Ineligible Cases Research Articles

Liver Stiffness, Not Steatosis, Predicts Mortality in MASLD Patients: An NHANES Analysis

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) has surged as a major cause of liver transplants in the United States. Existing studies have presented conflicting findings regarding the association between liver characteristics (specifically steatosis and fibrosis) and mortality. This study investigates the relationship between the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) via vibration-controlled transient elastography (VCTE) and all-cause mortality in MASLD patients. Methods: Using the NHANES 2017-2018 database, 3821 individuals representing the United States population with MASLD underwent VCTE for liver stiffness measurement. Exclusion criteria were applied, eliminating ineligible cases, incomplete examinations, underage individuals, and those with hepatitis B or C, along with significant alcohol consumption history. Cox proportional hazard models assessed the hazard ratio (HR) for all-cause mortality in CAP and LSM. Cox regression analysis with interaction terms was employed for deeper exploration. Results: The study unveiled a strong, independent correlation between LSM and all-cause mortality. However, the CAP failed to demonstrate a significant association with mortality in both univariate and adjusted analyses, contrary to recent findings. The analysis underscores the importance of accurately measuring liver stiffness via VCTE in predicting adverse outcomes in MASLD patients, emphasizing the pivotal role of fibrosis in assessing mortality risk. Conclusion: This study reaffirms the robust link between liver fibrosis (measured through VCTE) and mortality among MASLD individuals. The absence of a significant association between steatosis (indicated by CAP) and mortality challenges recent research, urging further comprehensive investigations with larger cohorts to delineate steatosis’ precise impact on MASLD-related mortality.

Outcome of Ewing sarcoma in children: Twenty years experience from a single center

ABSTRACT Objective: Ewing sarcoma (ES) is a significant malignancy in pediatric patients, with a notable impact on bone health. Despite advances in treatment, ES still poses challenges, particularly in cases of metastasis or relapse. This study aims to evaluate the outcomes of ES in children treated at our center over a twenty-year period. Patients and Methods: We retrospectively reviewed pediatric patients diagnosed with ES at our center between January 2004 and February 2024. Data including demographic information, tumor characteristics, treatment modalities, and survival outcomes were analyzed. Results: Among 986 pediatric solid tumor cases, 137 (13.8%) were diagnosed with ES. After excluding ineligible cases, 115 ES cases were included in the study. The most common sites of involvement were the lower extremities. Metastatic disease was observed in 35.8% of cases, with the lungs being the most common site. Advanced age, and pelvic involvement were associated with poor prognosis. Histopathological response to neoadjuvant chemotherapy, represented by tumor necrosis rate, metastatic and relapse disease significantly influenced survival outcomes. Conclusion: Despite multimodal therapies, ES in children, especially with metastatic disease or relapse, presents a challenging prognosis. Early diagnosis and the development of novel treatment strategies are imperative to improve outcomes for these patients.

Nonreversed great saphenous vein grafts for vascular reconstruction after resection of lower-limb sarcoma

ObjectiveReversed great saphenous vein (GSV) graft is widely used for revascularization in limb-sparing surgery for sarcoma invading great vessels. However, a mismatch in caliber between the reverse graft and the cut end of the artery can threaten graft patency. Recently, we introduced the use of a venous valvulotome to allow non-reversed GSV graft. The purpose of this study was to evaluate the safety and versatility of this technique. DesignWe retrospectively compared long-term patency and limb salvage rates between non-reversed GSV and reversed GSV in patients undergoing limb-sparing surgery for sarcoma. MethodsThirty-seven patients were included, with 21 in the non-reversed GSV group and 16 in the reversed GSV group. Patient characteristics, surgical details, and complications were reviewed from the hospital records. The patency of reconstructed vessels was assessed by contrast-enhanced CT or MRI. Statistical analyses, including Kaplan–Meier survival analysis, were employed for comparisons. ResultsThe median follow-up was 38 months. Overall graft patency was 90.4% (19 of 21 patients) in the non-reversed GSV group and 81.2% (13 of 16) in the reversed RGSV group. In the non-reversed GSV group, there was one case of graft occlusion each in the acute phase and chronic phase, but limb circulation remained intact and all limbs were spared. ConclusionNon-reversed GSV grafting with a valvulotome offers a safe and versatile alternative to reversed GSV grafts in limb-sparing sarcoma surgery. It eliminates the need for vein reversal and minimizes diameter mismatch, potentially expanding the indication for autologous revascularization in previously ineligible cases.

Tocilizumab use in giant cell arteritis: comparing Pharmaceutical Benefits Scheme eligible and ineligible cases in South Australia.

Tocilizumab (TCZ) is increasingly used as a steroid-sparing agent in giant cell arteritis (GCA), but there are strict Pharmaceutical Benefits Scheme (PBS) restrictions for its use in Australia. Patients who do not meet the PBS criteria can obtain TCZ through public hospital individual patient use (IPU) schemes which may not be universally accessible. We compared patients receiving IPU-approved TCZ with patients receiving PBS-subsidised TCZ and found IPU approvals were granted mainly for visual loss, a serious complication of GCA, in patients who otherwise failed to meet PBS criteria. Further studies demonstrating that TCZ is comparatively more effective than prednisolone monotherapy, as well as cost-effective, are needed to substantiate the rationale for expanding PBS approval criteria.

