Relevant Clinical Characteristics Research Articles

EFFICACY AND SAFETY OF NICORANDIL FOR PERIPROCEDURAL MYOCARDIAL INJURY IN PATIENTS UNDERGOING PCI

Coronary artery disease (CAD) remains a leading cause of morbidity and mortality globally, with percutaneous coronary intervention (PCI) being a typical therapeutic approach. Objectives: In this comparative study, we aimed to investigate the efficacy and safety of nicorandil for periprocedural myocardial injury in patients undergoing PCI. Methods: This comparative study was conducted at Ayub Teaching Hospital from September 2023 to December 2023. Data from 90 patients was recruited for the research using inclusion and exclusion screening standards. Our study was performed on 90 patients treated with percutaneous coronary intervention (PCI). Patients from Group 1 were different from those in Group 2. Group A: the critical study parameters will switch between those patients who received nicorandil and Group B: non-nicorandil patients. Baseline demographic data, past medical history, and relevant laboratory values and clinical characteristics were documented for all patients. In addition, an intraoperative laboratory investigation was conducted, including cardiac biomarkers. Results: Research data were drawn from 90 patients whose gender wasn't a factor based on the research protocol. In Group A, the mean age of the patients was 62 years. Players in group A played for 4 ± 8.5 years. In team B, the players had a slightly longer experience and played for 63. Humans on Earth could do the same, and it could significantly impact future generations: ± 7. 9 years. Of 58 men and 32 women in the control group, there were two persons and persons in the experimental group, respectively. Only one stent differed between the two groups; however, the number was similar. 8 ± 0. 6 mmol/l in the tricorandil group and 1. +9 ± 0 in Case 1. Patients in the Nicorandil group displayed the lowest level of heart problem-causing protein (troponin) at the peak (5. There is a statistically significant 1.8-fold (2 ng/mL versus seven ng/mL) decline in serum lysozyme levels in the group administered rhG-CSF. The treatment group exhibited a substantial increase in haemoglobin levels (t(12) = 3. 74, p-value <0.005) with a mean difference of 0. 5 ± 2 ng/mL. 001, 95% CI: 2. 1 to 3. 5). Conclusion: It is concluded that nicorandil shows positive results for the efficacy (the ability of a drug to bring the desired effect) and safety of the drug in reducing myocardial injury and in maintaining the function of myocardial during percutaneous coronary intervention in patients.

Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post-authorization safety study.

This study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin. Data from two large US claims databases were analyzed in an observational study of patients with T2D receiving metformin who were newly prescribed empagliflozin versus sulfonylurea (SU). Because dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists have been associated with the risk of acute pancreatitis in some studies, patients on these agents were excluded. Using pooled analyses of data from the two databases (2014-2021), patients initiating empagliflozin were matched 1:1 within database to patients initiating SU using propensity scores (PS) that incorporated relevant demographic and clinical characteristics. Prespecified sensitivity analyses were performed for design parameters. The analyses identified 72 661 new users of empagliflozin and 422 018 new users of SUs, with both patient groups on concurrent metformin therapy. Baseline characteristics within treatment groups appeared to be similar across the 72 621 matched pairs. After mean follow-up of ~6 months, incidence rates of acute pancreatitis in the pooled matched cohort were 10.30 (95% confidence interval [CI] 9.29-11.39) events per 1000 patient-years (PY) for empagliflozin and 11.65 (95% CI 10.59-12.77) events per 1000 PY for SUs. On a background of metformin, patients newly initiating empagliflozin did not have an increased risk of acute pancreatitis compared with those initiating an SU (pooled PS matched hazard ratio 0.88 [0.76-1.02]) across 75621.42 PY of follow-up. The results of this voluntary post-approval safety study provide additional evidence that the use of empagliflozin for the treatment of T2D is not associated with an increased risk of acute pancreatitis.

Differences between rural and urban residence in the detection and treatment of perinatal mood and anxiety disorders

