To estimate the prevalence of sleep problems among children aged 2–5 years residing in South India, assess its association with screen time and identify a predictive screen time threshold.
Population-based cross-sectional study.
Field practice areas in rural and urban centres of a medical college in South India.
In total, 523 children aged 2–5 years were selected by simple random sampling.
Sleep problems were assessed using the validated bedtime problems, excessive daytime sleepiness, awakenings during the night, regularity of sleep and snoring sleep screening tool. Sociodemographic and behavioural factors, including screen time, were also examined. The optimal predictive screen time cut-off was identified using receiver operating characteristic (ROC) analysis.
Sleep disturbances were reported in 39.6% of children (95% CI 35.5% to 43.8%). The most common sleep problems were irregular sleep (22.2%), bedtime resistance (20.8%) and night awakening (19.9%). Multivariate logistic regression showed strong associations between sleep problems and screen use in bed (adjusted OR (AOR) = 3.8; 95% CI 2.4 to 6.1), excess screen time (AOR=3.3; 95% CI 1.8 to 6), smaller family size (AOR=3.1; 95% CI 1.5 to 6.1), reduced physical activity (AOR=2.6; 95% CI 1.6 to 4.2), shorter birth spacing (AOR=1.8; 95% CI 1.1 to 2.8), lower socioeconomic status (AOR=1.8; 95% CI 1.2 to 2.8) and maternal screen time>2 hours/day (AOR=1.6; 95% CI 1.04 to 2.6). ROC analysis identified ≥2.4 hours per day of screen time as the optimal threshold for predicting sleep problems (area under the curve=0.800; sensitivity, 73.9% and specificity, 77.2%).
In this large population-based study, two of the five preschool children experienced sleep problems, with excess screen time, particularly screen use in bed, being the key contributing factor. This is one of the few Indian studies to establish an ROC-derived screen time threshold for identifying sleep problems. These findings can guide targeted parental advice and early preventive strategies to promote healthy sleep in preschool children.
by Mohajit Arneja, Swetharajan Gunasekar, Dharaneswari Hari Narayanan, Joshma Joseph, Harilalith Kovvuri, Sharath Shanmugam, Pavitraa Saravana Kumar, Asuwin Anandaram, Vinod Kumar Balakrishnan, Jayanty Venkata Balasubramaniyan, Sadhanandham Shanmugasundaram, Sankaran Ramesh, Nagendra Boopathy Senguttuvan
BackgroundFaster time to reperfusion can be achieved by minimizing various patient and system-level delays that contribute to total ischemic time. Procedural delays within the catheterization laboratory represent a non-negligible and modifiable component in the chain of reperfusion, but remain unquantified by conventional metrics such as door-to-ballon (D2B) time. Universal catheter approaches have rapidly gained traction as an alternative to the traditional two catheter approach for transradial coronary interventions. However, their utility for both diagnostic angiography and subsequent angioplasty is limited, and the impact of this strategy on reperfusion outcomes has remained unexplored. We utilized a procedural metric termed fluoroscopy-to-device (FluTD) time to quantify the efficiency of a single catheter strategy, and assessed its impact on epicardial and myocardial perfusion.
Methods and resultsIn this retrospective study, consecutive STEMI patients undergoing transradial primary PCI (pPCI) at a tertiary care center in India between May 2022 to October 2024 were analyzed. Patients were divided into two groups: 51 underwent PCI using a single universal guiding catheter (UGC), and 51 underwent the conventional two-catheter (CTC) approach. The primary outcome of the study was a comparison of the FluTD time between the two procedural strategies. Secondary outcomes included myocardial blush grade (MBG), Thrombolysis in Myocardial Infarction (TIMI) flow grade, total fluoroscopy time, radiation dose, device safety and efficacy, and procedural success.The median FluTD time was significantly shorter in the UGC compared to the CTC group (3 minutes [IQR 3–4] vs. 10 minutes [IQR 8–17], p Conclusion
A single catheter strategy for both angiography and pPCI in STEMI patients was associated with a significant reduction in FluTD time and improved microvascular perfusion, without compromising device safety or efficacy. In low- and middle-income countries (LMICs), where intra- and extra-procedural delays are often more pronounced, inclusion of the single catheter strategy can optimize catheterization workflows and yield substantial cost-savings.
