloid-beta (Aβ) in the cerebrovasculature. The glymphatic system is thought to be involved in the clearance of cerebral waste products, including Aβ. Stimulation of the glymphatic system through enhancing deep sleep with low-sodium oxybate (LXB) or inhibition of cortical spreading depolarisations via non-invasive vagus nerve stimulation (nVNS) could potentially increase clearance of Aβ and hence improve disease course.

We will perform a pre-post trial to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 participants, 30 with sporadic CAA and 30 with Dutch-type CAA, will be randomly assigned to receive either LXB, nVNS or both interventions, resulting in three groups (20 in each group: LXB, nVNS and both). The study spans 6 months, comprising a 3-month observational phase and a 3-month intervention phase. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. We will assess possible disease progression with (non-)haemorrhagic imaging markers on 7-Tesla MRI at baseline, before and after intervention, as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed with CSF-Selective T2-weighted Readout with Acceleration and Mobility encoding (CSF-STREAM) on 7-Tesla MRI.

The study was reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft (P23.100) on 8 April 2024. The first participant was enrolled on 27 March 2025. Study results will be published in peer-reviewed journals and presented at scientific conferences. Additionally, study updates and results will be shared with participants via our newsletter twice a year.

EU CT number 2023–5 06 128-10-00, Universal Trial Number U1111-1295-1113, ClinicalTrials.gov NCT06421532.

The digital transformation of healthcare has created an urgent need for primary care physicians (PCPs) to acquire competencies in digital health. However, the structure and scope of postgraduate training programmes remain poorly defined and unevenly implemented worldwide, and no scoping review has yet synthesised the evidence. This review aims to map existing postgraduate digital health training programmes for PCPs, including their content, structure and delivery approaches.

This scoping review will follow the Joanna Briggs Institute methodology and adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A systematic search will be conducted across five databases (PubMed, Scopus, Cochrane Library, ScienceDirect and Web of Science) and relevant grey literature, covering publications from January 2019 to June 2025. Studies describing postgraduate digital health training programmes for PCPs will be eligible for inclusion. Data will be extracted and synthesised descriptively and thematically using an inductive approach.

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through a peer-reviewed publication and conference presentations and will inform future curriculum development and policy in digital health education for PCPs. The results may also inform national curriculum reforms and accreditation standards, supporting more consistent and competency-based digital health education globally.

This scoping review protocol has been registered with the Open Science Framework.

To qualitatively explore patients’ lived experiences and coping mechanisms following mitral valve replacement (MVR) at the National Cardiac Institute in Tanzania.

A descriptive qualitative study using in-depth interviews and thematic analysis.

The study was conducted at the National Cardiac Institute, located in Dar es Salaam, the sole tertiary cardiac centre in Tanzania offering open-heart surgery.

17 participants were purposively sampled. Inclusion criteria were as follows: patients aged ≥18 years, had at least 28 days post-MVR, without chronic conditions (eg, diabetes and HIV) and attending postoperative cardiac clinics.

Semi-structured interviews conducted in May 2024 using an interviewer guide explored post-MVR challenges, daily life adjustments, patient-provider interactions and coping strategies. Thematic analysis was employed to identify key themes.

Three primary themes emerged: (1) Quality of life after MVR, encompassing physical, social, economic and psychological challenges; (2) Quality of care after MVR, highlighting patient-provider interactions and access to services; and (3) Adapting to post-MVR life, including psychological adaptation and lifestyle modification. Participants reported improved quality of life through shared experiences and support.

Patients experienced physical, socio-economic and psychological challenges post-MVR. However, quality of life improved through access to care, peer support and adaptive coping. Adaptation to life with an artificial valve is feasible with robust support systems, even in resource-limited settings.

The first objective was to establish the feasibility of conducting a definitive trial to evaluate the effectiveness of mobility and strength training with or without protein supplements for pre-frail/frail older people with low protein intake. The second objective was to finalise outcome measures for a definitive trial.

Multicentre feasibility randomised controlled trial.

Four National Health Service (NHS) community trust physiotherapy departments. We recruited via clinical caseloads, an existing cohort study and community advertising. Participants were adults aged ≥60 years, frail or pre-frail, reporting walking difficulties or slow walking and low protein intake (

All participants undertook two times a week mobility and strength training supported by a physiotherapist for 24 weeks. Half of the participants were randomised (1:1) to receive 24 weeks of daily protein supplements to increase protein intake up to 1.6 g/kgBW/day.

Feasibility outcomes assessed recruitment, intervention fidelity, adherence, tolerance and study retention.

We assessed clinical data collection at baseline and 5–8 month follow-up including the short physical performance battery (SPPB), 6 min walk test (6MWT) and participant-reported outcomes. Outcome assessors were blinded.

All participants were analysed in the groups as randomised provided they were not withdrawn from the study before their treatment started and contributed outcome data (modified intention to treat). Our primary feasibility and secondary outcome measures were summarised using descriptive statistics such as mean and SD, median and IQR or counts with percentages. Secondary objectives were exploratory, and mean between group differences at follow-up were estimated for each continuous outcome using linear regression models adjusted for baseline outcome score and frailty status, and presented with associated 95% CIs.

Initially, recruitment focused on existing caseloads, but patients were more unwell and disabled than anticipated and ineligible. No participants were recruited from the cohort. A community recruitment strategy was implemented. We screened 952 older adults and 20 participants were randomised. We ran out of time to reach our target.

