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Renato de Filippis,1 Raffaele Gaetano,1 Georgios Schoretsanitis,2 Giuseppe Verde,1 Cesare Anthony Oliveti,3 John M Kane,2,4,5 Cristina Segura-Garcia,6 Pasquale De Fazio1 1Psychiatry Unit, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy; 2The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA; 3Correnti - Centri Assistenziali Mons. Oliveti, Crotone, Italy; 4Department of Psychiatry, Zucker School of Medicine at Northwell/Hofstra, Hempstead, NY, USA; 5Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, USA; 6Psychiatry Unit, Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, ItalyCorrespondence: Pasquale De FazioPsychiatry Unit, Department Health Sciences, University Magna Graecia of Catanzaro, Viale Europa 88100, Catanzaro, ItalyTel/Fax +39 0961 712393Email defazio@unicz.itBackground: Clozapine is well known for its efficacy and clinical superiority compared to other antipsychotics in treatment-resistant schizophrenia (TRS). However, it is frequently underutilized worldwide because of its acute adverse events, as well as for its long-term cardiometabolic and hematological consequences.Objective: The aim of the study was to evaluate 5-year safety in chronic TRS inpatients with continuous clozapine use.Methods: Patients with TRS and clozapine treatment were evaluated for 5 years. All participants were assessed using the Brief Psychiatric Rating Scale (BPRS), Glasgow Antipsychotic Side-effect Scale for Clozapine (GASS-C), Social Performance Scale (PSP) and Short Portable Mental Status Questionnaire (SPMSQ). Clinical, cardiometabolic and hematological data were collected periodically. General linear models (GLM) repeated measures controlling for CLZ dose were utilized to determine differences in variables across the time.Results: Overall, 189 inpatients were screened for study participation. The final sample included twenty-one TRS patients (16 males, 76%) with an average age of 57.6 years, all with 5-year continuous use of clozapine (mean dose 266 mg/day). There was not a significant effect of time on BPRS (p=0.774), PSP (p=0.855) and SPMSQ (p=0.066); differences remained not significant after controlling for CLZ dose (p=0.585, p=0.467 and p=0.105, respectively). No changes were found in blood and clinical parameters except for red blood cell count, which decreased over time (p=0.024; η2= 0.952). Patients reported a significant BMI decrease (− 8.98 kg, p=0.008) between baseline and 5 years last observation.Conclusion: The findings show how the application of a structured dietary, clinical and therapeutic monitoring program in psychiatric care facilities could allow the safe and effective long-term cardiometabolic and hematological management of clozapine. The unique role that clozapine plays in the current treatment of patients with TRS requires greater clinical awareness. Although its acute and chronic side effects are notorious, its safety management is feasible and broadens its potential practical application.Keywords: clozapine, psychiatric care facilities, safety, schizophrenia, tolerability, treatment-resistant schizophrenia

Renato de Filippis,1,* Elvira Anna Carbone,1,* Raffaele Gaetano,1 Antonella Bruni,1 Valentina Pugliese,1 Cristina Segura-Garcia,2 Pasquale De Fazio11Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro 88100, Italy; 2Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro 88100, Italy*These authors contributed equally to this work Background: Diagnosis of schizophrenia (SCZ) is made exclusively clinically, since specific biomarkers that can predict the disease accurately remain unknown. Machine learning (ML) represents a promising approach that could support clinicians in the diagnosis of mental disorders. Objectives: A systematic review, according to the PRISMA statement, was conducted to evaluate its accuracy to distinguish SCZ patients from healthy controls. Methods: We systematically searched PubMed, Embase, MEDLINE, PsychINFO and the Cochrane Library through December 2018 using generic terms for ML techniques and SCZ without language or time restriction. Thirty-five studies were included in this review: eight of them used structural neuroimaging, twenty-six used functional neuroimaging and one both, with a minimum accuracy >60% (most of them 75–90%). Sensitivity, Specificity and accuracy were extracted from each publication or obtained directly from authors. Results: Support vector machine, the most frequent technique, if associated with other ML techniques achieved accuracy close to 100%. The prefrontal and temporal cortices appeared to be the most useful brain regions for the diagnosis of SCZ. ML analysis can efficiently detect significantly altered brain connectivity in patients with SCZ (eg, default mode network, visual network, sensorimotor network, frontoparietal network and salience network). Conclusion: The greater accuracy demonstrated by these predictive models and the new models resulting from the integration of multiple ML techniques will be increasingly decisive for early diagnosis and evaluation of the treatment response and to establish the prognosis of patients with SCZ. To achieve a real benefit for patients, the future challenge is to reach an accurate diagnosis not only through clinical evaluation but also with the aid of ML algorithms.Keywords: machine learning, schizophrenia, support vector machine, resting-state fMRI, sMRI, multivariate pattern analysis

