Categories
Nevin Manimala Statistics

Characteristics and outcomes in elderly patients with non-valvular atrial fibrillation and high bleeding risk: subanalysis of the J-RHYTHM Registry

Heart Vessels. 2023 Dec 16. doi: 10.1007/s00380-023-02343-9. Online ahead of print.

ABSTRACT

Recently, a once-daily dose of edoxaban (15-mg) has been approved for stroke prevention in non-valvular atrial fibrillation (NVAF) patients aged ≥ 80 years, in whom standard oral anticoagulants are not recommended because of high bleeding risk (HBR), based on the ELDERCARE-AF trial. However, information regarding the characteristics and clinical outcomes among such patients is limited. Thus, this study aimed to clarify the characteristics and event rates in elderly patients with NVAF and HBR defined by the ELDERCARE-AF criteria. Of the 7406 NVAF outpatients included in the J-RHYTHM Registry, 60 patients with creatinine clearance (CrCl) < 15 mL/min were excluded. The remaining 7346 patients (age, 69.7 ± 9.9 years; men, 70.9%; warfarin use, 78.7%) were divided into three groups: Group 1, aged < 80 years (n = 6165); Group 2, aged ≥ 80 years without HBR (n = 584); and Group 3, aged ≥ 80 years with HBR (at least one of the followings; CrCl, 15-30 mL/min, history of bleeding, body weight ≤ 45 kg, and antiplatelet use) (n = 597, eligible for 15-mg edoxaban). Patients in Group 3 had a higher prevalence of comorbidities, and therefore, both higher thromboembolic and bleeding risk scores than in the other groups. During the 2-year follow-up period, the incidence rates (per 100 person-years) of thromboembolism in Groups 1, 2, and 3 were 0.7, 1.5, and 2.1 (P < 0.001), major hemorrhage, 0.8, 1.2, and 2.0 (P < 0.001), and all-cause death, 0.8, 2.6, and 4.6 (P < 0.001), respectively. Adjusted hazard ratios of Group 3 were 1.64 (95% confidence interval 0.89-3.04, P = 0.116) for thromboembolism, 1.53 (0.85-2.72, P = 0.154) for major hemorrhage, and 1.84 (1.19-2.85, P = 0.006) for all-cause death compared with Group 1. The NVAF Patients aged ≥ 80 years with HBR defined by the ELDERCARE-AF criteria were certainly at a higher adverse event risk, especially for all-cause death. Clinical trial registration: The J-RHYTHM Registry is registered in the University Hospital Medicine Information Network (UMIN) Clinical Trials Registry (unique identifier: UMIN000001569) http://www.umin.ac.jp/ctr/ .

PMID:38103100 | DOI:10.1007/s00380-023-02343-9

Categories
Nevin Manimala Statistics

Injections prior to hip arthroscopy are associated with increased risk of repeat hip arthroscopy at 1 and 5 years

Arch Orthop Trauma Surg. 2023 Dec 16. doi: 10.1007/s00402-023-05164-7. Online ahead of print.

ABSTRACT

INTRODUCTION: Previous studies have shown that intra-articular hip injections prior to hip arthroscopy (HA) can be a helpful diagnostic tool. However, local anesthetic and corticosteroid injections can be chondrotoxic and corticosteroid injections have been shown to increase the risk of infection during subsequent surgical intervention. The purpose of this study was to evaluate whether preoperative injections adversely affect outcomes of HA using a national database.

MATERIALS AND METHODS: The TriNetX database was retrospectively queried. Patients undergoing HA for femoroacetabular impingement with at least 1 year of claims runout were included in the analysis. Patients were grouped by whether they had a hip injection within 1 year prior to HA. The rates of repeat HA, total hip arthroplasty (THA), infection, osteonecrosis, and new onset hip OA at 1- and 5-years postoperatively were compared between groups. Statistical significance was assessed at α = 0.05.

