Search Results (1,893)

Background: The EU Health Technology Assessment Regulation (EU-HTA R), effective January 2025, mandates Joint Clinical Assessments (JCAs) to harmonize HTA across Member States. However, its implementation raises fundamental questions about methodological coherence, institutional capacity, and epistemological alignment. Objectives: This manuscript (1) systematically assesses whether the stated strategic and operational objectives of the EU-HTA R are achievable under current implementation conditions; (2) examines the implications for EU institutional legitimacy if these objectives are not met; and (3) proposes an epistemological framework as a prerequisite for developing a coherent joint HTA methodology. Methods: We conducted a critical policy analysis of the EU-HTA R, its implementing guidance documents, and published templates, supplemented by a comparative review of Member State HTA methodologies and their underlying philosophical foundations. Results: The analysis reveals that the EU-HTA R is unlikely to achieve its strategic goals under current conditions. Key findings include: guidance documents of substandard methodological quality; a restricted assessment scope that excludes scientific judgement and contextualization; insufficient resources and additional workload for national HTA bodies without reducing existing obligations; unresolved epistemological divergences among Member States spanning Bayesian vs. frequentist approaches, Fisher vs. Neyman–Pearson frameworks, and utilitarian vs. deontological ethical foundations; and procedural shortcomings in stakeholder consultation and expert involvement. These shortcomings risk undermining the epistemic authority and legitimacy of EU institutions. Conclusions: Prior epistemological and normative alignment across Member States is a prerequisite for any robust shared HTA methodology. Revisions to the EU-HTA R and comprehensive updates of guidance documents are necessary, with concrete safeguards—including independent peer review, identified authorship, and adequate resourcing—to ensure substantive rather than merely nominal implementation. A phased roadmap is proposed: establishing clear objectives, aligning epistemological foundations, developing institutional structures, and creating operationally consistent guidance. Full article

Background/Objectives: Burnout among healthcare professionals has emerged as a major occupational and organizational challenge with important implications for workforce sustainability, patient safety, and healthcare system performance. Although the scientific literature on burnout has expanded substantially, an integrated understanding of its global development, research structure, and scientific impact remains limited. This study aimed to examine the evolution, thematic development, and citation dynamics of burnout research among healthcare professionals through an integrated bibliometric approach combining science mapping, multilevel citation modelling, and critical literature synthesis. Methods: A bibliometric analysis was conducted using publications indexed in the Web of Science Core Collection between 1987 and 2024. Science mapping techniques were applied using Bibliometrix and VOSviewer to evaluate publication trends, collaboration networks, thematic development, and citation patterns. In addition, a multilevel negative binomial regression model was used to identify publication characteristics associated with citation impact. Results: A total of 1232 publications were included in the analysis. Scientific production increased markedly after 2020, temporally coinciding with the COVID-19 pandemic and growing scientific interest in healthcare workforce wellbeing. Research output was concentrated in high-income countries, particularly the United States, China, the United Kingdom, Canada, and Australia. Physicians and nurses dominated the literature, while non-clinical healthcare workers remained underrepresented. The thematic analysis indicated an increasing emphasis on organizational and system-level determinants of burnout alongside the continued presence of individual-centered perspectives. The multilevel negative binomial model identified longer title length and a greater number of author-provided keywords as being associated with lower expected citation counts, whereas a greater number of Keywords Plus terms was associated with higher expected citation counts. Conclusions: Burnout research has evolved into a rapidly expanding and increasingly interdisciplinary field. However, important gaps persist regarding geographic representation, workforce diversity, methodological standardization, and organizational intervention research. Future studies should move beyond descriptive approaches and further evaluate organizational interventions and workforce-related strategies to strengthen the evidence base that may inform healthcare policy and organizational practice. Full article

