Post-COVID-19 condition (PCC) has emerged as a major public health concern. We aimed to estimate the 1-year incidence of PCC in adults with confirmed SARS-CoV-2 infection in Lombardy, Italy, comparing community-managed and hospitalised patients and to assess the prognostic value of the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) score to support estimation of long-term PCC prevalence.

Retrospective-prospective observational cohort study enrolling patients infected between 1 March 2020 and 31 December 2022. The study visit was conducted between 16 January and 23 December 2024.

Multicentre study involving seven public hospitals and general practitioners across Lombardy.

Randomly sampled adults aged 18–70 years with confirmed SARS-CoV-2 infection. Hospitalised patients (HP) were admitted for COVID-19; general practitioner patients (GPP) were managed in the community. The total sample comprised: 1162 (546 HP, 616 GPP).

This is an observational study with no active intervention.

Primary outcome: 1-year incidence of PCC retrospectively assessed at the study visit.

Secondary outcomes: symptom profiles, long-term PCC prevalence at the study visit and predictive value of the NIH RECOVER score.

Median age was 57.1 years in HP and 42.9 years in GPP; 66.1% of HP and 47.7% of GPP were male. PCC developed in 280 patients (223 HP, 57 GPP). The 1-year cumulative incidence was 39.9% in HP (95% CI 35.9% to 44.1%) and 9.1% in GPP (95% CI 7.1% to 11.7%). The NIH RECOVER score was associated with PCC at 1 year (OR 1.18, 95% CI 1.14 to 1.21). Model-based long-term PCC prevalence was 31.8% in HP and 6.3% in GPP.

PCC remained frequent and heterogeneous, particularly among previously HP. In this cohort, the NIH RECOVER score showed prognostic value for estimating longer-term PCC burden. These findings underscore the need for structured long-term follow-up across both hospital and primary care settings.

Congenital malformations (CMs) are the leading cause of infant mortality. Still, the aetiology remains unknown in 70% of cases. The most accepted hypothesis is that hereditary and environmental elements concur in altering embryo-fetal development. Recently, the role of the environment has been emphasised.

Women are exposed to several xenobiotics during pregnancy. This review aims to study the available literature on the exposure of pregnant women to pesticides through drinking water to see if there is any evidence of correlation to the onset of any kind of congenital anomalies.

We will conduct a systematic literature review in The Cochrane Library, Embase and PubMed for studies published between 1 January 2005 and 31 January 2026. Articles will be included if they examine pregnant women as the study population, exposure to pesticide active ingredients and metabolites present in drinking water, and any type of CM in their children as the main outcome. The screening of title, abstract and full text as well as the data extraction will be conducted independently through two investigators. A third investigator will resolve any eventual conflicts. Each included study will be evaluated according to the NIH’s quality assessment tools. Grading of Recommendations Assessment, Development and Evaluation approach will be used for summarising and assessing certainty in the bodies of evidence produced by the review. This study is registered with PROSPERO, CRD420251063011.

The completed work will be published in a scientific journal for dissemination. Due to the nature of the study, an ethical approval is not necessary since no patient data or other information will be directly collected.

Some cancers are diagnosed late, making them harder to treat. People with an undiagnosed cancer may use over-the-counter medications to manage non-specific cancer-related symptoms that often mimic other more common, easily treatable conditions. Results from the original Cancer Loyalty Card Study (CLOCS) suggest there may be an increase in purchases of pain and indigestion medication 8–9 months before an ovarian cancer diagnosis. We aim to validate the CLOCS findings by exploring whether a significant change in medication purchases could be an indication for early signs of the following cancer types: oesophageal, stomach (gastric), colorectal (bowel), pancreatic, liver, bladder, endometrial, uterine sarcoma, ovarian and vulval, using data collected through store loyalty cards.

