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☐ ☆ ✇ BMJ Open

Baseline sociodemographic and sexual and reproductive health characteristics of the AdSEARCH adolescent cohort study participants in rural Bangladesh: a cohort profile

Por: Alam · A. · Shiblee · S. I. · Rana · M. S. · Sheikh · S. P. · Rahman · F. N. · Sathi · S. S. · Alam · M. M. · Sharmin · I. · Arifeen · S. E. · Rahman · A. E. · Ahmed · A. · Nahar · Q. — Septiembre 25th 2025 at 11:09
Purpose

In Bangladesh, evidence on the long-term trajectory of adolescents' sexual and reproductive health (SRH) remains limited, largely due to the lack of longitudinal data to assess the changes over time. To address this gap, the Advancing Sexual and Reproductive Health and Rights (AdSEARCH) project of International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) set up an adolescent cohort study aimed at documenting changes in SRH knowledge, attitudes and practices, and identifying the factors affecting these changes. This article presents the baseline sociodemographic and SRH characteristics of this cohort as a pathway for future analyses.

Participants

This cohort study included 2713 adolescents from the Baliakandi Health and Demographic Surveillance System run by icddr,b. The cohort covered three age groups from girls and boys, giving a total of five cohorts: girls aged 12, 14 and 16 years; and boys aged 14 and 16 years. A total of seven rounds of data had been collected at 4-month intervals over 2-years follow-up period.

Findings from the baseline

The majority of adolescents were attending school (90%), and school dropouts were higher among boys. Around 17% of the respondents were involved in income-generating activities, which were mostly boys. Among girls, the mean age of menarche was 12.2 years. Overall, 6% of adolescents had major depressive disorder, with prevalence increasing with age. Gender differences were evident regarding knowledge about conception and contraception. Egalitarian attitudes towards social norms and gender roles were found higher among girls (52%) compared to boys (11%). The majority of adolescents reported experiencing social/verbal bullying (43%), followed by physical violence (38%) and cyberbullying (4%).

Future plans

This article presents the baseline findings only. A series of papers is in the pipeline for submission to different peer-reviewed journals. The findings from this study will be used to support data-driven policy formulation for future adolescent health programmes.

☐ ☆ ✇ BMJ Open

Evaluating the diagnostic accuracy of WHO-recommended treatment decision algorithms for childhood tuberculosis using an individual person dataset: a study protocol

Por: Olbrich · L. · Larsson · L. · Dodd · P. · Palmer · M. · Nguyen · M. H. T. N. · dElbee · M. · Hesseling · A. C. · Heinrich · N. · Zar · H. J. · Ntinginya · N. E. · Khosa · C. · Nliwasa · M. · Verghese · V. · Bonnet · M. · Wobudeya · E. · Nduna · B. · Moh · R. · Mwanga · J. · Mustapha · A. · B — Septiembre 18th 2025 at 03:51
Introduction

In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children

Methods and analysis

Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.

Ethics and dissemination

This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.

☐ ☆ ✇ BMJ Open

Predictive value of monocytes for coronary heart disease in Chinese adults: a population-based cohort study

Por: Pei · J. · Zaid · M. · Wu · Y. · Wang · N. · Liu · X. · Zhao · Q. · Jiang · Y. · Xu · W. H. · Zhao · G. — Septiembre 16th 2025 at 03:21
Objectives

The development of simple tools to identify individuals at high risk of coronary heart disease (CHD) would enable rapid implementation of preventive measures. This study was designed to construct predictive models and scoring systems for CHD using monocyte count and its ratio to high-density lipoprotein cholesterol (HDL-C) (MHR).

Design

Population-based prospective cohort study.

Setting

The Shanghai Suburban Adult Cohort and Biobank (SSACB).

Participants and outcome measures

This prospective study included 44 013 CHD-free participants of the SSACB. The Songjiang subcohort served as the training set, in which three predictive models and corresponding scoring systems were developed with monocyte count or MHR using stepwise Cox regression. The models and algorithms were tested internally using 10-fold cross-validation and externally in the Jiading subcohort. Discriminations were assessed based on area under the curve (AUC) values, while calibrations were evaluated using the Hosmer-Lemeshow goodness-of-fit test.

