Glenohumeral subluxation (GHS) is a common rehabilitation challenge in the hemiplegic upper limb following stroke, potentially leading to shoulder pain, secondary brachial plexus injury and various other complications. While electrical stimulation therapies, such as electromyography biofeedback, electroacupuncture and neuromuscular electrical stimulation, have shown promise in managing GHS, some controversy remains. Although clinical trials and meta-analyses have confirmed the efficacy of these therapies, healthcare professionals have yet to reach a consensus on which specific therapy is most effective for reducing shoulder subluxation (SS), alleviating pain and improving quality of life. This study will perform a network meta-analysis to compare the relative efficacy of different electrical stimulation therapies for treating GHS in patients following acute stroke.

We will systematically search the following databases: PubMed, MEDLINE, Embase, Cochrane Library, Web of Science, Chinese biomedical literature database (SinoMed), Wanfang databases (Wanfang), VIP Journal Integration Platform (VIP) and China National Knowledge Infrastructure (CNKI). Our search will cover the period from the inception of each database until 14 April 2025, and will be restricted to studies published in Chinese or English. The primary outcomes of interest will be the degree of improvement in SS, improvements in quality of life and reductions in pain. We will conduct pairwise meta-analyses using RevMan V.5.3 (The Cochrane Collaboration, Copenhagen, Denmark), and network meta-analyses using ADDIS V.1.16.6 (Drugis, Groningen, The Netherlands) and Stata V.16.0 (StataCorp, College Station, Texas, USA) to compare the relative efficacy of different electrical stimulation therapies. Screening, data extraction, risk of bias assessment and evaluation of the certainty of evidence will all be performed independently by two reviewers to ensure accuracy and reliability. The risk of bias within individual studies will be assessed using the Cochrane Risk of Bias 2 (ROB 2) tool, and the certainty of evidence will be evaluated using the Grading of Recommendations Assessment, and Evaluation (GRADE) and Confidence in Network Meta-Analysis (CINeMA) frameworks to ensure transparency and methodological rigour.

Ethical approval is not required for this study. The findings will be submitted to a peer-reviewed journal or conference.

CRD42024541228.

To explore existing evidence for the provision of support for return to work (RTW) in long COVID (LC) patients and the barriers and facilitators to taking up this support.

A rapid review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The study was preregistered in PROSPERO (ID: CRD42023478126).

Searches were completed in June 2024 across major databases including MEDLINE, Embase, PsycINFO, evidence-based medicine reviews, Web of Science and Google Scholar.

Included studies focused on people with LC (PwLC) symptoms lasting over 12 weeks and addressed either: (1) non-workplace- or workplace-based support for RTW and/or (2) barriers and facilitators to RTW in this population.

A quality assessment was conducted using the JBI Systematic Reviews critical appraisal tool. The data were summarised in tabular format and a narrative synthesis.

Twenty-five studies were included. While many studies demonstrated rigorous methodologies and low risk of bias levels, some had high and medium risk levels. Non-workplace-based support was mostly measured quantitatively and included interdisciplinary healthcare programmes, clinical interventions and rehabilitation programmes focusing on pacing and breathing strategies. Compensation and insurance schemes were important funders of these interventions.

Workplace-based support was mostly measured qualitatively. Barriers to the provision of support at organisational level included lack of understanding of LC symptoms, insufficient workplace guidance and educational gaps among managers. Individual barriers included threat of income loss, remote working and disconnection from the workplace. Facilitators for support included recognition and validation of LC and its symptoms, and eligibility for disability benefits associated with work.

RTW is an important outcome of health-related absence and should be systematically recorded in studies of PwLC. The heterogeneity and unpredictability of LC symptoms create challenges for supporting working age populations. Further research is crucial to better understand the specific RTW needs for PwLC and address potential barriers and facilitators to workplace-based support, particularly through interventions, organisational practices and employ-led policies that enable sustained RTW. Consistent guidelines on LC’s definition and disability status may facilitate the provision of support and the development of interventions.

CRD42023478126.

Suicide has a substantial economic burden, yet in low- or middle-income countries, the analysis is constrained by the absence of disaggregated economic data. Existing studies primarily rely on gross costing methods, overlooking sector-specific costs such as healthcare, law enforcement and productivity losses at the family and community levels. Furthermore, the societal perspective, essential for understanding the multifaceted economic impacts of suicide, remains insufficiently explored in the Indian context.

