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Prospective accuracy study on an artificial intelligence-based ultrasound system for gestational age estimation among pregnant women in Ghana, Kenya and South Africa: protocol

Por: Swarray Deen · A. · McDougall · A. R. A. · Chemway · R. · Craik · R. · Jayaratnam · S. · Joseph · N. · Mahar · R. · Koye · D. · Nguyen · L. · Simpson · J. · Gwako · G. · Hadebe · R. L. · Nartey · E. T. · Minckas · N. · Gülmezoglu · A. M. · Vogel · J. P. · Osman · A. · PEARLS Collaborat
Background

Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

Methods and analysis

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11+0 to 13+6 weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14+0 and 27+6 weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11+0 to 13+6 weeks’).

Ethics and dissemination

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

Benefits of childhood vaccines in ecological studies focusing on Germany: a scoping review protocol

Por: Nolting · T. · Martin · D. D.
Introduction

General statements that vaccinations are among the most important preventive measures in medicine are common in public health guidance. While the efficacy of individual vaccines is well established through randomised controlled trials and observational studies, ecological studies at the population level can provide complementary insights into the relative historical contributions of different childhood vaccinations to reductions in morbidity and mortality. To date, there has been a lack of systematic reviews of such comparative studies, especially with a focus on Germany. The aim of this scoping review is to map the state of research on ecological studies that compare the relative contribution of different childhood vaccinations to reducing morbidity and mortality, with a focus on reported data from Germany in an international comparison. A more precise scientific and public communication about vaccinations strengthens confidence in evidence-based vaccination recommendations.

Methods and analysis

This scoping review follows the Joanna Briggs Institute methodology for scoping reviews. Reporting will be in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews (PRISMA-ScR). A comprehensive search will be conducted in MEDLINE via PubMed, Embase via Elsevier, Web of Science, Scopus via Elsevier and Google Scholar, supplemented by grey literature sources. Studies will be selected and data charted by at least two independent reviewers using the Population/Concept/Context (PCC) framework. Results will be synthesised descriptively and presented thematically.

Ethics and dissemination

No ethical approval is required as this is a secondary analysis of published data. The findings will be disseminated through publication in a peer-reviewed journal and as part of the first author’s doctoral thesis. The protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/4FH3X).

Antibacterial consumption in four paediatric inpatient facilities in Sri Lanka in 2023: a cross-sectional descriptive study

Objective

To describe antibacterial consumption (ABC) in four paediatric inpatient facilities in Sri Lanka in 2023.

Design

Descriptive cross-sectional study, adapted from the WHO Global Antimicrobial Resistance and Use Surveillance System methodology.

Settings

Paediatric inpatient facilities in two tertiary and two secondary care government hospitals located across three provinces.

Data

Data on antibacterials for systemic use, J01 in the Anatomical Therapeutic Chemical (ATC) classification issued to these paediatric inpatient facilities in 2023 by their respective hospital pharmacies.

Outcome measures

(1) ABC at ATC third and fifth levels expressed as defined daily doses (DDDs)/100 admissions, (2) ABC as per WHO ‘Access, Watch and Reserve’ category, (3) choice of antibacterials within a class, (4) DU 75% for oral and parenteral dosage forms, (5) quality indicators such as amoxicillin index and broad:narrow spectrum ratio.

Results

In 2023, total antibacterial (J01) consumption across the four paediatric inpatient facilities was 94.49 DDDs/100 admissions. Together, non-penicillin beta-lactams, penicillins and macrolides/lincosamides/streptogramins accounted for 90–98%. Co-amoxiclav was the most consumed antibacterial, and six agents (co-amoxiclav, cefotaxime, clarithromycin, azithromycin, cefuroxime and meropenem) collectively accounted for 70–90%. Aminoglycosides, tetracyclines, sulfonamides and trimethoprim, and quinolones contributed minimally. Access and Watch group antibacterials accounted for 34 and 65%. Quality indicators demonstrated disproportionately higher use of broad-spectrum and Watch group antibacterials.

Conclusion

High use of broad-spectrum and Watch-group antibacterials was observed across the four paediatric inpatient facilities. The findings highlight targets for antibacterial stewardship programmes and demonstrate the feasibility of ABC surveillance in Sri Lanka.

PROspective Prostate Cancer Infrastructure: study protocol for the ProPCI 'trials within cohorts study

Por: Wissing · R. O. · van Elst · T. · Sedelaar · M. · Smeenk · R. J. · van den Berg · P. · van Dodewaard-de Jong · J. M. · Lont · A. P. · Hendriks · M. P. · Luijendijk-de Bruin · D. · van de Luijtgaarden · A. C. M. · Roelofs · L. A. J. · Vis · A. N. · Hoekstra · R. J. · Bloemendal · H
Introduction

The diagnostic and therapeutic landscape for high-risk localised prostate cancer and synchronous metastatic hormone-sensitive prostate cancer (mHSPC) is rapidly evolving, driven by advances in imaging, risk stratification and systemic therapies, including the advent of precision medicine. High-quality real-world data integrating clinical, imaging, molecular, quality-of-life information and outcome data remain scarce. The PROspective Prostate Cancer Infrastructure (ProPCI) is a nationwide, multicentre observational cohort designed to collect comprehensive longitudinal data and biomaterials to support real-world evidence generation, facilitate biomarker discovery and enable future cohort multiple randomised controlled trials (cmRCTs).

