Rendere competente la famiglia nei primi mesi successivi all’identificazione di una ipoacusia del figlio

Nelle più recenti linee guida internazionali sull’intervento precoce in audiologia pediatrica emerge l’importanza del coinvolgimento della famiglia nel percorso diagnostico- riabilitativo del bambino con deficit uditivo permanente. Questa modalità di approccio costituisce una ricchezza per lo sviluppo dei bambini con deficit uditivo. Vi sono ad oggi poche evidenze del panorama italiano rispetto a questo ambito e rimangono aperte perplessità e difficoltà di gestione pratica. L’obiettivo di questo articolo è presentare i risultati di un’analisi strategica che prende in considerazione i punti di forza, i punti di debolezza, le opportunità e i rischi di una presa in carico precoce che renda competente la famiglia. Le iniziali fasi della presa in carico devono fornire alle famiglie di bambini con recente diagnosi di ipoacusia permanente le informazioni e/o il sostegno necessario al fine di indurle a compiere la scelta del dispositivo protesico uditivo più idoneo, entro tre mesi dalla diagnosi audiologica. Nell’ambito del progetto del Ministero della Salute CCM 2013 “Programma regionale di identificazione, intervento e presa in carico precoci per la prevenzione dei disturbi comunicativi nei bambini con deficit uditivo” un gruppo di esperti ha identificato tre principali raccomandazioni utili per migliorare lo sviluppo comunicativo del bambino attraverso il coinvolgimento della famiglia e il rafforzamento dell’alleanza terapeutica. Queste considerazioni costituiranno il punto di partenza per riflessioni e analisi più dettagliate che potranno dare luce a linee guida e indicazioni specifiche su come buone prassi di presa in carico di bambino con deficit uditivo e famiglia possano inserirsi e concretizzarsi nel reale panorama italiano

L’attività di sorveglianza audiologica pediatrica in Italia: raccomandazioni preliminari

Sulla base dei risultati dei programmi di screening uditivo neonatale attivi in diverse regioni italiane, si è resa necessaria una riflessione riguardo all’identificazione delle ipoacusie sfuggite al programma di screening neonatale, delle ipoacusie progressive o insorte dopo la nascita. Nell’ambito del progetto del Ministero della Salute CCM 2013 “Programma regionale di identificazione, intervento e presa in carico precoci per la prevenzione dei disturbi comunicativi nei bambini con deficit uditivo” un gruppo di esperti ha identificato tre principali raccomandazioni utili per ottimizzare l’attività di sorveglianza audiologica pediatrica nell’ambito del Servizio Sanitari Nazionale. Il pediatra di famiglia è riconosciuto come la figura chiave per il monitoraggio delle capacità uditive e dello sviluppo del bambino

The Administrative Board of Review of the European Central Bank: Experience After 2 Years

This article examines the administrative remedy provided by the Administrative Board of Review (ABoR) of the European Central Bank (ECB), as part of the broader issue of the right of defence of natural and legal persons vis-à-vis ECB supervisory decisions within the Single Supervisory Mechanism (SSM). After presenting an overview of the review panels established in the financial sector in the EU, the article describes the experience with the ABoR by analysing its composition, its mandate and scope of review, the main procedural aspects and the relationship with judicial proceedings before the European Court of Justice. Particular attention is given to the substantial issues dealt with by the ABoR in its Opinions and to some of the major challenges faced in the first 2 years of practice. Among them is the assessment of the correct application of national laws implementing EU legislation by the ECB. The paper identifies two aspects giving particular cause for concern and requiring legislative reforms: (1) the assessment of the suitability of the members of management bodies (fit and proper assessment) and (2) the inclusion of bank holding companies within the scope of banking supervision

