Comparison Of Statistical Tests Research Articles

Effects of Local Anesthetics on Tissue Penetration Using Diode Lasers in Intraoral Tissues.

Objective: The purpose of this study was to demonstrate heat transfer within oral soft tissues using different lasers under the effect of local anesthetics (LA). Methods: Bovine tongue slices were placed in between two glass slides and at a distance from a thermographic camera. In total, 2-cm-long 240 incisions were made along the surface of the tissue parallel to glass slides and the camera capture field. Incisions were performed using 445-nm and infrared (IR) lasers (970 nm and 980 nm on a continuous wave at 2 W) with 320 µm-initiated (concentrated energy at the tip provided by a blue articulated paper and laser irradiation) and noninitiated (defused energy) fiber (30-sec irradiation period). LA was injected into the specimens before irradiation. The temperature changes in °C (ΔT) and vertical and lateral heat transfer (in mm) were recorded at 10-sec intervals for 30 sec, using thermographic images. The amount of lateral and vertical heat transfer was measured. A repeated analysis of variance statistical comparison test was used to analyze differences between the lateral (width) and the vertical (height) heat transfer for initiated and noninitiated lasers and different lasers. Results: The maximum ΔT in °C utilizing initiated tips of 970, 980, or 445 nm were 11.82 ± 3.46, 7.66 ± 3.24, and 18.94 ± 7.01 and using noninitiated tips were 8.27 ± 1.69, 8.87 ± 2.40, and 12.31 ± 8.65, respectively. Heat transfers (height/width) for initiated were 40.65 ± 10.40/90.65 ± 10.77 mm, 41.50 ± 11.83/83.95 ± 11.20 mm, and 33.70 ± 9.10/95.10 ± 11.17 mm and for noninitiated lasers were 52.95 ± 6.89/96.10 ± 11.17 mm, 47.75 ± 7.41/93.75 ± 14.96 mm, and 31.35 ± 11.40/75.20 ± 19.68 mm, respectively. A statistically significant difference was found between all lasers (p < 0.05) for initiated and noninitiated lasers (except for 970/980 nm for noninitiated lasers). Lower penetration depth (p < 0.05) at 445-nm diode and greater lateral heat spreading (p < 0.05) were identified under LA especially utilizing noninitiated tips without significant difference in IR lasers. Conclusions: LA might negatively influence soft tissues creating scattering when noninitiated tips are used and IR diode laser technology.

Abstract 2564: Circulating monocytes decrease significantly following disease-directed therapy and may reflect disease expansion in Langerhans cell histiocytosis

Abstract Introduction: Langerhans Cell Histiocytosis (LCH) is a rare disorder characterized by clonal hematopoietic cell expansion forming eosinophilic granulomas. Treatment approaches vary based on disease severity. Despite established therapies, assessing treatment response, particularly regarding peripheral blood monocytes, lacks comprehensive markers. Methods: We studied 76 LCH patients, collecting data on demographics, diagnostic methods, and treatment responses. Peripheral blood absolute monocyte counts were analyzed at key time points, including disease onset, progression, and post-therapy reinstatement, using statistical tests for comparison. Results: Analyzing data from 76 patients (average age: 38), we found diverse disease presentations, with common imaging modalities being CT (37), PET (29), and MRI (22). Complete responses were observed in 17 of 49 patients, with 11 undergoing local therapy. Conversely, 5 patients with pulmonary LCH and chronic tobacco use showed persistent progression. Notably, peripheral blood monocyte counts did not differ between initial and latest assessments, but on disease progression, the mean count (0.94 K/µL) significantly exceeded that following therapy reinstatement (0.31, p=0.000794). Results: Analyzing data from 76 patients (average age: 38), we found diverse disease presentations, with common imaging modalities being CT (37), PET (29), and MRI (22). Complete responses were observed in 17 of 49 patients, with 11 undergoing local therapy. Conversely, 5 patients with pulmonary LCH and chronic tobacco use showed persistent progression. Notably, peripheral blood monocyte counts did not differ between initial and latest assessments, but on disease progression, the mean count (0.94 K/µL) significantly exceeded that following therapy reinstatement (0.31, p=0.000794). Discussion: LCH is proposed to result from dysregulated hematopoiesis, leading to sequential somatic mutations during monocyte differentiation leading to clonal expansion of CD1A and CD207+ histiocytes. Our finding of increased monocyte count during disease progression may suggest elevated circulating LCH or heightened monocyte production for subsequent differentiation, potentially contributing to MHC Class 1 upregulation. This phenomena mirrors published findings from our own group in patients with Rosai Dorfman and Erdheim Chester Disease. To further elucidate the molecular underpinnings of LCH and explore the etiology of this monocyte trend, genetic sequencing analysis is in progress. Ultimately, monitoring peripheral blood monocyte dynamics could offer valuable insights into LCH progression and treatment response. Citation Format: Haadi Ali, Sam Reynolds, Sabrina Wilcox, Naina Chipalkatti, Asra Ahmed. Circulating monocytes decrease significantly following disease-directed therapy and may reflect disease expansion in Langerhans cell histiocytosis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2564.