BackgroundPerinatal mood and anxiety disorders are common, serious complications of pregnancy. Disparities exist by race and income in the prevalence and treatment of these conditions, and overall treatment rates remain low. Outside of pregnancy, a small body of literature suggests that rural residency may contribute to higher rates of depression for those who identify as women. Among more diverse populations, however, evidence suggests urban residency may be associated with higher rates of depression among women of color. It is not known whether these trends hold true for mood and anxiety disorders during pregnancy and postpartum. ObjectivesWe examined differences in the detection and treatment of perinatal mood and anxiety disorders by rural and urban residence and assessed if the observed differences varied by maternal race/ethnicity. Study DesignWe conducted a cross sectional study using linked Medicaid claims and birth certificate records from Oregon and South Carolina from 2016 to 2020. We identified perinatal mood and anxiety disorder diagnoses during the perinatal period (pregnancy and within 60 days postpartum) using International Classification of Disease 9/10 codes and enumerated receipt of pharmaco- and psychotherapy treatment using Medicaid claims. We used logistic regression models controlling for relevant clinical and sociodemographic characteristics to estimate associations between rural residence and mood disorder detection and treatment. ResultsAmong the 185,809 births in our sample, 27% of births (n=50,820) were to people who lived in rural areas and 73% (n=134,989) to those in urban areas. Prevalence of any perinatal mood and anxiety disorders diagnosis was higher for urban residents (19.5%) than for rural residents (18.0%, p<0.001). Overall treatment rates were low among people with a perinatal mood and anxiety disorder (42% (n=14,789)). In our adjusted models, those living in urban areas had higher odds of a perinatal mood and anxiety disorder diagnosis (aOR=1.059, 95% CI 1.059-1.059, p<0.001). We found a significant interaction between maternal race and rurality (p<0.001). When we stratified by race, we found that among those who identified as Black, the odds of a perinatal mood and anxiety disorder diagnosis were increased for urban residents (OR=1.188, 95% CI 1.188-1.188), whereas among those who identified as white there was no such increased odds (OR=1.027, 95% CI 0.843-1.252). ConclusionsWe saw small but meaningful differences between rural and urban residence in perinatal mood and anxiety disorder diagnosis rates. We detected an interaction between race and rural versus urban maternal residence that impacted the observed differences. By elucidating the intersection between race and other sociodemographic factors, we hope more targeted and meaningful investments can be made in the communities most at need.

Participant flow diagrams for health equity in AI

Selection bias can arise through many aspects of a study, including recruitment, inclusion/exclusion criteria, input-level exclusion and outcome-level exclusion, and often reflects the underrepresentation of populations historically disadvantaged in medical research. The effects of selection bias can be further amplified when non-representative samples are used in artificial intelligence (AI) and machine learning (ML) applications to construct clinical algorithms. Building on the “Data Cards” initiative for transparency in AI research, we advocate for the addition of a participant flow diagram for AI studies detailing relevant sociodemographic and/or clinical characteristics of excluded participants across study phases, with the goal of identifying potential algorithmic biases before their clinical implementation. We include both a model for this flow diagram as well as a brief case study explaining how it could be implemented in practice. Through standardized reporting of participant flow diagrams, we aim to better identify potential inequities embedded in AI applications, facilitating more reliable and equitable clinical algorithms.

Predictive impact of sarcopenia in advanced non-small cell lung cancer patients treated with immune checkpoint inhibitors: A retrospective study

BackgroundSarcopenia, characterised by an ongoing loss of skeletal muscle mass and reduced strength and function, is frequently observed in patients with non-small cell lung cancer (NSCLC). However, the relationship between sarcopenia and the prognosis of NSCLC treated with immune checkpoint inhibitors (ICIs) remains unclear. This aimed to assess whether sarcopenia is an independent prognostic factor for survival in patients with advanced NSCLC receiving ICIs. MethodsFor this retrospective cohort study, we analysed the medical records of patients attending our hospital aged 18–75 years who were newly diagnosed with stage IIIB to stage IV NSCLC, and who had received ICIs as first- or second-line therapy between May 2019 and April 2022. The skeletal muscle index (SMI) was calculated from computed tomography (CT) images and relevant clinical characteristics within 4 weeks of initiating treatment and used to diagnose sarcopenia status. The Kaplan-Meier method and log-rank test were used to calculate and compare patients' progression-free survival (PFS). Cox proportional hazard regression was used to examine the associations between sarcopenia and survival outcomes. The chi-square test was used to compare treatment response outcomes, such as the objective response rate (ORR), disease control rate (DCR), and immunotherapy-related adverse events (irAEs), between individuals with and without sarcopenia. Additionally, the Student's t-test was utilised to compare SMI values between patients by their objective response (OR) and disease control (DC). Finally, the Mann-Whitney U test was used to compare nutritional and inflammatory indicators between the sarcopenia groups. ResultsThe study enrolled 70 patients, of whom 34 (48.6%) were diagnosed with sarcopenia. The median PFS of patients with and without sarcopenia was 7.5 vs. 13.4 months, respectively (p = 0.006). The proportional hazards regression analysis showed sarcopenia to be an independent prognostic factor for shorter PFS (hazard ratio (HR): 0.504, 95% CI: 0.265–0.962, p = 0.038). Using chi square tests, we found significant differences in the ORR (20.59% vs. 58.33%, p = 0.001) and occurrence of any irAEs (44.1% vs. 22.2%, p = 0.028) between the sarcopenia and the non-sarcopenia groups, respectively. The Student's t-test showed a significant difference in SMI between the ORR group and the non-ORR group (49.99 ± 7.00 vs. 42.98 ± 2.18 cm2/m2, p = 0.0015). While the sarcopenia group were with significantly a lower CD4+/CD8+ ratios and a higher C-reactive protein (CRP) level (p = 0.026, p = 0.011, respectively). Conclusions: This study found that sarcopenia is a significant predictor of a poor prognosis for patients with advanced NSCLC receiving ICIs. Multiple inflammatory and immune functions related to prognosis also differ by sarcopenia status.

