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Nevin Manimala Statistics

Umbilical Cord Gas Analysis: Clinical Implications of a comprehensive, contemporary determination of normal ranges

Am J Obstet Gynecol MFM. 2023 Aug 18:101134. doi: 10.1016/j.ajogmf.2023.101134. Online ahead of print.

ABSTRACT

BACKGROUND: Umbilical cord gases are often use to assess the impact of labor and delivery on the fetus. However, no large series exists which reflects contemporary obstetric practice or analyses blood gas ranges by route of delivery. Baseline, pre-labor acid-base status in the human fetus is also poorly defined, rendering assessment of blood gas changes during labor difficult.

OBJECTIVE: To define normal umbilical cord gas and lactate values stratified by mode of delivery in a large contemporary series in which universal cord gas collection was dictated by protocol.

STUDY DESIGN: Retrospective cohort study. We analyzed umbilical cord gas and lactate data from an unselected population of infants born between March 2012 and April 2022 at a large teaching hospital. These values were then analyzed by mode of delivery and, for cesarean deliveries, by indication for cesarean and type of anesthesia. Cord gas values from infants delivered by elective cesarean under general anesthesia without labor were considered representative of baseline, pre-labor values.

RESULTS: Data was available for 45,475 infants. Median arterial pH values and interquartile ranges for vaginal births, elective cesarean births without labor and cesarean births performed for fetal heart rate concerns were 7.27 (0.09), 7.27 (0.06) and 7.25 (0.09), respectively. Arterial lactate values for these same 3 groups were 4.1 (2.5), 2.5 (1.2) and 4.0 (2.8) mmoles/l. Due to the very large sample size, most comparisons yielded differences which were statistically significant, but clinically irrelevant. Of all infants, 14% had an arterial pH < 7.20; a pH value of 7.1 represents 2 standard deviations from the mean.

CONCLUSION: This large, population-based study of cord gas/lactate levels in an unselected population stratified by delivery mode represents a previously unavailable benchmark for evaluation of umbilical cord gases. Arterial cord pH values for infants delivered by elective caesarean without labor (median pH 7.28) reflect a lower pre-labor fetal pH baseline than that previously assumed. This finding, coupled with our determination of a 2 standard deviation lower pH limit of 7.1 rather than the historic arbitrary pH 7.2 threshold of normal helps explain the poor positive predictive value of electronic fetal heart rate monitoring, a test designed to detect arterial pH levels which have fallen from an assumed baseline near pH 7.4 to an assumed potentially injurious pH level < 7.2. Uncomplicated labor, even when prolonged, does not generally result in a clinically significant cumulative hypoxic stress to the human fetus. These findings, along with our determination of no difference in acid-base status among infants delivered by cesarean for fetal heart rate concerns, help explain the failure of current approaches to labor and delivery management in reducing the rates of neonatal hypoxic-ischemic encephalopathy and cerebral palsy, condition which almost always reflect developmental events rather than the effects of labor on the fetus.

PMID:37598886 | DOI:10.1016/j.ajogmf.2023.101134

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Nevin Manimala Statistics

Mental fatigue, cognitive performance and autonomic response following sustained mental activity in clinical burnout

Biol Psychol. 2023 Aug 18:108661. doi: 10.1016/j.biopsycho.2023.108661. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the effects of sustained mental activity on perceptions of mental fatigue, cognitive performance, and autonomic response in patients with clinical burnout as compared to a healthy control group.

METHODS: Patients with clinical burnout (n = 30) and healthy control participants (n = 30) completed a 3-hour test session, in which they were administered a set of cognitive tests before and after an effortful cognitive task with concurrent sound exposure. Perceptions of mental fatigue and task demands (mental effort and concentration difficulties) were assessed repeatedly over the course of the test session. Heart rate variability was recorded to index autonomic response.