The Effect of Fenugreek on the Severity of Dysmenorrhea: A Systematic Review and Meta-analysis.

Dysmenorrhea is the most common periodic pain, which affects more than 50% of women with regular menstruation. Fenugreek is one of the medicinal plants with analgesic properties. This study aimed to determine the effect of fenugreek application in the severity of dysmenorrhea and its side effects in women with dysmenorrhea. PICO: Population: women with dysmenorrhea; Intervention: fenugreek; Comparison: control groups; and Outcome: reduction in the severity of dysmenorrhea and its side effects. English database (PubMed, Cochrane Library, Scopus, and Web of Science) and Persian database [SID (Scientific Information Database) and Magiran] were used for research until February 11, 2023, using the keywords "Dysmenorrhea [Mesh]," "Foenum [Mesh]," "fenugreek [Mesh]," and "Trigonella [Mesh]." The reference list of the selected articles was also checked. The quality assessment was conducted through the Cochrane Handbook for Systematic Reviews of Interventions version 5.2.0. The RevMan 5.3 software was used to analyze and report the data of the entered studies. Meta-analysis results were reported with the standardized mean difference (95% confidence interval). A subgroup analysis was performed based on the type of control groups. The quality of evidence was assessed using the GRADE approach. After removing duplicates and ineligible cases, four articles were included in the systematic review out of the 1526 records obtained. The results showed that the pain intensity caused by primary dysmenorrhea decreased with fenugreek compared to placebo (pooled result SMD: -2.21; 95% CI: -3.26 to -1.17; Z: 4.17; p <0.001). There was no significant difference between fenugreek with mefenamic acid (SMD: 0.05; 95% CI: -0.57 to 0.67; Z: 0.17; p = 0.86) and fenugreek with Chandrasura churna (SMD: 0.06; 95% CI: -0.56 to 0.68; Z: 0.19; p = 0.85). Bias, in terms of incomplete outcome data and selective reporting, was low risk in all studies, and the available evidence was low quality according to the GRADE approach. The results showed that the effect of fenugreek on pain intensity in dysmenorrhea is highly uncertain. The true effect is likely to be substantially different from the estimate of effect. Regarding the importance of the health and quality of life of women of reproductive age and the low quality of evidence of the studies, clinical trials with stronger methodology are suggested in this field.

A prospective multicenter phase II trial of total neoadjuvant therapy for locally advanced rectal cancer in JAPAN: ENSEMBLE-1 study.

123 Background: The short- and long-term prognosis of total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC) is elucidated in the world. We evaluated the feasibility and safety of TNT for patients with LARC in Japan. Methods: This prospective, multicenter, open-label, single-arm phase II trial was conducted at five institutions. The key eligibility criteria were age ≥20 years, LARC within 12 cm from the anal verge, and cT3-4N0M0 or TanyN+M0 at the time of diagnosis that enabled curative resection. Preoperative short-course radiation therapy (SCRT) 5 Gy × 5 days (total 25 Gy) + CAPOX (6 courses) followed by total mesorectum excision (TME) was the treatment protocol. Non-operative management (NOM) was allowed if clinical complete response (cCR) was obtained in the preoperative evaluation. The primary endpoint was the pathological complete response (pCR) rate. With a pCR rate threshold of 5%, an expected value of 28%, a one-sided significance level of 5%, and a power of at least 80%, the sample size required by the exact binomial distribution method would be ≥19 patients. Considering a few dropouts, ineligible cases, and patients in which resection was not performed, the target sample size was set to 27 patients. Results: Thirty patients (male, n=26; female, n=4; median age, 62.5 [44-74] years; cT [T2, n=1; T3, n=25; T4, n=4]; cN [N0, n=13; N1, n=13; N2, n=4]) were enrolled. The final analysis included 30 patients in total. The completion rates were 100% for SCRT and 83% for CAPOX. TME and NOM were performed in 20 and seven patients, respectively. pCR was observed in six patients (30% [95% CI 14.0%–50.8%]). The primary endpoint was met. pCR+cCR was observed in 13 (43.3%) patients at TME or restaging. There were no treatment-related deaths. Grade ≥3 (CTCAE ver. 5.0) adverse events (≥20%), including diarrhea (23.3%) and neutropenia (23.3%). The median follow-up period was 21.8 (10.9-29.6) months. Recurrences in three patients (10.0%) were observed. In NOM, regrowth (28.6%) in two patients occurred, of which one patient was performed TME and one patient is on chemotherapy. Conclusions: ENSEMBLE-1 demonstrated satisfactory pCR and cCR, and well-tolerated safety of TNT for patients with LARC in JAPAN. Further long-term prognosis observation is required. A phase III trial, ENSEMBLE (NCT05646511/jRCTs031220342) is currently ongoing in JAPAN. Clinical trial information: jRCT s051200113 .