Background: Individuals with intellectual and/or developmental disabilities (IDDs) experience persistent health inequities, exacerbated by the systemic lack of education of health care professionals about their care. In response to a 2020 call from the Administration for Community Living in the United States, five institutions formed the IDD Health Equity Consortium to develop a suite of educational materials and practice experiences to improve the education of health care professionals in the health and health care of individuals with IDDs. Methods: The Collective Impact Model, designed to align organizations and stakeholders around a shared agenda for system change, was used to organize IDD Health Equity Consortium programs. Backbone infrastructure included a cross-sector steering committee, an Advocate Advisory Committee, and three Consortium Action Networks focused on communication, measurement, and education, practice, and policy. A scoping review of the literature was conducted, and a Participatory Planning and Decision-Making process engaged individuals with IDDs, family members, students, faculty, and professionals in identifying important themes for developed materials. Results: Learning modules, case studies, service-learning experiences, and simulation experiences were developed across Consortium institutions and were disseminated across multiple other institutions, with beginning alignment with interprofessional and disability competencies. Mixed-methods evaluation strategies assessed learner outcomes, including knowledge checks and pre and post evaluations using established measures of skills, comfort levels, and approach; and interprofessional socialization, valuing, and collaborative practice behaviors. Conclusions: By involving individuals with IDDs in curriculum development and building multi-institution and cross-sector infrastructure, the Consortium developed scalable materials that address longstanding gaps in health care professional education. The developed suite of educational materials and practice experiences and early evaluation findings provided a foundation for further program refinement and future empirical studies examining long-term effects on practice and clinical outcomes. Full article

Background/Objectives: Vaccine-preventable disease may generate medico-legal disputes not only after an adverse event following immunization, but also when a clinician is alleged to have failed to mention, recommend, revisit, refer for, or document a clinically relevant vaccine. We examine this “unmentioned vaccine” problem while distinguishing existing law (lex lata) from proposed good practice (lex ferenda). Methods: We conducted a documented purposive narrative and comparative medico-legal review. PubMed/MEDLINE, PubMed Central, structured scholarly web searches, publicly accessible legal repositories, and official policy websites were searched from database inception through 21 July 2026 using combinations of vaccination, informed consent/refusal, failure to recommend or vaccinate, referral, documentation, negligence, causation, and LMIC terms. Authorities were selected for doctrinal relevance and jurisdictional contrast, with citation chaining. Results: In the selected jurisdictions, patient-centered disclosure of material risks and reasonable alternatives is recognized in differing forms. Vaccine-specific cases are sparse and fact-sensitive and do not establish a universal duty to recommend, refer, or revisit every vaccine. Provider recommendation influences uptake, but this behavioral evidence does not itself establish legal duty or causation, and direct empirical evidence linking counselling omissions to claims remains limited. We therefore present ADRR—assess, discuss and disclose, recommend or refer, and record and revisit—as proposed practice guidelines developed by the authors and presented in conceptual form, not as a validated legal or clinical standard. Conclusions: ADRR may support proportionate, system-level preparedness, especially in LMICs, but implementation must account for access, supply, workforce, financing, records, and legal context. Stakeholder co-design and empirical validation are required before routine adoption. Full article

Introduction: This study explores obstetric providers’ perceptions of intimate partner violence (IPV) screening in the Chinese clinical setting, guided by the social–ecological model. Methods: Purposive sampling was employed to recruit eight obstetricians and 12 obstetric nurses from a tertiary general hospital in Suzhou, Jiangsu Province, China. Individual semi-structured interviews were conducted between December 2024 and September 2025. Results: Guided by the social–ecological model, this study examines factors influencing healthcare professionals’ engagement in intimate partner violence screening across four levels. A multilevel framework was distilled; four key themes were identified, including the intrapersonal level, interpersonal level, institutional level and community and policy level. (1) The intrapersonal level—healthcare professionals’ competence (knowledge base, communication skills, role identity, screening attitudes, and diagnostic ability); (2) the interpersonal level—interdisciplinary collaboration (internal referrals and external support); (3) the institutional level—hospital screening efficacy (screening resources and management systems); and (4) the community and policy level—social environment (policy support, educational resources, and cultural context). Conclusions: Multilevel factors impact IPV screening in China. These results indicate that a multidimensional model of intervention should be designed to promote IPV screening in China, including integrating IPV curricula into mandatory medical student training, enhancing interdisciplinary collaboration, conducting public education on IPV, implementing socio-cultural adjustments, challenging authoritative attitudes, and providing comprehensive social support. Full article