Non-inferiority (NI) trial designs, which assess whether an experimental intervention is no worse than the standard of care, have become increasingly prevalent in recent years. Current thinking suggests that the intention-to-treat (ITT) analysis is considered anti-conservative in the presence of protocol violations when compared with the per-protocol (PP) analysis.
We aim to conduct a methodological review of NI trials to compare the results from ITT and PP analysis in NI trials. A comprehensive electronic search strategy will be used to identify studies indexed in MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases. We will include 390 NI trials published prior to 31 December 2024. The primary outcomes are the treatment effect estimates from ITT and PP analyses. Secondary outcomes are the CI widths and the bounds of the CIs from the ITT and PP analyses. Analysis will calculate the relative difference in the point estimates, CI widths and CI bounds between the two approaches. Linear models will be used to investigate the relationship between the outcomes and the proportion of patients excluded from the PP analysis.
This is a methodological review that has been registered on the International Prospective Register for Systematic Reviews (PROSPERO, CRD420251125360). Research ethics is not required as the project is a methodological review of previously published trials. Study findings will be shared via peer-reviewed publications and presentations at academic conferences.
Multimorbidity or the presence of two or more long-term conditions is now common in people undergoing surgery. However, current care pathways often miss these healthcare encounters to support long-term health promotion. Therefore, there is a need for practical, scalable approaches that can be integrated into routine surgical care, for which limited solutions exist at present. We have co-designed a structured preoperative checklist to help identify and manage long-term conditions in patients listed for elective surgery. This study aims to evaluate the feasibility and acceptability of this preoperative checklist in patients undergoing elective surgery.
This is a mixed-methods feasibility study in one National Health Service trust in the UK. We will recruit up to 50 adults scheduled for elective surgery and use the checklist during initial surgical clinic appointments. Quantitative data will include recruitment and retention rates, completion of the checklist and baseline clinical characteristics, analysed using descriptive statistics. Qualitative data will be collected through semistructured interviews with up to 16 patients and clinicians. These interviews will be analysed thematically, guided by the Consolidated Framework for Implementation Research. Triangulation of quantitative and qualitative data will allow us to explore fidelity, acceptability, barriers and facilitators to implementation and refine the intervention ahead of a future pilot cluster randomised trial.
This study has received approval from the Yorkshire & The Humber - Sheffield Research Ethics Committee (approval number: 25/YH/0045). All participants will give written informed consent. Results will be published in peer-reviewed journals and shared with participants, the public and policy stakeholders.
To examine chronic kidney disease (CKD) prevalence, incidence, prognosis, kidney function decline and associated risk factors among people with diabetes and/or hypertension.
Cross-sectional multicentre study.
14 primary care centres across Jakarta.
Adults (≥18 years) with diabetes and/or hypertension were included. Exclusion criteria were receiving kidney replacement therapy, language barrier, cognitive impairments, refusal to consent and pregnancy. Participants were grouped into three categories: hypertension only, diabetes only and both.
None.
Primary outcomes included CKD prevalence, incidence, number-needed-to-screen, KDIGO-based prognosis and annual kidney function decline. Secondary outcomes were risk factors for CKD, uncontrolled blood glucose, blood pressure and albuminuria.
A total of 1263 participants were enrolled: 51% had hypertension, 17.6% diabetes and 31.4% both. Mean age: 57.1±10.2 years, 72.2% female and 76% obese. Renin angiotensin aldosterone system inhibitors were prescribed in 32.3%, and only 1.2% used insulin despite a median glycated haemoglobin of 7.5% (IQR: 6.5–9.1). CKD prevalence was 14.8%, with an incidence rate of 9.1 per 100 person-years; number-needed-to-screen was 7. Based on KDIGO criteria, 48.9% were at moderate-to-very high risk of adverse outcomes. Baseline estimated glomerular filtration rate was 80.9 (SE=10.1), declining by 4.7 (SE=9.9) mL/min/1.73 m2 annually. CKD incidence was higher with albuminuria (OR 3.6, p=0.007) in the combined group; older age (OR 4.5, p
CKD burden is high among people with diabetes and hypertension. Nearly half were at elevated risk despite preserved kidney function, highlighting the need for targeted early screening.
