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☐ ☆ ✇ BMJ Open

Effects of government health and immunisation financing on routine childhood vaccination during the COVID-19 pandemic: a difference-in-differences study

Por: Lee · D. · Kim · T. T. · Griffiths · U. · Seidel · M. · Freitas Attaran · M. · Lavayen · M. C. · Cabrera-Clerget · A. — Octubre 13th 2025 at 16:51
Objectives

To evaluate the safeguarding impact of government commitment (defined as the proportion of government expenditure relative to total expenditure) to health and immunisation financing in mitigating the disruptions to routine childhood vaccination during the COVID-19 pandemic.

Design

A quasi-experimental difference-in-differences study with country fixed effect, leveraging the COVID-19 pandemic as a natural experiment.

Setting

Low-income and middle-income countries.

Participants

A cohort of 131 low- and middle-income countries from 2010 to 2023.

Primary outcome measures

Our primary outcomes included the coverage rates for the third dose of the diphtheria-tetanus-pertussis containing vaccine (DTP3) and the first dose of the measles containing vaccine (MCV1).

Results

Both high government commitment countries (ie, above the upper 20th percentile) and low government commitment countries (ie, below the upper 20th percentile) experienced declines in immunisation coverage over the 4 years following the COVID-19 pandemic, with DTP3 and MCV1 decreasing by 4 and 5 percentage points, respectively (p

Conclusion

Greater government commitment to health and immunisation financing may not be sufficient on its own to mitigate pandemic-related disruptions in routine childhood vaccination.

☐ ☆ ✇ BMJ Open

Time trend and geographical distribution of major depressive disorder in Iran, 1990 to 2021: results from the Global Burden of Disease Study

Por: Taheri Soodejani · M. · Shakeri Shamsi · F. — Octubre 13th 2025 at 16:51
Objective

Major depressive disorder (MDD) is a disabling disease and is recognised as a serious, public health concern. In this study, we aimed to determine the burden and trends of MDD in Iran.

Design and participants

Secondary data from the Global Burden of Disease study were used to analyse the time trend and geographical distribution of age-standardised rate incidence and disability-adjusted life years (DALYs) of MDD from 1990 to 2021 by sex and province, in Iran. Join point regression and ArcGIS software were used for these estimations.

Main outcomes and measures

Incidence and DALYs.

Results

The trend analysis from 1990 to 2021 generally showed an increasing trend of incidence and DALYs. The highest annual percent change (APC) for incidence (6.594 95% UI: 3.727, 9.473) and DALYs (6.396 95% UI: 3.552, 9.286) of MDD in Iran was observed from 2019 to 2021 segment. Also, the geographical distribution analysis showed that the highest average annual percent change (AAPC) for incidence and DALYs of MDD in both sexes was, respectively, in Kurdistan province (0.774; [95% UI: 0.619, 0.976] and Yazd province (0.760; [95% UI: 0.601, 0.918]). Finally, the highest incidence and DALYs for MDD in 2021 were in Kerman and Fars provinces and the lowest in East Azarbayejan, Lorestan, Hamedan, Chahar Mahal and Bakhtiari, Golestan and Khorasan-e-Razavi provinces.

Conclusion

The findings of this study indicate an increasing trend in the burden of MDD in Iran and show the necessity of creating national policies and preventive and therapeutic measures for mental health disorders in the population.

☐ ☆ ✇ BMJ Open

Sedating with volatile anaesthetics for COVID-19 and non-COVID-19 acute hypoxaemic respiratory failure patients in ICU (SAVE-ICU): protocol for a randomised clinical trial

Por: Jerath · A. · Slessarev · M. · Martin · C. · DAragon · F. · Carrier · F. M. · Senaratne · J. · Meggison · H. · Hooper · J. · Alexandros Cavayas · Y. · Goligher · E. C. · Couture · E. J. · Randall · I. · Hatzakorzian · R. · Jacka · M. · Wiener-Kronish · J. · Xie · Z. · Pinto · R. L. · Cut — Octubre 13th 2025 at 16:51
Introduction

Inhaled anaesthetics can be used in mechanically ventilated critically ill patients to provide sedation. This approach to sedation potentially improves patient and health system outcomes, but further supportive evidence is needed. The objective of the SAVE-ICU clinical trial is to compare the effectiveness of inhaled versus intravenous sedation in ventilated adults with acute hypoxaemic respiratory failure.

Methods and analysis

SAVE-ICU is a multicentre, open-label, pragmatic, randomised controlled trial conducted in 15 intensive care units (ICUs) in Canada and the USA. Eligible patients include mechanically ventilated and sedated adults with acute hypoxemic respiratory failure from COVID-19 or non-COVID causes with PaO2/FIO2 ratio 12 hour). A hierarchy of outcomes was identified at the time of trial design, as the trial was launched during the COVID-19 pandemic when study drug shortages, staffing challenges and healthcare system pressures were prevalent and there was a requirement for rapid evidence generation and implementation on this topic. The primary outcome and highest in the hierarchy is hospital mortality (requiring 758 participants). Secondary and lower hierarchical outcomes are ventilator-free days at day 30 (200 patients), quality of life at 3 months (144 participants) and ICU-free days at day 30 (128 participants). Additional secondary outcomes include median daily oxygenation at day 3 (PaO2/FIO2 ratio), need for adjunctive acute respiratory distress syndrome therapies (prone positioning, inhaled nitric oxide, paralysis with a neuromuscular blocking agent and extracorporeal membrane oxygenation) during ICU stay, days alive and free from delirium and coma at day 14, hospital-free days at day 60 and disability score at 3 months and 12 months after enrolment.

