Journal articles on the topic 'Outcome di salute'

RIASSUNTOScopo - Lo scopo di questo articolo è quello di analizzare la capacità dei sistemi di salute mentale dell'Europa Orientale di attuare reali riforme nel campo della salute mentale.Metodi - Partendo dalle ipotesi della scuola delle relazioni di gruppo, è stata messa in evidenza la tendenza delle organizzazioni ad abbandonare i principali compiti che esse dichiarano di avere, sotto influenze di tipo ideologico, politico e altre influenze legate al contesto. Lo stato della salute mentale dell'Europa orientale è discusso in questa prospettiva.Risultati - È stato accertato che i cambiamenti ed i progressi sono impediti dai ruoli che proibiscono la curiosita e che mettono in discussione le pratiche routinarie.Conclusioni - L'emergere in Europa orientale di una rete di operatori orientati verso la riforma è ritenuto un segno positivo. Un ulteriore importante obiettivo e la sostituzione delle strutture defunte di salute mentale (servizi, ricerca e training) con muove strutture. La sfida al sistema ereditato e inevitabile. Il ruolo di progetti di collaborazione con i paesi occidentali è di estrema importanza.

The link between social determinants, risk factors and health outcome is globally quite demonstrated. Much research is still needed to better understand the mechanism underneath these relationships. Although, study is still needed to define better measures of social determinants (both in relation to health outcome and risk factors), already existing data collection system on risk factors - surveillance - can offer several information on these relationships. Particularly, the observation of changes over time and trends can offer unique information on the effectiveness of health promotion programs and policies in decreasing (increasing) health inequalities.

Si presenta uno studio clinico di un gruppo ambulatoriale a tempo limitato con focus sui problemi interpersonali realizzato utilizzando un modello sviluppato originariamente da MacKenzie che ha concettualizzato un gruppo psicoterapeutico chiuso per adattare interventi brevi e focali all'ambito della salute pubblica. L'articolo intende illustrare l'uso del gruppo sui problemi interpersonali, esemplificare come misure individuali e di gruppo di outcome possono essere un aiuto aggiuntivo della pratica clinica e mostrare come i sintomi ansiosi e depressivi che cadono nello spettro dei disturbi dell'umore possano essere trattati con un modello di gruppo che interviene focalmente sulle relazioni interpersonali attuali. Lo studio mette in evidenza come il gruppo sui problemi interpersonali che prevede solo pochi criteri di esclusione (disturbi della condotta, fase acuta per separazioni, lutti, suicidalità, significative caratteristiche di un disordine borderline di personalità) rappresenti una modalità di trattamento a cui indirizzare un'ampia e difficile popolazione di pazienti afferenti all'area della salute mentale pubblica. 

Il presente lavoro si pone lo scopo di descrivere un intervento diretto ad un paziente con disabilità cognitiva e disturbo Bipolare e la valutazione degli esiti rispetto a: comportamenti di aggressività e furto, terapie farmacologiche assunte e Qualità della Vita. Metodo: È stato utilizzato un intervento integrato con tecniche di tipo Comportamentale e Cognitivo condotto dall'équipe riabilitativa a seguito di valutazione funzionale del caso con modello Comportamentale ABC (Antecedenti Behavior Conseguenze) con un paziente di 41 anni con disabilità cognitiva di tipo moderato e disturbo Bipolare. L'intervento è stato progettato con modelli di condizionamento operante e l'équipe riabilitativa è stata istruita. Al primo intervento è seguito un secondo additivo di token economy volto a rinforzare i comportamenti acquisiti. In fine è stato eseguito un intervento di tipo Cognitivo seguendo i principi della psicoeducazione ed è stato adattato alle capacità di comprensione dell'utente. Gli outcome sono stati il tipo e la quantità di farmaci assunti, il numero di comportamenti aggressivi e di comportamenti di furto, i risultati relativi alla Qualità della Vita percepita. È stato condotto uno studio di caso. Risultati: Sono diminuiti comportamenti di Aggressività e furto, diminuita l'assunzione di Benzodiazepine e di Antipsicotici, diminuita la somministrazione di terapie meccaniche restrittive quali terapia al bisogno Intra Muscolo e isolamento in camera, migliorata la Qualità della Vita nei domini Ruolo e salute Fisica, Salute in Generale, Vitalità, Attività Sociali Ruolo e Stato emotivo. Conclusioni: L'intervento si è dimostrato efficace a livello di decremento di comportamenti problema, diminuzione dei farmaci assunti e di Qualità della Vita percepita. Il lavoro offre spunti di riflessione relativi ai fattori del gruppo di lavoro e dei singoli che possono favorire l'intervento.

RiassuntoScopo - Il presente lavoro, oltre a fare il punto sui più recenti sviluppi della valutazione economica degli interventi effettuati nel settore della salute mentale, propone una metodologia per la valutazione dei costi, applicable nella situazione assistenziale italiana, messa a punto tenendo conto degli sviluppi suddetti. Metodo e risultati - I presupposti per realizzare questo tipo di valutazione sono l'identificazione dei servizi sanitari e sociali offerti ai pazienti con disturbi psichici, la raccolta di dati sull'utilizzazione dei servizi sanitari (costi diretti) e sull'uso di altri servizi e risorse all'interno del sistema socio-economico (costi indiretti) e l'assegnazione di un valore monetario a tali costi. È stato quindi realizzato un elenco dettagliato degli interventi effettuati e delle attività svolte nei Servizi Psichiatrici Territoriali italiani, con particolare riferimento al Servizio di Verona-Sud. Di ciascuno/a di essi è stato stimato il costo (Lista dei Costi Unitari o LICU). Si è tenuto conto, inoltre, degli altri servizi socio-sanitari, pubblici e privati, disponibili sul territorio, degli interventi delle Forze dell'ordine, delle associazioni di volontariato e dei gruppi di self-help. In questo articolo vengono descritte, in dettaglio, le procedure che hanno portato alia quantificazione dei costi per tre di queste attività (le degenze in SPDC, le visite ambulatoriali ed i gruppi socio-riabilitativi). È stata inoltre sviluppata un'intervista (ICAP) per raccogliere i dati sull'utilizzazione dei servizi e sulle condizioni socio-economiche degli utenti. Per verificarne l'applicabilità, le eventuali difficoltà di comprensione e la durata di somministrazione, l'ICAP è stata testata in cinque pazienti. Conclusioni - Uno sviluppo particolarmente interessante ci sembra quello di utilizzare su vasta scala PICAP e la LICU, allo scopo di realizzare studi epidemiologically-based e poter predire ed analizzare i costi in relazione a variabili socio-demografiche, alia diagnosi, alia storia psichiatrica precedente ecc. È necessario sottolineare l'importanza, per le politiche e la pratica sanitaria, di un'analisi combinata di costi, bisogni ed esito (outcome). Una ricerca di questo tipo è attualmente in corso a Verona-Sud.

