Burden of disease using disability adjusted life years in the Middle East and North Africa (MENA) region: protocol of a systematic review

Introduction
In the Middle East and North Africa (MENA) region, changing demographic and epidemiological profiles have resulted in a diverse and shifting burden of disease (BoD). Disability-adjusted life years (DALYs), which combine years of life lost (YLL) due to premature mortality and years lived with disability (YLD), offer a valuable metric for assessing disease burden at the national level. While global burden of disease (GBD) estimates provide broad insights, national burden of disease (NBD) estimates offer country-specific data that can better inform tailored health policies and resource allocation. This systematic review protocol outlines our methodology for collating and analysing the NBD estimates in the MENA region using DALYs as the primary outcome measure.

Methods and analysis
This review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We will systematically search PubMed, Scopus, Web of Science and EMBASE for studies published from 1993 to 2024 that report national-level DALY estimates for diseases, injuries or risk factors in MENA countries. Eligible studies must report DALY estimates using national methodologies, while studies using exclusively GBD estimates will be excluded. Two independent reviewers will conduct title/abstract and full-text screening, data extraction and quality assessment using Standardised Reporting of Burden of Disease Studies (STROBOD), with disagreements resolved by a third reviewer when necessary.

Ethics and dissemination
Ethical approval is not required for this review as it involves analysis of previously published data. The findings will be disseminated through publication in a peer-reviewed journal and presented at relevant academic and policy forums.

Prospero Registration Number
PROSPERO CRD42024498688.

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[Articles] Evaluating axillary lymph node metastasis risks in breast cancer patients via Semi-ALNP: a multicenter study

Semi-ALNP, which is based on the MLP algorithm, has high accuracy in assessing the statuses of ALNs across all types of BC patients. It is particularly effective for identifying high-risk patients with ALN metastasis, which can help guide personalized treatment decisions. Future prospective studies are planned to further validate the clinical utility of this approach in real-world settings.

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When Empathy, and Healing, Are Elusive

As studies suggest empathy in medicine continues to decline, mirroring the trend seen in other societal realms, poetry remains an important medium for questioning why, and reclaiming it. In the poem “20 Marlboro Reds,” smoking, both a communal bonding ritual and noisome health risk, becomes a complex metaphor for our vexed attempts to connect with others. The desire to belong and the harmful effects of smoking are simultaneously evoked when the speaker first experiences nausea after trying cigars offered by a friend. Colloquial, almost irreverent language belies the speaker’s nagging aloneness: as the stanzas wryly move through his adolescence and young adulthood, two “black cigarillos” at parties (accompanied by “thick liquor,” another fraught social lubricant) seem a jaunty rallying cry for teenage rebelliousness; and later, smoking marijuana because “a girl wanted me to” and finding “nothing happened” suggests that genuine human connection remains elusive. The irony in the search for shared feeling deepens when eventually, we infer, the speaker becomes a physician and a patient with metastatic lung cancer is craving a cigarette, so the speaker offers to fetch some. With roles reversed and the speaker and would-be healer now supplying the cigarettes, long-sought empathy is never really kindled, as the request is forgotten and instead they watch a wholesome television show together. Any facile notion of empathy is critiqued, however, as in the final lines, the speaker ruefully smokes the cigarettes himself after the patient dies, ever alone in his frustrated quest, “while I contemplated what/was killing me.”

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Does less invasive surfactant administration during high-flow nasal cannula oxygen treatment reduce the need for invasive ventilation in late preterm and early term born infants with respiratory distress? A study protocol for a single-centre study with a treatment and control arm

Introduction
Up to 40% of late preterm and early term infants require neonatal admission with respiratory disease being the most common cause. Less invasive surfactant administration (LISA) has previously been used with good success in the very preterm population, but it is unclear whether late preterm infants suffering from respiratory distress syndrome and early term infants suffering from secondary surfactant deficiency might also benefit from LISA. Continuous positive airway pressure (CPAP) in that population can increase asynchrony and air leaks, whereas these may be avoided by using high flow nasal cannula (HFNC). This trial will investigate whether LISA during HFNC reduces the need for invasive ventilation.