Results

During a mean follow-up period of 4.8 years, 883 CHD events occurred, with an incidence of 415.7/100 000. Monocyte count and MHR were significantly associated with the risk of CHD. The constructed model incorporating monocyte count (Model 2) achieved AUC values of 0.746 (0.726, 0.766) for 4-year CHD prediction in the training set, 0.746 (0.690, 0.796) in the cross-validation, and 0.717 (0.674, 0.761) in the external validation, comparable to the models including HDL-C (model 1) or MHR (model 3). Calibration plots demonstrated good agreement between predicted and actual probabilities. Similar results were observed for the corresponding scoring algorithms.

Conclusions

The monocyte-based model is a simple, low-cost and well-calibrated risk-stratification tool for CHD. However, the declined discrimination in external validation indicates limited generalisability. Prospective multicentre validation and recalibration are therefore warranted before clinical adoption.

☐ ☆ ✇ BMJ Open

Budget impact analysis of glecaprevir/pibrentasvir treatment for hepatitis C in Iran: a modelling study

Por: Jafari · M. · Mehdizadeh · P. · Keshavarz · K. · Teymourzadeh · E. · Abyazi · M. A. · Gholamreza Shirazi · P. — Septiembre 12th 2025 at 05:14
Objectives

Glecaprevir/pibrentasvir (GLE/PIB), despite being a highly costly medication, is considered a cost-effective approach compared with sofosbuvir/velpatasvir (SOF/VEL) and sofosbuvir/daclatasvir (SOF/DCV) in the treatment of hepatitis C virus (HCV) infection. No study has evaluated the effect of GLE/PIB’s introduction into Iran’s drug list from a health policy perspective and estimated the budgetary impact change. Therefore, this study was conducted to analyse the fiscal effect of the introduction of GLE/PIB into Iran’s drug list.

Design

Budget impact analysis. The assumptions and costs of including GLE/PIB in Iran’s drug list for the treatment of patients with hepatitis C were derived from a conducted cost-effectiveness analysis.

Setting

National level. In this study, the budgetary changes in Iran’s pharmaceutical market and health system, from the Ministry of Health’s perspective, have been estimated for a 5-year time horizon following the introduction of GLE/PIB in the country.

Results

Based on the results obtained from the budget impact model, currently, 4112 patients are receiving SOF/DCV and SOF/VEL therapeutic regimens, which is expected to decrease to 1093 in 2029 owing to the affordability of medications and a 50% estimated market share for GLE/PIB. According to the results, with the introduction of GLE/PIB into the market and assuming a market share of 10% in the first year, growing to 50% by the fifth year, the healthcare system costs will increase by approximately $0.61, $1.77, $3.86, $7.45 and $13.51 million over the next 5 years, respectively. Additionally, based on the drug’s selling price, there will be a 468% increase in hepatitis C drug market costs after 5 years, resulting in an overall budget increase of approximately 0.13% for Iran’s pharmaceutical market. According to the sensitivity analysis, a 20% reduction in chronic hepatitis C (CHC) costs could decrease the projected increase in health sector costs from $13.51 million (an 18.84% increase) to $10.52 million (an 18.16% increase). Conversely, a 20% rise in CHC costs would raise those costs to $16.49 million (a 19.31% increase).

Conclusion

Considering the high price of the GLE/PIB compared with the available options in Iran, with the introduction of GLE/PIB into Iran’s drug list, insurance coverage and appropriate allocation of necessary resources, a reduction in the cost burden because of hepatitis C treatment is expected for individuals and households. Additionally, with a well-regulated market share of existing medications, the optimal treatment choice for patients will be feasible.

☐ ☆ ✇ BMJ Open

Protocol: Faecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab - a multicentre, randomised, placebo-controlled, double-blind phase II trial (the FLORA trial)

Por: Rauber · C. · Roberti · M. P. · Vehreschild · M. J. · Tsakmaklis · A. · Springfeld · C. · Teufel · A. · Ettrich · T. · Jochheim · L. · Kandulski · A. · Missios · P. · Mohr · R. · Reichart · A. · Waldschmidt · D. T. · Sauer · L. D. · Sander · A. · Schirmacher · P. · Jäger · D. · Michl — Septiembre 10th 2025 at 05:45
Introduction