Methods and analysis

ProPCI includes adult men with high-risk localised prostate cancer or synchronous mHSPC across hospitals in the Netherlands. Clinical data are extracted from electronic health records using a standardised protocol and linked to national registries and healthcare use datasets. Patient-reported outcome measures are collected at baseline and regular intervals using validated instruments. Serial blood samples are biobanked for circulating tumour DNA and other molecular analyses. Outcomes include diagnostic and treatment patterns, Prostate-specific antigen kinetics, time to castration-resistant prostate cancer, radiological and clinical progression, health-related quality of life trajectories and healthcare use, including expenditure and exploratory biomarker associations. Statistical methods include descriptive analyses, time-to-event models, mixed-effects models and biomarker-outcome correlates.

Ethics and dissemination

Ethical approval has been obtained from the Committee on Research Involving Human Subjects (CMO) of Radboudumc. Written informed consent will be obtained from every participating patient and covers: (1) extraction and linkage of clinical, imaging, pathology and registry data, (2) future contact for potential cmRCT participation; and optional components (3) quality-of-life questionnaires, (4) collection of additional blood samples and (5) use of biomaterials for genomic testing. Results will be disseminated through peer-reviewed publications.

Trial registration number

NCT07560748.

Low-carbohydrate diet score subtypes and all-cause mortality in general and chronic disease populations: a systematic review and meta-analysis of prospective cohort studies

Por: Duc · T. Q. · Nguyen Di · K.
Objectives

To examine associations of overall, healthy and unhealthy low-carbohydrate diet (LCD) scores with all-cause mortality in general and chronic disease populations. Healthy and unhealthy subtypes were compared with assess whether the observed associations depend on macronutrient quality rather than carbohydrate restriction alone.

Design

Systematic review and pairwise category meta-analysis.

Data sources

PubMed, MEDLINE, ProQuest Medical Database and Web of Science Core Collection were searched from inception to 12 May 2026.

Eligibility criteria

Prospective cohort studies of adults assessing LCD adherence using a validated three-macronutrient composite score and reporting HRs for all-cause mortality were eligible.

Data extraction and synthesis

Two reviewers independently extracted data and assessed study quality using the Newcastle-Ottawa Scale (NOS). Random-effects meta-analyses compared each higher reported LCD category with the lowest category, stratified by LCD score subtype and population type. Certainty of evidence was assessed using NutriGrade.

Results

18 prospective cohort studies included 779 158 participants and 219 457 deaths; all scored 7–9/9 on the NOS. In chronic disease populations, the highest healthy LCD category was associated with lower mortality than the lowest category (HR 0.72, 95% CI 0.69 to 0.76; I²=0%; high certainty), as was the highest overall LCD category (HR 0.85, 95% CI 0.75 to 0.96; I²=68%; high certainty). In the general population, the highest healthy LCD category was not associated with lower mortality than the lowest category (HR 0.93, 95% CI 0.85 to 1.01; I²=69%; moderate certainty), and neither was the highest overall LCD category (HR 0.96, 95% CI 0.90 to 1.03; I²=87%; low certainty). Unhealthy LCD scores were not associated with mortality in either population.

Conclusions

Healthy LCD adherence was associated with lower all-cause mortality, particularly among individuals with chronic diseases. Unhealthy LCD scores were not associated with mortality in either population, suggesting that macronutrient quality and source may matter more than carbohydrate reduction alone.

RISE for recovery after acute whiplash injury: protocol for a randomised feasibility trial of a clinician-supported SMS-based behavioural intervention

Por: Elphinston · R. A. · Formosa · J. · Armfield · N. · van der Vegt · A. H. · Ashton-James · C. E. · Brain · K. · Buckley · L. · Papic · C. · Khan · A. · Eather · C.-E. · Liimatainen · J. · Hobbins King · A. · Hansen · K. · Staib · A. · Smith · G. M. · Chen · T. · Wright · K. · Garrad · E.
Introduction

Whiplash-associated disorders (WADs) are the most common and costly consequence of road traffic injury (RTI). Providing early and effective treatment is a healthcare priority; however, current guideline-based care which focuses on education and physiotherapy-led exercise does not routinely address the psychosocial effects of trauma, and access to early integrated treatment is limited. This study aims to evaluate the feasibility of delivering and evaluating recovery, information, support and empowerment (RISE), a co-designed short message service-based intervention integrating psychosocial and exercise/activity support for individuals with acute whiplash injury who are at risk of poor recovery in a randomised feasibility trial. Secondary aims are to explore preliminary changes in candidate clinical outcomes and opportunities for intervention personalisation and future implementation.

Methods and analysis

This mixed-methods randomised controlled feasibility trial with a nested process evaluation will recruit 50 participants (>18 years) with WAD grade II/III who are identified at medium to high risk of poor recovery and within 12 weeks of RTI from Queensland emergency departments and the community. Participants will be randomised in a 1:1 ratio to receive either the RISE intervention (tailored, daily messaging+optional brief clinician support session/s) or an active control (general health-related text messages plus access to an online resource, My Whiplash Navigator). Feasibility outcomes, including recruitment and retention rates, data collection (including wearable-derived and economic data) and intervention uptake will be descriptively summarised and evaluated against pre-defined traffic light progression criteria. Acceptability will be examined using validated questionnaires and purpose-built items, qualitative interviews with intervention participants and focus groups with patients, clinicians and funders. Secondary aims will be addressed through preliminary estimates of between-group differences in patient-reported outcomes with 95% CIs and exploratory analysis of multimodal data (eg, wearable-derived physiological data, intervention engagement metrics) using a large language model where possible to inform future personalisation and implementation planning.