Neutrophil CD64 index as a new early predictive biomarker for infected pancreatic necrosis in acute pancreatitis

ObjectiveInfectious pancreatic necrosis (IPN) is a serious complication of acute pancreatitis, and early recognition and timely intervention are the keys to improving clinical outcomes. The purpose of this study was to investigate the predictive capacity of the neutrophil CD64 index (nCD64 index) on IPN in patients with acute pancreatitisMethodsThis study comprises two independent cohorts: the training cohort consisted of 202 patients from Hunan Provincial People's Hospital, and the validation cohort consisted of 100 patients from Changsha Central Hospital. Peripheral blood samples were collected on the day of admission and on the 3rd, 5th, 7th, and 10th days of hospitalization, and the nCD64 index was detected by flow cytometry. Additionally, relevant clinical characteristics and laboratory biomarkers were collected and analyzed.ResultsWe observed that nCD64 index on admission was significantly higher in the IPN group than Non-IPN group (p < 0.001). In the training cohort, a higher occurrence rate of IPN was observed in the high nCD64 index group compared to the moderate and low nCD64 index group (p < 0.001). Further analysis showed that nCD64 index was significant positive correlated with the incidence rate of IPN (p < 0.001, correlation coefficient = 0.972). Furthermore, logistic regression analysis showed that high expression of the nCD64 index on admission was a risk factor for the occurrence of IPN (OR = 2.971, p = 0.038). We further found that the nCD64 index of IPN patients was significantly higher than the Non-IPN patients on the days 1, 3, and 5 after admission, and the nCD64 index of IPN patients before and after the onset (p < 0.05). At the same time, this study revealed that the nCD64 index on admission showed good predictive efficacy for IPN (AUC = 0.859, sensitivity = 80.8%, specificity = 87.5%), which was comparable to APACHE II score. And this finding was further validated in an independent cohort of 100 participants (AUC = 0.919, Sensitivity = 100.0%, Specificity = 76.6%).ConclusionThis study demonstrated the clinical value of nCD64 index in patients with IPN patients for the first time through two independent cohort studies. The nCD64 index can be used as an early prediction and risk assessment tool for the occurrence of IPN, contributing to the improvement of patient outcomes and efficiency of medical resource allocation.

Paget disease of bone in a southeastern Veteran population

BackgroundPaget disease of bone (PDB) is a disorder of accelerated bone remodeling resulting in bone overgrowth and impaired integrity that traditionally is described to be more frequent in individuals of European descent. Based on clinical observation, we hypothesized that among the US Southeastern Veteran population, the disease is more common among African American patients. Materials and methodsWe conducted a cross-sectional study using the Veterans Affairs’ Clinical Data Warehouse (CDW) and review of electronic medical records (EMR). Using the CDW, we identified patients from the Birmingham VA Medical Center (BVAMC) with an International Classification of Diseases code for PDB between January 2000 and December 2020. We extracted their self-reported race from the CDW and determined the proportion of African American patients, which we compared to the proportion of White patients. As a secondary goal, we extracted relevant clinical characteristics from the EMR. The statistical analysis was done using Stata/SE 14.2 for Mac. ResultsWe identified 285 individuals from the BVAMC with PDB between January 2000 and December 2020. The proportion of African American patients was significantly higher than White patients (0.51 vs. 0.4, p = 0.0036). African American patients presented at a younger age than their peers (mean[standard deviation] age at diagnosis: 64.6[11.6] vs. 70.1[10.7] years, p = 0.0009) but did not have higher alkaline phosphatase levels, higher proportion of polyostotic disease, or of symptoms and complications. ConclusionsIn the BVAMC population, PDB is more common among African American patients than White patients. Our findings and other publications hint at the existence of a cluster of PDB among the African American population in the US Southeast.

Identification of a lipid homeostasis-related gene signature for predicting prognosis, immunity, and chemotherapeutic effect in patients with gastric cancer

