Short-term and long-term outcomes of hybrid revascularisation procedures in peripheral artery disease: a systematic review protocol

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.

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Giugno 2025

Prediction Model to Optimize Long-Term Antithrombotic Therapy Using Covert Vascular Brain Injury and Clinical Features

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.

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Giugno 2025

Validation of urinary biomarkers for accurate diagnosis of urinary tract infections in older adults across primary care, hospitals and long-term care facilities in the Netherlands and UK (UTI-GOLD): a multicentre observational study protocol

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.

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Giugno 2025

Experiences of postnatal contraceptive care during the COVID-19 pandemic: a multimethods cross-sectional study

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.

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Giugno 2025

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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Giugno 2025

Epidemiological association of the COVID-19 pandemic on Mycoplasma pneumoniae infections in children in Tianjin, China: a single-centre retrospective study (2017-2024)

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

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Giugno 2025

[Articles] Long-term outcome in Wiskott-Aldrich syndrome and X-linked thrombocytopenia patients: an observational -prospective multi-center study of the Italian Primary Immune Deficiency Network (IPINET)

The evidence of the heterogeneity of WAS and XLT outcomes could be instrumental to draw updated recommendations for the management of the patients affected by these rare conditions. It would be desirable to expand the tools to estimate the risk of infectious and autoimmune events in patients with XLT and the impact of their treatment, including HSCT over time.

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Giugno 2025

Long-term impact of sevoflurane exposure on behavioural and neurocognitive outcomes in preschool children: protocol for a prospective cohort study

Background
The use of sevoflurane, a commonly used paediatric anaesthetic, raises concerns about potential long-term neurotoxic effects on behavioural and neurocognitive development, particularly during critical neurodevelopmental stages in preschool children. Endogenous hydrogen sulfide (H2S), a neuroprotective gasotransmitter, may be affected by anaesthetic exposure, but its role in sevoflurane-induced neurotoxicity remains unclear.

Methods/analysis
This prospective cohort study aims to evaluate behavioural and neurocognitive outcomes in 200 preschool children aged 4–6 years (1:1 allocation), with exposure to sevoflurane general anaesthesia (GA) as the primary predictor. A family-centred, professionally guided questionnaire-based assessment approach will be employed. Data accuracy and reliability will be ensured through the integration of real-time medical records and standardised instruments. Moreover, by investigating changes in serum H2S levels among children in the exposed group, this study offers a novel perspective on the potential neurotoxic mechanisms of GA and may inform the development of targeted neuroprotective interventions.

Ethics and dissemination
Ethical approval was obtained from Shengjing Hospital of China Medical University Ethics Examination Committee (2024PS1204K). We will present the results of the study at national and/or international conferences and in peer-reviewed journals. The study began in October 2024 and is expected to be completed in December 2025.

Trial registration number
ChiCTR2400090174.

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Giugno 2025

Experiences of stigma and access to care among long COVID patients: a qualitative study in a multi-ethnic population in the Netherlands

Objective
This study explored the experience of stigma and access to healthcare by persons with long COVID from the majority Dutch and two ethnic minority populations (Turkish and Moroccan) living in the Netherlands.

Design
This was a cross-sectional qualitative study that employed inductive and deductive thematic approaches to data analysis using MAXQDA.

Setting and participants
Between October 2022 and January 2023, 23 semi-structured interviews were conducted with participants of Dutch, Moroccan and Turkish ethnic origins with long COVID living in the Netherlands. Participants were men and women aged 30 years and above.

Results
Guided by the concepts of stigma and candidacy, the findings are structured according to the broader themes of stigma and access to care. The findings show that people with long COVID suffer self and public stigma resulting from the debilitating illness and symptoms. Especially among Turkish and Moroccan ethnic minority participants, strong filial obligations and gendered expectations of responsibility and support within their communities further worsen self-stigma. This experience of stigma persisted within healthcare where lack of information and appropriate care pathways led to feelings of frustration and abandonment, especially for participants with pre-existing health conditions which further complicate candidacy. Under the access to healthcare theme, the findings show multiple challenges in accessing healthcare for long COVID due to several multifaceted factors related to the various stages of candidacy which impacted access to care. Particularly for Turkish and Moroccan ethnic minority participants, additional challenges resulting from limited access to information, pre-existing structural challenges and experience of stereotyping based on ethnicity or assumed migrant identity by health professionals further complicate access to health information and long COVID care.

Conclusions
The findings call for urgent attention and research to identify and coordinate healthcare for long COVID. There is also a need for accessible, informative and tailored support systems to facilitate patients’ access to information and care pathways for long COVID. Providing tailored information and support, addressing the various barriers that hinder optimal operating conditions in healthcare and leveraging on social networks is crucial for addressing stigma and facilitating candidacy for persons with long COVID towards improving access to care.

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Giugno 2025