Ospedale di Parma

To compare two sodium hyaluronate formulations (HYMOVIS® ONE and MONOVISC®) for single intra-articular (IA) injection in patients with knee osteoarthritis pain. This randomized, controlled study included 347 subjects allocated to two treatment arms: HYMOVIS® ONE (n = 175) and MONOVISC® (n = 172). The primary endpoint assessed non-inferiority of HYMOVIS® ONE versus MONOVISC® based on change from baseline in the WOMAC LK3.1 A1 Pain subscale. Secondary outcomes evaluated patient response using OMERACT-OARSI criteria, changes in WOMAC stiffness and function scores, health-related quality of life (SF-12), global assessments by patients and clinicians, and rescue medication use. The mean WOMAC LK3.1 A1 walking pain subscale score decreased significantly from baseline at week 12 in both groups, with reductions of 65 % for HYMOVIS® ONE and 66 % for MONOVISC®. At week 26, reductions were 73 % for HYMOVIS® ONE and 69 % for MONOVISC®. The non-inferiority test yielded a p-value of 0.0003. Clinically significant change from baseline was observed for all secondary endpoints. For the WOMAC LK3.1 Function subscale, the comparison between groups at week 26 showed a statistically significant difference (p = 0.0367) favoring HYMOVIS® ONE. Both treatments were well tolerated. A single injection of HYMOVIS® ONE was well tolerated and non-inferior to MONOVISC®, with improvements across all study endpoints maintained through 26 weeks, indicating sustained symptomatic relief of knee OA. NCT06528600 (www.clinicaltrials.gov).

Mental disorders and chronic pain frequently co-occur. The prevalence of this comorbidity varies widely across investigations and is certainly overestimated using screening self-reports. The main aim of this cross-sectional research was to calculate prevalence rates of mental disorders in a chronic pain population during their first consultation in an Italian specialized pain clinic using the narrow diagnostic criteria of the DSM-5. Additionally, we examined the relationship between this psychiatric comorbidity and a broad range of socio-demographic and clinical parameters related to chronic pain. 174 participants were enrolled in the Pain Therapy Service at the Parma University Hospital. They completed the Structured Clinical Interview for DSM-5 mental disorders (SCID-5) and the Brief Pain Inventory (BPI). Associations between psychiatric comorbidity and other parameters were explored using regression analyses. 57 (32.7%) subjects with chronic pain had DSM-5 psychiatric comorbidity, particularly major depression and anxiety disorders. This comorbid psychopathology showed significant associations with BPI pain severity and interference scores, as well as with the presence of widespread chronic pain (including fibromyalgia) and the prescription of anti-neuropathic medication at entry. Notably, only a minority (n=18; 31.6%) of these participants with current comorbid mental disorders were treated in psychiatric services. A large portion of chronic pain patients with comorbid psychiatric syndromes remain undiagnosed and undertreated. The presence of mental health operators in multidisciplinary chronic pain teams is justified and recommended.

Psoriasis is a chronic inflammatory skin disease associated with significant physical and psychological burden. Tildrakizumab, an interleukin-23 p19 inhibitor, has demonstrated efficacy in treating moderate-to-severe plaque psoriasis both in clinical trials and real-world setting. However, limited data are available on the impact of the effective treatment of psoriasis on the psychological health of patients. The aim of this study was to assess changes in psychological well-being, as well as clinical and quality-of-life outcomes, in patients with moderate-to-severe plaque psoriasis treated with tildrakizumab in routine clinical practice in Italy. This was an interim analysis (IA) of a 52-week multicenter, prospective, observational study. Adults with moderate-to-severe plaque psoriasis initiating tildrakizumab were enrolled. Endpoints focused on well-being and psychological health and included changes, from baseline to week28, in Depression, Anxiety, and Stress Scale-21 (DASS-21) scores, Dermatology Life Quality Index (DLQI), European Social Survey (ESS) items, and World Health Organization-Five Well-Being Index (WHO-5). Effectiveness was also monitored via Psoriasis Area and Severity Index (PASI), and safety via treatment-emergent adverse event reporting. A total of 115 patients were included (mean age 52.5years, 60.8% male), 102 receiving ≥ 1 dose of tildrakizumab and completing DASS-21 evaluations at baseline and week28. At week28, improvements were observed in DASS-21 subscales [depression (-2.6, 95%CI -2.0 to -1.0), anxiety (-2.3, 95%CI -2.0 to -1.0), and stress (-3.4, 95%CI -4.0 to -2.0)], accompanied by marked PASI reduction (-13.7, 95%CI -12.8 to -10.1). DLQI, ESS, and WHO-5 scores also improved. Adverse events were generally mild or moderate, with no unexpected safety signals. In this real-world IA, tildrakizumab was observed to improve the psychological well-being of patients, reflected by a reduction in all items of the DASS-21 scale and, in parallel, confirmed its effectiveness in managing physical symptoms of psoriasis, establishing its role in the holistic management of psoriasis.