Combined vascular endothelial growth factor/programmed death-ligand 1 blockade through atezolizumab/bevacizumab (A/B) is the current standard of care in advanced hepatocellular carcinoma (HCC). A/B substantially improved objective response rates compared with tyrosine kinase inhibitor sorafenib; however, a majority of patients will still not respond to A/B. Strong scientific rationale and emerging clinical data suggest that faecal microbiota transfer (FMT) may improve antitumour immune response on PD-(L)1 blockade. Early trials in melanoma with FMT and reinduction of immune checkpoint blockade (ICI) therapy in patients with anti-PD-1-refractory metastatic melanoma were reported in 2021 and demonstrated reinstatement of response to ICI therapy in many patients. Due to anatomical vicinity and the physiological relevance of the gut-liver axis, we hypothesise HCC to be a particularly attractive cancer entity to further assess a potential benefit of FMT in combination with ICI towards increased antitumour immunity. Additionally, HCC often occurs in patients with liver cirrhosis, where liver function is prognostically relevant. There is evidence that FMT may increase hepatic function and therefore could positively affect outcome in this patient population.

Methods and analysis

This prospective, multicentre, randomised, placebo-controlled, double-blind phase II clinical trial has been designed to assess immunogenicity and safety of FMT via INTESTIFIX 001 combined with A/B in advanced HCC in comparison to A/B with placebo. Primary endpoints are measured as tumour CD8+ T cell infiltration after 2 cycles of treatment with vancomycin, A/B+INTESTIFIX 001 in comparison to vancomycin-placebo, A/B+INTESTIFIX 001-placebo and safety of the therapeutic combination in advanced HCC. INTESTIFIX 001 is an encapsulated FMT preparation by healthy donors with a high alpha-diversity in their gut microbiome for oral administration, manufactured by the Cologne Microbiota Bank (CMB). Sample size was calculated to achieve a specific expected accuracy for the primary immunological endpoint. 48 subjects will be randomised to reach a goal of 42 usable measurements in the modified intention-to-treat set. Subjects will be randomised in a 2:1 ratio to A/B or placebo (28 A/B, 14 placebo).

Ethics and dissemination

The study was approved by ethics committee review and the German Federal Ministry of Drugs and Medical Devices. The trial is registered under EU CT no. 2023-506887-15-00. The outcome of the study will be disseminated via peer-reviewed publications and at international conferences.

Trial registration number

NCT05690048.

☐ ☆ ✇ BMJ Open

Economic evaluation of integrating nutritional support intervention in Indias National Tuberculosis Elimination Programme: implications for low-income and middle-income countries

Por: Jyani · G. · Prinja · S. · Nadipally · S. · Shankar · M. · Rao · N. · Rao · V. · Singh · R. R. · Shah · A. · Chugh · Y. · Monga · D. · Sharma · A. · Aggarwal · A. — Septiembre 4th 2025 at 15:50
Objectives

This study aimed to evaluate the cost-effectiveness of integrating nutritional support into India’s National Tuberculosis Elimination Programme (NTEP) using the MUKTI initiative.

Design

Economic evaluation.

Setting

Primary data on the cost of delivering healthcare services, out-of-pocket expenditure and health-related quality of life among patients with tuberculosis (TB) were collected from Dhar district of Madhya Pradesh, India.

Intervention

Integration of nutritional support (MUKTI initiative) into the NTEP of India.

Control

Routine standard of care in the NTEP of India.

Primary outcome measure

Incremental cost per quality-adjusted life year (QALY) gained.

Methods

A mathematical model, combining a Markov model and a compartmental susceptible–infected–recovered model, was used to simulate outcomes for patients with pulmonary TB under NTEP and MUKTI protocols. Primary data collected from 2615 patients with TB, supplemented with estimates from published literature, were used to model progression of disease, treatment outcomes and community transmission dynamics over a 2-year time horizon. Health-related quality of life was assessed using the EuroQol 5-Dimension 5-Level scale. Costs to the health system and out-of-pocket expenditures were included. A multivariable probabilistic sensitivity analysis was undertaken to estimate the effect of joint parameter uncertainty. A scenario analysis explored outcomes without considering community transmission. Results are presented based on health-system and abridged societal perspectives.

Results

Over 2 years, patients in the NTEP plus MUKTI programme had higher life years (1.693 vs 1.622) and QALYs (1.357 vs 1.294) than those in NTEP alone, with increased health system costs (11 538 vs 6807 (US$139 vs US$82)). Incremental cost per life year gained and QALY gained were 67 164 (US$809) and 76 306 (US$919), respectively. At the per capita gross domestic product threshold of 161 500 (US$1946) for India, the MUKTI programme had a 99.9% probability of being cost-effective but exceeded the threshold when excluding community transmission.

