VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe

Background: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. Methods: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study characteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selection process. Results: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. Conclusions: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe.The VACCELERATE Site Network has received funding from the European Union’s Horizon 2020 research and innovation pro gramme (grant agreement No 101037867) and the German Federal Ministry of Education and Research (Bundesministerium für Bil dung und Forschung [BMBF]) (grant agreement No BMBF01KX2040).S

Reducing Duration of Antibiotic Use for Presumed Neonatal Early-Onset Sepsis in Greek NICUs. A “Low-Hanging Fruit” Approach

Antibiotics are commonly prescribed in Neonatal Intensive Care Units (NICU), where stewardship interventions are challenging. Lowering antibiotic consumption is desperately needed in Greece, a country with high antibiotic resistance rates. We sought to assess the effectiveness of a low-cost and -resource intervention to reduce antibiotic use in Greek NICUs implementing a “low-hanging fruit” approach. A prospective quasi-experimental study was conducted in 15/17 public NICUs in Greece (9/2016–06/2019). The intervention selected was discontinuation of antibiotics within 5 days for neonates with gestational age ≥ 37 weeks, no documented signs or symptoms of sepsis, CRP ≤ 10 mg/L and negative cultures within 3 days of antibiotic initiation. Impact was evaluated by the percentage of discontinued regimens by day 5, length of therapy (LOT) and stay. Trends of antibiotic consumption were assessed with days of therapy (DOT) per 1000 patient-days. Overall, there was a 9% increase (p = 0.003) of antibiotic discontinuation in ≤5 days. In total, 7/13 (53.8%) units showed a ≥10% increase. Overall, 615 days on antibiotics per 1000 patients were saved. Interrupted time-series analysis established a declining trend in DOT/1000 patient-days relative to the pre-intervention trend (p = 0.002); a monthly decrease rate of 28.96 DOT/1000 patient-days (p = 0.001, 95%CI [−45.33, −12.60]). The intervention had no impact on antibiotic choice. Antibiotic use was successfully reduced in Greek NICUs using a “low-hanging fruit” approach. In resource-limited settings, similar targeted stewardship interventions can be applied

Σχεδιασμός εφαρμογής και αξιολόγησης προγράμματος επιτήρησης χρήσης αντιβιοτικών σε παιδιατρικές μονάδες και μονάδες εντατικής νοσηλείας νεογνών