In a policy context characterized by both supportive initiatives (e.g., school-based mental health services) and enforcement-oriented approaches that may contribute to student stress, schools are increasingly tasked with addressing trauma-related needs. A rapid umbrella review was conducted on existing systematic reviews of trauma-informed school practices. The umbrella review synthesized findings from multiple systematic reviews to provide a comprehensive assessment of the evidence, identify areas of consensus or inconsistency, and explain discrepancies across studies. Fifteen reviews met the inclusion criteria of a systematic or scoping review of mental health and academic outcomes associated with trauma-informed school practices. Nine of these included studies with newcomer students. Overall, most reviews reported positive associations between trauma-informed practices and student outcomes, including reductions in trauma symptoms and behavioral problems, as well as improvements in resilience, engagement, and academic performance. Evidence was strongest for targeted clinical interventions delivered by trained mental health professionals, while classroom and schoolwide approaches showed promising but less conclusive results due to methodological limitations. Findings suggest that while trauma-informed approaches are beneficial, their implementation remains fragmented and often incremental. Greater attention to cultural, linguistic, and relational dimensions of displacement, along with improved cross-system coordination and rigorous evaluation, is needed. Trauma-informed school practices represent a promising but underdeveloped strategy for supporting newcomer students within complex and evolving policy environments. Full article

Tuberculosis (TB) continues to be a significant public health challenge in Europe, despite a sustained decline in disease incidence over recent decades. This narrative review briefly traces the historical development of TB diagnosis and focuses on the evolution of TB control protocols from the early twentieth century to the present across Europe, through a longitudinal comparative analysis of its geographical regions. A literature search was conducted using publications, guidelines, and surveillance reports from the World Health Organization (WHO), the European Centre for Disease Prevention and Control (ECDC), and national public health authorities. The analysis follows a geographical framework encompassing Eastern, Western, Northern, and Southern Europe, reflecting historical, socioeconomic, and healthcare system differences. This study presents the transition from traditional diagnostic approaches based on clinical assessment, chest radiography, and smear microscopy to modern molecular and immunological techniques, including Xpert MTB/RIF assays and interferon-gamma release assays (IGRAs). Similarly, treatment strategies have evolved from sanatorium-based supportive care to standardized, evidence-based short-course regimens employing first- and second-line anti-TB drugs. However, marked regional differences remain in the implementation of contemporary protocols. Western and Northern European countries have largely adopted advanced diagnostic technologies and comprehensive surveillance systems and are approaching TB elimination targets. In contrast, Eastern Europe continues to bear a disproportionate disease burden, driven by multidrug-resistant TB, HIV co-infection, and socioeconomic disparities. TB control protocols in Southern Europe are progressively converging with those of Western Europe through the adoption of modern diagnostic approaches, standardized treatment regimens, and WHO-endorsed guidelines. The findings of this study underscore the need for greater harmonization of TB control protocols across Europe through an initiative coordinated by the ECDC/WHO. Accelerating progress toward TB elimination in the European Region will depend on expanding access to modern diagnostic technologies, implementing targeted interventions in high-burden settings, and strengthening cross-border collaboration through coordinated public health policies. Full article

Background/Objectives: Diabetic foot infections (DFI) drive most non-traumatic lower-limb amputations, and empirical regimens must track local microbiology, which is itself evolving under broad-spectrum antibiotic pressure. Methods: We retrospectively analysed all consecutive bacterial cultures from clinically infected diabetic foot lesions at a single Polish outpatient centre over 2021–2025. Isolates were identified by MALDI-TOF mass spectrometry and susceptibility was interpreted under contemporaneous EUCAST breakpoints (v12.0–v15.0). Results: A total of 274 cultures yielded 443 isolates (polymicrobial index 1.62). Staphylococcus aureus remained the most common pathogen but fell from 55.0% to 38.9% of cultures, while Enterobacterales rose from 36.1% to 47.7% of all isolates. Proteus mirabilis and Streptococcus agalactiae emerged as major contributors, and Enterobacter hormaechei showed an apparent increase (the apparent rise in E. hormaechei reflects, at least in part, improved species-level identification rather than a true increase in incidence). Methicillin-resistant S. aureus was first documented in 2025 (6/38; 15.8%). P. mirabilis showed deteriorating activity against trimethoprim–sulfamethoxazole and ciprofloxacin, the first meropenem-resistant isolate appeared in 2025, and two carbapenem-non-susceptible Enterobacterales were also detected (2/18 carbapenem-tested isolates in 2025; 11%). Conclusions: The DFI profile has shifted from an S. aureus-dominated Gram-positive ecology toward a polymicrobial, increasingly Gram-negative one, with the first documentation of MRSA (on reintroduction of routine oxacillin testing) and of carbapenem-non-susceptible Enterobacterales. Empirical policy for moderate-to-severe DFI should reliably cover Enterobacterales and methicillin-resistant Gram-positives while preserving carbapenems and glycopeptides through active stewardship. Full article

