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Hoy — Abril 4th 2026BMJ Open

Megestrol acetate versus dexamethasone to prevent nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer treated with oxaliplatin-based chemotherapy: study protocol of a multicentre, randomised, non-inferiority trial

Por: Luo · H. · Hu · Q. · Zeng · L. · Huang · Q. · Luo · Y. · Li · T. · Chen · P. · Yi · C. · Gou · H.
Introduction

Oxaliplatin is widely used in the treatment of gastric and gastro-oesophageal junction cancer. However, oxaliplatin-induced nausea and vomiting often complicate treatment and negatively affect patients’ quality of life. The current standard antiemetic regimen—dexamethasone (DEX) plus palonosetron—offers only limited efficacy, benefiting approximately 70% of patients, and is associated with steroid-related adverse effects, including insomnia and gastrointestinal bleeding. Consequently, there is a clear clinical need for effective DEX-free antiemetic regimens. This study aims to evaluate the efficacy and safety of megestrol acetate versus DEX in preventing oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer.

Method and analysis

This is an investigator-led, multicentre, randomised-controlled, open-label, phase III, non-inferiority trial. Chemotherapy-naïve patients scheduled to receive oxaliplatin-based chemotherapy are randomly (1:1) assigned to receive either megestrol acetate (megestrol acetate group) or DEX (DEX group) in combination with palonosetron. The primary endpoint is the complete response (CR; no vomiting and no rescue therapy) rate during the first 120 hours following the initiation of chemotherapy (0–120 hours). Secondary endpoints include the following indicators: CR rate in acute period (0–24 hours), CR rate in delayed period (24–120 hours), time to treatment failure, frequency of salvage medication use, nausea, anorexia, adverse events and quality of life.

The study will evaluate the efficacy and safety of megestrol acetate compared with DEX for prevention of oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer. If proven effective, the results might inform future antiemetic strategies in the long term to (1) provide a novel DEX-free antiemetic treatment for prevention of moderate-emetogenic chemotherapy, (2) reduce DEX-related adverse effects and improve quality of life in patients with gastric or gastro-oesophageal junction cancer and (3) support the potential incorporation of megestrol acetate into standard antiemetic medications.

Ethics and dissemination

The study protocol is conducted in accordance with the Declaration of Helsinki and approved by the Certified Review Board of West China Hospital, Sichuan University (Ethics Approval No 1116/2023). The results of this study will be disseminated via presentations at national and international scientific conferences and publication in peer-reviewed journals.

Trial registration number

ChiCTR2300075943.

Alarm fatigue among critical care unit and emergency room nurses: a multicentre cross-sectional study in Iran

Por: Abbaszadeh · S. M. · Poursaadat · N. · Sadeghian · A. · Karimi · N. · Zarei · R. · Dehghan Nayeri · N.
Objectives

To assess the level of alarm fatigue among intensive care unit (ICU), cardiac care unit (CCU) and emergency room (ER) nurses, identify associated demographic and occupational factors, determine the most frequent sources of alarms and evaluate nurses’ psychological reactions to alarms.

Design

A cross-sectional, descriptive–analytical study.

Setting

ICUs, CCUs and ERs of six public teaching hospitals affiliated with Tehran and Kashan Universities of Medical Sciences in Iran.

Participants

Using a multistage stratified random sampling method, 285 nurses were approached, of whom 260 completed and returned the questionnaires (response rate: 91%). Participants were registered nurses with at least a bachelor’s degree or higher and 3 months of experience in ICUs, CCUs or ERs.

Primary and secondary outcome measures

The primary outcome was the level of alarm fatigue measured using the validated Nurses’ Alarm Fatigue Questionnaire. Secondary outcomes included factors associated with alarm fatigue and nurses’ reported psychological responses to frequent alarms.

Results

The mean score of alarm fatigue was 26.4±7.9, indicating a moderate level. After adjusting for confounders and hospital-level clustering using multivariable mixed-effects regression, higher monthly income was significantly associated with lower alarm fatigue (β=–0.15, p=0.03), and nurses working rotational shifts reported significantly higher fatigue compared with those with fixed shifts (β=0.18, p=0.02). Other demographic and occupational factors were not significant. Reported psychological reactions to alarms included indifference (14%), irritability (18%) and anxiety/stress (15%).

Conclusions

ICU, CCU and ER nurses experience a moderate level of alarm fatigue, with income and shift type as independent associated factors. The association between income and alarm fatigue may reflect the role of financial stress as an additional job demand that compounds the burden of frequent alarms, particularly in contexts where low base salaries lead nurses to rely on overtime and multiple shifts. These findings underscore the need for targeted managerial and educational interventions, including shift schedule optimisation and attention to workload-related stressors, alongside alarm prioritisation strategies. Due to the cross-sectional design, causal inferences cannot be drawn.