Ethics and dissemination

The protocol was approved by all hospital ethics committees and by Health Canada. Informed consent will be obtained from substitute decision makers or deferred consent (as permitted by site ethics board). Trial findings will be shared at the end of the study using peer-review publications, conference presentations and social media as part of the trial knowledge translation plan.

Trial registration number

NCT04415060.

☐ ☆ ✇ BMJ Open

PLAN-psoriasis: protocol for a randomised controlled feasibility trial comparing patient-led 'as-needed treatment and therapeutic drug monitoring-guided treatment to continuous treatment for adults with clear or almost clear skin on risankizumab monothera

Por: Ye · W. · Powell · K. · Dooley · N. · Thomas · C. M. · Coker · B. · McAteer · H. · Wei · J. R. · Tan · W. R. · Baudry · D. · Dasandi · T. · Pizzato · J. · Sach · T. H. · Gregory · J. · Yang · Z. · Pink · A. E. · Woolf · R. T. · Warren · R. B. · Weinman · J. · Barker · J. N. · Chapman · S. · St — Octubre 10th 2025 at 11:24
Introduction

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

Methods and analysis

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

Ethics and dissemination

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

Trial registration number

ISRCTN17922845.

☐ ☆ ✇ BMJ Open

Additional arm-hand boost therapy (AHA-BOOST) in an inpatient rehabilitation setting during the subacute phase after stroke: protocol for a randomised controlled trial including a clinical, process and health economic evaluation

Por: Cornelis · L. · Cruycke · L. · Meyer · S. · De Smedt · A. · Fobelets · M. · Michielsen · M. · Vander Plaetse · M. · Putman · K. · Verheyden · G. — Octubre 10th 2025 at 11:24
Introduction

A considerable number of patients present with an upper limb impairment after stroke, which has a significant impact on daily life activities and quality of life. Currently, based on a Cochrane review, there is no high-quality evidence for any of the upper limb interventions used in routine practice. Therefore, the Jessa Hospital developed an additional arm-hand boost programme (AHA-BOOST), a novel, stratified intervention that integrates neurophysiological knowledge with an early start to optimise poststroke upper limb recovery.

Methods and analysis

This multicentre randomised controlled trial with parallel design compares AHA-BOOST with a dose-matched programme for the lower limbs. Both interventions are in addition to usual care and consist of a combination of group sessions (1 hour per day, 5 times per week) and individualised therapy (two 30 min sessions per week) provided over 4 weeks. In total, 80 subacute stroke patients will be recruited from five rehabilitation centres in Belgium and randomised to one of both interventions. Patients will be followed up until 12 months post stroke to support a cost-utility analysis and assess long-term clinical effects of the programme. Various outcomes are collected at different time points: preintervention, immediately post intervention, 3 months post intervention, 6 months post stroke and 12 months post stroke. The Action Research Arm Test is the clinical primary outcome. The secondary outcomes are: Fugl-Meyer assessment—upper extremity, Stroke Upper Limb Capacity Scale, Barthel Index, modified Rankin Scale, Stroke Impact Scale and EuroQoL 5D-5L (EQ-5D-5L). The clinical analysis includes a multivariate analysis of variance (MANOVA) analysis for comparing clinical changes between both groups and a subgroup analysis to explore the effects in different types of stroke survivors. Additionally, a process evaluation, guided by the Medical Research Council Framework, will assess key aspects of the implementation, including delivery (structures and resources), dose, reach, fidelity, adaptations, quality, mechanisms of change and the context. Both quantitative and qualitative data will be collected using the following tools during the intervention: therapy diaries for each session; video recordings of AHA-BOOST group sessions and after the intervention using: interviews with patients, therapists and management. The qualitative data will be assessed using content and thematic analysis and the quantitative data with descriptive statistics. Ultimately, in addition to the EQ-5D-5L, direct and indirect healthcare costs are collected for the health economic evaluation. A cost-utility analysis will be performed with a time horizon of 12 months post stroke comparing both therapies, and a Markov model will assess the cost-effectiveness of AHA-BOOST on a lifetime horizon. To test the robustness of the results, sensitivity and scenario analysis will be performed.

Ethics and dissemination

Ethical approval has been obtained by different ethical committees (UZ/KU Leuven (central committee), UZ Gent, Gasthuiszusters Antwerpen and Maria Middelares). The study will be performed in accordance with the protocol, current International Council for Harmonisation (ICH) and Good Clinical Practice (ICH-GCP) guidelines, and applicable regulatory requirements. The current approved protocol is version 5, dated 7 May 2025. Protocol amendments will be submitted to all involved ethical committees. The study results will be disseminated through peer-reviewed publications, conference presentations and stakeholder reports.

Trial registration number

NCT06517251.

☐ ☆ ✇ BMJ Open

Evaluating diabetes-specific meal replacements for glycaemic control in overweight and obese patients with T2DM: a protocol for a randomised controlled trial

Por: Che Wan Mansor · W. A. N. · Shahar · S. · Mohd Tohit · N. · Rajikan · R. · Ismail · M. — Octubre 10th 2025 at 11:24
Introduction

Uncontrolled type 2 diabetes mellitus (T2DM) causes microvascular and macrovascular issues that hike healthcare costs and threaten global health. Previous studies have suggested meal replacement (MR) therapy for T2DM, but there were inconsistencies in the results. Thus, a randomised controlled trial is proposed to determine the efficacy of a diabetes-specific MR product on weight loss, glycaemic control, satiety, quality of life, metabolic gene expression and cost benefit in overweight and obese patients with T2DM.

