To examine the risk of severe cardiovascular (CV) events in patients with chronic obstructive pulmonary disease (COPD) across different time periods following COPD exacerbations and the incidence rate of cardiopulmonary events in a real-world setting in China.

Retrospective cohort study.

Regional electronic health records database from Yinzhou District of Ningbo City, China.

A total of 14 713 patients aged ≥40 years with a first COPD diagnosis between 1 January 2014 and 1 March 2022.

The risk of severe CV events (ie, hospitalisation and a primary or secondary discharge code for acute coronary syndrome, heart failure decompensation, cerebral ischaemia, arrhythmia and CV-related death) during different exposed time periods following a COPD exacerbation, the incidence rate of overall cardiopulmonary events (ie, severe exacerbation of COPD, all-cause mortality, inpatient CV events, inpatient ischaemic stroke and inpatient tachyarrhythmia/atrial fibrillation) and the incidence rate stratified by COPD exacerbation history.

We included a total of 14 713 patients. During a median (IQR) follow-up of 2.8 (4.0) years, 20.1% experienced severe CV events. Compared with the unexposed period, the risk of severe CV events was the highest in the first 10 days following a COPD exacerbation (adjusted HR 10.00, 95% CI 8.16 to 12.25). The risk of severe CV events decreased over time but remained significantly elevated up to 90 days post exacerbation. We found that 32.7% of COPD patients experienced cardiopulmonary events, with a crude incidence rate of 9.38 (95% CI 9.09 to 9.69) per 100 person-years.

This study is the largest retrospective cohort study investigating CV and cardiopulmonary events among patients with COPD in China. Our findings highlight an elevated risk of CV events closer to the time of COPD exacerbations and show that nearly one-third of COPD patients experience cardiopulmonary events.

Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.

The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).

A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.

The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.

ACTRN12618000932268.

Poor communication between healthcare professionals is one of the main causes of medical errors. Many articles about interprofessional communication (IPC) do not define what communication is and often describe it only as a domain of competencies of interprofessional collaboration. Three communication paradigms coexist: the transmission model, the transactional model and the constitutive model. These models focus on different aspects of communication and are complementary. No review about IPC, including all healthcare professionals or all healthcare settings, has been found.

A scoping review protocol was developed to map the research on the topic of IPC, the paradigms of communication used by the researchers, as well as to clarify the definition of this concept. We will follow the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews. Eligibility criteria follow the Population, Concept, Context framework. Articles about health professionals, allied health professionals and social workers and students in these fields will be included. Articles evaluating IPC in healthcare, either quantitatively or qualitatively, will be included. Articles investigating IPC in any type of healthcare setting in any country will be considered. All types of published articles in scientific journals will be included. The databases that were searched are MEDLINE, CINAHL, APA PsycINFO, EMBASE and Web of Science. In October 2025, 22 798 citations were retrieved, of which 9722 duplicates were deleted. Two researchers will then independently assess the remaining 13 078 citations against the eligibility criteria. This step is scheduled for completion in May 2026. They will then chart the data using a standardised data extraction tool.

Formal ethical approval is not required, as primary data will not be collected in this study. Findings of the scoping review will be disseminated through professional networks, conference presentations and publication in a scientific journal.

Because the study is a scoping and not a systematic review, registration was not possible on PROSPERO. The study was registered on Open Science Framework: https://osf.io/dyh2a.

Despite its serious impact, anorexia nervosa (AN) remains one of the least understood mental illnesses, with significant gaps in effective treatment options. No medications have been deemed effective and only 50% of individuals respond to conventional psychotherapies. Gastrointestinal (GI) bacteria have been found to be altered in individuals with AN. While, Fecal microbiota transplantation (FMT) has shown potential for alleviating anxiety and depression, its effects remain understudied for individuals with AN. This study aims to determine whether oral capsular FMT is acceptable to adolescents with AN and results in clinical improvement in weight and/or psychological symptoms.

This study will randomise 20 adolescents with AN, ages 12–17 years, to receive either FMT or placebo capsules. These 20 youth, as well as an additional 10 youth who decline trial enrolment, will participate in qualitative interviews. We will track recruitment rates and collect psychological and biological measures (blood, stool, urine and saliva) at multiple timepoints to assess how gut microbiota and their metabolites may influence the symptoms of AN. Interviews with participants and caregivers will explore their experiences and views on FMT as a treatment approach.

This study has received ethics approval by the Hamilton Integrated Research Ethics Board (#17493) and investigational drug approval by Health Canada (Dossier ID: c292423). Informed consent will be obtained by research staff from all participants. Findings will be disseminated through academic conferences, clinical forums and partnerships with advocacy organisations to reach clinicians, researchers and individuals with lived experience.

NCT06593366.

