The Challenges of Vaccine Trial Participation among Underserved and Hard-to-Reach Communities: An Internal Expert Consultation of the VACCELERATE Consortium.

Underserved and hard-to-reach population groups are under-represented in vaccine trials. Thus, we aimed to identify the challenges of vaccine trial participation of these groups in member countries of the VACCELERATE network. Seventeen National Coordinators (NC), each representing their respective country (15 European countries, Israel, and Turkey), completed an online survey. From 15 eligible groups, those that were more frequently declared underserved/hard-to-reach in vaccine research were ethnic minorities (76.5%), persons experiencing homelessness (70.6%), illegal workers and refugees (64.7%, each). When prioritization for education on vaccine trials was considered, ethnic groups, migrants, and immigrants (5/17, 29.4%) were the groups most frequently identified by the NC as top targets. The most prominent barriers in vaccine trial participation affecting all groups were low levels of health literacy, reluctance to participate in trials due to engagement level, and low levels of trust in vaccines/vaccinations. This study highlighted population groups considered underserved/hard-to-reach in countries contained within the European region, and the respective barriers these groups face when participating in clinical studies. Our findings aid with the design of tailored interventions (within-and across-countries of the European region) and with the development of strategies to overcome major barriers in phase 2 and phase 3 vaccine trial participation.

Dispensing of antibiotics without prescription in the metropolitan area of Athens, Greece, in 2021-Can new legislation change old habits?

Objective: To assess the effect of new legislation on the dispensing of antimicrobials without prescription from pharmacies in Greece. Design: In-person survey. Setting: The study included 110 pharmacies in the greater Athens Metropolitan area. Methods: Volunteer collaborators visited 110 pharmacies in the greater Athens Metropolitan area in December 2021 and January 2022. They asked for either ciprofloxacin or amoxicillin-clavulanate acid (6:5 ratio) without providing a prescription, without simulating symptoms, and without offering justification or insisting. Fluoroquinolones have additional dispensing restrictions in Greece. Results were compared to a 2008 study. In 2020, legislation allowed the dispensing of antibiotics from pharmacies only with an electronic prescription, overriding the 1973 forbidding the dispensing of all medications without prescriptions. Results: All pharmacists refused to dispense ciprofloxacin without a prescription. Only 1 pharmacy dispensed amoxicillin-clavulanate without a prescription. Compared to the 2008 study, dispensing of amoxicillin-clavulanate without a prescription dropped from 100% in 2008 to 1% in 2021 and dispensing ciprofloxacin without a prescription dropped from 53% in 2008 to 0% in 2021. Conclusions: A new and enforced law that requires electronic prescribing led to a dramatic reduction of antibiotic dispensing without prescription compared to 12 years ago. Similar initiatives could help solve the problem of antibiotic consumption and resistance in Greece and elsewhere.

A national study of antibiotic use in Greek pediatric hematology oncology and bone marrow transplant units.

Objective: We surveyed antimicrobials used in Greek pediatric hematology-oncology (PHO) and bone marrow transplant (BMT) units before and after an intervention involving education regarding the 2017 clinical practice guidelines (CPG) for the management of febrile neutropenia in children with cancer and hematopoietic stem-cell transplant recipients. Design: Antibiotic prescribing practices were prospectively recorded between June 2016 and November 2017. Intervention: In December 2017, baseline data feedback was provided, and CPG education was provided. Prescribing practices were followed for one more year. For antibiotic stewardship, days of therapy, and length of therapy were calculated. Setting: Five of the 6 PHO units in Greece and the single pediatric BMT unit participated. Participants: Admitted children in each unit who received the first 15 new antibiotic courses each month. Results: Administration of ≥4 antibiotics simultaneously and administration of antibiotics with overlapping activity for ≥2 days were significantly more common in PHO units in general hospitals compared to children's hospitals. Use of at least 1 antifungal was recorded in ∼47% of the patients before and after the intervention. De-escalation and/or discontinuation of antibiotics on day 6 of initial treatment increased significantly from 43% to 53.5% (P = .032). Although the number of patients requiring intensive care support for sepsis did not change, a significant drop was noted in all-cause mortality (P = .008). Conclusions: We recorded the antibiotic prescribing practices in Greek PHO and BMT units, we achieved improved prescribing with a simple intervention, and we identified areas in need of improvement.

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: • Neonates are frequently exposed to antibiotics for presumed EOS. • The Kaiser Permanente sepsis calculator can reduce antibiotic exposure in neonates.. What is New: • EOS calculator can be an effective antibiotic stewardship tool in a high prescribing country and can reduce invasive diagnostic procedures and mother-baby separation. • Incidence of EOS in Greece is higher compared to other European countries.

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.

Perioperative antimicrobial prophylaxis in adult patients: The first multicenter clinical practice audit with intervention in Greek surgical departments.