Methods and analysis

164 overweight and obese participants with T2DM will be randomly assigned to either an intervention group (n=82) or a control group (n=82). All participants will receive dietary counselling; however, only the intervention group will receive MR for 12 weeks. Glycaemic control and obesity indicators are the study’s main outcomes. Secondary outcomes include cardiovascular disease risk markers, metabolic risk, metabolic gene profile analysis, dietary data, physical activity, satiety level, quality of life and cost analysis. Baseline data will include sociodemographics, anthropometry, blood pressure, diet, physical activity, satiety level, quality of life, blood profile, metabolic gene expression profile and cost-benefit analysis. A follow-up is planned at intervention weeks 6 and 12. Week 6 will assess only anthropometry, blood pressure, diet, physical activity and satiety level. For compliance assessment, intervention group participants will bring their MR container. Week 12 will measure the same baseline parameter, except sociodemographic data. Individuals who consume less than 80% of the MR will be deemed non-compliant. All parameter modifications will be documented and analysed for comparison. All statistical analyses will be conducted using IBM SPSS V.29.0 software, with a significance level of p

Ethics and dissemination

This research protocol was approved by the Ethical Committee of the National University of Malaysia (JEP-2024-695) and registered on International Standard Randomised Controlled Trial Number. Study findings will be disseminated in peer-reviewed journals, conference presentations and social media.

Trial registration number

ISRCTN57040303).

☐ ☆ ✇ BMJ Open

Understanding the complexity of living with, and managing, secretions in motor neuron disease/amyotrophic lateral sclerosis (MND/ALS/ALS): protocol for a complex intervention systematic review

Por: Barry · C. · Farquhar · M. · Hawkes · M. · Massey · C. · Cross · J. L. — Octubre 10th 2025 at 11:24
Introduction

Motor neuron disease/amyotrophic lateral sclerosis (MND/ALS/ALS) is an incurable disease which leads to muscle weakness that worsens over time. MND/ALS is highly heterogeneous in its presentation, with many people experiencing a rapidly progressive trajectory of symptoms. Many people living with MND/ALS (plwMND/ALS) experience a combination of flaccidity and spasticity of the muscles involved in speech, swallowing, breathing and coughing. This makes it challenging to deal with the saliva and mucous (‘secretions") produced by the body. Failure to manage these problems effectively can lead to accumulation and aspiration of secretions, which may cause pneumonia and respiratory insufficiency. Knowing the best way to treat this problem is a challenge. Systematic reviews report substantive ongoing uncertainty regarding secretions management (SM). Little is known about the comparative effectiveness of secretion management interventions, their impact on quality of life and acceptability for plwMND/ALS and their unpaid/family.

Methods and analysis

A complex intervention systematic review of SM for plwMND/ALS and/or their carers will be conducted using an iterative logic model approach, designed in accordance with the principles and guidance laid out in a series of articles published by the Agency for Healthcare Research and Quality on complex intervention reviews . Eight electronic databases will be searched for publications between 1996 and present: Ovid Embase, EBSCO CINAHL, EBSCO Academic Search Ultimate, Scopus, EBSCO PsycInfo, Ovid MEDLINE and the Social Sciences Citation Index. This will be supplemented by hand searching of reference lists of included studies. Two reviewers will independently screen the results for potentially eligible studies using AS Review Lab (a semi-automated machine learning tool). Study selection, data extraction and risk of bias assessment, using Gough’s Weight of Evidence Framework, will be independently performed by two reviewers. A framework thematic synthesis approach will be employed to analyse and report quantitative and qualitative data. The reporting will be conducted in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Complex Intervention Extension Statement and Checklist.

Ethics and dissemination

This review will involve the secondary analysis of published information; therefore, ethical approvals are not required. Dissemination will be via presentation at scientific meetings, presentations to MND/ALS support groups and publications in peer-reviewed journals.

PROSPERO registration number

CRD42025102364.

☐ ☆ ✇ BMJ Open

Students perceptions of AI mental health chatbots: an exploratory qualitative study at Sultan Qaboos University

Por: AlMaskari · A. M. · Al-Mahrouqi · T. · Al Lawati · A. · Al Aufi · H. · Al Riyami · Q. · Al-Sinawi · H. — Octubre 9th 2025 at 10:17
Objectives

The aim of this study is to explore the perceptions, attitudes and previous experiences of Sultan Qaboos University (SQU) students towards artificial intelligence (AI) mental health chatbots.

Design

The study was conducted as an exploratory qualitative study, involving focus group discussions (FGDs).

Setting

The study was conducted at SQU. All FGDs were conducted via Google Meet.

Participants

A total of 60 students were recruited through convenience sampling. Both male and female students from different colleges were enrolled in the study. 10 FGDs were conducted.

Results

The interview findings revealed that most students were open to using AI mental health chatbots, with many already having used similar applications. Participants listed several benefits that such applications could have, including increased availability, reduced stigma and behaviour tracking. The participants also raised some concerns about such applications, including data security, cultural sensitivity and various ethical issues.

Conclusion

The future of AI chatbots for mental health is promising, as they have the potential to enhance mental healthcare services. Now that we know the disadvantages and limitations that may be associated with the use of such apps, it would be easier to design suitable apps that can properly triage mental health issues and provide supportive mental health.

☐ ☆ ✇ BMJ Open

Qualitative study of stakeholder perspectives on dementia policy implementation in Macao: progress, challenges and future directions

Por: Zheng · Y. · Tang · P. K. · Zhao · Y. · Song · M. · Hu · H. · Ung · C. O. L. — Octubre 9th 2025 at 10:17
Objectives

To better inform dementia management, it is important to understand how individuals experience, interpret and respond to dementia policy in real life. This study aimed to explore key stakeholders’ perspectives on the critical determinants of effective implementation of the first dementia policy in Macao, and the impact of policy implementation on dementia care.