Self-injurious behaviour (SIB) consists of persistent, repetitive movements that can result in serious injury without suicidal intent. These behaviours are prevalent among children with neurodevelopmental disorders, including profound autism. Although many individuals benefit from currently available therapies, some exhibit treatment-refractory SIB that necessitates ongoing use of personal protective equipment and restraint, presumably due to stronger neurobiological drivers. We recently completed a phase I, open-label clinical trial demonstrating the safety, feasibility and preliminary efficacy of bilateral deep brain stimulation targeting the nucleus accumbens (NAc-DBS) in children with profound autism and severe, refractory SIB. The objective of the proposed study is to characterise the effectiveness of NAc-DBS in treating severe, refractory SIB in this unique and vulnerable population.

A single-centre, randomised double-blinded, crossover trial is proposed. Informed by the results of our pilot study, 25 subjects with autism spectrum disorder and severe, refractory SIB will undergo bilateral NAc-DBS. Following a 4-week recovery period, participants will be randomised to either group A (stimulation ON then OFF) or group B (stimulation OFF then ON). Each block will last 12 weeks, separated by a 2-week washout period. Following completion of the second block, all participants will enter a 6-month open-label phase with stimulation ON. The primary outcome is the difference in the Repetitive Behaviour Scale–Revised total score, between DBS-ON and DBS-OFF conditions. Secondary outcomes include measures of quality of life, caregiver burden, daily logs of SIB events and direct observation of SIB under structured analogues.

The proposed trial has been approved by the institutional Research Ethics Board (1000081171). Trial results will be disseminated through peer-reviewed publications and conference presentations.

NCT06529380

To investigate the risk factors for primary non-central malposition of peripherally inserted central catheter (PICC) tip in neonates admitted to the neonatal surgical department, compare the malposition rates across different insertion sites in disease types, and explore whether different diseases affect PICC tip malposition.

A retrospective case–control study conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.

A 3A women’s and children’s hospital in South China (Guangdong Province).

A total of 558 neonates aged ≤28 days who underwent PICC insertion between January 2019 and November 2024 were enrolled. Neonates with congenital circulatory system malformations, incomplete clinical data and death or treatment withdrawal before tip positioning were excluded.

The primary outcome was the incidence of primary non-central PICC tip malposition confirmed by X-ray or ultrasound within 24 h after insertion. Secondary outcomes included comparison of primary non-central PICC tip malposition rates across different insertion sites and comparison of primary PICC tip malposition rates by insertion sites across different disease groups.

558 neonates were included in this study, including 460 cases with PICC tip in place and 98 with PICC tip malposition. In binary logistic regression analysis, the PICC insertion site was considered an independent risk factor (OR 2.908, 95% CI 1.748, 4.840, p

Medical staff can choose appropriate upper or lower limb veins for PICC insertion without worrying about the impact of abdominal diseases or thoracic diseases on non-central PICC tip malposition. PICC insertion via the head and neck veins should be performed with caution in neonates, as these sites carry a high risk of primary non-central tip malposition compared with other insertion sites.

We compared the cost-effectiveness of alternative fracture risk assessment strategies for people with intellectual disabilities (ID) aged ≥40 years from a UK National Health Services perspective over a lifetime horizon.

Cost-effectiveness analysis using a lifetime decision-analytical model.

UK primary care, with data from literature and national databases.

People with ID.

Three strategies were assessed: (S1) Risk assessment using the UK QFracture score; (S2) use of IDFracture (a fracture risk prediction tool specifically developed for adults with ID); and (S3) conducting a one-time dual-energy X-ray absorptiometry (DXA) scan in all. S1 and S2 were followed by DXA scan for those at risk. At-risk individuals received treatment according to UK practice (bisphosphonates plus vitamin D and calcium for osteoporosis, and vitamin D and calcium alone for osteopenia).

Direct healthcare costs and quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

In the base case, S2 (ICER: –£2568/QALY) was dominant (ie, less costly and more effective) and S3 (ICER: £1678/QALY) was cost-effective relative to S1 for major osteoporotic fracture (MOF). For hip fracture, S2 (ICER: £32 116/QALY) and S3 (ICER: £49 536/QALY) were not cost-effective relative to S1 under the National Institute for Health and Care Excellence-recommended cost-effectiveness thresholds. Findings from the sensitivity analyses were predominantly consistent with the base-case results. Subgroup analyses showed that age-specific and gender-specific strategies could be used.

For people with ID aged ≥40 years, a proactive approach to risk assessment for MOF is not only clinically beneficial, but also cost-effective.

Current Belgian guidelines state that chronic proton pump inhibitor (PPI) therapy is indicated for oesophagitis grade C and D, Barrett’s oesophagus, Zollinger-Ellison syndrome, or to prevent bleeding ulcers with chronic non-steroidal anti-inflammatory drugs (NSAID) intake in patients at risk. Guidelines justify empiric short-term PPI therapy in other cases to control symptoms. Yet, there is insufficient PPI down-titration and/or cessation. As such, concerns have risen related to the impact of PPIs on the healthcare budget and increasing number of risks and side effects. This study aims to provide evidence to determine which strategy provides the most effective approach for stopping chronic intake of PPIs in patients in whom there is no firm medical indication for their continued use.