RESULTS: In comparison with controls, perceived mental fatigue increased earlier in the session for the clinical burnout group and did not recover following a short rest period. Throughout the session, patients rated the tasks as more demanding and showed less improvement on measures of attention and processing speed, inhibition and working memory. While autonomic responses were initially comparable, there was a unique decrease in high-frequency heart rate variability in the clinical burnout group after extended testing and exposure.

CONCLUSION: Patients with clinical burnout are affected differently than healthy controls by sustained mental activity, as reflected by ratings of perceived mental fatigue, aspects of cognitive performance and autonomic response. Further investigation into the role of autonomic regulation in relation to cognitive symptoms in clinical burnout is warranted.

PMID:37598882 | DOI:10.1016/j.biopsycho.2023.108661

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Nevin Manimala Statistics

Photochemical outcomes triggered by gold shell-isolated nanorods on bioinspired nanoarchitectonics for bacterial membranes

Biochim Biophys Acta Biomembr. 2023 Aug 18:184216. doi: 10.1016/j.bbamem.2023.184216. Online ahead of print.

ABSTRACT

Boosted by the indiscriminate use of antibiotics, multidrug-resistance (MDR) demands new strategies to combat bacterial infections, such as photothermal therapy (PTT) based on plasmonic nanostructures. PTT efficiency relies on photoinduced damage caused to the bacterial machinery, for which nanostructure incorporation into the cell envelope is key. Herein, we shall unveil the binding and photochemical mechanisms of gold shell-isolated nanorods (AuSHINRs) on bioinspired bacterial membranes assembled as Langmuir and LS monolayers of DOPE, Lysyl-PG, DOPG and CL. AuSHINRs incorporation expanded the isotherms, with stronger effect on the anionic DOPG and CL. Indeed, FTIR of LS films revealed more modifications for DOPG and CL owing to stronger attractive electrostatic interactions between anionic phosphates and the positively charged AuSHINRs, while electrostatic repulsions with the cationic ethanolamine (DOPE) and lysyl (Lysyl-PG) polar groups might have weakened their interactions with AuSHINRs. No statistical difference was observed in the surface area of irradiated DOPE and Lysyl-PG monolayers on AuSHINRs, which is evidence of the restricted nanostructures insertion. In contrast, irradiated DOPG monolayer on AuSHINRs decreased 4.0 % in surface area, while irradiated CL monolayer increased 3.7 %. Such results agree with oxidative reactions prompted by ROS generated by AuSHINRs photoactivation. The deepest AuSHINRs insertion into DOPG may have favored chain cleavage while hydroperoxidation is the mostly like outcome in CL, where AuSHINRs are surrounding the polar groups. Furthermore, preliminary experiments on Escherichia coli culture demonstrated that the electrostatic interactions with AuSHINRs do not inhibit bacterial growth, but the photoinduced effects are highly toxic, resulting in microbial inactivation.

PMID:37598878 | DOI:10.1016/j.bbamem.2023.184216

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Nevin Manimala Statistics

An observational cohort study of histological screening for BK polyomavirus nephropathy following viral replication in plasma

Kidney Int. 2023 Aug 18:S0085-2538(23)00563-X. doi: 10.1016/j.kint.2023.07.025. Online ahead of print.

