Multicenter Study Research Articles

Prediction model for major bleeding in anticoagulated patients with cancer-associated venous thromboembolism using machine learning and natural language processing.

We developed a predictive model to assess the risk of major bleeding (MB) within 6 months of primary venous thromboembolism (VTE) in cancer patients receiving anticoagulant treatment. We also sought to describe the prevalence and incidence of VTE in cancer patients, and to describe clinical characteristics at baseline and bleeding events during follow-up in patients receiving anticoagulants. This observational, retrospective, and multicenter study used natural language processing and machine learning (ML), to analyze unstructured clinical data from electronic health records from nine Spanish hospitals between 2014 and 2018. All adult cancer patients with VTE receiving anticoagulants were included. Both clinically- and ML-driven feature selection was performed to identify MB predictors. Logistic regression (LR), decision tree (DT), and random forest (RF) algorithms were used to train predictive models, which were validated in a hold-out dataset and compared to the previously developed CAT-BLEED score. Of the 2,893,108 cancer patients screened, in-hospital VTE prevalence was 5.8% and the annual incidence ranged from 2.7 to 3.9%. We identified 21,227 patients with active cancer and VTE receiving anticoagulants (53.9% men, median age of 70years). MB events after VTE diagnosis occurred in 10.9% of patients within the first six months. MB predictors included: hemoglobin, metastasis, age, platelets, leukocytes, and serum creatinine. The LR, DT, and RF models had AUC-ROC (95% confidence interval) values of 0.60 (0.55, 0.65), 0.60 (0.55, 0.65), and 0.61 (0.56, 0.66), respectively. These models outperformed the CAT-BLEED score with values of 0.53 (0.48, 0.59). Our study shows encouraging results in identifying anticoagulated patients with cancer-associated VTE who are at high risk of MB.

Prevalence and risks of intravenous chemotherapy-induced severe neutropenia in solid cancers: a multicenter retrospective cohort study on real-life data.

We aimed at identifying prevalence, clinical outcomes and prognostic factors in cancer patients with intravenous chemotherapy-induced severe neutropenia (ICISN). In this multicenter retrospective cohort study on the clinical data warehouse of Greater Paris University Hospitals (AP-HP), we included all adult patients with solid cancer hospitalized between 2016 and 2021 with intravenous chemotherapy within 30 days prior to severe neutropenia (D70 or D611 ICD-10 codes AND a neutrophil count < 500/mm3). The primary endpoint was referral to intensive care unit (ICU) or death within 30 days. We collected cancer, patient, and treatment characteristics. Among 141,586 cancer inpatients, 40,660 received chemotherapy among whom 661 (1.6%) had ICISN. Median age was 63 years (interquartile range (IQR), 54-70) and 330 patients (49%) were female. The median Charlson score was 10 (IQR, 8-11). Main primary cancers were lung (n = 204, 31%) and breast (n = 87, 13%). Advanced cancers were found in 551 patients (83%), 331 (50%) were in 1st line of chemotherapy, 284 (42%) in the 1st cycle of the current line and 149 (22%) had primary G-CSF. Documented bacterial (mostly gram-negative bacilli) and fungal infections were observed in 113 (17%) and 19 (3%) patients; 58 (9%) were transferred to ICU and 82 (12%) died within 30 days, 372 (56%) patients received subsequent chemotherapy. Independent prognostic factors were the level of monocyte, lymphocyte counts or albuminemia and a documented bacterial infection, while Charlson index and primary prophylactic G-CSF were not associated with patient clinical outcomes. Despite the use of primary G-CSF, ICISN remains a frequent event, which leads to ICU death in one on five cases Some prognostic factors of severity have been highlighted and could help clinicians to prevent severe complications.

Development and validation of a CT-based deep learning radiomics signature to predict lymph node metastasis in oropharyngeal squamous cell carcinoma: a multicenter study.

