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Transforming the evidence landscape in mental health with platform trials
No full textClinical trials are at the core of evidence-based medicine, but many are underpowered and fail to inform clinical practice. In mental health, the number of regulatory drug approvals has consistently lagged behind other areas of medicine, the effects of established therapies may vary, and comparative effectiveness data for available treatments are scarce. Thus, there is an urgent need for more efficient, faster and more collaborative ways of generating evidence. Traditional approaches of ‘one treatment, one trial’ are slow, inefficient, and limit comparability across trials. In contrast, platform trials use a shared infrastructure for many treatments, shared control group(s) and a master protocol that allows treatments to be added over time and ineffective ones to be dropped early. Here we present examples of platform trials in mental health (M-PACT, EU-PEARLDIVER, PUMA and RESiLIENT) and discuss their potential to increase speed, reduce operational costs and participant burden, and improve statistical power and comparability
Exploring the complexities of radiomics: an in-depth analysis of a machine learning pipeline for predicting rectal cancer therapy response using MRI
No full textDeveloping radiomic biomarkers remains challenging due to the variability in imaging protocols across centres and the lack of standardised methodologies. This study evaluates the impact of different technical decisions in radiomics pipelines using multiparametric magnetic resonance imaging data from six centres for predicting therapy response in rectal cancer. Preprocessing, feature extraction, normalisation strategies, and machine learning (ML) models were assessed for robustness and generalisability. Key findings demonstrated that the preprocessing significantly enhanced the feature reproducibility and the importance of the selected ones over the complexity of the ML classifier. This analysis highlights the necessity of a unique pipeline and the complexity of radiomics biomarkers in real-world settings, particularly when handling highly imbalanced datasets. Several insights and methodologies have been presented that may support towards more conscious decisions when implementing radiomic systems. Future efforts should focus on integrating clinical/genomic/pathomics data to improve the predictive capabilities and facilitate the introduction into clinical practice
Influenza Vaccine Uptake and Associated Hospitalization Risk in Older Adults with or Without Dementia: Differences Between at Home-Living and Nursing Home Residents in Lombardy, Italy
No full textObjective: Our population-based cohort study aims to compute the uptake of the influenza vaccine and the associated risk of hospitalization for respiratory diseases of infectious origin based on the residency setting and dementia status of people aged 65 or over. Methods: We conducted a retrospective cohort study on the whole population of residents aged ≥65 in Lombardy, the most populated Italian region. Using region-wide administrative data, we computed the seasonal prevalence of vaccination for influenza from 1 October 2022 to 30 April 2023. To estimate the risk of hospitalization, we applied Fine-Gray sub-distribution hazard models, accounting for the competing risk of death and adjusting for confounders. Results: Our study analyzed 2,420,279 individuals aged 65+ in Lombardy. Overall, 51.4% received an influenza vaccination in 2022–2023. Among residents living at home, 50.8% were vaccinated, while nursing home residents had an uptake of 74.0%. People living with dementia reported a vaccination coverage of 62.6%, and vaccination rates were higher among those residing in nursing homes than those who lived at home. The adjusted sub-hazard ratios (SHRs) showed higher hospitalization risks of 1.88 for unvaccinated individuals with dementia and 1.74 for unvaccinated individuals without dementia living at home. In nursing homes, the SHR for respiratory hospitalization was 2.20 for individuals without dementia and 2.40 for dementia patients. Vaccination reduced risks across all groups, but disparities persisted. Conclusions: People living with dementia were more likely to be hospitalized for respiratory diseases. However, they reported an influenza vaccination coverage that was below expectations and similar to the general population, both in nursing homes and home-living settings. Public health institutions should extend and mention dementia as a higher-risk conditio
Observer Variation in the Diagnosis of Testicular Sex Cord-Stromal Tumors by a Genitourinary Pathology Society and International Society of Urological Pathology Panel: Paving the Way for a New Classification
No full textThe diagnosis of sex cord-stromal tumors is challenging. They show a wide spectrum of behaviors and associations with clinically important pathogenic germline variants. In view of recent advances in molecular subtyping and risk factors, we wished to investigate the differences in diagnosis for a range of these tumors using expert genitourinary pathologists with an interest in this area. Forty-four tumors were selected, and 18 pathologists (members of TEsticular Sex cord-Stromal Tumor group) were invited to view the cases online and give a diagnosis. Consensus was taken as 70% agreement. Consensus was achieved in 59% (26/44) cases. However, there were many areas of disagreement, which included variability in the diagnosis of Sertoli cell and Leydig cell tumors, particularly in malignant lesions, and difficulty in the assignation of fibrothecomas or myoid gonadal stromal tumors, as well as variability in the diagnosis of granulosa cell tumors and in the diagnosis of rarer pediatric tumors. Pathologists placed different weights on positivity with some markers, particularly beta-catenin, S100, and SMA. Some pathologists diagnosed novel diagnostic entities, such as inflammatory and nested testicular sex cord tumors, not currently in the World Health Organization classification. Recommendations to assist in the construction of a new classification to achieve more concordance and better treatment of these rare tumors are included