Impact of multiple different high-fat diets on metabolism, inflammatory markers, dysbiosis, and liver histology: study on NASH rat model induced diet.

The spectrum of non-alcoholic fatty liver disease (NAFLD), known as non-alcoholic steatohepatitis (NASH), can lead to advanced liver disease. It is known that a variety of diets play a significant role in the development of NAFLD/NASH. The goal of this study was to determine the most appropriate composition of diet to induce NASH in an animal model. This research used Rattus norvegicus strain Wistar (n=27), which were divided into four groups and given each diet for 12 weeks: normal diet (ND, n=7), high-fat diet (HFD, n=6), western diet (WD, n=7), and high-fat-high-fructose diet (HFHFD, n=7). Subjects were monitored for changes in body weight. Blood samples were collected for biochemical analysis, including low-density lipoprotein (LDL), triglyceride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), hepatic lipase, tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and lipopolysaccharide (LPS). Fecal samples were taken for short-chain fatty acid (SCFA) analysis. Liver histology was assessed using NAS (NAFLD activity score). A statistical comparison test was carried out using the one-way ANOVA or Kruskal-Wallis test. The highest average body weight was observed in the WD group (346.14 g). Liver enzymes, LDL, triglyceride, propionic acid, and acetic acid did not show significantly differences among the groups. TNF-α, IL-6, and hepatic lipase were significant (p = 0.000; p = 0.000; p = 0.004) and the highest level recorded in the HFD group. Butyrate acid level also showed significances (p = 0.021) with the lowest concentration seen in the HFHFD group (4.77 mMol/g). Only WD and HFHFD had a NAS ≥ 5 (14% and 14%). The highest percentage of borderline NAS was found in WD (57%). WD feeding is the most appropriate diet type to induce NASH in rats as it influences metabolic, inflammatory, dysbiosis, and liver histology of rats.

A review of studies on tourism and climate change from 2007 to 2021

PurposeThe purpose of this study is to review empirical studies on the relationship between climate change and tourism for a period of 15 years, from 2007 to 2021. The main variables analyzed were research subjects, topics and economic development levels.Design/methodology/approachLiterature review was used to analyze articles published on climate change and tourism from 2007 to 2021. A staged article selection process was followed using the Scopus database. Statistical comparison tests found differences among sub-groupings of articles.FindingsThe research articles on climate change and tourism continued their upward trajectory until 2021. The 893 articles analyzed were published in 254 different journals, with over 60% from non-tourism or cross-disciplinary journals. Significant differences were found by time period and between developed and developing countries.Research limitations/implicationsGaps in the literature were detected with respect to policy analysis and it was concluded that the research for developing nations remains insufficient. More research should be encouraged to focus on the situation and solutions to climate change and tourism in developing countries. Additional research is also needed on biodiversity declines in destinations because of climate change.Originality/valueThis research dealt exclusively with empirical research studies in academic articles. It compared results across three different time periods and between developing and developed countries. Statistical tests supported the comparisons.