Longitudinal studies provide insights into the outcomes of medical training curriculum. However, few educational cohort studies have been conducted in Iran. This study aims first to evaluate the impact of the current curriculum on medical students' medium- and long-term academic and career outcomes and, second, to identify medical students' characteristics and how they change through the doctor of medicine programme.
This protocol outlines a multi-phase, prospective cohort study that will take place in Mashhad, Iran. The study will implement the Kirkpatrick model, investigating medical students' knowledge, skills, behaviour and professionalism development over 10 years. Approximately 1000 medical students will be recruited through peer invitations and social networks. Data will be collected through baseline and follow-up questionnaires, academic performance records and comprehensive test scores throughout the Doctor of Medicine (MD) programme.
The data from the questionnaires will be reported using a Likert scale. Quantitative data will be described using means and SD, while qualitative variables will be presented as frequencies and percentages. We will evaluate the relationship between quantitative variables using correlation coefficients and the relationship between qualitative variables via the 2 or Fisher exact test. All tests will be two-sided, with a significance level set as p
All participants will complete written informed consent before data collection. All students can withdraw from the study at any time with no consequences. Results of this study will be presented at relevant conferences and will be submitted for publication in peer-reviewed journals. This study was approved by the Ethics Committee of Mashhad University of Medical Sciences.
IR.MUMS.REC.1400.311.
To systematically summarise evidence related to the use of non-sterile gloves when preparing and administering intravenous antimicrobials.
Scoping review.
A rigorous scoping review was undertaken following Arksey and O'Malley's (2005) framework and the modified Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review guidelines (2018). Five databases and grey literature were included in the search. Literature published between 2009 and 2024 was included.
Five databases (Medline, CINAHL, EMBASE, Scopus and Web of Science) and the grey literature were searched in February 2024.
Three studies were included; however, none directly addressed correct non-sterile glove use during intravenous antimicrobial preparation or administration in clinical practice.
We found no evidence to support the use of non-sterile gloves in intravenous antimicrobial preparation. There is an urgent need for rigorous research to inform the development of clear guidelines on non-sterile glove use to underpin evidence-based decision-making in nursing and other health professional education, improve patient outcomes, reduce healthcare costs and promote environmental sustainability in healthcare.
Inappropriate use of non-sterile gloves for preparing and administering intravenous antimicrobials hinders correct hand hygiene practices and increases healthcare-associated infections, healthcare costs and waste.
A critical gap in the existing evidence was a key finding of this review, highlighting the urgency for evidence-based guidelines to improve patient safety outcomes, reduce healthcare costs and promote environmental sustainability in healthcare.
This scoping review adhered to the relevant EQUATOR guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) reporting checklist.
This study did not include patient or public involvement in its design, conduct or reporting.
The protocol was registered on Open Science Framework (https://doi.org/10.17605/OSF.IO/QY4J2).
Medical oxygen supplementation is essential for treating severe illnesses and plays a critical role in managing life-threatening conditions, especially during the period of increased demand, such as the delta wave of COVID-19. The study aims to evaluate oxygen requirements and production to support effective capacity planning for future health crises.
Cross-sectional quantitative study. Data collection was carried out between 15 March and 19 December 2021.
The study used secondary data from Nepal’s Health Emergency Operation Centre. Regarding medical oxygen production, calculations included oxygen generated from both hospital-based oxygen plants and private companies, using their highest capacities for comparison. These production capacities were then assessed using three levels of efficiency (100%, 80% and 50%), revealing significant gaps when compared against the oxygen requirements of hospitalised COVID-19 patients, as guided by WHO recommendations. The results were communicated in terms of J-size cylinders, alongside average daily COVID-19 hospitalizations. Data was inputted and analysed using Microsoft Excel and presented in numbers and percentage.
The country’s oxygen demand relies largely on the production from private enterprises, with meeting approximately 85.2% of the total requirement. Optimal production ensures that national oxygen needs will be met. The analysis highlighted that at 80% operational efficiency, 90.8% of the hospital’s requirements could be fulfilled. However, if operational efficiency drops to 50%, the fulfilment rate diminishes to 56.7%. The differences in requirement and production of oxygen are consistent across the provinces; however, a huge disparity was notable in Karnali and Sudurpaschim.
