Prognostic nutritional index in the prediction of adverse cardiac and cerebrovascular events in ST-segment elevation myocardial infarction patients with type 2 diabetes mellitus in Urumqi, China: a retrospective cohort study

Objective
Prognostic nutritional index (PNI) is an index for assessing nutritional and immune status. The aim of this study is to investigate the predictive value of PNI for long-term major adverse cardiac and cerebrovascular events (MACCE) in ST-segment elevation myocardial infarction (STEMI) patients with type 2 diabetes mellitus (T2DM).

Design, setting and participants
This retrospective cohort study analysed 1582 STEMI patients with T2DM who underwent percutaneous coronary intervention from January 2015 to June 2023 in Urumqi, China. Patients were followed up for MACCE.

Primary and secondary outcome measures
The primary endpoint was new-onset MACCE including all-cause death, non-fatal MI and non-fatal stroke.

Results
This study ultimately included 1582 patients for analysis with a median follow-up period of 48 months (IQR: 24–84 months) and 282 patients (17.8%) developed MACCE. Of them, 138 (8.7%), 84 (5.3%) and 60 (3.8%) patients developed all-cause death, a non-fatal MI and a non-fatal stroke, respectively. Incidences of MACCE and all-cause death conversely correlated with PNI. Kaplan-Meier curves showed a significant difference in all components of MACCE between PNI quartiles (p

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Snapshot of Obstetric National Audit and Research Project (SONAR1): aprotocol for an international observational cohort study

Introduction
Caesarean birth (CB) under neuraxial anaesthesia (NA) is the most performed inpatient operation in the UK. The incidence of intraoperative pain during caesarean delivery performed under neuraxial anaesthesia is unclear, with limited data that used patient-reported measures to investigate intraoperative pain. The short- and medium-term impacts on patients of this adverse event are unknown.

Methods and analysis
We will undertake a multicentre, prospective observational cohort study to evaluate the incidence and impact of pain experienced by patients during CB performed under neuraxial anaesthesia. Routine audit data will be collected for all patients undergoing caesarean delivery for any indication during a 1 week window at participating hospitals within the UK and Queensland, Australia. The dataset will include patient, anaesthetic, obstetric and neonatal risk factors for intraoperative pain. Local investigators will then seek informed consent from patients either before or within 24 hours of delivery to record patient experience and patient-reported outcomes at 24 hours and 6 weeks postdelivery. Local investigators at participating hospitals will also complete a survey evaluating compliance with evidence-based structural standards at their sites. The patient characteristics, structures, processes and outcomes will be described. Inferential techniques will be used to evaluate the relationship between risk factors and postoperative outcomes.

Ethics and dissemination
This study received ethical approval from the Leicester Health Research Authority and Care Research Wales, REC reference 24/EM/0084) on 24 May 24. The study received ethical approval from the Human Research Ethics Committee of Metro North Health in Australia on 25 March 2024 (REC Ref HREC/2024/MNHA/103767). The results of the study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. The results will be disseminated via conference presentations, peer-reviewed academic journals and reports prepared for patients, the public and policy makers.

Trial registration number
ISRCTN15269213.

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Evaluation of the outpatient parenteral antimicrobial therapy (OPAT) service in Malaysian public hospitals: a mixed-methods study protocol

Introduction
Outpatient parenteral antimicrobial therapy (OPAT) is an innovative approach to manage infections that require extended courses of intravenous antibiotics by enabling patients to receive treatment in an outpatient setting. In Malaysia, there has yet to be a systematic evaluation of the OPAT service. This study aims to describe the safety, clinical indications and treatment outcomes of the OPAT service in Malaysia, assess patients’ satisfaction and experiences and determine the facilitators and barriers associated with the provision of the OPAT service in Malaysia.

Methods and analysis
A mixed-methods approach combining qualitative and quantitative methods will be employed for a comprehensive understanding of the provision of the OPAT service in Malaysian public hospitals. The study consists of four distinct parts: systematic review, retrospective cohort analysis of clinical outcomes, patients’ satisfaction survey and focus group discussions on providers’ experiences. A longitudinal analysis of the clinical outcomes (treatment success/failure, infection cure, adverse events, readmission and mortality) of the OPAT patients’ cohort will be conducted using descriptive and conclusive statistics, in addition to rates of patients’ satisfaction and evaluation of providers’ experiences.

Ethics and dissemination
This study is registered in the National Medical Research Register (NMRR ID-24-00941-2C8) and approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia (Ref: 24-00941-2C8). Written informed consent will be obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

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Prevalence of autism among adults in Canada: results from a simulation modelling study

Objective
To estimate the prevalence of autism among adults living in Canada.

Design
A Monte Carlo simulation modelling approach was employed. Input parameters included adult population estimates and mortality rates; autism population all-cause mortality risk ratios; and autism prevalence estimates derived from child and youth data due to the lack of adult data. This approach was executed through 10 000 simulations, with each iteration generating a distinct data scenario. Prevalence estimates were reported as the mean with the 2.5th and 97.5th percentiles, corresponding to a 95% simulation interval (SI).

Setting
Where possible, Canadian data sources were used, including the 2019 Canadian Health Survey on Children and Youth and Statistics Canada mortality rates and population estimates.

Primary outcome measure
National prevalence estimates of autistic adults living in private dwellings in Canada, with variations in prevalence by sex at birth and province/territory considered.