A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study

Background: The benefit of pharmacogenetic testing before starting drug therapy has been well documented for several single gene–drug combinations. However, the clinical utility of a pre-emptive genotyping strategy using a pharmacogenetic panel has not been rigorously assessed. Methods: We conducted an open-label, multicentre, controlled, cluster-randomised, crossover implementation study of a 12-gene pharmacogenetic panel in 18 hospitals, nine community health centres, and 28 community pharmacies in seven European countries (Austria, Greece, Italy, the Netherlands, Slovenia, Spain, and the UK). Patients aged 18 years or older receiving a first prescription for a drug clinically recommended in the guidelines of the Dutch Pharmacogenetics Working Group (ie, the index drug) as part of routine care were eligible for inclusion. Exclusion criteria included previous genetic testing for a gene relevant to the index drug, a planned duration of treatment of less than 7 consecutive days, and severe renal or liver insufficiency. All patients gave written informed consent before taking part in the study. Participants were genotyped for 50 germline variants in 12 genes, and those with an actionable variant (ie, a drug–gene interaction test result for which the Dutch Pharmacogenetics Working Group [DPWG] recommended a change to standard-of-care drug treatment) were treated according to DPWG recommendations. Patients in the control group received standard treatment. To prepare clinicians for pre-emptive pharmacogenetic testing, local teams were educated during a site-initiation visit and online educational material was made available. The primary outcome was the occurrence of clinically relevant adverse drug reactions within the 12-week follow-up period. Analyses were irrespective of patient adherence to the DPWG guidelines. The primary analysis was done using a gatekeeping analysis, in which outcomes in people with an actionable drug–gene interaction in the study group versus the control group were compared, and only if the difference was statistically significant was an analysis done that included all of the patients in the study. Outcomes were compared between the study and control groups, both for patients with an actionable drug–gene interaction test result (ie, a result for which the DPWG recommended a change to standard-of-care drug treatment) and for all patients who received at least one dose of index drug. The safety analysis included all participants who received at least one dose of a study drug. This study is registered with ClinicalTrials.gov, NCT03093818 and is closed to new participants. Findings: Between March 7, 2017, and June 30, 2020, 41 696 patients were assessed for eligibility and 6944 (51·4 % female, 48·6% male; 97·7% self-reported European, Mediterranean, or Middle Eastern ethnicity) were enrolled and assigned to receive genotype-guided drug treatment (n=3342) or standard care (n=3602). 99 patients (52 [1·6%] of the study group and 47 [1·3%] of the control group) withdrew consent after group assignment. 652 participants (367 [11·0%] in the study group and 285 [7·9%] in the control group) were lost to follow-up. In patients with an actionable test result for the index drug (n=1558), a clinically relevant adverse drug reaction occurred in 152 (21·0%) of 725 patients in the study group and 231 (27·7%) of 833 patients in the control group (odds ratio [OR] 0·70 [95% CI 0·54–0·91]; p=0·0075), whereas for all patients, the incidence was 628 (21·5%) of 2923 patients in the study group and 934 (28·6%) of 3270 patients in the control group (OR 0·70 [95% CI 0·61–0·79]; p <0·0001). Interpretation: Genotype-guided treatment using a 12-gene pharmacogenetic panel significantly reduced the incidence of clinically relevant adverse drug reactions and was feasible across diverse European health-care system organisations and settings. Large-scale implementation could help to make drug therapy increasingly safe. Funding: European Union Horizon 2020

Breakthrough Cancer Pain: Preliminary Data of The Italian Oncologic Pain Multisetting Multicentric Survey (IOPS-MS)

Introduction: An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here. Methods: Thirty-two clinical centers are involved in the survey. A diagnosis of BTP was performed by a standard algorithm. Epidemiological data, Karnofsky index, stage of disease, presence and sites of metastases, ongoing oncologic treatment, and characteristics of background pain and BTP and their treatments were recorded. Background pain and BTP intensity were measured. Patients were also questioned about BTP predictability, BTP onset (≤10 or >10 min), BTP duration, background and BTP medications and their doses, time to meaningful pain relief after BTP medication, and satisfaction with BTP medication. The occurrence of adverse reactions was also assessed, as well as mucosal toxicity. Results: Background pain was well controlled with opioid treatment (numerical rating scale 3.0 ± 1.1). Patients reported 2.5 ± 1.6 BTP episodes/day with a mean intensity of 7.5 ± 1.4 and duration of 43 ± 40 min; 977 patients (65.1%) reported non-predictable BTP, and 1076 patients (71.7%) reported a rapid onset of BTP (≤10 min). Higher patient satisfaction was reported by patients treated with fast onset opioids. Conclusions: These preliminary data underline that the standard algorithm used is a valid tool for a proper diagnosis of BTP in cancer patients. Moreover, rapid relief of pain is crucial for patients’ satisfaction. The final IOPS-MS data are necessary to understand relationships between BTP characteristics and other clinical variables in oncologic patients. Funding: Molteni Farmaceutici, Italy