RESULTS: 6511 HA patients with previous injection and 1178 HA patients without previous injection were included. Patients with a previous injection were overall younger (32.3 vs. 34.7 years, p < 0.001), more likely to be female (69 vs. 48%, p < 0.001) and had a higher BMI (26.3 vs. 25.7 kg/m2, p = 0.043). At 1 and 5-years postoperatively, patients with any injection were 1.43 (p < 0.001) and 1.89 (p < 0.001) times more likely to undergo repeat HA, respectively. At 1 and 5-years postoperatively, patients who underwent a corticosteroid injection were 2.29 (p < 0.001) and 1.89 (p < 0.001) times more likely to undergo repeat HA than patients with local anesthetic injection only and 1.56 (p < 0.001) and 2.08 (p < 0.001) times more likely to undergo repeat HA than patients with no injection.

CONCLUSIONS: Intraarticular hip injections prior to hip arthroscopy, particularly corticosteroid injections, are associated with increased risk of repeat hip arthroscopy at 1 and 5 years. Additional studies are needed to elucidate this risk.

PMID:38103052 | DOI:10.1007/s00402-023-05164-7

Categories
Nevin Manimala Statistics

Role of Preoperative Embolization in Surgical Management of Carotid Body Tumors: A Systematic Review and Meta-Analysis

Angiology. 2023 Dec 16:33197231215240. doi: 10.1177/00033197231215240. Online ahead of print.

ABSTRACT

The objective of this study is to evaluate the effect of preoperative embolization on carotid body tumor resection. A systematic review and meta-analysis were conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. PubMed, Scopus, and Web of Science were screened for studies published between 2010 and 2022. Primary outcomes investigated were intraoperative blood loss, operative time, length of hospital stay, and perioperative complications such as transient ischemic attack (TIA)/stroke, vascular injury, and cranial nerve injury (CNI). A random effects model was used in cases where study heterogeneity was high. Overall, 25 studies were included in the systematic review, involving 1649 patients: 23 studies were eligible for meta-analysis. The incidence of vascular injury was significantly less in the preoperative embolization group (odds ratio (OR) = 0.60; 95% CI: 0.42-0.84; P = .003). There was no statistically significant difference between the two groups regarding intraoperative blood loss, operative time, length of hospital stay, incidence of TIA/stroke, and CNI. Subgroup analyses did not demonstrate significant difference between Shamblin I, II, and III subgroups regarding operative time. This meta-analysis found preoperative embolization to be significantly beneficial in reducing incidence of vascular injury.

PMID:38103038 | DOI:10.1177/00033197231215240

Categories
Nevin Manimala Statistics

The Influence of Hospital Type, Insurance Type, and Patient Income on 30-Day Complication and Readmission Rates Following Lumbar Spine Fusion

Global Spine J. 2023 Dec 16:21925682231222903. doi: 10.1177/21925682231222903. Online ahead of print.

ABSTRACT

BACKGROUND CONTEXT: Several studies have shown that factors such as insurance type and patient income are associated with different readmission rates following certain orthopaedic procedures. The literature, however, remains sparse with regard to these demographic characteristics and their associations to perioperative lumbar spine fusion outcomes.

PURPOSE: The purpose of this study was to assess the associations between hospital type, insurance type, and patient median income to both 30-day complication and readmission rates following lumbar spine fusion.

PATIENT SAMPLE: Patients who underwent primary lumbar spine fusion (n = 596,568) from 2010-2016 were queried from the National Readmissions Database (NRD).

OUTCOME MEASURES: Incidence of 30-day complication and readmission rates.

METHODS: All relevant diagnoses and procedures were identified using International Classification of Disease, 9th and 10th Edition (ICD-9, 10) codes. Hospital types were categorized as metropolitan non-teaching (n = 212,131), metropolitan teaching (n = 364,752), and rural (n = 19,685). Insurance types included: Medicare (n = 213,534), Medicaid (n = 78,520), private insurance (n = 196,648), and out-of-pocket (n = 45,025). Patient income was divided into the following quartiles: Q1 (n = 112,083), Q2 (n = 145,755), Q3 (n = 156,276), and Q4 (n = 147,289), wherein quartile 1 corresponded to lower income ranges and quartile 4 to higher ranges. Statistical analysis was conducted in R. Kruskal-Wallis tests with Dunn’s pairwise comparisons were performed to analyze differences in 30-day readmission and complication rates in patients who underwent lumbar spine fusion. Complications analyzed included infection, wound injury, hematoma, neurological injury, thromboembolic event, and hardware failure.

