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Do professional experience and qualification influence knowledge about law concerning informed consent and end-of-life decisions? A quantitative online survey among German intensive care physicians

Por: Schumann · C. · Wachter · M. · Eslauer · E. · Angeli · R. · Girrbach · F. · Weiss · M. · Friedrich · S. · Simon · P. · Heller · A. R.
Background

Recently, legal questions have increasingly arisen in intensive care medicine (ICM), especially when it comes to end-of-life decisions. Still, for Europe, there is not much evidence about doctors’ situational legal knowledge and legal education during medical studies and further qualification. The present study was initiated to analyse these hitherto unexplored aspects in Germany.

Design

A quantitative online survey has been performed among German intensive care physicians. The voluntary participants of the anonymous online survey were asked to answer legal questions related to end-of-life policies, informed consent, surrogate decision making or advance directives. We tested pure factual knowledge in five questions. The other five questions tested situational knowledge using case vignettes. Every question could be answered with ‘yes’, ‘no’ or ‘do not know’. Furthermore, the participants were asked to assess their subjective certainty on a Likert scale and to provide information about their professional experience (PE) and qualification.

Setting

All members of the two German professional societies for anaesthesiology who work in ICM were asked to take part in the survey.

Participants

952 completed questionnaires were analysed. 86% of the participants were specialists, and 56% held the additional qualification in ICM. 78% had more than 10 years of general clinical experience, and 62% had more than 5 years of experience in ICM.

Results

On average, the participants answered the five facts–questions in 90.8% correctly. However, only 73.6% of the five case vignettes were answered correctly. Specialists, physicians with a lot of PE or physicians holding the additional qualification in ICM did not perform better than assistants or physicians with little PE.

Conclusion

German intensive care physicians have relevant gaps regarding situational legal knowledge, which are independent of their PE or qualification and persist. This may be due to difficulties in interpretation and implementation of law. Since these knowledge gaps can lead to liability and criminal prosecution, these gaps should be closed through awareness-raising and continuous education.

European Registry of Next Generation Imaging in Advanced Prostate Cancer (RING): protocol for an international, prospective registry study

Por: Chernysheva · D. · Fanti · S. · Bjartell · A. · Afferi · L. · Breda · A. · Palou · J. · Padhani · A. R. · Sanguedolce · F.
Introduction

Next-generation imaging (NGI), particularly with prostate-specific membrane antigen positron emission tomography (PSMA PET) tracers, enables earlier and more accurate detection of metastases. However, conventional imaging (CT and bone scan) remains more affordable and widely accessible and was the standard used in most pivotal trials that established current survival outcomes. As PSMA PET becomes more widely adopted, a stage migration effect is emerging. However, key uncertainties persist regarding the actual proportional employment of NGI in clinical practice, main indications for its use and the mid-term and long-term effects of an NGI-driven treatment pathway. Furthermore, when or whether CI alone might remain enough informative for the treatment decision-making is still unclear.

Methods and analysis

The European Registry of Next-Generation Imaging in Advanced Prostate Cancer is a non-profit, non-interventional, multi-centre, international, prospective, investigator-initiated registry that is intended to collect real-world data on how patients with prostate cancer at risk of harbouring metastasis (high-risk at initial diagnosis, or after primary treatment) are managed according to the type of imaging used for the systemic work-up. The registry is conducted in two phases: (1) cross-sectional analysis of imaging choices and their effect on clinical decision-making and (2) longitudinal follow-up evaluating survival outcomes such as progression-free survival (PFS), disease-specific survival (DSS) and skeletal-related events (SSEs). Statistical analyses will include descriptive analysis of demographic and clinical variables, comparative analysis between different imaging pathways, survival and prognostic analyses using Kaplan–Meier tests. The expected minimum sample size of the registry is 600 patients, and the planned follow-up duration is 24 months for the longitudinal follow-up.

Ethics and dissemination

The study protocol was approved by the ethics committee of Fundació Puigvert (#C2024/30), and ethics approval is required at all participating sites. All patients will provide written informed consent. The results will be disseminated widely and transparently to maximise their effect on clinical practice, research and patient care through peer-reviewed publications, presentations at international conferences as well as through patient advocacy groups and relevant patient websites.

Trial registration number

NCT06866782.

Optimising healthcare workforce training and deployment: qualitative experiences from stakeholders in Tanzania

Por: Nyongole · O. V. · Sirili · N. · Mwakilasa · M. T. · Temba · P. · Mkoka · D. A. · Akoko · L. · August · F. · Kiwango · G. · Kaale · E. · Kamori · D. · Mbawala · H. · Sangeda · R. Z. · Mbugi · E. V. · Balandya · E. · Kamuhabwa · A. A. R. · Kakoko · D.
Objective

To explore the experiences of different stakeholders on the balance of package training and deployment of highly skilled Human Resources for Health for specialised services in Tanzania.

Design

An exploratory qualitative case study was used as part of a larger tracer study conducted by Muhimbili University of Health and Allied Sciences (MUHAS) for its postgraduate programmes being a requirement for quality assurance. Semi-structured interview guides were used for in-depth interviews (IDIs) and focus group discussions (FGDs). Qualitative content analysis was adopted to analyse the data.

Setting

The trace study was carried out in all seven geopolitical zones of the Tanzania mainland and Unguja in Zanzibar.

