Search Results for: Long COVID: principali risultati, meccanismi e raccomandazioni

Introduction
Obesity combined with metabolic syndrome is a major global public health problem. This trial aims to investigate the therapeutic effects of low-frequency transcutaneous electrical nerve stimulation (Lo-TENS) in individuals with obesity and coexisting metabolic syndrome. The study will also delve into the underlying mechanisms through which Lo-TENS may mitigate the symptoms of metabolic syndrome, providing insights into its potential as a novel treatment approach.

Methods and analysis
This randomised controlled trial will enrol 63 individuals with obesity and metabolic syndrome, and randomly assign them to one of the three groups: (1) peripheral stimulation group, (2) central stimulation group and (3) sham stimulation group. Each participant will receive a 30 min daily session of their assigned stimulation, conducted 5 days a week for a duration of 12 weeks. The primary outcomes of interest are body mass index and fasting blood glucose, with secondary outcomes encompassing blood pressure, triglyceride levels and various metabolic biomarkers. Comprehensive assessments will be performed at baseline, immediately post intervention, and followed by a 12-week follow-up evaluation to monitor long-term effects and sustainability of potential benefits.

Ethics and dissemination
The trial has been granted ethical approval by the ethics committee of the Second People’s Hospital of Kunming (approval number: 202305001). The study’s findings will be disseminated through peer-reviewed journal publications and international conference presentations.

Trial registration number
Chinese Clinical Trial Registry Platform: www.chictr.org.cn (No. ChiCTR2400089104).

Introduction
Peripheral artery disease (PAD) is a chronic condition causing arterial narrowing or blockage, leading to significant morbidity and mortality. Hybrid revascularisation combines open surgical and endovascular techniques to manage multilevel disease by addressing inflow and outflow obstructions. Despite increasing adoption, evidence on the long-term outcomes of these procedures remains limited.

Objective
To evaluate the long-term outcomes of hybrid revascularisation procedures in PAD, including patency rates, limb salvage, survival, reintervention rates and complications, and to provide evidence-based insights for clinical practice and research.

Methods and analysis
This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. It will include randomised controlled trials, cohort studies, case-control studies and large case series (≥10 patients, with at least 1 year of follow-up) assessing adult patients undergoing hybrid revascularisation for PAD. Primary outcomes are patency rates, limb salvage and survival; secondary outcomes include complication rates, functional improvements and quality of life. Searches will be conducted in PubMed, Embase, Cochrane Library, CINAHL and ClinicalTrials.gov. Study selection, data extraction and quality assessment will be performed independently in duplicate by two reviewers. Meta-analyses with random-effects models will summarise findings where feasible, while narrative synthesis will address instances of insufficient data. Subgroup analyses will explore outcomes by demographics, lesion characteristics and procedural details. Risk of bias will be assessed using Cochrane and Newcastle-Ottawa tools.

Ethics and dissemination
Ethical approval is not required. Findings will be published in peer-reviewed journals and presented at conferences.

PROSPERO registration number
CRD42024615809.

