Cost-Impact Analysis of a Novel Diagnostic Test to Assess Community-Acquired Pneumonia Etiology in the Emergency Department Setting: A Multi-Country European Study.

BACKGROUND: We aimed to estimate the economic and clinical impacts of a novel diagnostic test called LIAISON® MeMed BV® (LMMBV), which can differentiate bacterial from viral infections, in patients with community-acquired pneumonia (CAP) in emergency departments. METHODS: A cost-impact simulation model was developed to investigate the financial consequences of the introduction of LMMBV into the standard of care (SOC) diagnostic process in Italy, Germany, and Spain. Clinical outcomes were expressed as antibiotic patients and days saved, reduced hospital admissions, and shortened hospital length of stay (LOS). Cost savings were evaluated from the perspectives of third-party payers and hospitals. A deterministic sensitivity analysis (DSA) was carried out. RESULTS: LMMBV was associated with a reduction in antibiotic prescriptions, treatment duration, and LOS. Furthermore, the adoption of LMMBV would allow savings per patient up to EUR 364 and EUR 328 for hospitals and EUR 91 and EUR 59 for payers in Italy and Germany, respectively. In Spain, average savings per patient could reach up to EUR 165 for both payers and hospitals. Savings were most sensitive to test accuracy, with DSA confirming the robustness of the results. CONCLUSIONS: Combining LMMBV with the current SOC diagnostic process is expected to provide clinical and economic benefits in Italy, Germany, and Spain.

Dupilumab: Direct Cost and Clinical Evaluation in Patients with Atopic Dermatitis.

Health care spending in Italy is high and continues to increase; assessing the long-term health and economic outcomes of new therapies is essential. Atopic dermatitis (AD) is a chronic, pruritic, immune-mediated inflammatory dermatosis, a clinical condition that significantly affects patients' quality of life at a high cost and requires continuous care. This retrospective study aimed to assess the direct cost and adverse drug reactions (ADRs) of Dupilumab and patients' clinical outcomes. All AD patients treated with Dupilumab at the Sassari University Hospital, Italy, between January 2019 and December 2021 were included. Eczema Area Severity Index, Dermatology Life Quality Index, and Itch Numeric Rating Scale scores were measured. ADRs and drug expenses were analyzed. A statistically significant posttreatment improvement was observed for all the indices measured: EASI (P < 0.0001), DLQI (P < 0.0001), NRS (P < 0.0001). The total expenditure for Dupilumab, in the observed period, amounted to € 589.748,66 for 1358 doses, and a positive correlation was shown between annual expenditure and delta percentage of variation pre- and posttreatment for the clinical parameters evaluated.

A systematic review of cost-utility analyses of screening methods in latent tuberculosis infection in high-risk populations.

BACKGROUND: The World Health Organisation (WHO) recommends that testing and treatment for latent tuberculosis infection (LTBI) should be undertaken in high-risk groups using either interferon gamma release assays (IGRAs) or a tuberculin skin test (TST). As IGRAs are more expensive than TST, an assessment of the cost-effectiveness of IGRAs can guide decision makers on the most appropriate choice of test for different high-risk populations. This current review aimed to provide the most up to date evidence on the cost-effectiveness evidence on LTBI testing in high-risk groups-specifically evidence reporting the costs per QALY of different testing strategies. METHODS: A comprehensive search of databases including MEDLINE, EMBASE and NHS-EED was undertaken from 2011 up to March 2021. Studies were screened and extracted by two independent reviewers. The study quality was assessed using the Bias in Economic Evaluation Checklist (ECOBIAS). A narrative synthesis of the included studies was undertaken. RESULTS: Thirty-two studies reported in thirty-three documents were included in this review. Quality of included studies was generally high, although there was a weakness across all studies referencing sources correctly and/or justifying choices of parameter values chosen or assumptions where parameter values were not available. Inclusions of IGRAs in testing strategies was consistently found across studies to be cost-effective but this result was sensitive to underlying LTBI prevalence rates. CONCLUSION: While some concerns remain about uncertainty in parameter values used across included studies, the evidence base since 2010 has grown with modelling approaches addressing the weakness pointed out in previous reviews but still reaching the same conclusion that IGRAs are likely to be cost-effective in high-income countries for high-risk populations. Evidence is also required on the cost-effectiveness of different strategies in low to middle income countries and countries with high TB burden.