Design

Semi-structured individual interviews were conducted in person with key stakeholders identified in earlier phases of the research. The participants were encouraged to share their opinions on the significance and objectives of the dementia policy, the changes in dementia care related to the launch of the policy, and how to better implement the policy for continuous improvement.

Setting

Interviews were conducted face-to-face at the participants’ office or at a location of their choice.

Participants

Individuals involved in the planning, establishing, leading, managing, operating, implementing, participating in, using and/or advocating for dementia policies and/or comprehensive dementia care models.

Results

All participants perceived the Macao Dementia Policy as a landmark initiative that raised public awareness, fostered inter-professional collaboration and established a foundational service network. At the service level, they reported improvements in the accessibility of diagnostic pathways and greater attention to caregiver support. Nevertheless, implementation challenges remained, including fragmented service information, inadequate non-pharmacological treatment options and limited service capacity. Participants recommended that future actions should focus on optimising long-term policy planning and resource allocation, strengthening the direct support network for caregivers, and enhancing public education and research-informed innovation.

Conclusion

Macao’s experience suggests that the successful implementation of a dementia policy requires not only the establishment of formal service structures but also a concerted focus on optimising resource allocation and strengthening caregiver support. To further enhance the policy’s effectiveness, future efforts should prioritise designing and assessing targeted interventions.

☐ ☆ ✇ BMJ Open

Trimodal age distribution of frequent attendance at the emergency department: a descriptive analysis of national, English, secondary care data using a retrospective cohort

Por: Marshall · C. · Kumar · A. · Saraiva · S. · West · R. M. · Mason · S. M. · Burton · C. D. · van der Feltz-Cornelis · C. M. · Lee · W. · Bojke · C. · Mattock · R. · de la Haye · S. · Relton · S. D. · Guthrie · E. — Octubre 9th 2025 at 10:17
Objectives

Frequent use of emergency departments (EDs) places a considerable burden on healthcare systems. Although frequent attenders are known to have complex physical, mental health and social needs, national-level evidence on their characteristics and patterns of attendance remains limited. This study aimed to provide a comprehensive, population-level description of frequent ED attendance in England, with a focus on age-based subgroups.

Design

Retrospective cohort study.

Setting

EDs in England via the Hospital Episode Statistics and the Emergency Care Dataset data linked with primary care prescribing and mortality data, between March 2016 and March 2021.

Participants

The dataset received from National Health Service Digital contained approximately 150 million ED attendances by 30 million adult (>18 years) patients over the time period April 2016 to March 2021. A random sample of 5 million people was used for this analysis.

Outcome measures

The primary outcome was the number of attendances in each financial year by frequent attenders compared with the remaining patients, split by age bands. Patients were classified as frequent attenders if they had ≥5 or ≥10 ED attendances within a rolling 12-month period. Secondary outcomes included demographic, diagnostic and prescribing characteristics, as well as the number of different ED sites visited.

Results

A Gaussian mixture model was used to identify age-based subgroups. Descriptive statistics were used to summarise key features; 95% CIs were reported where applicable. Among 3.91 million unique adult ED attenders, there were 8.7 million attendances. Of these, 222 160 individuals (5.7%) had ≥5 attendances in a year, accounting for 12.6% of total attendances. A trimodal age distribution was identified, with three distinct peaks corresponding to ages 18–34, 35–64 and 65+. Frequent attenders were more likely to live in deprived areas and have a history of psychotropic or analgesic prescribing. Mental health diagnoses and polypharmacy were particularly common in the younger and middle-aged groups. Multisite attendance was uncommon, with over 80% of frequent attenders using only one ED site annually.

Conclusions

This national analysis reveals a trimodal age pattern among frequent ED attenders, with differing clinical and socio-demographic profiles across age groups. These findings highlight the need for age-tailored approaches to managing high-intensity ED use and inform targeted service development.

☐ ☆ ✇ BMJ Open

Immediate versus gradual TocilizuMab discontinuAtion in GIant Cell Arteritis: protocol of the multicentre randomised open-label MAGICA trial

Por: Samson · M. · Fournel · I. · Bourredjem · A. · Cortier · M. · Galizzi · E. · Cransac · A. · Cladiere · C. · Fleck · C. · Brayer · M. · Carpentier · M. · Alberini · J.-L. · Devilliers · H. · Bonnotte · B. — Octubre 9th 2025 at 10:17
Introduction

Giant cell arteritis (GCA) is a large-vessel vasculitis occurring in people aged over 50 years. Recent studies have shown that tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, is remarkably effective in treating GCA and allows significant dose sparing of glucocorticoids. However, it makes it difficult to monitor disease activity. Furthermore, treatment is often prolonged over 1 year due to the fear of relapse after stopping TCZ and/or the absence of an optimal discontinuation scheme.

Methods and analysis

This study aims at comparing two discontinuation regimens in a population of GCA patients who have been treated with TCZ for 12–36 months and have discontinued glucocorticoids for at least 12 weeks. Patients will be randomised with a 1:1 ratio between two arms: immediate discontinuation (cessation) versus gradual discontinuation of TCZ (162 mg subcutaneously every 2 weeks for 12 weeks and then every 4 weeks for 12 additional weeks). Patients will be followed up for 78 weeks. The primary endpoint is relapse-free survival after 26 weeks of follow-up. A total of 120 patients will be randomised (60 in each group) for a period of 3 years.

Ethics and dissemination

The trial was approved by an independent ethics committee (CPP Sud Ouest et Outre Mer IV) and the French health authority (French National Agency for Medicines and Health Products Safety—ANSM) through the Clinical Trials Information System (CTIS) provided by the European Medicines Agency (EMA). The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Findings will be published in peer-reviewed journals and conference presentations.

