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Nevin Manimala Statistics

Impact of Chronic Kidney Disease on In-Hospital and 3-Year Clinical Outcomes in Patients With Acute Myocardial Infarction Treated by Contemporary Percutaneous Coronary Intervention and Optimal Medical Therapy - Insights From the J-MINUET Study

Circ J. 2021 Jun 3. doi: 10.1253/circj.CJ-20-1115. Online ahead of print.

ABSTRACT

BACKGROUND: The impact of chronic kidney disease (CKD) on long-term outcomes following acute myocardial infarction (AMI) in the era of modern primary PCI with optimal medical therapy is still in debate.Methods and Results:A total of 3,281 patients with AMI were enrolled in the J-MINUET registry, with primary PCI of 93.1% in STEMI. CKD stage on admission was classified into: no CKD (eGFR ≥60 mL/min/1.73 m2); moderate CKD (60>eGFR≥30 mL/min/1.73 m2); and severe CKD (eGFR <30 mL/min/1.73 m2). While the primary endpoint was all-cause mortality, the secondary endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause death, cardiac failure, myocardial infarction (MI) and stroke. Of the 3,281 patients, 1,878 had no CKD, 1,073 had moderate CKD and 330 had severe CKD. Pre-person-days age- and sex-adjusted in-hospital mortality significantly increased from 0.014% in no CKD through 0.042% in moderate CKD to 0.084% in severe CKD (P<0.0001). Three-year mortality and MACE significantly deteriorated from 5.09% and 15.8% in no CKD through 16.3% and 38.2% in moderate CKD to 36.7% and 57.9% in severe CKD, respectively (P<0.0001). C-index significantly increased from the basic model of 0.815 (0.788-0.841) to 0.831 (0.806-0.857), as well as 0.731 (0.708-0.755) to 0.740 (0.717-0.764) when adding CKD stage to the basic model in predicting 3-year mortality (P=0.013; net reclassification improvement [NRI] 0.486, P<0.0001) and MACE (P=0.046; NRI 0.331, P<0.0001) respectively.

CONCLUSIONS: CKD remains a useful predictor of in-hospital and 3-year mortality as well as MACE after AMI in the modern PCI and optimal medical therapy era.

PMID:34078824 | DOI:10.1253/circj.CJ-20-1115

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Nevin Manimala Statistics

Statistical Note: Using Scoping and Systematic Reviews

Pediatr Crit Care Med. 2021 Jun 1;22(6):572-575. doi: 10.1097/PCC.0000000000002738.

NO ABSTRACT

PMID:34078843 | DOI:10.1097/PCC.0000000000002738

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Nevin Manimala Statistics

Experimental Tracheal Replacement: Angiogenesis and Null Apoptosis Promote Stenosis

J Chest Surg. 2021 Jun 5;54(3):191-199. doi: 10.5090/jcs.20.146.

ABSTRACT

BACKGROUND: Tracheal replacement is a challenge for thoracic surgeons due to stenosis in the trachea-prosthesis anastomosis. We propose that stenosis occurs due to fibrosis as a result of an abnormal healing process, characterized by an increased expression of wound healing growth factors (vascular endothelial growth factor [VEGF], survivin, and CD31), which promote angiogenesis and decrease apoptosis. We analyzed the immunoreactivity of VEGF, survivin, CD31, and caspase-3 in the development of fibrotic stenosis in prosthetic tracheal replacement.

METHODS: Fourteen dogs were operated on: group I (n=7) received a 6-ring cervical tracheal segment autograft, while in group II (n=7), a 6-ring segment of the cervical trachea was resected and tracheal continuity was restored with a Dacron prosthesis. The follow-up was 3 months. Immunoreactivity studies for VEGF, survivin, CD31, and caspase-3 were performed. A statistical analysis was done using the Wilcoxon signed rank test.

RESULTS: Four animals in group I were euthanized on the 10th postoperative day due to autograft necrosis. Three animals completed the study without anastomotic stenosis. Moderate expression of VEGF (p=0.038), survivin (p=0.038), and CD31 (p=0.038) was found. All group II animals developed stenosis in the trachea-prosthesis anastomotic sites. Microscopy showed abundant collagen and neovascularization vessels. Statistically significant immunoreactive expression of VEGF (p=0.015), survivin (p=0.017), and CD31 (p=0.011) was observed. No expression of caspase-3 was found.

