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☐ ☆ ✇ BMJ Open

Ebola disease stigma: mixed methods insights from the 2022 Sudan ebolavirus outbreak

Por: Paterson · A. · Kabajaasi · O. · Gouws · M. · Dimitrios · K. H. · Cheyne · A. · Olliaro · P. · Kenya-Mugisha · N. · Rojek · A. — Diciembre 4th 2025 at 09:48
Objectives

Ebola disease stigma hinders outbreak control and recovery by deterring care-seeking and driving social exclusion. Although this phenomenon is well recognised, gaps remain in understanding how stigma emerges and operates in outbreak settings, limiting the development of effective reduction strategies. The objective of this study was to examine the drivers, manifestations and public health impacts of stigma following the 2022–2023 Sudan ebolavirus outbreak in central Uganda.

Design

We conducted a cross-sectional, mixed-methods survey to assess Ebola disease stigma in June 2024.

Setting

The study was conducted in the Ugandan districts of Mubende, Kassanda and Kyegegwa, which were heavily affected by the outbreak.

Participants

A total of 302 respondents completed the survey. Respondents included all 51 eligible adult Ebola survivors in the districts known to the research team, as well as household members, healthcare workers, outbreak support staff and the general public.

Outcomes measures

The interviewer-administered survey explored personal experiences of stigma, community attitudes and impacts on outbreak control. We used a pillar integration process to identify themes across quantitative and qualitative data in three domains (drivers, manifestations and impacts of stigma).

Results

Participants identified several perceived drivers of stigma, including fear, hygiene-focused public health messaging, distrust in public services and criminal connotations inferred from the outbreak response. Manifestations, including self-stigma and associative stigma, endured beyond the outbreak and across contexts. Nearly all survivors interviewed (n=48, 94%) reported multiple experiences of stigmatisation since discharge, with almost half (n=25, 49%) reporting physical harm or threats. Stigma was reported to affect care-seeking, healthcare worker morale and community socioeconomic well-being.

Conclusion

Stigma remains a major barrier to Ebola disease outbreak control and recovery. The high levels of stigma reported by survivors and anticipated by community members highlight the urgent need for targeted interventions in future outbreaks. We specifically show there are opportunities to address misinformation, avoid criminal connotations in outbreak control efforts and enable peer support.

☐ ☆ ✇ BMJ Open

Antibiotic stewardship in suspected neutropenic fever (ASTERIC trial): a multicentre, type 1 hybrid effectiveness-implementation, stepped-wedge, randomised controlled trial study protocol

Por: Rainer · T. H. · Lam · R. P. K. · Tsang · T. C. · Wai · A. K.-C. · Leung · S. C. · Leung · R. Y. Y. · Wong · C. K. H. · Gill · H. · Lam · W. W. T. · Wing Lok Chan · W. · Chi Kin Cheung · A. · Lau · M. T. · Lee · S. F. · Choi · Y. F. · Fong Lun Lee · H. · Mok · K. L. · Lam · H. C. · Lee — Noviembre 25th 2025 at 06:15
Introduction

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

Methods and analysis

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

Ethics and dissemination

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

Trial registration number

NCT06794320.

☐ ☆ ✇ BMJ Open

High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-label, randomised non-inferiority trial

Por: Choo · E. H. · Kim · C. J. · Hwang · B.-H. · Lee · K. Y. · Oh · G. C. · Lim · S. · Choi · I. J. · Kim · D.-B. · Kwon · O. S. · Lee · S. · Choi · Y. · Park · C.-S. · Park · M.-W. · Kim · H.-Y. · Lee · H. C. · Kang · T. S. · Sung · J. K. · Woo · S.-I. · Park · H. S. · Yun · K. H. · Chang · K. · On — Noviembre 6th 2025 at 06:00
Introduction

High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.

Methods and analysis

The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.

Ethics and dissemination

Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.

Trial registration number

NCT04499859.

☐ ☆ ✇ BMJ Open

Early life determinants of skeletal maturation, body composition and endocrine health in young adults (EPIPEAK): protocol for a nationwide birth cohort study

Por: Händel · M. N. · Jorgensen · N. R. · Bybjerg-Grauholm · J. · Jansen · R. B. · Eiken · P. · Tofteng · C. L. · Hermann · A. P. · Bach-Mortensen · P. · Heitmann · B. L. · Rubin · K. H. · Langdahl · B. L. · Vestergaard · P. · Abrahamsen · B. — Octubre 23rd 2025 at 09:28
Introduction

Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18–19 years.

