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Which Test Is Best: Evaluation of Traditional and Contemporary Statistical Tests for Analysis of Spherical Equivalent Prediction Error.
No full textPurpose: To characterize the performance of traditional and contemporary statistics tests for analysis of spherical equivalent prediction error (SEQ-PE) after cataract surgery, with regard to test significance and self-consistency.
Design: Comparison of the utility of statistical tests.
Methods: Subjects: Eyes from 5 academic centers and 2 private practices that had cataract surgery and postoperative manifest refraction between March 2011 and December 2022. SEQ-PE data were randomly divided into subsets with sample sizes of 100, 300, 500, 700, and 2600 eyes. Mean absolute error (MAE), median absolute error (MedAE), SD, root mean squared absolute error (RMSAE), and the proportion of eyes within 0.50 diopters (D) of predicted were calculated for 6 power prediction formulas and analyzed using Friedman post hoc Dunn, Cochran Q post hoc McNemar, Eyetemis, and Wilcox-Holladay-Wang-Koch (WHWK) statistical tests. All tests were corrected for multiple comparisons using the Holm correction.
Main outcome measures: The percentage of significant relationships (Percent Significance), proportion of inconsistencies (Inconsistency Ratio), and proportion of self-consistent significant relationships (Significance Index) for each statistical test.
Results: Analysis was performed on 7839 eyes of 7839 patients. WHWK.MAE (42%), WHWK.SD (41%), Eyetemis.MAE (40%), WHWK.RMSAE (39%), and Dunn.MAE (34%) were more robust, respectively, than the remaining 3 tests by Percent Significance (all P < .001). Dunn.MAE had the best Inconsistency Ratio (0.11) in the 100-eye subsets. The same top 5 tests were most robust by Significance Index (0.39, 0.35, 0.35, 0.34, and 0.31, respectively; all P < .02). WHWK.SD and WHWK.RMSAE had the best Significance Indices (both 0.77) in the 2600-eye subsets. McNemar had the poorest Significance Index overall (0.09).
Conclusions: The 5 high-performing tests produced significant results more often and were also self-consistent. WHWK.MAE and McNemar were highest and lowest performing overall, respectively. Dunn.MAE may be useful in sample sizes <150 eyes
Safe Implementation of Treatments in Stroke: a Study on Intravenous Thrombolysis in Patients Over 80 Years of Age with Acute Ischaemic Stroke.
No full textObjectives: To investigate the safety and efficacy outcomes of intravenous thrombolysis (IVT) in patients aged >80 years with acute ischaemic stroke (AIS) after IVT was approved in this patient population in several European and non-European countries during 2018-2019.
Design: This is an observational registry study using prospectively collected data from the Safe Implementation of Treatment in Stroke (SITS) registry. Comparisons will be performed between patients treated post-approval (July 2018 to December 2021) period with those treated pre-approval (June 2015 to June 2018) period using propensity score matching (PSM).
Setting: This is a multicentre international study in hospitals treating AIS with IVT.
Participants: Patients aged >80 years who otherwise followed the IVT Summary of Product Characteristics of European countries as part of the mutual recognition procedure.
Primary and secondary outcomes: The main outcomes were symptomatic intracerebral haemorrhage per SITS monitoring study definition, death and functional independency as defined by a modified Rankin Scale score of 0-2 at 90 days.
Results: After PSM, 614 patients remained in each group (mean age 87 years, 39% males). All baseline data were well balanced after PSM. There were no statistically significant differences in outcomes between pre- and post-approval patients for SICH (2.5% vs 2.3%, risk ratio (RR) 1.064, 95% CI 0.345-1.784), death (25.3% vs 28.4%, RR 0.889, 0.699-1.08) and functional independency at 90 days (40.3% vs 37%, RR 1.089, 0.942-1.237).
Conclusions: In this observational study of IVT treatment in patients >80 years of age with AIS before and after formal approval for this treatment, we did not find any difference in outcomes between the pre- and post-approval periods
Ortho-Monitorizer: A Portable Device for Quantitative Monitoring of Temperature and Pressure in a 3D-Printed Upper Limb Orthosis.