L’articolo ha l’obiettivo di mettere in luce potenzialità e criticità dell’inclusione della prospettiva dei pazienti nella ricerca sulle malattie rare e sui farmaci orfani. A tal fine, nella prima parte, si propone un’analisi epistemologica dell’utilizzo dei racconti dell’esperienza individuale della malattia nella ricerca scientifica e nei trial clinici, facendo emergere, anche attraverso gli strumenti della medicina narrativa, le sfide teoriche e operative poste dall’inclusione della soggettività del paziente e del vissuto di malattia nonché l’importanza della valorizzazione della prospettiva del paziente, sia in generale sia nella ricerca sulle malattie rare e sui farmaci orfani. Nella seconda parte, il testo analizza in particolare il ruolo degli esiti riportati dai pazienti o Patient Reported Outcomes (PROs), misure per la valutazione complessiva della salute basate sulla prospettiva dei pazienti stessi, incentrandosi sulla sperimentazione clinica nel campo delle malattie rare. In questo contesto, infatti, i racconti di malattia, raccolti e valorizzati da fonti istituzionali e associazioni di pazienti, hanno contribuito a far emergere importanti questioni critiche e difficoltà nell’impiego di outcome centrati sul paziente nello sviluppo di nuovi farmaci e trattamenti, generando una serie di documenti e raccomandazioni relative al loro utilizzo per il benessere della comunità dei malati rari. ---------- This paper aims to highlight the potentiality and criticality of including patients’ perspective in rare diseases and orphan drugs research. In the first part, we propose an epistemological analysis of individual narrations of disease experience as they are used in scientific research and clinical trials. With the help of narrative medicine approach, this analysis points out theoretical and operational challenges of a perspective that includes patient’s subjectivity and illness experience. Furthermore, it reveals the significance of patients’ standpoints in general and in rare diseases as well as in the orphan drugs research. The second part of our article focuses on the role of the Patient reported Outcomes (PROs) – which are measures for the health’s overall assessment based on patient’s perspective – by investigating the impact on clinical trials for rare diseases. In this context, illness stories, which are collected and promoted by institutional sources and patients’ associations, contribute to underline important critical issues at stake in the employment of patient-centered outcomes both in new drugs and in the treatments development. Moreover, these stories are crucial to elaborate documents and recommendations concerning the use of PROs for the rare patients’ community welfare.

In Italy, the National Health System (NHS) costs are controlled by the regional governments (which are financially accountable for health care expenditure, including hospital drug budgets), but agreements regarding price and discounts are decided in AIFA (Italian Medicine Agency). For this reason, some regional governments ask the pharmaceutical companies to produce a "Health Technology Assessment" before deciding to introduce a drug in the regional hospital list of accepted drugs. Thus, in terms of public policy maker and its decision process, the choice of well-specified points of view is an essential ingredient in the critical assessment of economic evaluation, which becomes more effective when information is presented in the general terms of a cost of illness analysis (COI), or, in a disaggregated way by means of a list of the costs and the outcomes or consequences of the intervention, namely as a cost consequence analysis (CCA). Furthermore, while it has been observed that economic evaluations are usually performed in different countries at national level, in local health care decision making there is lack of health economic data and evaluations, disconnecting economic evaluations from the types of decision that local institutions must normally face. The University of Padova financed a composite and interdisciplinary group of researchers to develop a proof-of-concept like program aimed at serving the Veneto region as a template for the evaluation of the impact of (high-cost) drugs. The program, financed as “Progetti di Ateneo” 2009, (Code CPDA093183/09, "Modello per la valutazione dell'impatto economico, sociale e di salute derivante dall'utilizzo dei nuovi farmaci oncologici nella regione Veneto") has come now to its end and this report represents the outcome of a two-year intense research work. Gratefully, the leading investigators acknowledge the contribution of the entire EIHCD-VeRo Research Project Agreement for their help and cooperation at the various stages of the project development.

This paper provides a sociological overview of the concept of social capital and explores how it is related to the notion of health. The theoretical section of the study addresses the issue of an operational definition of social capital and conducts detailed analysis of the dimensions and forms of the concept that stand out in terms of importance in the field of health research. It also takes into consideration the most significant causal mechanisms identified between social capital and health outcomes. The empirical part of the paper features analysis of data on the connection between social capital and self-perceived health, collected during the first survey conducted in Italy by the Osservatorio sulle Strategie di Consumo delle Famiglie (Observatory on Consumption Strategies in the Family). The survey shows that community social capital, generally expressed in terms of family trust, may, depending on the subject's social milieu of origin, not play any role in determining the level of self-perceived health in Italy. Alternatively, it may play either of two roles, acting as a multiplier or a substitute with regard to positive causal processes determined by parameters of a socio-demographic nature.