Methods and analysis
This non-blinded, single-centre study with a treatment and a control arm will take place on the Neonatal Intensive Care Unit at King’s College Hospital National Health Service (NHS) Foundation Trust and the local neonatal unit at the Princess Royal University Hospital. The study will recruit 245 infants born between 34+0 and 38+6 weeks gestational age, who are requiring respiratory support via HFNC. The 245 participants will be placed into a control and treatment group. Those infants eligible for SURFactant Or Not (SurfON) will be randomised as per the SurfON protocol. The remaining infants will, where possible, be recruited to the treatment group. All recruited infants will have 2 minutes of respiratory function monitoring. Those receiving LISA will receive a further 2 minutes of monitoring after the procedure. As HFNC, LISA and respiratory monitoring are part of routine clinical practice, retrospective consent will be gained from parents or guardians after the procedure to analyse the respiratory function data. The primary outcome will be the percentage of neonates needing invasive ventilation within 72 hours from birth. The secondary outcomes are length of neonatal unit stay; the cost of stay as estimated via standard NHS tariffs; and the lung function parameters including tidal volume, respiratory rate, end tidal CO2 (ET CO2), fraction of inspired oxygen (FiO2) and ratio of oxygen saturations to fraction of inspired oxygen (SpO2/ FiO2) ratio before and 2 minutes after LISA and the SpO2/FiO2 ratio 2 hours after the administration of LISA.

Ethics and dissemination
A favourable opinion was sought and obtained from the London – Hampstead Research Ethics Committee and Health Research Authority for the study protocol and other relevant documentation (informed consent forms and patient information leaflets) prior to commencing the study (REC reference: 24/PR/0431). Anonymised study data will be presented at conferences and published by the investigators in peer-reviewed journals

Trial registration number
NCT06421506.

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Community-based type 2 diabetes screening programmes designed for priority populations: a scoping review protocol

Background
Type 2 diabetes is a growing public health concern, and it continues to disproportionately impact priority populations. Although earlier and more frequent screening of diabetes promotes early detection to prevent adverse outcomes, this is a significant barrier for priority populations due to inequities that hinder access to critical preventive screening in primary care settings. The purpose of this scoping review is to better understand the design and implementation of screening and early detection of type 2 diabetes in community settings for priority populations to reduce missed or delayed diagnoses and future potential adverse outcomes.

Methods
This scoping review will adopt the methodological framework of Arksey and O’Malley and be enhanced using Levac et al recommendations. A search strategy was designed using insights from experienced librarians through the Peer Review for Electronic Search Strategies to conduct a comprehensive search using the following databases: Medline, Embase, PsycINFO, Web of Science, Scopus, CINAHL and Google. The search will capture studies focused on community-based diabetes screening using point-of-care testing and deployed in community settings serving priority populations with undiagnosed diabetes. Studies will be excluded if priority populations were not a focus, individuals living with diabetes, the intervention is not implemented in a community setting and did not use point-of-care screening. Two authors will independently review and screen the articles (title, abstract and full-text), while a team-based approach will be applied to chart the data. A thematic analysis will be used to identify emerging themes and subthemes according to barriers and enablers of implementing an equitable community-based diabetes screening intervention.

Ethics and dissemination
The findings from this review will inform future diabetes screening interventions in community settings to enable an equity-informed approach in the design, planning and implementation of such strategies. Equally important, it will inform a larger project, in which the team plans to implement a community-based diabetes screening programme in Ontario, Canada.

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Vacation and back-to-school effect on influenza transmission among school-age children in Guangzhou, China: an ecological study from 2010 to 2023

Objective
To examine whether influenza transmission risk decreased during summer and winter vacations and increased after vacations and statutory holiday.

Design
An ecological study.

Setting
Guangzhou, Guangdong Province of China.

Participants
A total of 458 343 influenza cases in school-aged children were included, including 160 067 (35.05%) in kindergarten, 223 817 (48.83%) in primary school, 50 053 (10.92%) in middle school and 23 801 (5.19%) in high school.

Data and methods
Data on influenza cases were obtained from the Notifiable Infectious Disease Surveillance System operated by Guangzhou Centre for Disease Control and Prevention. Influenza incidence rate ratio (IRR) by negative binomial regression model was used to analyse the influenza risk of school-age children during/after vacation to before/during breaks.