Η μείωση της κατανάλωσης αντιβιοτικών είναι απαραίτητη στην Ελλάδα, μια χώρα με υψηλά ποσοστά αντοχής στα αντιβιοτικά. Τα αντιβιοτικά είναι από τα συνήθως συνταγογραφούμενα φάρμακα σε Μονάδες Εντατικής Θεραπείας Νεογνών (ΜΕΝΝ) και σε παιδιατρικά τμήματα, όπου οι παρεμβάσεις αντιβιοτικής επιστασίας είναι δύσκολες. Η προσέγγισή μας στο πρόβλημα της χρήσης των αντιβιοτικών ήταν σε 3 άξονες. Ο πρώτος και κύριος στόχος ήταν η άμεση ελάττωση της χρήσης των αντιβιοτικών σε μονάδες εντατικής νοσηλείας νεογνών. Δευτερευόντως αναζητήθηκαν εύκολα υλοποιήσιμοι στόχοι περιορισμού της χρήσης είτε με την χρήση πρωτοποριακών εργαλείων είτε με γνωστούς από την βιβλιογραφία τομείς. Τέλος, διερευνήθηκε το ενδεχόμενο η αλόγιστη χρήση αντιμικροβιακών να είναι ένα πρόβλημα που έχει τις ρίζες του στην εκπαίδευση, ακόμα και στα χρόνια των προπτυχιακών ετών στην Ιατρική Σχολή. ΜΕΘΟΔΟΣ Ι. Σχεδιασμός, εφαρμογή και αξιολόγηση προγράμματος επιτήρησης χρήσης αντιβιοτικών σε μονάδες εντατικής νοσηλείας νεογνών (ΜΕΝΝ) Επιδιώξαμε να αξιολογήσουμε την αποτελεσματικότητα μιας χαμηλού κόστους και χαμηλών πόρων παρέμβασης για τη μείωση της χρήσης αντιβιοτικών στις ελληνικές ΜΕΝΝ εφαρμόζοντας την τεχνική “low-hanging fruit” ή σε ελεύθερη μετάφραση, «των καρπών που κρέμονται χαμηλά». Μια προοπτική quasi-experimental μελέτη διενεργήθηκε σε 15/17 δημόσιες ΜΕΝΝ της Ελλάδας (9/2016–06/2019). Νεογνά με τα ακόλουθα χαρακτηριστικά σχημάτισαν την ομάδα-στόχο για την παρέμβαση: ηλικία κύησης ≥37 εβδομάδες, καμία ένδειξη κλινικής σήψης, CRP ≤10 mg/ L κατά τις πρώτες 72 ώρες της ζωής και αρνητικές καλλιέργειες που ελήφθησαν εντός των πρώτων 3 ημερών από τη χορήγηση αντιβιοτικών. Για να αξιολογηθεί ο αντίκτυπος της παρέμβασης για κάθε μονάδα, υπολογίστηκετο ποσοστό των διακοπών των αντιβιοτικών αγωγών μέχρι την 5η ημέρα από την έναρξή τους, η διάρκεια της θεραπείας και η διάρκεια νοσηλείας Οι ημέρες θεραπείας (DOT) ανά 1000 ημέρες ασθενών χρησιμοποιήθηκαν για την αξιολόγηση των τάσεων της κατανάλωσης αντιβιοτικών ΙΙ. Αναζητώντας πιθανούς εύκολα υλοποιήσιμους μελλοντικούς στόχους α. Ελάττωση της χρήσης των αντιβιοτικών με την χρήση ηλεκτρονικών εργαλείων – Χρησιμοποιώντας τον υπολογιστή κινδύνου νεογνικής σήψης Kaiser Permanente Επιδιώξαμε να κάνουμε την εκτίμηση του πιθανού οφέλους από την εφαρμογή του υπολογιστή κινδύνου νεογνικής σήψης Kaiser-Permanente ως προς την χρήση των αντιβιοτικών και των εξετάσεων που ζητούνται σε ένα δίκτυο MENN στην Ελλάδα και δευτερεύον σκοπός ήταν η εκτίμηση της επίπτωσης της πρώιμης νεογνικής σήψης σε ελληνικές ΜΕΝΝ. Μια προοπτική μελέτη επιτήρησης σε 7 ΜΕΝΝ διενεργήθηκε μεταξύ Απριλίου 2018 και Ιουνίου 2019. Καταγράφηκαν στοιχεία για νεογνά με ηλικία κύησης ≥ 34 εβδομάδων που έλαβαν εμπειρική αγωγή εντός των 3 πρώτων ημερών ζωής. Ο αριθμός των γεννήσεων ζώντων και οι θετικές καλλιέργειες αίματος και ΕΝΥ τις 3 πρώτες ημέρες ζωής χρησιμοποιήθηκαν για τον υπολογισμό της επίπτωσης της πρώιμης νεογνικής σήψης. Η αξιολόγηση των πιθανών επιπτώσεων της εφαρμογής του υπολογιστή πραγματοποιήθηκε με τη σύγκριση της καταγεγραμμένης διαχείρισης των κλινικών ιατρών και της προτεινόμενης διαχείρισης από τον υπολογιστή. β. περιεγχειρητική προφύλαξη σε παιδιατρικό νοσοκομείο Προβήκαμε στην καταγραφή της περιεγχειρητικής πρακτικής σε τμήμα ΩΡΛ. Συγκεκριμένα, καταγράφηκαν όλες οι επεμβάσεις που πραγματοποιήθηκαν στο τμήμα ΩΡΛ τριτοβάθμιου Παιδιατρικού Νοσοκομείου μεταξύ 01/08/2018-31/10/2018. Τα δεδομένα που καταγράφηκαν περιλάμβαναν δημογραφικά στοιχεία ασθενών, τον τύπο της χειρουργικής επέμβασης και την κατηγορία τραυμάτων, αντιβιοτικούς παράγοντες που χορηγήθηκαν μαζί με το χρόνο, τη δόση και τη διάρκεια, καθώς και λόγους συνέχισης μετά την επέμβαση. ΙΙΙ. Η σημασία της εκπαίδευσης των φοιτητών ιατρικής. Πραγματοποιήθηκε μια εθελοντική, ανώνυμη, cross-sectional, μελέτη σε φοιτητές ιατρικής τελευταίου έτους με 40 ερωτήσεις σχετικά με τις αντιλήψεις, τις γνώσεις και την εκπαίδευση σχετικά με την αντιμικροβιακή συνταγογράφηση και αντίσταση. Η μελέτη αυτή έγινε μεταξύ 26/11/2018 και 7/12/2018. ΑΠΟΤΕΛΕΣΜΑΤΑ Σχεδιασμός, εφαρμογή και αξιολόγηση προγράμματος επιτήρησης χρήσης αντιβιοτικών σε μονάδες εντατικής νοσηλείας νεογνών Συνολικά υπήρξε μια αύξηση 9% (p = 0.003) της διακοπής των αντιβιοτικών αγωγών σε ≤5 ημέρες. Συνολικά, 7/13 (53.8%) τμήμτα είχαν μια αύξηση της διακοπής ≥10%. Σε όλο το δίκτυο διασώθηκαν 615 ημέρες αντιβιοτικών ανά 1000 ασθενείς. Η ανάλυση διακοπτόμενων χρονοσειρών (interrupted time series analysis) ανέδειξε στατιστικώς σημαντική μείωση μετά την παρέμβαση στα DOT/1000 ασθενοημέρες συγκρινόμενα με την περίοδο πριν την παρέμβαση (p = 0.002), που αντιστοιχεί σε μια μηνιαία ελάττωση 28.96 DOT/1000 ασθενοημέρες (p = 0.001,95%CI [−45.33, −12.60]). Να σημειωθεί ότι η παρέμβαση δεν είχε καμία επίπτωση στην επιλογή αντιβιοτικών στα τμήματα. Χρήση του υπολογιστή κινδύνου νεογνικής σήψης Kaiser Permanente Η ανά τμήμα υπολογιζόμενη επίπτωση EOS κυμαινόταν μεταξύ 0 και 2.99 /1000 ζώσες γεννήσεις. Η σταθμισμένη επίπτωση και για τις 7 ήταν 1.8/1000 ζώσες γεννήσεις. Η διαχείριση των περιστατικών με πιθανή EOS με την χρήση του θα μπορούσε να οδηγήσει σε μείωση των ενάρξεων εμπειρικών αντιβιοτικών μέχρι και στο 100% για νεογνά με «καλή εμφάνιση» και στο 86% αυτών με «Ασαφή εμφάνιση», μειώνοντας την έκθεση σε αντιβιοτικά κατά 4,2 και 3,8 ημέρες/νεογνό αντίστοιχα. Οι εργαστηριακές εξετάσεις όσον αφορά τις καλλιέργειες αίματος που θα ληφθούν θα μπορούσαν να μειωθούν έως και 100% και 68% αντίστοιχα. Η ευαισθησία του υπολογιστή στον εντοπισμό νεογνών με θετικές καλλιέργειες αίματος ήταν υψηλή. Περιεγχειρητική προφύλαξη σε παιδιατρικό νοσοκομείο Από τους 108 ασθενείς που υποβλήθηκαν σε αμυγδαλεκτομή, αδενοειδεκτομή και μυριγγοτομή σε οποιονδήποτε συνδυασμό, 57 (52,7%) δεν έλαβε αντιβιοτικά. 