Development and acceptability of a patient decision aid for people with degenerative cervical myelopathy: an international mixed-methods study

Por: Gamble · A. R. · Anderson · D. B. · McKay · M. J. · Davies · B. · Macpherson · S. · Van Gelder · J. · Hoffmann · T. · McCaffery · K. · Stevens · S. X. · Ammendolia · C. · Chauhan · R. V. · Zipser · C. M. · Boerger · T. F. · Tetreault · L. A. · Fehlings · M. G. · Dustan · E. · Nugent · C
Objectives

To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

Design

Mixed-methods study describing the development of a patient decision aid.

Setting

A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

Participants

Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

Results

We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

Conclusion

Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

Going the distance: a cross-sectional geospatial analysis quantifying province-wide inequities in travel-based access, and fragility of access to French-language primary care provided by family physicians in Ontario, Canada

Por: Belanger · C. · Timony · P. E. · Belizaire · A. · Desilets · A. · Fitzsimon · J. P. · Gauthier · A. P. · Godfrey · L. · Karunananthan · S. · Kehoe MacLeod · K. · Muray · M.-N. · Peixoto · C. · Bjerre · L. M.
Objectives

Language-concordant care, or healthcare in one’s preferred language, is important both for health equity and for improving health outcomes. Linguistic minorities, like Francophones in Ontario, Canada, are at risk of poorer clinical outcomes if they receive non-language-concordant primary care. However, common ratio-based access measures can provide misleading views of minorities’ actual access levels. This cross-sectional geospatial study demonstrates a new way to measure primary care access using average travel time to the nearest five English- and French-speaking family physicians. We also introduce the concept of primary care access fragility, where a region’s primary care access may depend on one or a few local family physicians. Our research question is: are there differences in travel burden and access fragility for census subdivisions (CSDs) across language (English/French), rurality (urban/rural) and region (north/south) in the province of Ontario, Canada?

Design

We conducted a cross-sectional geospatial analysis to estimate English-language and French-language primary care travel burdens and access fragility in Ontario, Canada. We used population and boundary data from Statistics Canada’s 2021 census, road-network data from OpenStreetMaps, and family physician practice locations and language abilities from the College of Physicians and Surgeons of Ontario. We measured travel burden using Valhalla, an open-source road-network analysis platform.

Setting

We conducted our analysis for Ontario, Canada’s 577 CSDs, which correspond roughly to municipalities and with populations ranging from 5 inhabitants in Rainy Lake 17B to a high of 2 794 356 in Toronto.

Participants

Using public data from January 2026, we identified 15 762 family physicians practising in Ontario, of whom 11.0% reported speaking French. Patient data were obtained from the most recent 2021 census.

Primary and secondary outcome measures

Our first primary outcome measures were CSD-level mean travel time to the nearest five English-speaking family physicians, and CSD-level mean travel time to the nearest five French-speaking family physicians, which we compared to explore regional inequities in travel burden. Our secondary outcome measures were based on a novel notion of the travel burden component of ‘primary care access fragility’. This metric indicates how dependent a region’s access is on a small number of local physicians and is defined as the difference between the CSD-level mean travel time to the nearest one physician and to the nearest five physicians. As the difference in travel times grows, so too does access fragility.

Results

Median differences in French-language and English-language travel burdens were strongly significant across rurality, regions and overall (median difference 13.4 min, p

Conclusions

Compared with the general public, Ontario’s French-speakers face higher travel burdens to language-concordant family physicians and higher access fragility, especially in rural and northern regions. Our results are of interest to policymakers and health-system planners, and our methods are applicable to other populations and regions.

Synthetic data-augmented machine learning for 30-day readmission prediction in patients with chronic conditions: a retrospective real-world study

Por: Brothers · T. · Adhikari · K. · Ramazani · M. · Imtiaz · A. · Al-Mamun · M.
Objectives

To develop and evaluate an explainable machine learning framework enhanced with synthetic data generation to predict unplanned 30-day hospital readmissions among patients with chronic obstructive pulmonary disease (COPD), heart failure (HF) and type 2 diabetes mellitus (T2DM), and to identify key clinical and social predictors of readmission.

Design

A retrospective cohort study using electronic health record data incorporating both structured variables and information extracted from unstructured clinical notes. Synthetic data were generated using advanced resampling and deep learning-based techniques to address outcome imbalance and improve model training.