Conclusion

The findings highlight the potential benefits of a cost-effective, holistic approach that addresses socio-economic determinants such as nutrition. Reduction in community transmission is the driver of cost-effectiveness of nutritional interventions in patients with TB.

☐ ☆ ✇ BMJ Open

Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol

Por: Ranard · B. L. · Qian · M. · Cummings · M. J. · Zhang · D. Y. · Lee · S. M. · Beitler · J. R. · Applebaum · J. R. · Schenck · E. J. · Mohamed · H. · Trepp · R. · Hsu · H. · Scofi · J. · Southern · W. N. · Rossetti · S. C. · Yip · N. H. · Brodie · D. · Sharma · M. · Fertel · B. S. · Adelman — Agosto 12th 2025 at 03:13
Introduction

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

Methods and analysis

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics and dissemination

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

Trial registration number

ClinicalTrials.gov: NCT06117605 and NCT06117618.

☐ ☆ ✇ BMJ Open

Clinical outcomes and interventions related to sedentary behaviours in childhood, adolescent, and young adult cancer patients and survivors: a scoping review protocol

Por: Ivory · B. J. · Moore · K. · Dinalo · J. E. · Ness · K. K. · Orgel · E. · Dieli-Conwright · C. M. · Kadan-Lottick · N. S. · Freyer · D. R. · Belcher · B. R. — Agosto 12th 2025 at 03:13
Introduction

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

Methods and analysis

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics and dissemination

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

Registration details

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

☐ ☆ ✇ BMJ Open

Sociocultural correlates and epidemiological patterns of non-alcoholic beer consumption: a cross-sectional study in Poland

Por: Silczuk · A. · Lewandowska · A. · Baran · T. · Koweszko · T. · Mularczyk-Tomczewska · P. · Gujska · J. · Tatara · M. · Gałecka · M. — Julio 29th 2025 at 06:15
Objectives

To investigate the sociocultural and epidemiological factors associated with non-alcoholic beer (NAB) consumption in Poland, including motivations for use, consumption context, and its reported impact on alcohol consumption patterns.

Design

Cross-sectional survey study.

Setting

Community setting across Poland; data were collected in December 2024.

Participants

A total of 1114 adults aged 18–84 years (mean age: 47.1±14.4 years; 54.3% female) completed the questionnaire. Participants were recruited through an online panel using stratified quota sampling to approximate national population distributions by age, sex and region. Inclusion criteria were age ≥18 years and residence in Poland. No exclusion criteria beyond informed consent were applied.

Interventions

Not applicable.

Primary and secondary outcome measures

The primary outcome was current NAB use, defined as self-reported consumption of NAB. Secondary outcomes included sociodemographic correlates, reasons for use, consumption contexts and self-reported changes in alcoholic beer consumption following NAB adoption.

Results

70.6% of respondents reported current NAB use. Multivariable logistic regression showed that age 18–49 years (p

Conclusions

NAB consumption in Poland is associated with identifiable sociodemographic characteristics and motivated by practical and health-related considerations. While nearly half of current users report reduced or substituted alcohol intake, a substantial proportion incorporate NAB into existing drinking routines without change or with increased alcohol use. These findings suggest a heterogeneous behavioural impact, underlining the need for nuanced public health messaging and further research into the long-term effects of NAB use on alcohol-related outcomes.

☐ ☆ ✇ BMJ Open

Effectiveness and cost-effectiveness of community-based TB screening algorithms using computer-aided detection (CAD) technology alone compared with CAD combined with point-of-care C reactive protein testing in Lesotho and South Africa: protocol for a pair

Por: Signorell · A. · van Heerden · A. · Ayakaka · I. · Jacobs · B. K. · Antillon · M. · Tediosi · F. · Verjans · A. · Brugger · C. · Harkare · H. V. · Labhardt · N. D. · Bosman · S. · Kamele · M. · Keitseng · M. · Madonsela · T. · Kurscheid · J. · Muhairwe · J. · Keter · A. K. · Murphy · K. — Julio 28th 2025 at 11:15
Introduction

Tuberculosis (TB) remains a significant public health challenge in many African communities, where underreporting and underdiagnosis are prevalent due to barriers in accessing care and inadequate diagnostic tools. This is particularly concerning in hard-to-reach areas with a high burden of TB/HIV co-infection, where missed or delayed diagnoses exacerbate disease transmission, increase mortality and lead to severe economic and health consequences. To address these challenges, it is crucial to evaluate innovative, cost-effective, community-based screening strategies that can improve early detection and linkage to care.