Background/Objectives: Access to dental care is a multilevel challenge shaped by healthcare systems, individual characteristics, and broader social determinants. This study aimed to identify parent-reported barriers to dental care among a sample of children in Saudi Arabia using Levesque’s Conceptual Framework for Access to Healthcare. Methods: A cross-sectional survey was conducted between March and April 2023 among parents of children aged 1–18 years. The 44-item survey assessed sociodemographic, oral health, and dental care utilization, organized using Levesque’s access dimensions. Difficulty accessing needed dental care within the past 12 months served as the main outcome. The chi-square test was used to examine bivariate associations between potential barriers and difficulty accessing needed dental care. Multivariable logistic regression was used to identify factors independently associated with difficulty accessing needed dental care after adjustment for the other variables. Results: This study included 351 parents. The mean age of children was 10.7 ± 4.7 years, and 45.9% were male. One-third of parents reported difficulty accessing needed dental care for their children. The adjusted regression model identified fair/poor oral health (aOR = 13.39, 95% CI: 6.19–28.97), general health condition (aOR = 2.31, 95% CI: 1.11–4.82), and the absence of a nearby dental clinic (aOR = 2.08, 95% CI: 1.11–3.90) as factors independently associated with difficulty accessing dental care. Conclusions: Applying Levesque’s framework highlighted the multidimensional nature of barriers to accessing dental care for the study population. These findings provide preliminary evidence on parent-reported access barriers and may inform larger, representative studies and future policies to improve equitable pediatric oral healthcare in alignment with Saudi Vision 2030. Full article

Sickle Cell Disease (SCD) is a hereditary hemoglobinopathy arising from a single-nucleotide transversion (GAG → GTG) at codon six of the HBB gene on chromosome 11, substituting glutamic acid with valine in the β-globin chain and producing hemoglobin S (HbS). Under hypoxic conditions, HbS polymerizes and distorts erythrocytes into the characteristic sickle shape, initiating a cascade of vaso-occlusion, chronic hemolytic anemia, and progressive multi-organ damage that defines the clinical burden of this disease. Although SCD has ancient origins in sub-Saharan Africa, the Indian subcontinent, the Middle East, and the Mediterranean, regions where it conferred heterozygous resistance to malaria, the ease of human migration has long since made it a global health concern, affecting an estimated 300,000–400,000 newborns annually. Advances in molecular and genomic research have deepened our understanding of SCD pathophysiology, revealing the central contributions of hemoglobin polymerization, oxidative stress, endothelial inflammation, and nitric oxide depletion to disease progression. Current management rests on supportive pharmacological interventions, including hydroxyurea, chronic transfusion therapy, L-glutamine, and multimodal pain management, complemented by lifestyle modifications. Curative approaches have advanced substantially: hematopoietic stem cell transplantation (HSCT) remains the established standard of cure, while the regulatory approvals in late 2023 of the CRISPR/Cas9-based exagamglogene autotemcel (Casgevy) and the lentiviral vector-based lovotibeglogene autotemcel (Lyfgenia) represent the most transformative development in the history of SCD therapeutics. This review traces the disease from its ancient origins and molecular characterization through to its clinical manifestations, inheritance patterns, screening strategies, and the full spectrum of current and emerging therapies. Persistent challenges, prohibitive treatment costs, healthcare inequities, the ethical dimensions of genome editing, and the urgent need for long-term safety data, are examined critically, with a view to informing the research and policy agenda that must accompany these remarkable scientific advances. Full article