Depression and Fatigue in Rheumatoid Arthritis- A Study in Southern India

Rheumatoid Arthritis is a chronic autoimmune condition in which the patient experiences pain, joint immobility which in some instance can also lead to disability, and thus difficulty in carrying out various activities of daily living. It is a natural consequence that patients may experience varying degrees of depressive symptoms and fatigue. Aim and Objectives: In our study, it is our objective to find out the prevalence of depression, its severity and its correlation with disease activity, pain and inflammatory markers like ESR. We also attempted to quantify the fatigue using the MAF scale by calculating the GFI (Global Fatigue Index) and its prevalence in remission vs non remission patients. Study design: The study is a cross-sectional observational study of consecutive patients with a diagnosis of RA as per EULAR 2020 criteria. The patients were interviewed using standard questionnaires MAF (multidimensional assessment of fatigue questionnaire) and PHQ9 (Patient Health Questionnaire 9). Tools used in the study: Fatigue was measured by using MAF (Multidimensional Assessment of Fatigue). Depression is measured using the PHQ9 questionnaire. Results: The population studied was found to have a prevalence of 33.5% depression. The patients’ mean age was 52.4510.53 years and disease duration 8.026.22 years. Their mean DAS28 was 2.961.1. The mean PHQ-9 score was 3.993.5., mild (26%), moderate (5.5%), moderately severe (1.5%) and severe (0.5%) degrees. Correlation of PHQ9 scores with DAS, VAS and ESR was done to see if there is a relation of depression to any of the clinical outcomes. It was found that depression had a positive correlation with disease activity score DAS 28 (coefficient of correlation 0.167, p = 0.018), VAS pain scores (coefficient = 0.361, p &lt; 0.001) as well as ESR (coefficient = 0.217, and p = 0.002). Fatigue was evaluated using the MAF which gave the Global Fatigue Index (GFI). The mean MAF score was 8.623.33. 78% of patients had fatigue in the level (0-10), 20.5% in the (10-20) level and 1.5% in the (20-30) level. Statistical test for comparison between groups using t test was found to be significant with p value 0.034. Conclusion: Our study on both depression and fatigue once again emphasises the need for rheumatologists especially in the Indian scenario to address them in their routine clinical practice. There should be regular screening for these conditions during the patient visits similar to other risk factors screening in RA.

Sonographic Predictors of Ovarian Torsion in Premenarchal Girls

To identify preoperative transabdominal sonographic predictors of surgically confirmed ovarian torsion (OT) in premenarchal girls METHODS: We conducted a retrospective case-control study of 32 premenarchal girls aged 0-12 undergoing surgery for OT (cases) or a non-torsed ovarian mass (controls) from 2006 to 2017 at a single academic center. Cases had ICD-9/10 codes for torsion of the ovary, adnexa, ovarian pedicle, or fallopian tube and surgically confirmed OT; controls had codes for ovarian mass or cyst and surgically confirmed absence of OT. Preoperative transabdominal ultrasounds were analyzed by 3 radiologists blinded to final diagnosis. We used χ2, Fisher[s exact, and Student's t tests for statistical comparisons. From 2016 to 2017, 32 patients presented with acute abdominal pain or symptoms concerning for ovarian mass requiring ultrasound imaging and subsequent diagnostic laparoscopy; 24 (75.0%) had confirmed OT by laparoscopy, and 8 (25.0%) did not. The mean age in both groups was similar (7.3±2.9 years). Preoperative sonographic variables significantly associated with OT included presence of a simple cyst (20.8% vs 12.5%), ovarian heterogeneity (100% vs 12.5%), presence of peripheralized follicles (70.8% vs 0%), and asymmetry of color Doppler (75.0% vs 37.5%; all P < .05). Presence of free fluid, arterial color Doppler, and a whirlpool sign were not predictive of OT. In premenarchal patients, although certain variables on transabdominal sonography predicted surgically confirmed OT, only the presence of peripheralized follicles was unique to girls with OT. The decision to proceed with diagnostic laparoscopy for suspected OT can be aided by these specific sonographic findings but should ultimately be based on high clinical suspicion.