Results
In all four groups, there was significantly lower incidence of influenza during winter and summer vacations compared with the 4 weeks preceding vacations. Compared with the 2 weeks preceding return, kindergarten students experienced the highest influenza risk in the third week after summer vacation (IRR=3.40, 95% CI 2.43to 4.79). Primary school students had the highest risk in the fourth week after winter vacation (IRR=9.59, 95% CI 6.71 to 13.87). Middle school students had the highest risk in the fourth week after summer (IRR=11.60, 95% CI 6.17 to 22.62). High school students also experienced the highest risk in the fourth week following summer (IRR=17.96, 95% CI 8.10 to 42.05). Despite the risk of influenza increasing after returning to school, it remained lower compared with before vacations and holidays.

Conclusions
Due to changes in contact patterns, influenza incidence was high towards the end of term, significantly decreased during vacations and started to rise on returning to school, peaking in the third or fourth week. These findings suggested using holiday periods strategically to promote influenza vaccination and implementing enhanced non-pharmaceutical interventions on students returning to school.

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Protocol for 'Re: CBT Dialysis: a realist evaluation–why, for whom and in what circumstances does cognitive behaviour therapy work for people with depressive symptoms receiving dialysis?

Introduction
Nearly 40% of adults receiving life-saving dialysis for kidney failure report depressive symptoms. With more than 40 000 Canadians on dialysis, this is a significant health burden. Cognitive behavioural therapy (CBT) has been shown to be effective for treating depressive symptoms; however, it is rarely considered or used for people receiving dialysis. The aim of this realist study is to evaluate and explain how, why, for whom and in what circumstances therapist-guided and remotely delivered CBT works in order to provide equitable mental healthcare to individuals with depressive symptoms receiving dialysis.

Methods and analysis
The project will include a realist synthesis, a quantitative cohort study and a realist evaluation. Realist methodology is a theory-driven approach that seeks to explain how generative mechanisms are shaped by contextual features, giving rise to outcome patterns. We will begin by developing an initial programme theory (IPT) from the literature and interviews with CBT therapists to understand how CBT is intended to work and for whom. We will use data from the quantitative cohort study to identify contexts that may shape outcome patterns in CBT for people receiving dialysis. This includes previously collected survey data and data from a longitudinal cohort study, both sourced from people across Canada undergoing dialysis. We will test and refine the IPT using data from a realist evaluation and existing literature. The realist evaluation will involve participants from the quantitative cohort study who received therapist-guided, remotely delivered CBT.

Ethics and dissemination
Ethical approvals have been granted. We have planned a wide range of dissemination strategies: journal manuscripts and conference presentations, executive memos for administrators of renal programmes in Canada, an online inventory of resources for depressive symptoms and presentations of findings together with patient partners at all participating sites.

PROSPERO registration number
CRD42023476184.

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Economic evaluation of a lifestyle intervention for individuals with overweight or obesity suffering from chronic low back pain (the BO2WL trial): a protocol for a health economic analysis

Introduction
Low back pain (LBP) is highly prevalent across the Western world, including Switzerland (CH) and Belgium (BE), with women experiencing higher disability rates than men. Chronic LBP (CLBP), persisting beyond 3 months, leads to diminished health-related quality of life and increased healthcare and societal costs. Evidence indicates a direct relationship between body mass index (BMI) and CLBP severity, with high BMI significantly driving LBP-related healthcare expenses. Current evidence supports combining pain neuroscience education (PNE) with cognition-targeted exercise therapy (CTET) to effectively manage CLBP.
An economic evaluation alongside a randomised controlled trial, entitled ‘Lifestyle Intervention in Overweight/Obese CLBP Patients: an International Multi-centre RCT’ (BO2WL), will be conducted in CH and BE. It aims to evaluate the addition of a lifestyle intervention to PNE and CTET compared with PNE and CTET alone for treating individuals with CLBP and overweight or obesity. This protocol outlines the details of the economic evaluation of this trial.

Methods and analysis
The trial consists of a 14-week intervention followed by a 52-week post-intervention follow-up. Primary outcomes include direct and indirect costs, as well as quality-adjusted life years and pain intensity. Cost data will be converted into 2026 Belgium (BE) and 2026 Swiss Francs (CHF) for CH, with a discount rate of 3.5%. Incremental cost-utility and cost-effectiveness ratios will be calculated from a societal perspective for each country.

Ethics and dissemination
Ethics approval was obtained by the local ethics committees (Bern, CH: project ID 2022–02210; Brussels and Geel, BE: BUN 1432022000296). Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal.

Trial registration number
NCT05811624.