Lymph node metastasis (LNM) is a pivotal determinant that influences the treatment strategies and prognosis for oropharyngeal squamous cell carcinoma (OPSCC) patients. This study aims to establish and verify a deep learning (DL) radiomics model for the prediction of LNM in OPSCCs using contrast-enhanced computed tomography (CECT). A retrospective analysis included 279 OPSCC patients from three institutions. CECT images were used for handcrafted (HCR) and DL feature extraction. Dimensionality reduction for HCR features used recursive feature elimination and least absolute shrinkage and selection operator algorithms, whereas DL feature dimensionality reduction used variance-threshold and recursive feature elimination algorithms. Radiomics signatures were constructed using support vector machine, decision tree, random forest, k-nearest neighbor, gaussian naive bayes classifiers and light gradient boosting machine. A combined model was then constructed using the screened DL, HCR, and clinical features. The area under the receiver operating characteristic curve (AUC) served to quantify the model's performance, and calibration curves were utilized to assess its calibration. The combined model exhibited robust performance, achieving AUC values of 0.909 (95% CI: 0.861-0.957) in the training cohort, 0.884 (95% CI: 0.800-0.968) in the internal validation cohort, and 0.865 (95% CI: 0.791-0.939) in the external validation cohort. It outperformed both the clinical model and best-performing radiomics model. Moreover, calibration was deemed satisfactory. The combined model based on CECT demonstrates the potential to predict LNM in OPSCCs preoperatively, offering a valuable tool for more precise and tailored treatment strategies. This study presents a novel combined model integrating clinical factors with deep learning radiomics, significantly enhancing preoperative LNM prediction in OPSCC.

Flexible endoscopic treatment of Zenker's diverticulum-a retrospective, observational multicenter study.

The European Society of Gastroenterology and Endoscopy recommends a primarily flexible endoscopic approach for the treatment of Zenker's diverticulum. Due to the rarity of the disorder, evidence for its effectiveness and safety comes mainly from small, retrospective, single-center studies. In this retrospective, observational, multicenter cohort study, data from six German tertiary referral centers were analyzed. The primary outcome parameters were technical and clinical success; among the secondary outcomes, the rates of adverse events (AE) and re-admission with symptomatic recurrence and mortality were the most relevant. Between 2003 and 2024, 384 treatments were performed in 327 patients (61.8% male, mean age 74.70 (± 10.60)). Incision methods/techniques were 250 needle knives, 44 ESD knives, 64 stag beetle knives, 24 staplers, one APC-probe, and one Z-POEM. The Zenker's diverticulum overtube was used in 65.1%, prophylactic clipping in 30.2%, and antibiotic therapy in 25.3% of treatments. The rates of technical and clinical success were 99.2% and 97.4%, and the rates of AE and re-admission with symptomatic recurrence were 11.2% and 16.7%, respectively. Mortality was 0.3%. Comparative subgroup analyses of 312 diverticula without prior treatment versus 72 symptomatic recurrences and incision methods/techniques showed no significant differences in outcome parameters. The use of additional devices and prophylactic measures (clipping, antibiotic therapy) were not independent predictors of technical/clinical success or AE in uni-/multivariable regression analysis. Flexible endoscopic Zenker's diverticulotomy is a safe and effective minimally invasive treatment. Recurrences can be treated by flexible endoscopy with comparable results. None of the cutting methods, ancillary devices, or prophylactic measures showed superiority in effectiveness or safety.

Role of Dietary Patterns in the Progression and Management of Heart Failure in Pakistani Patients: A Multicenter Study

Role of Dietary Patterns in the Progression and Management of Heart Failure in Pakistani Patients: A Multicenter Study

Exploring clinical factors to predict the survival for resectable non-small cell lung cancer patients with neoadjuvant immunotherapy.