Participants

We conducted 14 FGDs and 301 IDIs. Participants included alumni, immediate supervisors at employment sites, MUHAS faculty, continuing students at MUHAS and management of professional councils in Tanzania.

Results

Key findings revealed variations in demands and recognition within the scheme of services, even after registration by professional councils. Five main themes emerged from the qualitative interviews: Package training to improve service provision, Unprofessional collegial relationships or issues related to professionalism within interdisciplinary teams, Silence of scheme services on super specialisation in the medical cadre, Silence of scheme services on specialisation in the nursing cadre, Integrated scheme of services for specialties in pharmacy.

Conclusion

The findings highlight the demand for specialised training, challenges with professionalism and inconsistencies in the recognition and remuneration of specialists across medical, nursing and pharmacy cadres within existing service schemes. There is a need for harmonisation between specialisation/super specialisation and the scheme of services. This harmonisation is crucial to ensure the provision of quality healthcare services. Furthermore, harmonisation requires multistakeholder engagement to realise universal health coverage strategies.

From obstruction to ischaemia: a systematic review and meta-analysis on the diagnostic accuracy of CT scans in identifying small and large bowel obstruction, underlying causes and predicting critical complications in adults

Por: Ahmad · S. J. S. · Drvaric · I. · Ahmed · A. R. · Jakob · D. · Kyriazidis · I. P. · Pouwels · S. · Hajibandeh · S. · Tang · A. · Cripps · P. · Yang · W. · Parmar · C. · Kermansaravi · M. · Abdelwahed · A. · Gelber · E. · Lala · A. · Whiteley · G. · Wilkinson · D. · Agarwal · A. · Pritchard
Objectives

To evaluate the diagnostic accuracy of CT in identifying small and large bowel obstruction and associated complications, including ischaemia and perforation, in adult patients.

Design

Systematic review and meta-analysis reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Diagnostic Test Accuracy reporting guidelines.

Data sources

Ovid MEDLINE and Embase were searched from 1946 to 20 February 2025.

Eligibility criteria

The study included randomised controlled trials, cohort studies and case–control studies evaluating the diagnostic accuracy of CT for bowel obstruction in adults (aged ≥18 years). Only studies published in English were included. Conversely, case reports, editorials, conference abstracts without full data and studies focusing exclusively on paediatric populations or animal models were excluded.

Data extraction and synthesis

Three reviewers independently extracted data on study characteristics, CT modality, diagnostic accuracy metrics (sensitivity, specificity and predictive values) and complications. Risk of bias was assessed using the QUADAS-2 tool. A random-effects meta-analysis was conducted. Heterogeneity was assessed using I² and Tau² statistics.

Results

Sixty-five studies with 9418 patients were included. The pooled sensitivity and specificity of CT for bowel obstruction were 90% (95% CI 78 to 96; I²=56%, Tau²=0.36) and 88.8% (95% CI 78.0 to 94.8; I²=65%, Tau²=0.35), respectively. For bowel ischaemia, CT showed a pooled sensitivity of 47.0% (95% CI 32.4 to 59.9; I²=0%, Tau²=0.00) and specificity of 85.3% (95% CI 77.9 to 89.5; I²=1%, Tau²=0.45). Multidetector CT (MDCT) outperformed older modalities across all endpoints. Ischaemia was present in 22.05% of all cases, with higher rates in small bowel obstruction. Perforation and mortality rates were 3.98% and 4.40%, respectively. No significant publication bias was detected, and the certainty of evidence was graded as moderate for most diagnostic accuracy outcomes.

Conclusions

CT, particularly MDCT, offers high diagnostic accuracy for bowel obstruction and is a critical tool for detecting serious complications such as ischaemia and perforation. However, sensitivity for ischaemia remains modest. Standardised protocols and prospective studies are needed to enhance early identification and optimise care pathways.

Developing consolidated guidelines for reporting and evaluation of studies using transcranial electrical stimulation (CoRE-tES): protocol for an international Delphi study and expert consensus process

Por: Suhood · A. Y. · Summers · S. · Pascual-Leone · A. · Nitsche · M. A. · Ziemann · U. · Bikson · M. · Lefaucheur · J.-P. · Brunoni · A. R. · Bestmann · S. · Chipchase · L. S. · Razza · L. B. · Cavaleri · R.
Introduction

In recent decades, transcranial electrical stimulation (tES) has become a widely used non-invasive method for modulating brain function in clinical and non-clinical populations. However, existing tES trials exhibit substantial methodological heterogeneity, often limiting the reproducibility and interpretability of findings. There currently exists a paucity of consensus-driven, standardised recommendations outlining the key factors that should be reported and/or controlled in tES studies. Accordingly, this project aims to develop Consolidated Guidelines for Reporting and Evaluation of studies using tES (CoRE-tES), a tool designed to assess the methodological quality and reporting of laboratory-based and home-based tES studies. These guidelines will support improved quality, consistency, replication and transparency in research involving tES modalities, including transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation.

Methods and analysis

CoRE-tES will be developed and disseminated over five stages. Stage 1 will comprise a review of recent tES literature to assess methodological and reporting quality. Stage 2 will employ a Delphi process to seek agreement among international tES experts on a list of items for inclusion in CoRE-tES. In stage 3, a consensus meeting will be held to synthesise and prioritise the agreed items to form CoRE-tES. Stage 4 will involve production of the final CoRE-tES checklist and an accompanying evaluation and elaboration document. In stage 5, CoRE-tES will be disseminated via journal publication, conferences, professional meetings and social media campaigns.