The impact of chronic obstructive pulmonary disease on surgical outcomes after surgery for an acute abdominal diagnosis

PurposeThe current study was undertaken to describe the independent contribution of chronic obstructive pulmonary disease (COPD) to the risk of postoperative morbidity and in-hospital mortality among patients undergoing surgery for an acute abdominal diagnosis.MethodsPatients who underwent emergency abdominal procedures were identified from the electronic database of the Department of Visceral, Transplantation, Thoracic and Vascular Surgery of our institution. To evaluate differences in surgical risk associated with COPD, patients with COPD were matched for age, sex, and type of surgery with an equal number of controls who did not have COPD. Logistic regression was performed to evaluate the univariate and multivariate associations between the independent variables, including COPD and outcome variables.ResultsBetween January 2012 and December 2022, 3519 patients undergoing abdominal emergency surgery were identified in our abdominal surgical department. After removing ineligible cases, 201 COPD cases with an equal number of matched controls remained for analysis. The prevalence of COPD after the exclusion of ineligible cases was 5.7%. There were statistically significant differences in the rate of postoperative pulmonary complications (PPCs [57.7% vs. 35.8%; P < 0.001]), ventilator dependence (VD [63.2% vs. 46.3%; P < 0.001]), thromboembolic events (TEEs [22.9% vs. 12.9%; P = 0.009]), and in-hospital mortality (41.3% vs. 30.8%; P = 029) for patients with and without COPD. Independent of other covariates, the presence of COPD was not associated with a significantly increased risk of in-hospital mortality (OR, 1.16; 95% CI 0.70–1.97; P = 0.591) but was associated with an increased risk of PPCs (OR, 2.49; 95% CI 1.41–4.14; P = 0.002) and VD (OR, 2.26; 95% CI 1.22–4.17; P = 0.009).ConclusionsPreexisting COPD may alter a patient’s risk of PPCs and VD. However, it was not associated with an increased risk of in-hospital mortality.

The primary endpoint analysis of SCARLET study: A single-arm, phase II study of sotorasib plus carboplatin-pemetrexed in patients with advanced non-squamous, non-small cell lung cancer with KRAS G12C mutation (WJOG14821L).

9006 Background: Efficacy and safety of sotorasib in combination with platinum-doublet chemotherapy in KRAS G12C-mutated non-squamous, non-small cell lung cancer (non-Sq, NSCLC) has not been investigated. Methods: In this single-arm, phase 2 study, chemotherapy-naïve, advanced non-Sq, NSCLC patients with KRAS G12C mutation were enrolled. Participants were treated with sotorasib 960mg, QD plus carboplatin (AUC 5)/pemetrexed 500mg/m2 for four cycles, followed by sotorasib plus pemetrexed until disease progression. The primary endpoint was overall response rate (ORR) by independent review. The secondary endpoints were progression-free survival (PFS), overall survival (OS) and safety. Using plasma samples, next-generation sequencing analysis was done at baseline, 3 weeks and disease progression. Regarding statistical consideration, the threshold and the expected ORR were set as 40% and 65%, respectively with one-sided α = 0.1, and β = 0.1, the required sample size was 28 cases (Simon’s two-stage design). A total of 30 cases was planned to take into account the possibility of a few dropped or ineligible cases. This study was funded by AMGEN Inc. and Trial identification no. is jRCT2051210086. Results: Between Oct 2021 and Jul 2022, 30 patients were enrolled. Twenty-nine and 27 were analyzed for safety and efficacy, respectively. Of those, median age was 70, male/female: 25/5, never-/smoker: 1/29, ECOG performance status: 0/1 11/19 and PD-L1 expression level: ≥50%/1-49%/&lt;1% 15/10/5. The primary endpoint, ORR by independent review was 88.9% (80%CI 78.5-94.8%). Median PFS was not reached mainly due to shorter follow-up period (median 4.2 months) and PFS rate at 6 months was 61.2%. OS rate at 6 months was 87.0%. Subgroup analysis revealed that ORR did not differ by PD-L1 expression level (≥50%/1-49%/&lt;1%: 76.9%/77.8%/80.0%, respectively). Common adverse events were anemia, neutrophil count decreased, nausea and platelet count decreased. Grade≥3 AEs were mostly hematological toxicities, but one treatment-related death (pneumonia) occurred. At baseline, 70% of plasma samples were positive for KRAS G12C and most common co-occurring mutation was TP53 (50%). At 3 weeks, plasma KRAS G12C disappeared among 60% of patients. Conclusions: Sotorasib in combination with CBDCA/PEM demonstrated favorable ORR and tolerability in advanced non-Sq, NSCLC patients with KRAS G12C mutation. Clinical trial information: jRCT2051210086 .

Phase II study on feasibility of sentinel lymph node biopsy for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer (SHARE study).