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Reproducibility of published model-based cancer drug cost-effectiveness analyses: a study protocol for a cross-sectional analysis

Introduction
Model-based cost-effectiveness analysis (CEA) of pharmaceuticals informs reimbursement and pricing in many healthcare systems, and it is essential that CEA evidence is valid and reliable. Several studies have reported lacking transparency in CEA studies. In this study protocol, we describe a study that will investigate whether model-based CEA studies of cancer drugs are transparent and informative enough to enable the reproduction of study findings.

Methods and analysis
This study protocol outlines a study where we will identify CEA studies indexed in MEDLINE from 2015 to 2023 based on predefined search terms. We will include English-language CEA studies evaluating pharmaceutical treatments based on decision-analytical modelling methods that report cost-effectiveness results using life-years, quality-adjusted life-years and/or disability-adjusted life-years as health outcome metric(s). Two authors will screen abstracts and full text for inclusion. We anticipate that a maximum of 150 studies will be included after a full-text review. A data extraction template is designed to capture information used to determine reproducibility together with other information that will be analysed as potential determinants of reproducibility in logistic and linear regression analyses.

Ethics and dissemination
This study design has been deemed exempt from ethical approval. All collected data will be made available in an online repository that will host the study protocol and other supplementary data. Results from this proposed study will be published in peer-reviewed journals and at scientific conferences and workshops.

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What is the added value of handsearching Hungarian medical journals and grey literature for identifying controlled clinical trials? Protocol for a meta-epidemiological study

Introduction
Randomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy and safety of healthcare interventions. For valid systematic reviews and evidence-based clinical guidelines, it is essential that results of all eligible RCTs are accessible. However, articles about trials published in languages other than English are often not listed in well-known and open trial databases like Medline and therefore scarcely findable. Handsearching national journals is an important approach to identify these articles and enhance their global visibility. Consequently, the results of trials conducted and published in non-English-speaking countries are not lost but rather integrated into the global body of evidence.
The present study aims to evaluate the benefits of extensive handsearching in Hungary and to identify key medical fields for future efforts. We will also assess the extent of grey literature in Hungary. We will appraise the risk of bias in the identified RCTs and controlled clinical trials (CCTs; indicating quasi-randomised or possibly randomised controlled trials) and examine the reporting quality of articles in Hungarian medical journals. Additionally, we will explore whether the automation tool Paperfetcher, recommended by Cochrane for handsearching, can effectively support these efforts in a non-English language context.

Methods and analysis
We will conduct a cover-to-cover handsearch of all Hungarian medical journals publishing content in the year 2023 to identify all controlled clinical trials, including RCTs, CCTs and non-RCTs, which are trials that use a clearly non-random method for allocating participants to groups. We will also search conference proceedings submitted to the Hungarian National Széchényi Library, abstract supplements from journals available via the Hungarian Medical Bibliography database, preprints available on medRxiv, Hungarian theses and dissertations, as well as Google Scholar to identify grey literature.
Two independent researchers will screen the identified records, assess their eligibility, extract data and evaluate the risk of bias and reporting quality according to the CONSORT statement. To verify the availability of reports and publications derived from the identified trials in electronic databases, we will systematically search MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase and Scopus. All identified RCTs and CCTs not yet included in CENTRAL will be added to the database. Additionally, we will compare handsearching supported by the Paperfetcher tool with unsupported handsearching to evaluate the tool’s effectiveness in a Hungarian language context.

Ethics and dissemination
Since the publication resulting from the handsearching activity is a retrospective review of publicly available sources of evidence, ethical approval is not required. The study findings will be submitted for publication in a peer-reviewed journal and will be presented at international conferences.

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Effect of prednisolone on live birth rate in women with unexplained recurrent pregnancy loss: a study protocol for a double-blind, placebo-controlled, multicentre, randomised controlled trial (PREMI-study)

Introduction
Recurrent pregnancy loss (RPL) is defined as the occurrence of two or more spontaneous pregnancy losses from the time of conception until 24 weeks of gestation. Currently, an underlying cause can be identified in only a minority of the losses. Potentially, an impaired maternal immune response targeting the semiallograft pregnancy may lead to miscarriage. While prior studies have explored the use of immune-suppressing corticosteroids to modulate the maternal immune system and hopefully improve pregnancy outcome, the absence of sufficiently powered randomised controlled trials (RCT) underscores the need for further research. The primary aim of this study is to evaluate if prednisolone administration in early pregnancy (20 mg daily for 6 weeks, then tapering doses for 2 weeks) in women with unexplained RPL leads to a higher live birth rate (LBR) in comparison to placebo. Additionally, the study assesses the tolerability, safety and the cost-effectiveness of this intervention. Finally, we will explore the effect of prednisolone in various subgroups (based on maternal age, number of previous pregnancy losses, presence of specific antibodies and pre-pregnancy endometrial immune cell level).