Ethics and dissemination

Ethics approval has been obtained from the Western Sydney University Human Research Ethics Committee (approval number H16803). Findings will be disseminated through scientific conferences and peer-reviewed journal publications, and CoRE-tES will be indexed on the Enhancing the QUAlity and Transparency Of health Research Network website.

Neurofunctional phenotyping to investigate the role of the orexin system at the intersection of opioid use disorder and insomnia: a protocol for a randomised, placebo-controlled clinical trial of lemborexant in patients with insomnia receiving buprenorphi

Por: Marcus · M. M. · Alattar · M. · Chen · S. · Sabo · R. · Pignatello · T. · Ruddley · J. · Green · A. R. · Swan · K. · Keyser-Marcus · L. · Moeller · F. G. · Martin · C. E.
Introduction

Insomnia is a common complaint among patients with opioid use disorder (OUD) maintained on buprenorphine (BUP). However, people with OUD have historically been excluded from insomnia clinical trials, leaving clinicians without evidence-based treatment options for this patient population. Lemborexant, the Food and Drug Administration (FDA)-approved dual orexin receptor antagonist for the treatment of insomnia, was recently shown to be safe and tolerable among a sample of patients with insomnia who were maintained on BUP. We hypothesise that pharmacologically antagonising the orexin system with lemborexant may improve insomnia symptoms in individuals with OUD and also enhance BUP treatment benefits by improving performance in neurofunctional domains identified in the National Institute on Drug Abuse Phenotyping Assessment Battery.

Methods and analysis

Participants with insomnia and OUD who have been stabilised on BUP for at least 4 weeks will be randomly assigned to receive either lemborexant (n=50) or placebo (n=50) for 8 weeks. Participants will complete assessments at baseline, during the 8-week intervention, postintervention and at a 2-week follow-up. Primary outcomes are insomnia severity and impulsivity. Secondary measures include objective sleep metrics (total sleep time, sleep efficiency, sleep onset latency and wake after sleep onset) and performance in the neurofunctional domains of negative emotionality and metacognition.

Ethics and dissemination

The study was approved by the Virginia Commonwealth University Institutional Review Board in April 2025 (protocol number HM20031777). Data collection began in May 2025 and is expected to be completed by May 2029. The trial is conducted under FDA IND no. 154797 (FGM). The dissemination plan for the trial includes presentations at local and national conferences, submission of primary and secondary outcome manuscripts for publication in peer-reviewed journals and circulation of findings to popular media outlets, as available. Results will also be shared with interested participants and clinical collaborators upon completion of the trial.

Trial registration number

NCT06981195.

Bridging the representation gap in the surgical workforce: a scoping review protocol of programmes and interventions to support surgical careers for underrepresented minority learners

Por: Qureshi · A. R. · Halabian · N. · Malhotra · A. K. · Majeed · M. · Bhatt · V. · Anifowose · A. · Alam · A. · Nguyen · D.-D. · Yibrehu · B. · Ayoo · K. · Bondzi-Simpson · A. · Brar · S. · UpSurge Research Group · Covelli
Introduction

Despite increasing proportions of underrepresented minority (URM) medical school graduates, their progression into surgical training and leadership remains disproportionately low. Barriers such as financial constraints, limited mentorship and implicit bias contribute to this disparity, creating a disconnect between the diversity of patient populations and those providing care. While interventions such as mentorship programmes and pipeline initiatives have been implemented, their overall effectiveness has not been systematically evaluated. The primary aim of this scoping review is to map the current landscape of interventions, programmes and policies designed to enhance access to surgical careers for URM learners.

Methods and analysis

Searches will be conducted on EMBASE, Web of Science and OVID MEDLINE. Three independent reviewers will screen references, extract data and perform analyses with disagreements adjudicated by a fourth reviewer. This review will include studies conducted across all levels of training: secondary (high school or secondary school), postsecondary (undergraduate, medical school) and postgraduate (residency, fellowship), with no geographical restrictions. The definition of URM will be accepted as reported within each individual study, allowing for variability in racial, ethnic, gender, socioeconomic or other criteria. The review will include any structured interventions, programmes or policies aimed at increasing URM representation in surgical education. Data on the nature, duration and target population of each intervention will be extracted. The primary outcome will be the reported impact of interventions on URM representation or participation in surgical education. Secondary outcomes will include characteristics of the study participants, definitions of URM status and any qualitative or quantitative evaluations of intervention effectiveness.

Ethics and dissemination

Research ethics approval is not required under University of Toronto policy. Study results will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Results will be disseminated to relevant stakeholders at conference presentation(s) and submitted for publication in a peer-reviewed journal.

Mortality and associated factors among hospitalised COVID-19 patients in Lira regional referral hospital, a cross-sectional study

Por: Ongoli · A. · Opio · B. · Opollo · M. S. · Akello · A. R. · Kiweewa · F. · Omech · B.
Background

Coronavirus disease 2019 (COVID-19) caused a global public emergency between 2020 and 2022 with various morbidity and mortality across the regions. While the impact in sub-Saharan Africa appeared relatively limited, data from regional referral hospitals remain scarce.