This study will quantify the economic burden of suicide and suicide attempts in India. The initial phase will involve developing a resource-use measure instrument to capture the societal costs associated with suicide. Subsequently, a retrospective, incidence-based study will be conducted in India using the developed instrument. This will also be complemented with the Health-Related Quality of Life Assessment using EuroQOL (EQ-5D-5L). Exploratory subgroup cost comparisons (eg, suicide methods, healthcare facility type) will use non-parametric tests, including the Mann–Whitney U and Kruskal–Wallis tests. Generalised linear mixed models (gamma distribution and log link) will analyse longitudinal cost and HRQoL data, besides bootstrapping techniques and sensitivity analyses.

Ethics approval was obtained for the study from the institutional review board of the Indian Law Society (ILS/141/2024). All data collected during the study will adhere to ethical guidelines, taking informed consent. The findings of the study will be disseminated through peer-reviewed journals to aid data-driven decision-making.

Clinical Trial Registry of India (CTRI/2025/02/080380), date of registration: 12/02/2025.

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Multi-national cohort study using routinely collected electronic healthcare data

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

This study aims to develop a methodology to retrieve, harmonise and evaluate the completeness of national body mass index (BMI) data from linked electronic health record (EHR) sources to build a longitudinal research-ready data asset (RRDA).

A longitudinal study of BMI records spanning 23 years (1 January 2000 to 31 December 2022) from four data sources.

The national BMI RRDA is created within the Secure Anonymised Information Linkage (Databank), encompassing the entire population of Wales, UK.

We built a methodology that provides a reproducible framework for extracting and harmonising BMI data from four major linked EHRs across two age groups: children and young people (CYP; 2–18 years old) and adults (19 years and older). The methodology is adaptable across different trusted research environments. We evaluated the completeness and retention of records over 1-, 5- and 23-year periods by calculating the proportion of missing data relative to each year’s population.

We retrieved 53.4 million records for 3.2 million individuals across Wales from 1st January 2000 to 31 December 2022. Among these, 3% of CYP and 34% of adults had repeat BMI measurements recorded over periods ranging from 5 to 23 years. Throughout the entire population of Wales during this period, 49% of CYP and 26% of adults had at least one BMI reading recorded, resulting in a missingness rate of 51% for CYP and 74% for adults. Preserving BMI information by retaining the most recently recorded BMI over 1-, 5- and 23-year intervals from 2022 showed coverage rates of 10%, 33% and 68%, respectively, for CYP, and 25%, 51% and 73%, respectively, for adults.

Our findings highlight substantial variations in BMI data availability and retention across CYP and adults, as well as time periods within EHR in Wales. Wider adoption of this approach can enhance standardised approaches in using accessible measures like BMI to assess disease risk in population-based studies, strengthening public health initiatives and research efforts.

To investigate whether gestational diabetes mellitus (GDM) was associated with survival without bronchopulmonary dysplasia (BPD) in very preterm infants (VPIs).

Retrospective multicentre cohort study.

A total of 79 neonatal intensive care units across China, January 2019 to December 2021.

A total of 23 752 VPIs (

The primary outcomes are survival without BPD at 36 weeks’ postmenstrual age (PMA) and its components.

Infants exposed to GDM were associated with a higher rate of survival without BPD (aOR 1.12, 95% CI 1.04 to 1.21) at 36 weeks PMA and lower mortality (aOR 0.75, 95% CI 0.64 to 0.84) before 36 weeks PMA than unexposed infants. However, no significant association was observed between GDM and BPD at 36 weeks PMA (aOR 0.94, 95% CI 0.87 to 1.02), respiratory distress syndrome, need for advanced resuscitation or mechanical ventilation. After propensity score matching, GDM-exposed VPIs maintained higher survival without BPD (aOR 1.13, 95% CI 1.02 to 1.26) and lower mortality (aOR 0.81, 95% CI 0.68 to 0.97). These associations were strongest in infants born before 28 weeks (aOR 1.32, 95% CI 1.11 to 1.57) and those small for gestational age (aOR 1.41, 95% CI 1.11 to 1.80).

GDM was not associated with worsened BPD in VPIs. The positive association with survival and survival without BPD warrants could reflect a selection bias.

