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Ethnic and immigrant disparities in dialysis prevalence and chronic kidney disease trajectories in Toronto

Por: Sikaneta · T. · Martin · S. · Mucsi · I. · Lofters · A. K. · Taskapan · H. · Tam · P. · Mahdavi · S.
Background

Large differences exist in chronic kidney disease (CKD) rates between countries, but differences within diverse populations living in the same setting with universal healthcare are not well understood.

Objectives

To compare dialysis prevalence, CKD risk factors and control, and CKD progression by ethnicity and birth country in an ethnoculturally diverse setting with high rates of kidney disease and universal healthcare.

Setting

Scarborough, Toronto’s most diverse region and site of Canada’s largest regional dialysis programme.

Design and participants

Double observational cohort study of 2397 participants: a retrospective cohort of 1116 residents who received dialysis between 2016–2019, and a prospective cohort of 1281 individuals with non-dialysis CKD followed for 3 years between 2010–2015 in Scarborough.

Outcome measurements

Dialysis prevalence, calculated by comparing frequencies of birth countries and ethnicities in the dialysis cohort with census-derived community frequencies. Secondary outcome measurements were traditional CKD risk factor prevalence (diabetes, hypertension, cardiovascular disease) and control (haemoglobin A1c, blood pressure); and CKD progression (estimated glomerular filtration rate decline, proteinuria) adjusted for socioeconomic status in the non-dialysis cohort.

Results

Dialysis prevalence was 4.2 times higher in immigrants (p

Conclusions

Despite universal healthcare access, marked disparities in CKD risks and rates exist within ethnoculturally diverse immigrants living in this Canadian kidney disease hotspot. More focused research and tailored interventions are required.

Digital App for Speech and Health Monitoring Study (DASH): protocol for a prospective longitudinal case-control observational study for developing speech datasets in neurodegenerative disorders and dementia

Por: Tam · J. · Weaver · C. · Ihenacho · A. · Newton · J. · Virgo · B. · Barrett · S. · Neale · J. · Perry · D. · Smith · A. · Chandran · S. · Watts · O. · Pal · S. · DASH Consortium · Ali · Baxter · Bozkhurt · Burr · Chandran · Chau · Clancy · Coupland · Devon · Entwistle-Thompson · Gardiner
Introduction

Neurodegenerative disorders (NDDs) represent an unprecedented public health burden. These disorders are clinically heterogeneous and therapeutically challenging, but advances in discovery science and trial methodology offer hope for translation to new treatments. Against this background, there is an urgent unmet need for biomarkers to aid with early and accurate diagnosis, prognosis and monitoring throughout the care pathway and in clinical trials.

Investigations routinely used in clinical care and trials are often invasive, expensive, time-consuming, subjective and ordinal. Speech data represent a potentially scalable, non-invasive, objective and quantifiable digital biomarker that can be acquired remotely and cost-efficiently using mobile devices, and analysed using state-of-the-art speech signal processing and machine learning approaches. This prospective case–control observational study of multiple NDDs aims to deliver a deeply clinically phenotyped longitudinal speech dataset to facilitate development and evaluation of speech biomarkers.

Methods and analysis

People living with dementia, motor neuron disease, multiple sclerosis and Parkinson’s disease are eligible to participate. Healthy individuals (including relatives or carers of participants with neurological disease) are also eligible to participate as controls. Participants complete a study app with standardised speech recording tasks (including reading, free speech, picture description and verbal fluency tasks) and patient-reported outcome measures of quality of life and mood (EuroQol-5 Dimension-5 Level, Patient Health Questionnaire 2) every 2 months at home or in clinic. Participants also complete disease severity scales, cognitive screening tests and provide optional samples for blood-based biomarkers at baseline and then 6-monthly. Follow-up is scheduled for up to 24 months. Initially, 30 participants will be recruited to each group. Speech recordings and contemporaneous clinical data will be used to create a dataset for development and evaluation of novel speech-based diagnosis and monitoring algorithms.

Ethics and dissemination

Digital App for Speech and Health Monitoring Study was approved by the South Central—Hampshire B Ethics Committee (REC ref. 24/SC/0067), NHS Lothian (R&D ref. 2024/0034) and NHS Forth Valley (R&D ref. FV1494). Results of the study will be submitted for publication in peer-reviewed journals and conferences. Data from the study will be shared with other researchers and used to facilitate speech processing challenges for neurological disorders. Regular updates will be provided on the Anne Rowling Regenerative Neurology Clinic web page and social media platforms.

