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Mastering the Sequential Organ Failure Assessment Score: Critical Choices of Score Statistic, Timing, Imputations, and Competing Risk Handling in Major Trials—A Systematic Review
No full textObjectives: The Sequential Organ Failure Assessment (SOFA) score originated as a tool for assessing organ dysfunction in critical illness but has expanded to become an outcome measure in clinical trials. We aimed to assess how the SOFA score was used as the primary or secondary endpoint of major randomized controlled trials (RCTs). Data Sources: Independent reviewers searched MEDLINE/PubMed, Scopus, and Embase databases. Study Selection: Articles were selected when they fulfilled: 1) RCT; 2) SOFA score was primary or secondary endpoint; and 3) published in the Lancet, New England Journal of Medicine, or Journal of the American Medical Association. Data Extraction: Data collection included study details, outcomes, statistical differences in SOFA score, choice of score statistics, timepoints of SOFA reporting, and how missing data and competing risks analysis were managed. Data Synthesis: Twenty-three RCTs had SOFA score as outcome measure, eight used it as primary endpoint. Daily maximum SOFA was the key statistic in 11 RCTs, delta SOFA was used in eight, and mean SOFA in four. Mean SOFA was most frequently chosen as primary endpoint (4/8, 50%). There were 18 different outcome assessment timepoints, ranging from 1 to 28 days. Three RCTs reported statistically significant difference in SOFA between groups. Handling of missing SOFA scores was not described in ten of 23 RCTs. When described, it varied from study to study with variable imputation methods and variable accounting for the competing risk of mortality and ICU discharge. Conclusions: There is major variability in the choice of summary statistic for SOFA score analysis and assessment timepoints, when using it as outcome measure in RCTs. There was either no information or great variability in the handling of missing values, use of imputation, and accounting for competing risk. The current use of SOFA scores in RCTs lacks sufficient reproducibility and statistical and methodological robustness.OBJECTIVES: The Sequential Organ Failure Assessment (SOFA) score originated as a tool for assessing organ dysfunction in critical illness but has expanded to become an outcome measure in clinical trials. We aimed to assess how the SOFA score was used as the primary or secondary endpoint of major randomized controlled trials (RCTs). DATA SOURCES: Independent reviewers searched MEDLINE/PubMed, Scopus, and Embase databases. STUDY SELECTION: Articles were selected when they fulfilled: 1) RCT; 2) SOFA score was primary or secondary endpoint; and 3) published in the Lancet, New England Journal of Medicine, or Journal of the American Medical Association. DATA EXTRACTION: Data collection included study details, outcomes, statistical differences in SOFA score, choice of score statistics, timepoints of SOFA reporting, and how missing data and competing risks analysis were managed. DATA SYNTHESIS: Twenty-three RCTs had SOFA score as outcome measure, eight used it as primary endpoint. Daily maximum SOFA was the key statistic in 11 RCTs, delta SOFA was used in eight, and mean SOFA in four. Mean SOFA was most frequently chosen as primary endpoint (4/8, 50%). There were 18 different outcome assessment timepoints, ranging from 1 to 28 days. Three RCTs reported statistically significant difference in SOFA between groups. Handling of missing SOFA scores was not described in ten of 23 RCTs. When described, it varied from study to study with variable imputation methods and variable accounting for the competing risk of mortality and ICU discharge. CONCLUSIONS: There is major variability in the choice of summary statistic for SOFA score analysis and assessment timepoints, when using it as outcome measure in RCTs. There was either no information or great variability in the handling of missing values, use of imputation, and accounting for competing risk. The current use of SOFA scores in RCTs lacks sufficient reproducibility and statistical and methodological robustness
"S" come serpente, come snake, come Schlage ... Warburg, Kallir e Merleau-Ponty