Sex Affects Human Premature Neonates' Blood Metabolome According to Gestational Age, Parenteral Nutrition, and Caffeine Treatment.

Prematurity is the leading cause of neonatal deaths and high economic costs; it depends on numerous biological and social factors, and is highly prevalent in males. Several factors can affect the metabolome of premature infants. Accordingly, the aim of the present study was to analyze the role played by gestational age (GA), parenteral nutrition (PN), and caffeine treatment in sex-related differences of blood metabolome of premature neonates through a MS/MS-based targeted metabolomic approach for the detection of amino acids and acylcarnitines in dried blood spots. GA affected the blood metabolome of premature neonates: male and female very premature infants (VPI) diverged in amino acids but not in acylcarnitines, whereas the opposite was observed in moderate or late preterm infants (MLPI). Moreover, an important reduction of metabolites was observed in female VPI fed with PN, suggesting that PN might not satisfy an infant's nutritional needs. Caffeine showed the highest significant impact on metabolite levels of male MLPI. This study proves the presence of a sex-dependent metabolome in premature infants, which is affected by GA and pharmacological treatment (e.g., caffeine). Furthermore, it describes an integrated relationship among several features of physiology and health.

Ultrasonographic assessment of abdominal aortic elasticity in hypertensive dogs.

BACKGROUND: Systemic hypertension (SH) is a persistent and pathological increase in arterial blood pressure (BP). Chronic SH leads to an increase in aortic (Ao) stiffness, and measuring Ao elasticity is useful for estimating Ao stiffness in humans. Currently, no literature in veterinary medicine describes noninvasive assessment of abdominal Ao elasticity in dogs with SH. OBJECTIVE: Compare ultrasonographic-derived abdominal Ao strain (AoSt) between hypertensive (HT) and normotensive (NT) dogs. ANIMALS: Fifty privately-owned dogs with clinical signs, conditions, or both potentially associated with SH. METHODS: Prospective observational case-control study. Aortic stiffness was estimated by calculating AoSt as follows: AoSt = ([AoDs - AoDd]/AoDd) × 100, where AoDs and AoDd are the Ao diameter in systole and in diastole, respectively. Aortic stiffness was calculated from 2 different Ao transverse sections, the first caudal to the left renal artery (K_AoSt), and the second cranial to the external iliac arteries (I_AoSt). RESULTS: Thirty-two dogs were included in the HT group and 18 in the NT group. Both K_AoSt and I_AoSt in HT dogs were significantly lower (P < .05) than in NT dogs (7.4 ± SD 3.6) vs 10.3 (±3.8) and 5.7 (interquartile range [IQR], 3.9-7.5) vs 8.1 (IQR, 7-10.3), respectively. Only K_AoSt was significantly influenced by age. CONCLUSIONS AND CLINICAL IMPORTANCE: Ultrasonographic Ao elasticity assessment was feasible to compare HT and NT dogs. Results indicated that K_AoSt and I_AoSt indices can be used to assess SH-related Ao stiffness, especially when indirect BP measurements are inconsistent or inaccurate. Additional studies to assess the AoSt in healthy dogs of various ages are needed.

Determinants of patient and health system delay among Italian and foreign-born patients with pulmonary tuberculosis: a multicentre cross-sectional study.