Abstract Abstract 337 Background: 12-month results from TOPS showed an advantage for the high dose (800mg/day, HD-IM) arm for: (1) time to achievement of major molecular response (MMR); MMR rates at 3 and 6 months (mos); and (2) complete cytogenetic response (CCyR) at 6 mos (Guilhot et al. [TOPS] ASH 2008). There was no significant difference in the MMR rates at 12 mos, the primary endpoint, and results support 400 mg/day as the standard initial dose for imatinib (SD-IM) in CML-CP pts. The purpose of this update is to assess the outcome of the two arms at 24 mos, as well as the impact of dose intensity (DI) and dose interruption on pts outcome. Methods: 476 pts with newly diagnosed CML-CP were randomized 2:1 to receive HD-IM (n = 319) or SD-IM (n = 157) at 103 sites in 19 countries. The endpoints assessed at 24 mos were: rates of CCyR and MMR, event-free (EFS), progression-free (PFS), and overall survival (OS). CCyR and MMR rates were calculated based on pts with available assessments at specified timepoints. Adverse events (AE) and laboratory results were also monitored. Additional analyses were performed using DI (< 600 mg/d and ≥ 600 mg/d) and number of dose interruptions (periods of zero dose of > 5 days) as variables. In the trial dose interruptions were specified as an AE management strategy prior to dose reduction. Results: At 24 mos, 129/157 (82%) of SD-IM and 247/319 (77%) of HD-IM pts remained on study treatment. There was no significant difference in rates of MMR at 12 mos (SD-IM: 40% vs. HD-IM: 46%), 18 mos (52% vs 47%) or 24 mos (54% vs 51%) (intention to treat analysis). There was no significant difference in the cumulative rates of CCyR at 24 mos (76% in each arm). Overall, 9 (6%) pts on SD-IM and 15 (5%) pts on HD-IM had experienced an event (loss of complete hematologic response, loss of major cytogenetic response, progression to accelerated phase and blast crisis, or death due to any cause). There were no significant differences in estimated EFS (SD-IM: 95% vs. HD-IM: 95%), PFS (97% vs. 98%), or OS (97% vs. 98%) at 24 mos. The most common grade 3/4 hematologic AEs were neutropenia (17.8% vs. 28.2%) and thrombocytopenia (8.9% vs. 19.9%), and for the most part occurred during the first 12 mos. The most common grade 3/4 nonhematologic toxicities for SD-IM and HD-IM were rash (2.5% vs 5.7%), diarrhea (1.3% vs 6.0%) and myalgia (0.6% vs 3.5%), respectively. The most common reasons for discontinuation in both arms were AEs (4.5% vs. 10.7%) and unsatisfactory therapeutic effect (7.0% vs 7.2%). Median DI was 400 mg/d in the SD-IM arm and 728 mg/d in the HD-IM arm. Dose interruptions for > 5 days occurred more frequently in the HD-IM arm (71% vs. 44%). Pts in both arms combined who had ≤ 1 dose interruption during the first 12 mos achieved higher MMR rates at 12 (57.1% vs 33.3% for ≤ 1 vs > 1 interruption; P < 0.0001) and 18 mos (72.6 vs. 46.8; P < 0.0001), faster time to MMR (P = 0.0002), and higher CCyR rates at 12 mos (88.8 vs 63.8; P < 0.0001), compared with pts who had > 1 dose interruption during the same period. On the SD-IM arm pts with ≤ 1 (vs > 1) dose interruption also had higher MMR rates at 12 and 18 mos (12 mos: 49.6% vs 22.2%, P = 0.04; 18 mos: 70.9% vs 50%, P = NS). Comparing pts in the HD-IM arm with DI ≥ 600mg/d for the first 12 mos vs DI < 600 mg/d, the MMR rates at 12 mos (62.4% vs 34.1%, P < 0.0001) and 18 mos (75.2% vs 40.3%, P < 0.0001) were higher, the time to MMR was faster (P < 0.0001), duration of MMR was longer (P = 0.0141) and CCyR rates at 12 mos (89.6% vs 70.3%, P < 0.0001) were higher for pts with DI ≥ 600mg/d. Conclusions: TOPS continues to confirm the safety and efficacy of 400 mg/day IM for newly diagnosed pts with CML-CP, with very similar results to IRIS. HD-IM was also safe and generally well tolerated, but overall did not result in better outcomes at milestones up to 24 months. Frequent or prolonged dosage interruptions on IM adversely affect patient outcomes and should be avoided. These data emphasize the importance of maintaining dose intensity in CML-CP pts treated with imatinib. The TOPS study will continue to assess the impact of dose intensity on long-term outcomes. Disclosures: Baccarani: Novartis Pharma: Consultancy, Honoraria, Research Funding, Speakers Bureau; Bristol-Mayer Squibb: Consultancy, Honoraria, Research Funding, Speakers Bureau. Druker:OHSU patent #843 - Mutate ABL Kinase Domains: Patents & Royalties; MolecularMD: Equity Ownership; Roche: Consultancy; Cylene Pharmaceuticals: Consultancy; Calistoga Pharmaceuticals: Consultancy; Avalon Pharmaceuticals: Consultancy; Ambit Biosciences: Consultancy; Millipore via Dana-Farber Cancer Institute: Patents & Royalties; Novartis, ARIAD, Bristol-Myers Squibb: Research Funding. Cortes-Franco:Novartis: Honoraria, Research Funding, Speakers Bureau; Wyeth: Honoraria, Research Funding, Speakers Bureau; BMS: Honoraria, Research Funding, Speakers Bureau. Hughes:Bristol-Myers Squibb: Advisor, Honoraria, Research Funding; Novartis: Advisor, Honoraria, Research Funding. Kim:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Wyeth: Research Funding; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Pane:Novartis: Research Funding; Ministero dell'Università/PRIN: Research Funding; Regione Campania: Research Funding; Ministero della Salute/Progetto integrato Oncologia: Research Funding. Branford:Novartis Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding. Jin:Novartis: Employment. Krahnke:Novartis: Employment, Equity Ownership. Rudoltz:Novartis: Employment, Equity Ownership. Radich:Novartis: Consultancy, Honoraria, Research Funding. Guilhot:Novartis: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria.

Health-value adding is the new priority and a watchword for all clinicians and health service workers. The creation of health-value requires a team work involving different actors: A. the clinical staff, whose task consists in the creation of treatment models and in their formalization into guidelines and protocols; B. the managers, since effective clinical and therapeutic practices must go along with coherent organizational models and valuable control instruments; C. the public institutions responsible for the definition of health policy guidelines: among these, a prioritary role is played by funding methods, which can affect significantly the results of health-value adding initiatives. This work aims at studying the relationships between funding methods and health-value creation, with particular reference to mental health services. Particular relevance is given to the funding of mental health departments, with a view to putting aside the shortcomings of the current models and proposing the DRG as an alternative funding method for mental health services. The procedures for patients classification and evaluation envisaged in the psychiatric DRG can assist health service managers in evaluating the outcomes and the patients’ health conditions. In other words, the issues concerning funding and management evaluation will be articulated in the same language: this, in turn, will eliminate the lack of integration which can be presently identified as the main fault of most funding methods, and improve the degree of coherence among resource allocation, activities and results. The case of mental health services can therefore be taken as an example of successful and effective cooperation among management, health policy and clinical staff.

BACKGROUND:L’innesco globale di misure cautelative per la tutela della salute pubblica ha indubbiamente rafforzato l’interesse dei formatori per metodologie di simulazione virtuale. In quest’accezione formativa, i Serious Games sembrano consentire una miglior accessibilità, comprendendo la possibilità di essere fruiti o ripetuti un numero ipoteticamente infinito di volte senza rimanere necessariamente ancorati alla presenza dei docenti, alla disponibilità dei laboratori, al materiale presente ed agli eventuali impegni dei discenti stessi contribuendo all'esperienza di apprendimento migliorando la motivazione, l’impegno nel contesto della formazione cognitiva e la fiducia in sé stessi degli studenti infermieri. Gli ambiti di applicazione della gamification (intesa come l’integrazione di caratteristiche proprie dei giochi in contesti non di gioco sembrano essere piuttosto differenti, tuttavia, alcuni ambiti in particolare sembrano aver iniziato a riscontrare un certo interesse, fra cui, quello della Salute Mentale dove si riscontrano outcomes promettenti in studi con strutturazioni e obiettivi ancora eterogenei, mostrando la necessità di ampliare le evidenze a disposizione. METODI E ANALISI:Verrà effettuata una scoping review secondo la metodologia del Joanna Briggs Institute. Le banche dati biomediche consultate saranno MEDLINE (PubMed), Scopus, WebOfScience, Cochrane Library, Cinhal ed Embase; l’estensione della ricerca sulla letteratura grigia verrà effettuata consultando Google Scholar, ClincialTrials.gov, TRIP (Turn Research Into Practice), medRxiv, OSF Preprints, Networked Digital Library of Theses and Dissertations, Open Access Theses and Dissertations. Saranno inclusi articoli in lingua Italiana o Inglese disponibili in formato full text. La presentazione delle informazioni degli studi sarà effettuata sia attraverso tabelle specifiche che in forma narrativa.

- The use of socio-economic indicators in the analysis of health outcomes is not straightforward because those conditions act in a mediated and indirect way through the adoption of life styles, the characteristics of job or the capabilities of utilizing the opportunity of wellbeing offered by the modern health systems. Validity analyses of the national deprivation index based on indicators derived from national Census are summarized. Spatial and temporal stability of the association between deprivation and mortality are reviewed and Italian examples presented. Mutual standardization bias and ecological fallacy when using census tract data are also illustrated with original data based on longitudinal census cohorts studies. Keywords: material deprivation, mortality, validity, ecological fallacy, epidemiology, ecological bias. Parole chiave: deprivazione materiale, mortalitÀ, validazione, distorsione ecologica, epidemiologia, bias ecologico.