583 Background: Sentinel lymph node biopsy (SLNB)-guided axillary management is still debated for clinically node-positive breast cancer (BC) patients treated with neoadjuvant chemotherapy (NAC). Several phase II studies demonstrated high false-negative rates (FNR) in ycN0 BC, but precise diagnostic imaging for nodal involvement may reduce FNR. To explore ideal imaging and lymphatic mapping, the Japanese Society for Sentinel Node Navigation Surgery conducted a prospective non-randomized phase 2 study (SHARE study, UMIN000030558). Methods: Clinical T1-3N1M0 BC was eligible under multimodal imaging of breast ultrasound, CT and/or MR mammography. Nodal metastasis was histologically confirmed. Standard regimen for NAC was performed by physician’s choice. In case of ycN0 BC, SLNB was planned and lymphatic mapping depended on each institutional practice. The primary endpoint is FNR of SLNB and secondary endpoints are the identification rate and outcome of ycN0 BC patients at 2 years after surgery. Moreover, in cases of pN0(sn), pN0(i+)(sn) and pN1mi(sn), SLNB followed by lymph node sampling had been allowed instead of axillary lymph node dissection. Based on an estimated FNR of 5%, 224 patients were needed to give 80% power to reject the null hypothesis that the threshold of FNR is 15% with a one-sided type I error rate of 5%. Results: Between February 2018 and May 2021, 185 patients from 19 institutes were registered. After 27 ineligible cases of protocol deviation, non-ycN0 or withdrawal of SLNB were excluded, 158 ycN0 cases underwent SLNB and sentinel lymph nodes were detected in 153 cases. Among them, the median age was 52 years old. Clinical stage was IIA in 40 cases, IIB in 105 and IIIA in 8. Luminal subtype classified by ER, PR and HER2 expression was found in 60 cases, HER2 in 34, Luminal-HER2 in 35 and triple-negative in 24. Finally, 61 cases had positive nodes, which included 7 false-negative cases. FNR was 11.5% (90% confidence interval, 5.5% and 20.5%). The identification rate was 96.8% and the accuracy rate was 95.4%. Before NAC, multimodal imaging was performed in 148 cases (96.7%) and 1 nodal metastasis was detected in 62 cases (40.5%). When multimodal imaging, 1 nodal metastasis, multiple tracers, multiple sentinel lymph nodes were considered for subset analysis, the FNR was 12.1%, 9.1%, 11.1%, and 10.6%, respectively. If isolated tumor cells in lymph nodes had been defined as pathologically negative even after NAC, the FNR was 7.1%. Conclusions: Multimodal imaging could not improve FNR in ycN0 BC. However, SLNB-guided axillary management should be considered when one positive-node is clinically converted to ycN0 after NAC. We will report the outcome of ycN0 BC cases next year. Clinical trial information: UMIN000030558 .

A phase II study of afatinib in combination with pemetrexed and carboplatin in patients with EGFR mutation positive non-squamous, advanced non–small-cell lung cancer (NSCLC) refractory to first-line osimertinib treatment: NEJ025B.

9044 Background: To date, osimertinib has been commonly used as a first-line treatment for EGFR mutated advanced NSCLC. However, the issue of what constitutes effective treatment after osimertinib failure remains．We evaluated treatment with afatinib plus chemotherapy for EGFR mutated NSCLC resistant to osimertinib. Methods: Patients (pts) with EGFRm (Del19 or L858R) after failure of osimertinib treatment were assigned to a regimen of afatinib 20mg daily combined with carboplatin AUC5 mg/ml/min and pemetrexed 500mg/m2 every 3 weeks followed by maintenance treatment with afatinib plus pemetrexed until disease progression or unacceptable toxicity was noted. The primary endpoint was rate of PFS at 6 months after initiation of treatment (6M-PFSR). The threshold was set at 35% and the expected value at 60% (two-sided P-value of 5% and power of 80%). Thirty-one patients were required, and the target number of patients was set at 35 after accounting for ineligible cases. Secondary endpoints were PFS, OS, ORR, DOR, and Safety. In this study, blood samples were collected before and after study treatment and at the time of PD to examine biomarkers using CAPP-SEQ. This biomarker study is ongoing. Results: Between June 7, 2020 and January 19, 2022, 36 pts were enrolled. One patient was found to meet the exclusion criteria, and the efficacy was analyzed in the other 35 patients. The mean age was 70 years, 60% were women, and 54.3% were nonsmokers. The 6M-PFSR, the primary endpoint, was 57.1%. The confidence interval of 39.3%-71.5% exceeded the threshold of 35%, and the study met its primary endpoint. Notably, 24.1% of pts had a long-term PFS of 1 year or longer. ORR was 48.6%, DCR was 88.6%, median PFS was 8.2M, median DOR was 5.6 M, and median OS was not reached. By mutation type, ORR were similar for Del19 and L858R (46.7% and 50.0%, respectively), but median PFS tended to be longer for Del19 compared to L858R (9.6M and 5.2M, respectively). Pts who responded to previous osimertinib therapy (CR and PR: n = 29) tended to have longer mPFS compared to non-responders (SD, PD, and NE: n = 6) (8.5M and 5.8M, respectively). Adverse events due to TKI and chemotherapy were observed. Diarrhea (52.8%), anorexia (44.4%), fatigue (33.3%), and paronychia (36.1%) were the most frequent adverse events, and these adverse events were predictable and manageable. Interstitial pneumonia developed in three patients (8%), one of whom was the only death in the study. Conclusions: The combination of afatinib and the platinum doublet showed satisfactory efficacy with manageable adverse events in tumors refractory to osimertinib, and met its primary endpoint. OS follow-up and biomarker analyses are still ongoing. This regimen is expected to be a candidate for second-line therapy after osimertinib. Clinical trial information: jRCTs021200005 .