Background: Artificial intelligence (AI) is increasingly entering hospital practice through diagnostic, predictive, workflow, operational, and generative applications. Hospitals often govern these systems as procurement or information-technology projects rather than as clinical–organizational interventions requiring indication, evaluation, monitoring, accountability, and withdrawal. Objective: To refine the concept of an “AI Hospital Formulary” as an operational, proportional, and accountable framework for the safe, equitable, and sustainable adoption of hospital AI. Design and Methods: This is a perspective article using a structured, non-systematic narrative synthesis and conceptual framework development. Targeted literature and policy sources were identified through purposive searches and citation chaining through 20 July 2026. The synthesis compares the formulary with existing oversight approaches, maps its lifecycle gates to regulatory and risk management duties, and applies the framework to a worked example based on published evaluations of the Epic Sepsis Model. The EQUATOR reporting-guideline selection tool was consulted, and SANRA was used to strengthen the narrative synthesis component. Framework: The revised framework combines a hospital-wide AI register, a standardized formulary monograph, six lifecycle gates, proportional review pathways, governance-of-governance safeguards, cloud and data-sovereignty controls, continuous monitoring of technical and behavioral feedback loops, and explicit renewal or deprescribing criteria. The worked example shows how version-specific evidence can lead to local validation, controlled implementation, restriction, suspension, or renewal rather than automatic adoption. Conclusions: Hospitals should not merely purchase, install, and update AI systems. They should prescribe, monitor, audit, renew, restrict, and, when necessary, deprescribe them. The AI Hospital Formulary is proposed as a complementary institutional layer that converts external standards and existing governance approaches into documented portfolio decisions at the hospital level. Full article

Background: Migrant agricultural workers in Italy often experience social and health vulnerabilities, including unstable housing and limited access to primary care. In Southern Italy, many live in informal settlements and seek care through outreach services. This study describes patterns of pharmacological treatment in this population and examines how they relate to the clinical conditions managed in mobile clinics. Methods: We analyzed routinely collected data from 2928 unique patients (8547 clinical encounters; 8965 treatment occurrences) managed by Doctors with Africa CUAMM mobile clinics in 12 informal settlements in Apulia, Italy, between 2017 and 2026. Diagnoses were grouped into clinical categories, and pharmacological treatments were classified by therapeutic class. We conducted a descriptive analysis of the distribution of diagnostic categories and associated treatments. Results: The population was predominantly male (96.5%), young (81% <45 years), and largely excluded from regular primary care (93.5% without a General Practitioner). Musculoskeletal disorders and fatigue were the leading diagnostic category (34.0%), followed by gastrointestinal (13.5%) and respiratory conditions (13.0%). Non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics were the most frequently recorded treatments (32.6% of treatment occurrences). Among musculoskeletal presentations, NSAIDs were used in 76% of cases. Gastroprotective agents were documented in 52% of encounters with gastrointestinal symptoms. Among cardiovascular presentations, 87.7% of treatment occurrences involved chronic management with antihypertensives or beta-blockers. Conclusions: In this outreach setting, medication use provides a descriptive picture of common health problems and treatment responses among migrant agricultural workers living in informal settlements. The prominent use of symptomatic pharmacological relief, particularly NSAIDs in musculoskeletal conditions, suggests that care is often focused on managing pain and acute complaints in a population facing barriers to continuous primary care. These findings support the need for stronger inclusion of migrant workers in the National Health Service and for policies that address underlying social and structural determinants of health. Full article

Purpose: Breast cancer has been recognised as a chronic condition, with survivors experiencing long-term physical and psychosocial effects following treatment. Supporting breast cancer survivors to self-manage their health can optimise health-related quality of life and reduce symptom burden. Self-management education (SME) has been advocated at the policy and programme level in Australian primary care, but its uptake is often limited. This study explores healthcare professionals’ (HCPs) experiences and perceptions of SME in primary care, aiming to identify factors influencing its implementation and to support survivorship care for breast cancer survivors in Australia. Methods: A qualitative descriptive approach was adopted involving in-depth semi-structured interviews. Convenience sampling was used to recruit HCPs across the three primary care clinics in the Greater Brisbane area. The interviews were conducted based on an interview guide. Each interview was audio-recorded and transcribed verbatim. Descriptive content analysis was used to analyse the data. Results: Fourteen participants were interviewed across three primary care settings, including five general practitioners and nine registered nurses. Three categories were synthesised from the data: (1) Meaning and role of SM/SME; (2) Suboptimal SME in current practice; (3) Perceived factors impacting SME delivery in practice. Each category had two to six subcategories for the participants. Conclusions: The findings highlighted the importance and perceived benefits of SME for breast cancer survivors and HCPs in Australian primary care. However, the integration of SME into primary care remained suboptimal due to a combination of systemic, organisational, and healthcare provider factors. Evidence-based resources, particularly guidelines and training, are essential to equip HCPs to effectively integrate SME into routine care for breast cancer survivors. Full article