Trial registration

ClinicalTrials.gov NCT06450418 (pre-results).

Mixed-methods evaluation protocol for the Nurturing Connections Programme: a new Australian perinatal and infant mental health service

Por: Cibralic · S. · Fay-Stammbach · T. · Landry · A. · Meredith · L. · Pretty · D. · Allan · A. · Olsen · N. · Heath · J. · Costa · D. · Eapen · V.
Introduction

Forming secure attachment relationships provides children with the best possible start to life. Children from families with high psychosocial vulnerability and complex mental health needs (eg, caregivers with lived experience of trauma, experiencing mental illness or substance abuse, current or past domestic violence, and/or current or a history of child protection issues) are at the greatest risk of experiencing attachment disturbances. Nurturing Connections is a new early intervention service launched by the New South Wales State Ministry of Health targeting both caregiver adversity and the caregiver-child attachment relationships in families with high psychosocial vulnerability and complex mental health needs. This paper outlines the evaluation protocol of the Nurturing Connections Programme.

Methods and analysis

A mixed-methods design will be used to undertake an implementation and outcomes evaluation. The study will draw on both qualitative and quantitative data, including routinely collected service data, surveys, participant observations, and semi-structured interview and yarning circle data. Appropriate descriptive and inferential techniques will be used to analyse quantitative data while thematic analysis will be drawn on to analyse qualitative data.

Ethics and dissemination

This research was approved by the South Eastern Sydney Local Health District Research Ethics Committee (2024/ETH01715). The Mid North Coast Local Health District also received ethics approval from the Aboriginal Health and Medical Research Council of New South Wales (2380/25). Evaluation findings will be shared via published manuscripts, conference presentations, as well as a final report to funding bodies.

Digital mindfulness- and acceptance-based stress reduction intervention for individuals looking online for help: protocol for the CRISP randomised controlled trial

Por: af Ekenstam · L. · Nyman · P. · Änghagen · O. · Ahden · U. · Bendtsen · M. · Lundgren · O.
Introduction

Psychosocial stress is a major public health concern, contributing to significant suffering and costs to society. There is a lack of effective interventions that could be offered at an early stage to people who need to reduce their stress in life. Recent advances in psychology have provided evidence-based exercises suitable for testing in an entirely digital intervention. This study aims to estimate the effectiveness of a 12-week digital course in mindfulness- and acceptance-based stress reduction.

Methods and analysis

The effectiveness of the 12-week digital course will be estimated in a parallel-groups randomised controlled trial, in which the control group will receive referrals to self-studies on mental health information found online. The study population will be individuals 15 or older, seeking help online for stress and who have access to a mobile phone. Employing a Bayesian sequential design, the primary outcome will be monitored monthly, after the 6-month follow-up, to calculate target criteria for when to stop recruiting. Perceived stress (Cohen’s 10-item version) will be the primary outcome, with estimands of interest being differences between groups at 3 (immediate), 6 (prolonged) and 12 months (maintained). Mediation analysis will reveal if differences between groups are mediated by acquired equanimity. Effectiveness will be analysed with Bayesian regression models, and mediation will be analysed by using a causal inference framework.

Ethics and dissemination

The research was approved by the Swedish Ethical Review Authority on 2024-05-07 (2024-01974-01). The study will reach out to a vulnerable population, and participation may displace efforts to seek professional help. We have built-in automatic advice to seek additional help for participants scoring high on the depression scale at baseline, before allocation to study groups. The findings from this study will be submitted to peer-reviewed journals and presented at relevant national and international meetings.

Trial registration number

ISRCTN39222610.

Promising solution for standardised length of hospital stay based on time-to-event models and contemporary Australian administrative data

Por: Duke · G. J. · Hirth · S. · Santamaria · J. D. · Li · Z. · Read · C. · Hamilton · A. · Lapiz · E. · Le · T. · Fernando · T. · Merlo · R.
Objective

Hospital length of stay (LOS) is a key indicator of hospital efficiency and quality of care, but a reliable metric for benchmarking LOS remains problematic. This report describes a time-to-event methodology to generate a hospital standardised LOS ratio (HSLR).