Gastric cancer (GC) is one of the most common and deadliest cancers worldwide. Lipid homeostasis is essential for tumour development because lipid metabolism is one of the most important metabolic reprogramming pathways within tumours. Elucidating the mechanism of lipid homeostasis in GC might significantly improve treatment strategies and patient prognosis. GSE62254 was applied to construct a lipid homeostasis-related gene signature score (HGSscore) by multiple bioinformatic algorithms including weighted gene coexpression network analysis (WGCNA) and LASSO-Cox regression. A nomogram based on HGSscore and relevant clinical characteristics was constructed to predict the survival of patients with GC. TIMER and xCell were used to evaluate immune and stromal cell infiltration in the tumour microenvironment. Correlations between lipid homeostasis-related genes and chemotherapeutic efficacy were analysed in GSCAlite. RT‒qPCR and cell viability assays were applied to verify the findings in this study. HGSscore was constructed based on eighteen lipid homeostasis-related genes that were selected by WGCNA and LASSO-Cox regression. HGSscore was strongly associated with advanced TNM stage and showed satisfactory value in predicting GC prognosis in three independent cohorts. Furthermore, we found that HGSscore was associated with the tumour mutation burden (TMB) and immune/stromal cell infiltration, which are related to GC prognosis, indicating that lipid homeostasis impacts the formation of the tumour microenvironment (TME). With respect to the GSCAlite platform, PLOD2 and TGFB2 were shown to be positively related to chemotherapeutic resistance, while SLC10A7 was a favourable factor for chemotherapy efficacy. Cell viability assays showed that disrupted lipid homeostasis could attenuate GC cell viability. Moreover, RT‒qPCR revealed that lipid homeostasis could influence expression of specific genes. We identified a lipid homeostasis-related gene signature that correlated with survival, clinical characteristics, the TME, and chemotherapeutic efficacy in GC patients. This research provides a new perspective for improving prognosis and guiding individualized chemotherapy for patients with GC.

An assessment of survival outcomes among ovarian cancer patients at the National and Referral Hospital in Kenya.

Ovarian cancer has been shown to have poor survival outcomes attributed to late presentation. In Kenya, information on the survival outcomes of ovarian cancer patients is scarce. Therefore, the objective of this study was to examine the survival outcomes among patients with ovarian cancer treated at Kenyatta National Hospital (KNH). A hospital-based retrospective cohort study was performed at KNH to examine the survival outcomes of 112 ovarian cancer patients. The study employed a structured data abstraction tool to acquire patients' relevant socio-demographic and clinical characteristics from the patient's medical records. The data obtained were analyzed using SPSS version 29.0 statistical software. Kaplan-Meier and Cox regression analyses were used to determine the survival outcome and predictors of mortality among ovarian cancer patients, respectively. The mean age of the patients in this study was 51.28 ± 14.24 years. Most patients (59.8%) had evidence of distant metastasis during the follow-up period. One-third (33%) of patients were deceased. The mean-cancer-specific survival time among the study participants was 40.0 ± 3.0 months. The 5-year survival rate was 44%, with most patients experiencing disease progression during the last follow-up. Combination therapy (p < .001) was the only statistically significant predictor of mortality in ovarian cancer patients. The study found that the 5-year survival rate among ovarian cancer patients was poor, with most patients experiencing disease progression during the last follow-up period.

High-dimensional in situ proteomics imaging to assess γδ T cells in spatial biology.

This study presents a high-dimensional immunohistochemistry approach to assess human γδ T cell subsets in their native tissue microenvironments at spatial resolution, a hitherto unmet scientific goal due to the lack of established antibodies and required technology. We report an integrated approach based on multiplexed imaging and bioinformatic analysis to identify γδ T cells, characterize their phenotypes, and analyze the composition of their microenvironment. Twenty-eight γδ T cell microenvironments were identified in tissue samples from fresh frozen human colon and colorectal cancer where interaction partners of the immune system, but also cancer cells were discovered in close proximity to γδ T cells, visualizing their potential contributions to cancer immunosurveillance. While this proof-of-principle study demonstrates the potential of this cutting-edge technology to assess γδ T cell heterogeneity and to investigate their microenvironment, future comprehensive studies are warranted to associate phenotypes and microenvironment profiles with features such as relevant clinical characteristics.

Disproportional signal of pericarditis with biological diseasemodifying antirheumatic drugs (bDMARDs) in patients with ankylosing spondylitis: a disproportionality analysis in the FAERS database

Objective: This study aimed to investigate the potential association between biological disease-modifying antirheumatic drugs (bDMARDs) and pericarditis and uncover relevant clinical characteristics in ankylosing spondylitis (AS).Methods: Reports of pericarditis recorded in the FDA Adverse Event Reporting System (FAERS) (January 2004–December 2022) were identified through the preferred term “pericarditis.” Demographic and clinical characteristics were described, and disproportionality signals were assessed through the reporting odds ratio (ROR) and information component (IC). A significant signal was detected if the lower bound of IC (IC025) was more than zero.Results: We found 1,874 reports of pericarditis with bDMARDs (11.3% of cases with fatal outcomes). Adalimumab (IC025 3.24), infliximab (IC025 4.90), golimumab (IC025 5.40), certolizumab (IC025 5.43), etanercept (IC025 3.24), secukinumab (IC025 3.97), and ustekinumab (IC025 7.61) exhibit significant disproportionality signals compared to other medications in the FAERS database. After excluding pre-existing diseases and co-treated drugs that may increase the susceptibility of pericarditis, the disproportionality signal associated with infliximab, certolizumab, etanercept, secukinumab, and ustekinumab remained strong. Pericarditis cases associated with all bDMARDs were predominantly recorded in women aged 25–65 years.Conclusion: More reports of pericarditis were detected with AS patients on bDMARDs than with other drugs in the overall database. Further studies are warranted to investigate the underlying mechanisms and identify patient-related susceptibility factors, thus supporting timely diagnosis and safe(r) prescribing of bDMARDs.