OBJECTIVE: To audit clinical practice and implement an intervention to promote appropriate use of perioperative antimicrobial prophylaxis (PAP). DESIGN: Prospective multicenter before-and-after study. SETTING: This study was conducted in 7 surgical departments of 3 major Greek hospitals. METHODS: Active PAP surveillance in adults undergoing elective surgical procedures was performed before and after implementation of a multimodal intervention. The surveillance monitored use of appropriate antimicrobial agent according to international and local guidelines, appropriate timing and duration of PAP, overall compliance with all 3 parameters and the occurrence of surgical site infections (SSIs). The intervention included education, audit, and feedback. RESULTS: Overall, 1,447 patients were included: 768 before and 679 after intervention. Overall compliance increased from 28.2% to 43.9% (P = .001). Use of antimicrobial agents compliant to international guidelines increased from 89.6% to 96.3% (P = .001). In 4 of 7 departments, compliance with appropriate timing was already >90%; an increase from 44.3% to 73% (P = .001) and from 20.4% to 60% (P = .001), respectively, was achieved in 2 other departments, whereas a decrease from 64.1% to 10.9% (P = .001) was observed in 1 department. All but one department achieved a shorter PAP duration, and most achieved duration of ~2 days. SSIs significantly decreased from 6.9% to 4% (P = .026). After the intervention, it was 2.3 times more likely for appropriate antimicrobial use, 14.7 times more likely to administer an antimicrobial for the appropriate duration and 5.3 times more likely to administer an overall appropriate PAP. CONCLUSION: An intervention based on education, audit, and feedback can significantly contribute to improvement of appropriate PAP administration; further improvement in duration is needed.

Increasing healthcare workers' uptake of seasonal influenza vaccination in a tertiary-care pediatric hospital in Greece with a low-cost, tailor-made, multifaceted strategy.

BACKGROUND: Healthcare workers' (HCW) seasonal influenza vaccination (SIV) is critical to prevent nosocomial influenza. However, HCW vaccination rates remain unacceptably low in many European institutions. A two-year three-step initiative was implemented at a tertiary-care pediatric hospital with 750 beds in Athens, Greece with the aim of increasing SIV among HCW. METHODS: Α cross-sectional anonymous survey of HCWs was conducted during the 2015-16 influenza season with the aim to evaluate attitudes, knowledge, and specific barriers and facilitators for SIV. Stratified analysis was used to identify factors associated with no prior history of influenza vaccination. Multifaceted interventions were implemented in the 2016-2017 season. These included 1) education around influenza disease and SIV, and 2) communication of availability and opportunity (time and place) of SIV. Interventions were designed to target HCWs with the lowest SIV rates in the previous three years. RESULTS: We achieved a 67% response rate, with 363 respondents (106 doctors, 145 nurses, 101 other hospital staff; 11 did not provide their profession). Most (64%) had not been vaccinated in the previous three years; only 14% received the vaccine annually. Non-vaccination rates were significantly higher among nurses (76%) and cleaning and food-service workers (73%) compared to doctors (40%) (P < 0.001). Protection of self, family, patients and colleagues were the most common motivations. Concerns about the safety and effectiveness of the vaccine, the belief that one does not belong to a high-risk group were the most common barriers. The interventions led to an increase in SIV uptake by the HCWs in the hospital, from 19% to 31%. CONCLUSIONS: In a country with very low reported rates of vaccination among HCWs, a simple, low-cost, tailor-made intervention strategy can lead to an increase in SIV uptake. Stratifying data according to vaccination history may reveal a diversity of targets for improvement that might otherwise be missed.

Surveillance for central-line-associated bloodstream infections: Accuracy of different sampling strategies.

BACKGROUND: Active daily surveillance of central-line days (CLDs) in the assessment of rates of central-line-associated bloodstream infections (CLABSIs) is time-consuming and burdensome for healthcare workers. Sampling of denominator data is a method that could reduce the time necessary to conduct active surveillance. OBJECTIVE: To evaluate the accuracy of various sampling strategies in the estimation of CLABSI rates in adult and pediatric units in Greece. METHODS: Daily denominator data were collected across Greece for 6 consecutive months in 33 units: 11 adult units, 4 pediatric intensive care units (PICUs), 12 neonatal intensive care units (NICUs), and 6 pediatric oncology units. Overall, 32 samples were evaluated using the following strategies: (1) 1 fixed day per week, (2) 2 fixed days per week, and (3) 1 fixed week per month. The CLDs for each month were estimated as follows: (number of sample CLDs/number of sampled days) × 30. The estimated CLDs were used to calculate CLABSI rates. The accuracy of the estimated CLABSI rates was assessed by calculating the percentage error (PE): [(observed CLABSI rates - estimated CLABSI rates)/observed CLABSI rates]. RESULTS: Compared to other strategies, sampling over 2 fixed days per week provided the most accurate estimates of CLABSI rates for all types of units. Percentage of estimated CLABSI rates with PE ≤±5% using the strategy of 2 fixed days per week ranged between 74.6% and 88.7% in NICUs. This range was 79.4%-94.1% in pediatric onology units, 62.5%-91.7% in PICUs, and 80.3%-92.4% in adult units. Further evaluation with intraclass correlation coefficients and Bland-Altman plots indicated that the estimated CLABSI rates were reliable. CONCLUSION: Sampling over 2 fixed days per week provides a valid alternative to daily collection of CLABSI denominator data. Adoption of such a monitoring method could be an important step toward better and less burdensome infection control and prevention.