Design

Retrospective observational analysis of LOS from a jurisdictional administrative dataset using a time-to-event (hazard of discharge) analytic approach to generate risk-adjusted LOS (predicted LOS—pLOS), and the HSLR (= (sum observed LOS)/(sum total pLOS)).

Setting

219 (public and private) acute-care hospitals in the State of Victoria, Australia, adult population 5.28 million.

Participants

2.73 million adult multiday separations and 15.53 million bed-days from July 2019 to June 2024.

Interventions

Nil.

Outcome measures

Descriptive statistics for annual mean LOS (aLOS), pLOS and HSLR at the hospital level with model fit assessed for calibration (Cox-Snell residuals), classification (aLOS and HSLR results for hospital-years compared to benchmark), variance (intraclass correlation coefficient (ICC) at provider level) and model dispersion (value () and random effect SD ()) characteristics.

Results

Observed LOS was markedly right skewed and autocorrelated (p3 SD of benchmark); whereas 936 (99.5%) HSLR values were inliers (

Conclusions

aLOS is a simple descriptor but poor comparator. Time-to-event survival analytic models furnish risk-adjusted pLOS and HSLR metrics which indicate that the majority of LOS variation is due to patient-related, not hospital, factors.

Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study

Por: Murea · M. · Foley · K. L. · Gautam · S. C. · Flythe · J. E. · Raimann · J. G. · Abdel-Rahman · E. · Awad · A. S. · Niyyar · V. D. · Kovach · C. · Roberts · G. V. · Jefferson · N. M. · Conway · P. T. · Rosales · L. M. · Woldemichael · J. · Sheikh · H. I. · Raman · G. · Huml · A. M. · Kni
Introduction

Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

Methods and analysis

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

Ethics and dissemination

The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number

NCT05828823.

Is harmonisation of curriculum enough to ensure clinical competencies of graduates? Experience of faculty and students from two health training institutions in Tanzania: a qualitative study

Por: Sirili · N. · Temba · P. · Yoram · F. · Kitambala · E. · Hamad · A. K. · Sabas · D. · Mloka · D. · Moshi · M. J. · Mselle · L. T.
Objective

The growing complexity of global health issues underscores the need for a skilled workforce, achievable through competency-based training (competency-based curricula, CBC) that integrates knowledge and practice. Starting from 2022, medical and nursing CBC were harmonised across universities in Tanzania to ensure all graduates attain nationally defined core competencies. The reform aligned programme structure, learning outcomes and assessment methods to promote consistency and interprofessional collaboration. However, questions remain about whether harmonisation alone can ensure the development of practical clinical competencies among students. This study explored the experiences of medical and nursing faculty and students in implementing clinical training as a component of CBC in two health training institutions in Tanzania.

Design

An exploratory qualitative case study was conducted with 67 participants, using 8 in-depth interviews with administrators and 8 focus group discussions with faculty and students. Data were analysed using Braun and Clarke’s thematic approach.

Setting

Two private, faith-based medical universities in the United Republic of Tanzania.

Participants

The study purposefully recruited a total of 67 participants. The participants included university administrators (including Deputy Vice Chancellors for Academics, quality assurance officers and deans), medical and nursing faculty and students (fourth-year medical and third-year nursing students).

Results

Two main themes emerged: challenges in implementing clinical training and strategies used to enforce clinical training. Key challenges included curriculum design gaps, inadequate faculty and clinical instructors, a large number of students and a shortage of hospital staff. Strategies used were utilisation of clinical skills and simulation laboratories, involvement of non-academic clinical specialists’ staff, use of student-centred learning methodologies and leveraging regional, district and specialised private hospitals for clinical teaching.

Conclusions

Despite notable challenges in clinical training, the institutions in this study have implemented proactive strategies to support clinical training. Based on the findings, stakeholders should invest in increasing faculty and clinical instructors and expanding clinical placements to regional, district and private hospitals.