Using a retrospective case-control design, we aim to recruit 1450 participants with one of the cancers of interest (cases) and 1450 participants without cancer (controls) in the UK who (or whose household members) hold a loyalty card with at least one participating high street retailer. We will use pre-existing loyalty card data to compare past purchase patterns of cases with those of controls. To assess cancer risk in participants and their purchasing patterns, we will collect information on demographic characteristics, health risk factors, lifestyle habits and behaviours, family history of cancer and any symptoms experienced prior to diagnosis (cases) and in the last year prior to study recruitment (controls). In addition, cases will be asked about their cancer diagnosis.

CLOCS-2 was reviewed and approved by the East Midlands-Leicester South Research Ethics Committee (23/EM/0224). Study outcomes will be disseminated through peer-reviewed publications, conferences, presentations to the research communities as well as patients and the public, the study website and other social media outlets.

NCT06447064, CPMS58679; pre-results.

Quality collaboratives improve quality of care at the hospital and collaborative levels, but less is understood about how such efforts affect patient-level disparities. This study evaluated how a quality improvement (QI) effort (increasing multiarterial grafting during coronary artery bypass grafting (CABG)) translated into populations which historically receive lower-quality care (females and patients of low socioeconomic status).

Retrospective cohort study.

All non-federal hospitals in the state of Michigan that perform cardiac surgery and participate in a statewide collaborative database (n=33).

Patients undergoing first-time, isolated CABG receiving at least two bypass grafts from 2011 to 2022 were identified.

Association of sex and socioeconomic status with multiarterial grafting was evaluated across the study period. The distressed community index (DCI), a socioeconomic ranking (0—not distressed, 100—severely distressed), was matched to the patient’s zip code. Hierarchical regression modelling was performed to associate DCI and sex with multiarterial grafting, incorporating patient factors and hospital and surgeon effects. A sex-surgery year and DCI-surgery year interaction term was performed to assess the change in the rate of multiarterial grafting.

A total of 40 322 patients underwent CABG at 33 centres with a median age of 66 years and 24% were female. The rate of multiarterial grafting was 15%, although lower among females (10% vs 17%) and the highest (vs lowest) DCI quartile (14% vs 18%). After risk adjustment, females were less likely to receive multiarterial grafting (OR_adj 0.51 (95% CI 0.45 to 0.58), padj 0.35 per 10-point increase (95% CI 0.24 to 0.51), p0.05).

Despite a large overall increase in multiarterial grafting due to QI efforts, females and patients with low socioeconomic status had lower rates of multiarterial grafting. QI efforts should be evaluated both overall and among patients who historically receive lower quality care to improve quality and equity.

In May 2023, the US Food and Drug Administration (FDA) initially approved an AS01_E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) for adults aged ≥60 years. The approval was expanded in June 2024 to include adults 50–59 years of age at increased risk for RSV-associated lower respiratory tract disease. In this paper, we describe the protocol of a postmarketing safety study evaluating the association between adjuvanted RSVPreF3 and new-onset Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM) and atrial fibrillation (AF) among adults ≥50 years of age in the USA and provide our rationale for key methodological decisions.

The potential associations between adjuvanted RSVPreF3 and GBS, ADEM and AF will be evaluated using secondary healthcare data and the self-controlled risk interval (SCRI) design. Data from five research partners in the USA spanning August 2023 through June 2030 will be used for the conduct of yearly monitoring queries and, sample size permitting, SCRI analyses. Claims-based definitions for new-onset outcomes (first diagnosis in 365 days) are: ≥1 inpatient diagnosis for GBS and ADEM; ≥1 inpatient or ≥2 ambulatory/emergency diagnoses for AF. The primary risk and control windows are 1–42 and 43–84 days, respectively, for GBS and ADEM; and 1–8 and 9–16 days for AF. SCRI analyses for GBS and ADEM will include chart-confirmed cases. SCRI analyses for AF will adjust for the positive predictive value obtained from validation against charts. Conditional Poisson regression will be used to calculate incidence rate ratios.

This study was approved by the Institutional Review Boards (IRB) of Harvard Pilgrim Health Care Institute; WIRB-Copernicus Group, Inc and its affiliates (collectively, ‘WCG’); WCG IRB, Inc; and Sterling IRB, with Federal Wide Assurance (FWA) numbers FWA00000100, FWA00033319 and FWA00025632, respectively, for all participating research partners. Study results will be shared with the US FDA and publicly disseminated through national or international clinical or scientific conferences and peer-reviewed publications.