Objective

To determine the in-hospital mortality rate, risk factors and clinical characteristics of COVID-19 patients admitted to the COVID-19 treatment unit (CTU) at Lira Regional Referral Hospital (LRRH) in northern Uganda

Design

Cross-sectional study with the use of secondary data

Setting

This study was conducted at LRRH between January 2023 and December 2023. The data used were for patients admitted from May 2020 to March 2022.

Participant

Records of 490 patients admitted with laboratory confirmed COVID-19 were collected and analysed. Selection was by simple census sampling technique. Inclusion criteria were moderately to critically ill patients and those with mild/asymptomatic infection but with comorbidities.

Results

Of the 490 participants, 52% were females and 41% were aged ≥60 years. The most common symptoms were cough (89.6%), difficulty in breathing (78.8%) and chest pain (69.3%). Hypertension (30%), diabetes mellitus (19.5%) and human immunodeficiency virus (10%) were the leading comorbidities. Severe and critical illness was observed in 40% and 7% of cases, respectively. The overall in-hospital mortality rate was 29%. Factors significantly associated with reduced mortality included normal oxygen saturation (SPO2) (adjusted odds ratios (aOR) 0.11, 95% CI 0.03 to 0.44), normal body temperature (aOR 0.22, 95% CI 0.05 to 0.99), absence of chronic liver disease (aOR 0.01, 95% CI 0.001 to 0.46) and younger age (31–45 years; aOR 0.14, 95% CI 0.03 to 0.74).

Conclusion

The study revealed a high in-hospital mortality rate of 29% among COVID-19 patients admitted to the CTU at LRRH, primarily driven by severe disease presentation and limited access to critical interventions such as oxygen therapy. Independent predictors of survival included younger age, normal oxygen saturation, absence of chronic liver disease and normal body temperature at admission. These findings underscore the urgent need for early identification of high-risk patients and improved access to supportive care, particularly oxygen delivery systems, to reduce mortality in future outbreaks. Strengthening diagnostic capacity, clinical monitoring and preparedness for respiratory pandemics—alongside prospective studies capturing broader patient data—will be essential to refine response strategies and improve outcomes.

Pre-conception lifestyle intervention to optimise maternal health for a better start to life: the BEGIN BETTER prospective randomised controlled trial protocol

Por: Mitchell · M. · Deussen · A. R. · Louise · J. · Poprzeczny · A. J. · Keir · A. K. · Briley · A. L. · Oxlad · M. · Dodd · J. M.
Introduction

Overweight and obesity impacts approximately 50% of pregnant women. Professional medical colleges worldwide recommend women with a higher body mass index (BMI) lose weight before conception. While diet and lifestyle interventions before pregnancy are associated with improvements in diet and modest weight loss, subsequent clinical pregnancy outcomes are poorly reported.

Our aim is to conduct a randomised controlled trial of a comprehensive lifestyle intervention for women with overweight or obesity who are planning pregnancy. We will evaluate the impact of this intervention on maternal health and well-being prior to conception; and pregnancy, birth and newborn health outcomes in a subsequent pregnancy.

Methods and analysis

Women with a BMI ≥25.0 kg/m2 who plan to conceive within 2 years will be recruited.

Women randomised to the ‘Educational Control Group’ will attend a pre-conception health consultation with a research midwife, providing limited information about obesity and associated risks in pregnancy, nutrition, exercise and weight management.

Women randomised to the ‘Pre-pregnancy Lifestyle Intervention Group’ will attend a pre-conception health consultation with a research midwife, as above, and additionally consult with a research dietitian and trained health coaches throughout the 6-month intervention period. Women will also have access to a specifically designed mHealth application providing tailored content and interactive tasks delivered bi-weekly during this time.

The primary outcome is infant birth weight z-score

Secondary outcomes will include a range of maternal pre-conception health outcomes; maternal and infant pregnancy and birth outcomes; diet and physical activity changes; and quality of life.

We estimate a mean birth weight z-score of 0.43 (SD 1.09) and will recruit 800 women to detect 0.4 SD difference (alpha 0.05 (two-tailed); power 80%). Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.

Ethics and dissemination

The study protocol was approved by the Human Research and Ethics Committee of the Women’s and Children’s Hospital, Adelaide, South Australia (HREC/17/WCHN/177; 2020/HRE01445) on 17 August 2018. The first participant was recruited in June 2021, with recruitment anticipated through 2025. The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.

Trial registration number

ACTRN 12621000128897. This study has been registered at (https://www.anzctr.org.au/).

E-Prem checklist-driven strategy to improve outcomes in extremely preterm and low birth weight infants: a quasi-experimental study at a national referral hospital in Indonesia

Por: Marsubrin · P. M. T. · Sugiyarto · K. L. J. · Oswari · J. S. · Yulianti · D. A. · Rohsiswatmo · R. · Roeslani · R. D. · Iskandar · R. A. T. P. · Sukarja · D. · Sjahrullah · M. A. R. · Kautsar · A. · Chaudhari · T.
Objectives

This study aims to assess how implementing a checklist for managing extremely preterm or extremely low birth weight infants can reduce mortality rates and morbidities.

Design

A quasi-experimental, before-and-after study.