To explore clinical factors and build a predictive model for the disease-free and overall survival in non-small cell lung cancer patients receiving neoadjuvant chemotherapy combined with immune checkpoint inhibitors. Inclusion criteria for patients in this multicentre study were: (1) patients were diagnosed with stage I-III non-small cell lung cancer diagnosed by bronchoscopy biopsy or puncture; (2) computed tomography/positron emission tomography-computed tomography was applied before treatment and surgery; (3) neoadjuvant chemotherapy combined with immune checkpoint inhibitors were applied for 2-6 cycles preoperatively; (4) peripheral blood indicators and tumour markers were assessed before treatment and surgery; (5) patients underwent radical lung cancer surgery after neoadjuvant therapy. Cases were divided into high- and low-risk groups according to 78 clinical indicators based on 10-fold LASSO selection. We employed Cox proportional hazards models in predicting disease-free and overall survival. Then, we used time-dependent area under the curve and decision curve analyses to examine the accuracy of the results. Data were collected continuously, and 212 and 85 cases were randomly assigned to training and testing sets, respectively. The area under curve for the prediction of disease-free survival (training-1-year, 0.83; 2-year, 0.81; 3-year, 0.83 vs testing-1-year, 0.65; 2-year, 0.66; 3-year, 0.70), overall survival (training-1-year, 0.86; 2-year, 0.85; 3-year, 0.86 vs testing-1-year, 0.66; 2-year, 0.57; 3-year, 0.70) were determined. The coefficient factors including pathological response, preoperative tumour maximum diameter, preoperative lymph shorter-diameter, preoperative tumour&lymph maximum standardized uptake value, change in tumour standardized uptake value preoperative, and blood related risk factors were favorably associated with prognosis (P < 0.001). Our prediction model integrating data from preoperative positron emission tomography-CT, preoperative blood parameters, and pathological response was able to make high accuracy predictions for disease-free and overall survival in non-small cell lung cancer patients receiving neoadjuvant immunity with chemical therapy.

Visual Impairment at Presentation in Pediatric Uveitis: A Multicentric Study in 477 Children Across Southern and Eastern India

ABSTRACT Objective To evaluate visual impairment (VI) at presentation in pediatric uveitis cases in southern and eastern India. Methods Retrospective analysis of 477 children across four tertiary centers (2015–2020). Best-documented visual acuity (ETDRS letters) in the better eye was used to categorize VI. Results Mean age at presentation was 11 ± 3.7 years; 43.8% were females, and 64.8% bilateral. Of 205 patients with complete investigations, 32.7% were undifferentiated uveitis, 31.7% infectious, 25.7% juvenile idiopathic arthritis-associated uveitis, and 10.2% other non-infectious uveitis. At presentation, 79.0% had none to mild VI, 12.6% moderate VI, and 8.4% severe VI to blindness. On generalized estimating equations analysis for individual eyes, prior oral steroids and older age were risk factors, while female gender, prior topical corticosteroids and immunosuppressive therapy were protective against moderate and/or severe VI. Conclusions Over a fifth of pediatric uveitis cases present with moderate/severe VI, especially in older age or with prior oral corticosteroid therapy.

Comparative anatomic and symptomatic recurrence outcomes of diaphragmatic suture cruroplasty versus biosynthetic mesh reinforcement in robotic hiatal and paraesophageal hernia repair.

Hiatal and paraesophageal hernia (HH/PEH) recurrence is the most common cause of failure after gastroesophageal anti-reflux surgery. Crural reinforcement with mesh has been suggested to address this issue, but its efficacy remains debated. In this study, we aimed to determine the impact of biosynthetic mesh reinforcement compared to suture cruroplasty on anatomic and symptomatic hernia recurrence. Data of patients who underwent robotic HH/PEH repair with suture cruroplasty with or without biosynthetic mesh reinforcement between January 2012 and April 2024 were retrospectively reviewed. Gastroesophageal reflux disease symptoms and anatomic hernia recurrence were assessed at short-term (3months to 1year) and longer-term (≥ 1year) follow-up. Symptomatic hernia recurrence was defined as having both anatomic recurrence and symptoms. Out of the 503 patients in the study, 308 had undergone biosynthetic mesh repair, while 195 had suture-only repair. After the surgery, both groups demonstrated comparable improvements in symptoms. Short-term anatomic hernia recurrence rates were 11.8% and 15.6% for mesh and suture groups, respectively (p = 0.609), while longer-term rates were 24.7% and 44.9% (p = 0.015). The rates of symptomatic hernia recurrence in the same group were 8.8% and 14.6% in the short-term (p = 0.256), and 17.2% and 42.2% in longer-term follow-ups (p = 0.003). In the repair of medium and large-size hernias, mesh reinforcement resulted in a 50.0% relative risk reduction in anatomic hernia recurrences and a 59.2% reduction in symptomatic hernia recurrences at ≥ 1-year follow-up. After more than a year of follow-up, it has been found that using biosynthetic mesh for medium and large hiatal or paraesophageal hernia repair significantly reduces the likelihood of both anatomic and symptomatic recurrence compared to using only suture cruroplasty. These findings strongly support the use of biosynthetic mesh to manage larger hernias. However, further long-term multicenter randomized studies are needed to provide more conclusive evidence.