RESULTS: 30-day readmission was significantly higher in metropolitan teaching hospitals compared to metropolitan non-teaching hospitals and rural hospitals (P < .05). Patients from metropolitan teaching hospitals had significantly higher rates of infection (P < .001), wound injury (P < .001), hematoma (P = .018), and hardware failure (P < .002) compared to those treated at metropolitan non-teaching hospitals. Privately insured patients were significantly less likely to be readmitted at 30 days than those paying with Medicare or Medicaid (P < .01). Patients with private insurance also experienced significantly lower rates of hematoma formation than Medicare beneficiaries and out-of-pocket payers (P < .01), postoperative wound injury compared to Medicaid patients and out-of-pocket payers (P < .005), and infection compared to all other groups (P < .001). Patients in Quartile 4 experienced significantly greater rates of hematoma formation compared to those in Quartiles 1 and 2 and were more likely to experience a thromboembolic event compared to all other groups.

CONCLUSION: Patients undergoing lumbar spine fusion at metropolitan non-teaching hospitals and paying with private insurance had significantly lower 30-day readmission rates than their counterparts. Complications within 30 days following lumbar spine fusion were significantly higher in patients treated at metropolitan teaching hospitals and in Medicare and Medicaid beneficiaries. Aside from a few exceptions, however, patient income was generally not associated with differential complication rates.

PMID:38103012 | DOI:10.1177/21925682231222903

Categories
Nevin Manimala Statistics

Online false discovery rate control for LORD++ and SAFFRON under positive, local dependence

Biom J. 2023 Dec 16:e2300177. doi: 10.1002/bimj.202300177. Online ahead of print.

ABSTRACT

Online testing procedures assume that hypotheses are observed in sequence, and allow the significance thresholds for upcoming tests to depend on the test statistics observed so far. Some of the most popular online methods include alpha investing, LORD++, and SAFFRON. These three methods have been shown to provide online control of the “modified” false discovery rate (mFDR) under a condition known as CS. However, to our knowledge, LORD++ and SAFFRON have only been shown to control the traditional false discovery rate (FDR) under an independence condition on the test statistics. Our work bolsters these results by showing that SAFFRON and LORD++ additionally ensure online control of the FDR under a “local” form of nonnegative dependence. Further, FDR control is maintained under certain types of adaptive stopping rules, such as stopping after a certain number of rejections have been observed. Because alpha investing can be recovered as a special case of the SAFFRON framework, our results immediately apply to alpha investing as well. In the process of deriving these results, we also formally characterize how the conditional super-uniformity assumption implicitly limits the allowed p-value dependencies. This implicit limitation is important not only to our proposed FDR result, but also to many existing mFDR results.

PMID:38102999 | DOI:10.1002/bimj.202300177

Categories
Nevin Manimala Statistics

IL-21 promoting angiogenesis contributes to the development of psoriasis

FASEB J. 2024 Jan;38(1):e23375. doi: 10.1096/fj.202201709RRRR.

ABSTRACT

BACKGROUND: Elevated IL-21 expression which can effectively induce Th17 cell differentiation has been implicated in the pathogenesis of psoriasis, but its role in angiogenesis remains poorly understood.

METHODS: PASI and PSI score assessment was applied to evaluate the severity of psoriatic lesions. The expression of IL-21, IL-21 receptor (IL-21R), CD31, VEGFA, MMP-9, and ICAM-1 in skin was determined by immunohistochemistry or quantitative real-time polymerase chain reaction. The serum level of IL-21 was measured by enzyme-linked immunosorbent assay (ELISA). Then, their correlation was analyzed statistically. Human umbilical vein endothelial cells (HUVECs) cocultured with conditional medium from normal human epidermal keratinocytes (NHEKs) were treated with IL-21 and/or M5 cocktail (mixture of IL-1α, IL-17A, IL-22, TNF-α, and oncostatin M). The migration and tube formation of HUVECs were detected, and the levels of VEGFA, MMP-9, and ICAM-1 in NHEKs were measured by Western blotting or ELISA.