Ethics and dissemination

This trial is approved by the Townsville Hospital Human Research Ethics Committee (HREC/QTHS/121395) and ratified by the Human Research Ethics Committee at The University of Queensland, which is the study sponsor (2025/HE002491). Results will be published in peer-reviewed journals and presented at conferences and professional meetings.

Trial registration

ACTRN12626000506392; date registered: 23 April 2026; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=390706&isReview=true

Effect of active noise-cancelling headphones combined with music therapy on postoperative recovery quality after general anaesthesia for ankle fracture ORIF: a study protocol for a single-centre, four-arm 2x2 factorial randomised controlled trial in China

Por: Li · T. · Zhou · Y.
Introduction

Operating room noise levels during ankle fracture open reduction and internal fixation (ORIF) can reach levels well above the WHO recommended 35 dB(A) threshold for hospital treatment rooms. Neuroimaging evidence confirms that primary auditory cortex remains responsive to acoustic stimuli even under general anaesthesia (bispectral index 40–60), suggesting intraoperative noise may trigger stress responses via subcortical pathways. Active noise-cancelling (ANC) headphones combined with music therapy represent a promising non-pharmacological intervention for enhanced recovery after surgery protocols, yet no study has employed factorial design to isolate the independent and interactive effects of noise reduction and music therapy on postoperative recovery.

Methods and analysis

This prospective, randomised, participant and outcome-assessor-blinded, four-arm, 2x2 factorial design trial will enrol 224 adult patients (aged 18–65 years) scheduled for elective ankle fracture ORIF under standardised anaesthesia combining saphenous nerve block with popliteal sciatic nerve block plus general anaesthesia at Deyang Sixth People’s Hospital, Sichuan, China. Patients will be randomised 1:1:1:1 to: (1) NC-MT group: ANC plus personalised music; (2) NC group: ANC only; (3) MT group: passive isolation plus personalised music and (4) Sham group: passive isolation only. All groups will wear identical Soundcore Space One headphones, applied after anaesthesia induction (loss of consciousness) and removed before emergence (Bispectral Index<60), so that patients cannot perceive between-group difference in device operating mode. The primary outcome is the 15-item Quality of Recovery score (QoR-15) at 24 hours postoperatively. Secondary outcomes include pain (Visual Analogue Scale), anxiety (6-item State-Trait Anxiety Inventory), sleep quality (Richards-Campbell Sleep Questionnaire), melody recognition test, opioid consumption and adverse events.

Ethics and dissemination

This study was approved by the Institutional Review Board of Deyang Sixth People’s Hospital, Sichuan, China, on 23 December 2025 (DSLYIRB-2025-11) and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice of the International Council for Harmonisation (ICH-GCP) guidelines. Written informed consent will be obtained from all participants prior to enrolment. Findings will be disseminated through peer-reviewed publication and academic conference presentations.

Trial registration number

ChiCTR2600123100.

Which Way? Quit Pack study protocol: a national hybrid type 2 effectiveness-implementation study of mailed smoking and vaping cessation support for Aboriginal and Torres Strait Islander people

Por: Booth · K. · Bryant · J. · Roberts-Barker · K. · Mills · Z. · Ridgeway · T. · Kelly · R. · Collis · F. · Bonevski · B. · Maddox · R. · Whop · L. J. · Chamberlain · C. · Martiniuk · A. L. C. · Belfrage · M. · Segan · C. · Doran · C. · Oldmeadow · C. · Leigh · L. · Kennedy · M.
Introduction

Mailed smoking and vaping cessation support provided through the Which Way? Quit Pack programme has demonstrated acceptability and preliminary effectiveness in delivering culturally grounded support. However, there is no evidence of the effectiveness of mailed cessation programmes for Aboriginal and Torres Strait Islander people when implemented on a national scale. Building on previous work, this study aims to evaluate both the implementation effectiveness and cost-effectiveness analysis of the Which Way? Quit Pack mailed smoking and vaping cessation intervention for Aboriginal and Torres Strait Islander people.

Methods and analysis

A national single-group hybrid type 2 effectiveness-implementation study with 2000 Aboriginal and/or Torres Strait Islander people who use cigarettes and/or e-cigarettes (vapes) daily, want to quit and are aged ≥18 years. Participants will receive access to a culturally tailored mailed quit pack that includes up to a 12-week supply of nicotine replacement therapy, phone-based behavioural counselling and access to an online support forum. Cessation outcomes including 7-day point prevalence abstinence, prolonged abstinence and quit rates will be evaluated at 3, 6 and 12 months. An intention-to-treat approach will be used for cessation outcomes, with participants lost to follow-up classified as smokers or vapers. Exploratory logistic regression analyses will examine factors associated with quitting, and causal machine learning methods will be used to explore variation in intervention effectiveness across participant subgroups. The Reach-Effectiveness-Adoption-Implementation-Maintenance framework will guide evaluation of implementation and effectiveness outcomes. Analysis measures include cessation and quit attempt rates, number of participants recruited, representativeness and intervention uptake. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) will guide the cost-effectiveness analysis.