EFFECT OF MOTOR IMAGİNATİON TRAİNİNG ON TENNİS SERVİCE HİT

In this study, it was aimed to reveal the effect of motor imagination training on the hit of the service in the tennis game. 32 male tennis players between the ages of 18-25 participated in the study in the field of tennis in Kayseri. After the first measurements of age, height, body weight and Dewitt-Dugan service and ITN Service test of the athletes, control (n=16) and experimental (n=16) groups were separated by random method. While 8-week technical training was applied to both groups, technical and imagination trainings were applied to the experimental group. At the end of eight weeks, the final test values were taken. The obtained data were analyzed in the IBM-SPSS 25 for Windows package program. In the analysis, the data showed normal distribution. Descriptive statistics were shown with arithmetic mean and standard deviation. As a statistical comparison test, analysis of variance was applied in repeated measurements to see the main effects and the changes in the data with significant interaction over time. In order to reveal the change of the groups over time in the variables whose group time interaction was significant, the Bonfferroni test was applied and the group and time changes were compared. The significance level was taken as p &lt;0.05. In the comparisons between the experimental and control groups; According to the results of analysis of variance in repeated measurements of Dewitt-Dugan service test, no statistically significant difference was found in group main effect, time main effect and group time interaction (p&gt;0.05). According to the results of analysis of variance in repeated measurements in ITN service test measurements, no statistical difference was found in the group main effect (F=0.208, p=0.655, η2=0.015), while the time main effect (F=26.034, p&lt;0.001, η2=0.465) and group time interaction A significant difference was found (F=12.305, p=0.001, η2=0.291). As a result, it can be said that 8-week motor imagination training is effective in more complex motor skills such as the ITN s test, while there is no difference in the tests that do not include complex skills such as Dewitt-Dugan.

An ensemble neural network approach to forecast Dengue outbreak based on climatic condition

Dengue fever is a virulent disease spreading over 100 tropical and subtropical countries in Africa, the Americas, and Asia. This arboviral disease affects around 400 million people globally, severely distressing the healthcare systems. The unavailability of a specific drug and ready-to-use vaccine makes the situation worse. Hence, policymakers must rely on early warning systems to control intervention-related decisions. Forecasts routinely provide critical information for dangerous epidemic events. However, the available forecasting models (e.g., weather-driven mechanistic, statistical time series, and machine learning models) lack a clear understanding of different components to improve prediction accuracy and often provide unstable and unreliable forecasts. This study proposes an ensemble wavelet neural network with exogenous factor(s) (XEWNet) model that can produce reliable estimates for dengue outbreak prediction for three geographical regions, namely San Juan, Iquitos, and Ahmedabad. The proposed XEWNet model is flexible and can easily incorporate exogenous climate variable(s) confirmed by statistical causality tests in its scalable framework. The proposed model is an integrated approach that uses wavelet transformation into an ensemble neural network framework that helps in generating more reliable long-term forecasts. The proposed XEWNet allows complex non-linear relationships between the dengue incidence cases and rainfall; however, mathematically interpretable, fast in execution, and easily comprehensible. The proposal’s competitiveness is measured using computational experiments based on various statistical metrics and several statistical comparison tests. In comparison with statistical, machine learning, and deep learning methods, our proposed XEWNet performs better in 75% of the cases for short-term and long-term forecasting of dengue incidence.

Clinical Performance of I-gel versus Ambu AuraGain in Paediatric Patients undergoing General Anaesthesia: A Randomised Clinical Study

Introduction: Newer second-generation Supraglottic Airway Devices (SADs) are easy to insert and provide a smooth induction of anaesthesia with minimal haemodynamic pressor response. The paediatric I-gel and Ambu AuraGain are newer SADs that are increasingly being used as alternatives to endotracheal intubation in the paediatric population. Aim: To compare the clinical performance of I-gel and Ambu AuraGain in children undergoing general anaesthesia with respect to ease of insertion, haemodynamic changes, and the frequency and severity of postoperative sore throat. Materials and Methods: This randomised clinical study included 100 children aged 2 to 10 years, belonging to American Society of Anaesthesiologists (ASA) Grade I and II, scheduled for elective surgery under general anaesthesia. They were randomly allocated to Group I (I-gel) and Group A (Ambu AuraGain), comprising 50 patients each. The time taken for SAD placement, the number of attempts, ease of insertion, and the requirement of additional airway manipulations during insertion were observed. Haemodynamic Parameters Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), SpO2 , and End-tidal Carbon Dioxide [ (EtCO2 ) ]) during the procedure were observed. The frequency and severity of postoperative sore throat were assessed between both groups. Descriptive statistics were applied to all data and reported in terms of mean, Standard Deviation (SD), and percentages, and appropriate statistical tests of comparison were applied. Results: In this study, the demographic data of patients, such as age, weight, gender, and ASA status, were comparable in both groups. There was no statistically significant difference in the time taken for successful SAD placement and the number of attempts required to do the same. Ambu AuraGain was easier to insert than I-gel (p-value&lt;0.05). I-gel required a significantly higher number of additional airway manipulations during insertion compared to Ambu AuraGain (20% in Group I versus 4% in Group A). Haemodynamic parameters were comparable between both groups at all time intervals. The frequency and severity of postoperative sore throat were statistically non significant between I-gel and Ambu AuraGain. Conclusion: Both the I-gel and Ambu AuraGain are reliable and safe devices for maintaining an adequate airway in paediatric patients. However, Ambu AuraGain was easier to insert and required fewer airway manipulations than I-gel during insertion, making it a favourable choice.