This protocol has been registered in the Heads of Medicines Agencies–European Medicines Agency Real World Data Catalogues (EUPAS1000000486).

Patient falls in hospitals lead to patient harm, staff distress and economic burden on health systems. There are few strategies with robust evidence demonstrating benefit for the prevention of falls, especially in acute hospital settings. Education and multicomponent fall prevention approaches are promising. Rigorous systematic measurement of implementation has been lacking in most hospital fall prevention trials. This paper describes the protocol for a trial that will evaluate the impact of supported implementation of tailored multicomponent fall prevention interventions on patient falls in hospital.

A stepped-wedge hybrid type I effectiveness implementation cluster randomised trial will be conducted. Twelve inpatient wards across four metropolitan hospitals will be enrolled in the trial, clustered into groups of four and randomised to commence the intervention at one of three time periods. Patients and ward staff will be recruited to complete pre-implementation surveys, which, combined with analysis of routinely collected local falls data and staff brainstorming, will inform tailored multicomponent fall prevention interventions for each ward. Wards will receive quality improvement training, clinical facilitation and staff education for at least 4 months to support implementation of their fall prevention interventions. The primary outcome—rate of falls—will be measured using routinely collected hospital falls data from the incident management system and medical records. Pre-implementation and post-implementation patient and staff surveys, qualitative interviews and bedside audits will measure secondary effectiveness and implementation outcomes. Healthcare utilisation from hospital data will inform the cost-effectiveness analysis.

The Sydney Local Health District Human Research Ethics Committee (RPAH Zone) approved this trial (protocol number X24-0087 and 2024/ETH00583). The trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572). Data collection commenced in October 2024, due for completion in May 2026. Results will be published in reputable international journals and presented at relevant conferences.

Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572).

Enteric fever, primarily caused by Salmonella enterica Typhi and Salmonella enterica Paratyphi A (SPA), is endemic mainly in South Asia, disproportionately affecting school-age children. Although typhoid conjugate vaccines (TCVs) are effective and implemented in many countries, no licensed vaccine exists against paratyphoid A. Bivalent vaccines targeting both S. Typhi and SPA may address this gap. Although field efficacy trials are not considered feasible, controlled human infection models (CHIMs) offer an alternative pathway for evaluating vaccine efficacy. This will be the first efficacy study of a bivalent vaccine against typhoid and paratyphoid A using a paratyphoid CHIM.

This is a phase II multicentre, double-blind, randomised controlled trial assessing the efficacy and immunogenicity of a bivalent conjugate vaccine candidate, Serum Institute of India Typhoid Conjugate Vaccine (Bivalent) (SII-TCV(B)), against SPA using a CHIM in healthy UK adults aged 18–55 years. A total of 192 participants will be randomised 1:1 to receive either SII-TCV(B) or a licensed Vi-polysaccharide typhoid vaccine (Vi-PS). All participants will be orally challenged with S. Paratyphi A (strain NVGH308) 28 days postvaccination. Participants will be monitored closely for 14 days and treated at 14 days postchallenge or promptly on diagnosis, according to prespecified criteria. The primary objective is to evaluate vaccine efficacy of SII-TCV(B) against paratyphoid infection using a CHIM. The coprimary immunogenicity objective is to assess non-inferiority of the typhoid IgG response compared with a licensed Vi-PS control.

The study has received ethical approval from the Berkshire Research Ethics Committee (24/SC/0309) and regulatory approval from the UK Medicines and Healthcare products Regulatory Agency. Results will be disseminated via peer-reviewed publications and scientific meetings.

ISRCTN65855590.

Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.

The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.

Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.