Improving Data Integrity and Quality From Online Health Surveys of Women With Infant Children.

Online surveys have proven to be an efficient method to gather health information in studies of various populations, but these are accompanied by threats to data integrity and quality. We draw on our experience with a nefarious intrusion into an online survey and our efforts to protect data integrity and quality in a subsequent online survey. We aim to share lessons learned regarding detecting and preventing threats to online survey data integrity and quality. We examined data from two online surveys we conducted, as well as findings of others reported in the literature, to delineate threats to and prevention strategies for online health surveys. Our first survey was launched inadvertently without available security features engaged in Qualtrics, resulting in a number of threats to data integrity and quality. These threats included multiple submissions, often within seconds of each other, from the same internet protocol (IP) address; use of proxy servers or virtual private networks, often with suspicious or abusive IP address ratings and geolocations outside the United States; and incoherent text data or otherwise suspicious responses. After excluding fraudulent, suspicious, or ineligible cases, as well as cases that terminated before submitting data, 102 of 224 (45.5%) eligible survey respondents remained with partial or complete data. In a second online survey with security features in Qualtrics engaged, no IP addresses were associated with any duplicate submissions. To further protect data integrity and quality, we added items to detect inattentive or fraudulent respondents and applied a risk scoring system in which 23 survey respondents were high risk, 16 were moderate risk, and 289 of 464 (62.3%) were low or no risk and therefore considered eligible respondents. Technological safeguards, such as blocking repeat IP addresses and study design features to detect inattentive or fraudulent respondents, are strategies to support data integrity and quality in online survey research. For online data collection to make meaningful contributions to nursing research, it is important for nursing scientists to implement technological, study design, and methodological safeguards to protect data integrity and quality and for future research to focus on advancing data protection methodologies.

Effectiveness and Safety of Dabigatran Reversal with Idarucizumab in the Taiwanese Population: A Comparison Based on Eligibility for Inclusion in Clinical Trials.

Background and Objectives: The effectiveness and safety of idarucizumab for the reversal of the effects of dabigatran have been proven. However, there remains a paucity of literature comprehensively investigating outcomes in real-world patients. This is especially true when comparing patients who were eligible for inclusion in the RE-VERSE AD trial with patients who were ineligible. As the prescription of dabigatran has become increasingly popular, the generalizability of the results to real-world populations has come into question due to the broad variability of real-world patients receiving dabigatran. Our study aimed to identify all patients who were prescribed idarucizumab and examined how effectiveness and safety varied among those patients who were eligible and ineligible for the trial. Materials and Methods: This retrospective cohort study analyzed the largest medical database in Taiwan. We enrolled all patients who were prescribed and received idarucizumab from when it became available in Taiwan up until May 2021. A Total of 32 patients were included and analyzed, and they were further divided into subgroups based on their eligibility for inclusion in the RE-VERSE AD trial. Multiple outcomes were evaluated, including successful hemostasis rate, complete reversal efficacy of idarucizumab, 90-day thromboembolic events, intra-hospital mortality, and adverse event rate. Results: In our study, we found that 34.4% of real-world cases of idarucizumab use were ineligible for the RE-VERSE AD trials. The eligible group had higher successful hemostasis rates (95.2% vs. 80%) and anticoagulant effect reversal rates compared to the ineligible group (73.3% vs. 0%). The mortality rates were 9.5%, compared to 27.3% in the ineligible group. Few adverse effects (n = 3) and 90-day thromboembolic events (n = 1) were observed in either group. Among the ineligible cases, all acute ischemic stroke patients (n = 5) received definite, timely treatments without complications. Conclusions: Our study demonstrated the real-world effectiveness and safety of idarucizumab infusion for trial-eligible patients and all acute ischemic stroke patients. However, although it seems to be effective and safe, idarucizumab appears to be less effective in other trial-ineligible patients. Despite this result, our study provides further evidence for extending the applicability of idarucizumab in real-world scenarios. Our study suggests that idarucizumab can be a safe and effective option for reversing the anticoagulant effect of dabigatran, particularly for eligible patients.

The risk of ischemic stroke significantly increases in individuals with blepharitis: A population-based study involving 424,161 patients.