Parental Perspectives From the Survey of Sleep Quality in the PICU Validation Study on Environmental Factors Causing Sleep Disruption in Critically Ill Children.

Sleep promotion bundles being tested in PICUs use elements adapted from adult bundles. As children may react differently than adults in ICU environments, this study investigated what parents report disrupted the sleep of their child in a PICU. Secondary analysis of a multicenter validation study of the Survey of Sleep quality in the PICU. Four Northeastern U.S. PICUs, one hospital-based pediatric sleep laboratory. Parents sleeping at the bedside of a child in the PICU or hospital-based sleep laboratory. Anonymous one-time survey eliciting parts of hospital or ICU environments that have been described as disruptive to sleep in validated adult ICU and pediatric inpatient questionnaires. Level of sleep disruption was scored by Likert scale, with higher scores indicating more disruption. Age, demographics, baseline sleep, and PICU exposures were used to describe causes of sleep disruption in a PICU. Of 152 PICU parents, 71% of their children's sleep was disrupted significantly by at least one aspect of being in the PICU. The most prevalent were "being in pain or uncomfortable because they are sick" (38%), "not sleeping at home" (30%), "alarms on machines" (28%), and "not sleeping on their home schedule" (26%). Only 5% were disrupted by excessive nocturnal light exposure. Overall sleep disruption was not different across four PICUs or in those receiving sedation. The validation study control group, healthy children undergoing polysomnography, had less sleep disruption than those in a PICU despite sleeping in a hospital-based sleep laboratory. There are multiple aspects of critical care environments that affect the sleep of children, which are different from that of adults, such as disruption to home schedules. Future interventional sleep promotion bundles should include sedated children and could be applicable in multicenter settings.

Outcomes of chronic myeloid leukemia patients after therapeutic failure to conventional tyrosine kinase inhibitors and asciminib.

Patients with chronic myeloid leukemia (CML) who have failed conventional tyrosine kinase inhibitors (cTKIs) and asciminib constitute a complex group of patients with few therapeutic options. A retrospective descriptive multicenter observational study was carried out including patients with CML who had presented a therapeutic failure to ≥ 2 cTKIs and asciminib, and had received or were not candidates to ponatinib. Of the 19 patients enrolled, 8 patients failed asciminib due to intolerance and 11 due to resistance. The most common strategy for intolerant patients was to initiate a previously administered cTKI (6/8) with dose adjustments or symptomatic management of adverse events (AEs). Of the patients who failed due to resistance, only patients who underwent progenitor transplantation achieved profound long-term responses. A frequent strategy was to use ponatinib (4/11) in patients previously considered non-candidates, with poor responses in patients in whom dose reductions were used, and severe AEs in patients at standard doses. In the remaining patients, cTKIs and other agents (interferon, hydroxyurea, citarabine, busulfan) were used with poor responses. Patients who progressed to advanced stages had a dismal prognosis. With a median follow-up of 11.2 months, overall survival of the global cohort was 73%; 100% for intolerant patients, 71% for resistant patients and 25% for those who discontinue asciminib in accelerated/blastic phase.

Influence of age and self-stigmatization on social eating and drinking issues in French outpatients living with and beyond head and neck cancer: a mixed-method study.

Social eating (SE) is a corner stone of daily living activities, quality of life (QoL), and aging well. In addition to feeding functional disorders, patients with head and neck cancer (HNC) face individual and social psychological distress. In this aging population, we intended to better assess the influence of age on these challenges, and the role of self-stigmatization limiting SE in patients with and beyond HNC. This was an exploratory multicenter cross-sectional mixed method study. Eligibility criteria were adults diagnosed with various non-metastatic HNC, before, during, or until 5years after treatment. SE disorders were explored with the Performance Status ScalePublic Eating rate(PSS-HN PE). In the quantitative part of the study, SE habits, Functional Assessment of Cancer Therapy Body Image Scale (FACT-MBIS) and specific to HNC (FACT-HN35) were also filled in by the patients. In the qualitative study, the semi-structured interview guide was drawn out to explore stigma, especially different dimensions of self-stigmatization. A total of 112 patients were included, mean age 64.7years, 23.2% of female. One-third (n = 35) of patients had an abnormal PSS-HN PE rate < 100. Younger patients had more often an impaired Normalcy of Diet mean (70.4 vs 82.7, p = .0498) and PE rates (76 vs 86.9, p = .0622), but there was no difference between age subgroups in MBIS nor FACT-HN scores. Seventy patients (72.2%) found SE and drinking « important» to « extremely important» in their daily life. The qualitative study reported self-stigmatization in two older patients and strategies they have developed to cope with in their behaviors of SE. This study confirms that SE remains of high concern in patients with and beyond HNC. Even in older patients experiencing less often functional feeding disorders, body image changes and SE issues are as impaired as in younger patients and need to be addressed.