OBJECTIVES: The aim of this cross-sectional study was to identify key factors associated with patient delay (PD), health system delay (HSD) and total delay (TOTD) in patients with tuberculosis (TB) to inform control programmes. SETTING: The study was conducted in four Italian regions in 2014-2016. Data were obtained using a questionnaire including: sociodemographic and lifestyle data, TB comorbidities, patient knowledge and attitudes towards TB, stigma, access to TB care and health-seeking behaviours. PARTICIPANTS: Patients' inclusion criteria were being diagnosed as a new smear positive pulmonary TB case and living in one of the participating Italian regions. Overall, 344 patients from 30 healthcare centres were invited to participate and 253 patients were included in the analysis (26.5% non-response rate); 63.6% were males and 55.7% were non-Italian born. OUTCOME MEASURES: Risk factors for PD, HSD and TOTD in patients with TB were assessed by multivariable analysis. Adjusted ORs (aOR) and 95% CIs were calculated. RESULTS: Median PD, HSD and TOTD were 30, 11 and 45 days, respectively. Factors associated with longer PD were: stigma (aOR 2.30; 95% CI 1.06 to 4.98), chest pain (aOR 2.67; 95% CI 1.24 to 6.49), weight loss (aOR 4.66; 95% CI 2.16 to 10.05), paying for transportation (aOR 2.66; 95% CI 1.24 to 5.74) and distance to the health centre (aOR 2.46; 95% CI 1.05 to 5.74) (the latter three were also associated with TOTD). Shorter HSD was associated with foreign-born and female status (aOR 0.50; 95% CI 0.27 to 0.91; aOR 0.28; 95% CI 0.15 to 0.53, respectively), dizziness (aOR 0.18, 95% CI 0.04 to 0.78) and seeking care at hospital (aOR 0.35; 95% CI 0.18 to 0.66). Prior unspecific treatment was associated with longer HSD (aOR 2.25; 95% CI 1.19 to 4.25) and TOTD (aOR 2.55; 95% CI 1.18 to 5.82). Haemoptysis (aOR 0.12; 95% CI 0.03 to 0.43) and repeated visits with the same provider (aOR 0.29; 95% CI 0.11 to 0.76) showed shorter TOTD. CONCLUSIONS: This study identifies several determinants of delays associated with patient's behaviours and healthcare qualities. Tackling TB effectively requires addressing key risk factors that make individuals more vulnerable by the means of public health policy, cooperation and advocacy to ensure that all patients have easy access to care and receive high-quality healthcare.

Socioeconomic status and biomedical risk factors in migrants and native tuberculosis patients in Italy.

Action on social determinants is a main component of the World Health Organization End Tuberculosis (TB) Strategy. The aim of the study was to collect information on socioeconomic characteristics and biomedical risk factors in migrant TB patients in Italy and compare it with data collected among Italian TB patients. A cross-sectional study was conducted among TB patients aged ≥18 years over a 12-months enrolment period in 12 major Italian hospitals. Information on education, employment, housing and income was collected, and European Union Statistics on Income and Living Conditions index was used to assess material deprivation. Among migrants, we also analyzed factors associated with severe material deprivation. Migrants were compared with younger (18-64 years) and older (65+ years) Italians patients. Out of 755 patients enrolled (with a median age of 42 years, interquartile range: 31-53), 65% were migrants. Pulmonary, microbiologically confirmed, and new cases were 80%, 73%, and 87% respectively. Prevalence of co-morbidities (i.e. diabetes, chronic kidney disease, neoplastic diseases and use of immunosuppressive drugs) was lower among migrants compared to Italian TB patients, while indicators of socioeconomic status, income and housing conditions were worst in migrants. Forty-six percent of migrants were severely deprived vs. 9% of Italians (p<0.0001, 11.3% and 5.5% among younger and older Italians, respectively). Among migrants, being male, older, irregular, unemployed, with a shorter time spent in Italy, a lower education level, and without a co-morbidity diagnosis were factors associated with severe material deprivation at multi-variable logistic regression. Moreover, socioeconomic indicators for Italian patients did not differ from those reported for the general Italian population, while migrant TB patients seem to have a higher prevalence of severe material deprivation than other migrants residing in Italy. Intervention to address the needs of this population are urgent.

Breaking the barriers: Migrants and tuberculosis.