Adequate and balanced nutrition is essential to promote optimal child growth and a long and healthy life. After breastfeeding, the second step is the introduction of complementary feeding (CF), a process that typically covers the period from 6 to 24 months of age. This process is, however, still highly controversial, as it is heavily influenced by socio-cultural choices, as well as by the availability of specific local foods, by family traditions, and pediatrician beliefs. The Società Italiana di Pediatria Preventiva e Sociale (SIPPS) together with the Federazione Italiana Medici Pediatri (FIMP), the Società Italiana per lo Sviluppo e le Origine della Salute e delle Malattie (SIDOHaD), and the Società Italiana di Nutrizione Pediatrica (SINUPE) have developed evidence-based recommendations for CF, given the importance of nutrition in the first 1000 days of life in influencing even long-term health outcomes. This paper includes 38 recommendations, all of them strictly evidence-based and overall addressed to developed countries. The recommendations in question cover several topics such as the appropriate age for the introduction of CF, the most appropriate quantitative and qualitative modalities to be chosen, and the relationship between CF and the development of Non-Communicable Diseases (NCDs) later in life.

Background and Aims. Prediction of treatment efficacy is an active and growing field of pharmacology. In the Fondazione Italiana Linfomi (FIL) MCL0208 phase III trial (NCT02354313), a 24 months lenalidomide maintenance (LM, 15 mg days 1-21 every 28 days) after high-dose immuno-chemotherapy followed by autologous transplantation (ASCT) in 300 frontline mantle cell lymphoma (MCL) patients showed substantial clinical activity in terms of Progression-Free Survival (PFS) vs observation (OBS). However, this benefit seemed not uniform across patient series. To deeper investigate the differential pattern of response to lenalidomide, a wide analysis of the host pharmacogenomics (PG) background was planned, in order to dissect whether specific germline polymorphisms of transmembrane transporters, metabolic enzymes or cell surface receptors (ABCB1, ABCG2, VEGFA, FCGR2A, NCF4, GSTP1, CRBN) might predict the drug efficacy. Actually, several single nucleotide polymorphisms (SNPs) of ABCB1 exert an effect on substrate affinity of lenalidomide for the transmembrane transporter. Moreover, VEGFA is involved in the anti-angiogenic activity of lenalidomide and might eventually upregulate ABCB1 expression, too. Patients and methods. Genotypes for SNPs were obtained through allele-specific (ASO) probes on germline DNA from peripheral blood. Minor allele frequencies (MAFs) were obtained and the Hardy-Weinberg equilibrium (HWE) was checked. Genotypes were used to infer individual haplotypes by Arlequin and Haploview softwares. Minimal residual disease (MRD) was assessed with ASO primers on either IGH or BCL-1/IGH rearrangements by RQ-PCR in bone marrow samples. TP53 disruption was identified by NGS targeting resequencing and copy number variation analysis. Clinical-biological correlations were screened by automated machine learning methods and validated by both Kaplan-Meier at univariate level and Cox models for multivariate analysis (MV). A logistic regression was implemented to investigate correlations between polymorphisms and MRD kinetics. Results. 278 out of 300 patients (93%) were fully genotyped. The MAF values of the SNPs were very similar to published data and the HWE was confirmed. Most notably, ABCB1 c.2677G&gt;T/A(W) and VEGFA c.2055A&gt;C were significantly associated to outcome and are thus described in this abstract. In the case of ABCB1, the three loci were in strong linkage disequilibrium (p&lt;0.001). 31% of patients were homozygous for ABCB1 wild type alleles (GG, "WT"), 53% heterozygous (GW, "HET") and 16% polymorphic on both chromosomes (WW, "POL"). 20% were VEGFA WT (AA), 47% HET (AC) and 33% POL (CC). PG did not impact on induction therapy and randomization rates of this trial, as superimposable polymorphism frequencies were described between the enrolled and randomized population. Conversely, both ABCB1 HET and POL and VEGFA HET/POL associated with higher MRD clearance rates vs WT after 6 months of LM (93% vs 71% and 91% vs 67%, respectively). Interestingly, the risk of MRD reappearance during LM was 86% lower for patients harboring either polymorphism vs WT (odds ratio 0.14, 95% CI 0.02-0.99; p&lt;0.05). Actually, ABCB1 HET/POL predicted for a more favorable PFS vs WT in LM (3yPFS 85% vs 69% p&lt;0.05, Fig.1A), as well as VEGFA HET/POL (3yPFS 85% vs 59% p&lt;0.01, Fig.1B). The two polymorphisms co-occurred in 57% of patients, being 12% ABCB1 HET/POL only, 23% VEGFA HET/POL and 8% ABCB1/VEGFA WT. Interestingly, patients with either polymorphism had superimposable outcome to patients in whom both co-occurred (Fig.1C). Finally, MV showed that either polymorphism was protective for PFS among randomized patients (HR=0.42; 95% CI 0.20-0.85; p&lt;0.05). According to this hypothesis, among the 17 ABCB1/VEGFA WT patients LM did not improved PFS vs OBS (Fig.1D), independently from TP53 disruption. Conclusions. The first PG data on LM after ASCT in MCL suggested that: 1) ABCB1 and VEGFA polymorphisms did not impact on the chemotherapeutic efficacy of FIL-MCL0208 trial; 2) both polymorphisms favored sustained MRD clearance during LM; 3) either polymorphism conferred a survival advantage during LM. Taken together, these observations hint that a variable excretion of lenalidomide through ABCB1 (heralded by SNPs), as well as an altered VEGFA pathway, could predict treatment efficacy. This observation might be very useful in the future to tailor lenalidomide therapy to MCL patients. Disclosures Ferrero: Servier: Speakers Bureau; Gilead: Research Funding, Speakers Bureau; EUSA Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Boccomini:SC Ematologia, ASOU Città della Salute e della Scienza di Torino, Turin, Italy: Current Employment. Maria:Roche: Consultancy, Other: travel, accomodations, expenses; Abbvie: Consultancy, Other: travel, accomodations, expenses; BMS: Consultancy; MSD: Consultancy; Janssen: Consultancy, Other: travel, accomodations, expenses; Gilead: Consultancy, Other: travel, accomodations, expenses, Research Funding. Ferreri:Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Morphosys: Research Funding; Hutchinson: Research Funding; BMS: Research Funding. Palumbo:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Galimberti:Novartis: Speakers Bureau; Incyte: Honoraria. OffLabel Disclosure: Lenalidomide maintenance in mantle cell lymphoma