No full textThe article is divided into two parts. In the first, starting from Kallir’s analyses of the psychogenetic source of the alphabet we show how the sign “S” has a semantic field that within Indo-European languages designates with exceptional frequency slithering movement and hissing sound. In the second part, the reflection is enlarged by addressing the problem of the arbitrary relationship between sound and graphic sign within alphabetic culture
Five-year drug survival of dupilumab in atopic dermatitis: Italian landscape AD real-world study
No full textPsychometric Properties of the TWente Engagement with Ehealth Technologies Scale (TWEETS) Among Patients with Hypertension in Italy
No full textIntroduction Engagement with mobile health (mHealth) technologies among patients with hypertension is linked to reduced blood pressure and improved patient understanding of the condition. Aim This study aimed to evaluate the psychometric properties (validity and reliability) of the TWente Engagement with Ehealth Technologies Scale (TWEETS) in an Italian cohort with hypertension. This study is the first attempt to evaluate the psychometric characteristics of the TWEETS in this population. Methods The study was conducted in three phases. The first phase encompassed the translation and cultural adaptation of the TWEETS to the Italian setting. The second phase involved an expert panel evaluating the instrument’s face and content validities. The third phase was a cross-sectional study aiming to test construct validity and reliability. Adults diagnosed with hypertension were eligible for participation. Additional inclusion criteria included stable antihypertensive treatment for at least 2 weeks before enrolment and the provision of written informed consent. Patients were taught how to use two mHealth devices using the teach-back method. Results A total of 131 patients were enrolled. Exploratory and confirmatory factor analyses revealed that the TWEETS had a one-factor structure and a good level of fit. Cronbach’s alpha coefficients suggested good internal consistency. Conclusions The findings indicate that the TWEETS is a valuable tool for assessing the engagement of patients with hypertension with mHealth devices. Further assessment is needed in various cohorts to confirm the psychometric equivalence of the construct across different groups with hypertension
Recommendations on the use of gadolinium-based contrast agents in the diagnosis and monitoring of common adult intracranial tumours
No full textGadolinium-based contrast agents (GBCAs) have been indispensable in intracranial tumour imaging, particularly for detecting and characterising malignant lesions, as well as assessing treatment response and disease progression. However, growing concerns about gadolinium deposition in the central nervous system and its environmental impact have prompted a re-evaluation of its use, particularly in the management of benign or stable lesions. This review examines the role of GBCAs in imaging the most common types of intracranial tumours, including gliomas, meningiomas, pituitary adenomas, cranial nerve tumours, and metastases. Recent advancements in high-field MRI scanners and the increasing adoption of 3D T2-weighted sequences, which provide excellent soft-tissue contrast, offer significant opportunities to minimise or eliminate GBCA use. Moreover, advanced MRI methods, such as arterial spin labelling for perfusion imaging and the obtention of synthetic images, have emerged as non-invasive alternatives that further enable contrast-free imaging. Finally, the development of ultra-high-relaxivity contrast agents offers the potential to reduce doses when GBCAs are required. While GBCAs remain essential for imaging certain high-grade gliomas and complex tumour cases, alternative imaging techniques can often replace them in many benign or stable lesions, ensuring diagnostic accuracy and prioritising patient safety. This review highlights strategies to optimise GBCA use, focusing on reducing reliance on GBCAs across different intracranial tumour types
The Coronary Access After TAVI (CAvEAT) Study: A Prospective Registry of CA After TAVR