Tuberculosis (TB) can represent an important clinical and public health in developing and developed countries. Low- and middle-income countries are facing an epidemic which is difficult to address because of the drug-resistance spread and the association of TB with HIV/AIDS. High-income countries, whose TB incidence has decreased in the last decades, can be involved in new TB epidemic waves owing to social, healthcare, and economic hurdles and challenges. In particular, migrants coming from high TB incidence countries can represent a new epidemiological issue in the TB care and control in geographical areas where primary care and specialized centres are not equipped to face the clinical and public health issues associated with the TB disease. The healthcare management of individuals with a latent TB infection or the TB disease is heterogeneous and different policies are in place in Europe, and, specifically, in EU countries. Scientific evidence on how to early and efficiently detect TB cases is missing, as well as diagnostic tools to diagnose those who have latent TB infection do not show adequate accuracy. Countries like Greece and Italy have political difficulties in the management of migrants and the poor living conditions in the migration centres can increase the probability of Mycobacterium tuberculosis transmission. A clear advocacy and political commitment are urgently required. The current migration trends represent a threat from a human and a healthcare perspective. New homogeneous and target-oriented policies and strategies are needed to improve the health of the migrant and of the autochthonous populations.

Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.

Evidence-based approach for continuous improvement of occupational health.

INTRODUCTION: It was recognized early on that an Evidence-Based Medicine (EBM) approach could be applied to Public Health (PH), including the area of Occupational Health (OH). The aim of Evidence-Based Occupational Health (EBOH) is to ensure safety, health, and well-being in the workplace. Currently, high-quality research is necessary in order to provide arguments and scientific evidence upon which effective, efficient, and sustainable preventive measures and policies are to be developed in the workplace in Western countries. Occupational physicians need to integrate available scientific evidence and existing recommendations with a framework of national employment laws and regulations. OBJECTIVE: This paper addresses the state of the art of scientific evidence available in the field (i.e., efficacy of interventions, usefulness of education and training of workers, and need of a multidisciplinary strategy integrated within the national PH programs) and the main critical issues for their implementation. CONCLUSIONS: Promoting good health is a fundamental part of the smart, inclusive growth objectives of Europe 2020 - Europe's growth strategy: keeping people healthy and active for longer has a positive impact on productivity and competitiveness. It appears clear that health quality and safety in the workplace play a key role for smart, sustainable, and inclusive growth in Western countries.

Risk Assessment of Tuberculosis in Contacts by IFN-γ Release Assays. A Tuberculosis Network European Trials Group Study.

RATIONALE: Latent infection with Mycobacterium tuberculosis is defined by a positive IFN-γ release assay (IGRA) result in the absence of active tuberculosis. Only few, mostly monocentric studies have evaluated the role of IGRAs to predict the development of tuberculosis in recent contacts in low-incidence countries of tuberculosis. OBJECTIVES: To analyze IGRA results and the effect of preventive chemotherapy on tuberculosis progression rates among recent contacts. METHODS: Results from contact investigations at 26 centers in 10 European countries including testing for latent infection with M. tuberculosis by the QuantiFERON-TB Gold In-Tube (QFT) test or the T-SPOT.TB (TSPOT) were prospectively collected and analyzed. MEASUREMENTS AND MAIN RESULTS: Among 5,020 contacts of 1,023 index cases, 25 prevalent secondary cases were identified at screening. Twenty-four incident cases occurred among 4,513 contacts during 12,326 years of cumulative follow-up. In those with a positive IGRA result, tuberculosis incidence was 0.2 (QFT) and 0 (TSPOT) per 100 patient-years when contacts received preventive chemotherapy versus 1.2 (QFT) and 0.8 (TSPOT) per 100 patient-years in those not treated (38 and 37 patients needed to be treated to prevent one case, respectively). Positive and negative predictive values were 1.9% (95% confidence interval [CI], 1.1-3.0) and 99.9% (95% CI, 99.7-100) for the QFT and 0.7% (95% CI, 0.1-2.6) and 99.7% (95% CI, 99.1-99.9) for the TSPOT. CONCLUSIONS: Tuberculosis rarely developed among contacts, and preventive chemotherapy effectively reduced the tuberculosis risk among IGRA-positive contacts. Although the negative predictive value of IGRAs is high, the risk for the development of tuberculosis is poorly predicted by these assays.