Influenza A viruses circulated in Europe from September 2023 to January 2024, with influenza A(H1N1)pdm09 predominance. We provide interim 2023/24 influenza vaccine effectiveness (IVE) estimates from two European studies, covering 10 countries across primary care (EU-PC) and hospital (EU-H) settings. Interim IVE was higher against A(H1N1)pdm09 than A(H3N2): EU-PC influenza A(H1N1)pdm09 IVE was 53% (95% CI: 41 to 63) and 30% (95% CI: -3 to 54) against influenza A(H3N2). For EU-H, these were 44% (95% CI: 30 to 55) and 14% (95% CI: -32 to 43), respectively.

• Klíčová slova
• Europe, influenza, multicentre study, test-negative design, vaccine effectiveness,
• MeSH
• chřipka lidská * epidemiologie   prevence a kontrola   MeSH
• lidé MeSH
• nemocnice MeSH
• primární zdravotní péče MeSH
• roční období MeSH
• studie případů a kontrol MeSH
• vakcinace MeSH
• vakcíny proti chřipce * MeSH
• virus chřipky A, podtyp H1N1 * MeSH
• virus chřipky A, podtyp H3N2 MeSH
• virus chřipky B MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• vakcíny proti chřipce * MeSH

Background: Adverse events are indicators of patient safety and quality of care. Adverse events clearly have negative impacts on healthcare system costs. Organizational and unit characteristics are not very often studied in relation to adverse events. The aim of the study was to find the differences in the incidence of adverse events and healthcare-associated infections in hospitalized patients in Czech acute care hospitals according to type of hospital and type of unit. Methods: This cross-sectional multicentre study was conducted in 105 acute care medical and surgical units located in 14 acute care hospitals throughout the Czech Republic. The data on adverse events and healthcare-associated infections were reported monthly by nurse researchers. The data were collected from June 2020 to October 2020. Results: The incidence of healthcare-associated infections, pressure ulcers, and medication errors was significantly lower in large hospitals. Statistically significant differences have been further found between the incidence of pressure ulcers (<0.001), falls without injury (<0.001), and falls with injury (<0.001) in surgical and medical units. More pressure ulcers, falls without injury, and falls with injury have been reported in surgical units. Conclusion: The type of hospital and type of unit affected the incidence of adverse events at acute care hospitals. To reduce adverse events, a systematic adverse event measurement and reporting system should be promoted.

• Klíčová slova
• adverse events, healthcare acquired infections, multicentre study, safety management,
• MeSH
• bezpečnost pacientů MeSH
• dekubity * epidemiologie   MeSH
• incidence MeSH
• lidé MeSH
• nemocnice MeSH
• průřezové studie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH

BACKGROUND: To compare different ultrasound-based international ovarian tumour analysis (IOTA) strategies and risk of malignancy index (RMI) for ovarian cancer diagnosis using a meta-analysis approach of centre-specific data from IOTA3. METHODS: This prospective multicentre diagnostic accuracy study included 2403 patients with 1423 benign and 980 malignant adnexal masses from 2009 until 2012. All patients underwent standardised transvaginal ultrasonography. Test performance of RMI, subjective assessment (SA) of ultrasound findings, two IOTA risk models (LR1 and LR2), and strategies involving combinations of IOTA simple rules (SRs), simple descriptors (SDs) and LR2 with and without SA was estimated using a meta-analysis approach. Reference standard was histology after surgery. RESULTS: The areas under the receiver operator characteristic curves of LR1, LR2, SA and RMI were 0.930 (0.917-0.942), 0.918 (0.905-0.930), 0.914 (0.886-0.936) and 0.875 (0.853-0.894). Diagnostic one-step and two-step strategies using LR1, LR2, SR and SD achieved summary estimates for sensitivity 90-96%, specificity 74-79% and diagnostic odds ratio (DOR) 32.8-50.5. Adding SA when IOTA methods yielded equivocal results improved performance (DOR 57.6-75.7). Risk of Malignancy Index had sensitivity 67%, specificity 91% and DOR 17.5. CONCLUSIONS: This study shows all IOTA strategies had excellent diagnostic performance in comparison with RMI. The IOTA strategy chosen may be determined by clinical preference.

