Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the {CAESAR} project)

Background: This analysis describes the use of riluzole in amyotrophic lateral sclerosis (ALS) individuals with contraindications and off-label use for subjects with other motor neuron diseases (o-MND) in the Italian regions of Latium, Tuscany and Umbria.Methods: A cohort of adults with ALS prescribed with riluzole during the years 2016–2019 was enrolled from administrative healthcare databases, excluding subjects with o-MND in the preceding 5 years. Being affected by ALS for more than 5 years, presence of tracheostomy, renal or hepatic failure were considered as contraindications to the use of riluzole. A cohort of adults with o-MND was enrolled in 2016–2019 for whom off-label use of riluzole was retrieved up to 4 years, analysing over the time differences related to sex.Results: Among 206 ALS individuals prescribed with riluzole in Latium, 336 in Tuscany and 60 in Umbria, less than 1% were diagnosed with ALS for more than 5 years. Less than 2% were tracheotomised or affected by hepatic failure. Renal failure was documented for 1.9%, 2.7%, and 5.0% of ALS individuals in Latium, Tuscany and Umbria. The o-MND cohort comprised 264 subjects in Latium, 222 in Tuscany, and 66 in Umbria. Non-negligible off-label riluzole use was observed: 8.5%, 33.0%, and 4.2% in females, and 19.9%, 26.5% and 2.4% in males in Latium, Tuscany and Umbria.Discussion: Riluzole use in ALS individuals in the presence of contraindications is rare, with slightly higher numbers in presence of renal failure. Off-label use in o-MND was found to be non-negligible, with variations between sexes

Stima della prevalenza di broncopneumopatia cronico-ostruttiva basata su dati sanitari correnti, mediante l\u27uso di un algoritmo comune, in differenti aree italiane

Aim: to estimate the prevalence of chronic obstructive pulmonary disease (COPD) by integrating various administrative health information systems. Methods: prevalent COPD cases were defined as those reported in the hospital discharge registry (HDR) and cause of mortality registry (CMR) with codes 490*, 491*, 492*, 494* e 496* of the International diseases classification 9th revision. Annual prevalence was estimated in 35+ year-old residents in six Italian areas of different sizes, in the period 2002-2004. We in- Annunziata Faustini,1 Silvia Cascini,1 Massimo Arc?,1 Daniela Balzi,2 Alessandro Barchielli,2 Cristina Canova,3 Claudia Galassi,4 Enrica Migliore,4,5 Sante Minerba,6 Maria Angela Protti,7 Anna Romanelli,7 Roberta Tessari,3,8 Maria Angela Vigotti,9 Lorenzo Simonato3 1Dipartimento di epidemiologia, ASL RME, Roma 2Unit? operativa di epidemiologia, Azienda sanitaria 10, Firenze 3Dipartimento di medicina ambientale e sanit? pubblica, Universit? di Padova 4Servizio di epidemiologia dei tumori, ASO S. Giovanni Battista, CPO Piemonte e Universit? di Torino 5Unit? di pneumologia, CPA-ASL TO2, Torino 6Unit? di statistica ed epidemiologia, ASL 1 Taranto 7Sezione di epidemiologia e ricerca sui servizi sanitari, IFC-CNR, Pisa 8Unit? di epidemiologia, Dipartimento di prevenzione, Azienda ULSS 12 Veneziana 9Dipartimento di biologia, Universit? di Pisa Corrispondenza: Annunziata Faustini, Dipartimento di epidemiologia, ASL RME, via Santa Costanza 53, 00198 Roma; tel. 06 86060486; fax 06 86060463; e-mail [email protected] cluded cases observed in the previous four years who were alive at the beginning of each year. Results: in 2003, age-standardized prevalence rates varied from 1.6% in Venice to 5% in Taranto. Prevalence was higher in males and increased with age. The highest rates were observed in central (Rome) and southern (Taranto) cities, especially in the 35-64 age group. HDR contributed 91% of cases. Healthtax exemption registry would increase the prevalence estimate by 0.2% if used as a third data source. Conclusions: with respect to the National Health Status suraldelvey, COPD prevalence is underestimated by 1%-3%; this can partly be due to the selection of severe and exacerbated COPD by the algorithm used. However, age, gender and geographical characteristics of prevalent cases were comparable to national estimates. Including cases observed in previous years (longitudinal estimates) increased the point estimate (yearly) of prevalence two or three times in each area.Obiettivi: stimare la prevalenza della broncopneumopatia cronico-ostruttiva (BPCO) mediante l\u27utilizzo integrato di dati sanitari correnti. Metodi: la prevalenza ? stata stimata nella popolazione residente di et? superiore ai 34 anni, in sei aree geografiche, per gli anni 2002-2004. I casi prevalenti sono stati individuati dai registri delle schede di dimissione ospedaliera (SDO) e delle cause di morte (RCM), mediante i codici ICD9-CM 490*, 491*, 492*, 494* e 496* della Classificazione internazionale delle malattie 9? revisione (ICD9-CM). Ai casi osservati in ciascun anno sono stati aggiunti i pazienti ricoverati nei quattro anni precedenti e vivi all\u27inizio dell\u27anno di stima. Risultati: la prevalenza della BPCO, stimata mediante tassi standardizzati per et?, varia per il 2003 dall\u271,6% di Venezia sural 5% di Taranto. La prevalenza ? pi? alta negli uomini e aumenta con l\u27et?; Taranto e Roma presentano i valori pi? elevati, specialmente nelle classi d\u27et? dai 35 ai 64 anni. Fonte principale dei casi sono i ricoveri ospedalieri, con un contributo di almeno il 91%. L\u27uso delle esenzioni ticket come terza fonte incrementa la stima di prevalenza dello 0,2%. Conclusioni: la prevalenza della BPCO ? sottostimata dell\u271%-3% rispetto ai dati dell\u27indagine Istat sullo stato di salute; questo ? in parte attribuibile alla selezione dei casi medio- gravi da parte dell\u27algoritmo utilizzato. Tuttavia le stime mantengono le caratteristiche attese nella distribuzione per genere, et? e area geografica. Inoltre, l\u27uso longitudinale dei dati ospedalieri aumenta di 2-3 volte la stima di prevalenza basata sui dati dei singoli anni