Retrospective study on the outcomes and satisfaction with endometrial ablation by bipolar energy (NovaSure®) for the treatment of heavy menstrual bleeding.

To determine the effectiveness, safety, and participant satisfaction with endometrial ablation by bipolar energy (NovaSure®) in the treatment of heavy menstrual bleeding (HMB), and to investigate factors associated with poorer outcomes. Multicenter retrospective observational study based on medical record review of the outcomes related to endometrial ablation by the bipolar-energy technique procedure to treat HMB in the setting of three university teaching hospitals in Spain. A total of 333 women were included in the study. Most bipolar-energy ablations were successful (85.12%; n = 269 out of 316), with amenorrhea the most frequent outcome (39.6%, n = 131 out of 316). The majority of participants had no complications (95.5%; n = 317 out of 332), and of those who did, only 2.1% were related to the technique. No further treatment was required for HMB in 82.8% of women (n = 274 out of 331), and surgery was avoided in 91.8%; only 5.9% of women underwent ablation-related hysterectomy. In women with previous transverse cesarean sections (CS), 91.0% avoided subsequent surgical treatment. Eighty-six percent of women (n = 221 out of 257) were satisfied with the procedure. Bipolar-energy ablation is very effective and safe for the treatment of HMB and yielded a high rate of participant satisfaction in our setting. The presence of comorbidities or previous CSmay slightly reduce the effectiveness of the method, while performing concomitant surgery (mainly curettage) increases the rate of complications. Notably, despite the known increased risk of hysterectomy, most participants with previous CSs who underwent ablation avoided major surgery.

Investigating the relationship between spermogram parameters and sexual desire in infertile men: a cross-sectional study from a tertiary centre in Iran

BackgroundMale factor infertility can affect spermatogenesis, sexual desire, and thus the quality of life of couples. The present study was conducted to investigate the relationship between spermogram parameters, and the...

Germline genetic mutations in a multi-center cohort of 248 phyllodes tumors.

Germline genetic mutations in women with phyllodes tumors (PT) are understudied, although some describe associations of PT with various mutations. We sought to determine the prevalence of pathogenic/likely pathogenic (P/LP) variants in women with PT. A 6-site multi-center study of women with a PT was initiated, then expanded nationally through an online "Phyllodes Support Group." All women underwent 84-gene panel testing. We defined eligibility for testing based on select NCCN (National Comprehensive Cancer Network) criteria (v1.2022). Logistic regression was used to estimate the association of covariates with the likelihood of a P/LP variant. 274 women were enrolled: 164 (59.9%) through multi-center recruitment and 110 (40.1%) via online recruitment. 248 women completed testing; overall 14.1% (N = 35) had a P/LP variant, and over half (N = 19) of these individuals had a mutation in genes associated with autosomal dominant (AD) cancer conditions. The most common AD genes with a P/LP variant included CHEK2, ATM, and RAD51D. A quarter of participants (23.8%) met NCCN criteria for testing, but we found no difference in prevalence of a P/LP variant based on eligibility (p = 0.54). After adjustment, the presence of P/LP variants was not associated with age, NCCN testing eligibility, or PT type (all p > 0.05). Our study demonstrates that 7.7% of women with PT harbor germline P/LP variants in genes associated with AD cancer conditions. Early identification of these variants has implications for screening, risk reduction, and/or treatment. National guidelines for women with PT do not currently address germline genetic testing, which could be considered.