Trial registration number

NCT06037460.

☐ ☆ ✇ BMJ Open

Rebozo and maternal postures to prevent persistent occiput posterior position of the fetal head: protocol for a randomised clinical trial 'the ReMaP-POPP RCT

Por: Ornaghi · S. · Fumagalli · S. · Antolini · L. · Panzeri · M. · Spandrio · R. · Ferrini · S. · Nespoli · A. · Maini · M. · Locatelli · A. — Octubre 9th 2025 at 10:17
Introduction

Occiput posterior position is the most common fetal malposition, complicating up to 35% of initial labours, and its persistence can lead to increased risks of adverse maternal and perinatal outcomes. The role of maternal postures, such as lateral recumbent and hands-and-knees, in promoting the anterior rotation of the fetal head has been investigated in several randomised trials in the last two decades, with mostly negative results. However, both methodological and study design limitations may have contributed to such findings. Recently, the use of forward-leaning inversion and side-lying release procedures and of the Rebozo technique has been implemented into clinical practice as a non-invasive alternative to promote the anterior rotation of the fetal head. Yet, neither intervention has been rigorously assessed in a controlled study. Our aim is to conduct a randomised controlled trial to assess whether a combination of forward-leaning inversion and side-lying release procedures and the Rebozo technique in a pre-specified sequence during the first stage of labour of women with a posterior fetus would favour its anterior rotation.

Methods and analyses

The ReMaP-POPP (Rebozo and maternal procedures to prevent persistent occiput posterior position of the fetal head) trial will be an open-label single-centre randomised controlled trial with two parallel groups. Women will be eligible if they are ≥18 years old, in labour (3 to 8 cm) and with a singleton term fetus (≥370/7 weeks) in an occiput posterior position confirmed by transabdominal sonography. Eligible women will be randomised into two groups: (1) intervention, a sequence of forward-leaning inversion and side-lying release procedures and Rebozo technique (duration 90–105 min); and (2) control, standard of care (maternal postures, including upright, lateral recumbent and hands-and-knees). Blinding will be guaranteed only for the physician assessing the fetal head position by sonography. Randomisation will be performed using randomly permuted blocks of varying sizes (4, 6 and 8), stratified by parity, in a 1:1 ratio. The primary outcome will be the probability of occiput posterior position of the fetal head 3 hours and 30 min after randomisation, diagnosed by sonography. Secondary outcomes will include the probability of occiput posterior position at full cervical dilation and at birth, maternal and neonatal health-related outcomes, as well as maternal pain intensity and ability to cope with pain and birth satisfaction level. We will also assess safety outcomes regarding challenges in adequate fetal heart rate monitoring during the time interval between randomisation and primary outcome assessment. Sample size estimation considered the possibility to decrease the probability of occiput posterior position from 35.8% (control, based on prior retrospective data at our Institution) to 22% with the proposed intervention. With a power of 0.90 and a two-sided value of 0.05, the estimated sample size will be n=462 (n=231/arm). Considering a potential attrition rate of 20%, n=578 women will be needed. Enrolment will require approximately 16 months. Primary and secondary outcomes will be analysed on an intention-to-treat basis. The effects of the intervention will be estimated by relative risks and their 95% CI.

Ethics and dissemination

The study has been approved by the Lombardy Ethics Committee n.3 (n. 5499, 20 December 2024). Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time. Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of midwifery and obstetrics. Also, they will be disseminated to the public through outreach activities involving families and healthcare specialists.

Trial registration number

The study has been registered in the Clinical Trials database (NCT06887634).

☐ ☆ ✇ BMJ Open

Longitudinal Educational Achievement and Development Study (LEADS): a protocol for a prospective study assessing medical students competencies

Por: Ebrahimi · N. · Khadem-Rezaiyan · M. · Rasoulian Kasrineh · M. · Rajaee · P. · Meshkat · Z. · Kianifar · H. · Jafari · M. · Moradi · E. · Sadabadi · F. · Ghavami · H. · Kimiafar · K. · Alamdaran · S. A. — Octubre 9th 2025 at 10:17
Background

Longitudinal studies provide insights into the outcomes of medical training curriculum. However, few educational cohort studies have been conducted in Iran. This study aims first to evaluate the impact of the current curriculum on medical students' medium- and long-term academic and career outcomes and, second, to identify medical students' characteristics and how they change through the doctor of medicine programme.

Methods and analysis

This protocol outlines a multi-phase, prospective cohort study that will take place in Mashhad, Iran. The study will implement the Kirkpatrick model, investigating medical students' knowledge, skills, behaviour and professionalism development over 10 years. Approximately 1000 medical students will be recruited through peer invitations and social networks. Data will be collected through baseline and follow-up questionnaires, academic performance records and comprehensive test scores throughout the Doctor of Medicine (MD) programme.

The data from the questionnaires will be reported using a Likert scale. Quantitative data will be described using means and SD, while qualitative variables will be presented as frequencies and percentages. We will evaluate the relationship between quantitative variables using correlation coefficients and the relationship between qualitative variables via the 2 or Fisher exact test. All tests will be two-sided, with a significance level set as p

Ethics and dissemination

All participants will complete written informed consent before data collection. All students can withdraw from the study at any time with no consequences. Results of this study will be presented at relevant conferences and will be submitted for publication in peer-reviewed journals. This study was approved by the Ethics Committee of Mashhad University of Medical Sciences.

Study registration number

IR.MUMS.REC.1400.311.

