Estimate of Uncertainty of Measurement from a Single-Laboratory Validation Study: Application to the Determination of Lead in Blood

Abstract Background: Lead is an environmental pollutant, and human exposure is assessed by monitoring lead concentrations in blood. Because the main source of environmental exposure has been the use of leaded gasoline, its phase-out has led to decreased lead concentrations in the general population. Therefore, validated analytical methods for the determination of lower lead concentrations in blood (<150 μg/L) are needed. In addition, new ISO standards require that laboratories determine and specify the uncertainty of their results. Methods: We validated a method to determine lead in blood at concentrations up to 150 μg/L by electrothermal atomic absorption spectrometry with Zeeman background correction according to EURACHEM guidelines. Blood samples were diluted (1:1 by volume) with 2 mL/L Triton X-100. NH4H2PO4 (5 g/L) and Mg(NO3)2 (0.5 g/L) were used as modifiers. Matrix-matched standards were used for calibration. Results: We determined the limits of detection (3.1 μg/L) and quantification (9.4 μg/L). Repeatability and intermediate imprecision within the range 35–150 μg/L were <5.5% and <6.0%, respectively. We assessed trueness by use of certified reference materials, by recovery tests, and by comparison with target values of other reference materials (candidate external quality assessment samples). The expanded uncertainty ranged from 20% to 16% (with a confidence level of 95%) depending on concentration. Conclusions: This study provides a working example of the estimate of uncertainty from method performance data according to the EURACHEM/CITAC guidelines. The estimated uncertainty is compatible with quality specifications for the analysis of lead in blood adopted in the US and the European Union

Italian translation and cultural adaptation of the communication assessment tool in an outpatient surgical clinic

The aim of the study is to translate and cross-culturally adapt, for use in the Italian context, the Communication Assessment Tool (CAT) developed by Makoul and colleagues

How healthy is community-dwelling elderly population? Results from southern Italy

PURPOSE To explore the frequency of polypharmacy, functional and cognitive capacity among the elderly in Southern Italy. METHODS Populationbased retrospective cross-sectional study. Information were retrieved from electronic-geriatric-forms matched by record-linkage to outpatient pharmacy-records. The following domains were collected from geriatric forms: BMI, cognitive capacity (SPMSQ), functional status Barthel-index), mobility, living condition. Polypharmacy status was categorized as non-polypharmacy (0-4), polypharmacy (5-9) and excessive-polypharmacy (>10). Prevalence of all variables were stratified by age and polypharmacy group. RESULTS 88,878 old people received a geriatric assessment in the years 2013-2014. Mean age was 74.8 (±7.3) years, 56.6% females. Proportion of elderly in excessive-polypharmacy increased with age (18.9% in 65-75 age-group; 27.9% in >85). Referring to cognitive capacity, the proportion of lucid patients decreased with age (from 94.3% to 58.1%), while confused patient increased with age (from 4.7% to 30.9%). Proportion of subjects with a decline in cognitive status, functional status and mobility increased in polypharmacy and excessive polypharmacy group. CONCLUSION Polypharmacy is common in people aged 65 years and older with difficulties in activities of daily living and impaired cognition. Furthermore, its prevalence raises with increasing age. Preventive strategies such us optimization of drug regimen should be performed routinely to reduce risk of adverse-health-events

Drug repurposing in oncology: a systematic review of randomized controlled clinical trials

Quality pharmacological treatment can improve survival in many types of cancer. Drug repurposing offers advantages in comparison with traditional drug development procedures, reducing time and risk. This systematic review identified the most recent randomized controlled clinical trials that focus on drug repurposing in oncology. We found that only a few clinical trials were placebo-controlled or standard-of-care-alone-controlled. Metformin has been studied for potential use in various types of cancer, including prostate, lung, and pancreatic cancer. Other studies assessed the possible use of the antiparasitic agent mebendazole in colorectal cancer and of propranolol in multiple myeloma or, when combined with etodolac, in breast cancer. We were able to identify trials that study the potential use of known antineoplastics in other non-oncological conditions, such as imatinib for severe coronavirus disease in 2019 or a study protocol aiming to assess the possible repurposing of leuprolide for Alzheimer’s disease. Major limitations of these clinical trials were the small sample size, the high clinical heterogeneity of the participants regarding the stage of the neoplastic disease, and the lack of accounting for multimorbidity and other baseline clinical characteristics. Drug repurposing possibilities in oncology must be carefully examined with well-designed trials, considering factors that could influence prognosis