Bacteriologic Profile, Antibiotics Resistance Pattern, and Outcomes of Patients Admitted to Lancet General Hospital from June 2022 to June 2023: A Retrospective Cohort Study

Background: Prior studies indicated increased antimicrobial resistance in Ethiopia, with related health, economic, and environmental costs. Knowing an institutions and population microbiologic profile allows for proper antibiotic treatment, which substantially impact patients’ outcomes such as healthcare related costs, morbidity, and mortality. The current study assessed the bacteriologic profile, resistance pattern, and treatment outcome in Lancet General Hospital.&#x0D; Method: A retrospective cohort study on the bacteriologic profile, antibiotics resistance pattern, and outcome of patients was done on 128 eligible patients who were admitted to Lancet General Hospital from June 2022 to June 2023. Data from all hospitalized patients with culture-confirmed infection were analyzed. SPSS version 26.0 was used to analyze the data. Association between independent and dependent variables was analyzed using binary logistic regression model.&#x0D; Results: Gram-negative bacteria were recovered in 77% of the cases. Extended-spectrum beta-lactamase producing Enterobacteriaceae was found in 37.5% (54) isolates and carbapenem resistant bacteria were identified in 27.8% of patients. In-hospital mortality from multidrug resistant bacterial infection was 14.8%. Age ≥ 65 years, presence of septic shock, and presence of carbapenem-resistant bacteria were independently associated with increased in-hospital mortality.&#x0D; Conclusion: High number of resistant microorganisms was isolated, and increased mortality was documented from infections caused by carbapenem-resistant bacteria. Multi-center studies should be done to determine the extent of resistant organisms in health facilities throughout the country.epidemiology, and the findings should be factored into clinical decision making and program design for disease prevention, screening, and treatment. It also calls for further prospective research to learn more about the conditions in the context of additional relevant personal and clinical characteristics

Risk Factors and Determinants of Pulmonary Function Impairments in Chronic Respiratory Diseases in Ethiopia: A Hospital-based Cross-Sectional Study

Introduction: Chronic respiratory diseases (CRDs) are diseases of the airways and lung parenchyma. Although they are leading causes of morbidity and mortality globally, chronic respiratory diseases have received relatively little public attention. This study aimed to characterize the common chronic respiratory diseases, along with their lung function and possible determinants in symptomatic patients attending clinics at Bishoftu General Hospital, Ethiopia.&#x0D; Methods: A cross-sectional study was conducted at the outpatient department of Bishoftu Hospital from June 2019 to March 2020. Consecutive adult patients aged 18 and above with chronic respiratory symptoms (lasting more than 8 weeks) and no evidence of active tuberculosis were recruited. Questionnaires were used to collect data on demographics, symptoms, diagnoses, and potential risk factors. Lung function was measured by spirometry. Allergic status was assessed through allergen skin prick testing with standard allergens. &#x0D; Results: A total of 170 participants were recruited, with the majority being female (102, 60.0%). The mean age was 49 years (SD=16). The most common symptoms reported were wheezing in the last twelve months 156 (91.8%), cough 138 (81.2%) and severe exertional breathlessness 137 (80.6%). Thirty-nine (22.9%) participants were either active or passive smokers. Half of the patients (50.3%) were exposed daily to vapors, dust, gases, or fumes and 58 (34.3%) were exposed to biomass smoke. In total, 138 (81.2%) had a positive allergen skin prick test. Chronic bronchitis (49.1%) and asthma (36.1%) were the most common clinical diagnoses. Classification of lung function revealed 23 (15%) normal, 29 (19%) obstructive, 36(23.5%) restrictive and 61(39.9%) mixed obstructive/ restrictive patterns. Airflow obstruction (FEV1/FVC ratio) was independently associated with increasing age (p&lt;0.05), exertional breathlessness (p&lt;0.001), previous history of asthma (p&lt;0.05), BMI (p&lt;0.05), and doctordiagnosed chronic obstructive pulmonary disease (p&lt;0.001) and asthma (p&lt;0.05).&#x0D; Conclusion: This study demonstrated a high burden of abnormal lung function in patients attending clinics due to chronic respiratory symptoms. Increasing age, exertional breathlessness, prior diagnosis of asthma, BMI, and clinically diagnosed COPD and asthma were independently associated with obstructed lung function. These find ings highlight the critical need for spirometry services to identify lung abnormalities in patients with chronic respiratory symptoms. Epidemiology, and the findings should be factored into clinical decision making and program design for disease prevention, screening, and treatment. It also calls for further prospective research to learn more about the conditions in the context of additional relevant personal and clinical characteristics.

The predictive value of systemic immune-inflammatory markers before and after treatment for pathological complete response in patients undergoing neoadjuvant therapy for breast cancer: a retrospective study of 1994 patients.