Correctness of Cardiovascular Risk Perception in Primary Prevention Care: A Multicenter Cross-sectional Italian Study
No full textBackground: The assessment of individual risk for cardiovascular disease is recommended in primary prevention; however, people may not have a correct perception of their personal cardiovascular risk. Objective: The aim of this study was to compare cardiovascular risk perception with cardiovascular real risk among participants in Italian population screening events. Methods: This is a cross-sectional multicenter study. Men and women without cardiovascular events aged 40 and 69 years were included. For each participant, sociodemographic and clinical data were collected, cardiovascular risk perception was measured by one 5-point Likert question, and cardiovascular real risk was calculated using the SCORE2 algorithm. Results: A total sample of 286 participants was analyzed. The mean age was 53 years, and 69% were female; the larger part of participants demonstrated a low/moderate cardiovascular real risk (67.8%) and perceived the same level of cardiovascular risk perception (91.2%) as well. Most participants with a "high" or "very high" cardiovascular real risk (32.2% of the sample) reported an incorrect cardiovascular risk perception (91% and 94%, respectively). Incorrectness in cardiovascular risk perception was significantly (P < .001) associated with sociodemographic characteristics (sex, age, education, employment status) and clinical features of participants (smoking habit, arterial pressure, or lipid abnormalities). Conclusions: In a sample of the Italian general population, an incorrect cardiovascular risk perception is associated with sociodemographic characteristics or clinical features that increase cardiovascular real risk. Community cardiovascular screening should comprise the evaluation of cardiovascular risk perception; future research might be directed to explore more in depth its determinants and consequences
Polidocanol foam sclerotherapy in hemorrhoidal disease: shifting the focus to symptom relief, safety and repeatability
No full textAnalysis of morbid obese diabetic and non-diabetic patients: clinical and social characteristics, habits and workup to undergo bariatric surgery in Lombardy, Italy
No full textBackground: Studies on morbid obese diabetic and non-diabetic patients’ social characteristics and habits, in candidates for bariatric surgery (BS) are few. To gain further insights, we investigated 799 morbid obese diabetic (n = 111) and non-diabetic patients (n = 688). Methods: Family history of cardiometabolic diseases, personal history, education and occupation, comorbidities, daily habits, previous dietetic treatment, reasons and pathway to BS were investigated. Team members involved and examinations performed were also analyzed. Results: Family histories of obesity, diabetes and hypertension significantly associated with each other, and clinically overt diseases were also associated with family histories of the same disease, as diabetes and hypertension, and were more frequent in diabetic as compared to non-diabetic (p > 0.05, p < 0.0001 and p < 0.05). Females significantly differed from males for lower body mass index (BMI) (mean 41.2 vs 42.8 kg/m2), and a lower alcohol intake (p < 0.05 to p < 0.001). Knowledge about BS and reasons for BS varied according to age. BS was mostly requested for medical reasons (80.1%). Conclusions: Patients seeking bariatric surgery have a valid and well structured idea of obesity and are aware of the importance of eating less and physical activity in managing obesity, with differences linked to their educational levels. The interaction between physicians and surgeons improved the overall prognosis of patients seeking BS, based on screening of CV risk factors. Improved patients long term follow-up after surgery, identification of the suitable pre-BS diets, as well and identification of patients who might benefit from non-BS approaches, such as newer medical therapies could improve long term care of obesity
User requirements for quantitative radiological reports in multiple sclerosis
Get PDFObjectivesQuantitative radiological reports (QReports) can enhance clinical management of multiple sclerosis (MS) by including quantitative data from MRI scans. However, the lack of consensus on the specific information to include, on and clinicians' preferences, hinders the adoption of these imaging analysis tools. This study aims to facilitate the clinical implementation of QReports by determining clinicians' requirements regarding their use in MS management.Materials and methodsA four-phase Delphi panel approach was employed, involving neurologists and (neuro)radiologists across Europe. Initial interviews with experts helped develop a questionnaire addressing various QReport aspects. This questionnaire underwent refinement based on feedback and was distributed through the MAGNIMS network. A second questionnaire, incorporating