As recent studies indicate a correlation between patients’ spirituality and health outcomes, medical care is increasingly focusing on treatment of the whole person. Through spirituality, individuals attempt to perceive their world, themselves, and their needs in terms of their connection to the self, others, nature and God. One cannot provide whole-person care without taking into consideration the relevant spiritual needs of patients. Music is capable of affecting spiritual aspects with emotional needs in health care and can contribute to the ‘wholeness’ perception of a person. The purpose of this review was to explore the definitions of spirituality, their value in healthcare, while additionally viewing the difference between religion and spirituality, and the link between emotions and spirituality and music’s effect on their potential role in healthcare. Keywords: spirituality, healthcare, music, emotionsSpanishIntegración de la espiritualidad: música , emoción y cuidado de la salud Frances Hendriëhetta Le Roux, Christof SauerRecientes estudios indican correlación entre la espiritualidad de los pacientes y los resultados en la salud, por esto la asistencia médica esta focalizándose de manera creciente en el tratamiento de la persona completa. A través de la espiritualidad los individuos intentan percibir el mundo, a ellos mismos, y a su necesidad de conexión con ellos, con otros, con la naturaleza y con Dios. No podemos proveer asistencia integral de la persona sin considerar las necesidades espirituales de los pacientes. En la atención de salud la música es capaz de acceder a estos aspectos espirituales junto a las necesidades emocionales de los pacientes y contribuir a la percepción de integridad de la persona. El propósito de esta revisión es explorar las definiciones de espiritualidad, su valor en la atención de la salud, mientras observamos la diferencia entre religión y espiritualidad, la conexión entre emociones y espiritualidad y el efecto de la música en su rol en el cuidado de la salud. Palabras clave: espiritualidad, cuidado de la salud, música, emociones GermanIntergration von Spiritualität, Musik und Emotionen in die GesundheitsfürsorgeFrances Hendriëhetta Le Roux, Christof Sauer Da neuere Studien eine Korrelation zwischen der Spiritualität und dem Gesundheitsverlauf von Patienten anzeigen, beschäftigt sich die medizinische Versorgung zunehmend mit der Behandlung des Menschen als Ganzes. Über Spiritualität versuchen einzelne Menschen ihre Welt, sich selbst und ihre Bedürfnisse in Bezug auf ihre Verbindung zu sich selbst, zu anderen, zu Natur und Gott wahrzunehmen. Man kann einen Menschen als Ganzes nicht betreuen, ohne seine relevanten spirituellen Bedürfnisse zu berücksichtigen. Musik kann die spirituellen Aspekte mit emotionalen Bedürfnissen in der Gesundheitsfürsorge beeinflussen und zu der ganzheitlichen Betrachtung einer Person beitragen. Der Zweck dieses Review war es, Definitionen von Spiritualität, deren Wert im Gesundheitswesen zu erforschen, und zusätzlich die Unterscheidung von Religion und Spiritualität, die Verbindung zwischen Emotionen und Spiritualität, und die Wirkung von Musik auf deren mögliche Rollen in der Gesundheitspflege zu sichten. Keywords: Spiritualität, Gesundheitsfürsorge, Musik, Emotionen ItalianIntegrazione della Spiritualità, Musica ed Emozioni nell’Assistenza Sanitaria Frances Hendriëhetta Le Roux, Christof SauerPoiche recenti studi indicano una correlazione tra spiritualità e I risultati di salute dei pazienti, l’assistenza medica è sempre più concentrata sul trattamento di tutta la persona. Attraverso la spiritualità gli individui cercano di percepire il loro mondo, se stessi e le loro esigenze in termini di connessione con il sé, degli altri, la natura e Dio. Non si puó fornire una cura su tutta la persona senza prendere in considerazione le esigenze spirituali dei pazienti. La musica è in grado di influenzare gli aspetti spirituali con I bisogni emotive nell’asssistenza sanitaria e può contribuire alla percezione “dell’interezza“ di una persona. Lo scopo di questa revisione è stato quello di esplorare le definizioni di spiritualità, il loro valore nel settore sanitario, mentre in aggiunta la visualizzazione della differenza tra la religione e la spiritualità, e il legame tra le emozioni e la spiritualità e l’effetto della musica nel settore sanitario. Parole Chiave: spiritualità, assistenza sanitaria, musica, emozioniChinese融合心靈、音樂與情緒於健康照護最近的研究顯示病人的心靈狀態與健康狀態有關，醫療上也越來越重視全人的健康照護。通過心靈層面，個人試圖去感知他們的世界、自我以及內在的需求，包括他們如何與自我、他人、大自然和神靈產生連結。若我們不考慮病人相關的心靈需求，就沒辦法提供全人的照護。音樂能夠影響健康照護當中心靈層面的情緒需求，並有助於一個人的整體性。本篇回顧的目的在於探討心靈的定義以及在健康照護中的價值，同時看到宗教與靈性的差異，以及情緒與靈性之間的連結，並闡述音樂在健康照護中可能帶來的效果Japanese ヘルスケアにおけるスピリチュアリティ、音楽と感情の統合Frances Hendriëhetta Le Roux, Christof Sauer最近の研究では、患者のスピリチュアリティと健康状態の相関性が指摘され、医療的ケアにおいても全人的な治療が注目され始めている。スピリチュアリティを通して、個人は自己の世界、自分自身やニーズを、自己や他者、自然や神との関わりを通じて認識しようとする。全人的医療を提供するためには、患者のスピリチュアルなニーズを理解することが不可欠なのである。音楽は、ヘルスケアにおいて感情面のニーズに関係するスピリチュアルな要素を援助することができる。そして患者の全人的理解に対して貢献する。このレビューの目的は、ヘルスケアにおけるスピリチュアリティの定義とその価値を探求し、宗教とスピリチュアリティの違い、そして感情とスピリチュアリティの繋がりを検証する。さらに、ヘルスケアにおける音楽の効果的役割について考察する。 キーワード:スピリチュアリティ、ヘルスケア、音楽、感情 Korean건강관리에 영성성(spirituality), 음악, 감정의 통합Frances Hendriëhetta Le Roux, Christof Sauer 최근 연구들이 환자의 정신성과 건강의 상관관계를 보여주는 것처럼, 의학적 치료는 점차 그 사람 전체를 치료하는 것에 초점을 맞추고 있다. 정신성을 통해서, 사람들은 자아, 타인, 자연, 하느님과의 연관관계 등과 관련해서 자신의 세계, 자기 자신, 그리고 자신의 필요를 인식하려고 한다. 환자들의 관련 정신적 필요를 고려하지 않고 전인적 치료를 제공할 수는 없다. 음악은 건강관리에서 정서적 필요와 함께 정신적 측면에 영향을 끼칠 수 있으며, 어떤 사람의 “전체(wholeness)” 인식에 기여할 수 있다. 이번 검토의 목적은 종교와 정신성의 차이점, 정서와 정신성의 연관관계, 그리고 그것들이 건강관리에서 할 수 있는 역할에 음악이 끼치는 영향 등을 추가로 검토하면서 정신성의 정의, 건강관리에서 그것들이 갖는 가치 등을 살펴보는 것이다. 키워드: 정신성, 건강관리, 음악, 정서

