Background Childhood vaccination rates fluctuate over time and do not always meet the levels recommended by the WHO. Objective This study aims to provide an overview of measures countries have introduced to increase vaccination rates. Methods We developed a structured data collection template that was completed by country experts from Europe, Israel, the USA, and Canada. Experts were identified using the European Observatory on Health Systems and Policies' HSPM (Health Systems and Policy Monitor) network. We approached experts from 32 countries and received responses from 22 countries. In the template we asked for measures introduced between 2014 and 2019. The experts were asked to indicate the type of intervention, the target population, possible positive and negative effects, and evidence on effectiveness. The information was collected between September 2019 and January 2020. Results We identified four main types of interventions: restrictive measures for the unvaccinated, financial incentives, measures supporting the logistics of vaccination, and vaccination promotion campaigns. Restrictive measures often involved expanding existing mandatory vaccination policies or limiting access to pre-school activities for unvaccinated children. Financial incentives for healthcare providers showed some positive effects. Regarding logistical support, several countries used schools as alternative vaccination sites, though this presented organisational challenges. Many countries invested in improving knowledge among both healthcare professionals and parents to encourage vaccine uptake. Conclusions Most initiatives implemented in the countries covered focussed on communication and knowledge enhancement. However, there is limited evidence on the impact of these measures on vaccination coverage.
- MeSH
- Child MeSH
- Internationality MeSH
- Humans MeSH
- Immunization Programs * MeSH
- Health Promotion * methods MeSH
- Vaccination Coverage * statistics & numerical data MeSH
- Vaccination * statistics & numerical data MeSH
- Health Policy MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Comparative Study MeSH
- Geographicals
- Europe MeSH
- Israel MeSH
- Canada MeSH
- United States MeSH
Bacterial biofilms pose significant challenges, from healthcare-associated infections to biofouling in industrial systems, resulting in significant health impacts and financial losses globally. Classic antimicrobial methods often fail to eradicate sessile microbial communities within biofilms, requiring innovative approaches. This review explores the structure, formation, and role of biofilms, highlighting the critical importance of exopolysaccharides in biofilm stability and resistance mechanisms. We emphasize the potential of microbial enzymatic approaches, particularly focusing on glycosidases, proteases, and deoxyribonucleases, which can disrupt biofilm matrices effectively. We also delve into the importance of enzymes such as cellobiose dehydrogenase, which disrupts biofilms by degrading polysaccharides. This enzyme is mainly sourced from Aspergillus niger and Sclerotium rolfsii, with optimized production strategies enhancing its efficacy. Additionally, we explore levan hydrolase, alginate lyase, α-amylase, protease, and lysostaphin as potent antibiofilm agents, discussing their microbial origins and production optimization strategies. These enzymes offer promising avenues for combating biofilm-related challenges in healthcare, environmental, and industrial settings. Ultimately, enzymatic strategies present environmentally friendly solutions with high potential for biofilm management and infection control.
Face transplantation is a viable reconstructive approach for severe craniofacial defects. Despite the evolution witnessed in the field, ethical aspects, clinical and psychosocial implications, public perception, and economic sustainability remain the subject of debate and unanswered questions. Furthermore, poor data reporting and sharing, the absence of standardized metrics for outcome evaluation, and the lack of consensus definitions of success and failure have hampered the development of a "transplantation culture" on a global scale. We completed a 2-round online modified Delphi process with 35 international face transplant stakeholders, including surgeons, clinicians, psychologists, psychiatrists, ethicists, policymakers, and researchers, with a representation of 10 of the 19 face transplant teams that had already performed the procedure and 73% of face transplants. Themes addressed included patient assessment and selection, indications, social support networks, clinical framework, surgical considerations, data on patient progress and outcomes, definitions of success and failure, public image and perception, and financial sustainability. The presented recommendations are the product of a shared commitment of face transplant teams to foster the development of face transplantation and are aimed at providing a gold standard of practice and policy.