Valutazione di Health Technology Assessment del sistema di sanificazione biologico a base di probiotici del genere Bacillus (PCHS)

Le infezioni correlate all’assistenza: priorità per la salute pubblica Epidemiologia delle infezioni correlate all’assistenza in Italia e loro impatto per la salute pubblica Sistemi di sanificazione attualmente disponibili in Italia Il Probiotic Cleaning Hygiene System (PCHS): caratteristiche della tecnologia, aspetti di efficacia e sicurezza Un sistema di sanificazione a base di probiotici per la riduzione delle infezioni correlate all’assistenza e la resistenza antimicrobica: analisi dell’impatto sul budget Impatto ambientale per la salute pubblica degli attuali sistemi di sanificazione di ambienti/superfici in setting assistenziale e comunitario e potenziali benefici dei nuovi sistemi innovativi Analisi delle principali raccomandazioni nazionali su sanificazione e disinfezione degli ambienti sanitari Valutazione etica dell’utilizzo del Probiotic Cleaning Hygiene System (PCHS) in Italia Elementi chiave per il processo decisional

Numerical Modeling on Fate and Transport of Pollutants in the Vadose Zone

Soil contamination is an issue of paramount importance to assess human health (HHRA) as well as ecological (ERA) risk assessment. To analyze risk scenarios related to contaminated soils, the identification of sources, either of primary or secondary type, as well as the assessment of propagation and fate processes is needed. Although many studies refer to the transport of pollutants in fully saturated porous media, little efforts have been made concerning the case of partially saturated soils so far. The matter is of interest as the contamination in the fully saturated region may take place as a result of the percolation in the vadose zone. Governing equations ruling fate and transport processes in partially saturated soils are here solved numerically by means of a finite element method approach. Richards equations are adopted to describe flow dynamics through the hydraulic conductivity coefficient Ks, while contaminant fate is mainly described by the sorption coefficient Kp. As for the boundary conditions, we consider a local and continuous spill of contaminant at the upper ground of variable thickness. Precipitations are given as step functions whose intensity is derived by considering pluviometric data at the station of Gròmola, Campania Region, Italy. Benzene and tetrachloroethylene (PCE) are taken into account. A comparative analysis is carried out for permeability Ks and distribution Kd coefficients in the range [10−6, 10−4] m/s and [10−5, 10−3] m3/kg. Results are then compared and discussed