47 (43.5%) οι ασθενείς έλαβαν «αντιβιοτική προφύλαξη» μετά το τέλος της επέμβασης. Σε 34 (72,3%) από αυτά, τα αντιβιοτικά ξεκίνησαν την επομένη της επέμβασης. Σε κάθε περίπτωση , η διάρκεια του σχήματος ήταν 7 ημέρες. Σε 40/47 περιπτώσεις ξεκίνησαν αντιβιοτικά μετά την απόρριψη. ασθενής έλαβε θεραπεία λόγω της ανάπτυξης πυρετού και 3 (2,8%) λόγω προϋπάρχουσας λοίμωξης Η σημασία της εκπαίδευσης των φοιτητών ιατρικής. Το 71.5% των συμμετεχόντων δήλωσε ότι δεν είχαν ακούσει ποτέ τον όρο «Antimicrobial Stewardship/Επιστασία Αντιβιοτικών». Το 55% απάντησε σωστά στο μισό ή λιγότερο των 14 ερωτήσεων που αφορούσαν στην συνταγογράφηση των αντιβιοτικών ενώ η πλειοψηφία δεν κατάφερε να αναγνωρίσει ότι τα φάσματα των αντιβιοτικών που τους ζητήθηκαν. Κατά τη διάρκεια της φοίτησής τους είχαν ερωτηθεί λιγότερο από 5 φορές ή και καθόλου να διαλέξουν: κατά πόσο ένα αντιβιοτικό ήταν απαραίτητο (57.3%), ποιο ήταν το κατάλληλο αντιβιοτικό ( 48.5%) την οδό, τη δοσολογία και το σχήμα δόσεων (71.2%), την διάρκεια της θεραπείας (62.3%), ή το αντιβιοτικό με βάση τα αποτελέσματα της καλλιέργειας (67.4%). Σε ότι αφορά την αυτοπεποίθηση που δήλωσαν οι ίδιοι σχετικά με την συνταγογράφηση αντιβιοτικών (με κλίμακα από το 1 [καμία] έως το 10 [απολύτως], είχαν έναν μέσο όρο 6.28/10. ΣΥΜΠΕΡΑΣΜΑΤΑ Η χρήση αντιβιοτικών μειώθηκε με επιτυχία στις ελληνικές ΜΕΝΝ χρησιμοποιώντας μια προσέγγιση «low-hanging fruit». Σε περιπτώσεις που υπάρχουν περιορισμένοι πόροι, μπορούν να εφαρμοστούν παρόμοιες στοχευμένες παρεμβάσεις αντιβιοτικής επιστασίας. Η έγκριση στρατηγικών αντιβιοτικής επιστασίας σε νεογνά με βάση τον υπολογιστή κινδύνου νεογνικής σήψης Kaiser-Permanente μπορεί να μειώσει την έκθεση στα αντιβιοτικά, τις εργαστηριακές εξετάσεις και τις νοσηλείες σε νεογνά με ηλικία κύησης από 34 εβδομάδων και άνω. Υπάρχουν κι άλλοι γνωστοί από την βιβλιογραφία στόχοι που μπορούν να αποδώσουν σε ένα πρόγραμμα αντιβιοτικής επιστασίας. Για παράδειγμα, εντοπίσαμε την εσφαλμένη χρήση αντιβιοτικών σχετικά με την περιεγχειρητική προφύλαξη τόσο στην ένδειξη (τύπος χειρουργείου) όσο και στον χρόνο έναρξης σε σχέση με την τομή και την διάρκεια του σχήματος που χορηγήθηκε. Εντούτοις το πρόβλημα φαίνεται να έχει τις ρίζες του ήδη στην σχολή, καθώς αναγνωρίστηκαν σημαντικά κενά όσον αφορά την γνώση σχετικά με την συνταγογράφηση αντιβιοτικών, την ανθεκτικότητα των μικροβίων στα αντιβιοτικά και μη επαρκή πρακτική εξάσκηση ανάμεσα στους Έλληνες φοιτητές ιατρικής, η οποία επηρεάζει την αυτοπεποίθησή τους σε αυτόν τον τομέα. Εντούτοις, αποδείξαμε ότι υπάρχουν αρκετοί εύκολα υλοποιήσιμοι στόχοι που μπορούν να οδηγήσουν στον αποτελεσματικό περιορισμό της χρήσης των αντιβιοτικών ακόμα και σε περιβάλλοντα με λίγους πόρους όπως η χώρα μας.Reducing the consumption of antibiotics is necessary in Greece, a country with high rates of antibiotic resistance. Antibiotics are among the most commonly prescribed drugs in Neonatal Intensive Care Units (NICUs)and in pediatric departments, where antibiotic stewardship interventions are difficult. Our approach to the problem of the use of antibiotics was in 3 axes. The first and main objective was the immediate reduction of the use of antibiotics in neonatal intensive care units. Secondarily, easily achievable objectives of limiting use were easily sought either through the use of innovative tools or with already known usual targets from the literature. Finally, we investigated the possibility that the injudicious use of antimicrobials was a problem that has its roots in education, even as early as in the undergraduate years in the Medical School. METHODS Ι. Design, implementation, and evaluation of an antibiotic stewardship surveillance program in neonatal intensive care units (NICUs) We sought to assess the effectiveness of a low-cost and -resource intervention to reduce antibiotic use in Greek NICUs implementing a “low-hanging fruit” approach. A prospective quasi-experimental study was conducted in 15/17 public NICUs in Greece (9/2016–06/2019). The intervention selected was discontinuation of antibiotics within 5 days for neonates with gestational age ≥ 37 weeks, no documented signs or symptoms of sepsis, CRP ≤ 10 mg/L and negative cultures within 3 days of antibiotic initiation. Impact was evaluated by the percentage of discontinued regimens by day 5, length of therapy (LOT) and stay. Trends of antibiotic consumption were assessed with days of therapy (DOT) per 1000 patient-days. ΙΙ. Looking for potential future targets a. Reducing the use of antibiotics with the aid of electronic tools – Using the Kaiser-Permanente neonatal sepsis risk calculator We sought to assess the potential benefit from the implementation of the Kaiser Permanente early onset sepsis calculator (EOS-C) in terms of antibiotic use and requested laboratory tests, in a network of NICUs in Greece and secondarily to determine the incidence of