Setting

Neonatal intensive care unit at Dr. Cipto Mangunkusumo National General Hospital, a national referral hospital in Indonesia.

Participant

86 infants were born at

Interventions

Implementation of a modified Canberra Health Services extremely preterm-early management checklist during the initial management of extremely preterm or low birth weight infants, including humidified gas resuscitation, thermal management, early surfactant administration and standardised first-hour care protocols.

Main outcome measures

The primary outcome was the mortality rate. Secondary outcomes included comorbidities such as hypothermia, hypoglycaemia, acidosis, intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL) and retinopathy of prematurity (ROP).

Results

A total of 86 extremely premature and/or extremely low birth weight infants were enrolled, 48 neonates prior to and 38 neonates after the use of the checklist. Baseline characteristics were comparable between groups (median gestational age 27 weeks in both groups, median birth weight 795 g vs 868.5 g, p=0.09). Mortality at discharge showed a non-significant reduction from 52.1% to 47.4% (p=0.664, 0.91, 95% CI 0.64 to 1.30). Significant reductions were observed in IVH (79.2% to 28.9%, p

Conclusions

Implementation of a systematic checklist was associated with significant reductions in IVH and ROP, though mortality reduction was not statistically significant. These findings suggest potential benefits of structured early care protocols, but the observational design limits causal inference.

Leveraging emotional intelligence to alleviate mental health: protocol of a cluster randomised controlled trial among parents of children with neurodevelopmental disorders in Bangladesh

Por: Salwa · M. · Chowdhury · S. M. · Rois · R. · Uddin · M. K. · Akhter · S. · Nahar · K. · Mullick · A. R. · Mannan · M. · Kundu · G. K. · Fatema · K. · Maruf Haque Khan · M. · Haque · M. A.
Background

Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.

Methods and analysis

This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost–utility analysis of direct and indirect costs.

Ethics and dissemination

Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.

Trial registration number

NCT06166550.

Health economic assessment of the Landes public service 'Vivre a Domicile (VIVADOM) (Living at Home) based on personalised care for frail older adults with human support and digital solutions (telecare, tablet, home automation and connected objects): a Ma

Por: Sawadogo · A. R. · Gayot · C. · Nys · J. F. · Le Goff-Pronost · M. · Tchalla · A.
Introduction

Preventing loss of autonomy has become a public health issue due to the increase in healthcare costs associated with ageing. It has become even more pressing with the arrival of the baby-boomer generation. This has given rise to several initiatives. This is the background to the VIVADOM project. The project provides a complete kit for older adults aged 60 years and over living at home. First, the kit includes a technological package (telecare, light path and digital tablet). Then, these older adults benefit from personalised human support provided by postal workers trained in gerontology. The aim of this study will be to carry out a health economic assessment (HEA) of the VIVADOM project as part of the prevention of frailty and/or dependency (by comparing beneficiaries of the complete kit with non-beneficiaries). The comparator will be the fact of not benefiting from the complete kit. In addition, the efficiency of the project in preventing falls and cognitive problems will be studied. We will calculate three incremental cost-effectiveness ratios (ICER) for these three issues.

Methods and analysis

The economic model used will be the Markov model. Transition probabilities, average costs and average quality-adjusted life year (QALY) will be calculated for the two groups being compared. The ICER will be obtained by dividing the difference in average costs by the difference in average QALYs. Finally, ICERs will be compared with willingness-to-pay (WTP) to assess the efficiency of the system. Thus, the VIVADOM project will be efficient when these ICERs are lower than the WTP. Univariate and probabilistic sensitivity analysis will be carried out to ensure the robustness of the analysis results.

Ethics and dissemination

The HEA of the VIVADOM project has been approved by the research unit of the University of Limoges in France. The results will be published in a peer-reviewed journal and presented at relevant national and international conferences.

Tirzepatide for the treatment of adults living with concurrent type 1 diabetes and overweight or obesity (TZP-T1D): a double-blind, placebo-matched randomised controlled trial protocol

Por: Purcell · A. R. · Rodrigo · N. · Longfield · M. S. G. · Glastras · S. J.
Introduction

The increasing prevalence of overweight and obesity among individuals with type 1 diabetes (T1D) complicates glycaemic management and escalates insulin resistance, necessitating innovative therapeutic strategies. Tirzepatide, a dual agonist for glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, shows promise in managing weight and glycaemic control in type 2 diabetes but is unexplored in the context of T1D. This double-blind, placebo-controlled randomised trial will evaluate the efficacy of tirzepatide in adults with T1D and overweight/obesity over 32 weeks.

Methods and analysis

60 participants (aged 18–70 years) with a body mass index ≥27 kg/m2 and HbA1c≤10% will be randomised 1:1 to receive either tirzepatide or a placebo, alongside standard insulin therapy. The primary outcome is the change in body weight (%). Secondary measures include change in HbA1c (%), proportion of body weight lost (>5%, >10%, >15% and >20%), changes in insulin dosage, time in range by continuous glucose monitoring (CGM) criteria and severity of comorbidities. Compliance, adverse events and medication interactions will be closely monitored, with adjustments made for tolerability. Patient-reported outcomes and experiences will be measured to capture the benefits of glycaemic management, weight management and quality of life. To compare the means of body weight reduction (%) between the tirzepatide and control groups, an independent samples t-test will be employed under the assumption that data are normally distributed. Secondary outcome measures will be analysed by Student’s t-test. All data will be reported as group means with confidence intervals, with default statistical significance assumed at p

Ethics and dissemination

Ethical approval has been obtained from the Northern Sydney Local Health District’s Human Research Ethics Committee (approval ID #2024/ETH00180).

