Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia

<p>Abstract</p> <p>Background</p> <p>One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study.</p> <p>Methods/Design</p> <p>The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome.</p> <p>Discussion</p> <p>The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia.</p> <p>Trial Registration</p> <p><b>Clincaltrials.gov Identifier</b>: NCT00395915</p

Noi refertiamo così… voi? Guida rapida per la valutazione sonologica della stenosi carotidea.

Da oltre quarant’anni si utilizzano gli ultrasuoni per rilevare una placca carotidea e per seguire nel tempo la sua evoluzione. I protocolli terapeutici hanno ridotto enormemente il suo impatto sulla salute delle persone ma la scelta fra terapia medica e chirurgica si fonda su una valutazione clinica e strumentale che è solo apparentemente semplice. Nei referti di un esame ultrasonografico riportiamo il più delle volte delle percentuali di stenosi, a volte puntuali, a volte in termini di range oppure ci esprimiamo con aggettivi che descrivono la gravità della stenosi ma spesso ci facciamo confondere dai numeri e dalle differenti modalità di calcolo del range di stenosi ed è indubbio che, a volte, le conclusioni risultano ambigue ed estremamente dipendenti dall’interpretazione dell’operatore. Il problema è che l’angiografia digitale, gold standard diagnostico per la stenosi carotidea, adotta delle metriche non del tutto riproducibili con gli ultrasuoni. Con questo documento vogliamo condividere la ricerca di un linguaggio comune, a partire dal referto dei nostri esami. Noi refertiamo così… voi

Global disparities in surgeons’ workloads, academic engagement and rest periods: the on-calL shIft fOr geNEral SurgeonS (LIONESS) study

: The workload of general surgeons is multifaceted, encompassing not only surgical procedures but also a myriad of other responsibilities. From April to May 2023, we conducted a CHERRIES-compliant internet-based survey analyzing clinical practice, academic engagement, and post-on-call rest. The questionnaire featured six sections with 35 questions. Statistical analysis used Chi-square tests, ANOVA, and logistic regression (SPSS® v. 28). The survey received a total of 1.046 responses (65.4%). Over 78.0% of responders came from Europe, 65.1% came from a general surgery unit; 92.8% of European and 87.5% of North American respondents were involved in research, compared to 71.7% in Africa. Europe led in publishing research studies (6.6 ± 8.6 yearly). Teaching involvement was high in North America (100%) and Africa (91.7%). Surgeons reported an average of 6.7 ± 4.9 on-call shifts per month, with European and North American surgeons experiencing 6.5 ± 4.9 and 7.8 ± 4.1 on-calls monthly, respectively. African surgeons had the highest on-call frequency (8.7 ± 6.1). Post-on-call, only 35.1% of respondents received a day off. Europeans were most likely (40%) to have a day off, while African surgeons were least likely (6.7%). On the adjusted multivariable analysis HDI (Human Development Index) (aOR 1.993) hospital capacity &gt; 400 beds (aOR 2.423), working in a specialty surgery unit (aOR 2.087), and making the on-call in-house (aOR 5.446), significantly predicted the likelihood of having a day off after an on-call shift. Our study revealed critical insights into the disparities in workload, access to research, and professional opportunities for surgeons across different continents, underscored by the HDI

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

The European Account Preservation Order Procedure

The European Account Preservation Order Procedur

Una lettura sostanziale e funzionale dell'art. 342 c.p.c.

Una lettura sostanziale e funzionale dell'art. 342 c.p.c

La relativit&#224; della tutela camerale

Questa riflessione sistematica muove dalla percezione che la tutela camerale ha un significato relativo per la discrezionalit\ue0 che \ue8 implicita nella scelta del metodo d\u2019indagine e del sistema giurisdizionale di riferimento. L\u2019autore, ponendo al centro della riflessione le situazioni giuridiche sostanziali e la strumentalit\ue0 del processo rispetto a queste, osserva che il carattere relativo della tutela camerale non esclude il sistema, lo sposta semplicemente di pi\uf9 verso l\u2019elemento sostanziale, facendo dialogare rito e merito per mezzo dei principi costituzionali, pur con diverse modalit\ue0 e variet\ue0 di effetti. Cos\uec la tesi della relativit\ue0 della tutela camerale, come intesa dall\u2019autore, non solo non esclude il sistema, ma al contrario mette in evidenza in modo ancora pi\uf9 netto le possibili relazioni strumentali tra rito e merito e, segnatamente, la circostanza che il rito va modulato in correlazione alla peculiarit\ue0 delle situazioni soggettive coinvolte e in funzione delle specifiche esigenze di tutela quali derivano dal piano sostanziale. \uc8 questo il punto su cui \ue8 necessario insistere, secondo l\u2019autore, giacch\ue9 \ue8 vana fatica circoscrivere l\u2019ambito di applicazione della tutela camerale, quasi che ve ne fosse uno solo da considerarsi elettivo, mentre in realt\ue0 l\u2019ambito di applicazione dei procedimenti camerali \ue8 in funzione di quel rapporto tra forma e sostanza che sotto diverse apparenze si ripresenta in tutti i campi della scienza processuale. L\u2019indagine offre dunque una definizione relativa, fluida della tutela camerale, tale da potersi adattare alle diverse fattispecie sostanziali e rispondere alle specifiche esigenze di tutela: ci\uf2 \ue8 quanto richiede la riconosciuta strumentalit\ue0 del processo rispetto al diritto materiale

Il vecchio e il nuovo art. 26-bis, comma 1, c.p.c.: che cosa (non) cambia?

L'articolo analizza la modifica dell’art. 26-bis, comma 1, c.p.c. disposta dall’art. 1, comma 29, l. 26 novembre 2021, n. 206, in tema di competenza per territorio nel pignoramento presso terzi quando il debitore esecutato sia una pubblica amministrazione

Osservazioni sul principio di non contestazione

Osservazioni sul principio di non contestazione

Il vincolo di strumentalità «a doppio binario» tra tutela anticipatoria e tutela di merito nella novellazione del 2005

Il vincolo di strumentalità «a doppio binario» tra tutela anticipatoria e tutela di merito nella novellazione del 2005