Setting

Intensive care unit and general ward admissions at a single tertiary academic medical centre included in the MIMIC-IV (Medical Information Mart for Intensive Care IV) database.

Participants

Adult patients (≥18 years) were admitted with a primary diagnosis of COPD (n=14 050), HF (n=7097) or T2DM (n=12 735) between 2008 and 2019, with complete 30-day follow-up and no in-hospital mortality during the index admission.

Primary and secondary outcome measures

The primary outcome was unplanned all-cause hospital readmission within 30-days of discharge. Predictors were drawn from six domains, including demographics, comorbidities, clinical acuity, therapies, behavioural factors and care continuity. Predictive performance was evaluated using multiple machine learning methods and fivefold cross-validation, with model interpretability assessed using established goal and local explanation approaches.

Results

Ensemble-based machine learning models demonstrated the strongest predictive performance across all three disease cohorts. Key predictors of readmission included higher illness severity, greater comorbidity burden, medication non-adherence, gaps in preventive care and limited social support. Models incorporating synthetic data augmentation showed improved discrimination compared with models trained on original data alone.

Conclusions

An explainable synthetic-data driven framework incorporating clinical, behavioural and social data can support prediction of 30-day readmissions among patients with common chronic conditions using routinely available electronic health record data.

Interventions for improving home food environments and household food security in adult populations residing in low-income settings: a systematic review protocol

Por: Madlala · S. S. · Mabhida · S. E. · Hill · J.
Introduction

Overweight and obesity are a growing global public health problem. Eating behaviours of adults and children are largely influenced by the home food environment (HFE). The lack of access to nutritious food in homes contributes to unhealthy dietary habits and, consequently, overweight and obesity among adults and children, as well as chronic diseases associated with poor diets. The present systematic review aims to identify existing HFE and household food security interventions and to determine the effects of these interventions in improving the availability of healthy food in the home, household access to food, diet quality and nutritional status of adults.

Methods and analysis

This systematic review protocol was developed according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis protocols guidelines. Electronic databases including PubMed, Web of Science, Scopus, Science Direct and CINAHL (EBSCOhost) will be searched for relevant articles using keywords and MeSH terms. Risk of bias will be assessed using the adapted Cochrane effective practice and organisation of Care risk of bias tool for studies with a separate control group and Risk of Bias in non-randomised studies of interventions. The overall strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation tool. Two reviewers will independently screen the identified records and assess the eligible full texts for inclusion. Any discrepancies will be resolved through consensus or consultation with a third reviewer. Where sufficient homogeneous data are available, subgroup analysis will be conducted to explore heterogeneity. A thematic synthesis will be performed for qualitative studies.

Ethics and dissemination

This study has a systematic review and meta-analysis design, which will assess published data and does not require ethical approval. Findings of the systematic review will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD420251030896.

Multidimensional effects of virtual reality on motor dysfunction in patients who had a stroke: study protocol for a prospective, randomised, controlled clinical trial

Por: Yang · Z. · Lu · Q. · Chen · D. · Tang · L. · Ran · T. · Yang · L. · Bai · D.
Introduction

Poststroke motor dysfunction places a heavy burden on individuals and society. Virtual reality (VR) offers enhanced motor skill transfer and active rehabilitation by overcoming the scenario-specific constraints of conventional therapies. Validating the efficacy of VR rehabilitation could lead to scalable and cost-effective solutions, potentially enabling home-based rehabilitation. However, the widespread clinical application remains constrained by the lack of rehabilitation-specific VR and multidimensional quantitative assessments. The aim of this study was to investigate the multidimensional effects and neural mechanisms of VR rehabilitation in poststroke motor recovery.

Methods and analysis

This study is a prospective, randomised, controlled clinical trial protocol designed to evaluate the effects of multisensory VR training on motor dysfunction in patients who had a stroke using multidimensional assessments. The trial consists of a baseline assessment, a 4-week intervention period and an endpoint assessment. A total of 40 patients who had a stroke will be randomly allocated in a 1:1 ratio to either a VR combined with treadmill group or a treadmill-only group. The primary outcome measure is the Fugl-Meyer Assessment of Lower Extremity score, while secondary outcomes include three-dimensional gait analysis, the Berg Balance Scale score, the activities of daily living score and functional near-infrared spectroscopy results. Safety will be evaluated by monitoring the incidence of adverse events. This study aims to determine whether VR rehabilitation offers superior efficacy in improving motor function in patients who had a stroke by using a multidimensional assessment approach, including neural coupling function, muscle movement mechanics and clinical performance. The findings will provide robust, high-quality evidence to support the broader application of VR in clinical practice.

