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.

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.

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%).

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.

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

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.

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.

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).

Population-based prospective cohort study.

The Shanghai Suburban Adult Cohort and Biobank (SSACB).

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.

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.

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.

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.

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.

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.

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).

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.

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.

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).

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.

NCT05690048.

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

Economic evaluation.

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.

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

Routine standard of care in the NTEP of India.

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

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.

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.

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.

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.

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 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.

ClinicalTrials.gov: NCT06117605 and NCT06117618.

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.

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 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.

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

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.

Cross-sectional survey study.

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

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.

Not applicable.

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.

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

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.

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.

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.

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/).

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

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.

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.

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.

NCT06810440.

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.

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.

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.

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

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.

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

Cancer treatment sites in the UK.

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

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.

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.

NCT04523116.

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.

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.

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.

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.

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,

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.

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

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.

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.

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.

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.

To assess the severity of anaemia and associated factors among drug-resistant tuberculosis (DR-TB) patients treated in DR-TB treatment-initiating centers in Addis Ababa, Ethiopia.

A retrospective cross-sectional study.

This study was conducted in Alert and St. Peters specialised hospitals, Addis Ababa, from 20 September to 15 October 2022.

Data was collected from 331 patients with DR-TB. The data was entered into Epi-Data 4.1, and SPSS version 25 was used for data cleaning and analysis. A multinomial logistic regression model was fitted after the multi-collinearity assumptions, and goodness-of-fit tests were done. The OR with 95% CI was reported for each outcome variable, taking normal haemoglobin level as a reference category. Variables with a P value of 0.05 were considered statistically significant.

Of the 331 patients, 51.4% had baseline anaemia, of which 5.7%, 15.7% and 29.9% had severe, moderate and mild anaemia, respectively.

Patients who were urban residents (AOR: 0.06, 95% CI: 0.012, 0.32), government employees (AOR: 0.33, 95% CI: 0.001, 0.79), private job holders (AOR: 0.02, 95% CI: 0.001, 0.27), undernourished (AOR: 15.72, 95% CI: 2.46, 100.28), patients with HIV (AOR: 7.28, 95% CI: 1.627, 32.628) and farmers and students (AOR: 0.05, 95% CI: 0.004, 0.58) were significantly associated with severe anaemia.

Patients who were male (AOR: 0.31, 95% CI: 0.11, 0.93), single (AOR: 0.19, 95% CI: 0.04, 0.85), daily labourer (AOR: 6.19, 95% CI: 1.27, 30.2), undernourished (AOR: 12.83, 95% CI: 4.88, 33.7) and patients with HIV (AOR: 12.74, 95% CI: 4.67, 34.75) were significantly associated with moderate anaemia. Patients with undernutrition (AOR: 3.92, 95% CI: 2.1, 7.35), HIV (AOR: 2.79, 95% CI: 1.22, 6.39) and primary and secondary education (AOR: 0.36, 95% CI: 0.17, 0.77) were significantly associated with mild anaemia.

In our study, more than 50% of patients with DR-TB had baseline anaemia, of which mild anaemia was the most common typeanaemia. Rural residents were at a higher risk of developing severe anaemia (11.5%), while the overall rate of anaemia (58.8%) was higher among urban residents.

A ‘cluster’ is an area with a higher occurrence of tuberculosis (TB) than would be expected in an average random distribution of that area. Tuberculosis clustering is commonly reported in Ethiopia, but most studies rely on registered data, which may miss patients who do not visit health facilities or those who attend but are not identified as having TB. This makes the detection of actual clusters challenging. This study analysed the clustering of pulmonary TB and associated risk factors using symptom-based population screening in Dale, Ethiopia.

A prospective population-based cohort study.

All households in 383 enumeration areas were visited three times over a 1-year period, at 4-month intervals.

Individuals with pulmonary TB aged ≥15 years with demographic, socioeconomic, clinical and geographical data residing in 383 enumeration areas (ie, the lowest unit/village in the kebele, each with approximately 600 residents).

Pulmonary TB (ie, bacteriologically confirmed by sputum microscopy, GeneXpert or culture plus clinically diagnosed pulmonary TB) and pulmonary TB clustering.

We identified pulmonary TB clustering in 45 out of the 383 enumeration areas. During the first round of screening, 39 enumeration areas showed pulmonary TB clustering, compared with only 3 enumeration areas in the second and third rounds. Our multilevel analysis found that enumeration areas with clusters were located farther from the health centres than other enumeration areas. No other determinants examined were associated with clustering.

The distribution of pulmonary TB was clustered in enumeration areas distant from the health centres. Routine systematic community screening may be costly, but using existing health infrastructure with health extension workers through targeted screening, they can identify and refer persons with TB symptoms more quickly for diagnosis and treatment, thereby decreasing the duration of disease transmission and contributing to the reduction of TB burden.

To assess the cost-effectiveness of aducanumab at its updated price for treating patients with mild cognitive impairment (MCI) and mild Alzheimer’s disease (AD).

Cost-effectiveness analysis.

A five-state Markov model was constructed using 10 000 virtual patients to assess the cost-effectiveness of aducanumab from the perspective of the US healthcare system. The model employed a one-year cycle time and a lifetime time horizon. Transition probabilities and mortality rates were derived from a literature review. To address uncertainty and generalise the base case results, both one-way and probabilistic sensitivity analyses were conducted.

10 000 virtual patients with MCI and mild AD.

The study group consisted of patients using aducanumab, while the control group consisted of those using a placebo.

Primary outcomes included costs and quality-adjusted life years (QALYs). In line with the healthcare system perspective, only direct medical costs were included. Drug costs were obtained from official records, while other medical costs were derived from literature reviews. Utilities used to calculate QALYs were also obtained from the literature. Incremental analysis was conducted to assess cost-effectiveness in the base case analysis by comparing the incremental cost-effectiveness ratio (ICER) against the willingness-to-pay (WTP) threshold. A discount rate of 3% was applied to both costs and effectiveness.

From the perspective of the US healthcare system, compared with the control group, the study group had an incremental cost of US$143 821.1 and an incremental QALY of 0.10. The ICER of patients using aducanumab compared with those using placebo was US$1 012 219.0 per QALY gained, which was much greater than the WTP threshold of US$50 000 to US$150 000, indicating that using aducanumab was not cost-effective. One-way sensitivity analysis showed the five most sensitive parameters were relative risk of progressing from MCI to mild AD, the utility of MCI, initial age, discount rate and the price of aducanumab. In the probabilistic sensitivity analysis, when the WTP was the WTP threshold of US$150 000, the probability of aducanumab being cost-effective was 0%. In addition, when the probability of aducanumab being cost-effective was 50%, the WTP was US$1 180 000, and when the probability of aducanumab being cost-effective was 95%, the WTP was US$1 906 000.

Even with the updated price being half of the original, aducanumab is still not cost-effective, underscoring the need for affordable, evidence-based AD treatments.