Stroke, Ahead of Print. BACKGROUND:Defining the risk of developing major bleeding, especially intracranial hemorrhage (ICH), or ischemic stroke (IS) in patients receiving antithrombotic therapy is crucial. Existing risk prediction tools would inadequately assess the net clinical benefit of antithrombotic therapy. We aimed to develop novel risk scores incorporating covert vascular brain injury to personalize the risk assessment of major bleeding, ICH, and IS in patients receiving antithrombotic therapy.METHODS:The prospective, multicenter, observational study (BAT2 [Bleeding With Antithrombotic Therapy Study-2]) enrolled patients receiving oral antiplatelets or anticoagulants from 52 hospitals across Japan between 2016 and 2019. Multimodal brain magnetic resonance imaging was performed at baseline under prespecified conditions to determine cerebral small vessel disease (white matter hyperintensity, cerebral microbleed, lacune, enlarged perivascular space, and cortical superficial siderosis), nonlacunar infarct, and intracranial artery disease with central reading. Risk scores, collectively termed the BAT2 scores, were developed separately to evaluate the comparative risks of (1) major bleeding, (2) ICH, and (3) IS based on covariates from Cox proportional hazards models and clinical relevance. Model performance was assessed with the Harrell C-index and calibration slope adjusted for optimism via bootstrapping.RESULTS:Of 5378 patients enrolled, 5250 were analyzed (mean age, 71±11 years, 33% women); 93 experienced major bleeding, including 55 had ICH, and 197 had IS during a median follow-up of 2.0 years. Predictors for bleeding included age, underweight, renal impairment, hypertension, cerebral microbleed, lacune, and antithrombotic treatment type. Predictors for ICH further included deep white matter hyperintensity but not renal impairment. For IS, predictors included age, renal impairment, diabetes, atrial fibrillation, lacune, cerebral microbleed, nonlacunar infarct, and intracranial artery disease. Prediction performance showed optimism-adjusted C-index and calibration slope of 0.69 (95% CI, 0.64–0.74) and 0.82 (95% CI, 0.62–1.06) for bleeding, 0.75 (95% CI, 0.67–0.80) and 0.80 (95% CI, 0.56–1.02) for ICH, and 0.64 (95% CI, 0.60–0.68) and 0.92 (95% CI, 0.73–1.18) for IS.CONCLUSIONS:The BAT2 scores may help optimize the balance between risks and benefits of antithrombotic therapy.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT02889653. URL:https://www.umin.ac.jp/ctr; Unique identifier: UMIN000023669.

Stroke, Ahead of Print. BACKGROUND:Cerebral small vessel disease (SVD) causes up to 45% of dementias and 25% of ischemic strokes, but the understanding of vascular pathophysiology is limited. We aimed to investigate the contribution of pulsatility of intracranial arteries, veins, and cerebrospinal fluid (CSF) and cerebral blood flow to long-term imaging and clinical outcomes in SVD.METHODS:We prospectively recruited participants in Edinburgh/Lothian, Scotland, with lacunar or nonlacunar ischemic stroke (modified Rankin Scale score ≤2, as controls) and assessed medical and brain magnetic resonance imaging characteristics at baseline and 1 year (2018–2022). We used phase-contrast magnetic resonance imaging to measure flow and pulsatility in major cerebral vessels and CSF to investigate independent associations with baseline white matter hyperintensity (WMH) and perivascular space (PVS) volumes and their progression, as well as with recurrent stroke, functional, and cognitive outcomes at 1 year. We applied linear, logistic, and ordinal regression models in our analysis.RESULTS:We recruited 210 participants; 205 (66.8% male; aged 66.4±11.1 years) had useable data. In covariate-adjusted analyses, higher baseline arterial pulsatility was associated with larger volumes of baseline WMH (B=0.26 [95% CI, 0.08–0.44];P=0.01) and basal ganglia PVS (B=0.12 [95% CI, 0.04–0.20];P

New England Journal of Medicine, Ahead of Print.

Introduction
Severe intraventricular haemorrhage (IVH) and white matter injury (WMI) are major neurological complications in preterm infants, leading to long-term neurodevelopmental impairments. Despite advances in neonatal care, effective treatments are lacking. Umbilical cord blood cell (UCBC) therapy shows neuroprotective potential, with autologous sources ideal but often not feasible due to the unpredictability of preterm births. Allogeneic UCBCs offer an alternative, although immunogenicity and human leucocyte antigen (HLA) compatibility present challenges with knowledge gaps in their relevance in neonatal populations. This study aims to assess the feasibility and safety of partially HLA-matched allogeneic UCBC therapy in preterm infants with severe brain injury.