Trial registration number

NCT06180616.

Developing and validating a risk prediction model for conversion to type 2 diabetes mellitus in women with a history of gestational diabetes mellitus: protocol for a population-based, data-linkage study

Por: Versace · V. · Boyle · D. · Janus · E. · Dunbar · J. · Feyissa · T. R. · Belsti · Y. · Trinder · P. · Enticott · J. · Sutton · B. · Speight · J. · Boyle · J. · Cooray · S. D. · Beks · H. · OReilly · S. · Mc Namara · K. · Rumbold · A. R. · Lim · S. · Ademi · Z. · Teede · H. J.
Introduction

Women with gestational diabetes mellitus (GDM) are at seven-fold to ten-fold increased risk of type 2 diabetes mellitus (T2DM) when compared with those who experience a normoglycaemic pregnancy, and the cumulative incidence increases with the time of follow-up post birth. This protocol outlines the development and validation of a risk prediction model assessing the 5-year and 10-year risk of T2DM in women with a prior GDM diagnosis.

Methods and analysis

Data from all birth mothers and registered births in Victoria and South Australia, retrospectively linked to national diabetes data and pathology laboratory data from 2008 to 2021, will be used for model development and validation of GDM to T2DM conversion. Candidate predictors will be selected considering existing literature, clinical significance and statistical association, including age, body mass index, parity, ethnicity, history of recurrent GDM, family history of T2DM and antenatal and postnatal glucose levels. Traditional statistical methods and machine learning algorithms will explore the best-performing and easily applicable prediction models. We will consider bootstrapping or K-fold cross-validation for internal model validation. If computationally difficult due to the expected large sample size, we will consider developing the model using 80% of available data and evaluating using a 20% random subset. We will consider external or temporal validation of the prediction model based on the availability of data. The prediction model’s performance will be assessed by using discrimination (area under the receiver operating characteristic curve, calibration (calibration slope, calibration intercept, calibration-in-the-large and observed-to-expected ratio), model overall fit (Brier score and Cox-Snell R2) and net benefit (decision curve analysis). To examine algorithm equity, the model’s predictive performance across ethnic groups and parity will be analysed. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-Artificial Intelligence (TRIPOD+AI) statements will be followed.

Ethics and dissemination

Ethics approvals have been received from Deakin University Human Research Ethics Committee (2021–179); Monash Health Human Research Ethics Committee (RES-22-0000-048A); the Australian Institute of Health and Welfare (EO2022/5/1369); the Aboriginal Health Research Ethics Committee of South Australia (SA) (04-23-1056); in addition to a Site-Specific Assessment to cover the involvement of the Preventative Health SA (formerly Wellbeing SA) (2023/SSA00065). Project findings will be disseminated in peer-reviewed journals and at scientific conferences and provided to relevant stakeholders to enable the translation of research findings into population health programmes and health policy.

Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya

Por: Kwach · B. · Odoyo · J. B. · Lauff · A. R. · Omollo · V. · Rono · B. · Ogello · V. · Mann · V. · Kwena · Z. · Thomas · K. · Sharma · M. · Morton · J. F. · Ngure · K. · Bukusi · E. · Mugwanya · K. K. · PrEP Care Team · O.-S.
Introduction

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

Methods and analysis

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethics and dissemination

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Protocol amendments

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

Protocol version

V. 2.0 dated 21 May 2024.

Trial registration number

NCT03194308.

Development and pilot testing of a personalised decision aid for decision-making regarding fertility preservation in young female patients with cancer: a study protocol

Por: Jang · J. · Lee · E. M. · Chung · Y. K. · Lee · D. O. · Park · H. J. · Yim · G. W. · Lee · K. S. · Kim · J. H. · Ko · A. R. · Hong · J. H. · Kang · S.
Introduction

Infertility resulting from cancer treatment is known to be a major factor that reduces the quality of life of young cancer survivors. However, discussions and decision-making about fertility preservation before cancer treatment have been insufficient owing to barriers in the clinical field. In addition, selecting a fertility preservation option requires a complex decision-making process that considers not only medical information but also the patient’s values and preferences. Hence, an environment that more easily supports patient decision-making about fertility preservation needs to be created. Therefore, this protocol will develop and test a web-based decision aid (DA) for fertility preservation among young patients with cancer, considering patient preferences and values, evaluate acceptability and usability of the developed DA and assess its effectiveness.

