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☐ ☆ ✇ BMJ Open

Antibody development after three mRNA SARS-CoV-2 vaccinations in patients with systemic autoimmune rheumatic disease with and without treatment: an observational cohort study

Por: Simader · E. · Kartnig · F. · Tobudic · S. · Mrak · D. · Deimel · T. · Karonitsch · T. · Haslacher · H. · Perkmann · T. · Mitter · G. · Winkler · S. · Aletaha · D. · Blueml · S. · Mandl · P. — Septiembre 24th 2025 at 03:32
Objectives and design

To further elucidate the effects of rare systemic autoimmune rheumatic diseases (SARD) and their treatment on antibody development after vaccination against SARS-CoV-2, we compared patients with and without immunosuppressive therapy to healthy controls in an observational cohort study.

Participants and setting

We enrolled 52 patients with SARD and 72 healthy subjects in a prospective, observational study at the Medical University of Vienna and measured the humoral response 6 months after two mRNA vaccinations and 2–6 weeks after a third dose.

Results

Patients with vasculitis showed significantly (p=0.02) lower antibody titres 6 months after vaccination (median 247 BAU/mL, IQR [185–437]), as compared with healthy controls (median 514 BAU/mL, [185–437], IQR 323; 928, vasculitis patients: 247, IQR [185; 437], p

Conclusions

Patients with SARD displayed lower antibody development after booster vaccination, even if antibody levels after two immunisations were comparable to healthy controls. Our data may be limited due to sample size, but it provides pointers for a more individualised, antibody-titre-oriented approach and earlier booster vaccination in patients with SARD.

☐ ☆ ✇ BMJ Open

Exploring tools and measures for evaluating the quality of paid disability support for adults: a scoping review protocol

Por: Topping · M. · Douglas · J. · Winkler · D. — Agosto 11th 2025 at 03:13
Introduction

The quality of paid disability support services has significant implications for the autonomy, well-being and community participation of adults with disability. However, variability in service provision and evaluation persists. Despite the growing public investment and focus on improving support quality, there appears to remain a lack of comprehensive tools and measures to evaluate the quality of paid disability support. This scoping review aims to systematically identify and map the existing tools and measures used to evaluate the quality of paid disability support for adults with disability.

Methods and analysis

This scoping review will be conducted following the methodology outlined by Arksey and O’Malley, enhancements proposed by Levac et al and the Joanna Briggs Institute along with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis: Extension for Scoping Reviews guidelines. The research question guiding the review is: ‘What existing tools and measures are available to evaluate the quality of paid disability support services?’ Comprehensive searches will be conducted in MEDLINE, PsycINFO, Embase, CINAHL and Scopus to identify peer-reviewed articles published in English since 2014. Supplementary grey literature searches will also be conducted, alongside an online survey to obtain stakeholder input. Articles or grey literature sources that report on tools or measures for evaluating paid disability support for adults (aged 18–65 years) with disability will be included. Data extraction will focus on study characteristics, participant demographics and the characteristics of the quality of support measurement tools. A narrative synthesis will be used to present the findings.

Ethics and dissemination

Ethical approval will be obtained for the online stakeholder survey component of the review. No ethical approval is required for the scoping review of the literature. The results will be disseminated through peer-reviewed publications, conference presentations and accessible formats to ensure a wide audience is reached, including researchers, policymakers and disability service providers.

☐ ☆ ✇ BMJ Open

eHealth versus face-to-face support for remission of type 2 diabetes by calorie restriction (eHealth DIabetes remission Trial): study protocol for a non-inferiority parallel group randomised controlled trial

Por: Otten · J. · Tellström · A. · Schien · C. · Chninou · Y. · Lindholm · L. · Winkvist · A. · Liv · P. · Stomby · A. — Julio 23rd 2025 at 04:48
Introduction

If a person is in diabetes remission, even if only for a short time, this reduces the risk of later diabetes complications and lowers healthcare costs. A recent study shows that long-term remission of type 2 diabetes can be achieved through calorie restriction using total diet replacement. However, this intervention involves support through face-to-face meetings every 2 to 4 weeks over a 2-year period, which is not feasible in routine care with limited resources. Therefore, we have developed an eHealth programme to help patients achieve diabetes remission through calorie restriction in a cost-effective manner. Our primary hypothesis is that an eHealth programme will be non-inferior to face-to-face meetings in helping patients with type 2 diabetes achieve remission through caloric restriction. Our second hypothesis is that eHealth support will be more cost-effective than face-to-face support.