Quality of life in patients with chronic kidney disease in low- and middle-income countries: protocol for a systematic review and meta-analysis

Por: Muxunov · A. · Kalinina · D. · Gaipov · A. · Sarria-Santamera · A.
Introduction

Chronic kidney disease (CKD) affects over 850 million people globally, with nearly 80% residing in low- and middle-income countries (LMICs). Despite this high prevalence, there is limited understanding of health-related quality of life (HRQOL) among patients with CKD in these resource-constrained settings. This systematic review and meta-analysis aims to quantify HRQOL scores across CKD stages and treatment modalities in LMICs.

Methods and analysis

We will conduct a comprehensive search of electronic databases including PubMed, Medline, Scopus and Web of Science, for observational studies published from January 2000 onwards in English or Russian. Eligible studies will include adult patients (≥18 years) with CKD stages 1–5, those on dialysis or kidney transplant recipients in LMICs. Two independent reviewers will screen studies, extract data and assess methodological quality using the Joanna Briggs Institute critical appraisal checklist. We will perform random-effects meta-analyses to pool HRQOL scores, stratified by CKD treatment groups. Heterogeneity will be assessed using I² statistics, with subgroup analyses and meta-regression conducted to explore potential sources of heterogeneity. The primary outcome will be pooled estimates of HRQOL scores across different CKD stages and treatment modalities in LMICs. Secondary outcomes will include subgroup analyses by income classification, geographical region and CKD stage depending on the availability of the data.

Ethics and dissemination

Ethical approval is not required for this study. Results will be submitted to a peer-reviewed, open-access journal and presented at scientific conferences.

PROSPERO registration number

CRD420251016382.

Development and evaluation of a telepharmacy service in primary care for home-living older adults in Northern Swedens rural areas: protocol for a single-arm interventional study

Por: Westberg · A. · Andersson · P. · Sönnerstam · E. · Mattsson · S. · Holmner · A. · Edin-Liljegren · A. · Gustafsson · M.
Introduction

Medication-related problems (MRPs) are common among older adults. The global population is ageing and there are health-related challenges linked to ageing in rural areas. Home-living rural older adults often face barriers to access healthcare, like long distances to healthcare services and poor continuity of care. Telepharmacy is the remote provision of pharmaceutical care, and telepharmacy could be of particular importance for rural older adults to improve their access to clinical pharmacy services and reduce the incidence of MRPs. The objective of this study is to develop and evaluate a novel telepharmacy service in primary care for home-living older adults in Northern Sweden’s rural areas. The primary objective is to evaluate the effect of the telepharmacy service regarding the identification, classification and resolution of MRPs.

Methods and analysis

This study will be conducted as a single-arm interventional study. A total of 100 people ≥65 years will receive the telepharmacy service for 12 weeks. The key principles of the telepharmacy service are to perform medication interviews and follow-up meetings with study participants, to conduct structured medication reviews, to conduct regular electronic medical record reviews and to have interprofessional collaboration with primary care physicians. All meetings will be conducted through video conferencing via a secure virtual care platform. Identified MRPs will be classified, and the acceptance rate of the pharmacists’ recommendations will be evaluated. The results will be presented with descriptive statistics. As secondary objectives, intra-individual changes in participants’ medication adherence, health-related quality of life and beliefs about medicines will be assessed through self-report questionnaires. Statistical analysis will be conducted using two-sided McNemar’s tests. Semi-structured interviews will also be conducted to explore participants’ and healthcare professionals’ experiences and attitudes towards this telepharmacy service.

Ethics and dissemination

This study has been granted ethical approval by the Swedish Ethical Review Authority (registration number 2022-03819-01 and 2024-08441-02). Participant informed consent is required. The results will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

NCT05629936.

Effect of the FoodSwitch application on type 2 diabetes in Sweden: a study protocol for the randomised controlled DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients trial (DIATEST-HELP)

Por: af Geijerstam · P. · Johansson · E. · Fägerstam · S. · Wu · J. H. · Ghafouri · B. · Karlsson · K. · Hebib · L. · Kastbom · L. · Wennberg · P. · Gustafson Hedov · E. · Storgärds · M. · Sundström · J. · Radholm · K.
Introduction

A healthy diet improves glycaemic control and reduces cardiovascular risk in type 2 diabetes (T2D). However, access to dietitians is limited. Several countries have implemented mandatory interpretive front-of-pack labelling to guide consumers towards healthier food choices, but Sweden has not. Smartphone applications may offer an alternative platform to provide such information. This study evaluates the dietary and clinical impact of a novel application providing interpretive labelling to Swedish adults with T2D.