We achieved good intervention fidelity for both interventions. The median number of exercise sessions completed was 10.5/16 (IQR 7–13). Six participants received supplements which they tolerated well and took regularly. 14 participants (70%) attended follow-up assessments with no difference in retention between arms.

The median age of participants was 76 years (IQR 68.5–80.0) and 15/20 (75%) were frail. All clinical outcomes showed a trend towards larger improvements in the exercise and protein arm, but these were not statistically significant. For example, SPPB scores (mean difference 0.93, 95% CI (–2.70 to 4.56)) and 6MWT (mean difference 41.92 m, 95% CI (–39.05 to 122.89)) were both higher in the exercise and protein arm compared to control.

The study was not feasible based on the original protocol. Recruitment was the biggest challenge. We established a more efficient route to recruitment (community advertising) which requires further refinement. Clinical outcomes consistently favoured the exercise and protein group, which should be interpreted cautiously but suggest this question is worthy of further investigation.

ISRCTN30405954.

To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.

Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.

SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.

We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.

From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.

Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.

Pay-for-performance (P4P) programmes are increasingly implemented in healthcare to improve quality of care, but their application in dentistry remains limited. Evidence-based approaches are needed to guide incentive design in value-based dental care, particularly for preventive services, such as topical fluoride application in children. We sought to assess the potential cost-effectiveness of P4P incentives for increasing topical fluoride application among children and to illustrate how simulation modelling can identify conditions under which subgroup-specific incentive levels may be optimal.

We developed and validated a decision-analytic microsimulation model using nationally representative data from the National Health and Nutrition Examination Survey (NHANES 2011–2016) to simulate a cohort of 100 000 US children aged 0–19 years over a 10-year period starting in 2024. The model incorporated heterogeneity in demographic and clinical characteristics to estimate changes in dental caries, quality-adjusted life years (QALYs) and healthcare costs under hypothetical P4P programmes that increased topical fluoride coverage by 2.5% to 50% relative to the baseline rate of 24.5%, with incentive amounts ranging from 2.5% to 50% of provider salary. Sensitivity analyses assessed robustness to variation in key parameters.

Cumulative incidence of dental caries, QALYs, total healthcare costs and incremental cost-effectiveness ratios (ICERs).

Across a broad range of incentive–coverage combinations, P4P incentives were generally cost-effective. For example, a 10% salary-based incentive linked to a 5% relative coverage increase reduced 186.3 cases of tooth decay and yielded 33.8 QALY gains per 10 000 children, resulting in an ICER of $8501 per QALY gained. The intervention was estimated to be cost-saving at coverage increases ≥27.5%. Subgroup analysis indicated larger absolute benefits among racial/ethnic minority children.

P4P incentives to increase topical fluoride application in children could be cost-effective, and potentially cost-saving, under certain conditions. Cost-effectiveness modelling can help define incentive–coverage combinations that are likely to promote both efficiency and equity. Empirical studies are needed to validate provider responsiveness and establish achievable benchmarks for programme design.

Prostate cancer diagnosis and treatment planning depend on accurate histopathological assessment of needle biopsies, particularly through the Gleason scoring system. The inherently subjective nature of the grading creates variability between pathologists, potentially resulting in suboptimal patient management decisions. These reproducibility challenges extend beyond Gleason scoring to encompass other critical diagnostic and prognostic markers, including cancer volume quantification and detection of cribriform morphology patterns and perineural invasion. Artificial intelligence (AI) applications in digital pathology have emerged as promising solutions for enhancing diagnostic consistency and accuracy, with recent research demonstrating that automated systems can match expert-level performance in prostate biopsy evaluation. Nevertheless, comprehensive validation studies have revealed concerning limitations in model generalisability when deployed across different clinical environments and patient populations. Recent systematic reviews revealed widespread risk-of-bias limitations and insufficient external validation in AI diagnostic studies, highlighting critical needs for accumulated evidence supporting generalisability before clinical implementation. Rigorous external validation with preregistered protocols using independent datasets from diverse clinical settings remains essential to establish the reliability and safety of AI-assisted prostate pathology systems.

This study protocol establishes a framework for the retrospective external validation of an AI system developed for prostate biopsy assessment, to be conducted on the case-control samples of the National Prostate Cancer Register of Sweden, ProMort study (1998-2015). The primary aim is to evaluate the AI model’s diagnostic accuracy and Gleason grading performance using completely independent datasets separate from any model development or previously used validation cohorts. The diversity of the validation samples, spanning multiple geographic regions, temporal collection periods and reference standards, allows evaluation of model robustness across varied clinical contexts. Secondary aims encompass evaluating AI performance in cancer length estimation and detection of cribriform patterns and perineural invasion. This protocol delineates procedures for data collection, reference standard clarification and prespecified statistical analyses, ensuring comprehensive validation and reliable performance assessment. The study design conforms to established reporting guidelines Checklist for Artificial Intelligence in Medical Imaging (CLAIM) and Standards for Reporting Diagnostic Accuracy Studies using Artificial Intelligence (STARD-AI), and recognised best practices for AI validation in medical imaging.

Data collection and usage were approved by the Swedish Regional Ethics Review Board and the Swedish Ethical Review Authority (permits 2012/1586-31/1, 2016/613-31/2, 2019-01395, 2019-05220). The study adheres to the Declaration of Helsinki principles, and findings will be made available in open access peer-reviewed publications.