☐ ☆ ✇ BMJ Open

Nuts For Babies Study: protocol for a randomised controlled trial in Australia investigating if the risk of developing peanut and cashew nut allergies during infancy can be reduced by a high peanut and cashew nut maternal diet for the first 6 months of la

Por: Sullivan · T. R. · McWilliam · V. · OSullivan · M. · Netting · M. · Perrella · S. · Geddes · D. · Tang · M. · Campbell · D. E. · Perrett · K. P. · Palmer · D. J. — Octubre 9th 2025 at 10:17
Introduction

The predisposition to food allergy development and the induction of allergen-specific immune responses appears to be initiated early in infancy. Early exposure to food allergens, such as peanut and cashew nut, via human milk is likely important in initiating oral tolerance and reducing risk of food allergy development. This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a high peanut and cashew nut maternal diet during lactation.

Methods and analysis

This is a multisite, parallel, two-arm (1:1 allocation), single-blinded (outcome assessors, statistical analyst and investigators), randomised controlled trial. Target sample size is 4412 participants (2206 per group). Women (aged 18–50 years) with a singleton pregnancy, who are planning to breastfeed and do not have peanut and/or cashew nut allergies are eligible to participate. After obtaining written informed consent, participants are randomised to either a high peanut and cashew nut diet (at least 60 peanuts and 40 cashew nuts per week) or a low peanut and cashew nut diet (no more than 20 peanuts and 12 cashew nuts per week). Participants are asked to follow their allocated diet from birth to 6 months postnatal. Individual lactation consultant advice and support is provided as required. The study’s primary outcome is food challenge proven IgE-mediated peanut and/or cashew nut allergy during infancy (0–18 months). Key secondary outcomes include infant sensitisation to peanut and/or cashew nut. Analyses will be performed on an intention-to-treat basis according to a prespecified statistical analysis plan.

Ethics and dissemination

Ethical approval has been granted from the Western Australian Child and Adolescent Health Service Human Research Ethics Committee (approval number RGS0000006685). Trial results will be presented at scientific conferences and published in peer-reviewed journals.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN ACTRN12624000134527)

☐ ☆ ✇ BMJ Open

Association of anthropometry indices and metabolic syndrome in Iranians: a cross-sectional study of the Fasa adult cohort study

Por: Seyhoon · M. · Ahmadi · A. · Zare · M. · Honardoust · M. · Hejazi · N. · Mohsenpour · M. A. · Homayounfar · R. — Octubre 9th 2025 at 10:17
Objectives

To evaluate the associations between anthropometric indices and components of metabolic syndrome (MetS), including blood pressure, fasting blood sugar (FBS), triglycerides, high-density lipoprotein cholesterol and waist circumference (WC) in Iranian adults.

Design

Cross-sectional analysis of baseline data from a population-based cohort.

Setting

Fasa adults’ cohort study, a rural community-based cohort in Fars province, Iran.

Participants

A total of 1550 adults aged 35–70 years with MetS, identified from among 10 118 cohort participants using the National Cholesterol Education Programme Adult Treatment Programme III criteria.

Primary outcome measures

The anthropometric indices include abdominal volume index (AVI), a body shape index (ABSI), atherogenic index of plasma (AIP), body roundness index (BRI), body adiposity index (BAI), conicity index, ponderal index and visceral adiposity index (VAI).

Results

Participants (56.1% female) with a mean age of 49.8±9.5 years. AVI was significantly associated with systolic blood pressure (SBP) (β=0.010, p

Conclusions

Anthropometric indices, including VAI, AIP, BAI, BRI and AVI, exhibit significant associations with key components of MetS in Iranian adults, particularly blood pressure, glycaemic markers and central adiposity. Among these, BAI showed the strongest correlation with MetS parameters, while ABSI displayed the weakest.

☐ ☆ ✇ BMJ Open

Current pesticide suicide surveillance methods used across the African continent: a scoping review

Por: Jonker · M. · Karunarathne · A. · Utyasheva · L. · Eddleston · M. · Konradsen · F. · Rother · H.-A. — Octubre 9th 2025 at 10:17
Background

Suicide poses a significant global health challenge in low- and middle-income countries and is a leading cause of death worldwide. Although global suicide rates have decreased by 36% between 2000 and 2019, the decline in Africa has not been as substantial. Suicide surveillance data, particularly from pesticide ingestion, is lacking.

Objectives

This scoping review aimed to identify pesticide suicide surveillance methods currently used in African countries and to assess their viability for improving reporting of pesticide suicide deaths.

Design

A scoping review was conducted using a five-stage methodological framework across several databases.

Eligibility criteria

Peer-reviewed articles published in English that investigated (a) pesticide poisoning and (b) suicide in humans only and specific to the African continent.

Sources of evidence

MEDLINE (via PubMed), Scopus (with substantial Embase content), Web of Science Core Collection, Biological Abstracts, SciELO (on Web of Science platform), Academic Search Premier, Africa-Wide Information, Biological and Agricultural Index, CINAHL, Health Source Nursing/Academic, APA PsycInfo and General Science (EBSCOhost platform). The search was performed in January 2022, and the review of the results took place from February to May 2022.

Data charting methods

All authors developed and tested the data extraction tool. The charting framework remained dynamic, continuously updated as reviewers gained a deeper understanding of the studies included. Four independent reviewers charted the data to ensure inter-rater reliability. To address discrepancies, a sample of eligible articles was cross-rated by the reviewers.