- MeSH
- Delphi Technique MeSH
- Consensus MeSH
- Humans MeSH
- Facial Transplantation * methods MeSH
- Vascularized Composite Allotransplantation * MeSH
- Research Design MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
Face transplantation is a viable reconstructive approach for severe craniofacial defects. Despite the evolution witnessed in the field, ethical aspects, clinical and psychosocial implications, public perception, and economic sustainability remain the subject of debate and unanswered questions. Furthermore, poor data reporting and sharing, the absence of standardized metrics for outcome evaluation, and the lack of consensus definitions of success and failure have hampered the development of a "transplantation culture" on a global scale. We completed a 2-round online modified Delphi process with 35 international face transplant stakeholders, including surgeons, clinicians, psychologists, psychiatrists, ethicists, policymakers, and researchers, with a representation of 10 of the 19 face transplant teams that had already performed the procedure and 73% of face transplants. Themes addressed included patient assessment and selection, indications, social support networks, clinical framework, surgical considerations, data on patient progress and outcomes, definitions of success and failure, public image and perception, and financial sustainability. The presented recommendations are the product of a shared commitment of face transplant teams to foster the development of face transplantation and are aimed at providing a gold standard of practice and policy.
- MeSH
- Delphi Technique MeSH
- Consensus MeSH
- Humans MeSH
- Facial Transplantation * methods MeSH
- Vascularized Composite Allotransplantation * MeSH
- Research Design MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
BACKGROUND/OBJECTIVE: Increasing infectious rate estimates and low microbiological surveillance affect safety of gastrointestinal endoscopy globally. Single use endoscopes and accessories have been claimed to improve safety, but there is lack of data on their indication and sustainability. We aimed to identify a series of best practice recommendations for the use of single use endoscopes and accessories using a modified Delphi. METHODS/DESIGN: Consensus statements for the use of single use endoscopy and accessories were developed using a modified Delphi process, utilizing an international endoscopist expert panel of 62 experts from 33 nations. The main steps in the process were selecting the consensus group, conducting systematic literature reviews, developing statements, and anonymous voting on the statements until consensus was reached. High-risk patients were defined as those with multi-drug-resistant infections, immunosuppressive medication or chemotherapy, post-transplantation, or with severe neutropenia. RESULTS: Of the 26 statements that were voted upon through two rounds, 17 statements reached consensus. Category 1: single use accessories (8 statements), related to defining recommendations for the use of single use accessories in all patient populations or high-risk patients. Category 2: clinical indication for single use endoscopes (9 statements), including indications to high-risk patients, protecting the endoscope apparatus and contamination measures in endoscopy units. Category 3: technical factors (4 statements), related to superior performance and technical specifications with the new innovation. Category 4: environmental issues (2 statements), concerning mechanisms that reduce the detrimental burden to the environment. Category 5: financial implications (3 statements), related to healthcare policies, cost neutrality and other financial associations of single use endoscopy. CONCLUSIONS: This is the first international initiative in determining clinical indications for single use endoscopy and accessories. The study's findings should serve as a framework for future physicians to guide future research and aid the proper evidence-based indications for the implementation of single use endoscopes in clinical practice.
- MeSH
- Delphi Technique MeSH
- Endoscopy, Gastrointestinal * MeSH
- Consensus MeSH
- Humans MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
OBJECTIVES: Metabolomics aims for comprehensive characterization and measurement of small molecule metabolites (<1700 Da) in complex biological matrices. This study sought to assess the current understanding and usage of metabolomics in laboratory medicine globally and evaluate the perception of its promise and future implementation. METHODS: A survey was conducted by the IFCC metabolomics working group that queried 400 professionals from 79 countries. Participants provided insights into their experience levels, knowledge, and usage of metabolomics approaches, along with detailing the applications and methodologies employed. RESULTS: Findings revealed a varying level of experience among respondents, with varying degrees of familiarity and utilization of metabolomics techniques. Targeted approaches dominated the field, particularly liquid chromatography coupled to a triple quadrupole mass spectrometer, with untargeted methods also receiving significant usage. Applications spanned clinical research, epidemiological studies, clinical diagnostics, patient monitoring, and prognostics across various medical domains, including metabolic diseases, endocrinology, oncology, cardiometabolic risk, neurodegeneration and clinical toxicology. CONCLUSIONS: Despite optimism for the future of clinical metabolomics, challenges such as technical complexity, standardization issues, and financial constraints remain significant hurdles. The study underscores the promising yet intricate landscape of metabolomics in clinical practice, emphasizing the need for continued efforts to overcome barriers and realize its full potential in patient care and precision medicine.