Enhancing Origin Prediction: Deep Learning Model for Diagnosing Premature Ventricular Contractions with Dual-Rhythm Analysis Focused on Cardiac Rotation.

Several algorithms can differentiate inferior axis premature ventricular contractions (PVCs) originating from the right side and left side on 12-lead electrocardiograms (ECGs). However, it is unclear whether distinguishing the origin should rely solely on PVC or incorporate sinus rhythm (SR). We compared the Dual-Rhythm model (incorporating both SR and PVC) to the PVC model (using PVC alone), and quantified the contribution of each ECG lead in predicting the PVC origin for each cardiac rotation. This multicenter study enrolled 593 patients from 11 centers-493 from Japan and Germany, and 100 from Belgium, which used as the external validation dataset. Using a hybrid approach combining a Resnet50-based convolutional neural network and a Transformer model, we developed two variants-the PVC and Dual-Rhythm models-to predict PVC origin. In the external validation dataset, the Dual-Rhythm model outperformed the PVC model in accuracy (0.84 vs. 0.74, respectively; p < 0.01), precision (0.73 vs. 0.55, respectively; p < 0.01), specificity (0.87 vs. 0.68, respectively; p < 0.01), area under the receiver operating characteristic curve (0.91 vs. 0.86, respectively; p = 0.03), and F1-Score (0.77 vs. 0.68, respectively; p = 0.03). The contributions to PVC origin prediction were 77.3% for PVC and 22.7% for the SR. However, in patients with counterclockwise rotation, SR had a greater contribution in predicting the origin of right-sided PVC. Our deep learning-based model, incorporating both PVC and SR morphologies, resulted in a higher prediction accuracy for PVC origin. Considering SR is particularly important for predicting right-sided origin in patients with counterclockwise rotation.

UI-EWD hemostatic powder in the management of refractory lower gastrointestinal bleeding: a multicenter study

Introduction Lower gastrointestinal bleeding (LGIB) is a common cause of emergency hospitalization and may require readmission for re-bleeding. A novel adhesive endoscopic hemostatic powder (UI-EWD/NexpowderTM, Nextbiomedical, Incheon, South Korea) has been developed and recently utilized for LGIB hemostasis. The aim of the current study was to assess the efficacy and safety of UI-EWD as a rescue therapy for the treatment of refractory LGIB. Methods In this study, a total of 59 consecutive patients with LGIB who experienced initial hemostasis failure with conventional endoscopic therapy were enrolled into this multicenter single-arm study. These patients subsequently underwent UI-EWD application for the refractory LGIB hemostasis. We evaluated the success rate of hemostasis, re-bleeding rate within 30 d, and adverse events related to UI-EWD. Results UI-EWD was successfully administered to the bleeding sites in all enrolled refractory bleeding patients. Hemostasis was achieved in the entirety of the 59 patients (100%). The cumulative re-bleeding rate within 30 d was 8.5% (5/59). There were no UI-EWD-related adverse events, such as perforation nor embolism. Conclusion Based on our results, the utilization of UI-EWD demonstrated a remarkable success rate in achieving hemostasis for refractory LGIB, while also exhibiting promising outcomes in reducing the re-bleeding rate within a 30-day period. Particularly, UI-EWD exhibits a favorable safety profile across all segments of the colon in cases of refractory LGIB.

Management strategies and outcomes in pregnancy-related acute aortic dissection: a multicentre cohort study in China

BackgroundAcute aortic dissection (AD) in pregnancy poses a lethal risk to both mother and fetus. However, well-established therapeutic guidelines are lacking. This study aimed to investigate clinical features, outcomes and...

Association between admission systolic blood pressure and outcomes in patients with isolated traumatic brain injury: A cross-national multicentre cohort study.