Methods and analysis

This is a fully decentralised randomised controlled trial. 900 individuals with T2D for ≥2 years who regularly shop for groceries will be recruited via general practices and community advertisements. Participants will be randomised to receive either: (1) access to the FoodSwitch mobile application plus standard written dietary advice, or (2) standard written dietary advice only. The FoodSwitch application allows users to scan barcodes on packaged foods to receive recommendations of healthier alternatives within the same category. The primary outcome is the difference in change in mean self-measured glycated haemoglobin between groups after 6 months. Secondary outcomes include differences in changes in waist circumference, body weight, quality of life, medication use, hospitalisations and all-cause mortality at 26 weeks. Exploratory outcomes include omics analyses. Recruitment is ongoing. Expected study completion on 31 December 2026.

Ethics and dissemination

The trial has received ethical approval from the Swedish Ethical Review Authority (2023-06622-01, 2024-06668-02, 2024-07357-02 and 2025-01095-02) and is performed in line with World Medical Association Declaration of Helsinki and the General Data Protection Regulation. Results will be published in a peer-reviewed international journal.

Trial registration number

NCT05977218.

Testing psychosocial work adversities as a necessary condition for work-related emotional exhaustion in young workers: a cross-sectional necessary condition analysis on a national general working population-based survey

Por: Schelvis · R. M. C. · van Veen · M. · Tamminga · S. J. · Oude Hengel · K. M. · Nieuwenhuijsen · K. · Boot · C. R. L. · Dul · J.
Objectives

Being exposed to adverse psychosocial working conditions contributes to poor mental health in young workers. This study explores whether psychosocial work adversities are a necessary condition for work-related emotional exhaustion in young workers.

Design

Data from the ‘Netherlands Working Condition Survey 2021’ was used. By applying a novel method called Necessary Condition Analysis, we tested two psychosocial work adversities as necessary conditions for high work-related emotional exhaustion in young workers: (1) a composite score of high job demands and low job resources and (2) a composite score of high job demands. Additionally, we tested whether the threshold for job demands as a necessary condition for high work-related emotional exhaustion differed for young workers with low versus high resources.

Setting

Secondary data analysis on a national working population-based survey.

Participants

The sample included 5791 young workers in the Netherlands (aged

Primary outcome measure

Work-related emotional exhaustion.

Results

A high level of the composite on job demands and job resources is necessary for a high level of work-related emotional exhaustion in young workers (effect size=0.11, p

Conclusions

Both psychosocial work adversities were necessary conditions for high work-related emotional exhaustion in young workers. The necessity threshold for job demands was higher for young workers with high job resources, compared with the group with low resources. This indicates that removing psychosocial work adversities and ensuring the presence of job resources might contribute to the prevention of high work-related emotional exhaustion in young workers.

Optimising delivery models for evidence-based interventions to reduce stillbirth in Punjab, India: a study protocol for implementation research

Por: Gautam · D. · Pandey · A. K. · Banerjee · R. · Saroha · E. · Gupta · U. · Thalakiya · R. · Dutta · S. · Bharadwaj · S. · K · R. · Gupta · M. · Sawhney · I. K. · Aggarwal · A. K. · Neogi · S. B.
Background

Stillbirth remains a major global health challenge, with India bearing a substantial share of the burden. Despite the availability of evidence-based interventions, stillbirth rates (SBRs) remain high due to gaps in healthcare access, quality and the effective delivery of maternal and neonatal care. This study aims to develop and implement an optimised, context-specific model to reduce SBRs in Sangrur district, Punjab.

Methods and analysis

This mixed-methods implementation research will adopt a sequential explanatory design. The study will be conducted over 3 years in four blocks of Sangrur. Data will be collected through baseline and endline surveys, verbal autopsies of stillbirths, direct observations of antenatal and intrapartum care, and qualitative interviews with community members and healthcare providers. The intervention package will focus on preconception and antepartum care, intrapartum care and strengthening health systems. The study will use the plan-do-check-act model for continuous improvement, and real-time data collection through electronic systems will support timely decision-making.