Ethics, registration and dissemination

The trial was approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (2022–155). This study protocol was registered with the clinicaltrials.gov (NCT06275516). The results will be published in a peer-reviewed journal or presented at a conference.

Trial registration number

NCT06275516.

Integration of PrEP dispensing with HIV self-testing among heterosexual men in Sub-Saharan Africa: protocol for a scoping review

Por: Hlongwa · M. · Tsai · A. C. · Choko · A.
Background

Sub-Saharan Africa (SSA) continues to be the hub of the global HIV/AIDS pandemic, globally. Despite several attempts to meet their HIV prevention needs, men continue to have high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is an effective treatment that, when taken as prescribed, can be very efficient in preventing and reducing the risk of HIV acquisition. HIV self-testing (HIVST) has been demonstrated to be acceptable among men in SSA. As such, this review aims to explore the existing literature on the integration of PrEP dispensing with HIVST among men in SSA.

Methods

We will systematically search bibliometric databases, including PubMed/MEDLINE, Embase, Scopus, the Cumulative Index to Nursing and Allied Health Literature Plus, Sociological Abstracts, ProQuest Dissertations and Theses global. Our review will be guided by the Arskey and O’Malley framework and Levac et al. The review results will be reported using the preferred reporting items for systematic reviews and meta-analysis: extension for scoping reviews guidelines. To assess the methodological quality of the included articles, the mixed methods appraisal tool version 2018 will be used. We will use NVivo software (V.11) to synthesise data from the included studies using a thematic approach.

Ethics and dissemination

Ethical approval is not required, as this review uses publicly available data. Findings will be disseminated through peer-reviewed publication, conference presentations and engagement with key stakeholders in HIV prevention and treatment across SSA.

AnteayerBMJ Open

Prospective cohort study of TIMP-1 and myocardial fibrosis in Chagas disease at a reference clinic in Pernambuco, Brazil: PTICH trial protocol

Por: Martins · S. M. · Macedo · C. T. · Meira · C. S. · Paim Santos · L. H. · Larocca · T. F. · Cavalcanti da Silva · F. F. · Leandro Lira · C. N. · da Silva · I. P. M. · De Araujo · L. T. · Soares · M. B. P.
Background

Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Methods and analysis

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

Ethics and dissemination

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

Trial registration number

RBR-3dcrj98.

Trends and factors associated with previous induced abortions among young women in Foshan, China: insights from a retrospective cross-sectional study

Por: Ou · Y. · Chokkakula · S. · Chong · S. · Wang · H. · Liu · S. · Si · A. I.-C. · Pathakumari · B. · Lyu · J. · Yin · C. · Ye · X. · Huang · X.
Objectives

This study aims to explore the history of prior abortions and the factors influencing them among young women seeking abortion services in Foshan, Guangdong, China.

Design

This is a retrospective, cross-sectional study of young women seeking abortion care.

Setting

Gynaecological outpatient clinics at the Department of Gynaecology, Foshan Women and Children Hospital Affiliated to Guangdong Medical University, Foshan, Guangdong, China, between 2013 and 2023.

Participants

A total of 7361 young women aged 12–25 years seeking abortion services.

Measures

Data on abortion history, sociodemographic factors, contraceptive use and postabortion contraceptive choices were collected and analysed, with special emphasis on the incidence of repeat abortions and the factors associated with them.

Results

Of the 7361 participants, 34.2% reported at least one previous abortion, underscoring a notable public health concern. The mean age of the participants was 22.30 years (SD=2.13). Women with a history of abortion were significantly older than those without (22.57 vs 22.08 years, p

Conclusions

This study underscores the need for targeted interventions to address the multifaceted factors leading to repeat abortions among young women in China. The results offer valuable insights for improving reproductive health outcomes in this vulnerable population and highlight the importance of expanding access to contraceptive education and services in China.

Correction: Determining the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for patients with adrenal insufficiency using a randomised 2-way crossover trial: the STARLIT-3 study protocol

Date K, Baster K, Caunt S, et al. Determining the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for patients with adrenal insufficiency using a randomised 2-way crossover trial: the STARLIT-3 study protocol. BMJ Open 2026;16:e112708. doi: 10.1136/bmjopen-2025-112708

The article has been corrected following its online publication.

The authors wish to inform readers that co-author Trevor N Johnson (Translational Sciences Group, Certara UK Limited, Sheffield, UK) was inadvertently omitted from the author list. TNJ contributed to data provision, data interpretation and references which were integral to the study methodology in the calculation of the required wash-out period for the IMP and advised on the drafting of this section of the manuscript.