No full textBackground: As transcatheter aortic valve replacement (TAVR) is now performed in patients with longer life expectancy, the need for coronary access (CA) after TAVR is expected to rise. Objectives: The aim of this study was to evaluate the feasibility of CA after TAVR with 4 different types of transcatheter heart valves (THVs). Methods: In the multicenter, prospective CAvEAT (Coronary Access After TAVI; NCT04647864) registry, coronary angiography was performed immediately following transfemoral TAVR using short-frame SAPIEN 3 or SAPIEN 3 Ultra (SAPIEN 3/Ultra) and tall-frame ACURATE neo or ACURATE neo2 (ACURATE neo/neo2), Portico or Navitor, and Evolut Pro or Evolut Pro+ (Evolut Pro/Pro+) THVs. The primary endpoint was defined as selective CA of both coronary arteries. Results: In total, 632 patients were enrolled (mean age 82 years, 59% women). Selective CA of both coronary arteries was achieved in 89% of SAPIEN 3/Ultra, 63% of ACURATE neo/neo2, 62% of Portico or Navitor, and 45% of Evolut Pro/Pro+ THVs (P < 0.001). Unfeasible CA of at least 1 coronary artery occurred in 2%, 6%, 6%, and 9% of cases, respectively (P = 0.06). In pairwise comparisons, the incidence of the primary endpoint was significantly higher for the SAPIEN 3/Ultra compared with all tall-frame THVs (P < 0.001). Among tall-frame devices, no significant difference was observed between the ACURATE neo/neo2 and the Portico or Navitor (P = 0.9), but both devices demonstrated higher rates of the primary endpoint than the Evolut Pro/Pro+ (P = 0.005 and P = 0.002, respectively). Multivariate analysis identified implantation depth, moderate or severe commissural misalignment, and use of a tall-frame THV as independent predictors of unfeasible or nonselective CA. Conclusions: The short-frame SAPIEN 3/Ultra THV demonstrated the highest rate of selective CA following TAVR. Among tall-frame THVs, the large-cell designs of the Portico or Navitor and ACURATE neo/neo2 outperformed the closed-cell Evolut Pro/Pro+ in terms of selective CA
Prevalence, Risk Factors and Costs of Female Urinary Incontinence: A Multicentre Cross-Sectional Study
No full textWhat is the prevalence of urinary incontinence and its main subtypes among middle-aged women in Northern Italy? How do urinary incontinence severity and subtypes correlate with risk factors and healthcare costs? Urinary incontinence is a common yet underreported condition among women. Despite its impact, recent data on prevalence, severity and risk factors in Italy, particularly among middle-aged women, remain scarce. This study aims to investigate the correlation between urinary incontinence severity, subtypes and healthcare costs to inform targeted interventions. Urinary incontinence is the involuntary leakage of urine, classified into stress, urgency and mixed types. Its multifactorial aetiology includes demographic, lifestyle, comorbid and obstetric-gynaecological risk factors. Urinary incontinence negatively influences physical, psychological, social and financial well-being. A multicentre cross-sectional study was conducted in four hospitals in Northern Italy, enrolling 722 women. Participants were selected based on eligibility criteria and informed consent was obtained. Data on sociodemographic factors, lifestyle and gynaecologic history were collected. Urinary incontinence severity and subtypes were assessed using the International Consultation on Incontinence Questionnaire—Urinary Incontinence Short Form (ICIQ UI-SF). Multiple logistic regression was performed to identify predictors, while Pearson's correlation test analysed the relationship between urinary incontinence severity and healthcare costs. The prevalence of urinary incontinence was 44.8%, with stress urinary incontinence being the most common subtype (39.1%). Among participants, 19.6% experienced mild leakage, while 4.3% reported severe cases. Identified risk factors included hypertension, sleep disorders, bladder emptying difficulties, higher body mass index, multiple vaginal deliveries, depression and smoking. A significant positive correlation was found between urinary incontinence severity and healthcare costs (r = 0.480, p < 0.001). Urinary incontinence affects nearly half of middle-aged women in Northern Italy. Addressing modifiable risk factors and implementing targeted interventions based on urinary incontinence subtypes are crucial to reduce urinary incontinence prevalence, severity and improve outcomes. Further longitudinal research is essential to better understand urinary incontinence in this demographic
The Endoscopic Management of Anastomotic Strictures After Esophagogastric Surgery: A Comprehensive Review of Emerging Approaches Beyond Endoscopic Dilation