No full textBackground: Adherence to wrist-hand orthoses in patients with musculoskeletal conditions, such as Carpal Tunnel Syndrome, is crucial for effective rehabilitation. However, objective methods for monitoring wear time and pressure distribution remain limited.
Purpose: This study presents the Ortho-Monitorizer, a portable 3D-printed sensor-integrated device designed to provide real-time, quantitative monitoring of temperature and pressure in upper limb orthoses. The objective is to evaluate the system's feasibility in detecting patient adherence and identifying critical pressure points.
Study design: A descriptive and cross-sectional study was conducted to develop and validate the device, including sensor integration and data acquisition.
Methods: Using a 3D scanner and Fusion 360 software, the orthoses were customized and printed in thermoplastic polyurethane. Data from healthy participants (n = 55) and patients with Carpal Tunnel Syndrome (n = 2) were collected through the Ortho-Monitorizer's application, using six sensors (three temperature and three pressure sensors) placed at clinically relevant anatomical points. Data were acquired over five hand positions, and normal reference values were established.
Results: Mean temperature values ranged between 29.5∘C and 32.5∘C, while pressure values varied from 0.00 MPa to 0.08 MPa across different hand positions. One CTS patient exhibited pressure values above normal thresholds in specific positions, correlating with discomfort and numbness reports. The device achieved a System Usability Scale (SUS) score of 86.8% (healthy participants) and 92.5% (CTS patients), indicating high usability and acceptance.
Conclusions: The Ortho-Monitorizer provides a non-invasive, objective method for monitoring patient adherence to orthotic treatments. By offering real-time tracking of critical parameters, it enhances clinical decision-making and patient outcomes. Future research should explore wireless integration and long-term clinical validation to further optimize its applicability
Syphilis in Pregnancy: A Practical Guide for Prenatal Care Providers.
No full textSyphilis during pregnancy remains a persistent global public health challenge. Untreated or inadequately treated syphilis infection during pregnancy contributes significantly to preventable perinatal morbidity and mortality. In the last five years, a resurgence of syphilis among pregnant women in several regions has led to a concerning rise in congenital syphilis cases. Vertical transmission can occur at any point during pregnancy or delivery, with the highest risk observed during primary and secondary stages of infection compared to latent phases. To align with the World Health Organization (WHO) target of reducing the vertical transmission rate below 0.05%, the International Federation of Gynecology and Obstetrics (FIGO) has developed evidence-based guidance for the management of syphilis during pregnancy. The guidance advocates for universal early screening, strengthened health systems to ensure access to free and timely prenatal care, and the integration of effective follow-up strategies. As early diagnosis and treatment are highly effective in reducing transmission, syphilis screening should begin at the first prenatal visit. While regional protocols vary, at a minimum, screening should be repeated at delivery in countries that have not yet met WHO eradication targets. Benzathine penicillin remains the treatment of choice, with proven efficacy and safety. Additionally, screening and treatment of sexual partners are essential to prevent maternal reinfection and community transmission. Strengthening health systems to support these interventions is fundamental to improving maternal and fetal/neonatal health outcomes and advancing towards global elimination of congenital syphilis worldwide
Subdural Hematoma as a Complication of Endoscopic Third Ventriculostomy in a Pediatric Patient: a Case Report and Literature Review.
No full textBackground: Subdural hematoma (SDH) typically occurs due to traumatic brain injury but can arise as a rare complication of procedures like endoscopic third ventriculostomy (ETV).
Case presentation: We report an unusual case in a 9-year-old male with previous resection of a fourth-ventricle ependymoma at 2 years of age. Seven years post-surgery, he presented with worsening hydrocephalus and underwent ETV. One month later, he developed severe headaches and motor difficulties. Imaging revealed a significant right SDH, necessitating urgent drainage. Postoperative recovery was uneventful, and follow-up imaging showed resolution of the hematoma.
Literature review and discussion: ETV is generally preferred for obstructive hydrocephalus due to lower complication rates compared to shunt procedures. However, cases of SDH post-ETV remain reported, albeit rarely. Potential mechanisms include altered cerebrospinal fluid dynamics and intraoperative vessel injury. This case aligns with literature findings and reinforces the importance of postoperative monitoring and prompt intervention in symptomatic cases to prevent complications.
