The second most prevalent healthcare-associated infection in neonatal intensive care units (NICUs) is ventilator-associated pneumonia (VAP). This review aims to update the knowledge regarding the incidence of neonatal VAP and to summarize possible strategies for prevention. The VAP incidence ranges from 1.4 to 7 episodes per 1000 ventilator days in developed countries and from 16.1 to 89 episodes per 1000 ventilator days in developing countries. This nosocomial infection is linked to higher rates of illness, death, and longer hospital stays, which imposes a substantial financial burden on both the healthcare system and families. Due to the complex nature of the pathophysiology of VAP, various approaches for its prevention in the neonatal intensive care unit have been suggested. There are two main categories of preventative measures: those that attempt to reduce infections in general (such as decontamination and hand hygiene) and those that target VAP in particular (such as VAP care bundles, head of bed elevation, and early extubation). Some of the interventions, including practicing good hand hygiene and feeding regimens, are easy to implement and have a significant impact. One of the measures that seems very promising and encompasses a lot of the preventive measures for VAP are the bundles. Some preventive measures still need to be studied.

OBJECTIVE: This article’s objective is to critically assess the Bulgarian legislation on health technology assessment (HTA). It analyses how innovative therapies and orphan drugs in particular would respond to the regulators’ decision-making criteria for reimbursement. MATERIALS AND МETHODS: The study features critical analysis of current decision-making criteria for drug reimbursement in Bulgaria, as well as hypothetical scenario planning for orphan medicinal products. RESULTS: The approval for inclusion into the Positive Drug List (PDL) (which is a must for reimbursement) has been reorganised into an assessment scoring system with decisionmaking criteria (presence of therapeutic alternative, clinical effectiveness, safety, pharmacoeconomics and societal value) divided into weighted indicators. An explicit threshold has been set - a medicinal product must score 60 points at least to be included in PDL. Under the currently defined reimbursement decision-making criteria a hypothetical middle- of-the-road scenario planning shows that an orphan drug would score 20 points for therapeutic alternative, 28 for clinical effectiveness and 12 for safety. It would take no points for pharmacoeconomics and societal value. This leaves the orphan drugs with a total score of 60 points, making the final outcome of real-life assessment and decision-making heavily dependent on small fluctuations. CONCLUSIONS: The current reimbursement decision-making framework in Bulgaria seems to be generalised and not sufficiently transparent. It is unable to precisely assess innovative health technologies. The availability of a therapeutic alternative emerges as a key reimbursement decision-making criterion for orphan drugs, as these innovative products nominally provide the first medicinal therapy alternative to rare diseases.

The concept of improving the quality and safety of healthcare is well known. However, a follow-up question is often asked about whether these improvements are cost-effective. The prevalence of nosocomial infections (NIs) in the neonatal intensive care unit (NICU) is approximately 30% in developing countries. Ventilator-associated pneumonia (VAP) is the second most common NI in the NICU. Reducing the incidence of NIs can offer patients better and safer treatment and at the same time can provide cost savings for hospitals and payers. The aim of the study is to assess the direct costs of VAP in the NICU. This is a prospective study, conducted between January 2017 and June 2018 in the NICU of University Hospital “St. George” Plovdiv, Bulgaria. During this period, 107 neonates were ventilated for more than 48 h and included in the study. The costs for the hospital stay are based on the records from the Accounting Database of the setting. The differences directly attributable to VAP are presented both as an absolute value and percentage, based on the difference between the values of the analyzed variables. There are no statistically significant differences between patients with and without VAP in terms of age, sex, APGAR score, time of admission after birth and survival. We confirmed differences between the median birth weight (U = 924, p = 0.045) and average gestational age (t = 2.14, p = 0.035) of the patients in the two study groups. The median length of stay (patient-days) for patients with VAP is 32 days, compared to 18 days for non-VAP patients (U = 1752, p < 0.001). The attributive hospital stay due to VAP is 14 days. The median hospital costs for patients with VAP are estimated at €3675.77, compared to the lower expenses of €2327.78 for non-VAP patients (U = 1791.5, p < 0.001). The median cost for antibiotic therapy for patients with VAP is €432.79, compared to €351.61 for patients without VAP (U = 1556, p = 0.024). Our analysis confirms the results of other studies that the increased length of hospital stays due to VAP results in an increase in hospital costs. VAP is particularly associated with prematurity, low birth weight and prolonged mechanical ventilation.

Background: Patient registries and databases are essential tools for advancing clinical research in the area of rare diseases, as well as for enhancing patient care and healthcare planning. The primary aim of this study is a landscape analysis of available European data sources amenable to machine learning (ML) and their usability for Rare Diseases screening, in terms of findable, accessible, interoperable, reusable(FAIR), legal, and business considerations. Second, recommendations will be proposed to provide a better understanding of the health data ecosystem. Methods: In the period of March 2022 to December 2022, a cross-sectional study using a semi-structured questionnaire was conducted among potential respondents, identified as main contact person of a health-related databases. The design of the self-completed questionnaire survey instrument was based on information drawn from relevant scientific publications, quantitative and qualitative research, and scoping review on challenges in mapping European rare disease (RD) databases. To determine database characteristics associated with the adherence to the FAIR principles, legal and business aspects of database management Bayesian models were fitted. Results: In total, 330 unique replies were processed and analyzed, reflecting the same number of distinct databases (no duplicates included). In terms of geographical scope, we observed 24.2% (n = 80) national, 10.0% (n = 33) regional, 8.8% (n = 29) European, and 5.5% (n = 18) international registries coordinated in Europe. Over 80.0% (n = 269) of the databases were still active, with approximately 60.0% (n = 191) established after the year 2000 and 71.0% last collected new data in 2022. Regarding their geographical scope, European registries were associated with the highest overall FAIR adherence, while registries with regional and “other” geographical scope were ranked at the bottom of the list with the lowest proportion. Responders’ willingness to share data as a contribution to the goals of the Screen4Care project was evaluated at the end of the survey. This question was completed by 108 respondents; however, only 18 of them (16.7%) expressed a direct willingness to contribute to the project by sharing their databases. Among them, an equal split between pro-bono and paid services was observed. Conclusions: The most important results of our study demonstrate not enough sufficient FAIR principles adherence and low willingness of the EU health databases to share patient information, combined with some legislation incapacities, resulting in barriers to the secondary use of data.

The prevalence of hepatitis E virus (HEV) in the Bulgarian population remains underestimated. The aim of the present study was to evaluate age and gender trends in HEV prevalence in the heterogeneous Bulgarian population. Stored serum samples from blood donors and different patient sub-populations—kidney recipients (KR), patients with Guillain–Barre syndrome (GBS), Lyme disease (LD), patients with liver involvement and a clinical diagnosis other than viral hepatitis A and E (non-AE), hemodialysis (HD) and HIV-positive patients (HIV)—were retrospectively investigated for markers of past and recent/ongoing HEV infection. The estimated overall seroprevalence of past infection was 10.6%, ranging from 5.9% to 24.5% for the sub-populations evaluated, while the seroprevalence of recent/ongoing HEV infection was 7.5%, ranging from 2.1% to 20.4%. The analysis of the individual sub-populations showed a different prevalence with respect to sex. In regard to age, the cohort effect was preserved, as a multimodal pattern was observed only for the GBS sub-population. Molecular analysis revealed HEV 3f and 3e. The type of the population is one of the main factors on which the anti-HEV prevalence depends, highlighting the need for the development of guidelines related to the detection and diagnosis of HEV infection with regard to specific patient populations.