Methods and analysis
This ongoing multicentre, double-blind RCT will randomise 490 women with unexplained RPL and pregnancy

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Efficacy of oral nutrition supplementation enriched with hydroxymethylbutyrate (HMB) and undenatured type-II collagen (UC-II) combined with exercise training on osteoarthritis-related outcomes among adults with knee osteoarthritis in Klang Valley of Malaysia: study protocol for a randomised controlled trial

Introduction
Knee osteoarthritis (OA) is a serious public health problem since it is linked to loss of muscular function and independence, especially in older adults. In this study, the researchers have proposed a randomised controlled trial with a three-arm study strategy to explore the effectiveness of an oral nutritional supplementation containing hydroxymethylbutyrate and undenatured type-II collagen combined with exercise training (ET) on the OA-related symptoms and biomarkers among adults with knee OA.

Methods and analysis
Adults with knee OA aged between 50 years and 75 years will be invited to participate in the study and thereafter will be randomly assigned to either one of three groups: oral nutrition supplementation+ET, ET or usual care. The primary outcomes include changes in OA-related symptoms and biomarkers. The secondary outcomes include changes in body composition, blood profiles, physical fitness, quality of life, dietary intake, disability, psychology status and morphological changes of the knee.

Ethics and dissemination
Ethics approval was granted by the Medical Research Ethics Committee of the National University of Malaysia (reference number JEP-2024–264). Findings of this study will be disseminated via peer-reviewed presentations at scientific conferences as well as open access publications.

Trial registration number
ISRCTN14284561.

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Short-term and long-term outcomes of hybrid revascularisation procedures in peripheral artery disease: a systematic review protocol

Introduction
Peripheral artery disease (PAD) is a chronic condition causing arterial narrowing or blockage, leading to significant morbidity and mortality. Hybrid revascularisation combines open surgical and endovascular techniques to manage multilevel disease by addressing inflow and outflow obstructions. Despite increasing adoption, evidence on the long-term outcomes of these procedures remains limited.

Objective
To evaluate the long-term outcomes of hybrid revascularisation procedures in PAD, including patency rates, limb salvage, survival, reintervention rates and complications, and to provide evidence-based insights for clinical practice and research.

Methods and analysis
This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. It will include randomised controlled trials, cohort studies, case-control studies and large case series (≥10 patients, with at least 1 year of follow-up) assessing adult patients undergoing hybrid revascularisation for PAD. Primary outcomes are patency rates, limb salvage and survival; secondary outcomes include complication rates, functional improvements and quality of life. Searches will be conducted in PubMed, Embase, Cochrane Library, CINAHL and ClinicalTrials.gov. Study selection, data extraction and quality assessment will be performed independently in duplicate by two reviewers. Meta-analyses with random-effects models will summarise findings where feasible, while narrative synthesis will address instances of insufficient data. Subgroup analyses will explore outcomes by demographics, lesion characteristics and procedural details. Risk of bias will be assessed using Cochrane and Newcastle-Ottawa tools.

Ethics and dissemination
Ethical approval is not required. Findings will be published in peer-reviewed journals and presented at conferences.

PROSPERO registration number
CRD42024615809.

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CT Perfusion for Predicting Ischemic Stroke in Patients With Symptomatic Carotid or Middle Cerebral Artery Occlusion: A Post Hoc Analysis of the CMOSS Study