Systemic immune-inflammatory markers have a certain predictive role in pathological complete response (pCR) after neoadjuvant treatment (NAT) in breast cancer. However, there is a lack of research exploring the predictive value of markers after treatment. This retrospective study collected data from 1994 breast cancer patients who underwent NAT. Relevant clinical and pathological characteristics were included, and pre- and post-treatment complete blood cell counts were evaluated to calculate four systemic immune-inflammatory markers: neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and systemic immune-inflammation index (SII). The optimal cutoff values for these markers were determined using ROC curves, and patients were classified into high-value and low-value groups based on these cutoff values. Univariate and multivariate logistic regression analyses were conducted to analyze factors influencing pCR. The factors with independent predictive value were used to construct a nomogram. After NAT, 383 (19.2%) patients achieved pCR. The area under the ROC curve is generally larger for post-treatment markers compared to pre-treatment markers. Pre-treatment NLR and PLR, as well as post-treatment LMR and SII, were identified as independent predictive factors for pCR, along with Ki-67, clinical tumor stage, clinical lymph node stage, molecular subtype, and clinical response. Higher pre-NLR (OR = 1.320; 95% CI 1.016-1.716; P = 0.038), pre-PLR (OR = 1.474; 95% CI 1.058-2.052; P = 0.022), post-LMR (OR = 1.532; 95% CI 1.175-1.996; P = 0.002), and lower post-SII (OR = 0.596; 95% CI 0.429-0.827; P = 0.002) are associated with a higher likelihood of achieving pCR. The established nomogram had a good predictive performance with an area under the ROC curve of 0.754 (95% CI 0.674-0.835). Both pre- and post-treatment systemic immune-inflammatory markers have a significant predictive role in achieving pCR after NAT in breast cancer patients. Indeed, it is possible that post-treatment markers have stronger predictive ability compared to pre-treatment markers.

The Carolina hysterectomy cohort (CHC): a novel case series of reproductive-aged hysterectomy patients across 10 hospitals in the US south

BackgroundHysterectomy is a common surgery among reproductive-aged U.S. patients, with rates highest among Black patients in the South. There is limited insight on causes of these racial differences. In the U.S., electronic medical records (EMR) data can offer richer detail on factors driving surgical decision-making among reproductive-aged populations than insurance claims-based data. Our objective in this cohort profile paper is to describe the Carolina Hysterectomy Cohort (CHC), a large EMR-based case-series of premenopausal hysterectomy patients in the U.S. South, supplemented with census and surgeon licensing data. To demonstrate one strength of the data, we evaluate whether patient and surgeon characteristics differ by insurance payor type.MethodsWe used structured and abstracted EMR data to identify and characterize patients aged 18–44 years who received hysterectomies for non-cancerous conditions between 10/02/2014–12/31/2017 in a large health care system comprised of 10 hospitals in North Carolina. We used Chi-squared and Kruskal Wallis tests to compare whether patients’ socio-demographic and relevant clinical characteristics, and surgeon characteristics differed by patient insurance payor (public, private, uninsured).ResultsOf 1857 patients (including 55% non-Hispanic White, 30% non-Hispanic Black, 9% Hispanic), 75% were privately-insured, 17% were publicly-insured, and 7% were uninsured. Menorrhagia was more prevalent among the publicly-insured (74% vs 68% overall). Fibroids were more prevalent among the privately-insured (62%) and the uninsured (68%). Most privately insured patients were treated at non-academic hospitals (65%) whereas most publicly insured and uninsured patients were treated at academic centers (66 and 86%, respectively). Publicly insured and uninsured patients had higher median bleeding (public: 7.0, uninsured: 9.0, private: 5.0) and pain (public: 6.0, uninsured: 6.0, private: 3.0) symptom scores than the privately insured. There were no statistical differences in surgeon characteristics by payor groups.ConclusionThis novel study design, a large EMR-based case series of hysterectomies linked to physician licensing data and manually abstracted data from unstructured clinical notes, enabled identification and characterization of a diverse reproductive-aged patient population more comprehensively than claims data would allow. In subsequent phases of this research, the CHC will leverage these rich clinical data to investigate multilevel drivers of hysterectomy in an ethnoracially, economically, and clinically diverse series of hysterectomy patients.