Background: Approximately 40% of patients (pts) with non-Hodgkin lymphoma (NHL) have disease that will relapse or is refractory to chemotherapy and/or immunotherapies; management of these pts remains a challenge. Although follicular lymphoma (FL) generally responds well to first-line treatment (tx), this disease is characterized by frequent relapses with shorter intervals between tx lines. Pts with early relapse (ER) (progressive disease &lt;2 y after initial diagnosis) and those who are double-refractory (DR) to both rituximab and chemotherapy, have particularly poor outcomes. Avadomide (CC-122) is a small molecule oral agent that induces cereblon-mediated degradation of the transcription factors Ikaros and Aiolos and promotes antilymphoma activity. Results from the dose-escalation part of the CC-122-NHL-001 study demonstrated preliminary antitumor activity of avadomide in combination with obinutuzumab in pts with relapsed and/or refractory (R/R) FL. Here, we report long-term safety and efficacy results from the dose-escalation and dose-expansion parts of the CC-122-NHL-001 study in pts with R/R FL. Methods: CC-122-NHL-001 (NCT02417285) is an ongoing, open-label, phase 1b study of avadomide in combination with obinutuzumab conducted at 8 sites in 3 European countries with dose-escalation and dose-expansion parts in R/R FL. Eligible pts (age ≥18 y) had histologically confirmed, CD20-positive R/R NHL. Pts with FL (grade 1, 2, or 3a) had ≥1 prior standard regimen. Avadomide active ingredient in capsule (1.0-4.0 mg) or formulated capsules (3.0 or 4.0 mg) was administered orally once daily on days 1-5 followed by 2 days off (5/7-day schedule) every week of each 28-day cycle. Obinutuzumab 1000 mg was given intravenously on days 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-8. Primary objectives were to determine the safety and tolerability of the combination, including the non-tolerated dose, maximum tolerated dose, and recommended phase 2 dose (RP2D). Response was assessed using Cheson 2007 criteria every 2 cycles to cycle 6, then every 3 cycles to cycle 12, and every 6 cycles thereafter. Median duration of response (mDOR) and median progression-free survival (mPFS) were assessed by Kaplan-Meier estimates. Results: As of January 10, 2020, 73 pts with R/R NHL were enrolled and treated, including 19 with R/R diffuse large B-cell lymphoma, 1 with marginal zone lymphoma, and 53 with R/R FL; all 35 pts in the dose-expansion part of the study had R/R FL. The median age among treated pts was 61 y (range, 26-83), the median number of prior antilymphoma therapies was 3 (range 1-11), and 26 pts (36%) had prior autologous stem cell transplantation. As of July 14, 2020, tx was ongoing in 3/38 pts (8%) in dose-escalation (all ongoing in cycle &gt;24, 1 pt ongoing in cycle &gt;40). In the dose-expansion, tx was ongoing in 15/35 pts (43%); of these pts, all were ongoing in cycle &gt;21 and 1 was ongoing in cycle 30. The RP2D of avadomide was established as 3.0 mg formulated capsule. In the expansion part of the study, pts received a median of 15 tx cycles (range, 1-33), and median tx duration was 60 wk (range, 1-132). The most common (≥10%) grade 3/4 TEAEs were neutropenia, reported in 19 pts (54%) and thrombocytopenia, reported in 7 pts (20%). Sixteen pts (46%) had a serious TEAE; only pyrexia (11%) and sepsis (9%) occurred in &gt;2 pts. The objective response rate (ORR) among the 35 pts with R/R FL in the dose-expansion part of the study was 71%, including 40% with a complete response (CR). The mDOR was 14.6 mo (95% CI, 14.6-not estimable [NE]), and mPFS was 16.4 mo (95% CI, 8.3-NE). The median duration of PFS follow-up in dose-expansion was 14.4 mo (range, 0.8-30.3). Two pts had CRs lasting 13.7 mo and 15.3 mo before discontinuation owing to receiving allogeneic stem cell transplantation. Response rates were similar among all 53 R/R FL pts in both parts of the study (dose escalation and dose expansion) and in high-risk (ER and/or DR) FL pts (Table). Conclusions: Long-term follow-up results demonstrate that avadomide plus obinutuzumab has a manageable safety profile and durable responses in patients with R/R FL. The antitumor activity of cereblon modulators plus next-generation anti-CD20 antibodies in heavily pretreated R/R NHL warrants further investigation as a novel chemotherapy-free option. Disclosures Michot: Genentech: Research Funding; Abbvie: Research Funding; Forma: Research Funding; Eisai: Research Funding; Debiopharm: Research Funding; Daiichi Sankyo: Research Funding; Kyowa: Research Funding; AstraZeneca: Other, Research Funding; Gustave Roussy: Honoraria, Other: Abbvie, Aduro, Agios, Amgen, Argen-x, Astex, AstraZeneca, Aveo pharmaceuticals, Bayer, Beigene, Blueprint, BMS, Boeringer Ingelheim, Celgene, Chugai, Clovis, Daiichi Sankyo, Debiopharm, Eisai, Eos, Exelixis, Forma, Gamamabs, Genentech, Gortec, GSK, H3 bio, Research Funding; Janssen: Other, Research Funding; Celgene: Other; Mundi Pharma: Other; Eos: Research Funding; AZD: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Research Funding; Medimmune: Research Funding; Lytix Biopharma: Research Funding; Lysarc: Research Funding; Lilly: Research Funding; Astex: Membership on an entity's Board of Directors or advisory committees, Research Funding; Argen-x: Research Funding; Amgen: Research Funding; Agios: Research Funding; Xencor: Research Funding; Sanofi: Research Funding; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Other; Exelixis: Research Funding. Doorduijn:Roche: Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Boccomini:SC Ematologia, ASOU Città della Salute e della Scienza di Torino, Turin, Italy: Current Employment. Kersten:Takeda: Research Funding; Miltenyi Biotech: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Janssen/Cilag: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); BMS: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); MSD: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Novartis: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Roche: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Celgene: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Kite/Gilead: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Amgen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Chiappella:Servier: Honoraria; Takeda: Honoraria; Roche: Honoraria; Janssen: Honoraria; Gilead-Kite: Honoraria; Celgene: Honoraria; Iqone: Honoraria. Zinzani:Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; EUSA Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; TG Therapeutics, Inc.: Honoraria, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kirin Kyowa: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; MSD: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Immune Design: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kyowa Kirin: Consultancy, Speakers Bureau; Eusapharma: Consultancy, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Sandoz: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celltrion: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Verastem: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Immune Design: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; ADC Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Salles:Abbvie, Autolus, BMS/Celgene, Debiopharm, Genmab, Kite/Gilead, Epizyme, Janssen, Karyopharm, Morphosys, Novartis, F. Hoffmann-La Roche, Takeda: Consultancy; Abbvie, Amgen, Celgene, Gilead, Janssen, Kite, Morphosys, Novartis, Roche, Takeda: Other: Participation to educational events; Abbvie, Autolus, BMS/Celgene, Debiopharm, Genmab, Kite/Gilead, Epizyme, Janssen, Karyopharm, Morphosys, Novartis, Roche, Takeda: Membership on an entity's Board of Directors or advisory committees; Abbvie, Amgen, Celgene, Gilead, Janssen, Kite, Morphosys, Novartis, F. Hoffmann-La Roche, Takeda: Honoraria. Hentrup:Neuronetics, Inc: Current equity holder in publicly-traded company, Ended employment in the past 24 months; BMS Consultant: Current Employment. Rhee:I own stocks for publicly-traded companies: Current equity holder in publicly-traded company; Bristol-Myers Squibb: Current Employment. Hagner:Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Klein:Roche: Current Employment, Current equity holder in publicly-traded company, Patents & Royalties. Pourdehnad:Celgene: Ended employment in the past 24 months, Patents & Royalties: Various CC-122 patents; Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company, Patents & Royalties: Various CC-122 patents. Hege:Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Patents & Royalties: numerous, Research Funding; Celgene (acquired by Bristol Myers Squibb): Ended employment in the past 24 months; Mersana Therapeutics: Current equity holder in publicly-traded company, Membership on an entity's Board of Directors or advisory committees; Arcus Biosciences (Former Board of Directors): Divested equity in a private or publicly-traded company in the past 24 months. Dobmeyer:BMS: Consultancy. Nikolova:Celgene, A Bristol-Myers Squibb Company: Current Employment, Current equity holder in publicly-traded company, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Ribrag:nanostring: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; gustave roussy comprehensive cancer center: Current Employment; servier: Consultancy; pharmamar: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; argenX: Research Funding; epizyme (EPZ): Research Funding; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; EPZ: Honoraria, Membership on an entity's Board of Directors or advisory committees; AZD: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other; Infinity: Honoraria, Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: This is a phase I study evaluating the safety and efficacy of avadomide in combination with obinutuzumab in patients with R/R B-cell NHL. Avadomide is an investigational agent and has not yet been approved in the US.