Ethics and dissemination

This study is governed by Aboriginal and Torres Strait Islander leadership and community-controlled partnerships and is conducted in line with Indigenous data sovereignty and Indigenous research ethics principles. The study has also received approval from the following human research ethics committees: Aboriginal Health & Medical Research Council of NSW (2493/25), Aboriginal Health Committee South Australia (04-25-1209), the Western Australian Aboriginal Health (HREC1474), the Victorian Aboriginal Community Controlled Health Organisation (2025/HREC0061) and the University of Newcastle Human Research (H-2025-0311). Findings will be disseminated in forms determined, governed and endorsed by Aboriginal and Torres Strait Islander people and communities through the project Governance, including peer-reviewed publications, policy briefs, community-led knowledge translation activities and presentations at local, national and international conferences.

Trial registration number

ACTRN12626000459325.

Timing of anticoagulation after emergency endovascular therapy for acute ischaemic stroke with atrial fibrillation (TIMERS): protocol for a randomised controlled trial

Por: Guo · Y. · Jia · X. · Liu · W. · Zhang · W. · Dong · X. · Meng · R. · Ma · H. · Cui · G. · Cheng · Y. · Yi · T. · Hao · J. · Jiang · Y. · Ji · X. · Feng · Y. · Wu · C.
Introduction

The optimal timing for direct oral anticoagulants (DOACs) initiation after acute ischaemic stroke in patients with atrial fibrillation (AF) remains unclear, particularly in those undergoing endovascular thrombectomy (EVT), who are at higher risk of both haemorrhagic transformation and early embolic recurrence. Patients undergoing thrombectomy have been under-represented in previous randomised trials, resulting in limited evidence for guiding management in this high-risk population. The TIMERS trial aims to evaluate the efficacy and safety of early versus delayed initiation of DOACs therapy after EVT in patients with large vessel occlusion stroke and AF.

Methods and analysis

This is a multicentre, prospective, randomised, open-label trial with a blinded outcome assessment. In total, 438 patients with acute ischaemic stroke and AF treated with EVT will be enrolled in this study. Patients will be randomised in a 1:1 ratio within 72 hours after stroke onset to early initiation (≤4 days) or delayed initiation (5–14 days). The primary outcome is a composite of recurrent ischaemic stroke, symptomatic intracranial haemorrhage or all-cause death within 90 days. Secondary outcomes include individual components of the primary endpoint, venous thromboembolism, systemic embolism, myocardial infarction, functional outcome (modified Rankin Scale), health-related quality of life (EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)) and major extracranial bleeding events.

Ethics and dissemination

The study is approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University, the ethics approval document number is (2025)259-001. The trial findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Trial registration number

NCT07139301.

[18F]AlF-FAPI-74 PET/CT for preoperative assessment of the peritoneal cancer index and comparison with MRI-based, surgical and pathological assessment in colorectal cancer patients eligible for CRS-HIPEC: study protocol for a prospective observational pro

Por: van den Bos · M. · Vogel · W. V. · van Duijvenvoorde · M. · Kok · N. F. M. · Aalbers · A. G. J. · Snaebjornsson · P. · Lacle · M. M. · Willemse · J. R. J. · Kool · W. · Hendrikx · J. J. M. A. · de Hingh · I. H. J. T. · van Grevenstein · W. M. U. · Boerma · D. · Milne · A. N. · van
Introduction

Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.

Methods and analysis

TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [18F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.

Ethics and dissemination

This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.

Trial registration number

2024-512301-16-01

Ebetsu Active Future Study (EAFS): cognitive function and physical and mental health in elderly residents of Ebetsu City, Japan - cohort profile

Por: Kagami-Katsuyama · H. · Ito · N. · Hazama · M. · Toya · N. · Wataya · T. · Satoh · K. · Toda · N. · Kinoshita · K. · Honma · N. · Nishibe · T. · Satoh · H. · Koshino · K. · Saito · S. · Chiba · F. · Hattori · H. · Ogata · A. · Tanaka · N. · Maeda-Yamamoto · M. · Kimoto · H. · Kim · M. · Kumano
Purpose

Ebetsu Active Future Study (EAFS) conducts comprehensive annual surveys of individuals who are independent in activities of daily living (ADLs) to track age-related physical and mental changes. These surveys include a variety of assessments such as cognitive function tests, physical function tests, blood tests, self-administered questionnaires about lifestyle and health, and interviews regarding medical and family history. In addition, serum, plasma and DNA samples from these assessments are stored at –80°C to facilitate future analyses and accommodate the potential addition of new measurement items. The purposes of this study are: (1) to identify potential blood-based biomarkers applicable to the detection of various types of mild cognitive impairment (MCI), (2) to explore diet-based strategies for preventing MCI and the progression of dementia, (3) to examine the relationship between urban characteristics, individual attributes and healthy life expectancy in Ebetsu City and (4) to return the research findings to the city.

Participants

From August to October 2023, EAFS invited Ebetsu residents to participate in the study. As a result, 1340 individuals applied and 1189 residents aged between 55 and 75 years who were independent in ADLs participated in the baseline survey for the first year.