• MeSH
• endometrióza diagnostické zobrazování   MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• nádory vaječníků diagnostické zobrazování   MeSH
• proporcionální rizikové modely MeSH
• prospektivní studie MeSH
• ROC křivka MeSH
• serózní cystadenom diagnostické zobrazování   MeSH
• ultrasonografie MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• metaanalýza MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH

INTRODUCTION: Supraglottic airway devices represent a less invasive method of airway management than tracheal intubation during general anaesthesia. Their continued development is focused mainly on improvements in the insertion success rate and minimalisation of perioperative and postoperative complications. The i-gel Plus is a novel, anatomically preshaped supraglottic airway device which achieves a perilaryngeal seal due to a non-inflatable cuff made of a soft thermoplastic elastomer. The purpose of this cohort study is to assess the success rate of the i-gel Plus use during elective procedures under general anaesthesia, its intraoperative performance, and the degree of postoperative complications. METHODS AND ANALYSIS: This is a multicentre, prospective, interventional cohort study. The enrolment will take place in seven centres in four European countries. We plan to enrol 2000 adult patients in total, who are scheduled for elective surgery under general anaesthesia, and with an indication for use of a supraglottic airway device for management of their airway. The study is projected to run over a period of 18 months. The primary outcome of the study is the total success rate of the i-gel Plus insertion in terms of successful ventilation and oxygenation through the device. Secondary outcomes include perioperative parameters, such as insertion time, seal/leak pressures, number of insertion attempts and postoperative adverse events and complications. Postoperative follow-up will be performed at 1 hour, 24 hours in all patients, and for selected patients at 3 and 6 months. ETHICS AND DISSEMINATION: The cohort study has received the following ethical approvals: General University Hospital Prague, University Hospital Olomouc, University Military Hospital Prague, University Hospital Barcelona, University Hospital Lodz, Antrim Area Hospital, Craigavon Area Hospital, Office for Research Ethics Committees Northern Ireland. The results will be published in peer-reviewed journals and presented at relevant anaesthesia conferences. TRIAL REGISTRATION NUMBER: ISRCTN86233693;Pre-results.

• Klíčová slova
• adult anaesthesia, adult surgery, anaesthesia in orthopaedics, anaesthesia in urology,
• MeSH
• celková anestezie * škodlivé účinky   MeSH
• dospělí MeSH
• intratracheální intubace metody   MeSH
• kohortové studie MeSH
• laryngální masky * škodlivé účinky   MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• prospektivní studie MeSH
• zajištění dýchacích cest metody   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

INTRODUCTION: Hepatic artery complications (HACs), such as a thrombosis or stenosis, are serious causes of morbidity and mortality after paediatric liver transplantation (LT). This study will investigate the incidence, current management practices and outcomes in paediatric patients with HAC after LT, including early and late complications. METHODS AND ANALYSIS: The HEPatic Artery stenosis and Thrombosis after liver transplantation In Children (HEPATIC) Registry is an international, retrospective, multicentre, observational study. Any paediatric patient diagnosed with HAC and treated for HAC (at age <18 years) after paediatric LT within a 20-year time period will be included. The primary outcomes are graft and patient survivals. The secondary outcomes are technical success of the intervention, primary and secondary patency after HAC intervention, intraprocedural and postprocedural complications, description of current management practices, and incidence of HAC. ETHICS AND DISSEMINATION: All participating sites will obtain local ethical approval and (waiver of) informed consent following the regulations on the conduct of observational clinical studies. The results will be disseminated through scientific presentations at conferences and through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: The HEPATIC registry is registered at the ClinicalTrials.gov website; Registry Identifier: NCT05818644.

• Klíčová slova
• hepatology, interventional radiology, paediatric transplant surgery,
• MeSH
• arteria hepatica * MeSH
• dítě MeSH
• incidence MeSH
• kojenec MeSH
• lidé MeSH
• mladiství MeSH
• multicentrické studie jako téma MeSH
• pooperační komplikace * epidemiologie   etiologie   MeSH
• předškolní dítě MeSH
• registrace * MeSH
• retrospektivní studie MeSH
• stenóza etiologie   MeSH
• transplantace jater * škodlivé účinky   MeSH
• trombóza * etiologie   epidemiologie   MeSH
• Check Tag
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• předškolní dítě MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH

BACKGROUND: ZD9331 is a novel, direct-acting and specific inhibitor of thymidylate synthase that has shown clinical activity and manageable tolerability in solid tumours. This phase II trial was designed to determine the antitumour activity and tolerability of ZD9331 given as a first-line therapy to patients with advanced gastric cancer. PATIENTS AND METHODS: Eligible patients who were chemonaïve with histologically or cytologically proven gastric cancer entered an open-label, multicentre, two-stage trial. Initially, patients were dosed at 130 mg/m2 (Regimen 1); however, following a protocol amendment, the starting dose was reduced to 65 mg/m2 (Regimen 2). Patients received ZD9331 as a 30-min i.v. infusion once weekly for 2 weeks followed by 1 week without treatment (3-week cycle). RESULTS: Twenty-nine patients with advanced, relapsed or inoperable gastric cancer were recruited from 11 centres across Europe. Five patients (17.2%), all from Regimen 2, showed a partial response and 16 patients (55.2%) had a best response of disease stabilisation. Most patients (72.4%) had a best response of disease control with median time to progression being 98 days. ZD9331 had manageable toxicity with the most frequently reported adverse events being neutropenia (62%) and diarrhoea (38%). CONCLUSIONS: ZD9331, as a first-line treatment for patients with advanced gastric cancer, demonstrated clinical activity and manageable toxicity.