Methods and analysis

We conduct a prospective, community-based, diagnostic, pragmatic trial in communities of the Butha Buthe District in Lesotho and the Greater Edendale area of Msunduzi Municipality, KwaZulu-Natal in South Africa to compare two strategies for population-based TB screening: computer-aided detection (CAD) technology alone (CAD4TBv7 approach) versus CAD combined with point-of-care C reactive protein (CRP) testing (CAD4TBv7-CRP approach). Following a chest X-ray, CAD produces an abnormality score, which indicates the likelihood of TB. Score thresholds informing the screening logic for both approaches were determined based on the WHO’s target product profile for a TB screening test. CAD scores above a threshold prespecified for the CAD4TBv7 approach indicate confirmatory testing for TB (Xpert MTB/RIF Ultra). For the CAD4TBv7-CRP approach, a CAD score within a predefined window requires the conduct of the second screening test, CRP, while a score above the respective upper threshold is followed by Xpert MTB/RIF Ultra. A CRP result above the selected cut-off also requires a confirmatory TB test. Participants with CAD scores below the (lower) threshold and those with CRP levels below the cut-off are considered screen-negative. The trial aims to compare the yield of detected TB cases and cost-effectiveness between two screening approaches by applying a paired screen-positive design. 20 000 adult participants will be enrolled and will receive a posterior anterior digital chest X-ray which is analysed by CAD software.

Ethics and dissemination

The protocol was approved by National Health Research Ethics Committee in Lesotho (NH-REC, ID52-2022), the Human Sciences Research Council Research Ethics Committee (HSRC REC, REC 2/23/09/20) and the Provincial Health Research Committee of the Department of Health of KwaZulu-Natal (KZ_202209_022) in South Africa and from the Swiss Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2022–00044). This manuscript is based on protocol V.4.0, 19 January 2024. Trial findings will be disseminated through peer-reviewed publications, conference presentations and through communication offices of the consortium partners and the project’s website (https://tbtriage.com/).

Trial registration

ClinicalTrials.gov (NCT05526885), South African National Clinical Trials Register (SANCTR; DOH-27-092022-8096).

☐ ☆ ✇ BMJ Open

Cluster randomised controlled trial of a household-level, group preconception nutrition awareness and norm intervention (SUMADHUR) combined with multiple micronutrient supplements (MMS) for newly married households: a protocol

Por: Diamond-Smith · N. · Puri · M. C. · Borak · L. · Walker · D. · Charlebois · E. · Weiser · S. D. · McDonald · C. M. — Julio 25th 2025 at 10:04
Introduction

Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.

Methods and analysis

This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B12). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.

Ethics and dissemination

The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.

All data will be made publicly available (deidentified) after the publication of the main impact paper.

Trial registration number

NCT06810440.

☐ ☆ ✇ BMJ Open

Study protocol for a multi-centre randomised controlled trial of the Thai early intervention for autism: Assistive Technology for Caregivers (TEI4A-ATC) across nine hospitals in health region 1, northern Thailand

Por: Tangviriyapaiboon · D. · Sirithongthaworn · S. · Thaineua · V. · Kanshana · S. · Sriminipun · A. · Lersilp · S. · Panyo · K. · Changsom · K. · Panyaphab · M. · Srikummoon · P. · Thumronglaohapun · S. · Sricharoen · N. · Traisathit · P. — Julio 22nd 2025 at 06:08
Introduction

The management of autism spectrum disorder (ASD) involves a varied and comprehensive range of support services at various stages of an autistic individual’s life. In Thailand, parents/legal guardians of children with ASD often encounter challenges such as difficulty travelling from rural areas to access support services. The aim of the present study is to investigate the effectiveness of a computer-based intervention programme for caregivers of children with ASD called the Thai Early Intervention for Autism—Assistive Technology for Caregivers (TEI4A-ATC), designed and implemented by a multidisciplinary team.