Methods
The ALLO trial is an open-label, phase I, single-arm feasibility and safety study conducted at Monash Children’s Hospital, Victoria, Australia. Preterm infants born before 28 weeks (ALLO-1) or between 28 weeks and 36+6 weeks (ALLO-2) gestational age with severe brain injury identified on neuroimaging will be enrolled. Severe brain injury is defined as grade 3 or 4 IVH or significant WMI. Exclusion criteria include major congenital anomalies or redirection to comfort care. Eligible infants will receive a single intravenous infusion of unrelated, allogeneic, partially HLA-matched (4/6 or 5/6 HLA match) UCBCs sourced from a public cord blood bank. The target dose is 50 million total nucleated cells per kilogram body weight. Infusion will occur within 2–3 weeks of confirmation of eligibility, contingent on clinical stability and absence of active sepsis. Primary outcome includes: (1) feasibility, defined as having more than 60% of enrolled infants with an eligible allogeneic partially matched cord blood unit available and (2) safety, defined as absence of severe adverse events within 48 hours of infusion or graft-versus-host disease within 3 months of infusion. Secondary outcomes include survival, neonatal morbidities, neurodevelopmental assessments and serum cytokine analysis.

Ethics and dissemination
Monash HREC has granted full ethics approval (RES-23-0000-297A) for the study, including the research use of allogeneic cord blood from compassionate donations by healthy donors, facilitated through the Bone Marrow Donor Institute Cord Blood Bank within the AusCord network. Findings will be disseminated through peer-reviewed publications and conference presentations, contributing to the development of novel neuroreparative therapies for preterm brain injury.

Trial registration number
ACTRN12623001352695 (The Australian New Zealand Clinical Trials Registry).

Introduction
Psychosis, characterised by chronic symptoms often emerging in youth, imposes a substantial burden on individuals and healthcare systems. While early detection and intervention can mitigate this burden, there is limited evidence on the cost-effectiveness of such approaches. To address this lack of evidence, this study protocol outlines the health economic implications of an artificial intelligence (AI)-based intervention, the Computer-Assisted Risk-Evaluation (CARE), designed to prevent psychosis. The intervention uses AI technologies to enhance the diagnosis and treatment quality for individuals at high risk of psychosis.

Methods and analysis
The health economic evaluation has been designed alongside a 12-month multicentre randomised controlled trial comparing CARE with treatment as usual from both payer and societal perspectives. An implementation cost analysis will complement the evaluation, and long-term consequences beyond the trial will be explored descriptively. Based on a literature review, an initial economic logic model will guide subsequent analyses by depicting CARE’s programme theory.
The cost-effectiveness assessment will include averted cases of manifest psychosis and quality-adjusted life-years using the EuroQol 5-Dimensions 3-Level instrument. Other effectiveness outcomes will also be incorporated into a cost–consequence analysis. Cost-effectiveness acceptability curves reflecting statistical uncertainty will be constructed, incorporating various payer and societal willingness-to-pay values. The implementation cost analysis will follow a mixed-methods approach to capture facility-specific costs.
A dark logic model, emphasising negative outcomes, will be developed to investigate long-term consequences. Further, the initial economic logic model will be refined using trial data and expert interviews. This comprehensive approach aims to provide decision-makers not only with evidence on the cost-effectiveness of CARE, but also with a broader understanding of the implications of the intervention.

Ethics and dissemination
The study has received ethical approval and plans to disseminate its findings through publication in a peer-reviewed journal and conference presentations.

Trial registration number
NCT05813080.