CONCLUSION: We found a strong correlation between fibrosis in trachea-prosthesis anastomoses and excessive angiogenesis, moderate to intense VEGF, CD31, and survivin expression, and null apoptotic activity. These factors led to uncontrolled collagen production.

PMID:34078753 | DOI:10.5090/jcs.20.146

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Nevin Manimala Statistics

Modulatory Effect of Chaetomorpha gracilis on Erythrocytes Functions and Metabolic Disorders in Mice Fed a High-cholesterol Diet

J Oleo Sci. 2021;70(6):837-848. doi: 10.5650/jos.ess20104.

ABSTRACT

The current study was carried out to estimate the protective effect of methanolic extract of Chaetomorpha gracilis (MECG) against High Cholesterol Diet (HCD) induced erythrocyte damage in mice. The results of the in vitro assay showed that MECG have higher antioxidant capacities in the DPPH, TAC, ABTS, NBT, NO. inhibition assays. The HPLC analysis confirmed that this potential antioxidant seems to be due to the active compounds, in particular polyphenols, flavonoids. HCD promoted oxidative stress with a rise the level of malonaldehyde (MDA), advanced oxidation protein product (AOPP) levels and a significant decrease of the Vitamin C content, as well the antioxidant enzyme activities such as superoxide dismutase and glutathione peroxidase. In addition, HCD treatment caused significant lipid profile disorders via increase the cholesterol, triglycerides and LDL levels and reduction HDL-Ch level. A statistically significant decrease of Mg2+ and Ca2+ ATPase activities accompanied with a severe damage in the erythrocytes structure and hematological parameters alterations were also noted in hypercholesterolemic mice. Pre-treatment with MECG significantly restored biochemical markers and pathological lesions. It can be suggest that supplementation of MECG displays high potential to quench free radicals and attenuates high cholesterol diet induced erythrocytes oxidative stress and related damages.

PMID:34078760 | DOI:10.5650/jos.ess20104

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Nevin Manimala Statistics

Prediction Performance and Economic Efficiency of Soft Sensors for in-Line Water Content Monitoring in Fluidized Bed Granulation: PP-Based Model vs. NIRS-Based Model

Chem Pharm Bull (Tokyo). 2021;69(6):548-556. doi: 10.1248/cpb.c20-01016.

ABSTRACT

Soft sensors play a crucial role as process analytical technology (PAT) tools. They are classified into physical models, statistical models, and their hybrid models. In general, statistical models are better estimators than physical models. In this study, two types of standard statistical models using process parameters (PPs) and near-infrared spectroscopy (NIRS) were investigated in terms of prediction accuracy and development cost. Locally weighted partial least squares regression (LW-PLSR), a type of nonlinear regression method, was utilized. Development cost was defined as the cost of goods required to construct an accurate model of commercial-scale equipment. Eleven granulation lots consisting of three laboratory-scale, two pilot-scale, and six commercial-scale lots were prepared. Three commercial-scale granulation lots were selected as a validation dataset, and the remaining eight granulation lots were utilized as calibration datasets. The results demonstrated that the PP-based and NIRS-based LW-PLSR models achieved high prediction accuracy without using the commercial-scale data in the calibration dataset. This practical case study clarified that the construction of accurate LW-PLSR models requires the calibration samples with the following two features: 1) located near the validation samples on the subspace spanned by principal components (PCs), and 2) having a wide range of variations in PC scores. In addition, it was confirmed that the reduction in cost and mass fraction of active pharmaceutical ingredient (API) made the PP-based models more cost-effective than the NIRS-based models. The present work supports to build accurate models efficiently and save the development cost of PAT.

PMID:34078801 | DOI:10.1248/cpb.c20-01016

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Nevin Manimala Statistics

Patient Derived Xenograft Engraftment and Breast Cancer Outcomes in a Prospective Neoadjuvant Study (BEAUTY)

Clin Cancer Res. 2021 Jun 2:clincanres.0641.2021. doi: 10.1158/1078-0432.CCR-21-0641. Online ahead of print.

ABSTRACT

PURPOSE: Patient derived xenografts (PDXs) are a research tool for studying cancer biology and drug response phenotypes. While engraftment rates are higher for tumors with more aggressive characteristics, it is uncertain whether engraftment is prognostic for cancer recurrence.