Method and analysis

160 children and their caregivers are being recruited. They will be randomised 1:1 into two treatment arms: access to TEI4A-ATC for the intervention group and standard care for the control group. Before enrolment, ASD diagnosis will be conducted using the Thai Diagnostic Autism Scale: children’s ASD scores will be determined using the Thai Autism Treatment Evaluation Checklist for evaluating communication, sociability and sensory/cognitive awareness and the Thai Early Developmental Assessment for Intervention for evaluating motor skills, social interaction, language development and problem-solving. Both assessment tools will be used again after 3 months of treatment. Similarly, the caregivers’ knowledge, attitude and practice (KAP) for ASD care will be assessed using a questionnaire at enrolment and again after treatment. Comparison of the children’s ASD scores and caregivers’ KAP responses between the treatment groups and before and after treatment will be performed based on the intention-to-treat principle.

Ethics and dissemination

This study was approved by the Human Research Ethics Committee for Mental Health and Psychiatry, Department of Mental Health, Ministry of Public Health (DMH.IRB.COA 037/2565). Written informed consent will be obtained from the participants prior to enrolment. The study’s findings may be disseminated through scientific publications and conference presentations. The results of the study will be shared with key stakeholders, including caregivers, psychiatrists, policymakers and the general public, via appropriate dissemination channels to aid in creating appropriate practice and policy guidelines.

Trial registration number

This study was registered with the Thai Clinical Trials Registry (TCTR20240320010) on 20 March 2024.

☐ ☆ ✇ BMJ Open

Participants perspectives of the advanced ovarian cancer biomarker study VALTIVE1: a qualitative study

Por: Holland-Hart · D. · Carucci · M. · Slusarczyk · M. · Longo · M. · Campbell · S. · Irving · A. · Noble · S. · Jayson · G. · Hopewell-Kelly · N. — Julio 14th 2025 at 04:23
Objectives

VALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants’ perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test.

Design

This qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis.

Settings

Cancer treatment sites in the UK.

Participants

Participants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites.

Results

Participants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects.

Conclusion

A future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials.

Trial registration number

NCT04523116.

☐ ☆ ✇ BMJ Open

Mis- and disinformation and perceptions of healthcare policy among Latinos in the USA: protocol for a multi-method social media sentiment analysis study

Por: Wilson · F. A. · Stimpson · J. P. · Young · M.-E. D. T. · Bustamante · A. V. · Ponce · N. A. · Ortega · A. N. — Julio 4th 2025 at 04:45
Introduction

It is unclear how mis- and disinformation regarding healthcare policy changes propagate throughout Latino communities via social media. This may lead to chilling effects that dissuade eligible individuals from enrolling in critical safety net programmes such as Medicaid. This study will examine pathways and mechanisms by which sentiment in response to mis- and disinformation regarding healthcare policies on social media differentially impact health disparity populations, thus supporting the design of tailored social media interventions to mitigate this.

Methods and analysis

We will search social media from X/Twitter, Facebook/Instagram and Reddit for keywords relating to health benefit programmes. Demographic, geographical location and other characteristics of users will be used to stratify social media data. Posts will be classified as fake-news-related or fact-related based on curated lists of fake-news-related websites. The number, temporal dissemination and positive or negative sentiment in reacting to posts and threads will be examined using the Python-based Valence Aware Dictionary and sEntiment Reasoner (VADER). Using a crowd-sourcing methodology, a novel Spanish-language VADER (S-VADER) will be created to rate sentiment to social media among Spanish-speaking Latinos. With the proposed approach, we will explore reactions to the dissemination of fake-news- or fact-related social media tweets and posts and their sources. Analyses of social media posts in response to healthcare-related policies will provide insights into fears faced by Latinos and Spanish speakers, as well as positive or negative perceptions relating to the policy over time among social media users.

Ethics and dissemination

Our study protocol was approved by the University of California, Los Angeles IRB (IRB#23–0 01 123). Results from this study will be disseminated in peer-reviewed journals and conference presentations, and S-VADER will be disseminated to public repositories such as GitHub.