Introduction
In 2016, the United States Preventive Services Task Force (USPSTF) recommended depression screening for all adults in the public sector, with screening frequency determined by clinical judgement and patient circumstances. This practice aims to enable timely diagnosis and treatment, reducing long-term healthcare costs associated with this chronic health condition. However, the USPSTF offered no written recommendations for primary care settings serving non-English-speaking populations, particularly where providers speak English and patients speak Spanish. While some research exists on depression screening in linguistically diverse settings, the use of validated Spanish-language screenings in primary care settings is underexplored when it comes to implementing the USPSTF’s recommendation. This scoping review addresses this knowledge gap by (1) assessing the extent to which Spanish-speaking patients in the USA receive depression screening in Spanish and (2) using the Consolidated Framework for Implementation Research (CFIR) 2.0 to categorise barriers and facilitators to implementing Spanish-language depression screening tools in USA primary care settings. The findings will identify areas needing further research to improve depression screening guidelines for primary care practices serving Spanish-speaking patients.

Methods and analysis
This scoping review follows the Joanna Briggs Institute Manual for Evidence Synthesis and the Arksey and O’Malley scoping review methodology, updated by Levac and colleagues. The reporting protocol adheres to PRISMA-ScR. A systematic search will be conducted in PubMed, Embase, APA PsycINFO, CINAHL and Web of Science Core Collection for studies on Spanish-language depression screening for adults in non-Veterans Affairs Medical Centers in the USA, excluding those focused on youth or adolescents. We will extract data from qualitative, quantitative and mixed-methods studies on screening. We will also examine studies addressing provider-reported comfort and competency in screening Spanish-speaking patients. We hypothesise that primary care clinics have implemented strategies for screening Spanish-speaking patients for depression driven by healthcare provider initiatives, local policies, research funding or community needs. The review will extract data on sample size, study methodology, primary care settings, patient and provider demographics, depression screeners used, and barriers and facilitators to screening. The quality of the studies will be appraised using the Mixed Methods Appraisal Tool (MMAT).

Ethics and dissemination
At Brown University, scoping reviews that analyse and synthesise existing research do not require Institutional Review Board (IRB) approval, provided they do not involve primary data collection or direct interaction with human subjects. Findings will be disseminated through peer-reviewed journals, conference presentations and community workshops to improve practices and policies addressing language barriers in depression screening and care.

Registration details
This scoping review protocol is registered with the Open Science Framework (OSF) at https://osf.io/dyru5.

Introduction
The treatment of paediatric AIS is particularly challenging due to its rarity, limited clinical awareness and absence of targeted treatment protocols and evidence-based data. This study aims to address these gaps by investigating the epidemiology, risk factors, aetiology and treatment of stroke in children in China and to observe the short-term and long-term functional outcomes of paediatric stroke and explore the factors that influence outcomes.

Method and analysis
The Chinese Paediatric Ischaemic Stroke Registry (CPISR) is a multicentre, prospective observational study that plans to consecutively recruit patients at 85 centres across 20 provinces in China. To streamline data collection, a WeChat-based programme has been developed to allow participating institutions to input standardised questionnaire data directly and upload electronic medical records. Comprehensive demographic, clinical, neuroimaging and laboratory data are collected and tracked for registered patients. All patients undergo detailed assessment at the time of admission and during scheduled follow-up visits.

Ethics and dissemination
Ethical approval has been obtained from the Ethics Committee of the First Affiliated Hospital of University of Science and Technology of China (2022KY071). The findings of this study will be disseminated through peer-reviewed journals, national and international conference presentations and reports to participating institutions and relevant stakeholders.

Trial registration number
ChiCTR2200059915.

Introduction
Urinary tract infections (UTIs) are highly prevalent and pose a significant burden among older adults. Accurate diagnosis in this population is challenging due to the high prevalence of pre-existing lower urinary tract symptoms, inability to express symptoms and asymptomatic bacteriuria. Current diagnostic tests are unreliable, often resulting in over- and underdiagnosis. A previous pilot study proposed a higher cut-off for pyuria and identified five promising biomarkers for the diagnosis of UTIs in older adults. The UTI-GOLD study aims to validate these five new biomarkers and the higher leucocyte cut-off as a diagnostic tool for UTIs in older people in a real-world setting.