Findings to date

EAFS initiated a follow-up of 1189 participants (38.9% male; 64.5±5.6 years) in the baseline year of 2023 and maintained a high follow-up rate of 98.5% by wave 3 (2025). The Montreal Cognitive Assessment-Japanese demonstrated that 53.6% of the participants had operational MCI. The proportion of participants with operational MCI increased with ageing. Regarding the APOE4 gene, which is associated with an increased risk of Alzheimer’s disease, 1.2% of the total population were homozygous carriers and 22.1% were heterozygous carriers.

Future plans

EAFS will conduct annual follow-up surveys until 2032. In addition to analysing data for each objective, we also plan to perform further analysis of the stored specimens.

Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial

Por: Rouleau · G. W. · Smith · A. W. · Parrish · C. G. · Allen · L. J. · Jayaram · J. E. · Ruble · S. R. · Adkins · C. M. · Eden · S. · Shotwell · M. S. · Yaghmour · E. T. · Statzer · N. J. · Wanderer · J. P. · Henson · C. P. · Shams · D. · Kertai · M. D. · Investigators · I. · IMPALA Inves
Introduction

Multimodal analgesic strategies designed to minimise perioperative opioid exposure are fundamental components of enhanced recovery after surgery (ERAS) pathways. Despite widespread implementation of ERAS protocols, the optimal analgesic regimen remains undefined, as the individual contributions of specific agents to overall analgesic efficacy and opioid-sparing effects are not fully elucidated. Intravenous lidocaine, a widely utilised local anaesthetic, possesses both analgesic and anti-inflammatory properties and has been associated with improved gastrointestinal recovery. This study seeks to pragmatically evaluate the impact of incorporating perioperative intravenous lidocaine infusion into established ERAS pathways on postoperative functional recovery.

Methods and analysis

The Impact of PerioperAtive LidocAine Infusions (IMPALA) on ERAS trial is a single-centre, pragmatic, cluster-randomised, double-blinded, placebo-controlled study. A total of 2290 patients undergoing elective colorectal surgery, emergency general surgery, urology, ventral hernia repair, surgical oncology or spine surgery will be randomly assigned to receive either intraoperative and postoperative intravenous lidocaine infusions (administered for up to 48 hours) or placebo as part of a standardised multimodal analgesic regimen integrated into established ERAS pathways. The primary outcome is case mix index–adjusted resource length of stay, defined as the time interval from surgical initiation to hospital discharge adjusted for case mix index. The primary outcome is total inpatient opioid consumption within the first 72 hours, reported in oral morphine milligram equivalents. Secondary outcomes include various in-hospital clinical endpoints derived from the electronic health record.

Ethics and dissemination

This protocol and accompanying statistical analysis plan outline the study design, primary and secondary endpoints and analytic methodology. The IMPALA-ERAS trial has received ethical approval from the Vanderbilt University Institutional Review Board (IRB: 250617). The findings will be disseminated via peer-reviewed publications and presentations at national conferences. Results from this trial are expected to inform evidence-based practices regarding perioperative lidocaine infusion and its potential contributions to enhanced postoperative recovery in surgical patients.

Trial registration number

NCT07224711.

Cross-sectional analysis of safety reporting in sleep disorder clinical trials

Por: Lackey · M. · Forbes · C. · Keefer · K. · Hazlitt · R. · Harris · T. · Archer · D. · Corwin · L. · Ford · A. I. · Vassar · M.
Study objectives

Adverse event reporting is critical for evaluating the safety of interventions in sleep disorders. Inconsistent reporting between trial registries and publications may alter clinical decision-making and patient safety. We assessed the concordance of adverse event reporting between ClinicalTrials.gov and peer-reviewed publications for interventional trials in sleep disorders. Primary outcomes included the consistency of reporting serious adverse events, other adverse events and patient/event counts. The location and detail of adverse event reporting within publications were also evaluated.

Methods

Results

Among 168 trials, 143 (85.1%) showed discrepancies in serious adverse event counts between registry and publication. Patient count variations occurred in 73.2% and 35.1% of publications reported no adverse event data. Post-Final Rule trials demonstrated improved registry-based reporting, though discordance remained.

Conclusions

Substantial inconsistencies in adverse event reporting between registries and publications persist in sleep disorder trials. Improved standardisation and adherence to reporting guidelines are necessary to protect patient safety.

Trial registration details

Registered on Open Science Framework.

Proficiency in lung ultrasound and perceived barriers to adoption among emergency physicians after a short pneumonia training programme: a multicentre observational study in Swiss emergency department

Por: Bessat · C. · Erard · A. · Roux · A. · Brahier · T. · Suttels · V. · Bingisser · R. · Schwendinger · M. · Bulaty · T. · Fournier · Y. · Della Santa · V. · Pfeil · M. · Schwab · D. · Leuppi · J. D. · Geigy · N. · Steuer · S. · Roos · F. · Christ · M. · Sirova · A. · Atzl · A. · Napieralski · F
Objectives

Lung ultrasound (LUS) is accurate for diagnosing pneumonia in the emergency department (ED), but standard training is time-intensive, limiting its widespread implementation. We evaluated LUS proficiency for pneumonia diagnosis and perceived adoption barriers after a short training programme.

Setting

This study was conducted in the frame of the PLUS-IS-LESS trial (Procalcitonin and Lung UltraSonography-based antibiotherapy in patients with Lower rESpiratory tract infection in Swiss Emergency Departments) (NCT05463406), a pragmatic stepped-wedge cluster-randomised clinical trial evaluating a clinical management algorithm combining LUS and procalcitonin to guide antibiotic use for lower respiratory tract infections (LRTIs) in 10 Swiss EDs.