additional questions, was circulated following a plenary discussion at the MAGNIMS workshop in Milan in November 2023. Responses from both questionnaire iterations were collected and analyzed, with adjustments made based on participant feedback.ResultsThe study achieved a 49.6% response rate, involving 78 respondents. Key preferences and barriers to QReport adoption were identified, highlighting the importance of integration into clinical workflows, cost-effectiveness, educational support for interpretation, and validation standards. Strong consensus emerged on including detailed lesion information and specific brain and spinal cord volume measurements. Concerns regarding report generation time, data protection, and reliability were also raised.ConclusionWhile QReports show potential for improving MS management, incorporation of the key metrics and addressing the identified barriers related to cost, validation, integration, and clinician education is crucial for practical implementation. These recommendations for developers to refine QReports could enhance their utility and adoption in clinical practice.Key PointsQuestionA lack of consensus on essential features for quantitative magnetic resonance imaging reports limits their integration into multiple sclerosis management.FindingsThis study identified key preferences, including detailed lesion information, specific brain and spinal cord measurements, and rigorous validation for effective quantitative reports.Clinical relevanceThis study identified essential features and barriers for implementing quantitative radiological reports in multiple sclerosis management, aiming to enhance clinical workflows, improve disease monitoring, and ultimately provide better, data-driven care for patients through tailored imaging solutions.Key PointsQuestionA lack of consensus on essential features for quantitative magnetic resonance imaging reports limits their integration into multiple sclerosis management.FindingsThis study identified key preferences, including detailed lesion information, specific brain and spinal cord measurements, and rigorous validation for effective quantitative reports.Clinical relevanceThis study identified essential features and barriers for implementing quantitative radiological reports in multiple sclerosis management, aiming to enhance clinical workflows, improve disease monitoring, and ultimately provide better, data-driven care for patients through tailored imaging solutions.Key PointsQuestionA lack of consensus on essential features for quantitative magnetic resonance imaging reports limits their integration into multiple sclerosis management.FindingsThis study identified key preferences, including detailed lesion information, specific brain and spinal cord measurements, and rigorous validation for effective quantitative reports.Clinical relevanceThis study identified essential features and barriers for implementing quantitative radiological reports in multiple sclerosis management, aiming to enhance clinical workflows, improve disease monitoring, and ultimately provide better, data-driven care for patients through tailored imaging solutions
Real-world effectiveness comparison of first-line palbociclib, ribociclib or abemaciclib plus endocrine therapy in advanced HR-positive/HER2-negative BC patients: results from the multicenter PALMARES-2 study
No full textBackground: The cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) palbociclib, ribociclib and abemaciclib in combination with endocrine therapy (ET) are the standard-of-care, first-line treatment for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (HR-positive/HER2-negative aBC). However, no large head-to-head comparisons of the three CDK4/6is have been conducted so far. Patients and methods: We carried out a multicenter, observational, population-based study to compare the effectiveness of first-line palbociclib, ribociclib and abemaciclib in combination with ET in consecutive HR-positive/HER2-negative aBC patients who initiated the treatment between January 2016 and September 2023 in 18 Italian cancer centers. The primary endpoint of this analysis was real-world progression-free survival (rwPFS). Multivariable Cox regression models were used to adjust the association between individual CDK4/6i and rwPFS for clinically relevant variables. Results: Of 1982 patients enrolled in the PALMARES-2 study, 789, 736 and 457 patients received palbociclib, ribociclib and abemaciclib, respectively. Median rwPFS was 34.1 months. In the whole study cohort, abemaciclib and ribociclib were associated with better rwPFS when compared with palbociclib [adjusted hazard ratio (aHR) 0.76, 95% confidence interval (CI) 0.63-0.92, P = 0.004 and aHR 0.83, 95% CI 0.73-0.95, P = 0.007, respectively]. In patients with endocrine-sensitive disease, only abemaciclib was associated with better rwPFS when compared with palbociclib. On the contrary, abemaciclib and ribociclib were more effective than palbociclib in patients who were premenopausal or had endocrine-resistant or luminal B-like disease, while abemaciclib was more effective than ribociclib and palbociclib in patients with de novo metastatic disease, and more effective than palbociclib in patients with poorer Eastern Cooperative Oncology Group performance status. The three CDK4/6i were similarly effective in patients who had bone-only disease. Conclusions: Palbociclib, ribociclib and abemaciclib have different real-world effectiveness in HR-positive/HER2-negative aBC patients. Our findings can support clinicians in choosing the most appropriate CDK4/6i in specific clinical contexts