early onset sepsis (EOS) in Greek NICUs. A prospective surveillance study was conducted in 7 NICUs between April 2018 and June 2019. Data were collected for all newborns ≥ 34 week’s gestation receiving empiric antibiotic therapy within the first 3 days of life. Number of live births and positive blood or cerebrospinal fluid cultures within the first 3 days of life were used for calculation of EOS incidence. Evaluation of possible impact of implementing the calculator was done by comparing the clinicians’ recorded management to the calculator’s suggested course of action. b. perioperative prophylaxis in a pediatric hospital We recorded the perioperative practice in an ENT department. Specifically, all the operations performed at the ENT Department of a Tertiary Pediatric Hospital between 01/08/2018-31/10/2018 were recorded. The data recorded included patient demographic data, the type of surgery and the category of injuries, antibiotic agents administered along with time, dose and duration, as well as reasons for continuation after surgery. III. The importance of medical students’ education. A voluntary, anonymous, cross-sectional study was carried out among last year medical students which included 40 questions on perceptions, knowledge and their education regarding antimicrobial prescribing and resistance. This study took place between 26/11/2018 and 7/12/2018. RESULTS Design, implementation, and evaluation of an antibiotic stewardship surveillance program in neonatal intensive care units (NICUs) Overall, there was a 9% increase (p = 0.003) of antibiotic discontinuation in ≤5 days. In total, 7/13 (53.8%) units showed a ≥10% increase. Overall, 615 days on antibiotics per 1000 patients were saved. Interrupted time-series analysis established a declining trend in DOT/1000 patient-days relative to the pre-intervention trend (p = 0.002); a monthly decrease rate of 28.96 DOT/1000 patient-days (p = 0.001,95%CI [−45.33, −12.60]). The intervention had no impact on antibiotic choice. Use of the Kaiser Permanente neonatal sepsis risk calculator The unit-specific incidence of culture proven EOS ranged between 0-2.99 /1000 live births. The weighted incidence rate for all 7 units was 1.8/1000 live births. Management of EOS guided by the calculator could lead to a reduction of empiric antibiotic initiation up to 100% for the group of “well-appearing” neonates and 86% for “equivocal”, lowering exposure to antibiotics by 4.2 and 3.8 days/neonate respectively. Laboratory tests in terms of blood cultures drawn could be reduced up to 100% and 68% respectively. Sensitivity of the EOS-C in identifying neonates with positive blood cultures was high. Perioperative prophylaxis in a pediatric hospital Of the 108 patients who underwent tonsillectomy, adenoidectomy and myringotomy in any combination, 57 (52.7%) did not take antibiotics. 47 (43.5%) patients received "antibiotic prophylaxis" after the end of the operation. In 34 (72.3%) of them, antibiotics began the day after the operation. In any case, the duration of the regimen was 7days. In 40/47 cases, antibiotics were started after discharge. patient received treatment due to the development of fever and 3 (2.8%) due to pre-existing infection The importance of educating medical students. 71.5% of the participants said they had never heard of the term "Antimicrobial Stewardship." 55% answered correctly in half or less of the 14 questions concerning the prescription of antibiotics while the majority failed to recognize that the spectrum of antibiotics were requested. During their studies they were asked less than 5 times or not at all to choose: whether an antibiotic was necessary (57.3%), what was the appropriate antibiotic (48.5%) the route, dosage and dose regimen (71.2%), the duration of treatment (62.3%), or to select the appropriate antibiotic based on the results of the culture (67.4%). In terms of the self-confidence prescribing antibiotics (on a scale of 1 [none] to 10 [absolutely], they had an average of 6.28/10. CONCLUSIONS The use of antibiotics was successfully reduced in the Greek NICUs using a «low-hanging fruit» approach. In cases where there are limited resources, similar targeted antibiotic stewardship interventions can be applied. Endorsement of antibiotic stewardship strategies in newborns based on the Kaiser-Permanente neonatal sepsis risk calculator may reduce exposure to antibiotics, laboratory tests and hospitalizations in newborns with a gestational age of 34 weeks and above. There are other well-known targets from the literature that can be used in an antibiotic stewardship program in pediatrics. For example, we identified the incorrect use of antibiotics related to perioperative prophylaxis both in the indication (type of surgery) and in the time of antibiotic initiation in relation to the incision, and also the duration of the regimen administered. However, the problem seems to have its roots already in the medical school, as there were significant gaps in the knowledge of last year medical students on antibiotic prescribing and resistance while they also declared insufficient practical training which affected their self-confidence in this field. Still, we showed that there are a lot of easily attainable targets even in a resource limited country as our own