Methods and analysis

This protocol outlines the development of a web-based DA for fertility preservation targeting females of reproductive age diagnosed with cancer. It includes alpha testing to evaluate the usability and acceptability of the DA, as well as beta testing to assess its effectiveness outside of clinical settings, both based on an online survey. The web-based DA for fertility preservation consists of three modules: 1) an information collection module, 2) an option suggestion module and 3) a value communication module. The information collection module collects information essential to select appropriate fertility preservation options. The option suggestion module returns all applicable fertility preservation options based on the patient’s characteristics, which are essential for determining the appropriate option, such as menarche status and desire for pregnancy. The value communication module provides information on the extent to which each fertility preservation option satisfies the patient’s values and preferences. After the development of the DA, a small group of young patients with cancer (n=10) and health providers (n=5) will be asked to use this web-based DA for fertility preservation and assess the acceptability and usability of this DA based on a survey (alpha-testing). By reflecting the feedback of acceptability and usability testing, the DA will be updated for improvement, and clinical field testing (beta-testing pilot trial) will be performed using the updated DA. Beta-testing will be conducted on young patients with cancer (aged 18–40 years) before they receive any curative cancer treatment (n=32). These patients with cancer will be randomly allocated to the DA group (intervention group) or the usual care group (control group). The DA group will use the web-based DA before treatment, and the control group will not have access to the web-based DA and will be asked to decide whether to consult a fertility preservation specialist. The primary outcome of the beta testing will be the level of decisional conflict, and the secondary outcomes will include knowledge, decision self-efficacy, decision readiness, depression severity, quality of life, counselling on fertility preservation and decision-making about fertility preservation. Outcomes, including decisional conflict, knowledge, decision self-efficacy, quality of life and depression severity, will be measured before the intervention (T0), 1 week after the intervention (T1) and 1 month after the intervention (T2). The readiness for decision-making will be assessed at T1 for the intervention group only. Counselling on fertility preservation and decision-making about fertility preservation will be assessed once after testing (T2) for both the intervention and control groups.

Ethics and dissemination

The study will be conducted in accordance with ethical standards and was approved by the Institutional Review Board at the National Cancer Centre, Korea (IRB No. NCC2024-0050). All study participants will provide written informed consent before participation. The results generated from this study will be presented at conferences or scientific meetings and disseminated through publication in a peer-reviewed journal.

Trial registration

NCT07038174 (beta-testing phase).

Impact of abnormal ambulatory ECG findings when screening for atrial fibrillation in primary care: a qualitative study among participants of the PATCH-AF trial

Por: Brik · T. · Niekel · M. S. · Bak · M. A. R. · Himmelreich · J. C. L. · Harskamp · R. E. · Moll van Charante · E. P.
Background and aim

European cardiovascular guidelines recommend systematic atrial fibrillation (AF) screening in community-dwelling high-risk patients. However, little is known about the impact of abnormal screening findings, including AF and non-AF incidental findings on the target population. This gap highlights the need to assess both the benefits and potential harms from patients’ perspectives to fully understand the impact of AF screening. Therefore, the aim of this study is to explore patients’ experiences with AF screening among those who received abnormal findings from ambulatory ECG monitoring.

Design

We conducted a qualitative study using semistructured interviews, analysed thematically. Participants in the PATCH-AF trial, based in Amsterdam primary care, were purposively sampled based on their screening results (AF or non-AF incidental findings), sex and socioeconomic status.

Results

We achieved data saturation after conducting 16 interviews (6 with interviewees diagnosed with AF and 10 with non-AF incidental findings). Participants had a median age of 76 (73–79) years, and 56% were male. Their experiences, whether positive or negative, fluctuated throughout the screening process and depended on their initial motivations for participation in AF screening (seeking extra health checks, finding explanations for pre-existing symptoms or contributing to medical research), expectations and perceived benefits from clarification, diagnostic workup or treatment. Influencing factors included the type of finding (AF or non-AF incidental finding), healthcare provider communication and individual characteristics such as age, socioeconomic status and medical history.

Conclusion

This qualitative study highlights both positive and negative AF screening experiences from the patients’ perspective. It underscores how patients’ motivations and expectations for participation, the type of ambulatory ECG finding and communication and follow-up by healthcare providers shape their overall experiences. Healthcare providers should be aware of these factors to optimise screening consultations. Clear guidelines on communicating abnormal ambulatory ECG findings, especially incidental findings, are warranted.

Trial registeration number

The Netherlands Trial Register (NTR) number NL9656.

Readiness to reduce primary care-associated carbon emissions in England: a cross-sectional survey of clinical and non-clinical staff views

Por: Geddes · O. · Twohig · H. · Dahlmann · F. · Eccles · A. · Karaba · F. · Nunes · A. R. · Spencer · R. · Dale · J.
Objectives

To describe current levels of interest and action around decarbonisation in general practice settings, and awareness and use of currently available materials designed to support general practice teams undertake decarbonisation activity.

Design

Cross-sectional, mixed methods, online survey.

Setting

473 general practices in three Integrated Care Board regions in England.

Participants

Multiprofessional general practice staff.

Results

There were 328 responses from 163 (34.5%) practices. Most respondents were general practitioner (GP) partners (98; 29.9%), other clinical staff (93; 28.3%) or managerial staff (76; 23.2%). 229 (69.8%) respondents felt that acting to reduce carbon emissions from primary care is a legitimate part of general practice activity. However, only 44 (13.4%) felt that there is sufficient training and resources to support such activity, and only 59 (18.0%) agreed that there was sufficient leadership from higher levels within the health service to enable this. 58 (35.6%) practices had a lead for sustainability, generally managerial staff (22; 37.9%) or GP partners (17; 29.3%). Compared to other practices, those with a decarbonisation lead reported increased levels of decarbonisation actions currently being undertaken (mean = 5.2 vs 3.1; t(161) = 7.7, p2=31.9, p2=32.3, p

Conclusions

This survey provides insight into how English general practices and their staff regard decarbonisation activities. The findings highlight the importance of leadership, resources and incentives in driving such activities and have implications for initiatives to help achieve wider decarbonisation goals in healthcare.