- MeSH
- Chromatography, Liquid MeSH
- Humans MeSH
- Metabolomics * methods MeSH
- Surveys and Questionnaires MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
OBJECTIVE: To demonstrate the therapeutic similarity of CT-P42 compared with reference aflibercept (Eylea) in adult patients with diabetic macular edema (DME). DESIGN: Randomized, active-controlled, double-masked, phase III clinical trial PARTICIPANTS: Patients with a diagnosis of either type 1 or 2 diabetes mellitus with DME involving the center of the macula. METHODS: Patients were randomized (1:1) to receive either CT-P42 or reference aflibercept (2 mg/0.05 ml) by intravitreal injection every 4 weeks (5 doses), then every 8 weeks (4 doses), in the main study period. Results up to week 24 are reported herein. MAIN OUTCOME MEASURES: The primary end point was mean change from baseline at week 8 in best-corrected visual acuity (BCVA) using the ETDRS chart. Equivalence between CT-P42 and reference aflibercept was to be concluded if the 2-sided 95% confidence interval (CI) (global assumptions) and 2-sided 90% CI (United States Food and Drug Administration [FDA] assumptions) for the treatment difference fell entirely within the equivalence margin of ±3 letters, as assessed in the full analysis set. RESULTS: Overall, 348 patients were randomized (CT-P42: 173; reference aflibercept: 175). Best-corrected visual acuity improved from baseline to week 8 in both groups, with a least squares mean (standard error) improvement of 9.43 (0.798) and 8.85 (0.775) letters in the CT-P42 and reference aflibercept groups, respectively. The estimated between-group treatment difference was 0.58 letters, with the CIs within the predefined equivalence margin of ±3 letters (95% CI, -0.73 to 1.88 [global]; 90% CI, -0.52 to 1.67 [FDA]). Through week 24, other efficacy results for the 2 groups, in terms of change in BCVA and retinal central subfield thickness, as well as ETDRS Diabetic Retinopathy Severity Scale score, supported therapeutic similarity. Pharmacokinetics, usability, safety (including the proportions of patients experiencing ≥1 treatment-emergent adverse event [CT-P42: 50.3%; reference aflibercept: 53.7%]), and immunogenicity were also comparable between groups. CONCLUSIONS: This study in patients with DME demonstrated equivalence between CT-P42 and reference aflibercept (2 mg/0.05 ml) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
- MeSH
- Biosimilar Pharmaceuticals administration & dosage MeSH
- Time Factors MeSH
- Diabetic Retinopathy * drug therapy diagnosis complications MeSH
- Double-Blind Method MeSH
- Angiogenesis Inhibitors * administration & dosage MeSH
- Intravitreal Injections MeSH
- Middle Aged MeSH
- Humans MeSH
- Macula Lutea pathology diagnostic imaging MeSH
- Macular Edema * drug therapy diagnosis etiology MeSH
- Follow-Up Studies MeSH
- Tomography, Optical Coherence methods MeSH
- Receptors, Vascular Endothelial Growth Factor * administration & dosage antagonists & inhibitors MeSH
- Recombinant Fusion Proteins administration & dosage MeSH
- Aged MeSH
- Vascular Endothelial Growth Factor A antagonists & inhibitors MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Visual Acuity MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
INTRODUCTION: Rheumatic heart disease (RHD) poses a substantial global health challenge, especially impacting resource-limited nations, with over 40.5 million cases reported in 2019. The crucial role of Benzathine penicillin G in both primary and secondary prevention, particularly the latter, emphasizes its significance. METHOD: Following PRISMA guidelines, our systematic review explored Medline, Scopus, Google Scholar, and Embase databases from 1990 to 2022. Registered with PROSPERO ), the review utilized quality appraisal tools, including the PRISMA checklist, Cochrane bias tool and Newcastle-Ottawa scale. The objective was to identify and stratify the impact of socio-economic factors on adherence to secondary prophylaxis in RHD. RESULTS AND DISCUSSION: The impact of education on adherence has been found to be significant. Socially disadvantaged environments significantly influenced adherence, shaped by education, socio-economic status, and geographical location and access to healthcare. Surprisingly, lower education levels were associated with better adherence in certain cases. Factors contributing to decreased adherence included forgetfulness, injection-related fears, and healthcare provider-related issues. Conversely, higher adherence correlated with younger age, latent disease onset, increased healthcare resources, and easy access. CONCLUSION: Patient education and awareness were crucial for improving adherence. Structured frameworks, community initiatives, and outreach healthcare programs were identified as essential in overcoming barriers to secondary prophylaxis. Taking active steps to address obstacles like long-distance commute, waiting time, injection fears, and financial issues has the potential to greatly improve adherence. This, in turn, can lead to a more effective prevention of complications associated with RHD.