Utilisation of brain MRI for the diagnosis of dementia in low and middle-income countries: systematic review and meta-analysis

Por: Nassanga · R. · Nakasujja · N. · Mubuuke · A. G. · Lwere · K. · Kawooya · M. G. · Ocan · M. · Kaddumukasa · M.
Objectives

To synthesise the prevalence and patterns of dementia-relevant structural brain MRI abnormalities in adults with suspected or confirmed dementia in low- and middle-income countries (LMICs), and to summarise MRI protocols and the incremental diagnostic contribution of MRI beyond cognitive screening.

Design

Systematic review and meta-analysis.

Data sources

PubMed, EMBASE, Web of Science and PsycINFO (January 1990–27 January 2025), plus reference list screening and targeted manual searches.

Eligibility criteria

Observational or diagnostic-accuracy studies from World Bank-defined LMICs including adults (≥50 years) with suspected or confirmed dementia who underwent brain MRI as part of diagnostic evaluation.

Data extraction and synthesis

Two reviewers independently screened, extracted data and assessed risk of bias using ROBINS-I. Random-effects models pooled prevalence of dementia-relevant MRI abnormalities; diagnostic-accuracy outcomes were synthesised narratively due to heterogeneous reference standards and incomplete reporting.

Results

39 LMIC studies were included; 23 studies (2513 participants) contributed to the meta-analysis. Dementia-relevant MRI abnormalities (defined as ≥1 clinically relevant structural abnormality per study definition) were present in 1248/2513 participants. The pooled prevalence of dementia-relevant MRI abnormalities was 58% (95% CI 43% to 72%), with substantial heterogeneity (I²=95%) and a wide prediction interval (8–96%), indicating marked between-study variability; this estimate should be interpreted as a descriptive summary of study-level proportions rather than a precise population parameter.

Conclusions

Brain MRI frequently demonstrates dementia-relevant pathology in LMIC clinical cohorts, usually with mixed neurodegenerative-vascular patterns. Structured visual ratings may add aetiologic specificity beyond cognitive screening, but pooled estimates should be interpreted as summaries of heterogeneous study-level findings rather than precise population parameters, given high heterogeneity and risk of bias.

PROSPERO registration number

CRD42024510241.

Retinal vascular phenotyping for early detection of coronary artery disease: quantitative assessment and diagnostic modelling

Por: Wu · Z. · Jiang · X. · Xin · Y. · Liu · J. · Ling · S. · Guo · C.
Objectives

To investigate the association between quantitative retinal vascular parameters and coronary artery disease (CAD) and to evaluate the efficacy of a retinal phenotype-based diagnostic model as a non-invasive tool for early CAD screening.

Design

A retrospective cross-sectional study.

Setting

A single-centre study conducted at the Cardiovascular Center of Beijing Tongren Hospital, Capital Medical University, China, between January and October 2024.

Participants

417 patients with suspected angina undergoing their first coronary angiography (CAG) were enrolled. Inclusion criteria were age >18 years and high-quality fundus photography within 24 hours pre-CAG. Major exclusions were prior coronary interventions, severe systemic/valvular heart diseases and ocular conditions impairing retinal vascular visualisation.

Primary and secondary outcome measures

The primary outcome was the association between quantitative retinal vascular parameters and the presence of CAD (defined as ≥50% stenosis). Secondary outcomes included the diagnostic performance area under the receiver operating characteristic curve (AUROC) of three predictive models: one based on quantitative retinal vascular parameters alone, one based on traditional risk factors and a combined model integrating both retinal and clinical variables.

Results

This study enrolled 417 patients undergoing initial CAG. Compared with non-CAD controls (n=190), patients with CAD (n=227) had higher prevalence of hypertension, dyslipidaemia and diabetes, along with elevated levels of fasting blood glucose, lipoprotein(a) (Lp(a)), triglyceride (TG) and glycated haemoglobin (HbA1c) (all p

Conclusion

Our findings, derived from an artificial intelligence-based fully automated quantitative retinal vascular parameters measurement method, revealed that multiple quantitative fundus parameters—including FD, VD and other morphological parameters were significantly associated with CAD risk. The CAD diagnostic model we developed demonstrates strong performance and high interpretability, making it suitable for early CAD screening and diagnosis.

Determinants of delayed care-seeking during acute exacerbations of chronic obstructive pulmonary disease: protocol for a systematic review and meta-analysis

Por: Fang · L. · Zhu · X. · Li · N. · Gu · Y.
Introduction

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are major drivers of hospitalisation, readmission and mortality. Patient delay, the interval between the onset or recognition of exacerbation symptoms and the first contact with a healthcare professional, represents a potentially modifiable part of the overall prehospital delay. Existing evidence on why people with COPD delay seeking care is fragmented, based on heterogeneous definitions of delay and limited sets of predictors, and has not yet been synthesised within a coherent theoretical framework. This protocol describes a systematic review and meta-analysis to identify determinants of delayed care-seeking during AECOPD, structured by Andersen’s Behavioural Model of Health Service Use.