Comparison of outpatient attendance, cardiovascular risk management and cardiovascular health across preCOVID-19, during and postCOVID-19 periods: a prospective cohort study

Por: Zondag · A. G. M. · Haitjema · S. · de Groot · M. C. H. · de Boer · A. R. · van Solinge · W. W. · Bots · M. L. · Vernooij · R. W. M.
Objective

During the COVID-19 pandemic, a substantial decrease was observed in hospital admissions and in-hospital procedures for patients with acute cardiovascular diseases (CVDs). The extent to which measures to prevent COVID-19 transmission, for example, lockdowns, affected the outpatient care of patients at higher cardiovascular risk remains unclear. We aimed to compare outpatient department (OPD) attendance, cardiovascular risk management (CVRM) and cardiovascular health (CVH) of patients at higher cardiovascular risk referred to an OPD of a tertiary care centre between preCOVID-19, during and postCOVID-19 periods.

Design, setting and participants

We included all adult patients at higher cardiovascular risk referred to the cardiology, vascular medicine, diabetology, geriatrics, nephrology or multidisciplinary vascular surgery OPDs of the University Medical Centre Utrecht, the Netherlands, between March 2019 and December 2022, in a prospective cohort study.

Main outcome measures

We assessed trends in the number of first and follow-up appointments and in the completeness of extractable CVRM indicators from the electronic health record (EHR) as a proxy for CVRM guideline adherence. CVH was determined using the Life’s Essential 8 metric (score 0–100, the higher score, the better). We investigated whether CVH differed between COVID-19 periods compared with the reference period (ie, 2019) and stratified by OPDs, using multivariable linear regression, adjusted for age, gender, CVD history and whether the patient had a previous appointment before the reference period.

Results

Among 15 143 patients, we observed a 33% reduction in the weekly number of first appointments during the COVID-19 pandemic, with the largest reductions in the cardiology and nephrology OPDs, with no differences between women and men. Follow-up appointments conducted remotely, compared with before the COVID-19 pandemic, increased significantly for all OPDs. CVRM indicators were up to 11% less extractable during the first lockdown yet returned to prepandemic levels directly after the first lockdown period. The CVH score of patients visiting the nephrology, vascular medicine and geriatrics OPDs during the first lockdown was 11.23 (95% CI 2.74 to 19.72), 5.68 (95% CI 0.82 to 10.54) and 5.66 (95% CI 0.01 to 11.31) points higher, respectively, compared with the prepandemic period. In between the second and third lockdowns, the CVH score was comparable to the preCOVID reference period, yet for the cardiology OPD it was significantly higher (5.54, 95% CI 2.04 to 9.05).

Conclusions

During the COVID-19 pandemic, weekly numbers of first appointments to OPDs decreased, and a population with a higher CVH score (ie, better CVH) visited certain OPDs, especially during the first lockdown period. These suggest that patients with poorer CVH more often avoided or were unable to visit OPDs, which might have resulted in missed opportunities to control cardiovascular risk factors and potentially may have led to preventable disease outcomes. For future epidemics and pandemics, it seems vital to develop a strategy that includes an emphasis on seeking healthcare when needed, with specific attention to patients at higher CVD risk.

Community-based rehabilitation approach in older adult population: a scoping review protocol

Por: Mollaei · M. · Javazm · A. R. · Metanat · F. · Shirozhan · S. · Motie · M.
Introduction

The global population of individuals aged 60 years and older is growing rapidly, presenting multiple complex challenges, including frailty, cognitive decline, functional impairments, multimorbidity and polypharmacy. Consequently, addressing the rehabilitation needs of this age group poses significant difficulties in today’s world. There is some evidence that community-based rehabilitation approaches can meet the unique rehabilitation needs of older individuals. Therefore, this scoping review aims to explore the application of community-based rehabilitation approaches for the older adult population.

Methods and analysis

This scoping review will follow the methodological framework outlined by Arksey and O'Malley. The search will be conducted using academic databases, including PubMed, ScienceDirect, Embase, CINAHL and Web of Science, with the search terms ‘community-based rehabilitation,’ ‘aged,’ ‘older,’ ‘elder’ and ‘geriatric’. Additionally, Google Scholar will be used to identify relevant literature. Publications in English from inception to January 2025 that explicitly address community-based rehabilitation programmes for older adults will be eligible. Inclusion criteria encompass studies reporting on CBR interventions, outcomes or implementation targeting older adults with disabilities or vulnerabilities, across diverse geographic and socioeconomic contexts. Both peer-reviewed articles and grey literature (eg, reports, guidelines, theses) will be considered. Studies focusing solely on clinical or institutional rehabilitation without community components will be excluded. The study selection process will occur in two stages, involving the participation of three reviewers. A data extraction form will be used to systematically extract data from all included studies.

Ethics and dissemination

This scoping review was approved by the Ethics Committee of the University of Social Welfare and Rehabilitation Sciences (Code:IR.USWR.REC.1404.034), and the results will be published in a peer-reviewed scientific journal.

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