Conclusion: Clinicians should consider SDH in pediatric patients with new symptoms post-ETV. Further research should focus on understanding the risk factors and mechanisms for SDH development
Persistent Proinflammatory Cytokine Profile in the Tear Fluid of Stable Keratoconus: Rethinking Clinical Quiescence.
No full textPurpose: Keratoconus is traditionally classified as a noninflammatory corneal ectasia, despite growing evidence suggesting an underlying inflammatory component. This study evaluates whether patients with stable keratoconus exhibit persistent inflammatory activity in tear fluid compared to healthy controls.
Methods: Cross-sectional case-control study. Keratoconus progression was evaluated using tomographic and clinical criteria. Tear fluid samples were collected under standardized conditions and concentrations of nine cytokines (IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12p70, IL-17A, and TNF-α) were quantified using a multiplex assay. Group comparisons, correlation analyses, and receiver operating characteristic (ROC) curves were performed to evaluate cytokine expression and network behavior.
Results: A total of 23 stable keratoconus patients and 25 age-matched healthy controls were included. The stable keratoconus group exhibited significantly elevated levels of tear fluid inflammatory cytokines compared to controls (all P < 0.05, except IL-2). Spearman correlation heatmaps revealed a coordinated cytokine network in the keratoconus group, suggesting persistent immunological activation despite clinical quiescence. No significant correlations were observed between cytokine levels and keratoconus staging indices. ROC analysis indicated moderate discriminatory performance of IL-6 (area under the curve = 0.68).
Conclusions: Even clinically stable keratoconus is associated with a distinct proinflammatory tear fluid cytokine profile, challenging the traditional paradigm of keratoconus as a noninflammatory disease. These findings highlight the potential utility of tear fluid-based inflammatory biomarkers in keratoconus and suggest inflammation may persist independently of clinical progression.
Translational relevance: This study highlights the potential role of tear-based inflammatory biomarkers for monitoring disease activity, understanding keratoconus pathophysiology and guiding adjunctive anti-inflammatory therapies in keratoconus beyond structural stabilization
Predictive Model for Very Early Recurrence of Patients with Perihilar Cholangiocarcinoma: a Machine Learning Approach.
No full textBackground: Although offering the best chance of potential cure for patients with localized perihilar cholangiocarcinoma (pCCA), resection has been associated with high morbidity and sometimes poor long-term outcomes due to recurrence. We sought to develop a predictive model to identify individuals at high risk for very early recurrence (VER) after curative-intent surgery for pCCA.
Methods: Patients who underwent curative-intent surgery for pCCA between 2000-2023 were identified from a multi-institutional database. An eXtreme Gradient Boosting (XGBoost) model was developed to estimate the risk of VER, defined as recurrence within 6 months after resection. The relative importance of clinicopathologic factors was determined using SHapley Additive exPlanations (SHAP) values.
Results: Among 434 patients undergoing curative-intent resection for pCCA, 65 (15.0%) patients developed VER. Median overall survival (OS) among patients with and without VER was 8.4 [interquartile range (IQR) 6.6-11.3] versus 38.5 (IQR 31.9-45.7) months (P<0.001). An XGBoost model was able to stratify patients relative to the risk of VER [low-risk: 6-month recurrence-free survival (RFS) 94.6% vs. intermediate-risk: 6-month RFS 88.3% vs. high-risk: 6-month RFS 40.0%; P<0.001]. Similarly, 3-year OS incrementally worsened based on VER risk (low-risk: 75.3% vs. intermediate-risk: 19.5% vs. high-risk: 4.6%; P<0.001). The SHAP algorithm identified age, preoperative carbohydrate antigen 19-9 (CA19-9) levels, tumor size and differentiation/grade, as well as lymph node metastasis as the five most important predictors of VER. The predictive accuracy of the model was good in the training [c-index: 0.74, 95% confidence interval (CI): 0.67-0.81] and internal validation (c-index: 0.77, 95% CI: 0.71-0.83) cohorts. An easy-to-use risk calculator for VER was developed and made available online at: https://junkawashima.shinyapps.io/VER_hilar/.