Participants

All medical supervisors (senior registrars and senior physicians) from the participating EDs were invited to go through the PLUS-IS-LESS LUS training programme and all those who completed the training programme were included in this study.

Methods

The training programme included an e-learning course, followed by a half-day on-site training session with theory and hands-on practice. For proficiency evaluation, a validated structured assessment of LUS skills (LUS-OSAUS) was adapted into a 32-question online quiz and five bedside LUS examinations. Success was defined as achieving a score ≥80% on both the online quiz and supervised practical assessment. Success rates were compared between physicians according to their characteristics (age, sex, medical experience, previous use of ultrasound or LUS, linguistic region of work and type of hospital) using a ² test. A 6-month follow-up survey identified factors associated with non-certification and barriers to the clinical use of LUS for managing LRTIs.

Results

Of 122 trained physicians, 83 (68 %) completed both quiz and supervised LUS and 61 (50%) achieved certification. The most challenging items were pleural line assessment (83% success), recognition of consolidations (83%) and decision-making based on LUS findings (72%). Physicians <40 years had a higher success rate (p=0.009). Among those without complete certification, limited access to an ultrasound machine and low perceived added value of LUS were the main identified reasons. Lack of time was the most frequently reported barrier overall to LUS integration into ED workflows (77%).

Conclusion

After receiving short training and focused proficiency testing, only half of physicians achieved certification, underscoring the challenges of broad LUS implementation. Limited time, equipment access and low perceived clinical value were key barriers, and integrating LUS findings into decision-making remained difficult. Ongoing support, supervision and protected time may be needed to enhance LUS adoption in EDs.

Trial registration number

NCT05463406.

Protocol for project FIERCE: A randomized controlled trial to evaluate a positive emotion-focused meditation intervention for physicians with elevated stress

by J. Richard T. Korecki, Diana Winston, Elizabeth Ko, Sun Yoo, Joshua Khalili, Julienne E. Bower

Introduction

Nearly 80% of healthcare providers experience adverse psychological symptoms (e.g., depression, burnout, sleep disturbance) stemming from workplace stressors. Elevated levels of stress have been associated with unfavorable occupational, patient, and provider-related outcomes, imposing a heavy burden on a strained system. Given the impact of stress on both employee and patient health, effective interventions are urgently needed to reduce distress and promote well-being among healthcare professionals. Mindfulness-based interventions show promise for addressing these challenges. We developed a six-week, remotely delivered mindfulness intervention, the Building Emotional Strength Training (BEST) program, based on the Buddhist Four Immeasurables practice to cultivate the distinct emotional qualities of loving-kindness, compassion, joy, and equanimity. The present study aims to evaluate the feasibility and efficacy of a Four Immeasurables-based mindfulness intervention on perceived stress (primary outcome), burnout, depressive symptoms, and inflammatory biomarkers, while enhancing psychological well-being and sleep quality (secondary outcomes) in physicians. We will also investigate potential mediators of intervention effects, including compassion, positive affect, equanimity, and mindfulness.

Method

We will enroll 90 full-time physicians in a remote, two-arm randomized controlled trial with 1:1 allocation to either the meditation intervention or waitlist control. Participants will complete self-report questionnaires and provide blood samples at baseline, mid-course, and post-intervention to assess outcomes and mediators.

Discussion

The project aims to advance the study of mindfulness-based interventions that reduce distress and promote well-being through practices that cultivate prosocial and altruistic feelings toward oneself and others. While mindfulness interventions have gained considerable interest, none have specifically drawn from the Four Immeasurables practice to target loving-kindness, compassion, joy, and equanimity. This novel investigation could expand our understanding of practices that foster kindness and compassion to reduce distress in an at-risk population.

Trial registration

ClinicalTrials.gov NCT07283744, registered on 2025/10/14. The Open Science Framework, registered on 2026/06/26.

Lived experiences of health workers job satisfaction at the health facility level in Ethiopia: a phenomenological study

Por: Berhe · T. T. · Feleke · A. K. · Nigatu · D. T. · Weldeyohhans · G.
Objectives

This study aimed to explore healthcare workers’ lived experiences of job satisfaction and examine the multilevel factors perceived to shape these experiences at Yekatit 12 Hospital Medical College, Addis Ababa, Ethiopia.

Design

A descriptive phenomenological qualitative study was conducted using in-depth interviews and focus group discussions (FGDs).

Setting

Yekatit 12 Hospital Medical College, Addis Ababa, Ethiopia.

Participants

A total of 24 in-depth interviews and 12 FGDs were conducted with purposively selected hospital staff.

Methods

Data were collected using semistructured interview guides informed by the Social Ecological Model to explore experiences and factors across individual, interpersonal, organisational, community and policy levels. All interviews and discussions were audio-recorded, transcribed verbatim and thematically analysed using ATLAS.ti V.9

Findings

Job satisfaction emerged as a multidimensional experience formed by interconnected factors across individual, interpersonal, organisational, community and policy levels. At the individual level, high workload, burn-out and low salary were key challenges. Interpersonal factors included strained patient–provider relationships and lack of recognition. Organisational barriers such as staff shortages, inadequate infrastructure and limited training opportunities contributed to difficult working conditions and dissatisfaction. At the community level, limited or changing public respect for health workers was reported. At the policy level, delays in procurement systems and inconsistencies in benefit distribution contributed to demotivation. Despite these challenges, many participants expressed a strong sense of professional commitment and purpose.