Results

We identified 110 relevant studies describing eight different surveillance systems, conducted in 30 different African countries. Of these studies, 50.1% (56/110) reported on the number of pesticide suicides (totalling 1554); however, 49% (54/110) did not differentiate the cause of death further than either a poisoning death or a suicide, making it difficult to determine if pesticides were involved in the death or if the death was an intentional poisoning case. The surveillance systems identified included health facility records (hospital admissions data), poison control centre (PCC) data, forensic/mortuary data (including police reports), media reports, surveys/interviews with patient/family, case reports, systematic/literature reviews and civil registration and vital statistics (CRVS) data. Hospital admissions data was the most frequently used surveillance system (61/110, 55.5%).

Conclusions

The number of studies and surveillance methods found was higher than anticipated. While this is a positive sign, several areas of improvement were identified for pesticide suicide surveillance in Africa. These included improving reporting of the specific pesticides (including the active ingredient) linked to suicide cases for improving policy (since this is required for pesticide regulation) and making use of more than one surveillance system to enhance surveillance of pesticide suicides, allowing for under-used sources, such as PCCs, to be used more effectively in pesticide suicide surveillance. Finally, although a comparison of these surveillance methods outside of Africa was not directly possible for each surveillance system due to a lack of similar high-quality reviews, we did refer to publications where similar pesticide suicide surveillance systems were discussed.

☐ ☆ ✇ BMJ Open

Intensive outpatient interventions for youth with complex mental illness: a scoping review protocol

Por: Choudhary · W. · Morgan · R. · Szatmari · P. · Besa · R. · Selvachandran · J. · Aitken · M. · Kozloff · N. — Octubre 9th 2025 at 10:17
Introduction

Mental illness typically onsets during the developmental stages from adolescence to emerging adulthood (ages 15–24 years), referred to as ‘youth’. A subset of youth with mental illness may be identified as having ‘complex’ mental health needs, defined based on requiring prolonged, extensive and resource-intensive services across multiple sectors, functional impairment, and comorbid challenges or multimorbidity . Effective early intervention for youth with complex mental illness is crucial to prevent the sequelae of long-term mental health problems. Several resource-intensive outpatient models have been developed to meet the needs of youth with complex mental illness; however, to the best of our knowledge, no scoping review has synthesised the available evidence on these interventions. A comprehensive synthesis of existing intensive outpatient interventions is needed to identify, target and inform future research and clinical efforts to better serve youth with complex mental illness. As such, the proposed scoping review will address the following research questions: (1) What intensive outpatient interventions have been evaluated for youth with complex mental illness? (2) To which populations are these interventions targeted? and (3) What outcomes have been examined within the context of these models?

Methods and analysis

This review will follow the Arksey and O’Malley framework for scoping reviews, and we will report the results following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) recommendations. We will conduct a comprehensive literature search across seven academic databases to identify relevant peer-reviewed material in English from 1990 to the present. Inclusion criteria will address evaluations of outpatient models of care with intensive components targeted to youth ages 15–24 with features of complex mental illness. Studies will be screened independently for eligibility by two reviewers in Covidence using clear inclusion criteria. We will then collate, summarise and present the findings to provide a comprehensive overview of the existing evidence.

Ethics and dissemination

Ethical approval will not be required, as no data will be collected for the proposed project. Results will be disseminated in peer-reviewed articles, presented at conferences and shared with stakeholders to inform the development, implementation and evaluation of comprehensive transdiagnostic services targeting youth with complex mental illness.

☐ ☆ ✇ BMJ Open

What is the access to NHS fertility treatments for women with Mayer-Rokitansky-Küster-Hauser syndrome across England? A freedom of information study

Por: Milford · K. · Melo · P. · Suleman · M. · Crouch · N. · Mair · I. · Armstrong · S. C. — Octubre 9th 2025 at 10:17
Objectives

The aims of this study were (1) To investigate the availability of NHS funded in vitro fertilisation (IVF) treatment for individuals affected by Mayer-Rokitansky-Küster-Hauser syndrome (MRKH) from all Integrated Care Boards (ICBs) across England and (2) To assess the ethical implications of piecemeal funding for those with MRKH.

Design

This was a mixed-methods study containing both quantitative and qualitative data. We filed freedom of information (FOI) act requests on 01/06/2023 for all 42 ICBs across England via secure email.

Setting

The study focused on England.

Participants

All 42 ICBs across England were contacted.

Outcome measures

The FOI requests asked for information concerning the provision of funded IVF for uterine factor infertility, and if this included individuals with MRKH. Where assistance was available, we recorded what it comprised along the IVF cycle. If IVF was not offered, we recorded the rationale provided by the ICB.

Results

Responses were received from all 42 ICBs across England. Seven stated that they would fund IVF and cryopreservation of embryos to women with MRKH and other absolute uterine factor infertility diagnoses (NHS Humber and North Yorkshire, NHS Dorset, NHS Devon, NHS Cornwall and Isles of Scilly, NHS Buckinghamshire, Oxford and Berkshire, NHS South Yorkshire and NHS West Yorkshire). However, the number of cycles, the length of cryopreservation and whether they would fund embryo transfer into a surrogate differed between ICBs.

Of the remainder, three (NHS Leicester, Leicestershire and Rutland, NHS Greater Manchester and NHS Hampshire and Isle of Wight) described some provision of fertility preservation (cryopreservation of oocytes or embryos) for women with uterine factor infertility, two of whom suggested their policy may include women with MRKH (NHS Greater Manchester and NHS Hampshire and Isle of Wight). Two ICBs (NHS Gloucester and NHS Bedford, Luton and Milton Keynes) explained that individual funding applications would be considered when made by clinicians on the patient’s behalf, but no information was provided on how many times requests had been made and granted. The remaining 30 ICBs explained that no part of a surrogacy pregnancy would be funded, owing to concerns around commercial surrogacy, which is illegal in the UK.