Continuous assessment of production capacities in both hospital and private enterprises producing oxygen is necessary to plan and address the gaps.
To compare in-hospital and long-term outcomes between culprit-only percutaneous coronary intervention (PCI) and multivessel PCI in patients with acute myocardial infarction complicated by cardiogenic shock and multivessel coronary artery disease.
Retrospective subgroup analysis of the multicentre Gulf-Cardiogenic Shock registry.
13 tertiary care centres across six Gulf countries (Saudi Arabia, Qatar, Oman, UAE, Kuwait and Bahrain) between January 2020 and December 2022.
961 patients with angiographically confirmed multivessel coronary artery disease who underwent PCI were included from the Gulf-Cardiogenic Shock registry. Patients were divided into culprit-only PCI group (n=792, 82.4%) and multivessel PCI group (n=169, 17.6%). Patients with single-vessel disease were excluded.
Patients underwent either culprit-only PCI (intervention limited to the culprit artery) or multivessel PCI (immediate intervention to both culprit and non-culprit arteries during the same procedure).
The primary outcome was in-hospital all-cause mortality. Secondary outcomes included reinfarction, cerebrovascular accident, major and minor bleeding events, target lesion revascularisation, target vessel revascularisation, hospital stay duration and freedom from major adverse cardiac and cerebrovascular events (MACCEs) at 6 and 12 months.
Hospital mortality was comparable between multivessel PCI and culprit-only PCI groups (43.2% vs 46.1%; p=0.493). Freedom from MACCE rates at 6 and 12 months were 62% and 46% for multivessel PCI versus 70% and 49% for culprit-only PCI, respectively (log-rank p=0.711). Subgroup analysis revealed that culprit-only PCI was associated with increased hospital mortality in patients older than 70 years (OR 1.55, 95% CI: 1.01 to 2.39). Multivariable analysis of the interaction between revascularisation strategy and the subgroups revealed that culprit vessel revascularisation was associated with increased mortality in patients with left main disease (OR: 1.99 (95% CI: 1.22 to 3.27), p=0.006) and left anterior descending lesions (OR: 1.54 (95% CI: 1.06 to 2.25), p=0.025).
No statistically significant differences in hospital mortality or long-term MACCE-free survival were observed between culprit-only PCI and multivessel PCI strategies in patients with cardiogenic shock complicating acute myocardial infarction. However, patients older than 70 years may benefit from a multivessel PCI approach. These findings support current guideline recommendations favouring culprit-only PCI due to reduced procedural complexity while highlighting the need for individualised treatment strategies based on patient age and clinical factors. Further prospective randomised studies are needed to validate these age-specific findings and identify optimal patient selection criteria for each revascularisation strategy.
Simulation is well established in medical education. However, with rising numbers of medical students globally, provision of high-quality, equitable simulation teaching on a large, multisite scale is increasingly challenging. We sought to explore whether a centrally designed, multisite simulation programme could enhance student confidence equitably across multiple clinical sites with differing resources.
An evaluative study on the changes in medical student confidence on defined intended learning outcomes (ILOs) in 3 undergraduate year groups across 11 simulation sessions delivered at eight different clinical sites with variable resources and facilitators.
Eight hospitals affiliated with Imperial College School of Medicine.
Students’ self-reported confidence in achieving the ILOs via a questionnaire at the end of each session. Changes in confidence following each session were analysed and compared across sites.
522 students responded to the survey over 3 academic years. Students’ mean confidence in achieving ILOs increased in all sessions. Nine out of 10 sessions showed no statistically significant difference in the confidence increases between sites.
Our study suggests it is possible to deliver an equitable, centrally designed, large-scale simulation teaching programme to medical students across multiple clinical sites with different facilitator teams. The programme is sustainable, easily facilitated by new teaching fellows each year and is likely adaptable to other healthcare professions and settings.