Methods and analysis

Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18–19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.

Ethics and dissemination

This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will be enrolled in the study following their informed written consent. Results will be submitted for publication. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guidelines will be used for reporting.

Trial registration number

NCT06509776.

☐ ☆ ✇ BMJ Open

A prospective protocol for remotely investigating brain-behaviour-genetics associations in adolescent patients in a paediatric health system with pre-existing clinical brain MRIs

Por: Mercedes · L. · Buczek · M. J. · Kafadar · E. · DiDomenico · G. · Jung · B. · Zimmerman · D. · Schabdach · J. M. · Himes · M. M. · Sotardi · S. · Vossough · A. · Driesbaugh · K. H. · Moore · T. · Barzilay · R. · Calkins · M. E. · Gur · R. E. · Roalf · D. R. · Satterthwaite · T. D. · Whit — Octubre 15th 2025 at 09:50
Introduction

Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.

Methods and analysis

The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.

Ethics and dissemination

Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.

☐ ☆ ✇ BMJ Open

Retrospective analysis of value-driven outcomes of diabetic foot ulcer in a tertiary hospital in Singapore

Por: Chia · A. C. K. · Tan · I. E.-H. · Tan · Z. N. · Yeo · W. J. · Zhao · Y. · Yap · C. J. Q. · Ang · K. A. · Au · M. K. H. · Chong · T. T. — Septiembre 29th 2025 at 07:52
Objective

This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.

Design

This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.

Setting

Tertiary centre within a population suffering from a diabetic epidemic.

Participants

All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.

Results

A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.

Conclusions

DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.

☐ ☆ ✇ BMJ Open

PUTRA-CV study protocol: a multicentre observational study of ethnic-specific genetic variants and dietary patterns in relation to lipoprotein(a) levels and their association with coronary artery disease severity in Malaysian adults

Por: Pannirselvam · S. · C Thambiah · S. · Appannah · G. · Ling · K. H. · Samsudin · I. N. · Hooper · A. J. · Yusoff · M. R. · Zakaria · A. F. · Razali · R. · Kiong · G. L. S. · Zahari Sham · S. Y. · Lai · Y. Y. · Abdul Rahman · T. H. · Zainal Abidin · I. — Septiembre 24th 2025 at 03:32
Introduction

Although low-density lipoprotein cholesterol (LDL-C) is established as the primary cardiovascular disease (CVD) risk factor, some individuals with LDL-C within desirable limits still develop coronary artery disease (CAD). Lipoprotein(a) (Lp(a)) has emerged as a genetically determined independent risk factor for CVD. This study aims to investigate Lp(a) by determining its association with coronary artery stenosis severity, identifying its ethnic-specific genetic determinants and assessing its relationship with an energy-dense dietary pattern.

Methods and analysis

The PUTRA-CV study is a 3-year, multicentre, case-control observational study involving adult patients who have undergone coronary angiography. The primary outcome is the association between Lp(a) levels and the severity of angiographic CAD (assessed by Gensini or Syntax score). Secondary outcomes include the frequencies of Lp(a)-associated single nucleotide polymorphisms (SNPs) (rs10455872 and rs3798220) and the association between dietary patterns and Lp(a) levels. Lp(a) will be measured using a particle-enhanced immunoturbidimetric method, and SNPs will be genotyped using high-resolution melting. Dietary intake will be assessed using a validated semiquantitative food frequency questionnaire. Data will be analysed using SPSS. Descriptive statistics will be used to summarise population characteristics. Bivariate analyses will use chi-square (2), independent t-tests or Mann-Whitney U tests as appropriate. The independent association between Lp(a) and coronary artery stenosis severity will be determined using multivariable logistic regression, adjusting for confounders. Empirically driven dietary patterns will be derived using reduced rank regression, and their association with Lp(a) will be assessed. For genetic analysis, allele frequencies of the LPA SNPs rs10455872 and rs3798220 will be calculated and compared between cases and controls.