ABSTRACT

Systematic screening for BKPyV-DNAemia has been advocated to aid prevention and treatment of polyomavirus associated nephropathy (PyVAN), an important cause of kidney graft failure. The added value of performing a biopsy at time of BKPyV-DNAemia, to distinguish presumptive PyVAN (negative SV40 immunohistochemistry) and proven PyVAN (positive SV40) has not been established. Therefore, we studied an unselected cohort of 950 transplantations, performed between 2008-2017. BKPyV-DNAemia was detected in 250 (26.3%) transplant recipients, and positive SV40 in 91 cases (9.6%). Among 209 patients with a concurrent biopsy at time of first BKPyV-DNAemia, 60 (28.7%) biopsies were SV40 positive. Plasma viral load showed high diagnostic value for concurrent SV40 positivity (ROC-AUC 0.950, 95% confidence interval 0.916-0.978) and the semiquantitatively scored percentage of tubules with evidence of polyomavirus replication (pvl score) (0.979, 0.968-0.988). SV40 positivity was highly unlikely when plasma viral load is below 4 log10 copies/ml (negative predictive value 0.989, 0.979-0.994). In SV40 positive patients, higher plasma BKPyV-DNA load and higher pvl scores were associated with slower viral clearance from the blood (hazard ratio 0.712, 95% confidence interval 0.604-0.839, and 0.327, 0.161-0.668, respectively), whereas the dichotomy positivity/negativity of SV40 immunohistochemistry did not predict viral clearance. Although the pvl score offers some prognostic value for viral clearance on top of plasma viral load, the latter provided good guidance for when a biopsy was unnecessary to exclude PyVAN. Thus, the distinction between presumptive and proven PyVAN, based on SV40 immunohistochemistry, has limited clinical value. Hence, management of BKPyV-DNAemia and immunosuppression reduction should be weighed against the risk of occurrence of rejection, or exacerbation of rejection observed concomitantly.

PMID:37598855 | DOI:10.1016/j.kint.2023.07.025

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Nevin Manimala Statistics

Comparison of ambient radiofrequency electromagnetic field (RF-EMF) levels in outdoor areas and public transport in Switzerland in 2014 and 2021

Environ Res. 2023 Aug 18:116921. doi: 10.1016/j.envres.2023.116921. Online ahead of print.

ABSTRACT

Mobile communication technology has evolved rapidly over the last ten years with a drastic increase in wireless data traffic and the deployment of new telecommunication technologies. The aim of this study was to evaluate the ambient radiofrequency electromagnetic field (RF-EMF) levels and temporal changes in various microenvironments in Switzerland in 2014 and 2021. We measured the ambient RF-EMF levels in V/m in the same 49 outdoor areas and in public transport in 2014 and 2021 using portable RF-EMF exposure meters carried in a backpack. The areas were selected to represent some typical types of microenvironments (e.g. urban city centres, suburban and rural areas). We calculated the summary statistics (mean, percentiles) in mW/m2 and converted back to V/m for each microenvironment. We evaluated the distribution and the variability of the ambient RF-EMF levels per microenvironment types in 2021. Finally, we compared the ambient RF-EMF mean levels in 2014 and 2021 using multilevel regression modelling. In outdoor areas, the average ambient RF-EMF mean levels per microenvironment in 2021 ranged from 0.19 V/m in rural areas to 0.43 V/m in industrial areas (overall mean: 0.27 V/m). In public transports, the mean levels were 0.27 V/m in buses, 0.33 V/m in trains and 0.36 V/m in trams. In 2021, mean levels across all outdoor areas were -0.022 V/m lower (95% confidence interval: 0.072, 0.030) than in 2014. Results from our comprehensive measurement study across Switzerland suggest that RF-EMF levels in public places have not significantly changed between 2014 and 2021 despite an 18-fold increase in mobile data transmission during that period. The absence of temporal changes may be owed to the shift to newer mobile communication technologies, which are more efficient.

PMID:37598840 | DOI:10.1016/j.envres.2023.116921

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Nevin Manimala Statistics

WHEY PROTEIN, VITAMINS C AND E DECREASE IL-10 IN CHRONIC HEMODIALYSIS PATIENTS: A PIONEER, RANDOMIZED, DOUBLE-BLIND PILOT TRIAL

J Ren Nutr. 2023 Aug 18:S1051-2276(23)00129-2. doi: 10.1053/j.jrn.2023.08.007. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effects of supplementation with whey protein combined with vitamins C and E on inflammatory markers in hemodialysis (HD) patients.