Evaluation of retinal nerve fibre layer thickness and visual evoked potentials in optic neuritis associated with multiple sclerosis

Background: The aim was to compare the retinal nerve fibre layer (RNFL) thickness and visual evoked potentials (VEP) among eyes with multiple sclerosis (MS)-associated optic neuritis, unaffected eyes of the same patients and eyes of disease-free controls. Changes in RNFL thickness, visual acuity (VA) and VEP over time are evaluated in MS-associated optic neuritis. Methods: Forty-six eyes of 23 patients (six male and 17 female), who suffer from MS and were diagnosed with unilateral or bilateral optic neuritis, participated in the study. Forty eyes of 20 age- and gender-matched controls were tested. VA measurement, optical coherence tomography and VEP were performed in all patients at presentation and at one, three and six months thereafter. Results: There was a statistically significant difference in VA between MS eyes with optic neuritis and controls (p < 0.0001), as well as between MS eyes with and without optic neuritis (p < 0.005). VA improved over time. Average RNFL thickness was reduced in MS eyes with or without optic neuritis in comparison to control eyes. This reduction in RNFL thickness was more marked over time. The amplitude of P 100 was significantly decreased in MS eyes with optic neuritis in comparison to controls (p < 0.0001) and there was a statistically significant delay in peak time of P 100 in MS eyes with optic neuritis versus the eyes of normal subjects (p < 0.0001), which improved over time. Conclusion: The present study suggests that there is a progressive decrease in RNFL over time in eyes with optic neuritis associated with MS. The amplitude and latency of P 100 in VEP examination returned to normal ranges over time. © 2012 The Authors. Clinical and Experimental Optometry © 2012 Optometrists Association Australia