Il nostro gruppo di ricerca è nato nel 2001, nel contesto degli insegnamenti esterni all'Università di Milano-Bicocca: “Valutazione dell’efficacia in psicoterapia” e “Interventi psicologici nel servizio pubblico”. Inizialmente era formato da me, Mariangela Villa e Riccardo Scognamiglio per quanto riguardava le ricerche sull’outcome in area clinica; da me, Valentina Stirone e Ilaria Peri per gli interventi nei centri di salute e nelle comunità terapeutiche. Le aree di ricerca che abbiamo approfondito in questi anni sono state: 1) La valutazione multi-strumentale del processo psicoterapeutico in “single cases”; 2) Alessitimia e psicosomatica: ricerca che ha portato allo sviluppo della scala di intelligenza emotiva (Scognamiglio, 2008, 2009); 3) Contributo alla validazione di nuove tecniche psicoterapeutiche, in particolare l’EMDR; 4) Monitoraggio del percorso clinico degli interventi nelle istituzioni (DSM e comunità terapeutica): ricerca che ha portato alla costruzione del Community Functioning Questionnaire, CFQ-28 (Vigorelli, Zanolini, Belfontali, Tatti, Buratti, & Peri, 2008).

Gli Autori intendono con questo lavoro proporre un contributo nell’analisi delle difficili problematiche etiche che derivano dagli allotrapianti di mano. Nell’articolo si descrive brevemente la storia del primo trapiantato e l’iter che ha condotto, nel settembre del 1998, a Lione, a questo tipo d’intervento. Ci si è soffermati altresì sulle complicazioni nate di seguito e che hanno alfine obbligato all’amputazione dell’arto trapiantato, imputandone le cause ad una superficiale valutazione psichiatrica del ricevente. Questo recente tipo d’intervento obbliga a riflettere, a causa della novità e della particolarità dell’organo da trapiantare, sull’opportunità di quei trapianti cosiddetti “non-salvavita” in base ai rischi conosciuti cui conduce una terapia imunosoppressiva a lungo termine. Ciò porta a riconsiderare anche il concetto di salute e i principi di libertà e autodeterminazione. Ci si è altresì interrogati sulle modalità di scelta dei riceventi e sull’approccio più opportuno da tenersi nei loro riguardi soprattutto a livello psicologico prima e dopo l’operazione. Tutte le recenti acquisizioni sono state valutate in rapporto a ciò che la legislazione italiana e la deontologia medica impongono. Si è detto anche dei vizi di un consenso per lo meno scarsamente informato, derivante dalla carenza di dati sperimentali. Nel prosieguo dell’articolo gli Autori hanno evidenziato come possano sollevarsi numerosi interrogativi e remore culturali e inconsce oltre che morali circa l’acquisizione da parte del ricevente di un organo che più di altri appare visibile e intimamente legato alla propria identità e personalità, la qual cosa rende possibile che venga ancor più percepito come estraneo e intollerabile da alcuni. In conclusione gli Autori ritengono che i candidati ideali dovrebbero essere giovani che hanno perduto di recente entrambe le mani, soprattutto se è stata compromessa anche la loro vista, mentre poco ragionevole appare il trapianto di mano in un amputato unilaterale. ---------- The bioethical issues arising from hand transplantation are discussed in this paper. We briefly recall the first case ever performed of hand transplant, in France in the year 1998. Unfortunately a superficial evaluation of the recipient caused the failure of the transplant with the consequent explant of the graft. The peculiarity of hand transplant poses serious doubts on the opportunity of the non life-saving transplant especially for the controversial costs–benefits relationship of such interventions and the lifelong immunodepressant therapy needed. Most important is therefore the clinical and psychological evaluation of the recipients and the correct communication before and after the intervention. We also underline the limits of the “informed” consent due to the lack of scientifical data on the outcome of such transplant, in respect to the Italian legal framework. In addiction we examine the possible psychological difficulties of the patients to adapt to an organ coming from a dead donor due to the high visibility and strong symbolic meaning of the hand. Our conclusion is for a selection of the recipients limited to strongly motivated, psychologically stable and refusing the protesis application patients such as to get a real improvement to their “health” according to WHO definition.

Negli ultimi vent’anni si sono diffuse e perfezionate nella pratica clinica specifiche tecnologie per il trattamento delle ferite di difficile guarigione, come la terapia a pressione negativa (negative pressure wound therapy, NPWT). Tale terapia consente l’accelerazione dei tempi di guarigione di ferite inveterate e una sicura riduzione dei tempi di degenza nei pazienti ricoverati. All’interno di un reparto clinico per acuti risulta tuttavia indispensabile definire le corrette indicazioni ed il modello organizzativo che consenta di ottimizzare le risorse, ridurre gli sprechi e dare risposte tempestive ed efficaci alle persone che possono beneficiare di questo trattamento. È stata condotta un’analisi quantitativa sull’uso della metodica NPWT nei reparti acuti dell’Ospedale Beata Vergine di Mendrisio nell’anno 2017, base per la realizzazione di un audit clinico; i dati ottenuti sono stati rapportati alle attuali evidenze scientifiche sul tema per evidenziare allineamenti e/o scostamenti nella pratica clinica quotidiana. L’audit è uno strumento di Governo Clinico; utilizzare questa metodologia vuol dire favorire una migliore conoscenza da parte degli operatori sanitari delle attività cliniche e gestionali. È, infatti, un processo di revisione strutturata fra pari che ha come obiettivo quello di individuare le opportunità di miglioramento al fine di introdurle nella pratica professionale quotidiana. Gli assistiti che necessitano di medicazione NPWT hanno solitamente un grado di complessità medio-alta, richiedono quindi un assessment preciso ed approfondito, oltre ad una presa a carico multiprofessionale. Gli staff infermieristici necessitano di formazione specifica, consulenza medica e/o infermieristica esperta, adeguato supporto documentale ed informatico al fine di assicurare sicurezza, qualità e razionalità delle cure, outcome positivi di salute. Molti sono gli articoli scientifici e le esperienze a favore di una presa a carico infermieristica di pazienti con medicazioni complesse gestite tramite dispositivi NPWT. I presupposti affinché questo possa avvenire in sicurezza prevedono un processo definito in modo chiaro e condiviso fra professionisti sanitari ed assistiti, formazione aggiornata, documentazione corretta. During last twenty years, tailored technologies were spread and improved; they are aimed to support the treatment of difficult-toheal wounds, such as negative pressure wound therapy (NPWT). This type of treatment lead to promote healing process and to reduce hospital stay of patients. In an acute care setting, planning and managing these new technologies represent a key-point. We did a retrospective study about NPWT in acute care setting in Beata Vergine Regional Hospital in 2017, aimed at performing a clinical audit; the results were compared to scientific literature to detect differences in daily clinical practice. Audit is a very helpful tool for Clinical Government: this method leads to improve the management of clinical activities because the entire staff (physicians and nurses) obtains important data about care setting. Patients treated by NPWT are usually difficult to treat and need a correct assessment and a multidisciplinary approach. Consequently, fundamental aspects are represented by nursing staff education and its relationship with medical staff, data collections and computer-assisted technologies development. Significant scientific literature and clinical experience seem to recommend a nursing management of NPWT patients. This aspect is very interesting and it can be improved by specific education, adequate organization and correct data collection.