☐ ☆ ✇ Nursing Research

Z-Coding for Social Contributors to Health in Colorado Federally Qualified Health Centers

imageBackground Federally Qualified Health Centers (FQHC) provide services to individuals facing systemic barriers to health equity and are disproportionately affected by adverse social determinants of health. To better align healthcare services with the needs of those individuals experiencing health inequities, it is essential to screen for and document problematic social contributors to health in electronic health records, which health systems have been mandated to document by 2026. Objectives The aims of this study were to 1) determine the prevalence of documented social contributors to health Z-codes among patients receiving care through Colorado nurse-led FQHCs across urban, rural, and frontier settings; and 2) estimate healthcare utilization and expenditures associated with the presence of documented social contributors to health Z-codes compared to a matched sample of patients without that Z-code documentation. Methods We conducted a secondary analysis of the Colorado All Payers Claim Database. Social contributor of health ICD-10 Z-codes, reflecting problematic social structural circumstances as defined by Healthy People 2030, were extracted from patients receiving care in FQHCs. Social contributor of health-related charges were computed using propensity matching to compare individuals with and without documented social contributors of health. Results Documentation of social contributors of health Z-codes was notably low. Housing instability was the most common Z-code documented. Chronic pulmonary disease, diabetes, and heart disease were the most prevalent comorbidities among those with identified social contributors of health. The majority of patients with social contributors of health Z-codes were insured through Medicaid and lived in rural areas. Persons with documented social contributors of health had significantly higher predicted annual medical expenditures compared to those without documentation. Discussion The low prevalence of social contributors of health coding aligns with previous studies and represents a missed opportunity to provide targeted interventions for populations experiencing adverse social contributors. These findings underscore the need for strategizing and implementing plans to identify and code social contributors of health, especially in facilities serving those experiencing health inequities. Improved documentation of social contributors to health can facilitate data-driven resource allocation and tailored interventions to address adverse social determinants and promote health equity.
☐ ☆ ✇ Nursing Research

Factors Related to Stroke Awareness and Severity in an Underserved Urban Community

imageBackground Despite experiencing an increased incidence in stroke, minority groups have the lowest reported knowledge of stroke signs and symptoms and are less likely to receive time-sensitive interventions. There is a need to explore the relationship between social determinants of health and stroke awareness and severity within at-risk communities. Objectives The aim of this study was to explore relationships between social determinants of health and stroke awareness and severity in an underserved area located in a city borough in Northeastern United States. Methods We used an exploratory descriptive retrospective design and existing data. Data from 1,162 patients discharged with a principal diagnosis of stroke (ischemic stroke, subarachnoid hemorrhage, or intracerebral hemorrhage) were analyzed to explore the relationship between social determinants of health (age, sex, race, ethnicity, payer status, zip code) and stroke awareness and severity. Results Age group, race, and hospital arrival method were all significant indicators of time to arrival at the hospital. When holding all other factors in the model constant, being 65 years of age or older was associated with a decrease in time to reach the hospital compared to those under 65 years of age. Those who traveled by private transport had longer discovery to arrival times when holding all other factors constant, as compared to those who arrived by emergency medical services. Compared to persons who were White, persons who were Black or Asian saw increased times to hospital arrival. Discussion This study found that social determinants of health including age, race, sex, and insurance type significantly influenced stroke awareness and/or severity. These study findings can be used by stroke program leadership and community nurses to direct community-centered stroke awareness outreach.
☐ ☆ ✇ Nursing Research

Urine Metabolites as Indicators of Chronic Pain and Related Symptoms in Active-Duty Service Members: A Secondary Data Analysis of a Pragmatic Clinical Trial With SMART Design

imageBackground Chronic pain is a major cause of distress and disability, and biomarkers may aid in the assessment and treatment of it. Urine metabolites may be valuable bioindicators that can provide biological insight regarding chronic pain. Objectives To investigate the relationship between a multimarker composite measure of metabolites and patient-reported outcomes scores in adults with chronic pain, using data from a pragmatic clinical trial with a sequential, multiple-assignment randomized trial design. Methods Self-reported measures and urine samples from 169 active-duty service members with chronic pain were collected. Urine was analyzed using a preestablished panel of metabolites, including four previously identified biomarkers of pain: kynurenic acid, pyroglutamic acid, ethylmalonic acid, and methylmalonate. Multivariable linear regression models—adjusted for participant characteristics such as age and sex—were used to cross-sectionally examine the relationship between 11 patient-reported outcomes (fatigue, sleep-related impairment, anxiety, depression, anger, pain catastrophizing, physical function, pain interference, satisfaction with participation with social roles, pain intensity, and pain impact score) and the four urine metabolites both individually and as a composite (urine metabolite pain indicator, or UMPI). Given the study’s small sample size and exploratory nature, a significance threshold of p ≤ .10 was used for all analyses. Results The UMPI showed statistically significant associations with five self-reported measures (fatigue, anxiety, depression, physical functioning, and pain impact score); adjusted Pearson correlations ranged from .18 to .25. Individual metabolite analyses supported these findings, with all relationships between individual metabolites and self-reported measures showing positive associations. Kynurenic acid and ethylmalonic acid showed the strongest associations, each having statistically significant relationships with four individual self-reported measures, while pyroglutamic acid had statistically significant relationships with three self-reported measures and methylmalonate with none. The UMPI demonstrated feasible reliability. Discussion Our finding of associations between the UMPI and components of the self-reported measures supports the development of the UMPI and these four urine metabolites as biomarkers for chronic pain outcomes. Further research is planned and will be essential for establishing mechanistic insight and guiding biomarker development within the context of pain management.
☐ ☆ ✇ BMJ Open