The optimal prehospital blood pressure in patients following traumatic brain injury (TBI) remains controversial. We aimed to assess the association between the systolic blood pressure (SBP) at emergency department triage and patient outcomes following isolated moderate-to-severe TBI. We conducted a cross-national multicentre retrospective cohort study using the Pan-Asia Trauma Outcomes Study database from January 1, 2016, to November 30, 2018. The enrollees were adult patients with isolated moderate-to-severe TBI defined by the International Classification of Diseases code, a Glasgow Coma Scale (GCS) < 13 at triage, and a non-head Abbreviated Injury Scale ≤ 3. The studied variables were SBPs at triage categorised into different ranges. The primary outcome was 30-day mortality and the secondary outcome was poor functional status at hospital discharge defined by the modified Rankin Scale ≥ 4. Multivariable logistic regression were applied to adjust for confounders including country, sex, age, mechanism of injury, prehospital vascular access, respiratory rate, GCS, oxygen saturation, intubation, Injury Severity Score, head surgery, intensive care unit admission, and length of hospital stay. Subgroup analyses were performed on different severity of TBI. A total of 785 patients (median age, 42 years; male patients 77.5%; mean SBP at triage, 136.3 ± 33.1 mmHg) were included in the primary analysis. The lowest 30-day mortality rate existed in patients with SBP of 100-119 mmHg. Taking it as baseline, the adjusted odds ratios (aORs) and 95% confidence intervals (CIs) of SBP < 100 mmHg, 120-139 mmHg, 140-159 mmHg, and ≥ 160mmHg were 7.05 (2.51-19.78), 3.14 (1.14-8.65), 2.91 (1.04-8.17), and 3.28 (1.14-9.42). As for the secondary outcome, the aORs and 95% CIs were 1.36 (0.68-2.68) of < 100 mmHg, 0.99 (0.57-1.70) of 120-139 mmHg, 1.23 (0.67-2.25) of 140-159 mmHg, and 1.52 (0.78-2.95) of ≥ 160 mmHg. Subgroup analyses revealed trends of the best outcomes in both moderate and severe TBI patients with SBP 100-119 mmHg, while statistical significance appeared only in patients with severe TBI. SBP of 110-119 mmHg at triage is associated with the lowest 30-day mortality in patients following isolated moderate-to-severe TBI, and possibly related to a better functional outcome.

Identification of biomarkers for assessing treatment efficacy of chemotherapy plus nivolumab as the first line in patients with unresectable advanced or recurrent gastric cancer: a multicenter study.

In this study, we aimed to identify biomarkers for predicting treatment outcomes and efficacy of chemotherapy plus nivolumab, as well as predict immune-related adverse events (irAEs) characteristics of immune checkpoint inhibitors. This multicenter study included 104 patients who received chemotherapy plus nivolumab as the primary treatment for unresectable advanced recurrent gastric cancer. Blood test results were collected before the start and after two courses of treatment. The neutrophil-lymphocyte ratio, prognostic nutritional index (PNI), and lactate dehydrogenase/albumin ratio (LAR) were examined after treatment in each case to determine changes compared to values before the start of treatment. A total of 57 (54.8%) patients experienced a complete or partial response. The LAR of the stable disease (SD)/progressive disease (PD) group significantly increased (p=0.018). An examination of the presence of grade ≥3 irAEs and changes in related factors showed that the LAR of all patients increased. The LAR was correlated with the best therapeutic response; therefore, it may be a potential biomarker of treatment outcomes and efficacy.

Risk scores predicting disease progression in early-stage CLL: Comparative analysis and usefulness of IGHV subset #2 to improve their accuracy.

Overall, the prognosis of patients with chronic lymphocytic leukemia (CLL) in the early phase of the disease (Rai 0, Binet A) is favorable; some patients never require therapy. However, some patients require intervention shortly after diagnosis. In the past decade, several risk scores (RS) have been developed to predict disease progression, yet some patients are misclassified. On the other hand, IGHV subset 2 (IGHV2) predicts poor outcomes. A retrospective and multicentric study was conducted to compare the accuracy of five different RS (IPS-E, CR0, AIPS-E, CLL-IPI, and Barcelona-Brno) to predict disease progression in 781 stage A previously untreated patients with CLL. As an exploratory analysis, it was further investigated whether the inclusion of the IGHV2 as a poor prognostic parameter improved the accuracy of RS. All the scores identified a similar group of patients with CLL in early stage with low-, intermediate-, and high-risk progression. Discrimination was high and similar in all RS (c-index=0.74-0.79, area under the curve=0.7-0.75), as well as calibration (p=.98) and parsimony, although CLL-IPI showed the best results (Akaike information criterion=441). A total of 34.4% of patients were categorized within the same RS and concordance was at least moderate between RS. Moreover, the results suggest that IGHV2 may improve the accuracy of RS.