RESULTS: Increased IL-21 and IL-21R expression was observed in psoriatic sera or skin specimens, with IL-21R mainly locating in keratinocytes and IL-21 in immune cells. Pearson analysis showed significantly positive correlation between IL-21/IL-21R and erythema scores/microvessel density in psoriatic lesions. Moreover, the expression of proangiogenic genes, VEGFA, ICAM-1, and MMP-9 was upregulated in skins of psoriasis. Additionally, in M5 microenvironment, migration and tube formation could be magnified in HUVECs using IL-21 pre-treated NHEK medium. Mechanically, the co-stimulation of IL-21 and M5 to NEHKs increased the expression of ICAM-1.

CONCLUSION: IL-21 could regulate keratinocytes to secrete ICAM-1, thereby promoting angiogenesis in psoriasis.

PMID:38102968 | DOI:10.1096/fj.202201709RRRR

Categories
Nevin Manimala Statistics

The clinical impacts of the prognostic nutritional index for the esophageal cancer patients who received curative treatment

J Cancer Res Ther. 2023 Dec 15. doi: 10.4103/jcrt.JCRT_1595_20. Online ahead of print.

ABSTRACT

BACKGROUND: We investigated the impact of the prognostic nutritional index (PNI) on esophageal cancer survival and recurrence after curative treatment.

METHODS: This study included 120 patients who underwent curative surgery followed by the adjuvant treatment for esophageal cancer between 2008 and 2018. The risk factors for overall survival (OS) and recurrence-free survival (RFS) were identified.

RESULTS: The PNI of 49 was regarded to be the optimal critical point of classification considering the 1-year, 3-year, and 5-year survival rate. The OS rates at three and five years after surgery were 47.4% and 36.0% in the PNI low group, respectively, and 62.5% and 56.5% in the PNI high group, which amounted to a statistically significant difference (P = 0.020). The RFS rates at three and five years after surgery were 31.0% and 24.8% in the PNI low group, respectively, and 50.9% and 42.8% in the PNI high group, which amounted to a statistically significant difference (P = 0.020). A multivariate analysis demonstrated that the PNI was a significant independent risk factor for the OS and a marginally significant independent risk factor forRFS.

CONCLUSION: The PNI was a risk factor for survival in patients who underwent curative treatment for esophageal cancer. It is necessary to develop the effective plan of the perioperative care and the surgical strategy according to the PNI.

PMID:38102916 | DOI:10.4103/jcrt.JCRT_1595_20

Categories
Nevin Manimala Statistics

Peripheral blood stem cells mobilization in patients with relapsed or refractory lymphomas: A single-center experience

J Cancer Res Ther. 2023 Dec 15. doi: 10.4103/jcrt.JCRT_1621_20. Online ahead of print.

ABSTRACT

CONTEXT: High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (AHSCT) is an established treatment for chemosensitive patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL).

AIMS: We present the results of using different salvage chemotherapy plus granulocyte colony stimulating factor (G-CSF) for mobilization of peripheral blood stem cells in R/R lymphoma patients.

SUBJECTS AND METHODS: For salvage chemotherapy, 93 patients received platinum-containing regimens, 4 patients received cytarabine-containing regimens, and 5 patients received other regimens. Patient distributions were HL (n = 35) and NHL (n = 67).

RESULTS: In 87.2% of patients, first mobilization trial was successful (>2 × 106 CD34+ cells/kg). In 58.8% of patients, first apheresis season >5 × 106 CD34+ cells/kg collections was achieved. All 12.7% of patients were poorly mobilized at the first mobilization. There was no statistical difference between the previous chemotherapy numbers and failed mobilization (P > 0.05). Five patients who were poorly mobilized and 4 patients who were successfully mobilized underwent a previous radiotherapy (P < 0.05). Thirteen patients who were poorly mobilized in the first mobilization underwent a platinum-containing salvage regimen. At the time of the first mobilization, the average peripheral CD 34 counts in the successfully mobilized group were statistically higher than that in the poorly mobilized group (P < 0.01).