EXPERIMENTAL DESIGN: In a prospective study of breast cancer patients treated with neoadjuvant chemotherapy (NAC) with taxane+/-trastuzumab followed by anthracycline-based chemotherapy, we report the association between breast cancer events and PDX engraftment using tumors derived from treatment naïve (pre-NAC biopsies from 113 patients) and treatment resistant (post-NAC at surgery from 34 patients). Gray’s test was used to assess whether the cumulative incidence of a breast cancer event differs with respect to either pre-NAC PDX engraftment or post-NAC PDX engraftment.

RESULTS: With a median follow up of 5.7 years, the cumulative incidence of breast cancer relapse did not differ significantly according to pre-NAC PDX engraftment (5-year rate: 13.6% versus 13.4%; p=0.89). However, the incidence of a breast event was greater for patients with post-NAC PDX engraftment (5-year rate: 50.0% versus 19.6%), but this did not achieve significance (p=0.11).

CONCLUSIONS: In treatment-naive breast cancer receiving standard NAC, PDX engraftment was not prognostic for breast cancer recurrence. Further study is needed to establish whether PDX engraftment in the treatment-resistant setting is prognostic for cancer recurrence.

PMID:34078650 | DOI:10.1158/1078-0432.CCR-21-0641

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Nevin Manimala Statistics

Economic perspective of evaluating fertility treatment in obese and overweight infertile women

Saudi Med J. 2021 Jun;42(6):666-672. doi: 10.15537/smj.2021.42.6.20200733.

ABSTRACT

OBJECTIVES: To evaluate direct cost of in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle and reproductive outcomes among infertile women with different body mass index (BMI).

METHODS: A retrospective study of 826 subfertility patients who had IVF or IVF-ICSI in 2017 to 2018 were reviewed. The patients were divided into 4 groups bestowing to BMI to normal weight (18.5-24.9 kg/m2), underweight (<18.5 kg/m2), overweight(25-29.9 kg/m2), and obese(≥30 kg/m2). Data on treatment costs of IVF/ICSI and reproductive outcomes were collected and analyzed. A total of 338 patients (40.9%) were overweight, and 300 (36.3%) patients were obese. A bottom-up methodology was used to measure the resource utilization. The capital inputs needed for individual procedures were defined and calculated by consulting with appropriate clinicians and priced using market prices for 2017-2018.

RESULTS: There was no statistical significant difference for live birth rate (LBR) among the BMI groups, with the occurrence of LBR in 23 women with normal BMI (13.1%), in 48 (14.2%) women who were overweight, in 48 (16%) in women who were obese (p=0.7). The median cost for IVF/ICSI treatment cycle did not differ across BMI groups; the cost was 10,380 SAR for women of normal weight, 10,440 SAR for women who are overweight and obese (p=0.6).

CONCLUSION: Our results suggest that costs of IVF/IVF-ICSI is not significantly affected in women who are overweight or obese.

PMID:34078730 | DOI:10.15537/smj.2021.42.6.20200733

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Nevin Manimala Statistics

Severity of Bronchopulmonary Dysplasia Among Very Preterm Infants in the United States

Pediatrics. 2021 Jun 2:e2020030007. doi: 10.1542/peds.2020-030007. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network recently proposed new, severity-based diagnostic criteria for bronchopulmonary dysplasia (BPD). This study provides the first benchmark epidemiological data applying this definition.

METHODS: Retrospective cohort study of infants born from 22 to 29 weeks’ gestation in 2018 at 715 US hospitals in the Vermont Oxford Network. Rates of BPD, major neonatal morbidities, and common respiratory therapies, stratified by BPD severity, were determined.

RESULTS: Among 24 896 infants, 2574 (10.3%) died before 36 weeks’ postmenstrual age (PMA), 12 198 (49.0%) did not develop BPD, 9192 (36.9%) developed grade 1 or 2 BPD, and 932 (3.7%) developed grade 3 BPD. Rates of mortality before 36 weeks’ PMA and grade 3 BPD decreased from 52.7% and 9.9%, respectively, among infants born at 22 weeks’ gestation to 17.3% and 0.8% among infants born at 29 weeks’ gestation. Grade 1 or 2 BPD peaked in incidence (51.8%) among infants born at 25 weeks’ gestation. The frequency of severe intraventricular hemorrhage or cystic periventricular leukomalacia increased from 4.8% among survivors without BPD to 23.4% among survivors with grade 3 BPD. Similar ranges were observed for late onset sepsis (4.8%-31.4%), surgically treated necrotizing enterocolitis (1.4%-17.1%), severe retinopathy of prematurity (1.2%-23.0%), and home oxygen therapy (2.0%-67.5%).