The substantial case detection gap in the field of child tuberculosis (TB) disease is largely driven by inadequate diagnostic tools and approaches. Chest radiographs (CXRs) remain a key component in the evaluation of children and young adolescents (0–15 years) with presumptive TB, aiding clinicians in making the diagnosis and discriminating children with TB from those with other diseases. Widespread use and optimal interpretation of CXR is hampered by a lack of access to well-trained specialists to interpret images. Artificial intelligence CXR interpretation software, termed computer-aided detection (CAD), is now well developed for adults, yet few products have been evaluated in children. The CXR features of child TB are different from those of adults, and as a result, the performance of these CAD algorithms, largely developed for use in adults, will be suboptimal when used in children. Adapting, or fine-tuning adult CAD algorithms, using CXR images from children with presumptive TB, could allow optimisation of these products for use in children. We, therefore, set out to develop a large image and data repository collected from children evaluated for TB (called Catalysing Artificial Intelligence for Paediatric Tuberculosis Research, CAPTURE) with the purpose of evaluating current CAD products and then working with developers and other partners to optimise CAD algorithms for use in children.

We identified approximately 20 studies, from which potentially up to 11 000 CXRs could be used for the proposed project. CXRs and data were eligible for inclusion in the CAPTURE repository if collected from high-quality child TB diagnostic studies that enrolled children with presumptive TB and if CXRs were obtained as part of the baseline assessment. All lead investigators of these studies are members of the CAPTURE consortium. The images and metadata contributed are centrally collated and the key variable of TB case classification as confirmed, unconfirmed or unlikely TB, using an established consensus case definition, is available. All CXRs included in the CAPTURE repository have a consensus radiological interpretation allocated by a panel of independent expert child TB CXR readers who have classified them as ‘unreadable’, ‘normal’, ‘abnormal typical of TB’ or ‘abnormal not typical of TB’. To determine diagnostic performance of existing CAD products, we will evaluate these against a primary composite clinical reference standard (confirmed TB and unconfirmed TB vs unlikely TB), as well as other secondary microbiological and radiological reference standards. A subset of images will be subsequently allocated to a ‘training set’ and made available to developers, academic groups or other parties to either develop novel paediatric CAD products or fine-tune existing adult ones, which will then be re-evaluated by the CAPTURE team using an image subset (‘validation set’) that is independent of the training set.

The CAPTURE study has been approved by Stellenbosch University Health Research Ethics Committee (N22/09/113), with additional ethics approval or waivers by relevant local authorities obtained by consortium members contributing data if required. The final pooled, harmonised and cleaned dataset, as well as the deidentified, renamed CXR images, is stored on a secure cloud-based server. All analyses of existing CAD products, as well as the paediatric-optimised products, will be published in peer-reviewed publications and shared with other stakeholders like the WHO and donor and procurement organisations to guide policy updates and procurement pathways to ensure widespread uptake.

The objective of this study was to determine the association between viral subtype/clade and disease severity.

Multicentre retrospective cohort study.

This study used data from the Global Influenza Hospital Surveillance Network (GIHSN). The dataset comprised hospitalised influenza patients with viral sequencing data across 14 countries, collected from August 2022 through October 2023.

A total of 761 hospitalised patients were enrolled during the study period, and 745 patients were included in the analysis. We excluded patients with missing data on explanatory or outcome variables, those infected with viral clades represented by fewer than 11 sequences, and those enrolled at study sites contributing fewer than 5 patients.

Disease severity was defined by admission to intensive care unit (ICU), receipt of non-invasive oxygen supplementation, 3-variable definition (ICU, mechanical ventilation or death) or 4-variable definition (3-variable plus oxygen supplementation).

Outcomes were analysed in association with subtype or clade using the mixed-effects logistic regression models, adjusting for age group, sex, underlying medical conditions, influenza vaccination status, antiviral use, country income level and epidemic period, while study site was included as a random effect.

745 patients were included: 263 A(H1N1)pdm09, 380 A(H3N2), 102 B/Victoria. A(H1N1)pdm09 infection was associated with increased odds of ICU admission (adjusted ORs (aORs) 2.5, 95% CI 1.1 to 5.8) compared with A(H3N2). 6B.1A.5a.2a.1 clade of A(H1N1)pdm09 was associated with increased severity compared with 6B.1A.5a.2a clade (aOR 3.0, 95% CI 1.0 to 9.5) and (aOR 5.4, 95% CI 1.6 to 18.3) for the 3-variable and 4-variable definitions respectively. Among A(H3N2), the (3C.2a1b.2a.)2b clade showed a trend toward increased severity using the 4-variable definition compared with the 2a.1b clade (aOR 2.9, 95% CI 0.8 to 10.0).