Greek population's perceptions of non-pharmacological interventions towards the first wave of COVID-19 pandemic mitigation: A regression-based association analysis

INTRODUCTION In the ongoing coronavirus disease 2019 (COVID-19) pandemic, even though vaccines have been rolled out and the vaccination campaigns in some countries have already been followed by a decline in number and severity of cases, non-pharmaceutical interventions (NPI) are still playing an important role on COVID-19 management (e.g. social distancing) that are imposed by the authorities and require the public’s adherence and behavioral adjustment. This study aims to identify factors that affect the general public’s attitudes towards the importance of NPI in Greece. METHODS This prevalence study, enrolled 657 adults from the general Greek population in order to assess their beliefs and identify possible factors that influence their perceptions of NPI. All associations were assessed through multivariate logistic regression. RESULTS Overall, Greeks considered NPI important for health protection. The participants who were less likely to consider NPI important were men compared to women (OR=1.64; 95% CI: 1.15-2.36, p=0.007), people aged <40 years compared to those >= 40 years (OR=0.48; 95% CI: 0.34-0.68, p<0.001), and people who did not choose the Hellenic National Public Health Organization (NPHO) to get informed about COVID-19 compared to other sources (OR=0.65; 95% CI: 0.46-0.92, p=0.014). CONCLUSIONS This study profiled Greek people who do and do not consider NPI important, primarily on their demographic characteristics. Focused communicational strategies in certain population subgroups are recommended