Methods and analysis
Between August 2024 and December 2027, an observational multicentre diagnostic accuracy study is being conducted across primary, secondary and tertiary healthcare facilities in the Netherlands and the UK. Adults ≥65 years with a suspected UTI will be considered eligible. Patients with pre-existing decision-making incapacity or an indwelling catheter will be excluded. UTI will be defined according to an international consensus-based reference standard. Biomarkers will be measured by liquid chromatography-mass spectrometry (neutrophil gelatinase-associated lipocalin, tissue inhibitor of metalloproteinase 2 and CXC motif chemokine ligand 9) and enzyme-linked immunosorbent assay (interleukin 6 and azurocidin). Pyuria will be quantified by automated microscopy and/or flow cytometry. Diagnostic accuracy measures will be calculated using the receiver operating characteristic curves, and sensitivity, specificity, likelihood ratios and predictive values will be reported for optimal cut-offs.

Ethics and dissemination
The protocol was reviewed by the local Leiden University Medical Center research committee, who declared on 15 April 2024 that the medical research involving human subject act (Dutch abbreviation: WMO) does not apply to the current study (reference number nWMODIV2_2024025). The study also received approval from the NHS Research Ethics Committee in the UK (reference number 24/LO/0649).
The study findings will be published in a peer-reviewed journal, presented at academic congresses and shared with healthcare providers.

Trial registration number
The study was registered at clinicaltrial.gov on the 24 September 2024 with registration number: NCT06610721.

Objective
To investigate the epidemiological characteristics and temporal-spatial distribution of Mycoplasma pneumoniae (MP) infections among paediatric inpatients with respiratory tract infections in Tianjin, China, across three distinct phases: pre-pandemic (2017–2019), pandemic (2020–2022) and post-pandemic (2023–2024). The primary hypothesis is that the COVID-19 pandemic altered the epidemiology of MP infections in children.

Design
Retrospective, single-centre study.

Setting
Secondary care paediatric hospital in a metropolitan area.

Participants
A total of 60 213 paediatric patients hospitalised with respiratory infections between January 2017 and December 2024 were included. The study population consisted of children aged 0–18 years, with a male-to-female ratio of 1.22:1.00. Selection criteria included children admitted with a diagnosis of respiratory infection, while those with incomplete clinical data or non-respiratory infections were excluded.

Primary and secondary outcome measures
The primary outcome was the overall positive detection rate of MP-RNA. Secondary outcomes included annual and seasonal variations in MP-RNA detection rates, differences by sex and age group, and the impact of the COVID-19 pandemic on MP epidemiology. All statistical methods, including those used to control for confounding, involved the use of ² tests for comparing positive rates between groups.

Results
The overall positive detection rate of MP-RNA among children hospitalised for respiratory infections during the study period was 36.58% (22 023/60 213). The annual MP-RNA-positive detection rates from 2017 to 2024 were as follows: 50.74% (411/810) in 2017, 36.28% (1150/3170) in 2018, 27.41% (1459/5323) in 2019, 10.18% (222/2181) in 2020, 11.42% (928/8129) in 2021, 13.27% (579/4364) in 2022, 28.97% (3064/10575) in 2023 and 55.38% (14 210/25 661) in 2024. The highest annual positivity rate was observed in 2024 (55.38%, 14 210/25 661), while the lowest rate occurred in 2020 (10.18%, 222/2181). Statistical analysis revealed significant differences in MP-RNA detection rates across different years (²=8331.511, p

Objectives
This study aimed to examine the impact of the first COVID-19 lockdown period on access to postnatal contraception (PNC) and wider postnatal care and to explore the experiences of PNC care within the North East and North Cumbria (NENC) Integrated Care System (ICS) during the same period.

Design
This study reports a subanalysis of the NENC Postnatal Contraception (PoCo) study, an online survey of a convenience sample of women in the NENC ICS who completed pregnancies between 2019 and 2023.