To investigate the association of blepharitis and ischemic stroke. This nationwide retrospective cohort study used population-based data in Taiwan. Individuals aged 20 and above with diagnosis of blepharitis was included based on electrical medical records. After exclusion of ineligible cases, 424,161 patients were identified between 2008 and 2018. The blepharitis and non-blepharitis cohorts were matched based on sex, age, and comorbidities. Multivariable-adjusted Cox proportional hazards model was adopted to calculate the hazard ratio and 95% confidence interval (CI) between blepharitis and non-blepharitis cohorts. The incidence of ischemic stroke was estimated by Kaplan-Meier analysis. 424,161 pairs of blepharitis cohort and non-blepharitis cohort were 1:1 propensity score matched for statistical analysis. Patients with blepharitis had significantly increased risk of ischemic stroke compared with the individuals without blepharitis (adjusted hazard ratio 1.32, 95% CI 1.29-1.34, P < 0.001). A significantly higher risk of ischemic stroke was observed in blepharitis cohort with a previous diagnosis of cancer than in those without cancer (P for interaction < 0.0001). Kaplan-Meier survival analysis revealed the cumulative incidence of ischemic stroke increased in the blepharitis cohort compared with that in the non-blepharitis cohort in 10 years (log-rank P < 0.001). The follow-up period analysis further indicated 1.41-fold adjusted hazard (95% CI 1.35-1.46, P < 0.001) of ischemic stroke within a year after blepharitis diagnosis. Patients with blepharitis had an elevated risk of developing ischemic stroke. Early treatment and active surveillance are suggested for patients with chronic blepharitis. Further research is required to determine the casual relationship between blepharitis and ischemic stroke, as well as the underlying mechanism.

Multicenter study of the clinicopathological features and recurrence risk prediction model of early-stage breast cancer with low-positive human epidermal growth factor receptor 2 expression in China (Chinese Society of Breast Surgery 021)

Background: Breast cancer with low-positive human epidermal growth factor receptor 2 (HER2) expression has triggered further refinement of evaluation criteria for HER2 expression. We studied the clinicopathological features of early-stage breast cancer with low-positive HER2 expression in China and analyzed prognostic factors.Methods: Clinical and pathological data and prognostic information of patients with early-stage breast cancer with low-positive HER2 expression treated by the member units of the Chinese Society of Breast Surgery and Chinese Society of Surgery of Chinese Medical Association, from January 2015 to December 2016 were collected. The prognostic factors of these patients were analyzed.Results: Twenty-nine hospitals provided valid cases. From 2015 to 2016, a total of 25,096 cases of early-stage breast cancer were treated, 7642 (30.5%) of which had low-positive HER2 expression and were included in the study. After ineligible cases were excluded, 6486 patients were included in the study. The median follow-up time was 57 months (4–76 months). The disease-free survival rate was 92.1% at 5 years, and the overall survival rate was 97.4% at 5 years. At the follow-up, 506 (7.8%) cases of metastasis and 167 (2.6%) deaths were noted. Multivariate Cox regression analysis showed that tumor stage, lymphvascular invasion, and the Ki67 index were related to recurrence and metastasis (P < 0.05). The recurrence risk prediction model was established using a machine learning model and showed that the area under the receiving operator characteristic curve was 0.815 (95% confidence interval: 0.750–0.880).Conclusions: Early-stage breast cancer patients with low-positive HER2 expression account for 30.5% of all patients. Tumor stage, lymphvascular invasion, and the Ki67 index are factors affecting prognosis. The recurrence prediction model for breast cancer with low-positive HER2 expression based on a machine learning model had a good clinical reference value for predicting the recurrence risk at 5 years.Trial registration: ChiCTR.org.cn, ChiCTR2100046766.

Comparing Oncological Outcomes and Surgical Complications of Hand-Assisted, Laparoscopic and Robotic Nephroureterectomy for Upper Tract Urothelial Carcinoma.

PurposeThis study aimed to compare the oncological outcomes and surgical complications of patients with upper tract urothelial carcinoma (UTUC) treated with different minimally invasive techniques for nephroureterectomy.MethodsFrom the updated data of the Taiwan UTUC Collaboration Group, a total of 3,333 UTUC patients were identified. After excluding ineligible cases, we retrospectively included 1,340 patients from 15 institutions who received hand-assisted laparoscopic nephroureterectomy (HALNU), laparoscopic nephroureterectomy (LNU) or robotic nephroureterectomy (RNU) between 2001 and 2021. Kaplan-Meier estimator and Cox proportional hazards model were used to analyze the survival outcomes, and binary logistic regression model was selected to compare the risks of postoperative complications of different surgical approaches.ResultsAmong the enrolled patients, 741, 458 and 141 patients received HALNU, LNU and RNU, respectively. Compared with RNU (41.1%) and LNU (32.5%), the rate of lymph node dissection in HALNU was the lowest (17.4%). In both Kaplan-Meier and univariate analysis, the type of surgery was significantly associated with overall and cancer-specific survival. The statistical significance of surgical methods on survival outcomes remained in multivariate analysis, where patients undergoing HALNU appeared to have the worst overall (p = 0.007) and cancer-specific (p = 0.047) survival rates among the three groups. In all analyses, the surgical approach was not related to bladder recurrence. In addition, HALNU was significantly associated with longer hospital stay (p = 0.002), and had the highest risk of major Clavien-Dindo complications (p = 0.011), paralytic ileus (p = 0.012), and postoperative end-stage renal disease (p <0.001).ConclusionsMinimally invasive surgery can be safe and feasible. We proved that compared with the HALNU group, the LNU and RNU groups have better survival rates and fewer surgical complications. It is crucial to uphold strict oncological principles with sophisticated technique to improve outcomes. Further prospective studies are needed to validate our findings.