Ethics and dissemination

Ethical approval has been obtained from the ethics committees of the Ministry of Health Malaysia (NMRR ID-24-00877-2ID-IIR), Universiti Putra Malaysia (JKEUPM-2024–246), Universiti Teknologi MARA (REC/07/2024-OT/FB/2) and Universiti Malaya Medical Centre (MREC ID NO: 2 02 453–13692). The findings will be disseminated via peer-reviewed journals and conferences.

☐ ☆ ✇ BMJ Open

Theory-based chatbot for promoting colorectal cancer screening in a community setting in Hong Kong: study protocol of a randomised controlled trial

Por: Hu · Y. · Lau · W. M. · Wang · Z. J. · Tang · R. S. Y. · Wu · X. · Mo · P. K. H. · Wong · S. Y. S. · Meng · M. L. H. · Dong · D. · Sung · J. J. Y. · Lam · T. Y. T. — Julio 10th 2025 at 14:13
Background

Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality worldwide. Despite the organised CRC screening programme, the uptake rate of the population-based CRC screening was still low. Thus, we will conduct a randomised controlled trial in a community setting to evaluate the effectiveness of a theory-based chatbot in promoting CRC screening uptake.

Methods and analysis

A total of 500 eligible participants will be randomly assigned to a WhatsApp Messenger-initiated chatbot outreach group or a standard text reminder group at a ratio of 1:1. The intervention group will deliver Chinese culturally tailored education texts and videos developed based on the Health Belief Model and the Trans-Theoretical Model. The control group will deliver a standard text reminder of information about the Hong Kong organised CRC screening programme. In addition to the baseline assessment and postintervention assessment, all subjects will be followed up for 3 months and 6 months, respectively. The primary outcome will be the CRC screening uptake rate at the 3 month and 6 month follow-up. The secondary outcomes will be the intention to undergo CRC screening uptake, time interval to participate in and complete screening after recruitment, and reasons for not participating in screening at the 3 month and 6 month follow-up. Quantitative data will be analysed using Student’s t-test, Pearson’s 2 test or Fisher’s exact test. Qualitative data will be analysed by thematic analysis.

Ethics and dissemination

Ethical approval of this trial was granted by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (2022.614). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.

Trial registration number

The study was registered on clinicaltrials.gov (NCT06192862).

☐ ☆ ✇ BMJ Open

Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults: The BLOCK Trial - a protocol for a multicentre randomised controlled trial

Por: Dupont Harwood · C. · Jellestad · A.-S. L. · Bahuet · A.-X. R. · Knudsen · R. L. · Andersen · L. C. · Mathiesen · O. · Asko Andersen · J. · Jakobsen · J. C. · Rothe · C. · Jorgensen · C. C. · Viberg · B. · Brorson · S. · Brabrand · M. · Gundtoft · P. H. · Terndrup · M. · Lange · K. H. — Julio 9th 2025 at 03:44
Introduction

Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

Methods and analysis

The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

Ethics and disseminationf

The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

Trial registration number

NCT06678438.

☐ ☆ ✇ BMJ Open

Associations between optimism and mental health in postradiotherapy cancer survivors: a cross-sectional survey study

Por: Man · K. H. · Ho · G. W. K. — Julio 7th 2025 at 06:01
Objectives

Cancer patients often experience psychological distress, while optimism has been identified as a protective factor. However, the mental health of postradiotherapy cancer survivors and its association with optimism remain largely unexplored. This study assesses the mental health status and optimism levels of postradiotherapy cancer survivors and evaluates their associations.

Design

Cross-sectional survey study.

Participants

114 Hong Kong cancer survivors who (1) were aged 18 years or above and (2) had received radiotherapy for their cancer treatment and finished the radiotherapy within the previous 3 years (2021–2024).

Outcome measures

Mental health was assessed using the Chinese Depression, Anxiety and Stress Scale, and optimism was measured using the Revised Life Orientation Test. Correlation and regression analyses were used to examine the associations between these measures.

Results

Participants reported overall low optimism with mild to moderate depression, anxiety and stress. Strong negative correlations were identified between optimism and depression (r=–0.833, p

Conclusions

This study highlights the importance of incorporating optimism-promoting interventions in postradiotherapy care. Routine optimism screening and gender-specific support are proposed to improve mental health outcomes for radiotherapy patients. While this study provides novel insights into postradiotherapy survivorship, further research should employ longitudinal designs and evaluate intervention effectiveness in clinical settings.

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