Results
The findings suggest the prevalence of autism among adults in Canada to be 1.8% (95% SI 1.6%, 2.0%). National prevalence estimates by sex at birth were 0.7% (95% SI 0.6%, 0.9%) for females and 2.9% (95% SI 2.6%, 3.2%) for males. Provincial/territorial estimates ranged from 0.7% in Saskatchewan (95% SI 0.3%, 1.3%) to 3.6% in New Brunswick (95% SI 2.4%, 5.1%).

Conclusions
The limited availability of data on autistic adults constrains our ability to fully understand and address their unique needs. In this study, autism prevalence was estimated based on diagnosed cases, which excludes individuals without a formal diagnosis. Additionally, other factors such as data availability and methodological assumptions may influence the modelling of prevalence estimates. As a result, our findings should be interpreted within the context of these limitations. Nevertheless, this study provides a valuable reference point for understanding autism prevalence among adults in Canada.

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Does less invasive surfactant administration during high-flow nasal cannula oxygen treatment reduce the need for invasive ventilation in late preterm and early term born infants with respiratory distress? A study protocol for a single-centre study with a treatment and control arm

Introduction
Up to 40% of late preterm and early term infants require neonatal admission with respiratory disease being the most common cause. Less invasive surfactant administration (LISA) has previously been used with good success in the very preterm population, but it is unclear whether late preterm infants suffering from respiratory distress syndrome and early term infants suffering from secondary surfactant deficiency might also benefit from LISA. Continuous positive airway pressure (CPAP) in that population can increase asynchrony and air leaks, whereas these may be avoided by using high flow nasal cannula (HFNC). This trial will investigate whether LISA during HFNC reduces the need for invasive ventilation.

Methods and analysis
This non-blinded, single-centre study with a treatment and a control arm will take place on the Neonatal Intensive Care Unit at King’s College Hospital National Health Service (NHS) Foundation Trust and the local neonatal unit at the Princess Royal University Hospital. The study will recruit 245 infants born between 34+0 and 38+6 weeks gestational age, who are requiring respiratory support via HFNC. The 245 participants will be placed into a control and treatment group. Those infants eligible for SURFactant Or Not (SurfON) will be randomised as per the SurfON protocol. The remaining infants will, where possible, be recruited to the treatment group. All recruited infants will have 2 minutes of respiratory function monitoring. Those receiving LISA will receive a further 2 minutes of monitoring after the procedure. As HFNC, LISA and respiratory monitoring are part of routine clinical practice, retrospective consent will be gained from parents or guardians after the procedure to analyse the respiratory function data. The primary outcome will be the percentage of neonates needing invasive ventilation within 72 hours from birth. The secondary outcomes are length of neonatal unit stay; the cost of stay as estimated via standard NHS tariffs; and the lung function parameters including tidal volume, respiratory rate, end tidal CO2 (ET CO2), fraction of inspired oxygen (FiO2) and ratio of oxygen saturations to fraction of inspired oxygen (SpO2/ FiO2) ratio before and 2 minutes after LISA and the SpO2/FiO2 ratio 2 hours after the administration of LISA.

Ethics and dissemination
A favourable opinion was sought and obtained from the London – Hampstead Research Ethics Committee and Health Research Authority for the study protocol and other relevant documentation (informed consent forms and patient information leaflets) prior to commencing the study (REC reference: 24/PR/0431). Anonymised study data will be presented at conferences and published by the investigators in peer-reviewed journals

Trial registration number
NCT06421506.

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Clinically directed initiation versus routine use of amoxicillin-clavulanate and the risk of local complications among patients with haemotoxic snakebite envenomation treated at a teaching hospital in southern India: a randomised, non-inferiority trial

Objective
Amoxicillin-clavulanate is commonly used to prevent infections following snakebites despite the lack of clinical evidence. We aimed to demonstrate that clinically directed initiation of amoxicillin-clavulanate would be non-inferior to routine use in this setting.

Design
Open-label, randomised, non-inferiority trial with blinded adjudication of endpoints.

Setting
Emergency department of a teaching hospital in southern India.

Participants
Adults with local swelling following snakebites within 24 hours of bite.

Interventions
In the routine use strategy, intravenous followed by oral amoxicillin-clavulanate was administered for at least 5 days. In the clinically directed strategy, the antibiotic was only initiated for clinical failures.

Primary and secondary outcome measures
Primary outcomes were protocol-defined clinical failure and total antibiotic consumption. Non-inferiority margin was prespecified as 10%. Secondary outcomes were the length of hospital stay, total antivenom consumption, new-onset organ failure, bleeding requiring transfusion, death/need for surgical intervention and drug-related adverse events.

Results
The trial was prematurely stopped due to the COVID-19 situation after randomising 66 patients—34 to clinically directed initiation and 32 to routine use arms. Russell’s viper was the most common (21 (32%)) biting snake species identified; 52 (79%) patients had evidence of haemotoxic envenomation at baseline, and 24 (36%) patients developed AKI. There were 10 clinical failures—six in the clinically directed initiation arm and four in the routine use arm. The difference in clinical failure between the two arms was 5.2% (–12.0%–21.7%; p=0.291); the upper bound of the CI exceeded the prespecified non-inferiority margin. Total antibiotic consumption, expressed in DDDs, was significantly lower in the clinically directed initiation arm (0 (0–1) vs 5.31 (4.67–6.17); p

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