MP44-19 PRENATAL AND EARLY POSTNATAL OUTCOMES FOR FETUSES WITH ANATOMIC OR FUNCTIONAL RENAL AGENESIS

You have accessJournal of UrologyPediatric Urology II (MP44)1 Sep 2021MP44-19 PRENATAL AND EARLY POSTNATAL OUTCOMES FOR FETUSES WITH ANATOMIC OR FUNCTIONAL RENAL AGENESIS Eniola Ogundipe, Nicholas Behrendt, Colton Leavitt, Regina Reynolds, and Vijaya Vemulakonda Eniola OgundipeEniola Ogundipe More articles by this author , Nicholas BehrendtNicholas Behrendt More articles by this author , Colton LeavittColton Leavitt More articles by this author , Regina ReynoldsRegina Reynolds More articles by this author , and Vijaya VemulakondaVijaya Vemulakonda More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002065.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: With the advent of novel fetal interventions, including amnioinfusion, there has been increased interest in fetal intervention for previously “lethal” anomalies such as bilateral renal agenesis or other CAKUT diagnoses associated with in utero renal failure (functional renal agenesis). While there have been rare reports of successful births following intervention in these cases, there is a paucity of data regarding the risks, benefits, and outcomes of intervention. To address this gap, we reviewed our experience with fetal intervention for anatomic or functional renal agenesis. METHODS: A retrospective review was conducted for patients referred to the Colorado Fetal Care Center (CFCC) for evaluation of complex CAKUT anomalies. Patients were included if they had severe oligohydramnios associated with bilateral renal agenesis, renal dysplasia, or other etiologies consistent with primary renal failure. Eligibility for amnioinfusion was determined by a multidisciplinary team including social work and psychology. Data collected included patient demographics, eligibility for fetal intervention, survival to birth, ventilatory support, survival to dialysis, and 30-day mortality. RESULTS: 14 patients met eligibility criteria. Of these, 50% were deemed eligible for serial amnioinfusion. Age did not differ between eligible and ineligible patients (mean 29 years). 86% (6/7) of eligible patients identified as white compared to 57% (4/7) of ineligible patients. 86% (6/7) of eligible patients were married, while 43% (3/7) of those ineligible were married.Postnatal data was available for 5/7 eligible cases and 2/7 ineligible cases. In the eligible group, respiratory intervention occurred in 3/5 cases. 2/5 cases survived to dialysis. In the ineligible group, respiratory intervention occurred in ½ cases. 0/2 cases survived to dialysis. 30-day mortality for the eligible group was 60% (3/5) compared to 100% (2/2) for the ineligible group. CONCLUSIONS: Individuals carrying a pregnancy complicated by anatomic or functional renal agenesis face a difficult choice when considering intervention. In this small cohort, patients considered eligible were more likely to be white and married, suggesting potential implicit bias or other confounding social variables. While these diagnoses are considered lethal, intervention is associated with significant morbidity and mortality. These findings reinforce that treatment of these cases should be considered experimental and large-scale multicenter trials are needed to determine the optimal indications for prenatal intervention. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e800-e800 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Eniola Ogundipe More articles by this author Nicholas Behrendt More articles by this author Colton Leavitt More articles by this author Regina Reynolds More articles by this author Vijaya Vemulakonda More articles by this author Expand All Advertisement Loading ...

A Self-Learning Knowledge Based System for Credit Evaluation of Loan Application: The Case of Commercial Bank of Ethiopia

This study on prototype self-learning knowledge based system (KBS) is focused on evaluation of loan application used to overcome the challenges that resulted from lack of domain experts and poor loan evaluations. We attempted to design and develop a prototype self-learning KBS that provide advisory services for any credit customers and assists the domain experts in evaluation of customer’s requests for the loan. To develop this prototype system, knowledge was acquired using semi-structured interview from domain experts which are selected using purposive sampling technique from Commercial Bank of Ethiopia (CBE) and critique the acquired knowledge. Explicit knowledge is acquired by analyzing the secondary source of knowledge by method of document analysis. Then, the acquired knowledge is modeled using decision tree that represents concepts and procedures involved in credit evaluation and production rules are used to represent the domain knowledge. The prototype system is implemented using SWI Prolog editor tool. To determine the applicability of the prototype system in the domain area, the system has been evaluated and tested by the domain experts. Eighteen (18) test cases were selected purposively. Test cases are equally selected from both ineligible and eligible cases. The overall total performance of the prototype system is 77.71%. The performance of the prototype system is hopeful and meets the objective of the study. The study concludes that the major credit production type that advanced to customer is import letter of credit facility, export credit facility, pre-shipment credit facility and merchandise. The eligibility of application is focused on general and specific criteria. Credit customer is classified as business, corporate and commercial based on the score sheet they achieved. Generally, in this study, the applicability of knowledge of prototype self-learning KBS is proved as hopeful approach in banking industry for credit evaluation. Keywords : KBS, self-learning and credit (loan). DOI: 10.7176/IKM/10-6-03 Publication date: September 30 th 2020

A Self-Learning Knowledge Based System for Credit Evaluation of Loan Application: The Case of Commercial Bank of Ethiopia