Prevalence of chronic kidney disease in the Lazio region, Italy: a classification algorithm based on health information systems

Background Estimating CKD prevalence is difficult. Information on CKD prevalence is rather scanty in Italy and available figures come from surveys in selected geographical areas. Administrative data have been already demonstrated to be an effective tool in estimating the epidemiological burden of diseases, however there is limited experience in literature as far as CKD is concerned. Methods The aim of this study is to develop an algorithm based on regional Health Administrative Databases to identify individuals with CKD and provide estimates of disease prevalence in Lazio Region (Italy); about 5.500.000 inhabitants in 2017. A population-level analysis based on a record-linkage strategy using data from Health Administrative Databases has been applied in Lazio Region. CKD cases were identified between January 1, 2012 and December 31, 2017 using Outpatient Specialist Service Information System, Hospital Discharge Registry, Ticket Exemption Registry and Drug Dispensing Registry. Age-specific and standardized prevalence rates were calculated by gender. CKD cases were classified as higher and lower severity. Results The algorithm identified 99,457 individuals with CKD (mean age 71 years, 55.8% males). The exclusive contributions of each regional source used were: 35,047 (35.2%) from Outpatient Specialist Service Information System, 27,778 (27.9%) from Hospital Discharge Registry, 4143 (4.2%) from Ticket Exemption Registry and 463 (0.5%) from Drug Dispensing Registry; 5.1% of cases were found in all databases. The standardized prevalence rate at December 31, 2017 was 1.76, 2.06% for males and 1.50% for females. The prevalence increased with age, rising from 0.33% (age 0-18) up to 14.18% (age 85+) among males and from 0.25% up to 8.18% among females. The proportion of CKD individuals with lower severity disease was 78.7% in both genders. Conclusions The proposed algorithm represents a novel tool to monitor the burden of CKD disease, that can be used by the regional government to guide the development and implementation of evidence-based pathways of care for CKD patients. The high prevalence of people with CKD of lower severity should be carefully considered in order to promote diagnosis and optimal management at early stages

Validation of a Classification Algorithm for Chronic Kidney Disease Based on Health Information Systems

Background: Chronic kidney disease (CKD) is a common condition, characterized by high burden of comorbidities, mortality and costs. There is a need for developing and validating algorithm for the diagnosis of CKD based on administrative data. Methods: We validated our previously developed algorithm that used administrative data of the Lazio Region (central Italy) to define the presence of CKD on the basis of serum creatinine measurements performed between 2012 and 2015 at the Policlinico Gemelli Hospital. CKD and advanced CKD were defined according to eGFR (2, respectively). Sensitivity, specificity, positive and negative predictive values (PPV/NPV) were computed. Results: During the time span of the study, 30,493 adult participants residing in the Lazio Region had undergone at least 2 serum creatinine measurements separated by at least 3 months. CKD and advanced CKD were present in 11.1% and 2.0% of the study population, respectively. The performance of the algorithm in the identification of CKD was high, with a sensitivity of 51.0%, specificity of 96.5%, PPV of 64.5% and NPV of 94.0%. Using advanced CKD, sensitivity was 62.9% (95% CI 59.0, 66.8), specificity 98.1%, PPV 40.4% and NPV 99.3%. Conclusion: The algorithm based on administrative data has high specificity and adequate performance for more advanced CKD; it can be used to obtain estimates of prevalence of CKD and to perform epidemiological research

How to assess landslide activity and intensity with Persistent Scatterer Interferometry (PSI) : the PSI-based matrix approach