The study expects to achieve a 25% reduction in SBRs through the optimised delivery of high-quality antenatal and intrapartum care services. Additionally, the research will provide critical evidence on the barriers and facilitators to optimise service delivery, as well as insights into the health system and community factors influencing stillbirth outcomes. This study aims to create a scalable and adaptable intervention model to reduce SBRs in low-resource settings like Sangrur and Punjab. The findings will inform future maternal and neonatal health policies and provide a framework for the broader implementation of similar interventions in other regions of India.

Ethics and dissemination

The study protocol has been approved by the International Institute of Health Management Research, Delhi (IIHMR) Institutional Ethics Committee (IRB/2024-2025/01). The study is funded through a competitive call for proposals on stillbirths by the Indian Council of Medical Research (ICMR) under the National Health Research Priority Projects (5/7BMIPR/2022-RBMCH). The research has been awarded by ICMR (project ID NHRP05586) to IIHMR under grant number 5/7/BMIPR/2022-RCN.

NuPOWER (Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis): protocol for an open-label, single-arm, multicentre study

Por: Srivastava · A. · Kanny · A. · Langer · F. · Kubicek-Hofmann · C. · Alvarez Roman · M. T. · Nunez Vazquez · R. · Boban · A. · Dejanova-Ilijevska · V. · Miljic · P. · Garcia · J. · Halimeh · S. · Drillaud · N. · Valentin · J.-B. · Mancuso · M. E. · Castaman · G. · Santoro · R. C. · Leht
Introduction

Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.

Methods and analysis

NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.

Ethics and dissemination

Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.

Trial registration number

CT EU 2022-502060-21-00; NCT05935358.

Prevalence and determinants of vitamin D deficiency among pregnant women in Gondar Town 2024: a cross-sectional study from the first and second trimesters

Por: Chane · E. · Teketelew · B. B. · Berta · D. M. · Walle · M. · Angelo · A. A. · Cherie · N. · Tamir · M. · Abriham · Z. Y. · Bitew · G. · Mekuanint · A.
Objective

Vitamin D deficiency during pregnancy is a global health concern, contributing to adverse maternal and fetal outcomes. Despite its importance, limited data exist on vitamin D status and its determinants among pregnant women in Ethiopia. This study aimed to assess the prevalence and determinants of vitamin D deficiency among pregnant women in their first and second trimesters in Gondar Town, Ethiopia, 2024.

Design and setting

A facility-based cross-sectional study was conducted at the antenatal care unit of University of Gondar Comprehensive Specialized Hospital from January to March 2024.

Methods

Eligible participants were selected using a simple random sampling technique. Sociodemographic, behavioural and clinical data were collected through structured questionnaires and medical record reviews. Serum levels of vitamin D, calcium and alkaline phosphatase were analysed using the Beckman Coulter clinical chemistry analyser. Statistical comparisons between pregnant women in the first and second trimesters were performed using the independent t-test. Determinants of vitamin D deficiency were identified using multivariate logistic regression analysis.

Participants

384 pregnant women in their first or second trimester.

Results

The prevalence of vitamin D deficiency (90 mm Hg) (AOR 0.28, 95% CI 0.11 to 0.70), lower dietary diversity (AOR 3.17, 95% CI 1.13 to 8.89), lower fish and fish oil consumption habit (AOR 3.01, 95% CI 1.03 to 8.77; AOR 12.27, 95% CI 1.50 to 100.42) were the key predictors associated with serum vitamin D defiency.

Conclusion and recommendation

Nearly half of the pregnant women in Gondar Town exhibit vitamin D deficiency, showing a challenging public health concern. Thus, targeted interventions, such as dietary supplementation and lifestyle modifications, are urgently needed to address the problem and improve maternal and neonatal health outcomes.

Protocol for a multi-country retrospective observational paediatric sepsis epidemiological study (SENTINEL International)

Por: Long · E. · Williams · A. · George · S. · Hearps · S. · Yock-Corrales · A. · Pavlicich · V. · Krishnamurthy · K. · Seymour-Hanna · Y. · Raman · R. · Choudhary · B. · Kusuma · W. · Ribaya · V. · Mudithakumara · N. · Lertamornkitti · N. · David · A. · Mohamed · S. · Heye · T. B. · Njiramma
Introduction

Improving outcomes from sepsis in children is a WHO Global Health Priority, yet mortality from sepsis remains high, particularly in low- and middle-income countries (LMICs). This database from children with community-acquired childhood sepsis in LMICs and some high-income countries will allow analysis of the burden of disease, including incidence, severity and outcomes. Understanding these aspects of sepsis care is fundamental for the design and conduct of future international interventional trials to improve childhood sepsis outcomes.