Background/Objectives: Medical devices are essential to modern healthcare, but their adoption is often driven by regulatory conformity, clinical enthusiasm, procurement pressures and vendor-led innovation rather than systematic evaluation of comparative value. CE marking and related regulatory mechanisms are necessary for market access; however, they do not determine whether a device improves patient-related outcomes compared with existing alternatives, whether its benefits justify its total costs, or whether it can be implemented safely in routine care. This narrative review examines why medical devices require a dedicated life-cycle health technology assessment (HTA) approach and proposes an operational framework linking assessment to adoption, evidence generation, reassessment and disinvestment. Methods: A structured targeted search covered peer-reviewed literature and policy or institutional documents addressing HTA, medical devices, regulation, economic evaluation, real-world evidence, hospital-based HTA, procurement digital and AI-enabled devices, patient involvement and post-market reassessment. Results: Medical devices differ from pharmaceuticals through user dependence, learning curves, procedure dependence, short product life cycles, incremental modification, heterogeneous comparators, limited randomized evidence and hidden life-cycle costs. These features create clinical, economic, organizational and implementation uncertainty after market entry. The proposed model specifies six linked phases: horizon scanning and early dialogue, pre-adoption appraisal, an explicit adoption decision, controlled implementation, real-world monitoring and scheduled or trigger-based reassessment leading to continuation, scale-up, restriction, or disinvestment. Practical constraints include fragmented data infrastructure, the cost of maintaining registries and residual confounding in real-world evidence. Conclusions: Medical device HTA should move beyond one-time pre-adoption assessment toward a decision-linked life-cycle model that integrates comparative value, patient and public involvement, procurement, implementation governance, real-world evidence, version monitoring, reassessment and disinvestment. This approach can support responsible innovation, patient safety, transparent procurement and sustainable health-system value. Full article

Introduction: Ultra-processed foods (UPFs) are characterized by high levels of additives such as sugars, fats, and preservatives and, due to their composition, represent a major public health concern, being associated with several adverse effects, including impacts on the immune system. People living with HIV (PLHIV) present immune dysfunctions resulting from viral infection and may therefore be particularly vulnerable to the effects of UPF consumption. In this context, investigating this association is necessary to support healthcare strategies and improve assistance for PLHIV. Objective: To investigate the relationship between UPF consumption and the lymphocyte profile of PLHIV. Methods: This was a cross-sectional study. PLHIV receiving outpatient follow-up care for at least six months participated in the study and were categorized according to UPF consumption (≤2 times/week; >2 times/week). Sociodemographic data, UPF consumption assessed through a food frequency questionnaire, anthropometric measurements, and blood samples were collected. Association, comparison, and correlation tests were performed, with statistical significance set at p < 0.05. After adjustment, lymphocyte percentage remained independently associated with UPF consumption. Results: A total of 92 PLHIV participated in the study, with a mean age of 43.0 ± 12.0 years. PLHIV with higher UPF consumption presented lower counts of CD3+ lymphocytes (p = 0.03), CD45+ lymphocytes (p = 0.01), and total lymphocytes (p = 0.03) compared to those with lower UPF consumption. UPF consumption was negatively correlated with CD3+ (r = −0.21; p = 0.04), CD4+ (r = −0.20; p = 0.05), CD45+ (r = −0.23; p = 0.02), and total lymphocyte counts (r = −0.25; p = 0.01). No associations were found between sociodemographic or clinical variables and UPF consumption among PLHIV (p > 0.05). Conclusions: High UPF consumption was associated with lower lymphocyte counts in PLHIV, suggesting a potential association between dietary patterns and immune status. Therefore, the implementation of public health policies and nutritional follow-up is necessary to reduce UPF consumption and promote healthy eating among PLHIV. Full article