Purpose: Inadequate subscapularis repair has been advocated as one of the contributing factors for dislocation in reverse total shoulder arthroplasty; nonetheless the need to restore the subscapularis tendon integrity is under debate. The aim of this systematic review was to answer the question: does subscapularis reattachment following reverse total shoulder arthroplasty improve joint stability, range of motion and functional scores? Methods: The literature was systematically screened in accordance with PRISMA guidelines looking for papers evaluating clinical outcomes of reverse total shoulder arthroplasty in relation to the management of subscapularis tendon. Studies comparing clinical outcomes, complications and dislocation rate with or without subscapularis repair were included. Studies in which reverse total shoulder arthroplasty was performed for trauma or tumors were excluded. The methodology of included articles was scored with MINORS scale and the Risk of Bias was assessed adopting the ROBINS-I (Risk Of Bias In Non-randomized Studies of Interventions) developed by the Cochrane Group. A meta-analysis was also performed combining the studies to increase the sample size and hence the power to obtain meaningful data. Results: The database search identified 1062 records, and 6 full-text articles were finally included. A total number of 1085 reverse total shoulder arthroplasty were assessed on. Except for one study, lateralized prosthetic designs have been used. Dislocation occurred in 0.8% (5/599 patients) of the patient with repaired subscapularis and in 1.6% (8/486 patients) of the tenotomized patients, and subscapularis repair was not associated with a higher risk of dislocation (pooled Peto OR: 0.496, 95% CI: 0.163 to 1.510, p = 0.217). Qualitative assessment revealed no differences in the range of motion and clinical scores. Conclusion: Subscapularis repair after reverse total shoulder arthroplasty produces no clinically meaningful benefits, particularly using lateralized prosthetic designs. Subscapularis re-attachment does not improve implant stability, nor increases range of motion or clinical scores. Given these results, keeping in mind the antagonistic effect of the repaired subscapularis on external rotation, no evidence lead to suggest subscapularis reattachment following reverse total shoulder arthroplasty with lateralized prosthetic designs. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The clinical efficacy and tolerability of denosumab in severe osteoporosis are well-known. However, the evaluation on general health and quality of life over time and compared to population norms is still lacking. We aimed at evaluating denosumab effectiveness in a real-world clinical sample with a 6-years average follow-up. PATIENTS AND METHODS: In this retrospective-matched study with prospective data collection, a total of 101 patients affected by severe osteoporosis and treated with denosumab between 2014 and 2020 were evaluated. All patients completed the self-perceived quality of life (36-Item Short Form - SF-36) survey and visual analogue scale (VAS) before and after treatment. RESULTS: Overall, 13 patients died of causes unrelated to the procedure, 12 stopped therapy with denosumab, and 30 did not participate in the follow-up; thus, 46 patients completed the study. There were 44 (95.7%) women and 93.4% of patients reported history of osteoporotic fractures. The mean follow-up was 59±17.8 months and the mean age at follow-up was 73.9±10.6 years. We found a significant improvement in bodily pain (baseline 53.8±33.4, follow-up 62.7±26.6; p=0.002) and in general health (baseline 35±25.4, follow-up 41.7±24.2; p=0.002) over time. The bodily pain score at follow-up was similar to the mean of the age-matched healthy population (62.7±26.6 vs. 67.6±26, p=0.374). The MCS-36 scores were higher than the normative values before treatment and at follow-up (51.6±9.8 vs. 45.8±9, p=0.004 and 50.6±11.7 vs. 45.8±9, p=0.030, respectively). The PCS-36 score at follow-up was comparable to the normative values (39.4±10.4 vs. 42.7±9, p=0.107). CONCLUSIONS: Denosumab is effective to improve bone health and global mental and physical wellbeing, and quality of life over time. [ABSTRACT FROM AUTHOR]

Purpose: To assess whether the combination of HTO and cartilage treatment produced an additional clinical benefit compared to HTO alone. The secondary aim was to identify if there was any difference among different cartilage procedures in terms of healing potential and clinical outcome.Methods: A systematic review of the literature was performed on PubMed database by three independent observers according to the following inclusion criteria: clinical reports of any level of evidence, written in the English language, with no time limitation, about HTO associated with cartilage surgical and injective treatment, including surveys reporting clinical, radiological, or second-look outcomes at any follow-up time.Results: The database search identified 1956 records: 21 studies were included for the final analysis, for a total of 1068 patients; 10 case series and 11 comparative studies. While overall good results were reported in the case series, the analysis of the comparative studies showed less uniform results. Among the eight studies investigating HTO with cartilage surgical procedures, improved tissue regeneration was found in 5/8 studies, whereas a clinical improvement was reported only in two studies. Three studies on HTO combination with injective treatment showed better tissue regeneration and clinical benefit.Conclusions: Literature presents low-quality studies, with only few heterogeneous comparative papers. While surgical treatments targeting only the cartilage layer did not achieve clinical improvements, injective treatments targeting the overall joint environment showed promising findings. This prompts further research towards the development of treatments able to improve knee osteotomies outcomes. However, until new evidence will prove otherwise, there is no indication for a combined cartilage treatment in routine clinical practice.Level Of Evidence: Level IV. [ABSTRACT FROM AUTHOR]

Pregabalin (PRE) acts as a presynaptic inhibitor of the release of excessive levels of excitatory neurotransmitters by selectively binding to the α2-δ subunit of voltage-gated calcium channels. In this randomised, double-blind comparison trial with naltrexone (NAL), we aimed to investigate the efficacy of PRE on alcohol drinking indices. Craving reduction and improvement of psychiatric symptoms were the secondary endpoints. Seventy-one alcohol-dependent subjects were detoxified and subsequently randomised into two groups, receiving 50 mg of NAL or 150-450 mg of PRE. Craving (VAS; OCDS), withdrawal (CIWA-Ar) and psychiatric symptoms (SCL-90-R) rating scales were applied. Alcohol drinking indices and craving scores were not significantly different between groups. Compared with NAL, PRE resulted in greater improvement of specific symptoms in the areas of anxiety, hostility and psychoticism, and survival function (duration of abstinence from alcohol). PRE also resulted in better outcome in patients reporting a comorbid psychiatric disorder. Results from this study globally place PRE within the same range of efficacy as that of NAL. The mechanism involved in the efficacy of PRE in relapse prevention could be less related to alcohol craving and more associated with the treatment of the comorbid psychiatric symptomatology. [ABSTRACT FROM AUTHOR]