• MeSH
• bolesti břicha chemicky indukované   MeSH
• chinazoliny aplikace a dávkování   škodlivé účinky   MeSH
• krevní nemoci chemicky indukované   MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• nádory žaludku farmakoterapie   MeSH
• neutropenie chemicky indukované   MeSH
• protinádorové látky aplikace a dávkování   škodlivé účinky   MeSH
• průjem chemicky indukované   MeSH
• thymidylátsynthasa antagonisté a inhibitory   MeSH
• tolerance léku * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• Názvy látek
• chinazoliny MeSH
• protinádorové látky MeSH
• thymidylátsynthasa MeSH
• ZD 9331 MeSH Prohlížeč

INTRODUCTION: The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) may be as high as 38% in the adult population with potential serious complications, multiple comorbidities and a high socioeconomic burden. However, there is a general lack of awareness and knowledge about MASLD and its progressive stages (metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis). Therefore, MASLD is still far underdiagnosed. The 'Global Research Initiative for Patient Screening on MASH' (GRIPonMASH) consortium focuses on this unmet public health need. GRIPonMASH will help (primary) healthcare providers to implement a patient care pathway, as recommended by multiple scientific societies, to identify patients at risk of severe MASLD and to raise awareness. Furthermore, GRIPonMASH will contribute to a better understanding of the pathophysiology of MASLD and improved identification of diagnostic and prognostic markers to detect individuals at risk. METHODS: This is a prospective multicentre observational study in which 10 000 high-risk patients (type 2 diabetes mellitus, obesity, metabolic syndrome or hypertension) will be screened in 10 European countries using at least two non-invasive tests (Fibrosis-4 index and FibroScan). Blood samples and liver biopsy material will be collected and biobanked, and multiomics analyses will be conducted. ETHICS AND DISSEMINATION: The study will be conducted in compliance with this protocol and applicable national and international regulatory requirements. The study initiation package is submitted at the local level. The study protocol has been approved by local medical ethical committees in all 10 participating countries. Results will be made public and published in scientific, peer-reviewed, international journals and at international conferences. REGISTRATION DETAILS: NCT05651724, registration date: 15 Dec 2022.

• Klíčová slova
• EPIDEMIOLOGY, Gastroenterology, Hepatology, INTERNAL MEDICINE, Mass Screening,
• MeSH
• diabetes mellitus 2. typu komplikace   MeSH
• jaterní cirhóza diagnóza   MeSH
• lidé MeSH
• metabolický syndrom komplikace   MeSH
• multicentrické studie jako téma MeSH
• nealkoholová steatóza jater * diagnóza   MeSH
• plošný screening * metody   MeSH
• prospektivní studie MeSH
• výzkumný projekt MeSH
• ztučnělá játra * diagnóza   epidemiologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• protokol klinické studie MeSH

Introduction: Within an International Atomic Energy Agency (IAEA) co-ordinated research project (CRP), a remote end-to-end dosimetric quality audit for intensity modulated radiation therapy (IMRT)/ volumetric arc therapy (VMAT) was developed to verify the radiotherapy chain including imaging, treatment planning and dose delivery. The methodology as well as the results obtained in a multicentre pilot study and national trial runs conducted in close cooperation with dosimetry audit networks (DANs) of IAEA Member States are presented.Material and methods: A solid polystyrene phantom containing a dosimetry insert with an irregular solid water planning target volume (PTV) and organ at risk (OAR) was designed for this audit. The insert can be preloaded with radiochromic film and four thermoluminescent dosimeters (TLDs). For the audit, radiotherapy centres were asked to scan the phantom, contour the structures, create an IMRT/VMAT treatment plan and irradiate the phantom. The dose prescription was to deliver 4 Gy to the PTV in two fractions and to limit the OAR dose to a maximum of 2.8 Gy. The TLD measured doses and film measured dose distributions were compared with the TPS calculations.Results: Sixteen hospitals from 13 countries and 64 hospitals from 6 countries participated in the multicenter pilot study and in the national runs, respectively. The TLD results for the PTV were all within ±5% acceptance limit for the multicentre pilot study, whereas for national runs, 17 participants failed to meet this criterion. All measured doses in the OAR were below the treatment planning constraint. The film analysis identified seven plans in national runs below the 90% passing rate gamma criteria.Conclusion: The results proved that the methodology of the IMRT/VMAT dosimetric end-to-end audit was feasible for its intended purpose, i.e., the phantom design and materials were suitable; the phantom was easy to use and it was robust enough for shipment. Most importantly the audit methodology was capable of identifying suboptimal IMRT/VMAT delivery.