No full textAnastomotic strictures are a common complication following esophagogastric surgery, with prevalence varying depending on the type of surgery and anatomical site. These strictures can lead to debilitating symptoms such as dysphagia, pain, and malabsorption, significantly impacting patients’ quality of life. Endoscopic treatment of anastomotic strictures has established a role as the first-line strategy in this setting instead of revision surgery, offering benefits in terms of lower morbidity. Various endoscopic methods are available for anastomotic stricture management, including balloon dilation, stent placement, the new lumen-apposing metal stent, and endoscopic incision techniques. However, there is currently no strong evidence and established guidelines for the optimal treatment strategy. Available data suggest that endoscopic treatments, when performed in tertiary referral centers, can provide favorable outcomes in terms of symptom relief and reduced need for rescue surgical intervention. Nonetheless, challenges remain regarding the management of recurrent strictures and procedural complications, underscoring the need for a personalized, multidisciplinary approach to optimize clinical outcomes. This review aims to provide an updated overview of endoscopic techniques and available evidence with a focus on the most recent technologies, supporting clinicians in effectively managing anastomotic strictures in complex clinical settings
Deep brain stimulation in Parkinson's disease: a comparison of accuracy and clinical outcomes of frame-based, frameless and frameless fiducial-less techniques
No full textBackground: The effectiveness of deep brain stimulation (DBS) for Parkinson's disease (PD) depends on implantation accuracy. DBS initially employed a stereotactic frame (frame-based, FB), but technological advancements led to the development of less invasive methods based on fiducial markers (F + F) or intraoperative imaging (F-F). This study compares the accuracy and efficacy of three DBS-STN implantation techniques. Methods: This retrospective study involved 18 patients with PD who underwent bilateral STN DBS between 2018 and 2023. Patients were divided into three groups: FB (n = 6), F + F (n = 7), and F-F (n = 5). Postoperative CT and preoperative MRI fusion were used to evaluate electrode accuracy via deviations from planned targets in x, y, z axes, and calculate the radial error (RE) and vector error (VE). We analyzed Unified Parkinson's Disease Rating Scale (UPDRS) III scores in four "on/off medication-stimulation" combinations, LEDD, and disease stage before DBS, and 3 and 12 months post-DBS. Results: No statistically significant differences were observed between the three methods in|Δx| (FB = 1.30 ± 0.91; F + F = 1.05 ± 0.93; F-F = 1.33 ± 1.09 mm),|Δy| (FB = 0.95 ± 0.98; F + F = 1.11 ± 1.17; F-F = 1.28 ± 1.14 mm), RE (FB = 1.82 ± 0.29; F + F = 1,71 ± 0,36; F-F = 1,91 ± 1,49 mm) and VE (FB = 3,14 ± 0,35 mm; F + F = 4,92 ± 0,54 mm; F-F = 4,42 ± 1,22 mm). All groups demonstrated significant UPDRS III (> 50%) and LEDD reduction (> 40%) at 12 months, with no intergroup differences. Conclusions: The study concludes that all three techniques provide equivalent accuracy and clinical efficacy. Centers should select DBS-STN methods based on available resources and expertise
Tight and stable glucose control is associated with better prognosis in patients hospitalized for Covid-19 and pneumonia
Get PDFAims To investigate possible associations of glucose patterns with outcomes of Corona Virus Disease 19 (COVID-19) using continuous glucose monitoring (CGM) in 43 patients hospitalized for COVID-19 mild-to-moderate pneumonia, regardless of diabetes. Methods Prospective observational study conducted during two pandemic waves in 2020-2021. Glucose sensor metrics of 7-day recording were obtained from blinded CGM. Respiratory function was evaluated as arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO(2)) ratio (PaO2:FiO(2)). Results PaO2:FiO(2) ratio was positively correlated with time in tight range (TITR) 70-140 (r = 0.49, p < 0.001) and time in range (TIR) 70-180 (r = 0.32, p < 0.05), and negatively correlated with average glucose (r =- 0.31, p < 0.05), coefficient of glucose variation (CV) (r =- 0.47, p < 0.01) and time above range (TAR) > 140 (r =- 0.49, p < 0.001). No relations were observed with HbA1c. Multivariate regression analysis showed that normal respiratory function at time of CGM removal correlated positively with TITR 70-140 mg/dL (p < 0.01), negatively with CV and TAR > 140 mg/dL (both p < 0.05) and not with TIR 70-180 and average glucose. Conclusions Lower glucose variability and optimal glucose control, expressed as CV and TITR, are CGM metrics predictive of a better prognosis in COVID-19 patients with pneumonia