Stroke, Ahead of Print. BACKGROUND:It is unknown whether computed tomographic perfusion (CTP) parameters predict ischemic stroke in patients with symptomatic chronic carotid or middle cerebral artery occlusion.METHODS:A post hoc analysis of medically treated patients enrolled in the CMOSS trial (Carotid or Middle Cerebral Artery Occlusion Surgery Study; REGISTRATION: URL:https://www.clinicaltrials.gov; Unique identifier: NCT01758614), a randomized controlled trial conducted at 13 centers in China between June 2013 and March 2018. It aimed to compare extracranial-intracranial bypass surgery to medical therapy in patients with symptomatic carotid or middle cerebral artery occlusion and hemodynamic insufficiency. CTP-derived mean transit time and relative cerebral blood flow were collected. The primary outcome was defined as ischemic stroke in the territory of the qualifying artery within 2 years after randomization. The predictive value of CTP for the primary outcome was analyzed by a Cox regression model. Receiver operating characteristic curves were used to calculate optimal cutoff values of CTP parameters.RESULTS:All 165 per-protocol patients (median age=53.7 years, 81.2% males) treated with medical treatment alone were analyzed. Sixteen (9.7%) patients suffered the primary outcome during the 2-year follow-up. Cutoff values of mean transit time >6.5 seconds (symptomatic side) and relative cerebral blood flow ≤0.5 were associated with recurrent stroke. In multivariate Cox regression, mean transit time (adjusted hazard ratio, 3.50 [95% CI, 1.19–10.30];P=0.02) and relative cerebral blood flow (adjusted hazard ratio, 7.36 [95% CI, 2.27–23.85];P=0.001) were independently associated with the primary outcome.CONCLUSIONS:CTP-based hemodynamic parameters are predictive of recurrent ischemic stroke in symptomatic patients with chronic carotid or middle cerebral artery occlusion. CTP could be used in patient selection for stratified secondary prevention of stroke in future studies.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT01758614.

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Trends and regional disparities in the global burden of disease attributable to household air pollution in 204 countries and territories, 1990-2021: an analysis of the global burden of disease study

Objectives
We aimed to analyse the disease burden and trends related to household air pollution (HAP) from 1990 to 2021 and to assess the correlation between development status and HAP burden using the Sociodemographic Index (SDI).

Design
Observational study using data from the global burden of disease (GBD) 2021.

Main outcomes and measures
The GBD results tool provided comprehensive data on disability-adjusted life years (DALYs) attributable to HAP, stratified by age, sex, year, and geographical location.

Results
A significant reduction of approximately 50% in global HAP-related DALYs was observed between 1990 and 2021. However, a minor increase in HAP-related DALYs was noted between 2020 and 2021. The highest burden was found in children under five. Males generally had higher DALY rates than females. A negative correlation was identified between SDI and HAP-related DALY rates, with the highest rate in Oceania and the lowest in high-income North America. Maternal and neonatal disorders, cardiovascular diseases, respiratory infections and tuberculosis, and chronic respiratory diseases were the leading causes of HAP-related DALYs.

Conclusion
The study highlighted the progress in reducing the global burden of HAP-related diseases, yet it also revealed persistent disparities that require targeted public health interventions. Continued efforts to promote cleaner energy solutions and address regional, age and gender-specific vulnerabilities are essential for further reducing the health impact of HAP. Future research should focus on understanding the contributing factors to these disparities and developing innovative mitigation strategies.

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Patient-informed outpatient intervention to improve pregnancy outcomes through connections to social services: protocol for the BETTER randomised controlled trial

Introduction
A substantial portion of the 3.6 million births per year in the USA (approximately 25%–30%) occur in the context of adverse pregnancy outcomes (APOs), including preterm birth (PTB), hypertensive disorders of pregnancy (HDP) and small-for-gestational-age (SGA) birth. Black individuals have a 2–3-fold higher risk of APOs and a similarly increased risk of maternal morbidity and mortality compared with White individuals. Adverse social determinants of health (SDoH) are at the root of this disparity and contribute to it through multiple mechanisms. Maternal anaemia is an upstream factor associated with severe maternal morbidity, maternal mortality and other APOs and is also associated with adverse SDoH. Effectively and efficiently addressing social needs arising from adverse SDoH in the obstetric setting can be difficult due to varying patient preferences, resource accessibility and clinic workflows. The Better Birth Outcomes Through Technology, Education and Reporting (BETTER) intervention attempts to account for these barriers by encouraging patients to address social needs through motivational interviewing and by sending recurring text messages that provide links to multiple kinds of social service resources.

Methods and analysis
We will use a two-arm randomised controlled trial to evaluate the effects of providing patients with a motivational interviewing session and text messages with links to multiple resources to address their social needs compared with patients receiving usual care. We will recruit 550 pregnant individuals less than 21 weeks of gestation from two university prenatal clinics that primarily serve Medicaid-covered individuals in an urban city in the Midwestern USA. We will assess whether the intervention reduces the primary outcome of maternal anaemia measured as haemoglobin

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