Estimating risk of rapid disease progression in pediatric patients with autosomal dominant polycystic kidney disease: a randomized trial of tolvaptan

BackgroundTolvaptan preserves kidney function in adults with autosomal dominant polycystic kidney disease (ADPKD) at elevated risk of rapid progression. A trial (NCT02964273) evaluated tolvaptan safety and pharmacodynamics in children (5–17 years). However, progression risk was not part of study eligibility criteria due to lack of validated criteria for risk assessment in children. As risk estimation is important to guide clinical management, baseline characteristics of the study participants were retrospectively evaluated to determine whether risk of rapid disease progression in pediatric ADPKD can be assessed and to identify parameters relevant for risk estimation.MethodsFour academic pediatric nephrologists reviewed baseline data and rated participant risk from 1 (lowest) to 5 (highest) based on clinical judgement and the literature. Three primary reviewers independently scored all cases, with each case reviewed by two primary reviewers. For cases with discordant ratings (≥ 2-point difference), the fourth reviewer provided a secondary rating blinded to the primary evaluations. Study participants with discordant ratings and/or for whom data were lacking were later discussed to clarify parameters relevant to risk estimation.ResultsOf 90 evaluable subjects, primary reviews of 69 (77%) were concordant. The proportion considered at risk of rapid progression (final mean rating ≥ 3.5) by age group was: 15–17 years, 27/34 (79%); 12– < 15, 9/32 (28%); 4– < 12, 8/24 (33%). The panelists agreed on characteristics important for risk determination: age, kidney imaging, kidney function, blood pressure, urine protein, and genetics.ConclusionsHigh ratings concordance and agreement among reviewers on relevant clinical characteristics support the feasibility of pediatric risk assessment.Graphical abstractA higher resolution version of the Graphical abstract is available as Supplementary information

ASSOCIATION OF LEVEL OF EDUCATION AND OCCUPATION WITH DIABETIC FOOT ULCER IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

Objective: Diabetic foot ulcer (DFU) is a well-known microvascular complication of Type 2 Diabetes mellitus (T2DM) with several risk factors. This study intended to determine the association of the level of education and occupation with the severity and outcome of DFU in diabetic patients. Materials and Methods: This study was conducted from 1st January 2023 to 25th January 2023 in the Endocrinology Division of the Department of Medical Specialties, Khyber Teaching Hospital, Peshawar. Adult diabetic patients with DFU were enrolled in the study. All the relevant demographic, clinical, and biochemical characteristics were measured. Results: Out of 148 patients, only 50 (33.8%) patients were educated. The study participants had a mean age, BMI, HbA1c, and duration of DM of 56.48 years, 27.3 kg/m2, 10.3 % and 9.4 years, respectively. There was a substantial association between the level of education and occupation with the severity of DFU which was statistically significant (p-value = 0.001 and p-value = 0.01, respectively). Regarding the outcome of DFU, it was found that patients with medium and high levels of literacy and skilled occupation had lower rates of major amputations. These results were statistically non-significant however they were found to be clinically significant. Conclusion: A significant association was observed between the education level and occupation with the severity and outcome of DFU. This underpins the significance of structured education of patients with low and medium literacy levels and those with unskilled and semiskilled jobs regarding their foot care. Keywords: Type 2 Diabetes Mellitus, Diabetic Foot ulcer, Occupation

Mortality after cardiovascular surgery and percutaneous coronary intervention prior to versus during the COVID-19 pandemic

Abstract Background The COVID-19 pandemic disrupted the usual delivery of health care services globally. However, little is known about its specific impact on cardiovascular procedure rates and outcomes. Purpose To compare rates of isolated coronary artery bypass graft (CABG) surgery, isolated open valve surgery (iValve) and percutaneous coronary intervention (PCI), and 30-day all-cause mortality among patients undergoing these procedures before versus during the COVID-19 pandemic. Methods We undertook a retrospective cohort study of patients aged 18 years and older in Ontario, Canada, comparing procedure and outcome event rates between April 1, 2018 and March 31, 2020 (pre-pandemic) with those between April 1, 2020 and March 31, 2022 (pandemic). Procedures were identified from hospital records, available for all patients hospitalized in the province, and were calculated per 100,000 population. Deaths were identified from the Ontario Health Insurance Plan Registered Persons Database. Multivariable logistic regression models were used to compute mortality rates adjusted for relevant sociodemographic and clinical characteristics. Additionally, we estimated the number of procedures needed to result in one excess death as the difference between the two periods divided by the pre-pandemic rate. Results During the study period, 24,823, 7,768 and 86,549 patients underwent CABG, iValve and PCI respectively. Between the pre-pandemic and pandemic periods, CABG, iValve and PCI rates declined 18.8%, 19.3% and 14.7%, respectively (Figure). Overall, the 30-day mortality rates were 1.9%, 2.4% and 2.6% following CABG, iValve and PCI, respectively. Adjusted 30-day mortality after CABG increased from 1.92 per 100 procedures (95% CI 1.69-2.15) pre-pandemic to 2.25 (2.01-2.49) during the pandemic (p=0.043). Adjusted 30-day mortality also increased among patients receiving iValve [from 2.25 (1.78, 2.71) to 3.29 (2.76, 3.82); p=0.016] and PCI [from 2.41 (2.28, 2.54) to 2.74 (2.60, 2.88); p&amp;lt;0.001]. These differences translate to an estimated excess of one death per 303 CABG surgeries, 96 iValve surgeries and 303 PCIs during the pandemic period. Conclusions In Ontario, Canada, CABG, iValve and PCI rates decreased during the COVID-19 pandemic and had not fully returned to pre-pandemic levels by two years following its initiation. While 30-day mortality rates following cardiovascular procedures significantly increased during the pandemic, the incremental number of additional deaths was small.