CONCLUSIONS: More than one-half of very preterm infants born in the United States died before 36 weeks’ PMA or developed BPD. Greater BPD severity was associated with more frequent development of major neonatal morbidities, in-hospital mortality, and use of supplemental respiratory support at discharge.

PMID:34078747 | DOI:10.1542/peds.2020-030007

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Nevin Manimala Statistics

Volume-outcome relationships for kidney cancer may be driven by disparities and patient risk

Urol Oncol. 2021 May 31:S1078-1439(21)00193-9. doi: 10.1016/j.urolonc.2021.04.036. Online ahead of print.

ABSTRACT

PURPOSE: Provider and hospital factors influence healthcare quality, but data are lacking to assess their impact on renal cancer surgery. We aimed to assess factors related to surgeon and hospital volume and study their impact on 30-day outcomes after radical nephrectomy.

MATERIALS AND METHODS: Renal surgery data were abstracted from Maryland’s Health Service Cost Review Commission from 2000 to 2018. Patients ≤18 years old, without a diagnosis of renal cancer, and concurrently receiving another major surgery were excluded. Volume categories were derived from the mean annual cases distribution. Multivariable logistic and linear regression models assessed the association of volume on length of stay, intensive care days, cost, 30-day mortality, readmission, and complications.

RESULTS: 7,950 surgeries, completed by 573 surgeons at 48 hospitals, were included. Demographic, surgical, and admission characteristics differed between groups. Radical nephrectomies performed by low volume surgeons demonstrated increased post-operative complication frequency, mortality frequency, length of stay, and days spent in intensive care relative to other groups. However, after logistic regression adjusting for clinical risk and socioeconomic factors, only increased length of stay and ICU days remained associated with lower surgeon volume. Similarly, after adjusted logistic regression, hospital volume was not associated with the studied outcomes.

CONCLUSIONS: Surgeons and hospitals differ in regards to patient demographic and clinical factors. Barriers exist regarding access to high-volume care, and thus some volume-outcome trends may be driven predominantly by disparities and case mix.

PMID:34078583 | DOI:10.1016/j.urolonc.2021.04.036

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Nevin Manimala Statistics

Patient-reported opioid use for tissue expander-based breast reconstruction

J Plast Reconstr Aesthet Surg. 2021 Apr 18:S1748-6815(21)00218-7. doi: 10.1016/j.bjps.2021.03.114. Online ahead of print.

ABSTRACT

INTRODUCTION: There is limited evidence for appropriate post-operative opioid prescribing in breast reconstruction patients. We sought to describe postoperative outpatient prescription opioid use patterns (quantity and duration) following discharge after immediate breast reconstruction with tissue expanders (TE) and to identify demographic and/or clinical risk factors associated with postoperative outpatient opioid use.

METHODS: Patients 18 years and older undergoing immediate TE-based breast reconstruction were given a 28-day postoperative pain medication log book. Descriptive statistics were performed to describe the quantity and duration of opioid use. Preoperative, intraoperative, and postoperative characteristics were examined and tested for their associations with postoperative opioid use.

RESULTS: A total of 45 logbooks were completed. On average, patients used opioids for 7.42 days (SD = 6.45) after discharge home and used 15.9 (SD = 18.71) oxycodone 5 mg tablet equivalents (119.3 morphine milligram equivalents, SD = 140.31). The total number of oxycodone 5 mg equivalents consumed prior to discharge was associated with the amount of post-discharge opioid consumption (IRR=1.08, p<0.01). Each additional year of age was associated with a reduction in the days-to-opioid cessation by a factor of 0.97 (p=0.01). Each additional oxycodone 5mg equivalent consumed prior to hospital discharge was associated with an increase in the days-to-cessation after discharge by a factor of 1.04 (p=0.026).

CONCLUSIONS: These patient-reported data will provide a benchmark which plastic surgeons can use to minimize narcotic use in patients and will help prevent issues of dependence, misuse, and diversion, while being mindful of adequate pain control. For patients discharging home after a one-night stay for immediate TE breast reconstruction, we recommend a prescription for 10 oxycodone 5 mg tablets, or 15 tablets if they are less than age 49 or have had high inpatient opioid use. Patients should also be counseled that the expected duration of outpatient opioid use is 7-11 days, and that 20 % of patients did not use any opioids following hospital discharge, making nonnarcotic pain regimens a real possibility.

PMID:34078588 | DOI:10.1016/j.bjps.2021.03.114