People identified as higher risk by a machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation [FIND-AF]) are at increased risk of cardio-renal-metabolic-pulmonary disease and cardiovascular death. The OPTIMISE-1 randomised controlled trial aims to test the effect of community-based specialist-led identification and management of cardio-renal-metabolic-pulmonary (CRMP) disease and risk factors compared with usual care on the use of therapeutic interventions over a follow-up of 6 months among high FIND-AF risk community-dwelling individuals.
OPTIMISE-1 is a multicentre, pragmatic, prospective, randomised, open-label, blinded-endpoint strategy trial that will recruit 138 participants aged 30 years or older, with a high FIND-AF risk score and previously enrolled in the FIND-AF pilot study (NCT05898165), to be randomised 1:1 to a specialist-led care intervention or usual care. The primary endpoint is a composite of initiation or increase of guideline-directed CRMP therapies. The secondary endpoints are the components of the primary endpoint, time to primary endpoint, diagnosis of new CRMP diseases or risk factors, time to diagnosis of new CRMP diseases or risk factors, initiation or increase of guideline-directed CRMP therapies for participants with recorded CRMP disease, initiation or increase of guideline-directed CRMP therapies for participants with newly diagnosed CRMP disease and change in participant-reported quality of life.
The study has ethical approval (the North East & North Tyneside 2 Research Ethics Committee reference 24/NE/0188). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder’s open access policy.
Clinicaltrials.gov NCT06444711.
Individuals living with severe mental illness (SMI) are at a significantly higher risk of mortality. This mixed-methods systematic review identifies and explores factors, including access inequalities to annual health checks (AHCs), for people living with SMI sharing protected characteristics in the UK, as identified in Core20PLUS5.
Mixed-methods systematic review.
MEDLINE, EMBASE, PsycINFO, CINAHL, ASSIA, Google Scholar and the grey literature were searched from 1 January 2004 to 30 January 2025.
Inclusion criteria were adults >18 years of age living with SMI. We included studies of AHCs, short health screening interventions, health promotion interventions, considering or aiming to improve uptake and/or access to screening for people living with SMI. We included mixed-methods and quantitative studies: randomised controlled trials, non-randomised controlled studies, cohort studies, cross-sectional studies and process evaluations. We also included qualitative studies.
Two reviewers independently assessed the evidence for inclusion using the eligibility criteria at title, abstract and at full-text screening. Quality Assessment with Diverse Studies was used for methodological quality. Analysis used Levesque’s Conceptual Framework of Access as an a priori framework and dimensions of equality from Core20PLUS5 and PROGRESS PLUS. Separate and independent quantitative and qualitative narrative syntheses and integration of the evidence from both occurred.
36 studies were included. Five studies applied reasonable adjustments to increase access to AHCs but lacked evaluation, controls and comparisons. 26 studies failed to discuss deprivation or ethnicity and only 6 studies discussed barriers and facilitators of access to AHCs for people of different ethnic, linguistic or cultural backgrounds. There was no evidence for interventions improving access to AHCs. Access focused primarily on dimensions of services, over abilities to access AHCs for people living with SMI.
There are access inequalities to AHCs for people living with SMI sharing protected characteristics. Robust research is urgently needed to identify, modify and ameliorate barriers to the policy recommended AHCs.
CRD42023437905.
To determine the time to full recovery and its predictors among children with severe acute malnutrition (SAM) admitted to therapeutic feeding centres (TFCs) in Sana’a, Yemen.
A prospective cohort study conducted from August 2023 to November 2024.
Two public hospitals in Sana’a City (Al-Sabeen and Al-Zubairi hospital) that provide therapeutic feeding services for children with SAM.
Children aged 6–59 months who were admitted to TFCs based on WHO SAM criteria and successfully transferred to outpatient therapeutic programmes (OTPs).
The primary outcome was time to full recovery from SAM, defined as the normalisation of both weight-for-height z-score (WHZ) and mid-upper arm circumference (MUAC). Secondary outcomes included identification of predictors associated with recovery time.
Among 267 children, 51% were aged 6 to
Three months and a half were the median time to full recovery from complicated SAM. Concurrent WHZ and MUAC deficits, antibiotic use and the absence of diarrhoea were the significant predictors. Standardising the use of combined WHZ and MUAC recovery is recommended to improve comparability across programmes and better reflect nutritional outcomes.
Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.
CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.
214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.
The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.
CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.