Background: Fully automated Gram staining systems integrating staining, microscopy, image acquisition, and artificial intelligence (AI)-assisted interpretation have the potential to reduce laboratory workload and standardize workflows. However, their diagnostic performance in routine clinical practice remains unclear. We evaluated a fully automated Gram staining system using clinical urine specimens from multiple institutions. Methods: In this prospective multicenter study, residual urine specimens from two Japanese university hospitals were evaluated using Mycrium, a fully automated system integrating Gram staining, microscopy, image acquisition, and AI-assisted interpretation. The standalone performance of the initial and updated AI models and the performance of manual microscopy were compared with a consensus reference standard established by three experienced clinical microbiology technologists. Results: Among 892 collected specimens, 882 were eligible for analysis. Manual microscopy demonstrated a sensitivity of 93.4%, specificity of 89.9%, and Cohen's kappa of 0.83 for overall Gram stain interpretation. The initial AI model achieved a sensitivity of 91.0%, specificity of 49.3%, and kappa of 0.41, whereas the updated model showed a sensitivity of 88.3%, specificity of 59.0%, and kappa of 0.48. Model updating resulted in category-specific trade-offs between sensitivity and specificity. Most false-negative results occurred in 1+ specimens. Conclusions: The automated Gram staining system demonstrated high sensitivity but moderate specificity. Although its diagnostic performance remained inferior to experienced technologists, it enabled a fully automated workflow integrating staining, microscopy, image acquisition, and AI-assisted interpretation. These findings support the feasibility of integrated Gram stain workflow automation and provide a benchmark for further refinement of automated microscopy and AI algorithms.
OBJECTIVES:To determine whether key institutional and clinical differences exist between highly and moderately active hospitals in Japan with respect to brain-dead organ donation practices. DESIGN:Retrospective multicenter cohort study. SETTING:Sixteen tertiary emergency and critical care centers across Japan. PATIENTS:All brain-dead organ donors from participating institutions who had at least one organ procured and transplanted between July 17, 2010, and December 31, 2023. Hospitals were categorized as highly active (≥ 14 donations) or moderately active (≤ 13 donations) during the study period. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:Institutional donation practices were compared, including donor management strategies, use of vasopressors and corticosteroids, time intervals in the donation process, and frequency of multidisciplinary team meetings. A total of 204 donors were included; the median age was 47 years (interquartile range, 37-56), and 92 (45.1%) were female. Donor characteristics were similar between groups. Vasopressin was used in nearly all donors, though dosing protocols varied. Corticosteroid use was significantly higher in highly active hospitals compared with moderately active ones (58.3% vs. 38.0%; p = 0.004). Time from admission to coordinator notification was similar; however, time to family consent (median, 8 vs. 5 d; p < 0.001) and time to organ procurement (median, 12 vs. 9 d; p = 0.006) were longer in highly active hospitals. These hospitals also conducted more multidisciplinary meetings during donor management (median, 2 vs. 0; p < 0.001). CONCLUSIONS:Highly active hospitals demonstrated more intensive donor management practices, longer timeframes for key donation steps, and greater multidisciplinary engagement. Standardization of donation practices may enhance efficiency and support broader dissemination of effective institutional strategies to improve brain-dead organ donation rates in Japan.
BACKGROUND/AIM:In advanced renal cell carcinoma (RCC), immune checkpoint inhibitor (ICI) combinations (ICI-ICI) and ICI plus tyrosine kinase inhibitor (TKI) combinations (ICI-TKI) are standard first-line therapies. However, real-world data directly comparing these approaches remain limited. This study aimed to compare treatment outcomes between ICI-ICI and ICI-TKI therapies. PATIENTS AND METHODS:We retrospectively analyzed 58 patients who received first-line ICI-ICI therapy (ipilimumab plus nivolumab) or ICI-TKI therapy (pembrolizumab plus axitinib, avelumab plus axitinib, nivolumab plus cabozantinib, or pembrolizumab plus lenvatinib) for advanced RCC at Nagasaki University Hospital (March 2018 to June 2024). Primary endpoints were progression-free survival (PFS), overall survival, and objective response rate (ORR). Safety profiles were also evaluated. RESULTS:We included 36 patients in the ICI-ICI group and 22 in the ICI-TKI group. The median follow-up was 17.5 months. The median age of patients in the ICI-TKI group was significantly older than that in the ICI-ICI group (74 vs. 66 years, p<0.001). The median PFS was 30 months in the ICI-ICI group and 25 months in the ICI-TKI group. The median overall survival was 51 months in the ICI-ICI group and 49 months in the ICI-TKI group, with no significant difference observed for either endpoint. The ORR was also similar between the groups. Notably, two complete responses occurred in the ICI-ICI group. The treatment discontinuation rate due to grade ≥3 adverse events was not significantly different between the ICI-ICI and ICI-TKI groups (30.6% vs. 40.9%). CONCLUSION:Across all International Metastatic RCC Database Consortium risk groups, PFS, OS, and ORR showed no significant differences between ICI-ICI and ICI-TKI therapies. Treatment selection should consider patient-specific factors. Validation through larger prospective studies is warranted.
INTRODUCTION:Eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD; EG/EoD) are rare, chronic inflammatory disorders lacking approved treatments. METHODS:We report a randomized, double-blind, placebo-controlled phase 3 trial evaluating cendakimab, an anti-IL-13 monoclonal antibody, in 48 Japanese patients with EG/EoD. RESULTS:At week 16, cendakimab significantly reduced mean peak gastrointestinal eosinophil counts versus placebo (least squares mean difference -223.2 eosinophils/high-power field; P=0.003), with numerical improvements across symptom domains. Histologic effects were maintained at week 48 and a favorable safety profile was observed. DISCUSSION:These findings highlight IL-13 inhibition as a potential treatment strategy for EG/EoD.