Conclusion

Hospital staff’s job satisfaction was experienced as a multidimensional phenomenon formed by interconnected conditions across multiple levels of the work and broader health-system environment. The findings suggest that efforts to improve healthcare workers’ experiences should consider these interconnected levels, including fair compensation, supportive leadership, adequate staffing and infrastructure, equitable access to opportunities, and responsive institutional and policy support. Such contextually responsive approaches may contribute to a more supportive working environment and strengthen healthcare workforce well-being and retention in Ethiopia.

Human immunodeficiency virus knowledge and stigma among medical students in Egypt: a national cross-sectional study

Por: Omar · Y. M. · Saad · M. A. · Eltarazy · O. M. · Deibes · T. · Kamel · A. A. · Basha · M. Y. · Elsaeed · M. M. · Soliman · E. M. · Atta · S. Y. · El-Gilany · A.-H. · IFMSA-Egypt team of collaborators · Fathi · Nabil · Salem · Ali · Obad · Shehata · Adly · Khalil · Mohamed · Mohammed
Objectives

To assess HIV knowledge, stigma and perceived adequacy of HIV curricular coverage among medical students in Egypt and to identify factors associated with HIV stigma.

Design

An online-based cross-sectional study.

Setting

Medical schools across Egypt. Data were collected in August 2025 using a bilingual (Arabic/English) online questionnaire using convenience sampling.

Participants

First- through fifth-year students enrolled in Egyptian medical schools.

Primary and secondary outcome measures

HIV knowledge was assessed using the Brief HIV Knowledge Questionnaire (HIV-KQ-18); HIV-related stigma was assessed using the Healthcare Providers HIV/AIDS Stigma Scale (HPASS) and perceived adequacy of HIV curricular coverage.

Results

A total of 1503 students participated (mean age 20.6 years; 57.4% female), half of whom (48.9%) rated curricular coverage of stigma and psychosocial aspects of HIV as inadequate. The mean HIV-KQ-18 score was 8.96/18 (SD 4.26). Only 39.9% recognised that HIV cannot be transmitted through kissing, 47% believed washing after sex is protective and just 41.3% knew that not all infants born to mothers with HIV will have AIDS. The mean HPASS score was 60.1/108 (SD 17.6). Most students (76.8%) worried about contracting HIV from patients, 52% believed patients acquired HIV through risky behaviours and 43.6% endorsed a right to refuse providing care. Knowledge and stigma were inversely but weakly correlated (r = –0.17, p<0.001), and higher knowledge was independently associated with lower stigma on multivariable regression (B=–0.16, p<0.001). Despite higher knowledge, males reported significantly higher stigma (B=0.25, p<0.001) compared with their female counterparts. Similarly, participants who completed the Arabic form had significantly lower knowledge and higher stigma (B=0.24, p<0.001).

Conclusions

HIV stigma is prevalent among medical students in Egypt, with significant variations observed across gender, survey language and levels of HIV knowledge. These findings call for multifaceted interventions and curriculum reform to reduce stigma among future clinicians.

Pragmatic randomised controlled trial to evaluate the clinical and cost-effectiveness of compression therapy for surgical wounds healing by secondary intention following excision of lower limb keratinocyte cancers in UK skin cancer surgery centres (HEALS2

Por: Konwea · H. · Ransom · M. · Abbott · R. · Ashraf · I. · Bojke · C. · Brown · S. T. · Collier · H. · Connor · J. · Gilberts · R. M. · Mann · J. · Muli · A. · Nixon · J. · Pynn · E. · Veitch · D. · Wernham · A. G. H. · McGinnis · E.
Introduction

Keratinocyte cancers (KCs) are increasing in incidence in the UK, with over 234 000 cases annually, largely due to demographic changes and sun exposure. Skin cancers, including malignant melanoma and KCs, are projected to cost the NHS over £180 million annually and impose healthcare demands. Although KCs have high cure rates following surgical excision and primary closure, wounds healing by secondary intention (HBSI) particularly on the lower leg present clinical challenges. Compression therapy (CT) known to improve venous insufficiency and venous ulcer healing may also benefit HBSI following lower limb KC excision but current evidence is sparse.

Methods and analysis

Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS2) is a multicentre, prospective, Phase III, parallel group, open-label, randomised controlled trial with embedded internal pilot and blinded endpoint assessment. A total of 396 participants (≥18 years) from UK skin cancer surgery centres will be randomised 1:1 to assess the clinical and cost-effectiveness of standard care (SC) alone or with CT (SC+CT) for surgical wounds HBSI following excision of lower limb KCs.

The primary outcome is time to healing from randomisation (maximum 52-week follow-up). Secondary outcomes include incidence of infection, antibiotic usage, scar quality, safety (including complications and hospitalisations), quality of life, cost-effectiveness and relationship between post-partial closure wound area, type of partial closure method and time to healing. Exploratory objectives include association between short-term wound area reduction and time to HBSI, patient acceptability, adherence and associations between wound breakdown post-healing and CT use. A qualitative sub-study will explore patients’ experiences and decision-making during CT use.