DESIGN AND METHODS: This was a pioneer, randomized and double-blinded study. Patients were randomised into two groups and stratified by HD frequency. The supplementation group received 20 g of whey protein, 250 mg of vitamin C, and 600 IU of vitamin E; the placebo group, 20 g of rice flour, and microcrystalline cellulose capsules. The interventions were given after HD, 3 times a week, for 8 weeks. The inflammatory markers were assessed: interleukin (IL) IL-12p70, IL-10, IL-6, IL-8, and tumor necrosis factor alpha. For statistical analysis, the χ2 test, Student’s t-test, Mann – Whitney test, analysis of variance for repeated two-way measurements, paired t test, and Wilcoxon test were performed. P < 0.05.

RESULTS: Twenty-three patients completed the study. No significant differences were found in inflammatory markers when comparing the groups post-intervention. In the intragroup was a decrease in IL-10 in the supplementation group after 8 weeks (p=0.0382). IL-6 tended to decrease by 810.95% in the supplementation group and increased by 732.8% (non-significant) in the placebo group.

CONCLUSION: The supplementation with whey protein combined with vitamins C and E could be beneficial to reduce inflammatory markers in HD patients. Future studies are suggested with a larger sample size, different supplementation doses, and longer interventions.

PMID:37598813 | DOI:10.1053/j.jrn.2023.08.007

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Nevin Manimala Statistics

Adaptation of closed-chest infarction porcine model to adult Pannon minipigs

J Pharmacol Toxicol Methods. 2023 Aug 18:107469. doi: 10.1016/j.vascn.2023.107469. Online ahead of print.

ABSTRACT

The aim of the recent study was to collect data on the genotype characteristics of the Hungarian self-bred Pannon minipigs by adapting a standardized infarct model procedure. Closed chest AMI was induced by balloon occlusion for 90 min in the left anterior descendent coronary artery (LAD) in 24 adult intact female minipigs followed by reperfusion. To assess the left ventricular (LV) function, serial cardiac magnetic resonance imaging (cMRI) was performed prior to the experimental procedure, on day 3 post-AMI (72 ± 12 h), and at 1 month follow-up (Day 30 ± 2 days). Compared to baseline cMRI scans the end-diastolic volume (EDV) was increased on days 3 and 30 On day 3 the left ventricular ejection fraction (LVEF) decreased significantly but there was no statistical difference between the baseline and day 30 measurements. Cardiac output, stroke volume, and end-systolic volume significantly were increased compared to baseline on day 30 A high percentage (54%) of malignant arrhythmias occurred during the AMI procedure, with a 25% mortality rate. The compensatory capacity of the Pannon minipig heart is excellent therefore the use of different cardiac parameters and invasive measurements is advisable in chronic pharmacological experiments to complement cMRI data.

PMID:37598810 | DOI:10.1016/j.vascn.2023.107469

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Nevin Manimala Statistics

Demystifying Statistics and Machine Learning in Analysis of Structured Tabular Data

J Arthroplasty. 2023 Aug 18:S0883-5403(23)00857-4. doi: 10.1016/j.arth.2023.08.045. Online ahead of print.

ABSTRACT

Electronic health records have facilitated the extraction and analysis of a vast amount of data with many variables for clinical care and research. Conventional regression-based statistical methods may not capture all the complexities in high-dimensional data analysis. Therefore, researchers are increasingly using machine learning (ML)-based methods to better handle these more challenging datasets for the discovery of hidden patterns in patients’ data and for classification and predictive purposes. This article describes commonly used ML methods in structured data analysis with examples in orthopaedic surgery. We present practical considerations in starting an ML project and appraising published studies in this field.

PMID:37598784 | DOI:10.1016/j.arth.2023.08.045

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Nevin Manimala Statistics

FUNCTIONAL OUTCOME CHANGE OVER 10 YEARS AFTER PRIMARY TOTAL KNEE ARTHROPLASTY. A PROSPECTIVE LONGITUDINAL COHORT STUDY

J Arthroplasty. 2023 Aug 18:S0883-5403(23)00853-7. doi: 10.1016/j.arth.2023.08.042. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to assess whether there were clinically important differences in functional outcome over regular follow-up intervals up to 10 years after primary TKA.