Methods and analysis

We will include observational analytic studies (prospective or retrospective cohort, case-control and cross-sectional designs) involving adults (≥18 years) with physician-diagnosed COPD who have experienced at least one AECOPD. The primary outcome is delayed care-seeking, defined as the time interval between onset or recognition of exacerbation symptoms and first contact with a healthcare professional or facility; studies must report a clear definition of "delay" and provide effect estimates (or sufficient data to calculate them) for associations between candidate determinants and delayed presentation or delay duration. Determinants of interest will be mapped onto Andersen’s predisposing, enabling and need-related domains. We will search PubMed, Web of Science, CINAHL, Cochrane Library and EMBASE from database inception to the date of the final search, supplemented by grey literature searching, backward reference list screening and forward citation tracking, without restrictions on country or, where feasible, language. Two reviewers will independently perform study selection and data extraction and will assess risk of bias using study design-specific critical appraisal tools appropriate to cohort, case-control and cross-sectional studies. Where at least three studies report comparable effect measures for the same determinant–outcome pair, random-effects meta-analyses will be conducted; otherwise, findings will be synthesised narratively. Certainty of evidence for key associations will be graded using the grading of recommendations assessment, development and evaluation approach adapted for observational and prognostic evidence.

Ethics and dissemination

Ethical approval is not required for this systematic review and meta-analysis, as it will use data extracted exclusively from published studies and other publicly available sources, with no involvement of individual participants or identifiable personal data. The findings of this review will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic and clinical conferences. The results are expected to inform clinicians, nurses and policymakers about key determinants of delayed care-seeking during AECOPD, and to support the development of theory-informed, targeted interventions aimed at promoting timely healthcare utilisation.

PROSPERO registration number

This study has been registered in the PROSPERO (CRD420251244791).

Spiritual care challenges and needs of carers, health professionals and relatives of individuals living with neurodegenerative diseases in palliative and end-of-life care: a scoping review protocol

Por: De Luca · E. · Saba · A. · Bertarini · L. · Brusini · A. · Artioli · G. · Dellafiore · F.
Introduction

Spirituality has gained increasing attention in healthcare, particularly in palliative care, as it supports meaning, purpose and connection during illness. While literature extensively explores patients’ spiritual needs, growing evidence highlights the importance of addressing the spiritual needs of caregivers and healthcare professionals. Caregivers and relatives often face emotional, ethical and practical challenges during prolonged care pathways, impacting their well-being. Limited training and tools can hinder spiritual care, contributing to distress and burnout among professionals and unmet needs for families. Addressing spirituality in neurodegenerative disease palliative care is essential for holistic, person-centred approaches that foster coping, hope and ethical decision-making. This scoping review aims to map evidence on spiritual needs and challenges of caregivers, relatives and healthcare staff in end-stage neurodegenerative disease care.

Methods and analysis

This review will follow the Joanna Briggs Institute framework (JBI) for scoping reviews. The search and reporting process will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist. Inclusion criteria followed JBI’s population, concept and context framework with no date or geographical limits; only English and Italian sources ensured accurate interpretation. Searches will use university-access databases and grey literature to capture policy and non-peer-reviewed sources. Databases selected: PubMed, CINAHL, APA PsycINFO and Scopus for comprehensive, multidisciplinary coverage. This inclusive approach is aligned with the purpose of scoping reviews, which aim to map the breadth and depth of available literature. Researchers independently screened titles/abstracts in Rayyan software with blinding, resolved discrepancies collaboratively, piloted and refined extraction tables, and jointly synthesised themes through iterative meetings to ensure rigour and consensus. Findings will highlight existing knowledge, identify gaps and inform future research and practice.

Ethics and dissemination

Since secondary data will be analysed, no ethical approval is required. The results will be disseminated through publications subject to peer review. The protocol has been registered with the Open Science Framework https://doi.org/10.17605/OSF.IO/X9275

Measuring subjective well-being for people racialised as Black in the USA: a scoping review protocol

Por: Ford · T. N. · Hanneke · R. · Ezeani · T. · Mitchell · U. A.
Introduction

Subjective well-being, a measurement of quality of life, varies systematically across racialised groups. However, the use of inconsistent subjective well-being measures across academic disciplines results in conflicting subjective well-being findings for people racialised as Black or African American in the USA. The aim of this scoping review is to provide a comprehensive overview of how subjective well-being is measured for people racialised as Black or African American in the USA and to examine how subjective well-being reports differ between people racialised as Black and white in the nation.