Primary endpoint analysis will be conducted on the intention-to-treat population using a multivariable Cox Proportional Hazards modelling. Secondary outcomes and safety will be evaluated using other regression models and descriptive statistics, respectively. Cost-effectiveness will be evaluated using within-trial analysis and decision-analytic modelling. Patient and public involvement representatives are contributing to trial design and oversight. The study protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement.

Ethics and dissemination

Ethics approval has been granted by the Yorkshire & The Humber – Leeds East Research Ethics Committee (ref 23/YH/0247). Findings will be published in high-impact peer-reviewed journals.

Trial registration number

ISRCTN12417689.

Measuring and understanding geographic inequities in physician distribution in the Philippines: a multi-method study protocol

Por: Pepito · V. C. F. · Molen · R. G. C. · Migrino · J. R. · Capeding · T. P. J. Z. · Payumo · A. R. D. · Jeremias · H. I. M. · Ubial · K. R. · Tiu · W. C. · Dayrit · M. M.
Introduction

The Philippines faces physician shortages, exacerbated by their propensity to practise in urban centres. Despite government placement programmes, recruitment and retention of physicians in many areas throughout the country remain difficult. This study aims to: (1) describe the distribution of general physicians and board-certified specialist physicians and (2) identify the individual, work environment, local environment, national environment and international environment factors that may influence physicians to establish their practice in areas with below-optimal physician-to-population ratios in the Philippines.

Methods and analysis

To describe the distribution of general physicians and board-certified specialist physicians, we will map Philippine Health Insurance Corporation (PhilHealth)-accredited physicians at the regional and at the provincial level, superimposing medical schools and corresponding training institutions. To identify the individual, work environment, local environment, national environment and international environment factors that may influence physicians to establish their practice in areas of the Philippines with below optimal physician-to-population ratios, we will conduct three rounds of data collection: (1) an online survey of current Philippine Department of Health (DOH)-deployed physicians; (2) online or face-to-face focus group discussions and key informant interviews with a subset of DOH-deployed physicians, senior general and specialist physicians practising in Metro Manila and outside and DOH personnel involved in the implementation of these physician placement programmes at the national, regional and local level; and (3) a stated preference experiment administered to resident physicians of the specialties under study to determine which government interventions can encourage them to establish their practice in areas with lower than optimal physician-to-population ratios in the Philippines.

Ethics and dissemination

We have obtained ethics clearance from the Ateneo de Manila University School of Medicine and Public Health Research Ethics Committee. We will disseminate our findings in online or face-to-face dissemination sessions with the DOH, Philippine Health Insurance Corporation, Association of Philippine Medical Colleges, the Philippine Statistics Authority, the Professional Regulation Commission Board of Medicine, the Commission on Higher Education and partner specialty societies. We will also publish our results in peer-reviewed medical or public health journals.

Large-scale multiethnic electronic health record resource for diabetes complications research: the North West London Diabetes Cohort (NWLDC) - cohort profile

Por: Schaefer · Z. · Santhirasekaran · S. · Warwick · A. · Grainger · T. · Hingorani · A. · Tufail · A. · Dixon · L. · Anderson · J. · Moutzouris · D. · Rudnicka · A. R. · Roy · I. N. · Owen · C. G.
Purpose

The North West London Diabetes Cohort is established to provide systematic characterisation of a large diabetes population as a foundation for complications research and prognostic modelling. Many predictive modelling studies neglect the essential descriptive characterisation of underlying cohorts, focusing narrowly on model accuracy. This cohort profile addresses this gap by comprehensively describing the demographic composition, clinical characteristics and complication incidence patterns. The notably diverse, multiethnic population enables examination of ethnic disparities and supports future development of reliable prognostic models and evidence-based prevention strategies for diabetes complications.

Participants

At baseline, 337 271 patients with diabetes were identified. It includes 279 067 patients with type 2 diabetes, 17 638 with type 1 diabetes, 33 590 with gestational diabetes and 6916 with unspecified diabetes. The earliest diabetes diagnosis dates to January 1932, with data updated to 27 May 2025.

Findings to date

This cohort profile describes baseline characteristics of patients with comprehensive data collected on demographics (age, sex, Deprivation Index, ethnicity), clinical measures (glycated haemoglobin, body mass index, blood pressure, lipids and estimated glomerular filtration rate) and 14 major diabetes complications tracked longitudinally. Key findings for patients with type 2 diabetes reveal diabetic retinopathy as the most common complication (74.6 per 1000 person-years), followed by hypertension (51.0) and kidney disease (31.4). Cumulative incidence analyses using the Aalen-Johansen estimator, which accounts for mortality as a competing risk, demonstrated significant ethnic disparities, with black, Asian, mixed and other ethnic groups showing elevated risk compared with white patients. Time-varying Cox models identified strong clustering between cardiovascular and renal complications, confirming a cardiometabolic-renal syndrome. Mental health conditions (depression and anxiety) were prevalent throughout the disease timeline, occurring both before and after diabetes diagnosis.

Future plans

This cohort will be used as a platform for developing and validating prognostic models for diabetes complications, enabling risk stratification and targeted interventions. Future work will incorporate medication data to refine diabetes type classification, examine the effectiveness of antidiabetic medications in preventing different complications and address demographic differences in prognostic model performance and prediction accuracy. To better characterise lifestyle, further interrogation of electronic health record data will examine recording of advice given, including dietary advice, referral to weight management schemes and presence of alcohol consumption codes.

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