METHODS: A prospective registry-based observational cohort study was performed in 309 patients older than 60 years at surgery who underwent primary TKA for osteoarthritis. Patients were assessed preoperatively and postoperatively at 1, 3, 5, 7 and 10 years with the Knee Society scores (KSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Clinically important improvement was defined according to the minimal clinically important difference (MCID). Patient satisfaction was also evaluated. Patients were also categorized as type A (unilateral knee osteoarthritis), type B (bilateral knee osteoarthritis) or type C (various sites of osteoarthritis).

RESULTS: Follow-up was 10 years in all patients. The mean age at the TKA surgery was 69.2 (SD 7.3) years, 197 (63.7%) were women. Maximum postoperative improvements in KSS and WOMAC scores occurred at 3 postoperative years, remained relatively stable up to 5-year. There were significant decreases in all KSS and WOMAC scores at 7-year follow-up (p= 0.001), remained relatively stable up to 10-year. At 10-year, KSS and WOMAC scores were significantly higher than preoperatively (p= 0.001). Differences between maximum scores at 3-year and those at 10-year were significantly lesser than MCID in all scores (p= 0.001). In multivariate analysis, type-C patient at TKA surgery was the only significant predictor of unsuccessful KSS score and dissatisfaction at 10-year follow-up.

CONCLUSION: Primary TKA provides clinically important improvements in functional and quality of life outcomes over 10-year follow-up compared to preoperatively. Although there were statistically significant declines in KSS and WOMAC scores from 3 to 10 years, the differences were lesser than the MCID.

PMID:37598778 | DOI:10.1016/j.arth.2023.08.042

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Nevin Manimala Statistics

Analysis of radiation therapy quality assurance in NRG Oncology RTOG 0848

Int J Radiat Oncol Biol Phys. 2023 Aug 18:S0360-3016(23)07781-7. doi: 10.1016/j.ijrobp.2023.08.014. Online ahead of print.

ABSTRACT

PURPOSE: NRG/RTOG 0848 is a two-step randomized trial to evaluate the benefit of the addition of concurrent fluoropyrimidine and radiotherapy (RT) following adjuvant chemotherapy (2nd step) for patients with resected pancreatic head adenocarcinoma. Real-time quality assurance (QA) was performed on each patient who underwent RT. This analysis aims to evaluate adherence to protocol-specified contouring and treatment planning and to report the types and frequencies of deviations requiring revisions.

METHODS AND MATERIALS: In addition to a web-based contouring atlas, the protocol outlined step-by-step instructions for generating the clinical treatment volume (CTV) through the creation of specific regions of interest. The planning target volume (PTV) was a uniform 0.5cm CTV expansion. One of two radiation oncology study chairs independently reviewed each plan. Plans with unacceptable deviations were returned for revision and resubmitted until approved. Treatment started after final approval of the RT plan.

RESULTS: From 2014-2018, 354 patients were enrolled in the second randomization. Of these, 160 patients received RT and were included in the QA analysis. Resubmissions were more common for patients planned with 3D-CRT (43%) than with IMRT (31%). In total, at least one resubmission of the treatment plan was required for 33% of patients. Among patients requiring resubmission, most only needed one resubmission (87%). The most common reasons for resubmission were unacceptable deviations with respect to the pre-operative gross target volume (60.7%) and the pancreaticojejunostomy (47.5%), CONCLUSION: One-third of patients required resubmission to meet protocol compliance criteria, demonstrating the continued need for expending resources on real-time, pretreatment QA in trials evaluating the use of radiotherapy, particularly for pancreas cancer. Rigorous QA is critically important for clinical trials involving RT to ensure that the true impact of RT is assessed. Moreover, RT QA serves as an educational process through providing feedback from specialists to practicing radiation oncologists on best practices.

PMID:37598723 | DOI:10.1016/j.ijrobp.2023.08.014