Global Distribution, Dispersal Patterns, and Trend of Several Omicron Subvariants of SARS-CoV-2 across the Globe

Our study aims to describe the global distribution and dispersal patterns of the SARS-CoV-2 Omicron subvariants. Genomic surveillance data were extracted from the CoV-Spectrum platform, searching for BA.1*, BA.2*, BA.3*, BA.4*, and BA.5* variants by geographic region. BA.1* increased in November 2021 in South Africa, with a similar increase across all continents in early December 2021. BA.1* did not reach 100% dominance in all continents. The spread of BA.2*, first described in South Africa, differed greatly by geographic region, in contrast to BA.1*, which followed a similar global expansion, firstly occurring in Asia and subsequently in Africa, Europe, Oceania, and North and South America. BA.4* and BA.5* followed a different pattern, where BA.4* reached high proportions (maximum 60%) only in Africa. BA.5* is currently, by Mid-August 2022, the dominant strain, reaching almost 100% across Europe, which is the first continent aside from Africa to show increasing proportions, and Asia, the Americas, and Oceania are following. The emergence of new variants depends mostly on their selective advantage, translated as enhanced transmissibility and ability to invade people with existing immunity. Describing these patterns is useful for a better understanding of the epidemiology of the VOCs’ transmission and for generating hypotheses about the future of emerging variants

Hand Hygiene Compliance Rates in 9 Pediatric Intensive Care Units Across Europe: Results from the Reducing Antimicrobial use and Nosocomial Infections in Kids Network.