Methods and analysis

This scoping review will use the Joanna Briggs Institute methodology and report findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A predefined search strategy was used on 17 April 2024 to search PubMed (includes MEDLINE), APA PsycINFO (ProQuest), Sociological Abstracts (ProQuest), EconLit (EBSCOhost) and Scopus for studies published in English. Articles will be included if they specify Black or African American population, subjective well-being, and include populations within the USA. Data will be extracted and presented quantitatively and qualitatively in tabular and/or figure form to describe the characteristics and conclusions of included studies, grouped by subjective well-being component and measure. Analysis will identify methodological inconsistencies and research gaps.

Ethics and dissemination

This study does not require review by our institution’s review board as primary data will not be collected in this study. The findings of this scoping review will be disseminated through peer-reviewed publications, conference presentations, and condensed summaries for key partners in the field.

Trial registration number

10.17605/OSF.IO/M9GA8.

Characteristics and functionalities of digital tools supporting motivation and adherence to physical activity in older adults with health conditions: a protocol for a scoping review

Por: Burin-Chu · S. · Agbangla · N. F. · Caby · I. · Bossede · F.
Introduction

Regular physical activity declines with age, particularly among older adults with health conditions. Digital tools, including wearable devices, mobile applications, virtual reality systems and tele-exercise platforms, offer promising ways to promote physical activity. However, the technological components of these tools and their reported associations with motivation, adherence and physical activity levels remain underexplored. This scoping review aims to map the characteristics and functionalities of digital tools used to promote physical activity among older adults with health conditions and to examine how these components are described in relation to psychobehavioural outcomes.

Methods and analysis

This review will follow the Joanna Briggs Institute methodological guidance. Searches will be conducted in PubMed, Web of Science, PsycInfo and SportDiscus. The reference lists of included studies will also be screened to identify additional relevant articles. Eligible studies will include adults aged 60 years or older with health conditions using digital tools for physical activity. Two reviewers will independently select studies and extract data on the components of digital tools. A descriptive synthesis will summarise the key technological characteristics, and a content analysis will identify and categorise tool components, describing how they are reported in relation to psychobehavioural outcomes and theoretical constructs.

Ethics and dissemination

This review does not involve human participants, so ethical approval is not required. Findings will be disseminated through peer-reviewed publications, conference presentations and stakeholder summaries.

Stereotactic ablative radiotherapy versus video-assisted lobectomy for operable stage I non-small-cell lung cancer: study protocol for an emulated target trial

Por: Bedir · A. · Hassan · L. · Wittenberg · I. · Müller · J. A. · Oesterling · F. · Walles · T. · Stang · A. · Vordermark · D. · Medenwald · D.
Introduction

Video-assisted thoracoscopic surgery (VATS) lobectomy is a commonly employed surgical technique for the management of operable early stage non-small cell lung cancer (NSCLC). This procedure, however, is dependent on the patient’s ability to tolerate surgery. In light of this, stereotactic ablative radiotherapy (SABR) has emerged as a viable alternative treatment strategy for patients who are inoperable or who refuse surgery. Considering the lack of randomised controlled trials and the increased risk of bias in observational cohort studies, this study protocol proposes an emulated target trial design to investigate the causal effect of SABR, in comparison to VATS, on overall survival in operable early stage NSCLC patients.

Methods and analysis

Data on NSCLC patients will be collected from routinely collected university hospital records linked with German cancer registry data. This study protocol was developed using the target trial methodology outlined by Hernan et al. The protocol establishes specific parameters for key trial components in order to mitigate bias in the analysis of observational data and to facilitate the calculation of causal estimands. The target trial design that would be emulated is a multicentre open-label two-parallel arm superiority randomised trial. Mediators and confounding variables were determined through the use of a directed acyclic graph. The statistical analysis aims to measure the per-protocol and intention to treat effect of SABR versus VATS within 3 months of diagnosis, on survival, through the difference in restricted mean survival times, using weighted non-parametric Kaplan-Meier curves.