Methods and analysis

This multicountry retrospective observational study will include children up to 18 years of age presenting to emergency departments with suspected sepsis, defined as admission to hospital for treatment with intravenous antibiotics plus (1) a provisional diagnosis of sepsis and/or (2) treatment for suspected sepsis (operationalised as the administration of one or more fluid bolus to treat impaired perfusion or vasoactive infusion). Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length of stay, and mortality censored at hospital discharge or 30 days from enrolment (whichever occurs first).

Ethics and dissemination

Central ethics approval was received from the Royal Children’s Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/100648/RCHM-2023). Each international site will be required to obtain local Institutional Research Ethics Board approval. The findings will be disseminated in peer-reviewed journals, at academic conferences and through lay media. A cleaned study database and individual site-level data will be made available to site investigators upon completion of the study.

Trial registration number

This study was registered with the Australian and New Zealand Clinical Trials Registry on 23 January 2024 prior to commencement of recruitment (ACTRN12624000052538).

Shared decision-making using a decision aid for patients with breast cancer considering breast reconstruction: study protocol for a cluster-randomised controlled trial in Japan

Por: Sowa · Y. · Osaka · W. · Tsuge · I. · Komiya · T. · Saiga · M. · Taminato · M. · Nagura · N. · Shiraishi · T. · Seki · H. · Otsuki · Y. · Matsuoka · Y. · Tomita · S. · Akita · S. · Fujimoto · H. · Otani · K. · Yoshimura · K.
Introduction

Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.

Methods and analysis

A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0–III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.

Ethics and dissemination

This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.

Trial registration number

UMIN000052161.

Protocol for an observational cohort study integrating real-world data and microsimulation to assess imaging surveillance strategies in stage I-IIIA NSCLC patients in OneFlorida+

Por: Braithwaite · D. · Karanth · S. D. · Bian · J. · Meza · R. · Jeon · J. · Tammemagi · M. · Wheeler · M. · Cao · P. · Rackauskas · M. · Shrestha · P. · Yoon · H.-S. · Borondy Kitts · A. · Verma · H. · Blair · M. C. · Chen · A. · Das · D. · Lou · X. · Wu · Y. · Han · S. · Hochhegger · B. · Guo · Y
Introduction

Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.

Methods and analysis

PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.

Ethics and dissemination

This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.

Satisfaction and self-confidence levels among midwifery students in clinical training programmes at multisite Palestinian universities: a cross-sectional study

Por: Aqtam · I. · Shouli · M. · Hmod · H. · Torman · S. · Salman · R.
Objectives

To evaluate the satisfaction and self-confidence levels among midwifery students in clinical training programmes at Palestinian universities and to identify associated factors.

Design

A descriptive, cross-sectional study.

Setting

Clinical training programmes at five universities across the West Bank, Palestine, during the second semester of the 2023—2024 academic year.

Participants

A convenience sample of 116 final-year (third- and fourth-year) midwifery students actively engaged in clinical training.

Primary and secondary outcome measures

The primary outcomes were satisfaction and self-confidence, measured using validated scales adapted from the National League for Nursing. Demographic factors (university, academic year, training area, gender) were analysed as secondary measures influencing the primary outcomes.

Results

Students reported moderate satisfaction (mean=3.38±0.75, 95% CI: 3.25 to 3.51) and high self-confidence (mean=3.61±0.73, 95% CI: 3.49 to 3.73). A strong positive correlation was found between satisfaction and training area (r=0.693, p

Conclusions

Geographical disparities and gender significantly influence midwifery students’ clinical training experiences in Palestine. These findings highlight the need for equitable distribution of training resources, the implementation of gender-sensitive mentorship programmes and tailored support for students in advanced academic years to improve educational outcomes and build a capable healthcare workforce.