A unified surveillance mechanism for hand hygiene and hospital-acquired infections for pediatric wards is lacking in Europe. We managed to setup such a mechanism in 9 pediatric intensive care units in 7 European countries, using World Health Organization's definitions and common methodology which allows for benchmarking among units and countries. Median hand hygiene compliance was found high 82.3% (interquartile range 71.6-94.5%), but gaps in practices were identified

Potential benefit from the implementation of the Kaiser Permanente neonatal early-onset sepsis calculator on clinical management of neonates with presumed sepsis

To assess the potential benefit from the implementation of the Kaiser Permanente early-onset sepsis calculator (EOS-C), in terms of antibiotic use and requested laboratory tests, in a network of neonatal intensive care units (NICUs) in Greece, and to determine the incidence of early-onset sepsis (EOS) in Greek NICUs, a prospective surveillance study was conducted in 7 NICUs between April 2018 and June 2019. Data were collected for all newborns >= 34 weeks’ gestation receiving empiric antibiotic therapy within the first 3 days of life. The number of live births and positive blood or cerebrospinal fluid cultures within the first 3 days of life were used for calculation of EOS incidence. Evaluation of possible impact of implementing the calculator was done by comparing the clinicians’ recorded management to the calculator’s suggested course of action. The unit-specific incidence of culture-proven EOS ranged between 0 and 2.99/1000 live births. The weighted incidence rate for all 7 units was 1.8/1000 live births. Management of EOS guided by the calculator could lead to a reduction of empiric antibiotic initiation up to 100% for the group of “well-appearing” neonates and 86% for “equivocal,” lowering exposure to antibiotics by 4.2 and 3.8 days per neonate, respectively. Laboratory tests for blood cultures drawn could be reduced by up to 100% and 68%, respectively. Sensitivity of the EOS-C in identifying neonates with positive blood cultures was high. Conclusion: Management strategies based on the Kaiser Permanente neonatal sepsis calculator may significantly reduce antibiotic exposure, invasive diagnostic procedures, and hospitalizations in late preterm and term neonates. What is Known: center dot Neonates are frequently exposed to antibiotics for presumed EOS. center dot The Kaiser Permanente sepsis calculator can reduce antibiotic exposure in neonates.. What is New: center dot EOS calculator can be an effective antibiotic stewardship tool in a high prescribing country and can reduce invasive diagnostic procedures and mother-baby separation. center dot Incidence of EOS in Greece is higher compared to other European countries

Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study

Background: The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry network provides access to vaccine trial sites across the European region and supports a sustainable volunteer platform for identifying potential participants for forthcoming vaccine clinical research. Objective: The aim of this study was to approach members of patient advocacy groups (PAGs) across Europe to assess their willingness to register for the VACCELERATE Volunteer Registry and their perspectives related to participating in vaccine trials. Methods: In an effort to understand how to increase recruitment for the VACCELERATE Volunteer Registry, a standardized survey was developed in English and translated into 8 different languages (Dutch, English, French, German, Greek, Italian, Spanish, and Swedish) by the respective National Coordinator team. The online, anonymous survey was circulated, from March 2022 to May 2022, to PAGs across 10 European countries (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) to share with their members. The questionnaire constituted of multiple choice and open-ended questions evaluating information regarding participants' perceptions on participating in vaccine trials and their willingness to become involved in the VACCELERATE Volunteer Registry. Results: In total, 520 responses were collected and analyzed. The PAG members reported that the principal criteria influencing their decision to participate in clinical trials overall are (1) the risks involved, (2) the benefits that will be gained from their potential participation, and (3) the quality and quantity of information provided regarding the trial. The survey revealed that, out of the 520 respondents, 133 individuals across all age groups were "positive" toward registering in the VACCELERATE Volunteer Registry, with an additional 47 individuals reporting being "very positive." Respondents from Northern European countries were 1.725 (95% CI 1.206-2.468) times more likely to be willing to participate in the VACCELERATE Volunteer Registry than respondents from Southern European countries. Conclusions: Factors discouraging participants from joining vaccine trial registries or clinical trials primarily include concerns of the safety of novel vaccines and a lack of trust in those involved in vaccine development. These outcomes aid in identifying issues and setbacks in present registries, providing the VACCELERATE network with feedback on how to potentially increase participation and enrollment in trials across Europe. Development of European health communication strategies among diverse public communities, especially via PAGs, is the key for increasing patients' willingness to participate in clinical studies