Ethics and dissemination

The Ethics Committee of the Medical Faculty of Martin Luther University Halle-Wittenberg with an approved addendum with Dnr 2023–112 has approved this study. The study uses anonymised routinely collected hospital and cancer registry data in accordance with applicable data protection regulations. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Using the suicide audit method to examine trajectories of adolescent girls following a suicide attempt in Quebec, Canada: a study protocol

Por: Kourgiantakis · T. · Mercier · E. · Cote · M. · Tousignant · R.-N. · Dumais Michaud · A.-A. · Maltais · N. · Rassy · J. · Lesage · A.
Introduction

Suicide is a major public health concern among youth in Canada and worldwide. The most rapid increases in suicidal ideation, self-harm, and suicide attempts have been observed among adolescent girls, particularly since the COVID-19 pandemic. Recent studies report disproportionately high rates of emergency department visits and hospitalisations for suicide-related concerns among adolescent girls. Despite these concerning trends, limited evidence exists on the life trajectories, needs, and service pathways of adolescent girls who attempt suicide. This protocol describes a qualitative suicide audit focused on adolescent girls aged 12–17 who were hospitalised following a suicide attempt in two regions of the province of Québec, Canada. The aim is to understand developmental trajectories, document services received and identify individual, relational and systemic factors influencing these trajectories to generate recommendations that inform suicide prevention.

Methods and analysis

Using a narrative qualitative design and a community-based research approach, data will be collected from semi-structured interviews with adolescents and parents, parent questionnaires and hospital health records. These data will be integrated to develop anonymised case vignettes. A multidisciplinary panel, including clinicians, health system stakeholders, community partners and individuals with lived experience, will review each case to identify gaps and strengths in care and generate case-level and cross-case recommendations for clinical practice, health policy and professional training.

Ethics and dissemination

Ethics approval was obtained from the research ethics committee (REC) of the Centre intégré de santé et de services sociaux de Chaudière-Appalaches, which serves as the reviewing REC, with administrative reviews underway at two other health authorities. Findings will be disseminated through peer-reviewed publications, conference presentations and collaborative knowledge-mobilisation activities with clinical and community partners, including practice-oriented tools and accessible materials for adolescents and parents.

Comparison of the identification and practicability of non-invasive diagnostic indicators under NAFLD, MAFLD and MASLD in China: a cross-sectional study

Por: Tan · X.-Y. · Zou · H.-H. · Huang · X. · Guo · M.-J. · Yu · R.-L. · Liu · X.-L. · Peng · T. · Yang · X. · Qin · C.-X.
Objectives

Early screening of non-alcoholic fatty liver disease (NAFLD) is critical for early diagnosis and management. The disease was renamed and its diagnostic criteria revised as metabolic-associated FLD (MAFLD) in 2020 and further updated to metabolic dysfunction-associated steatotic liver disease (MASLD) in 2023. This study evaluated the predictive performance and clinical feasibility of non-invasive diagnostic indicators across the NAFLD, MAFLD and MASLD diagnostic criteria.

Design

Cross-sectional study.

Setting

Health Management Centre in China.

Participants

A total of 5810 participants aged ≥18 years were enrolled. Individuals with missing laboratory data, imaging results or self-reported information were excluded.

Primary and secondary outcome measures

Disease-specific indicators included Fatty Liver Index (FLI), Hepatic Steatosis Index and Zhejiang University index (ZJU). Non-disease-specific indicators included lipid accumulation product (LAP), Visceral Adiposity Index and the Triglyceride and Glucose Index. Subgroup analysis was performed by gender and Body Mass Index (BMI).

Results

The area under the receiver operating characteristic curve (AUROC) for all six non-invasive indicators exceeded 0.7. FLI showed the optimal predictive performance across the three criteria (NAFLD-AUROC: 0.802, MAFLD-AUROC: 0.847 and MASLD-AUROC: 0.811), with comparable performance observed for ZJU (0.797, 0.838 and 0.809, respectively). Pairwise z-tests demonstrated a significant difference between FLI and ZJU for MAFLD (p0.05). Subgroup analyses revealed that ZJU performed better in males (NAFLD-AUROC: 0.790, MAFLD-AUROC: 0.839 and MASLD-AUROC: 0.803), while FLI was superior in females (NAFLD-AUROC: 0.832, MAFLD-AUROC: 0.838 and MASLD-AUROC: 0.838) and in participants who were overweight (NAFLD-AUROC: 0.709, MAFLD-AUROC: 0.765 and MASLD-AUROC: 0.709). LAP exhibited the highest predictive efficacy in the normal BMI subgroup (NAFLD-AUROC: 0.758, MAFLD-AUROC: 0.804 and MASLD-AUROC: 0.796).

Conclusions

FLI exhibited the highest predictive efficacy across all diagnostic criteria, and ZJU showed comparable performance. Considering diagnostic accuracy and clinical practicality, ZJU is recommended as a favourable, non-invasive tool for population-based screening in the Chinese population.

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