CONCLUSIONS: We demonstrated that peripheral CD 34 cell count in the peripheral blood on the first apheresis day was a significant factor for more stem cell mobilization, fewer apheresis sessions, less volume, and earlier neutrophil engraftment for patients with R/R lymphoma and eligible for AHSCT. The history of the previous radiotherapy was a significant factor for poor mobilization.

PMID:38102912 | DOI:10.4103/jcrt.JCRT_1621_20

Categories
Nevin Manimala Statistics

Evaluation of salivary endothelin-1 as a biomarker for oral cancer and precancer

J Cancer Res Ther. 2023 Dec 15. doi: 10.4103/jcrt.jcrt_2664_22. Online ahead of print.

ABSTRACT

CONTEXT: Oral cancer is highly prevalent in India. Lack of awareness and delay in diagnosis and treatment of patients with oral cancer leads to high mortality and poor survival of patients. Salivary endothelin-1 is proposed as a prospective biomarker for oral squamous cell carcinoma.

AIMS: Aim of the study was to evaluate salivary level of endothelin-1 in oral cancer and precancer as a biomarker.

SETTINGS AND DESIGN: We planned a case control study to evaluate salivary level of Endothelin-1 in oral cancer and precancer as a biomarker.

MATERIALS AND METHODS: A total of 72 subjects were taken in study out of which 24 cases were of histopathologically confirmed premalignat oral lesion (oral leukoplakia and oral submucous fibrosis), 24 cases were of histopathologically confirmed oral squamous cell carcinoma, and 24 cases of healthy age and gender matched controls without any addiction to tobacco in any form from a tertiary care hospital were taken. Saliva was collected from all following standard guidelines and estimation of salivary endothelin-1 was done by ELISA.

STATISTICAL ANALYSIS USED: SPSS software version 15.

RESULTS: Salivary endothelin-1 values of controls ranged between 0.09 and 1.88 pg/ml while that of premalignant cases ranged between 1.16 and 16.135 pg/ml and of SCC cases ranged between 2.567 and 22.98 pg/ml.

CONCLUSIONS: Salivary endothelin-1 is raised in oral squamous cell carcinoma compared to premalignant and controls therefore, shows capability to differentiate between premalignant lesion and oral cancer. So, it could be used as a biomarker for early diagnosis.

PMID:38102911 | DOI:10.4103/jcrt.jcrt_2664_22

Categories
Nevin Manimala Statistics

Clinicopathological profile and survival analysis of esophageal carcinoma: A retrospective study in a tertiary care hospital in Northeast India

J Cancer Res Ther. 2023 Dec 15. doi: 10.4103/jcrt.jcrt_7_23. Online ahead of print.

ABSTRACT

BACKGROUND: Esophageal cancer (EC) is an extremely aggressive tumor with one of the highest geographic, ethnic, and gender variations. Various factors including tobacco consumption, unhealthy diet, and socioeconomic status have been implicated in the etiology of EC. Despite the advent of modern treatments, the prognosis of EC is dismal. This study has been undertaken to review the clinical and pathologic profiles, treatment approach, and survival pattern in patients with EC in a tertiary care hospital in northeast India.

MATERIALS AND METHODS: A retrospective descriptive study was done with 179 EC patients presented to our department between January 2013 and December 2020. Statistical analysis was done by using IBM Statistical Package for the Social Sciences version 21. P- value <0.05 was considered significant.

RESULTS: The majority of the patients presented in the sixth decade of life from rural areas with male to female ratio of 3.7:1. Dysphagia was the most common presenting feature. High incidence of tobacco and alcohol use was found. Mid-esophagus is the most common site and squamous cell carcinoma is the most common type. Fifty-two (29.1%) and 71 (39.6%) patients presented in stages III and IV, respectively. Twenty-four (13.4%) patients presented with metastatic disease, the lung being the most common site. Patients were treated with surgery, chemotherapy, radiotherapy, or combination of any of these. Overall median survival for the EC patients was 6 months. Patients treated with concurrent chemoradiation had better survival.

CONCLUSION: EC is a serious malignancy with a dismal prognosis due to the advanced stage at presentation. Larger clinical trials using new therapeutic strategies are the need of the hour.

PMID:38102907 | DOI:10.4103/jcrt.jcrt_7_23