Methods and analysis

The eHealth DIabetes remission Trial is a multicentre, two-arm, non-inferiority, open-label, randomised controlled parallel group trial with blinded endpoint assessment conducted at two centres in Sweden. The study duration is 2 years. People with type 2 diabetes (≤6 years duration) use total diet replacement (approximately 900 kcal/day) with the aim of losing 15 kg and achieving diabetes remission. Participants are randomly assigned to either the eHealth support group or the face-to-face support group. The treatment programme to achieve and maintain weight loss is the same in both groups, but the method of support differs between the groups. The primary outcome is haemoglobin A1c (HbA1c) after 1 year. The secondary outcome is HbA1c at 6 months and 2 years. Other important secondary outcomes are diabetes remission rate, body weight and cost-effectiveness. The latter is assessed using the incremental cost per quality-adjusted life-years gained.

Ethics and dissemination

The study was approved by the Swedish Ethical Review Authority (Dnr 2022-02242-01, 2023-03707-02). The results will be published in peer-reviewed scientific journals and discussed at national and international conferences and with patient organisations.

Trial registration number

ClinicalTrials.gov (NCT05491005).

☐ ☆ ✇ BMJ Open

Wearable device monitoring of HIV health in the face of climate change and weather exposures: protocol for a mixed-methods study

Por: Kassem · N. · Boutros · P. · Kwaro · D. · Muma · J. · Obor · D. · Munga · S. · Maggioni · M. A. · Bärnighausen · T. · Winkler · V. F. · Barteit · S. — Junio 25th 2025 at 18:45
Introduction

Climate change and HIV are interconnected epidemics that increase vulnerability in people living with HIV (PLWH), particularly in sub-Saharan Africa. Despite their public health significance, research on the synergistic effects of these epidemics on the health of PLWH is limited. The advancement of non-invasive wearable technology offers an opportunity to leverage objective health data for large-scale research, addressing this knowledge gap. This study will examine the impact of weather events on distinct health variables of PLWH within the Siaya Health and Demographic Surveillance System (HDSS) in rural Kenya.

Methods and analysis

Over a period of 6 months, we continuously monitored health parameters of a total of 200 participants including heart rate, activity and sleep, using consumer-grade wearable devices. We will correlate these health data with real-time weather parameters (ambient temperature, wet bulb globe temperature, precipitation level) from five weather stations within the HDSS area and compare between HIV-positive participants and an HIV-negative control group. Additionally, a convergent mixed-methods approach will explore participants’ perceptions of the impact of weather events on their health and personal experiences. The study aims to inform future research on the complex relationship between HIV and weather events, which are projected to increase in frequency in this region due to climate change and provide valuable insights for policymakers to develop effective measures to protect this vulnerable population amid the growing climate crisis.

Ethics and dissemination

This study has been approved by the Research Ethics Committees at Kenya Medical Research Institute, Nairobi (approved on 23 October 2023; SERU 4826) and Heidelberg University Hospital, Germany (approved on 14 February 2023; S-824/2022). Written informed consent was obtained from all participants prior to enrolment, with data anonymised and handled according to Kenyan and German data protection regulations. Research findings will be disseminated through peer-reviewed publications and presented at scientific conferences.

☐ ☆ ✇ BMJ Open

Understanding stakeholders perceptions of the impact of extractive industries on adolescent health and well-being in Mozambique: a qualitative study

Por: Cambaco · O. · Galvao · C. · Brugger · C. · Munguambe · K. R. · Utzinger · J. · Knoblauch · A. M. · Winkler · M. S. — Junio 6th 2025 at 09:15
Objectives

Adolescent health is critical for achieving Sustainable Development Goal 3, ‘health for all at all ages’. In sub-Saharan Africa (SSA), mining projects hold promise for social and economic development. Yet, the extent to which the health and well-being of adolescents are impacted by industrial mining is poorly understood. In this paper, we aim to investigate how adolescent health and well-being is perceived by key informants and caregivers in communities that have been affected by industrial mining projects in Mozambique.

Design and settings

A qualitative study was implemented from May–July 2022 in two rural districts in Mozambique’s northern and central regions. Both districts have large industrial mining projects: a coal mine in Moatize district and a mineral sands mine in Moma district.

Participants

A total of 21 key informant interviews (KIIs) were conducted with a range of stakeholders, including health professionals and civil society and private sector representatives. In addition, four focus group discussions (FGDs) were conducted with adolescents’ caregivers.