• MeSH
• celková dávka radioterapie MeSH
• fantomy radiodiagnostické * MeSH
• jaderná energie MeSH
• kritické orgány * MeSH
• lidé MeSH
• mezinárodní agentury MeSH
• pilotní projekty MeSH
• plánování radioterapie pomocí počítače metody   MeSH
• počítačová rentgenová tomografie MeSH
• radiometrie metody   normy   MeSH
• radioterapie s modulovanou intenzitou metody   normy   MeSH
• revize kvality lékařské péče metody   normy   MeSH
• studie proveditelnosti MeSH
• zajištění kvality zdravotní péče MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH

Cavernous sinus meningiomas (CSMs) remain a surgical challenge due to the intimate involvement of their contained nerves and blood vessels. Stereotactic radiosurgery (SRS) is a safe and effective minimally invasive alternative for the treatment of small- to medium-sized CSMs. Objective: To assess the medium- to long-term outcomes of SRS for CSMs with respect to tumour growth, prevention of further neurological deterioration and improvement of existing neurological deficits. This multicentric study included data from 15 European institutions. We performed a retrospective observational analysis of 1222 consecutive patients harbouring 1272 benign CSMs. All were treated with Gamma Knife stereotactic radiosurgery (SRS). Clinical and imaging data were retrieved from each centre and entered into a common database. All tumours with imaging follow-up of less than 24 months were excluded. Detailed results from 945 meningiomas (86%) were then analysed. Clinical neurological outcomes were available for 1042 patients (85%). Median imaging follow-up was 67 months (mean 73.4, range 24-233). Median tumour volume was 6.2 cc (+/-7), and the median marginal dose was 14 Gy (+/-3). The post-treatment tumour volume decreased in 549 (58.1%), remained stable in 336 (35.6%) and increased in only 60 lesions (6.3%), yielding a local tumour control rate of 93.7%. Only 27 (2.8%) of the 60 enlarging tumours required further treatment. Five- and ten-year actuarial progression-free survival (PFS) rates were 96.7% and 90.1%, respectively. Tumour control rates were higher for women than men (p = 0.0031), and also for solitary sporadic meningiomas (p = 0.0201). There was no statistically significant difference in outcome for imaging-defined meningiomas when compared with histologically proven WHO Grade-I meningiomas (p = 0.1212). Median clinical follow up was 61 months (mean 64, range 6-233). Permanent morbidity occurred in 5.9% of cases at last follow-up. Stereotactic radiosurgery is a safe and effective method for treating benign CSM in the medium term to long term.

• Klíčová slova
• Gamma Knife, cavernous sinus, meningioma, multicentre study, stereotactic radiosurgery,
• Publikační typ
• časopisecké články MeSH

BACKGROUND: The arteriovenous access stage (AVAS) classification provides evaluation of upper extremity vessels for vascular access (VA) suitability. It divides patients into classes within three main groups: suitable for native fistula (AVAS1) or prosthetic graft (AVAS2), and patients not suitable for conventional native or prosthetic VA (AVAS3). We validated this system on a prospective dataset. METHODS: A prospective, international observational study (NCT04796558) involved 11 centres from 8 countries. Patient recruitment was from March 2021 to January 2024. Demographic data, risk factors, vessels parameters, VA types, AVAS class and early VA failure were collected. Percentage agreement was used to assess predictive ability of AVAS (comparison of AVAS and created VA) and consistency of AVAS assessment between evaluators. Pearson's Chi-squared test was used for comparison of early failure rate of conventional (predicted by AVAS) and unconventional (not predicted by AVAS) VA. RESULTS: From 1034 enrolled patients, 935 had arteriovenous fistula or graft, 99 patients did not undergo VA creation due opting for alternative renal replacement therapies, experiencing health complications, death or non-compliance. AVAS1 had 91.2%, AVAS2 7.2% and AVAS3 1.6% of patients. Agreement between evaluators was 89%. The most frequently created VAs were radial-cephalic (46%) and brachial-cephalic (27%) fistulae. The accuracy of AVAS versus created access was 79%. In comparison, VA predicted by clinicians versus created access was 62.1%. Inaccuracy of AVAS prediction was more common with higher AVAS classes, and the most common reason for inaccuracy was creation of distal VA despite less favourable anatomy (17%). Patients with unconventional VA had higher early failure rate than patients with conventional VA (20% vs 9.3%, respectively, P = .002). CONCLUSION: AVAS is effective in predicting VA creation, but overall accuracy is reduced at higher AVAS classes when the complexity of decision-making increases and proximal vessels require preservation. When AVAS was followed by clinicians, early failure was significantly decreased.

• Klíčová slova
• arteriovenous fistula, classification system, haemodialysis access, multicentre study, vascular mapping,
• Publikační typ
• časopisecké články MeSH