The increasing volume of radiological images and the associated workload of report generation necessitate efficient solutions, making artificial intelligence (AI) a crucial tool to streamline this process for radiologists. Recent years have seen a surge in research exploring AI-driven radiological report generation directly from images, particularly with the emergence of large vision language models. However, a comprehensive understanding of the current landscape, including specific limitations and the extent to which efforts move beyond abnormality detection to full textual report generation, remains unclear. This scoping review aims to systematically map the existing literature to provide an overview of the current state of AI in generating radiological reports from medical images, including the scope and limitations of existing research. To our knowledge, no prior scoping review has comprehensively mapped this landscape, especially considering recent advancements in foundation models in medicine and related AI architectures. Considering the explosive growth of related studies in recent years, a comprehensive scoping review will be significant in mapping the current research status and understanding relevant limitations.

This scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews guidelines to map the literature on AI generating radiological reports from medical images. We will search PubMed, Scopus and Web of Science for peer-reviewed articles (January 2016 to March 2025) using keywords related to AI, radiological reports and medical images. Original research in English focusing on AI-driven report generation from images will be included and studies without report generation or not using medical images as input will be excluded. Two independent reviewers will perform a two-stage screening. Data extraction, guided by the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies checklist and focusing on study characteristics, AI methods, image modalities, report features, limitations and key findings, will be analysed using narrative and descriptive synthesis, with results presented in tables, figures and a narrative summary.

This protocol describes a scoping literature review methodology that does not involve research on humans, animals or their data; therefore, no ethical approval is required. Following the review, the results will be considered for publication in a relevant peer-reviewed journal and may be shared with stakeholders through reports or summaries.

Anxiety and depression are among the top contributors to disability in the Kingdom of Saudi Arabia (KSA), but little is known about their economic impact. This study estimates the economic burden of moderate to severe symptoms of anxiety and depression among adults in KSA.

A cross-sectional survey was administered via a web panel. Participants were asked to fill out the Patient Health Questionnaire-4 (PHQ-4) for themselves and on behalf of other household members to capture prevalence rates. Those who reported at least moderate symptoms of anxiety or depression filled out a longer survey with questions on healthcare utilisation and productivity losses due to symptoms. These responses were monetised using prevalence rates and population estimates to calculate per-person and total annual costs.

Prevalence estimates are based on responses from 1164 participants on behalf of 3202 Saudi adults. Of these, 269 individuals with symptoms completed the longer survey.

Prevalence of anxiety and depression; healthcare utilisation (medications, outpatient, inpatient) and productivity losses due to absenteeism and presenteeism.

In total, 26.2% reported at least moderate symptoms consistent with anxiety and/or depression. Among those with symptoms, direct healthcare costs due to anxiety and depression averaged Saudi riyal (SAR) 3431.95 per person annually. Indirect costs via absenteeism and presenteeism averaged SAR 9702.87 and SAR 24 577.28 per person assuming that anxiety and/or depression episodes last for 6 months. Summing up the healthcare costs and productivity losses yields a total annual economic burden of SAR 163.3 billion. Absenteeism accounts for 24.8% of this total (SAR 40.5 billion), presenteeism accounts for 62.8% (SAR 102.5 billion) and healthcare resource utilisation accounts for 12.4%(SAR 20.3 billion).

The overall prevalence of anxiety and depression in KSA is estimated at 26.2%. The economic burden associated with these symptoms amounts to SAR 163.3 billion or 4.1% of GDP. Absenteeism and presenteeism costs account for the vast majority of the total, but a large percentage (nearly 60%) also report emergency department visits and unplanned hospital admissions. Evidence-based interventions should be considered to address the health and economic burden of these conditions in KSA.

Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.

POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.

748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm³, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm². When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).

Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.

As care needs increase in complexity, a shift to people-centred, integrated care is required to meet the full range of health and social care needs of clients. However, limited opportunities exist for care providers to develop interprofessional competencies as part of pre-licensing and/or continuing education. New learning models, such as case-based learning (CBL), that facilitate the development of interprofessional competencies and are aligned with practice realities of providers are needed. This scoping review will collate and codify leading practices and knowledge gaps in the development and delivery of CBL programmes in pre-licensing and continuing education for health and social care providers.

A scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. MEDLINE, CINAHL Plus, Scopus, ERIC Institute of Education Sciences, PsycINFO and Education Source will be searched for peer-reviewed literature; Google Scholar, ProQuest Dissertations and Web of Science will be searched for grey literature. Reference lists of full-text scholarly sources, key journals and authors will be searched manually. Study selection and extraction will be conducted by two independent reviewers. English sources published between 2014 and 2024 that discuss CBL epistemologies, characteristics, delivery mechanisms, programme limitations and/or programme evaluation in health and social care pre-licensing and/or professional training will be included. Data will be analysed using directed content analysis and synthesised as a narrative summary.

This scoping review protocol was reviewed by the Southlake Health Research Ethics Board and received ethics exemption. Findings will be disseminated through peer-reviewed publication, conferences, professional networks and social media, and used to inform the development of an evidence-based training programme for health and social care providers.

Open Science Framework https://doi.org/10.17605/OSF.IO/6YXHN

Mentalising, the capacity to understand behaviour via underlying mental states, is a key construct in psychopathology. While self-report instruments are widely used to assess mentalising, significant questions about their psychometric properties persist and no systematic review has comprehensively evaluated them using standardised criteria. This systematic review, guided by the COnsensus-based Standards for the selection of health Measurement Instruments () methodology, aims to: (1) identify all available self-report mentalising measures for adults; (2) evaluate the methodological quality of their validation studies; (3) synthesise and grade the quality of evidence on their measurement properties and (4) provide evidence-based recommendations for their use in research and clinical practice.

Five electronic databases (SCOPUS, Web of Science, PsycINFO, PubMed, ProQuest) will be searched from their inception, supplemented by a search of grey literature and reference lists. We will include studies of any design that report on at least one measurement property of a self-report measure of mentalising in adults. Two reviewers will independently screen all records, extract relevant data and assess the methodological quality of included studies using the COSMIN Risk of Bias checklist. For each instrument, the evidence for each measurement property will be synthesised, and the overall quality of the evidence will be graded using a modified Grading of Recommendations Assessment, Development and Evaluation approach.

As this systematic review will synthesise data from previously published studies, it does not require formal ethical approval. The findings will be disseminated through a peer-reviewed, open-access publication and presentations at scientific conferences. The results will provide a comprehensive inventory of available measures and a rigorous evaluation of their psychometric quality, creating an evidence base to guide clinicians and researchers in selecting the most appropriate instruments for mentalising assessment.

CRD420251031469.

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Observational study.

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

The functional cure of chronic hepatitis B (CHB) is an ideal goal of therapy, as it is associated with improved long-term outcomes. Patients with low levels of HBsAg have higher rates of functional cure by pegylated interferon α (PEG-IFNα) therapy, and similar results have been observed in patients treated with PD-1 antibody. However, the combination therapy of PD-1 antibody and PEG-IFNα for promoting functional cure has not been studied. This study protocol aims to evaluate the efficacy and safety of a novel combined strategy, PD-1 antibody combined with PEG-IFNα therapy, in nucleos(t)ide analogues (NAs)-treated CHB patients.

This is a prospective, multicentre, open-label, randomised controlled study. Virologically suppressed CHB patients by NAs therapy will be recruited and randomised into PEG-IFNα group, PD-1 antibody group or PD-1 antibody combined PEG-IFNα group. PD-1 antibody will be injected intravenously once per 3 weeks for 24 weeks, and PEG-IFNα will be injected subcutaneously once a week for 48 weeks. The primary outcomes are the rate of HBsAg loss at 24 weeks. For safety analysis, adverse events in different groups will be compared.

This study has been approved by the Ethics Committee of the Fifth Medical Center of the Chinese PLA General Hospital (KY-2023-12-86-3). All results of the study will be submitted to a peer-reviewed journal.

NCT06357806.

The North East of England has the lowest healthy life expectancy and the highest health inequalities of any region in England. The conventional model, whereby we ‘expect’ individuals to be motivated to attend a ‘healthcare setting’ to undergo cardiovascular disease (CVD) health checks every 5 years has low levels of uptake, with populations most at risk frequently failing to engage.

The objective of this study was to gather behavioural insights into the barriers/challenges that limit engagement with the current NHS CVD Health Checks.

Drawing on a Behavioural Insight approach, 7 qualitative focus groups with members of ethnic minorities and underserved groups (n=45 participants) were conducted to understand barriers and challenges to uptake of NHS CVD Health Checks in one region in North East England (Middlesbrough). Data were analysed using a Behavioural Insights approach, applied to establish key themes, barriers and enablers.

Our findings identified that underserved communities in North East England find engaging with NHS CVD Health Checks challenging due to issues related to access, understanding and attitudes. Communities identified that harnessing relationships with existing community champions would raise awareness and confidence in engaging. Making services accessible where communities gathered, while also increasing understanding and knowledge, was also recognised as key to engagement.