Chimeric antigen receptor (CAR)-T cell therapy has revolutionized outcomes in relapsed/refractory lymphomas, yet nonrelapse mortality (NRM) has emerged as a notable concern, with older age and infections identified as major determinants of NRM in real-life studies. The aim of the present study was to describe the rate and causes of NRM after CAR-T cells and identify risk factors. Within the framework of the prospective, multicenter, observational CART‑SIE study, we analyzed causes and determinants of NRM in a large real-world cohort of lymphoma patients receiving CAR‑T cells from 2019 to 2025. Associations between NRM and clinical or biological factors were assessed using Fine and Gray subdistribution hazard models. From 2019 to 2025, 1132 patients were enrolled in the CART-SIE Study; among those, 932 were evaluable for outcomes, with a median follow-up of 17.8 months (IQR 6.3-25.4). In this cohort, 305 deaths were observed, mainly occurring after disease progression (n = 258); overall, 47 deaths were solely attributable to NRM (5%), either early (≤28 days, 40.4%), late (29-90 days, 23.4%) or very late (>90 days, 36.2%). The 1- and 2-year cumulative incidence of NRM were 5.5% and 8.8%. Infections were the leading cause (51%), followed by CAR-T acute toxicities (CRS, ICANS, and HLH/MAS; 30%), and secondary malignancies (11%). In univariable analysis, age > 60 gt; 60 years, diabetes, atrial fibrillation, high CAR-HEMATOTOX score, elevated ferritin, baseline cytopenias, CRS grade ≥3, any-grade or grade ≥3 ICANS and infectious events were risk factors for NRM. Multivariable models revealed that, among pre-infusion factors, only high ferritin levels (HR 3.23, 95% CI: 1.37-7.62, P = .007) and diabetes (HR 3.93, 95% CI: 1.28-12.1, P = .017) independently predicted NRM, while only severe CRS, ICANS, and infections remained strong post-infusion predictors. These findings emphasize the role of host-related factors and inflammation in shaping CAR-T outcomes. Optimized patient selection, rigorous management of acute toxicities, tailored infectious prophylaxis and long-term oncologic surveillance are essential components of long-term survivorship care, aiming to mitigate NRM and sustain long-term benefits of CAR-T cells. Clinical trial registration ClinicalTrials.gov ID: NCT06339255.

The PANSS Autism Severity Score (PAUSS) has recently become a popular measure of autistic features in psychosis populations, but evidence on its longitudinal reliability and factor configuration is poor. The aims of this investigation were to examine psychometric characteristics of the PAUSS in young patients with First Episode Psychosis (FEP) treated in an early intervention service, with primary interest for its long-term stability across 2 years of follow-up and factor configuration. All FEP participants completed the Positive And Negative Syndrome Scale (PANSS) and Autism Quotient (AQ) at baseline and across the follow-up. Statistical analysis mainly included Cronbach's α to examine internal consistency of the PAUSS, Cohen's k statistics and Spearman's ρ correlation coefficients for its longitudinal stability and convergent validity with AQ scores, and exploratory factor analysis to explore its dimensions' configuration. 301 FEP participants were recruited (170 with Schizophrenia Spectrum Disorder [SSD]). Cronbach's α value for the PAUSS was 0.806, but with unacceptable inter-item correlations for PANSS G5 and G15 items. K value for examining PAUSS convergent validity with AQ score was unacceptable (0.295), as well as ρ and k values to quantify long-term test-retest reliability (< 0.750 and < 0.600, respectively). No long-term stability of the PAUSS scores across the follow-up was also found using Wilcoxon's test for repeated measure. Our EFA found a 2-factor model in the FEP total sample and a 3-factor configuration in the SSD subgroup. Our results suggest that the PAUSS does not represent a valid instrument to assess autistic features in FEP and SSD. Indeed, the it probably captures psychotic symptom severity rather than autistic features, especially reflecting negative symptom load.

<title>Abstract</title> Background Invasive intracranial pressure (ICP) monitoring is not universally available in low-resource settings, mainly due to high costs. In this scenario, non-invasive ICP (nICP) estimation could be integrated in therapeutic protocols. The objective of this international survey was to describe the utilization of nICP monitoring in this setting. Methods The survey was composed by 23 items. Target respondents were doctors treating severe traumatic brain injury (TBI) patients in low-resource settings without the availability of invasive ICP monitoring. Results One hundred and twenty-six physicians from 114 centers among 21 countries worldwide responded. The main findings of this study were: a) a predominant use of optic nerve sheath diameter (ONSD) as nICP assessment tool; b) the utilization of at least two methods for nICP estimation in approximately half of the cases; and c) the absence of specific protocol for nICP monitoring. We also reported a certain degree of variability regarding the parameters suggestive of intracranial hypertension for each of the methods used. Conclusions Brain ultrasounds, particularly ONSD assessment, are the most frequently utilized tools for nICP estimation in TBI patients managed in low-resource settings worldwide. Educational efforts linked with protocols development could be a step forward to improve the care of TBI in resource-limited settings.

Background/Objectives: Surgical clipping remains a fundamental treatment modality for intracranial aneurysms, particularly in complex cases and those not amenable to endovascular approaches. However, it is associated with several technical challenges and potential complications that may compromise patient outcomes. This study aims to identify and analyze the most frequent and critical intraoperative pitfalls encountered during microsurgical clipping. We discuss experience-based strategies for avoiding these complications as well as practical solutions for managing them effectively when they occur. Methods: A retrospective review of our institutional experience with surgically treated intracranial aneurysms is reported. The study includes a comprehensive analysis of complications encountered across a defined series of cases, along with representative clinical cases. Results: Several categories of complications were identified, including aneurysm rupture, incomplete clipping and aneurysm remnant, vessel stenosis and brain ischemia, and new-onset seizures. Specific microsurgical techniques, intraoperative tools (e.g., indocyanine-green angiography, neurophysiological monitoring, micro-Doppler flowmetry evaluation), and decision-making algorithms are discussed to help mitigate these risks. For each scenario, tailored rescue strategies are outlined based on both the literature evidence and our clinical experience. Conclusions: Awareness of the potential pitfalls in aneurysm clipping and a structured approach to their prevention and management are crucial for optimizing surgical outcomes, and for preparing young vascular neurosurgeons. Through a combination of technical refinement and scenario-based preparedness, many complications can be anticipated and effectively addressed.