This is a multicentre, pragmatic, randomised clinical trial. General practitioners will randomise 609 to one of three PPI deprescription strategies. Patients on a high-dose PPI are allowed to participate after down-titrating their dose to a maintenance dose for 1 month before being randomised. Patients unable to decrease the high-dose PPI are not to be randomised. Following randomisation, patients will be requested to adapt their PPI intake for 1 month to the allocated deprescription scheme: (a) on-demand PPI intake, (b) replace PPI to alginate intake and (c) intermittent PPI intake with a fixed scheme. After successfully following the deprescription strategy, patients are requested to completely stop their use of PPI. Patients are followed up for 1 year. The primary endpoint of the study is the percentage of patients achieving a successful therapeutic outcome, defined as limited PPI intake and willingness to continue the therapy, at the end of the follow-up period. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach.

This trial was approved through the platform for Clinical Trials in the European Union by a Belgian ethics committee (CTIS reference: 2022-502375-37-00). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations. Trial registration number NCT05629143.

NCT05629143, clinicaltrial.gov.

Mindfulness-based interventions are widely used, yet concerns about potential negative effects—particularly those related to mindfulness meditation practice—have gained increasing attention. Individuals with difficult-to-treat depression (DTD) represent a population of particular relevance due to heightened vulnerability, but comparative evidence on clinically relevant negative outcomes of mindfulness-based cognitive therapy (MBCT) versus established alternative psychotherapies in this group is lacking. This protocol describes a systematic review and individual participant data (IPD) network meta-analysis to assess and compare the incidence of clinically relevant negative outcomes associated with MBCT and the cognitive behavioural analysis system of psychotherapy (CBASP), an established individual psychotherapy for DTD.

Randomised controlled trials of MBCT and CBASP for adults with DTD were identified through systematic searches of major databases. Eligible studies must compare MBCT or CBASP (alone or with treatment as usual) to each other or to control groups. The primary outcome is clinically significant deterioration, defined as a ≥6-point increase on the Patient Health Questionnaire-9 or equivalent. Secondary outcomes are suicidality and treatment dropout. IPD will be requested from trial investigators; aggregate data will be used when IPD is unavailable. One-stage random-effects IPD network meta-analyses will be conducted to integrate direct and indirect evidence and to examine participant-level moderators of deterioration. Adverse events reported in the included trials will be summarised descriptively at the study level.

No local ethical review was required following consultation with the Swedish Ethical Review Authority. Primary trial investigators obtained local ethical approval and will share pseudonymised IPD. Findings will inform clinical decision-making and guideline development by strengthening the evidence base on potential negative effects of MBCT and CBASP in adults with DTD, including identification of subgroups at increased risk. Results will be disseminated through peer-reviewed publication and accessible summaries for relevant stakeholders.

CRD42022332039

Patients discharged from intensive care units (ICUs) are at high risk of adverse long-term outcomes including cardiovascular and/or renal events and a 1-year mortality of approximately 22%. Plasma biomarkers measured at ICU discharge have demonstrated strong prognostic value, with elevated cardiac or renal biomarkers identifying patients at particularly high risk of poor outcomes. Sodium-glucose cotransporter 2 inhibitors are now widely recognised for their cardioprotective and nephroprotective effects in chronic conditions such as type 2 diabetes, heart failure or chronic kidney disease. These agents improve both morbidity and mortality across a range of high-risk populations. We hypothesise that a therapeutic strategy aimed at preventing the progression of cardiovascular and/or renal injury following ICU discharge may improve long-term outcomes in ICU survivors.

This is a multicentre, double-blind, randomised, placebo-controlled clinical trial conducted across 16 teaching and non-teaching ICUs in France. We will enrol 600 adult patients (18 years of age or older) who have received mechanical ventilation and/or vasopressors for at least 24 hours during their ICU stay, and who meet at least one of the following criteria at ICU discharge: N-terminal pro-B-type natriuretic peptide (NT-proBNP) >800 pg/mL or BNP >90 ng/L, an estimated glomerular filtration rate between 25 and 90 mL/min/m². Eligible patients will be randomised in a 1:1 ratio to receive either dapagliflozin (10 mg once daily) or a matching placebo for a duration of 1 year. The primary outcome is a composite endpoint assessed at 1 year after randomisation, comprising: all-cause mortality, unscheduled hospitalisation for acute heart failure and decrease in renal function. Feasibility will be assessed based on patient and clinical acceptability and recruitment performance, including enrolment rates across participating centres.

This study has been approved by the Institutional Review Board (CPP Ile-de-France 5). Written informed consent will be obtained from all participants prior to enrolment and the initiation of any study-related procedures. Dapagliflozin is a widely available medication with an established safety profile. If proven effective, it would represent a readily deployable strategy to improve long-term outcomes in ICU survivors. The study is described in accordance with the Standard Protocol Items: Recommendations for Interventional Trials framework, and key design features and methodological decisions are outlined accordingly. DAPA-ICU aims to evaluate the efficacy of dapagliflozin in cardiorenal protection among critically ill patients following ICU discharge. The main trial results will be submitted for publication in a peer-reviewed journal as soon as they become available after final analysis.

NCT07025629.