This study on prototype self-learning knowledge based system (KBS) is focused on evaluation of loan application used to overcome the challenges that resulted from lack of domain experts and poor loan evaluations. We attempted to design and develop a prototype self-learning KBS that provide advisory services for any credit customers and assists the domain experts in evaluation of customer’s requests for the loan. To develop this prototype system, knowledge was acquired using semi-structured interview from domain experts which are selected using purposive sampling technique from Commercial Bank of Ethiopia (CBE) and critique the acquired knowledge. Explicit knowledge is acquired by analyzing the secondary source of knowledge by method of document analysis. Then, the acquired knowledge is modeled using decision tree that represents concepts and procedures involved in credit evaluation and production rules are used to represent the domain knowledge. The prototype system is implemented using SWI Prolog editor tool. To determine the applicability of the prototype system in the domain area, the system has been evaluated and tested by the domain experts. Eighteen (18) test cases were selected purposively. Test cases are equally selected from both ineligible and eligible cases. The overall total performance of the prototype system is 77.71%. The performance of the prototype system is hopeful and meets the objective of the study. The study concludes that the major credit production type that advanced to customer is import letter of credit facility, export credit facility, pre-shipment credit facility and merchandise. The eligibility of application is focused on general and specific criteria. Credit customer is classified as business, corporate and commercial based on the score sheet they achieved. Generally, in this study, the applicability of knowledge of prototype self-learning KBS is proved as hopeful approach in banking industry for credit evaluation. Keywords : KBS, self-learning and credit (loan). DOI: 10.7176/IKM/10-5-02 Publication date: August 31 st 2020

Prognostic value of NT-proBNP in patients with severe COVID-19

BackgroundThe outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China has been declared a public health emergency of international concern. The cardiac injury is a common condition among the hospitalized patients with COVID-19. However, whether N terminal pro B type natriuretic peptide (NT-proBNP) predicted outcome of severe COVID-19 patients was unknown.MethodsThe study initially enrolled 102 patients with severe COVID-19 from a continuous sample. After screening out the ineligible cases, 54 patients were analyzed in this study. The primary outcome was in-hospital death defined as the case fatality rate. Research information and following-up data were obtained from their medical records.ResultsThe best cut-off value of NT-proBNP for predicting in-hospital death was 88.64 pg/mL with the sensitivity for 100% and the specificity for 66.67%. Patients with high NT-proBNP values (> 88.64 pg/mL) had a significantly increased risk of death during the days of following-up compared with those with low values (≤88.64 pg/mL). After adjustment for potential risk factors, NT-proBNP was independently correlated with in-hospital death.ConclusionNT-proBNP might be an independent risk factor for in-hospital death in patients with severe COVID-19.Trial registrationClinicalTrials, NCT04292964. Registered 03 March 2020,

Utilization and Outcomes of Local Anesthesia and Peripheral Nerve Block for Hybrid Lower Extremity Revascularization

Purpose: To investigate the utilization of local anesthesia or peripheral nerve block with monitored anesthesia care (LPMAC) and its impact on the perioperative outcomes of hybrid lower extremity revascularization (LER) compared with general anesthesia (GA). Materials and Methods: A search of the ACS-NSQIP database between 2005 and 2017 identified 9430 patients who underwent hybrid LER for peripheral artery disease. Excluding 449 ineligible cases left 8981 hybrid LER patients for analysis. The patients were dichotomized based on the anesthetic technique: 8631 (96.1%) GA and 350 (3.9%) LPMAC. The GA patients were matched 3:1 based on propensity scores to patients in the LPMAC group based on gender, age, race, functional status, transfer status, chronic obstructive pulmonary disease (COPD), dialysis status, American Society of Anesthesiologists (ASA) class, emergent surgery, preoperative sepsis, indication, and type of open and endovascular procedure. Outcomes including complications, mortality, procedure time, and hospital length of stay were compared between the matched groups (801 GA vs 267 LPMAC). Results: Comparing the unmatched groups, those treated under LPMAC were older (72.7±9 vs 68±8.4 years, p<0.001) and had higher rates of COPD (24.3% vs 17%, p=0.001), dialysis dependence (8.1% vs 4.2%, p=0.002), preoperative sepsis (6.6% vs 4.2%, p=0.029), and ASA class ≥IV (29.1% vs 24.1%, p=0.036) than in the unmatched GA cohort. In the matched comparison, LPMAC was associated with lower overall morbidity (25.5% vs 32.3%, p=0.042) and shorter operating time (202.7±98 vs 217.7±102 minutes, p=0.034) compared with GA. The rate of myocardial infarction was lower (1.1% vs 2.4%) and ventilator use for >48 hours was less frequent (0.4% vs 2.6%) for LPMAC patients, though statistical significance was not reached. There was no difference in mortality or hospital length of stay. Conclusion: LPMAC is an infrequent anesthetic technique for hybrid LER and is primarily used for patients with a high burden of comorbidities. LPMAC is associated with reduced overall morbidity and operating time. Further studies are needed to identify which patients undergoing hybrid LER benefit most from LPMAC.