Conclusions

This work has revealed that only a small proportion of ICBs (7/42, 17%) treat women with MRKH like any other woman applying for NHS fertility treatment. The study revealed that decisions by ICBs not to fund IVF treatments based on concerns about commercial surrogacy create significant inequities. It unfairly penalises individuals with MRKH who require surrogacy as part of their fertility treatment. These individuals face a unique set of reproductive challenges, and denying them access to NHS-funded IVF treatments exacerbates existing inequalities. Furthermore, if individuals with MRKH accept that the expenses of the surrogate will be met by them rather than the ICB, it is unjustifiable to deny them the IVF component of the treatment if they meet all the other criteria for eligibility. Moreover, the fact that some ICBs do fund IVF for individuals with MRKH indicates that legal concerns regarding surrogacy are unfounded and inconsistently applied. This discrepancy highlights the need for a standardised approach that ensures equitable access to fertility treatments across all regions.

☐ ☆ ✇ BMJ Open

Predictors, mediators, effect modifiers and preventive actions regarding secondary school teacher burnout, anxiety and depression--protocol for a systematic scoping review

Por: König · M. · Wallraff · J. P. · Glenewinkel · F. · Wild · U. · Erren · T. C. · Lewis · P. — Octubre 9th 2025 at 10:17
Introduction

The teaching profession plays a crucial role in society. From educating and forming future generations to fulfilling various administrative tasks and managing expectations and experiences that reach beyond the classroom—teachers face immense demands on their time, energy, and emotional resources. Consequently, they are subject to high work burden. This is reflected in the high prevalence of burnout, anxiety, and depression among teachers. A scoping review of factors associated with these outcomes in teachers is required to inform the further development of preventive occupational medicine strategies. In this scoping review, we aim to (i) identify and (ii) appraise the factors (eg, workplace, environmental, lifestyle, psychological) associated with burnout, anxiety, and depression specific to secondary school teachers and to (iii) synthesise the findings from the perspective of preventive occupational medicine.

Methods and analysis

The scoping review will be performed following the PRISMA extension for Scoping Reviews guidance. A systematic literature search will be conducted in the Medline, Web of Science Core Collection, PsychInfo, and Cochrane Library databases using search terms pertinent to secondary school teachers as the population of interest and depression, anxiety, and burnout as the outcomes of interest. Returned articles from the database search published pre-2017 will be excluded for the following reasons; namely, (a) that current literature will more closely reflect the current demands of the teachers, (b) the timing fits with recent systematic reviews highlighting burnout, anxiety, and depression as major problems among teachers, and (c) it facilitates feasibility of review in terms of the volume of studies. Remaining records will then be deduplicated and screened against predefined eligibility criteria that also add focus on teachers and these outcomes. Relevant data concerning factors associated with burnout, anxiety, and depression in teachers will be extracted and mapped. A narrative appraisal of included studies will be employed that will be specific to the validity of the results regarding factors (exposures, mediators, effect modifiers) that may affect the outcomes of interest (as opposed to more generic appraisal of the entirety of individual articles). Findings will be narratively synthesised from the perspective of preventive occupational medicine.

Ethics and dissemination

Formal ethical approval is not required as primary data will not be collected in this study. The findings of this study will be disseminated through peer-reviewed publication, conference presentation, and condensed summaries for key stakeholders and partners in the field (including teachers, schools, and governing bodies).

Registration details

The protocol was registered on the Open Science Framework on 26.06.2025 and can be identified using the following link: https://doi.org/10.17605/OSF.IO/BKX56.

☐ ☆ ✇ BMJ Open

Model-based pharmacoeconomic analysis of anti-VEGF strategies for neovascular age-related macular degeneration: a value-based comparison of real-world administration approaches

Por: Gismero Moreno · S. M. · Jodar Sanchez · F. · Garcia-Agua Soler · N. · Rivas Ruiz · F. · Garcia-Ruiz · A. J. — Octubre 8th 2025 at 05:59
Objectives

To evaluate the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) using a value-based model that considers drug durability, dosing regimens and real-world administration strategies, including safe vial fractionation.

Design and setting

Model-based pharmacoeconomic analysis using data from randomised clinical trials and network meta-analyses. Analysis conducted from the payer perspective using cost data from the Spanish National Health System.

Methods

A model-based analysis compared five anti-VEGF agents—innovator and biosimilar ranibizumab, aflibercept 2 mg, brolucizumab and faricimab—across three dosing regimens: fixed, Pro Re Nata and Treat-and-Extend (TAE). Administration formats included single-use vials, prefilled syringes and vial fractionation (VF), with or without dead-space-free (DSF) syringes to minimise waste. The primary outcome was cost per optimal responder, defined as a patient gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with and without adverse events. Cost-effectiveness was evaluated using Number Needed to Treat (NNT), Net Efficacy Adjusted for Risk-NNT (adjusted for safety) and incremental cost-effectiveness ratios. Secondary outcomes included the number of treated patients and optimal responders achievable within a fixed 1 000 000 budget.

Results

The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of 6214 per patient and a cost per optimal responder of 27 155. Under a fixed budget of 1 000 000, this approach allowed treatment of 160 patients, yielding 36 optimal responders. Faricimab with DSF VF ranked second, with a total cost of 5847 and a cost per optimal responder of 28 652, treating 171 patients and achieving 34 responders. In contrast, single-use vials without VF led to substantially higher total costs (eg, 11 305 for aflibercept TAE) and lower treatment capacity (eg, 88 patients treated).

Conclusions

This model demonstrates that combining durable agents, extended dosing intervals and optimised delivery strategies (eg, prefilled syringes and DSF VF) can substantially improve the cost-effectiveness and sustainability of anti-VEGF therapy in public health systems.

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