Our study suggested that despite there being substantial barriers to engagement with NHS CVD Health Checks, novel methods encouraging uptake may be effective to address the significant health inequalities seen in deprived communities. Ensuring a co-developed and co-delivered approach to CVD risk reduction with underserved communities, together with social marketing campaigns to raise awareness about the importance of CVD, and why reducing its risk is so important, is key to success.

Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.

The ventilatory ratio (VR) is a simple and accessible index that reflects ventilatory efficiency in critically ill patients. Although several studies have examined its potential as a prognostic marker in acute respiratory distress syndrome (ARDS), the results remain inconsistent and inconclusive. This systematic review and Bayesian meta-analysis aimed to evaluate the association between VR and mortality in adult patients with ARDS.

Two investigators will independently conduct systematic literature searches in the PubMed, Embase, Scopus, Cochrane Library and Latin American and Caribbean Health Sciences Literature / Literatura Latinoamericana y del Caribe en Ciencias de la Salud (LILACS) databases, covering all publications from database inception to July 2025.

This systematic review and meta-analysis will include prospective and retrospective cohort studies evaluating the association between the VR and mortality in adult patients with ARDS. Specifically, we aim to answer the following Patient, Population or Problem, Intervention, Comparison, and Outcome (PICO) question: In adult patients with ARDS (Population), is an elevated VR (Exposure), compared to lower or normal VR values (Comparison), associated with an increased risk of mortality (Outcome)?

The primary outcome will be mortality, as defined in each included study. Outcomes will be analysed according to the characteristics and reporting of the original publications.

The methodological quality of the included studies will be assessed using the Quality In Prognosis Studies tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A hierarchical Bayesian random-effects model will be used to synthesise the data, with effect sizes expressed as ORs and 95% credible intervals. Weakly informative priors will be applied to model parameters.

Between-study heterogeneity will be assessed through the estimation of the between-study variance (²) and the I² statistic. Subgroup analyses will be conducted based on study design and ARDS aetiology, and a bivariate meta-regression will explore potential effect modifiers. A leave-one-out sensitivity analysis will also be performed to assess the robustness of the findings.

Publication bias will be evaluated using a Bayesian funnel plot and an adapted version of Egger’s test.

This systematic review does not require ethics approval. The results will be published in scientific journals, presented at national and international conferences and shared on social media in accessible language.

CRD420251008773

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

CRD42024568297.

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

CRD42024568532.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147

This study aimed to analyse the number of myocardial infarction (MI) admissions during the COVID-19 lockdown periods of 2020 and 2021 (March 15th to June 15th) and compare them with corresponding pre-pandemic period in 2019. The study also evaluated changes in critical treatment intervals: onset to door (O2D), door to balloon (D2B) and door to needle (D2N) and assessed 30-day clinical outcomes. This study examined MI care trends in India during the COVID-19 lockdown period, irrespective of patients’ COVID-19 infection status.

Multicentre retrospective cohort study

Twenty-three public and private hospitals across multiple Indian states, all with 24/7 interventional cardiology facilities.

All adults (>18 years) admitted with acute myocardial infarction between March 15 and June 15 in 2019 (pre-pandemic), 2020 (first lockdown) and 2021 (second lockdown). A total of 3614 cases were analysed after excluding duplicates and incomplete data.

Number of MI admissions, median O2D, D2B and D2N times.

30-day outcomes including death, reinfarction and revascularisation.

MI admissions dropped from 4470 in year 2019 to 2131 (2020) and 1483 (2021). The median O2D increased from 200 min (IQR 115–428) pre-COVID-19 to 390 min (IQR 165–796) in 2020 and 304 min (IQR 135–780) in 2021. The median D2B time reduced from 225 min (IQR 120–420) in 2019 to 100 min (IQR 53–510) in 2020 and 130 min (IQR 60–704) in 2021. Similarly, D2N time decreased from 240 min (IQR 120–840) to 35 min (IQR 25–69) and 45 min (IQR 24–75), respectively. The 30-day outcome of death, reinfarction and revascularisation was 4.25% in 2020 and 5.1% in 2021, comparable to 5.8% reported in the Acute Coronary Syndrome Quality Improvement in Kerala study.

Despite the expansion of catheterisation facilities across India, the country continues to fall short of achieving international benchmarks for optimal MI care.