Conclusions: A novel, machine learning based model was able to predict accurately the chance of VER after curative-intent resection of pCCA. In turn, the tool may help surgeons in the selection of patients likely to benefit the most from resection, as well as counsel individuals about the anticipated risk of recurrence in the early post-operative period
Eyelid Arteriovenous Malformation With Orbital Fistula: Literature Review and Case Report.
No full textOrbital arteriovenous malformations (AVMs) are rare entities, either congenital or acquired, that can significantly impair ocular function and aesthetics. Diagnostic evaluation requires multimodal imaging, and treatment is extremely complex, not only due to the limited information available in the literature, but also because of the high recurrence rate of the lesion, therefore requiring a multidisciplinary approach. Treatment involves a multimodal approach, often requiring AVM embolization followed by surgical excision. Endovascular embolization with agents such as ethylene-vinyl alcohol (Onyx®) or N-hexyl cyanoacrylate (Magic Glue®) should be ideally performed prior to subsequent surgical approaches. Recurrence is frequent, especially when nidus occlusion is incomplete, underscoring the importance of long-term follow-up and reintervention when necessary. We present a review of the recent literature and a clinical case of a left upper eyelid AVM associated with an orbital fistula in a young patient, managed with endovascular embolization and surgical excision
Metabolism-Targeted Therapy in NSCLC - A New Theranostics Inhalation Approach Using Lactate Functionalized and Selenium-Chrysin Loaded Nanoparticles (SeChry@PURE-LA).
No full textLung cancer is one of the most lethal cancers globally, primarily due to delayed diagnosis and lack of specific and effective therapy. Increased lactate production and consumption, along with cysteine metabolic reliance, are features identified in NSCLC in our recent studies. Cancer metabolic remodeling leads to excessive ROS production, triggering oxidative stress, promoting angiogenesis, causing cellular and tissue damage, and contributing to various pathophysiological changes. This study aimed to investigate the therapeutic potential of selenium-chrysin (SeChry), a cysteine metabolism inhibitor, and its delivery targeted at MCT1 by encapsulation in fourth-generation polyurea dendrimers functionalized with lactic acid (PURE-LA), the nanoformulation SeChry@PURE-LA, in NSCLC. We explored the impact of SeChry nanoformulation on cell death mechanisms, including ferroptosis, and its influence on angiogenesis in in vitro and in vivo models. SeChry@PURE-LA induces cell death through the induction of intracellular ROS and lipid peroxides, resulting in distinct expression patterns of ferroptosis-associated genes across cell lines. Experiments using chicken embryo chorioallantoic membrane (CAM) and mouse orthotopic xenograft models revealed a trend toward decreased tumor growth and angiogenesis with SeChry@PURE-LA administration. These findings suggest the potential of SeChry@PURE-LA as an innovative therapeutic approach for NSCLC, highlighting its impact on cell death mechanisms and anti-angiogenic effects
Contemporary Assessment of Short- and Functional 90-Days Outcome in Old Intensive Care Patients Suffering From COVID-19.
No full textPurpose: There are limited data about the outcome of old intensive care (ICU) patients suffering from Covid-19 in the post-vaccination era. This study distinguishes the pre- and post-acute illness living conditions of ICU survivors from non-survivors.
Methods: This prospective international multicenter study included 642 old (≥ 70 years) ICU patients, including data ranging from pre-illness condition to functional 90-days follow-up. The primary endpoint was the difference of living conditions of ICU-survivors before ICU admission and 90-days after ICU discharge. Secondary outcomes were 90-days mortality, and quality of life.
Results: A total of 642 patients were included. Significantly more ICU survivors lived at their own homes without support before ICU admission than non-survivors (p = 0.016), while more non-survivors resided in nursing homes (p = 0.016). ICU mortality was 39 %, 30-days and 90 days mortality were 47 %and 55 %. After 90 days, only 22 % maintained the same living conditions. Surviving patients viewed ICU admission positively after 90 days, while relatives were more uncertain. Quality of life indicated a self-reported average score of 60 (50-75).
Conclusion: Living conditions influence the outcome of critically ill old patients suffering from Covid-19. Only a minority returned to their initial habitat after ICU survival. Trial registration numberNCT04321265