The tosca registry: an ongoing, observational, multicenter registry for chronic heart failure

The ageing of the population in western countries, the continuous increase of the prevalence of chronic diseases, the frequent coexistence of several morbid conditions (comorbidity) requires health professionals and Institutions to face difficult challenges, including increasing costs, need for more effective and sustainable therapies, and organizational issues. The European Innovation Partnership on Active and Healthy Ageing aims at enabling European citizens to lead healthy, active and independent lives while ageing. We herein discuss some key concepts bearing a special significance in the light of the Partnership aims, and present research and educational projects active in our local environment. Among these, the multicentre project TOSCA (Trattamento Ormonale nello Scompenso CArdiaco) that, although primarily focused on the understanding of the interactions between hormones and chronic heart failure (CHF), is also aimed at developing more effective models of clinical care. We provide the scientific background and current stage of the project. In the context of a growing complexity of the patients’ clinical management, the polipharmacy is a new arising challenge for clinicians, bearing direct economic, organizational and clinical implications. A better understanding, characterization and management of this issue represent an additional target of the TOSCA network

PharmaCare 2018

[Italiano]: Il farmaco, nella sua accezione più ampia e generale, può essere ritenuto un bene sociale, la cui valenza simbolica e curativa varia in relazione alla dimensione ambientale e culturale nel quale si inserisce. In tal senso, le prescrizioni farmaceutiche rappresentano un indicatore privilegiato per la conoscenza del sistema salute di un determinato territorio, poiché costituiscono un punto di intersezione ideale tra la prospettiva medica e quella di mercato. Siffatte considerazioni hanno sollecitato l’elaborazione di questo Report che si pone, come obiettivi dichiarati, quello di essere uno strumento utile alla pianificazione di interventi di sanità pubblica, quanto quello di svolgere analisi approfondite sulle caratteristiche dei soggetti che usano i farmaci e sulle modalità di trattamento degli stessi, permettendo studi di appropriatezza prescrittiva su specifiche aree di rilevanza clinica e su specifiche coorti di soggetti. “PharmaCaRe Report 2018” è stato realizzato dal CIRFF (Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione) dell’Università degli Studi di Napoli Federico II, in collaborazione con la Direzione Generale della Tutela della Salute della Regione Campania, per delineare un quadro dettagliato circa il consumo e la prescrizione dei farmaci in Campania nel 2018. Questo Report intende infatti fornire una fotografia dettagliata dell’utilizzo che, in Campania, viene fatto dei farmaci in termini di spesa, volumi e tipologia. Le analisi dei dati prodotte offrono spunti importanti per correlare la prevalenza delle patologie nel territorio con il corrispondente utilizzo dei farmaci e suggeriscono un’interpretazione dei principali fattori che influenzano la variabilità nella prescrizione. La disponibilità di una banca dati che copre una popolazione assistibile di circa sei milioni di abitanti è d’altronde un potente strumento di ricerca per studiare gli effetti dell’utilizzo dei farmaci in condizioni di Real-World. La conoscenza delle dinamiche prescrittive, in termini qualitativi (appropriatezza d’uso), oltre che quantitativi (volumi di utilizzo) è la condizione necessaria per inquadrare in un contesto razionale la politica del farmaco, anche sotto il profilo della valutazione degli effetti degli interventi che il mercato, le normative o la cultura del farmaco sviluppano nel tempo. Per tali ragioni, “PharmaCaRe Report 2018” rappresenta un utile quanto prezioso supporto ai decisori per individuare strategie volte a ottimizzare l’allocazione delle risorse, nonché migliorare i percorsi di cura attraverso un monitoraggio costante, la promozione di più elevati standard di cura e l’uso sicuro, efficiente ed efficace dei farmaci ./[English]: In its broadest and most general sense, the drug can be considered a public resource, whose symbolic and curative value varies in relation to the environmental and cultural dimension in which it is embedded. In this sense, pharmaceutical prescriptions represent a privileged indicator for the knowledge of the health system of a given territory, since they constitute an ideal intersection point between the medical and the market perspective. Such considerations prompted the preparation of this Report. “PharmaCaRe Report 2018” has been produced by CIRFF (Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione) of the Federico II University of Naples, in collaboration with the Directorate-General for Health Protection of the Campania Region, to provide a detailed overview of the pharmaceutical consumption and prescriptions in Campania in 2018. This Report aims to provide a detailed picture of the use of medicines in the general population in Campania, in terms of expenditure, volumes and type. The analyses of the data produced offer important clues for correlating the prevalence of diseases in this area with the respective use of medicines and suggest an interpretation of the main factors influencing prescriptions' variability. The availability of a database covering a patient population of around six million is a powerful research tool for studying the effects of drug use in Real-World conditions. Knowledge of the dynamics of prescription, in qualitative terms (appropriateness of use), as well as quantitative (volumes of use) is the necessary condition to frame the drug policy in a rational context, also in terms of evaluating the effects of the interventions that the market, regulations or drug culture develop over time. For these reasons, “PharmaCaRe Report 2018” represents a useful and valuable tool for political decision-makers in identifying strategies aimed at optimizing the allocation of resources, as well as improving care pathways through constant monitoring, the promotion of higher standards of care and safe, efficient and effective use of drugs