We provide a step-by-step analysis and discussion of the ‘PSI-based matrix approach’, a methodology employing ground deformation velocities derived through Persistent Scatterer Interferometry (PSI) for the assessment of the state of activity and intensity of extremely to very slow landslides. Two matrices based on PSI data are designed respectively for landslides already mapped in preexisting inventories and for newly identified phenomena. Conversely, a unique intensity scale is proposed indiscriminately for both. Major influencing factors of the approach are brought to light by the application in the 14 km2 area of Verbicaro, in Northern Calabria (Italy). These include lack of PSI data within the landslide boundaries, temporal coverage of the available estimates, and need of field checks as well as the operative procedures to set the activity and intensity thresholds. For the area of Verbicaro, we exploit 1992–2011 PSI data from ERS1/2 and RADARSAT1/2 satellites, projecting them along the maximum slope directions. An activity threshold of ±5 mm/year is determined by applying the average projection factor of local slopes to the PSI data precision. The intensity threshold between extremely and very slow phenomena (16 mm/year) is reduced by ~20% to account for temporal and spatial averages being applied to attribute representative velocities to each landslide. The methodology allows assessing the state of activity and the intensity for 13 of the 24 landslides premapped in the 2007 inventory and for two newly identified phenomena. Current limitations due to characteristics and spatial coverage of PSI data are critically tackled within the discussion, jointly with respective implications

One‐year mortality associated with COPD treatment: a comparison of tiotropium and long‐acting beta2‐agonists in three Italian regions: results from the OUTPUL study

Abstract Purpose Long‐acting bronchodilators, i.e. beta‐2‐agonists (LABA) and tiotropium are commonly used in COPD treatment. Choice of a specific agent is based on effectiveness and safety. Evidence yields controversial results with respect to mortality. The present study compared one‐year mortality associated to treatment with tiotropium versus LABA. Methods: A population‐based cohort study using data from Italian health information systems was performed. Patients aged 45+ years, discharged with COPD diagnosis in 2006–2009 were identified. Through record linkage with drug claims, patients who received a first prescription of LABA or tiotropium within 6 months after discharge were enrolled. The main analysis was restricted to naïve users (no prior use of either LABA or tiotropium). We used ‘intention to treat’ (ITT) and ‘as treated’ (AT) approaches. We followed patients for a maximum of 12 months. Hazard ratios (HRs) were calculated by Cox regression including quintiles of propensity score. In sensitivity analysis patients receiving tiotropium + LABA combination were included in the tiotropium group. Results: Among the 33 891 enrolees, 28% were exposed to Tio, 56% to LABA, 16% to both. Overall mean age was 74 years and the mortality rate was 122/1000 person‐years (py) at the ITT analysis and 108/1000 py at the AT analysis. The adjusted HR for tiotropium only compared with LABA only was 1.06 (95%CI: 0.94–1.20) at the ITT analysis and 1.00 (95%CI: 0.93–1.08) at the AT analysis. Results were robust in sensitivity analysis. Conclusions: In this real‐world study use of tiotropium was not associated with an increased risk of one‐year mortality compared with LABA. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd

Population-based cohort study on comparative effectiveness and safety of biologics in inflammatory bowel disease

Background: The comparison of effectiveness and safety of anti-tumor necrosis factor-alpha agents for the treatment of inflammatory bowel disease (IBD) is relevant for clinical practice and stakeholders. Objective: The objective of this study was to compare the risk of abdominal surgery, steroid utilization, and hospitalization for infection in Crohn\ue2\u80\u99s disease (CD) or ulcerative colitis (UC) patients newly treated with infliximab (IFX) or adalimumab (ADA). Methods: A retrospective population-based cohort study was performed using health information systems data from Lazio region, Italy. Patients with CD or UC diagnosis were enrolled at first prescription of IFX or ADA during 2008\ue2\u80\u932014 (index date). Only new drug users were followed for 2 years from the index date. IFX versus ADA adjusted hazard ratios were calculated applying \ue2\u80\u9cintention-to-treat\ue2\u80\u9d approach, controlling for several characteristics and stratifying the analysis on steroid use according to previous drug utilization. Sensitivity analyses were performed according to \ue2\u80\u9cas-treated\ue2\u80\u9d approach, adjusting for propensity score, censoring at switching or discontinuation, and evaluating different lengths of follow-up periods. Results: We enrolled 1,432 IBD patients (42% and 83% exposed to IFX for CD and UC, respectively). In both diseases, treatment effects did not differ in any outcome considered, and sensitivity analyses confirmed the results from the main analysis. Conclusion: In our population-based cohort study, effectiveness and safety data in new users of ADA or IFX with CD or UC were comparable for the outcomes we tested