Comparative effectiveness and safety of apixaban and low-molecular weight heparin among patients with venous thromboembolism and active cancer in an extended treatment setting

Abstract Background The 2020 European Society of Cardiology guidelines recommend extended anticoagulant (AC) treatment among patients with VTE and with progressive or persistent risk factors (such as cancer) as they are at a high risk of a recurrent VTE episode. Purpose The study evaluated the risk of recurrent VTE and major bleeding (MB) among patients with VTE and active cancer prescribed apixaban or LMWH (reference) for ≥3 months. Methods This retrospective study included patients ≥18 years with VTE who initiated apixaban or LMWH within 30 days following the first VTE event using a large administrative claims database, representing ≥140 million patients enrolled in US health plans. Data from July 1, 2016, through April 30, 2022, was used. Patients were required to have ≥3 months of continuous enrollment (CE) and ≥3 months of continuous primary AC treatment following the date of apixaban/LMWH initiation. The end of 3 months of primary treatment was designated as index date. The follow-up period was from the day after the index date until the earliest of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or the end of the study period. The MB and recurrent VTE outcomes were evaluated and compared in the follow-up period. Inverse-probability treatment weighting (IPTW) was used to balance the treatment cohorts on relevant demographic and clinical characteristics including VTE and cancer-related variables. Incidence rate for the outcomes were calculated per 100 person-years. Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE and MB reported as hazard ratios (HR) along with 95% confidence interval (CI). Results After the eligibility criteria was met, the study included 13,527 apixaban and 2,914 LMWH treated patients with VTE and active cancer. Post IPTW, the treatment cohorts were balanced on baseline patient characteristics (Figure 1). In the follow-up period, the incidence rates (IR) per 100 person-years for recurrent VTE and MB were lower for apixaban than LMWH among patients with VTE and active cancer (Figure 2). Apixaban patients had a lower risk of recurrent VTE (HR: 0.42; 95% CI: 0.34–0.53) and MB (HR: 0.50; 95% CI: 0.41–0.61) when compared to LMWH (Figure 2). Conclusion In this observational cohort analysis of patients with VTE and active cancer, extended anticoagulation treatment of ≥3 months with apixaban was associated with a lower risk of recurrent VTE and MB compared with LMWH. Additional research is required to confirm these findings.Figure 1Figure 2

Abstract 18451: Point-of-Care Aid-to-Diagnosis for Heart Failure Using Artificial Intelligence Based on Seismocardiography Acquired With a Smartphone in the Emergency Department

BACKGROUND The number of new heart failure (HF) diagnoses in hospitals constantly increases. The associated clinical signs lead to a delay in treatment. Reliable and rapid diagnostic assistance is needed at earlier stages. Kinocardiography (KCG), based on Seismocardiography (SCG), allows the computation of non-invasive cardiac kinetic energy that is used to characterize the cardiac function and could detect HF among patients at risk. PURPOSE In a multi-centric study, test the performance of smartphone-based KCG recording in diagnosing HF in the emergency department (ED). METHODS Adult patients presenting with dyspnea in the ED were recruited. Relevant clinical characteristics were recorded. A blood sample was collected for NT-proBNP measurement, and a 180-sec KCG was acquired with a smartphone. The patient is supine on the back; the smartphone is placed on his chest to acquire the precordial vibrations due to the heartbeats. Cardiac kinetic energy (CKE) metrics are derived from these vibrations, including diastolic gradient kinetic energy ( ΔiK diastolic ). The final HF diagnosis was assessed from the medical record at discharge from the ED. The primary outcome is the performance of an AI-based on CKE metrics at classifying HF, measured using metrics including the area under the receiver operating characteristic curve (AUROC), negative predictive value (NPV), and specificity, with two-sided 95% CIs. RESULTS 375 patients were recruited; among these, 137 patients were diagnosed with HF (78 [70.2;85.7] years, 26.8 [23.4;29.6] kg/m 2 , 45.7% male, 4843.0 [3199;7845] pg/ml, 88 HFpEF, 17 HFmrEF, 37 HFrEF) and 243 without HF (65 [54;74] years, 27.9 [25.3;31.3] kg/m 2 , 50.2% male, 291.0 [71;803] pg/ml). ΔiK diastolic was significantly lower in patients with HF (0.37 [0.11;0.72] vs. 0.06 [-0.05;0.29] %, p&lt;0.005). The AI approach resulted in an AUROC of 0.85 (0.80-0.89), sensitivity of 85.0% (74.2-90.3), and NPV of 79.0% (77·7-82·9). CONCLUSION This study shows that an AI system applied to SCG acquired during a 3-mins examination with a smartphone can detect HF among patients presenting dyspnea. These findings highlight the potential for a non-invasive, workflow-adapted, point-of-care, aid-to-diagnosis for earlier diagnosis.