This analysis highlights the differential impact of influenza subtypes and clades on disease severity in hospitalised patients. Future research should investigate the role of specific viral mutations of these clades in modulating immune evasion or disease severity. These findings reinforce the GIHSN’s critical role in global surveillance. Ongoing genomic surveillance is crucial for understanding the clinical impact of emerging influenza variants and informing public health responses.

Atrial Fibrillation (AF) is the most common arrhythmia worldwide affecting an estimated 5% of people over the age of 65 and is a leading cause of stroke and heart failure. Identification of patients at risk allows preventative measures and treatment before these complications occur. Conventional risk prediction models are static, do not have flexibility to incorporate dynamic risk factors and possess only modest predictive value. Artificial intelligence and machine learning-powered health virtual twin technology offer transformative methods for risk prediction and guiding clinical decisions.

In this prospective observational study, 1200 patients will be recruited in two tertiary centres. Patients hospitalised with acute illnesses (sepsis, heart failure, respiratory failure, stroke or critical illness) and patients having undergone high-risk surgery (major vascular surgery, upper gastrointestinal surgery and emergency surgery) will be monitored with a patch-based remote wireless monitoring system for up to 14 days. Clinical and electrocardiographic data will be used for modelling the risk of new-onset AF. The primary outcome is episodes of AF >30 s and will be described as ratio of episodes/patient and as percentage of patients having episodes of AF. Secondary outcomes include 30-day and 90-day readmission rates and complications of AF.

The aim of this study is to generate data for the development and validation of health virtual twins predicting onset of AF in an at-risk population. The intelligent monitoring to predict atrial fibrillation (NOTE-AF) study is part of the TARGET project, a Horizon Europe funded programme which includes risk prediction, diagnosis and management of AF-related stroke (https://target-horizon.eu/).

The study has received approval by the Health Research Authority and the National Research Ethics Service (REC reference 24/NW/0170, IRAS project ID: 342528) in the UK and has been registered on clinicaltrials.gov (NCT06600620). Results will be disseminated as outlined in the TARGET protocol to communicate project ideas, activities and results to diverse audiences.

NCT06600620.

Establishing comparability between measured outcomes in clinical trials poses a significant obstacle for systematic reviewers. Core outcome sets (COSs) were developed to address this issue. The macular degeneration (MD) COS is designed to standardise outcome measurement across clinical trials for MD. This study investigates the uptake of the MD COS in standardising outcome measurement across clinical trials.

Cross-sectional analysis

We conducted a search on ClinicalTrials.gov to locate MD clinical trials that were registered 5 years prior to COS publication through the search date of 26 June 2023 and obtained a pool of 2152 registered studies. After applying various inclusion and exclusion criteria, we analysed 159 trials. We then analysed the COS uptake using an interrupted time series analysis (ITSA) and performed performed analyses of variance (ANOVAs) and Pearson correlations to evaluate associations between trial characteristics and outcome measurement.

ITSA showed no significant change in uptake following the MD COS (2016): mean percentage of completion of the COS increased by 0.24% per month before publication (p=0.27) and by 0.07% per month after publication (p=0.62), indicating no meaningful post-publication slope change in COS use. For context, visual acuity was most commonly measured, while several patient-reported and disutility domains were infrequently captured.

No discernible patterns in COS usage for MD trials were observed. We recommend further collaboration between regulators and COS developers to help with COS uptake. Additionally, we suggest that further studies analyse adherence to COSs in respect to regulatory recommendations.

The rate of impaired metabolic regulation is rising among premenopausal women, characterised by decreased insulin sensitivity, increased fasting blood sugar levels and abnormal lipid profiles.1 This metabolic dysfunction is linked to the...