Canakinumab for the treatment of postprandial hypoglycaemia: study protocol for a randomised, placebo-controlled, parallel-group, double-blind, multicentric, superiority trial--the CanpHy study

Por: Hepprich · M. · Fischer · J. · Cattaneo · M. · Ferreira · A. · Herzig · D. · Bally · L. · Donath · M. — Mayo 27th 2025 at 06:51
Introduction

Postbariatric hypoglycaemia (PBH) is a complex medical condition with a significant impact on patients’ quality of life. The underlying mechanisms remain to be elucidated. We have shown that food ingestion increases IL-1β and subsequently stimulates insulin secretion. We therefore hypothesised that overactivation of the IL-1β pathway could lead to PBH by promoting excessive insulin secretion after a meal. In a proof-of-concept study, we have shown that acute treatment with the IL-1 receptor antagonist anakinra can attenuate PBH after a single liquid mixed meal. This study aims to validate this therapeutic approach over a longer period of time using the long-acting anti-IL-1β antibody canakinumab.

Methods and analysis

In this prospective, randomised, double-blind, placebo-controlled, multicentre trial, we plan to enrol 62 adult patients after bariatric surgery with frequent, postprandial hypoglycaemia (ie,

Ethics and dissemination

The trial was approved by the Cantonal Ethics Committee ‘Ethikkommission Nordwest- und Zentralschweiz’ in January 2022 (#2021–02325), as well as by Swissmedic in April 2022 (#701280). Current, approved protocol version 1.3 of 28.03.2023. The study is actively recruiting. Results will be published in a relevant scientific journal and communicated to participants and relevant institutions through dissemination activities. Individual data are accessible on request.

Trial registration

The study is registered with the www.clinicaltrials.gov registry (NCT05401578) and the Swiss National Clinical Trials Portal (SNCTP) on www.kofam.ch (SNCTP000004838).

☐ ☆ ✇ BMJ Open

Understanding the relationship between adolescents with tuberculosis and health services: an indepth qualitative study from Cape Town

Por: Wademan · D. T. · Hoddinott · G. · Kavalieratos · Z. · Mlomzale · M. · Marthinus · A. J. · Jola · L. N. · Jacobs · S. · Mcimeli · K. · Seddon · J. — Mayo 25th 2025 at 02:10
Introduction

Adolescents’ experiences (10–19 years-old) with tuberculosis (TB) remain poorly understood. Descriptions of adolescent TB experiences, particularly how they interact with the health system, are scarce. We aimed to understand adolescents’ experiences of TB health services in the Western Cape, South Africa. We focused on how TB services were aided or hindered through interactions with healthcare providers and health system processes.

Methods

Teen TB, an observational study in Cape Town, enrolled 50 newly diagnosed adolescents with multidrug-resistant and drug-susceptible TB. A subset of 20 was selected for serial qualitative data collection, with 19 completing all tasks between December 2020 and September 2021. 52 interviews were conducted and thematically analysed using a case descriptive process for experiences across the TB care cascade.

Findings

Adolescents criticised the difficulties and delays they encountered in obtaining an accurate TB diagnosis. Initial misdiagnoses and delayed TB diagnoses were reported, despite seeking help from multiple healthcare providers at different facilities. Adolescents questioned whether the financial, social and emotional costs of TB care outweighed the costs of delaying treatment initiation and adherence. Adolescents reported that the treatment regimen, adherence support processes and interactions with the health system posed significant challenges to maintaining adherence. Encouragingly, however, most adolescents reported being well treated and cared for by health workers.

Conclusion

Our study shows that adolescents experience challenges throughout their TB treatment journeys. More adolescent-focused research is needed to tailor treatment and healthcare processes to their needs.

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