Implementing an ict-based polypharmacy management program in Italy

Although there is evidence of a growing awareness of the problem, no official policy statements or regulatory guidelines on polypharmacy have been released up to date by Italian Health Authorities. Medication review, application of appropriateness criteria and computerized prescription support systems are all possible approaches in order to improve the quality of prescribing in older persons. More focused training courses on multimorbidity and polytherapy management are encouraged. Furthermore a multidisciplinary approach integrating different health care professionals (physicians, pharmacists, and nurses) may positively impact on reducing the sense of fear related to discontinue or substitute drugs prescribed by others; the fragmentation of therapy among different specialists; reducing costs; and improving adverse drug reaction detection and reporting. Aiming at achieving the individualized pharmacotherapy, a multidisciplinary approach starting with identification of patients and risk for drug-related problems, followed by medication review overtime and use of inappropriateness criteria, supported by computerized systems has been proposed

Innovative approaches to active and healthy ageing: Campania experience to improve the adoption of innovative good practices

The demographic projections on the European population predict that people aged over 60 will increase by about two million/year in the next decades. Since 2012, the Campania Reference Site of the European Innovation Partnership on Active and Healthy Ageing supports the innovation of the Regional Health System, to face up demographic changes and sustainability. Campania Reference Site provides the opportunity to connect loco-regional stakeholders in social and health care services (universities, healthcare providers, social services, local communities and municipalities), with international organizations, in order to adopt and scale up innovative solutions and approaches. This paper describes the building process of Campania Reference Site and the main results achieved, that have been allowing it to become a hub for open innovation in the field of active and healthy aging at regional, national and international level

ARIA digital anamorphosis : Digital transformation of health and care in airway diseases from research to practice

Digital anamorphosis is used to define a distorted image of health and care that may be viewed correctly using digital tools and strategies. MASK digital anamorphosis represents the process used by MASK to develop the digital transformation of health and care in rhinitis. It strengthens the ARIA change management strategy in the prevention and management of airway disease. The MASK strategy is based on validated digital tools. Using the MASK digital tool and the CARAT online enhanced clinical framework, solutions for practical steps of digital enhancement of care are proposed.Peer reviewe

Cabbage and fermented vegetables : From death rate heterogeneity in countries to candidates for mitigation strategies of severe COVID-19

Large differences in COVID-19 death rates exist between countries and between regions of the same country. Some very low death rate countries such as Eastern Asia, Central Europe, or the Balkans have a common feature of eating large quantities of fermented foods. Although biases exist when examining ecological studies, fermented vegetables or cabbage have been associated with low death rates in European countries. SARS-CoV-2 binds to its receptor, the angiotensin-converting enzyme 2 (ACE2). As a result of SARS-CoV-2 binding, ACE2 downregulation enhances the angiotensin II receptor type 1 (AT(1)R) axis associated with oxidative stress. This leads to insulin resistance as well as lung and endothelial damage, two severe outcomes of COVID-19. The nuclear factor (erythroid-derived 2)-like 2 (Nrf2) is the most potent antioxidant in humans and can block in particular the AT(1)R axis. Cabbage contains precursors of sulforaphane, the most active natural activator of Nrf2. Fermented vegetables contain many lactobacilli, which are also potent Nrf2 activators. Three examples are: kimchi in Korea, westernized foods, and the slum paradox. It is proposed that fermented cabbage is a proof-of-concept of dietary manipulations that may enhance Nrf2-associated antioxidant effects, helpful in mitigating COVID-19 severity.Peer reviewe