Il 12 e il 13 giugno 2005 si sono svolti in Italia i referendum parzialmente abrogativi della Legge 40/2004 sulla procreazione medicalmente assistita. La facoltà di astensione, esercitata dalla maggioranza degli italiani, ha consentito di salvaguardare quei principi biopolitici fondamentali dei quali la legge si è fatta espressione, tutti riconducibili a imprescindibili valori costituzionali. Tuttavia, nonostante l’esito referendario, la legge 40 continua a sollecitare approfondimenti e dibattiti, soprattutto tra chi – insoddisfatto per i limiti che impone – vorrebbe modificarla in tempi brevi. Eppure, a ben vedere, questa legge tanto criticata e contestata è stata il frutto di precise scelte attuate dal Legislatore, ben consapevole dei principi in gioco innanzi al prevalere della tecnologia riproduttiva nella trasmissione della vita umana. In particolare, due sono le questioni di fondo che ancor oggi ritornano nel dibattito: la violazione della libertà di autodeterminazione procreativa della coppia; e la richiesta di una legittimazione di desideri procreativi, che si vorrebbe trasformare in “diritti”: il “diritto alla salute riproduttiva”, il “diritto al figlio sano”, il “diritto all’eugenetica prenatale”. In tale contesto, la riflessione filosofico-giuridica sul significato del progetto procreativo della coppia e sulle dinamiche relazionali che attiva può consentire di recuperare quella dimensione di autentica responsabilità e di amore donativo, che dovrebbe costituire il presupposto etico per compiere delle scelte procreative, nel pieno rispetto di tutti i soggetti coinvolti nelle tecniche che la medicina riproduttiva mette oggi a disposizione e, prima ancora, nel pieno rispetto della propria dignità umana. ---------- On June 12th and 13th, 2005 partially abrogative referendum about the law 40/2004 on medically assisted reproduction took place in Italy. The faculty of abstention, exercised by the main part of Italian people, allowed safeguarding those fundamental biopolitical principles expressed in the law, all of them coming from absolute constitutional values. However, although the referendary outcome, the law 40/2004 continues to request deepening and debates, specially among those who – unsatisfied of the limits which it imposes – would like to modify it in a short time. And yet, this law, so criticized and contested, was the fruit of precise choices made by the Legislator, well aware of the principles at stake in front of prevailing of reproductive technology in the transmission of human life. Particularly, the fundamental questions which are debated still today are two: violation of the liberty of couple’s procreative self-determination; and the request of a legitimating of procreative desires, which one’s would like to transform in “rights”: the “reproductive health right”, the “right of having a healthy child”, the “prenatal eugenic right”. In this contest, philosophical-juridical reflection on the meaning of the couple’s procreative project and on its relational dynamics can allow to recover that dimension of authentic responsibility and donative love, which should constitute the ethical presupposition to do procreative choices, in the full respect of every subject involved in the technique that reproductive medicine offers today and, more before, in the full respect of one’s own human dignity.

Il contributo propone all’attenzione il II Rapporto sull’applicazione della legge italiana in materia di “procreazione medicalmente assistita” (PMA) (Legge 40/2004), elaborato nell’aprile 2009 all’indomani della quarta relazione ministeriale del 25 marzo 2009 sullo stesso tema. La particolarità del presente Rapporto consiste nell’indagare su uno dei due obiettivi della legge 40/2004: tutelare il diritto alla vita del concepito. Infatti, mentre è alta la concentrazione sull’obiettivo di “superare la sterilità e la infertilità”, lo scopo di difendere il diritto alla vita del concepito considerato dalla stessa legge “soggetto” al pari degli altri soggetti coinvolti nelle procedure di PMA, è troppo spesso dimenticato. Il Rapporto vuole proprio rimediare a tale dimenticanza e si chiede: di quanti nuovi esseri umani è stata evitata la distruzione per effetto della legge? Poiché, come si legge nel contributo, è chiaro che le tecniche di PMA per il fatto stesso di procreare “in vitro” espongono alla morte gli embrioni anche quando vengono trasferiti nelle vie genitali della donna (ed è questa, infatti, una delle principali riserve etiche nei confronti delle tecniche di PMA), l’indagine si occupa solo di vedere come è stato tutelato il diritto alla vita degli embrioni non trasferiti, cioè non destinati alla nascita, dalla Legge 40/2004. Emerge che l’effetto più benefico della legge è quello di aver evitato nel solo triennio 2005-2006-2007 la possibile formazione soprannumeraria di embrioni e la conseguente possibile distruzione, diretta o dovuta alla crioconservazione, di oltre 120.000 embrioni. La seconda parte della ricerca è condotta confrontando anche i dati di altri Paesi europei e dimostra che il rispetto dei limiti posti a tutela del diritto alla vita hanno anche garantito meglio la salute della donna e non hanno diminuito la percentuale del “successo”. Come è noto la recente sentenza n. 151/2009 della Corte Costituzionale ha gravemente compromesso la legge proprio nel punto di maggiore sensibilità nei confronti della tutela concreta del diritto alla vita del concepito. L’auspicio è che i dati raccolti in questo II rapporto vengano comunque presi in seria considerazione. ---------- The contribution proposes the II Report of April 2009 on the application of the Italian Law on “medically assisted reproduction” (PMA) (Law 40/2004). The peculiarity of the present Report consists of investigating one of the two purposes of the Law 40/2004: to protect the right to life of newborns. In fact, if, on one hand, attention to the purpose of “overcoming sterility and infertility” the Law considers, on the other hand the purpose of defending the right to life of newborn, that is considered as “subject” just like the others subjects involved in PMA procedures from the same law, is too often forgotten. The Report intends to remedy for this forgetfulness and it asks: how many new human beings have been saved thanks to the Law? It makes clear that the most beneficent effect of the Law is that, in the period 2005-2007, it has avoided the possible production of excess embryos and the consequent possible suppression – direct or due to the cryoconservation – of over 120.000 embryos. The second part of the search is conducted also comparing data of other European Countries and it shows that the respect of the imposed limits for protecting the right to life has also guaranteed the woman’s health and it has not reduced the outcome percentage.