- Publication type
- Journal Article MeSH
- Review MeSH
BACKGROUND: Chronic kidney disease (CKD) has a global prevalence of 9.1-13.4%. Comorbidities are abundant and may cause and affect CKD. Cardiovascular disease strongly correlates with CKD, increasing the burden of both diseases. SUMMARY: As a group of 15 clinical nephrologists primarily practicing in 12 Central/Eastern European countries, as well as Israel and Kazakhstan, herein we review the significant unmet needs for patients with CKD and recommend several key calls-to-action. Early diagnosis and treatment are imperative to ensure optimal outcomes for patients with CKD, with the potential to greatly reduce both morbidity and mortality. Lack of awareness of CKD, substandard indicators of kidney function, suboptimal screening rates, and geographical disparities in reimbursement often hamper access to effective care. KEY MESSAGES: Our key calls-to-action to address these unmet needs, thus improving the standard of care for patients with CKD, are the following: increase disease awareness, such as through education; encourage provision of financial support for patients; develop screening algorithms; revisit primary care physician referral practices; and create epidemiological databases that rectify the paucity of data on early-stage disease. By focusing attention on early detection, diagnosis, and treatment of high-risk and early-stage CKD populations, we aim to reduce the burdens, progression, and mortality of CKD.
- MeSH
- Early Diagnosis * MeSH
- Renal Insufficiency, Chronic * therapy diagnosis MeSH
- Humans MeSH
- Nephrologists * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Geographicals
- Europe MeSH
- Europe, Eastern MeSH
Managed Entry Agreements (MEAs) play a pivotal role in addressing the challenges arising from escalating prices of innovative medical technologies, especially in areas like oncology, immunology, and rare diseases. Among MEAs, Performance-Based MEAs (PB MEAs) and Outcome-Based MEAs (OB MEAs) stand out as innovative strategies. This study examines the adoption of PB MEAs in the Czech Republic post a 2022 legislative change. Interviews with key stakeholders, including the Ministry of Health, pharmaceutical companies, insurers, and patient groups, were conducted to explore perceptions and challenges. Stakeholders expressed concerns about legislation completeness, data quality, transparency, and methodology. Interestingly, pharmaceutical companies were less concerned about transparency and methodology, likely due to their multinational experience. Despite legislative progress, challenges persist, especially in data infrastructure, risk-sharing perceptions, and stakeholder readiness. Addressing these issues requires collaboration between pharmaceutical companies and payers. Patient involvement, though mandated, remains limited, potentially due to a lack of awareness. This study emphasizes the need for a comprehensive transformation beyond legislation for a successful PB MEA implementation. Trust, technical infrastructure, and data availability are crucial, necessitating a holistic approach. It contributes to the global discourse on PB MEAs, stressing the adjustment of financial frameworks, embracing value-based healthcare principles, and ensuring high-quality health data metrics. A more holistic, value-based MEA approach could reshape pharmaceutical reimbursement in the future.
- Publication type
- Journal Article MeSH