Results

Through the combined results from the KIIs and FGDs, four main health concerns affecting adolescents in mining areas were identified: sexually transmitted infections, respiratory tract infections, diarrhoeal diseases and malaria. Mining activities were perceived to exacerbate negative health effects and contribute to poor health outcomes among adolescents. Although mining companies invested in public infrastructure, most participants did not perceive this investment as a positive contribution to the health and well-being of adolescents.

Conclusion

Our study sheds light on the multifaceted challenges perceived by stakeholders that adolescents residing in mining communities in Mozambique face. Insufficient priority is given to effective interventions that specifically target adolescent health in the two study mining areas. In order to leave no one behind, as stipulated by the sustainable development agenda, more emphasis should be placed on the role and responsibility of mining companies in adequately addressing adolescents’ unique health needs in mining settings in SSA.

☐ ☆ ✇ BMJ Open

Study protocol of the multicentre, randomised, triple-blind, placebo-controlled MERCURI-2 trial: promoting effective renoprotection in cardiac surgery patients by inhibition of sodium glucose cotransporter (SGLT)-2

Por: Oosterom-Eijmael · M. · Monteiro de Oliveira · N. P. · Niesten · E. D. · Tolsma · M. · Snellen · F. T. · Gerritse · B. M. · Scohy · T. V. · Rettig · T. · Godfried · M. B. · Voogd · M. F. · Wink · J. · van der Werff · L. M. · Eberl · S. · Preckel · B. · Hermanides · J. · van Raalte · D — Mayo 16th 2025 at 14:45
Introduction

Acute kidney injury (AKI) is a major complication after cardiac surgery and is associated with postoperative morbidity and mortality. Currently, no effective therapy exists to reduce the incidence of postoperative AKI. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are effective in reducing AKI in outpatient settings for patients with chronic kidney disease. We hypothesised that perioperative SGLT2 inhibition will also reduce AKI incidence after cardiac surgery according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria.

Methods and analysis

We designed a multicentre, randomised, placebo-controlled, triple-blinded, superiority trial. A total of 784 patients, aged above 18 years, undergoing cardiac surgery will be included with stratification for sex and type 2 diabetes in a 1:1 ratio. Patients will receive either dapagliflozin 10 mg or placebo from the day before until 2 days after surgery. Serum creatinine will be measured preoperatively and daily for the first 7 days after the operation, and urine output will be measured until the urinary catheter is removed. The primary outcome is the incidence of postoperative AKI according to the KDIGO criteria.

Ethics and dissemination

The medical ethics committee of the Amsterdam University Medical Centre (UMC) and the Dutch competent authority approved the study protocol (currently, version 9, 19 January 2024). This is an investigator-initiated study. The Amsterdam UMC, as sponsor, retains ownership of all data and publication rights. After completion of the trial, results will be disseminated to participants, patient societies and physicians via a network meeting and digital newsletter. Results will be submitted for publication in a peer-reviewed international medical journal and presented on (inter)national congresses.

Trial registration number

Clinicaltrials.gov identifier: NCT05590143.

☐ ☆ ✇ PLOS ONE Medicine&Health

SHINE study: Developing an intervention for safe hospital insulin use for older or frail adults with diabetes undergoing surgical hospital admission: Study protocol

by Christina Lange Ferreira, Sara Donetto, Hellena Habte-Asres, Jyothish Govindan, Angus Forbes, Kirsty Winkley

Aims

To present a study protocol for the development of an intervention to enhance safe insulin use for older or frail adults undergoing a surgical admission to hospital.

Design

Following the United Kingdom’s Medical Research Council and National Institute for Health and Care Research Frameworks for development and evaluation of complex interventions; this qualitative study will use a co-design approach using design thinking, to develop a theoretical model for the intervention.

Methods

Non-participatory observations, interviews and co-design workshops will be conducted with older or frail individuals with diabetes, their caregivers and healthcare staff responsible for their care during surgical admissions at a single National Health Service hospital in England. We will utilise their experiences and perspectives to establish priorities and generate ideas for the development of a conceptual model aimed at supporting the insulin safety review process in hospitals. Data will be analysed using framework analysis. People with diabetes were involved in the design of this study. The protocol was approved by the East-Midlands-Derby Research Ethics Committee (24/EM/0022). Study registered on Open Science Framework: https://osf.io/4wvu5.

Results

Results of this study will be shared with study participants and disseminated through presentations at conferences/meetings and peer-reviewed publications.

Conclusion

This article outlines the methodology for the planned study which will employ a novel methodology to tackle the problem of hospital insulin safety. Its findings will contribute to a better understanding of the multiple interacting components implicated in hospital insulin use (patient, staff, context) and support further work around system-based strategies to enhance insulin safety resilience in hospital.

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