Setting
Women who completed pregnancies between 2019 and 2023 in the NENC ICS.

Participants
Out of the total 2509 eligible participants who completed the PoCo survey, women who delivered in April–June 2020, April–June 2021 and April–June 2022 were included within this subanalysis, resulting in 457 eligible survey responses. There were no additional exclusion criteria.

Primary and secondary outcome measures
Primary outcome measures were PNC uptake and number of healthcare professional contacts during the postnatal period. Secondary outcome measures were self-reported experiences of PNC care.

Results
Women who delivered in April–June 2020 had fewer postnatal contacts than women who delivered in subsequent non-lockdown cohorts and were less likely to be offered PNC prior to discharge. There were no significant differences in relation to PNC uptake. In qualitative analyses, several women who delivered in 2020 highlighted COVID-19 as a factor perceived to be associated with poor postnatal care. Across all three groups, experiences of PNC care were diverse; feeling pressured to accept PNC was frequently reported.

Conclusions
While the first COVID-19 lockdown appears to have had a significant impact on women’s experiences of postnatal care, this did not result in a substantive decrease in PNC provision, likely reflecting pre-existing shortcomings. These women and families may benefit from additional support postpandemic to mitigate the potential life course implications of restricted support in the postpartum period, and policy-makers and healthcare providers should continue to explore innovative and patient-centred approaches to improving PNC provision. Future research should continue to evaluate the longer-term impacts of these changes in non-pandemic contexts.

Introduction
Patients with frailty are at risk of adverse outcomes such as mortality, falls, deconditioning and hospital readmissions. With an increasingly ageing population and a greater likelihood of frailty, there is a significant need to ensure that patients are managed in the right place and at the right time. There has been a focus on offering hospital-level care at home as a way to meet this need, incorporating strategies to integrate care and use digital solutions. Digital twin (DT) technology is one advancement, offering a virtual replica of an object/environment, which has the potential to make use of real-time data personalised for an individual patient and/or setting to inform and support patient management decisions. We are yet to realise the full potential of this new way of integrated working and technological advancements. This scoping review aims to ascertain the current evidence for the components of the DT architecture to enable the monitoring and management of patients with frailty living at home.

Methods
This scoping review will follow the Joanna Briggs Institute methodology for scoping reviews and will be reported following the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews guidelines. The following electronic databases will be searched: Medline, Embase, CINAHL, Cochrane CENTRAL, Web of Science and Scopus. Relevant websites will be searched for grey literature or case reports to capture the required information, as well as any documents provided by stakeholders. Primary studies, published in the English language from 2019 to the present day, which report on the monitoring or management of patients with long-term conditions and frailty within their home environment, will be included. Screening will be conducted by at least two independent reviewers against eligibility criteria, and a piloted data extraction form will be used to align with the research questions. Qualitative content analysis will be used. Data will be presented in tabular form, as well as descriptive and illustrative formats, to address the objectives of this review.

Ethics and dissemination
This scoping review does not require ethical approval. The findings of this review will be disseminated through peer-reviewed journals and conferences and will support the development of a conceptual model of a hospital-at-home DT for the management of patients with frailty.

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.

Objectives
Heated tobacco products (HTPs) are electronic devices that heat tobacco instead of burning it to produce an inhalable aerosol. This study aimed to investigate usage patterns, sociodemographic and socioeconomic factors, as well as co-use characteristics of people who use HTPs within the German population to inform interventions and preventive measures.

Methods
We conducted analysis with pooled cross-sectional data from the German Study on Tobacco Use (DEBRA) from June 2018 till November 2023. We estimated weighted, descriptive and bimonthly data on current and ever HTP usage and descriptive data on user patterns. To analyse the variance between people who ever versus people who never used HTPs in relation to user characteristics, we performed ² tests and calculated percentages and CIs.

Results
The proportions of both people who currently use and people who ever used HTPs have increased from 2018 (current user: 0.1% [95%CI: