Assessing the impact of novel social media policies in the USA restricting youth exposure to food and beverage advertisements: a protocol for a difference-in-difference study

Introduction
Social media is the most prominent source of online food and beverage advertisements (ads) seen by adolescents. Companies target adolescent social media users with ads that feature calorie-dense, nutrient-poor products, and exposure to ads drives poor diet and risk for future diet-related diseases. Black, Hispanic and lower socio-economic status youth are exposed to significantly more ads than White peers. Several state-level policies in the USA have passed restricting youth from accessing social media without parental approval, and some policies have banned advertising to youth. This protocol paper describes a current study that aims to understand the impact of such policies in two states, Louisiana and Texas, as they were among the first to be implemented with racially/ethnically diverse populations.

Methods and analysis
This study employs a repeated cross-sectional difference-in-difference design in which 700 youth ages 13–17 years are being recruited each year for 5 years (Louisiana n=175, Texas n=175, matched comparisons from other states n=350). Youth screen record their mobile devices for 60 minutes while they browse social media platforms (eg, TikTok, Instagram) or use the internet. They also complete a brief survey about a variety of topics (eg, health behaviours, mental health). Adolescents are compensated for screen recording ($75) and the survey ($25). Study team members are coding recordings for several characteristics, including media platforms used, appearances of food or beverages, and food or beverage type. We will estimate the impact of policies on food and beverage ads seen per hour using Ordinary Least Squares regression models and heterogeneity-robust standard errors clustered at the state level (by year and cumulatively). We will run additional models with interaction terms with income and race/ethnicity, separately, to test the role of the policies on health disparities.

Ethics and dissemination
Study procedures have been approved by the Institutional Review Board of the NYU Grossman School of Medicine. We will distribute findings in peer-reviewed journals and at local and national conferences. To complement traditional dissemination pathways, we will create infographics to share with relevant community stakeholders. We will also share findings with policymakers in states that have passed or considered similar policies.

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Exploring cognitive function and postoperative neurocognitive recovery after cardiac surgery in older adults (ECPON): a protocol for an observational study

Introduction
Cardiovascular disease is one of the most common health issues facing the older population, and the number of older adults undergoing cardiac surgery is expected to increase. Postoperative neurocognitive impairment is a frequent and often unrecognised complication that can adversely affect a patient’s recovery, quality of life and daily activities, as well as impact the lives of their family members. Patients may express cognitive difficulties as a feeling of ‘not being the same since the operation’. This study aims to investigate the factors that influence neurocognitive function and patient-reported cognitive symptoms among patients aged 65 and older following cardiac surgery, and explore the impact on the overall postoperative recovery. Additionally, the study aims to describe the perspectives of close relatives on the recovery process.

Methods and analysis
A longitudinal observational study with a mixed-methods approach will be conducted in two thoracic surgical departments in Sweden. A total of 220 patients and 1 close relative for each patient will participate. Neurocognitive function will be assessed preoperatively and at 1, 3 and 6 months postoperatively using a digitalised neurocognitive test battery. We will also evaluate postoperative patient-reported cognitive symptoms and signs, delirium, frailty, health-related quality of life, depression, perceived self-efficacy, fatigue and functional capacity. Each patient’s close relative will assess the observed cognitive function and report on caregiver burden. At the 6-month mark, a purposive sample of patients and their close relatives will be interviewed to explore their experiences of postoperative cognitive recovery.

Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority (Reference number: 2024-03380-01) and will adhere to the Helsinki Declaration and its amendments. The results will be disseminated through peer-reviewed journals and scientific conferences, as well as presented in various popular science forums and patient organisations.

Trial registration number
NCT06469515; Pre-results.

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Effects of ondansetron applied before the induction of anaesthesia on postoperative nausea and vomiting in high-risk patients: protocol for a randomised controlled trial

Introduction
Postoperative nausea and vomiting (PONV) is a common complication following various surgical procedures, significantly contributing to patient discomfort and increasing healthcare costs. Despite the widespread use of multiple drug combinations, PONV remains a persistent challenge, particularly in high-risk populations. Existing evidence suggests a potential interaction between 5-HT3 receptors and μ-opioid receptors, indicating that they may function as co-receptors with a competitive relationship. Based on this hypothesis, we designed experiments to investigate this correlation.

Methods and analysis
This randomised, parallel, positive-controlled, double-blind (both intervener and participant) trial will take place at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Based on relevant literature and our pre-test, the incidence of PONV in the intervention group is estimated to be approximately 30%. With an expected 10% loss-to-follow-up rate and a desired statistical power of 0.9 (1-β), the required sample size for each group is 65 participants, totalling 130 subjects to be enrolled from 30 March 2025 to 30 April 2025. Eligible patients will be randomly allocated to either the intervention or control group. Ondansetron will be administered 15 min before anaesthesia induction in the intervention group (n=65) and at the end of surgery in the control group (n=65). The primary outcome is the incidence of PONV within the 0–24-hour postoperative period. The sample size will be calculated using PASS 15, statistical analysis will be conducted using SPSS 25 and missing data will be addressed using the Last Observation Carried Forward method. Two-tailed tests will be employed, with significance set at α=0.05. Results will be considered significant if p

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Impact of 2014 Japanese practice guidelines on treatment patterns in patients with myasthenia gravis: an insurance claims database study

Objectives
To evaluate changes in oral corticosteroid (OCS) use after the publication of the 2014 Japanese clinical practice guidelines for myasthenia gravis (MG).

Design
Retrospective cohort study performed in three Japanese health insurance databases: the JMDC database between 2005 and 2021; the DeSC database covering the National Health Insurance (NHI) and the DeSC database covering the Late-Stage Elderly Healthcare Service (LSEHS) between 2014 and 2021. Achievement of OCS ≤5 mg/day was defined as ≥90 days of consecutive OCS ≤5 mg/day during follow-up, without any gap longer than 60 days between two consecutive claims. The time to achieve OCS ≤5 mg/day was estimated using Kaplan-Meier survival analysis.

Setting
Real-world treatment setting in Japan.

Participants
Patients aged ≥16 years with a record of MG (International Classification of Diseases 10th edition code: G70.0) with a serological test, who had baseline period ≥180 days before inclusion with no MG claim and who started immunotherapy (including OCS) within 90 days of MG diagnosis.

Outcome measures
Prescription of OCS and other therapies for MG.

Results
Overall, 811 patients were included. The mean age was 49 years in the JMDC, 61 years in the NHI and 80 years in the LSEHS. In the JMDC, the median time to achieve OCS ≤5 mg/day was significantly shorter (p=0.042; log-rank test) in patients included in 2015 or later (11.0 months) than in patients included before 2015 (17.9 months). The median time to achieve OCS ≤5 mg/day was shorter in the LSEHS (6.5 months) than in the JMDC (11.0 months) and the NHI (11.7 months).

Conclusions
Faster tapering of the OCS dose was observed in patients starting treatment after the publication of the 2014 guidelines, although use of higher-dose OCS remained widespread after this date. This highlights the need to improve awareness of guidelines by healthcare providers in order to decrease the burden of higher-dose OCS.

Trial registration number
Clinical Trials Registry (UMIN-CTR): UMIN000051155; Post-results.

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Promoting smoking cessation and preventing relapse to tobacco use following a smoke-free mental health inpatient stay (SCEPTRE feasibility study): a multicentre randomised controlled feasibility study protocol

Introduction
Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.

Methods and analysis
This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.

Ethics and dissemination
Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.

Trial registration number
ISRCTN77855199.

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Cuff leak test and airway obstruction in mechanically ventilated ICU patients (COSMIC): a pilot feasibility randomized controlled trial protocol

Introduction
The cuff leak test (CLT) is hypothesised to help optimise extubation by assessing for laryngeal oedema which, if unrecognised and untreated, could lead to post-extubation stridor, post-extubation airway obstruction, and reintubation. However, the diagnostic accuracy of the CLT to detect post-extubation stridor (and hence potentially airway obstruction) remains uncertain. Given the equipoise that exists surrounding the CLT, we are conducting a pilot randomised clinical trial (RCT) examining the CLT as part of the pathway to extubation. Herein, we report the protocol for the Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): a Pilot Feasibility Randomized Clinical trial (RCT).

Methods and analysis
This is a multicentre, international, parallel-group, pragmatic, pilot RCT. We will enrol 100 mechanically ventilated patients in the intensive care unit (ICU) who are deemed ready for extubation and have at least one risk factor for laryngeal oedema. In the intervention arm, respiratory therapists will perform a qualitative CLT before extubation. If a patient passes the CLT (suggesting no laryngeal oedema), extubation will be performed in keeping with standard care. If the patient fails the CLT (suggesting laryngeal oedema), extubation will be delayed allowing for administration of dexamethasone, consideration of diuresis, and the CLT will be repeated in 12–24 hours. In the control arm, patients will be extubated without completing a CLT, without steroid administration, and without delay. Randomization will be by a 1:1 allocation, stratified by centre. The primary feasibility outcomes will include recruitment and protocol adherence. Secondary outcomes will include post-extubation stridor, reintubation within 72 hours, emergency surgical airway within 72 hours, and ICU and hospital mortality within 30 days.

Ethics and dissemination
This trial has been approved by Clinical Trials Ontario, Hamilton Integrated Research Ethics Board, State of Kuwait Ministry of Health, University of Texas Health Committee for the Protection of Human Subjects and Brant Community Health Systems Research Ethics Committee. The trial has received a No Objection Letter from Health Canada. Trial results will be disseminated via publication in peer-reviewed journals.

Trial registration number
NCT05456542.

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Implementation and effectiveness of a nurse-enabled, shared-care follow-up model for early breast cancer survivors (The IBIS-Survivorship Study): protocol for a stepped-wedge cluster randomised trial

Introduction
Breast cancer is the most commonly diagnosed cancer among women worldwide. Survivors often experience physical and psychological effects arising from breast cancer and its treatment, which can last months and years, adversely impacting quality of life. As the number of early breast cancer survivors increases, models of specialist-led follow-up care in hospital settings are not sustainable and evidence suggests that they may not meet survivors’ needs. Nurse-enabled, shared-care, follow-up models between cancer specialist and primary care teams have potential to address this need.

Methods and analysis
The proposed research is a multicentre, prospective, pragmatic, stepped-wedge cluster-randomised trial designed to test the effectiveness and implementation of IBIS-Survivorship, a follow-up care model for patients with early breast cancer who have completed primary treatment. The IBIS-Survivorship intervention involves a nurse-led consultation, development of a Survivorship Care Plan and case-conferencing between a breast care nurse and the patient’s primary care provider. This study seeks to recruit 1079 breast cancer survivors across six cancer centres (clusters) in Australia. Health-related quality of life at 12 months assessed by the Functional Assessment of Cancer Therapy – Breast Cancer questionnaire will be the primary endpoint, along with a range of patient-reported outcomes, safety indicators and cost-effectiveness measures as secondary endpoints. General and generalised linear mixed models will be used to assess the effectiveness of the intervention versus usual care. Implementation and process outcomes will be assessed using the Reach Effectiveness Adoption Implementation Maintenance framework.

Ethics and dissemination
Ethical approval was provided by the Metro South Hospital and Health Service Human Research Ethics Committee (HREC/2020/QMS/59892) and reciprocally across the other five trial sites under National Mutual Acceptance arrangements. Results will be disseminated through peer-reviewed academic journal publications and presentations at national and international conferences.

Trial registration
Australia and New Zealand Clinical Trials Registry (ANZCTR) Trial ID: ACTRN12621000188831.

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Modulating verticality representation and uprightness by virtual reality: rationale and protocol for a within-person randomised intervention associating a basic study in healthy individuals and a pilot clinical trial in individuals exhibiting post-stroke lateropulsion (VIRGIL)

Introduction
Balance and gait disorders represent the most frequent and disabling sequelae after stroke. Impaired body orientation with respect to gravity (lateropulsion) is one of the primary underlying mechanisms, increasingly investigated. After hemisphere stroke, lateropulsion is caused by an impaired internal representation of verticality, for which developing rehabilitation techniques has become a priority. Among various approaches, virtual reality appears to be a promising tool for modulating spatial reference frame. The objective of this study is to investigate the effects of immersion in virtual tilted reality (VTR) on the postural vertical (PV) as a primary outcome, as well as main secondary outcomes on the visual vertical (VV) and the active standing posture (body orientation with respect to gravity and weight-bearing (WB) distribution on lower limbs), both in healthy individuals and individuals exhibiting lateropulsion at the subacute phase after a hemispheric stroke. The cumulative effect of the VTR on the post-stroke lateropulsion will also be analysed.

Methods and analysis
This pilot study is a single-centre, within-person randomised trial conducted in the department of Physical and Rehabilitation Medicine of the University Hospital of Grenoble-Alpes (France). We will include 40 individuals from 18 to 85 years old, 20 healthy individuals and 20 individuals with lateropulsion tested 0.5 on the Scale for Contraversive Pushing), the study lasts 4 weeks: W1 for inclusion, randomisation, planning and conventional rehabilitation; W2 and W4 to collect clinical data and conventional rehabilitation; and W3 for the VTR intervention over four consecutive mornings at the same time: 2 to test the VTR effects on verticality perception (PV and VV) and 2 to test the VTR effects on active standing (body orientation and WB distribution on lower limbs). Immediate effects and post-effects of the VTR immersion are analysed by comparing results of the following time points: for verticality perception baseline, during and after VTR and for active standing at only baseline and during VTR immersion. Linear mixed-effect models will be run with different factors/covariates according to objectives. We will analyse the proportion and features of responders (PV modulation ≥2°). The cumulative effect of the 4 days of VTR sessions will be analysed by comparing scores of the SCAle for LAteropulsion assessed at the end of every week.

Ethics and dissemination
The study was approved by an institutional review board at the national level (Comité de Protection des Personnes Ile de France X; 2020-A02941-38, amendment 2024). All participants will provide written informed consent before enrolment. Findings will be submitted to peer-reviewed journals related to rehabilitation, stroke or neuroscience.

Trial registration number
ClinicalTrials.gov, NCT04911738.

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Validation of salivary uric acid remote self-monitoring for early prediction of hypertensive disorders of pregnancy: study protocol for a prospective, observational, multicentre cohort study

Introduction
Hypertensive disorders of pregnancy (HDP), including gestational hypertension and pre-eclampsia, affect approximately 10% of pregnancies worldwide and contribute significantly to fetal and maternal morbidity and mortality. Early identification of HDP would facilitate targeted surveillance and personalised care in order to mitigate the severity of complications and improve pregnancy outcomes. Uric acid is a marker of oxidative stress, inflammation and endothelial dysfunction, and has been proposed as a predictor of hypertensive disease. Salurate is a salivary uric acid test that has the potential to identify pregnant women at risk of developing HDP several weeks before clinical manifestation.

Methods and analysis
This is a prospective, multicentre, observational, cohort study with health economics evaluation. Women aged 16 and above, with a viable singleton pregnancy at 1:300 will be eligible for recruitment. Participants will perform weekly remote salivary uric acid testing from enrolment until the conclusion of pregnancy and upload results of colourimetric paper tests via a smartphone application. We will validate a predictive algorithm that analyses colour data from several consecutive samples to detect patterns that predict whether HDP is likely to occur. The primary outcome is test performance for the prediction of HDP. Secondary outcomes include adherence to sampling and test performance for predicting gestational diabetes, stillbirth and fetal growth restriction. Data on pregnancy outcomes will be collected from the medical notes, compared with the predictions made by the algorithm and subjected to statistical analysis.

Ethics and dissemination
Approval has been obtained from Cambridge East Research Ethics Committee (REC reference 24/EE/0123), Medicines and Healthcare products Regulatory Agency (CI/2024/0038/GB) and Health Research Authority (IRAS ID 337290). Results of the study will be published in peer-reviewed journals and presented at national and international conferences.

Trial registration number
ISRCTN17992452.

Protocol version
4, 4 July 2024.

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The MOTILITY Mother-Child Cohort: a Danish prospective longitudinal cohort study of the infant gut microbiome, nutrition and bowel habits – a study protocol

Introduction
Concurrent with infants’ progression in dietary complexity and gut microbiome diversity, infants gradually change their defecation patterns during the first year of life. However, the links between bowel habits, the gut microbiota and early life nutrition remain unclear. The primary outcome is to characterise the gut microbiome development from birth to 1 year of age. Second, to investigate how bowel habits and nutrition in early life relate to the gut microbiome and metabolome during this period of life, and to explore how the development of the gut microbiome associates with host development.

Methods and analysis
The MOTILITY Mother-Child Cohort (MOTILITY) is a Danish prospective longitudinal cohort study enrolling up to 125 mother–infant dyads. Assessments occur at 36 weeks gestation (visit 1), birth (screening of infant) and 3, 6, 9 and 12 months (±2 weeks) post partum (visits 2–5). At visit 1, maternal anthropometrics, self-collected faecal and urine samples, and questionnaires on bowel habits and lifestyle are obtained. Between visits, infant faecal (biweekly), urine (monthly) and maternal breast milk (monthly until 6 months of age) samples are collected at home, and bowel habits and dietary intake are assessed biweekly by self-reported questionnaires. At visits 2–5, infant blood and saliva samples are collected, and anthropometric measurements are obtained. In addition, dietary intake is recorded thrice throughout the study period for mother and infant, respectively, and infant whole-gut transit time is estimated by sweet corn tests at 9 and 12 months of age. Birth, growth, motor development, sleep patterns, tooth development, overall health and well-being are assessed using questionnaires. Univariate and multivariate statistics will be applied to identify associations between the gut microbiome, early life nutrition and host physiology including bowel habits during the first year of life.

Ethics and dissemination
The MOTILITY study has been approved by the Research Ethics Committee for the Capital Region of Denmark (reference number: H-21063016). Selected results will be made available to the participants in the form of a summary document. Results will be published in peer-review journals and by means of national and international conferences.

Trial registration number
NCT05491161.

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Validation of EuroQol instruments in paediatric patients and their caregivers in China: protocol for a prospective observational study

Introduction
The EQ-5D-Y (the youth version of EQ-5D) is widely used to assess children’s health-related quality of life (HRQoL), yet its psychometric properties across administration modes remain insufficiently explored, particularly in paediatric oncology and rare diseases. Additionally, the broader impact of childhood illness on family caregivers (spillover effects) is underexamined. This study aims to evaluate the validity, reliability and responsiveness of the three-level version of EQ-5D-Y (EQ-5D-Y-3L) and the five-level version of EQ-5D-Y (EQ-5D-Y-5L) across different modes while also assessing the EQ-5D five-level version (EQ-5D-5L) and the new EQ Health and Well-being Short Version (EQ-HWB-9) in capturing spillover effects. Originally designed for social care interventions, the EQ-HWB-9 is expected to be applicable to caregivers.

Methods and analysis
This prospective observational study will recruit children aged 5–16 years with pneumonia, central nervous system (CNS) solid tumours or immune thrombocytopenic purpura (ITP) from three hospitals in China, along with their caregivers. A total of 360 dyads (patients and their caregivers) are planned for recruitment. Children will complete EQ-5D-Y-3L, EQ-5D-Y-5L and Paediatric Quality of Life Inventory (PedsQL) in self-complete (SC), interviewer-administered (IA) and proxy-reported modes by caregivers. Caregivers will complete EQ-5D-5L and EQ-HWB-9 to assess spillover effects. Data will be collected at baseline and follow-up (2–3 weeks). Primary outcomes include psychometric assessments (construct validity, reliability and responsiveness) of all the instruments. Secondary outcomes include HRQoL scores, ceiling effects and the correlation between EQ-5D-Y and PedsQL. A qualitative substudy will explore children’s response interpretation and factors contributing to ceiling effects. Statistical analyses will include intraclass correlation coefficients for test–retest reliability, analysis of variance for known-groups validity, effect sizes for responsiveness, regression for spillover effects and thematic analysis for qualitative data.

Ethics and dissemination
Ethical approval has been obtained from three ethics committees: the Guizhou Medical University (IRB:2024159), the Children’s Hospital, Zhejiang University School of Medicine (IRB:2024-IRB-0158-P-01) and Guizhou Provincial People’s Hospital (IRB:2024073). Written informed consent will be secured from caregivers, and assent will be obtained from children aged 8 years and older. Study findings will be disseminated through national/international conferences and peer-reviewed journals.

Trial registration number
ClinicalTrials.gov, NCT06873672.

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Routine testing for group B streptococcus in pregnancy: protocol for a UK cluster randomised trial (GBS3)

Introduction
It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy.

Methods and analysis
Cluster randomised trial.

Sites and participants
320 000 women from up to 80 hospital maternity units.

Strategies
Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design.

Outcomes
The primary outcome is all-cause early (

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Determinants of post COVID-19 clinic attendance among SARS-CoV-2-infected individuals in Stockholm, Sweden: a population-based cohort study

Objectives
Investigate determinants of post-COVID-19 condition (PCC) clinic attendance among participants not hospitalised versus hospitalised during the SARS-CoV-2 infection.

Design
Retrospective cohort study.

Setting
Six population-based registers with high coverage to cover all adults residing in Stockholm County, Sweden.

Participants
Adults residing in Stockholm County on 31 January 2020, with a SARS-CoV-2 infection through 30 November 2022, who did not die or move out of Stockholm County within 90 days.

Primary outcome measures
PCC clinic attendance from 90 days after the SARS-CoV-2 test until date of death, date of moving out, or 30 November 30,2023.

Results
Of non-hospitalised and hospitalised participants, 737 of 464 674 (0.2%) and 433 of 23 374 (1.9%), respectively, attended a PCC clinic. A total of 75 878 (16.3%) of non-hospitalised participants and 6190 (26.5%) of hospitalised participants presented with new-onset symptoms that could indicate PCC in primary care. The strongest determinants of attendance among non-hospitalised participants were mental health disorder (adjusted risk ratio (aRR) 2.57, 95% CI 2.21 to 2.98), asthma (2.39, 1.97–2.92) and >4 PCC symptoms in 2019 (2.27, 1.60–3.24), and among hospitalised participants were >31 sick days in 2019 (1.94, 1.47–2.56), 1–30 sick days in 2019 (1.56, 1.06–2.29) and obesity (1.51, 1.19–1.93). The most common clinical presentation was fatigue (n=526, 71.4%) among non-hospitalised and dyspnoea (n=148, 34.2%) among hospitalised participants.

Conclusions
PCC clinic attendance characteristics differed between non-hospitalised and hospitalised participants. Distinguishing PCC from conditions with overlapping symptoms and determining the appropriate level of care may be challenging, with risk of resource displacement effects and inappropriate care.

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Predicting 14-day readmission in middle-aged and elderly patients with pneumonia using emergency department data: a multicentre retrospective cohort study with a survival machine learning approach

Objectives
Unplanned pneumonia readmissions increase patient morbidity, mortality and healthcare costs. Among pneumonia patients, the middle-aged and elderly (≥45 years old) have a significantly higher risk of readmission compared with the young. Given that the 14-day readmission rate is considered a healthcare quality indicator, this study is the first to develop survival machine learning (ML) models using emergency department (ED) data to predict 14-day readmission risk following pneumonia-related admissions.

Design
A retrospective multicentre cohort study.

Setting
This study used the Taipei Medical University Clinical Research Database, including data from patients at three affiliated hospitals.

Participants
11 989 hospital admissions for pneumonia among patients aged ≥45 years admitted from 2014 to 2021.

Primary and secondary outcome measures
The dataset was randomly split into training (80%), validation (10%) and independent test (10%) sets. Input features included demographics, comorbidities, clinical events, vital signs, laboratory results and medical interventions. Four survival ML models—CoxNet, Survival Tree, Gradient Boosting Survival Analysis and Random Survival Forest—were developed and compared on the validation set. The best performance model was tested on the independent test set.

Results
The RSF model outperformed the other models. Validation on an independent test set confirmed the model’s robustness (C-index=0.710; AUC=0.693). The most important predictive features included creatinine levels, age, haematocrit levels, Charlson Comorbidity Index scores, and haemoglobin levels, with their predictive value changing over time.

Conclusions
The RSF model effectively predicts 14-day readmission risk among pneumonia patients. The ED data-based model allows clinicians to estimate readmission risk before ward admission or discharge from the ED, enabling timely interventions. Accurately predicting short-term readmission risk might also further support physicians in designing the optimal healthcare programme and controlling individual medical status to prevent readmissions.

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