Psycho-social experiences and coping strategies of infertile couples attending infertility clinics in Saint Pauls Hospital Millennium Medical College, Addis Ababa, Ethiopia: a qualitative study

Por: Behude · Y. T. · Sendo · E. G. · Tamir · H. H.
Background

Infertility is a significant reproductive health issue that affects couples physically, emotionally and socially. This qualitative study aims to explore the psycho-social experiences and coping strategies of infertile couples attending infertility clinics at Saint Paul’s Hospital, Addis Ababa, Ethiopia.

Methods

This study employed a descriptive phenomenological research design. In-depth interviews were conducted with 12 purposively selected couples experiencing infertility. The study used thematic analysis to capture the emotional, social and psychological impacts of infertility on individuals and their relationships.

Results

Key themes identified include emotional distress, social stigma, marital strain and a sense of isolation. Participants reported experiencing feelings of shame, depression and anxiety, often exacerbated by societal expectations and pressure to conceive. Coping strategies varied across individuals and included seeking medical intervention, social support, religious faith and, in some cases, withdrawal from social interactions.

Conclusions

The study highlights the need for comprehensive psychological support and counselling services in infertility care to address the mental health and social challenges faced by infertile couples. Promoting awareness to reduce stigma and enhancing social support systems may improve the overall well-being of affected individuals.

Diagnostic performance of the Hightop Rapid Diagnostic Test for the detection of anti-Treponema pallidum antibodies in Cameroon: a laboratory-based cross-sectional and comparative study

Por: Taheu Ngounouh · C. · Nguwoh · P. S. · Fokam · J. · Essomba · R. G. · Halilou · I. · Al-Maye Bit Younouss · A. · Ibnou Moussa · N. · Yuosembom · E. · Pepa · S. · Mbarga Foe · M. · Orock Eta · E. · Mpiwouo Panyere · G. · Madie Tamo · C. · Ngantchui Tchuisseu · J. · Moussa · A. · Zotie
Objective

The study was conducted to assess the diagnostic performance of the Hightop Syphilis Rapid Diagnostic Test (RDT) in comparison with the ELISA test used as a reference method.

Design

A laboratory-based cross-sectional and comparative study was conducted to assess the diagnostic performance of the Hightop Syphilis RDT.

Setting

Blood samples obtained from adult participants in eight health facilities were analysed at the National Public Health Laboratory (NPHL), Ministry of Public Health, Yaounde, Cameroon.

Participants

From 29 April to 25 August 2023, 583 adult participants of both sexes (aged ≥21 years), including both syphilis positive and syphilis negative, were recruited consecutively in eight health facilities in eight regions of Cameroon.

Outcome measures

Blood samples were screened for the detection of anti-Treponema pallidum antibodies using the One Step Rapid Test (Qingdao Hightop Biotech), a non-treponemal test and ELISA (Biorex Diagnostics, UK), a treponemal test used as a reference method. Diagnostic performance of the Syphilis RDT was analysed using Epi Info V.7 and validated through online statistical tools such as StatPages, GraphPad, QuickCalcs and MedCalc software.

Results

Of the 583 samples tested, the Hightop Syphilis RDT revealed a sensitivity of 84.6% (95% CI: 74.8% to 91.1%) and specificity of 98.5% (95% CI: 97.5% to 99.1%). The positive predictive value (PPV) and negative predictive value (NPV) were 84.6% (95% CI: 74.8% to 91.1%) and 98.5% (95% CI: 97.5% to 99.1%), respectively. Regarding the stratification of diagnostic performance by clinical stage, the test showed a sensitivity of 100.0% (95% CI: 71.51% to 100.0%) and specificity of 99.06% (95% CI: 94.86% to 99.98%). The PPV and NPV were 91.67% (95% CI: 61.00% to 98.72%) and 100.0% (95% CI: 96.55% to 100.0%), respectively, in symptomatic individuals. Among asymptomatic individuals, sensitivity was 97.56% (95% CI: 87.14% to 99.94%) and specificity was 100.0% (95% CI: 99.14% to 100.0%). The PPV and NPV were 100.0% (95% CI: 91.19% to 100.0%) and 99.77% (95% CI: 98.40% to 99.97%), respectively.

Conclusions

The Hightop Syphilis RDT demonstrated adequate diagnostic performance, particularly among symptomatic individuals, supporting its utility as a reliable tool for syphilis detection in clinical settings.

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