Programa “Problemas Reales” y actitud hacia la matemática en estudiantes de educación secundaria

The research was carried out with the objective of demonstrating that the application of the “real problems” program improves the attitude towards mathematics in first-grade secondary school students at the “Miguel Grau Seminario” school in Salaverry in 2019. It was decided to work on a quasi-experimental design with pre and post test (attitude towards mathematics scale) to a sample of 46 students distributed in 2 groups: control and experimental, with the latter the “real problems” program was executed for two months. Then the data obtained in the tests were processed through the student's T statistical test for comparison of means; for both groups; and difference of means for related samples in the experimental group; in the later, the results reflected that the value of the T statistic at the 0.05 level of significance had a p-value of p &lt; 0.05, with which demonstrated that the “real problems” program significantly improved the attitude towards mathematics in 1st grade secondary school students.

Weighted p-norm distance t kernel SVM classification algorithm based on improved polarization

The kernel function in SVM enables linear segmentation in a feature space for a large number of linear inseparable data. The kernel function that is selected directly affects the classification performance of SVM. To improve the applicability and classification prediction effect of SVM in different areas, in this paper, we propose a weighted p-norm distance t kernel SVM classification algorithm based on improved polarization. A t-class kernel function is constructed according to the t distribution probability density function, and its theoretical proof is presented. To find a suitable mapping space, the t-class kernel function is extended to the p-norm distance kernel. The training samples are obtained by stratified sampling, and the affinity matrix is redefined. The improved local kernel polarization is established to obtain the optimal kernel weights and kernel parameters so that different kernel functions are weighted combinations. The cumulative optimal performance rate is constructed to evaluate the overall classification performance of different kernel SVM algorithms, and the significant effects of different p-norms on the classification performance of SVM are verified by 10 times fivefold cross-validation statistical comparison tests. In most cases, the results using 6 real datasets show that compared with the traditional kernel function, the proposed weighted p-norm distance t kernel can improve the classification prediction performance of SVM.

Intestinal ultrasonography and fecal calprotectin for monitoring inflammation of ileal Crohn's disease: two complementary tests.

Background/AimsTight control of inflammation and adjustment of treatment if activity persists is the current strategy for the management of Crohn’s disease (CD). The usefulness of fecal calprotectin (FC) in isolated involvement of the small intestine in CD is controversial. To assess the usefulness of FC to determine the inflammatory activity detected by intestinal ultrasonography (IUS) in ileal CD. MethodsPatients with exclusively ileal involvement CD who underwent IUS and an FC were prospectively included. Simple ultrasound index was used to determine inflammatory activity. The usual statistical tests for comparison of diagnostic techniques were used. ResultsOne hundred and five patients were included, IUS showed inflammatory activity in 59% of patients and complications in 18.1%. FC showed a significant correlation with IUS in the weak range (Spearman coefficient r=0.502; P<0.001); the area under the receiver operating characteristic curve was 0.79 (95% confidence interval, 0.70–0.88; P<0.001). The FC value that best reflected the activity in IUS was 100 μg/g with sensitivity, specificity, and positive and negative predictive values of 73.0%, 71.4%, 79.3% and 63.8%, respectively. There were no differences in FC concentration between patients with or without transmural complications. The addition of serum C-reactive protein to FC did not improve the ability to assess IUS activity.ConclusionsFC has a significant correlation with IUS to monitor ileal CD activity. This correlation is weak and it does not allow assessing the presence of CD complications. Both tests should be used in conjunction for tight control of ileal CD. More studies on noninvasive tests in this location are needed.

Wellbeing index avoiding scaling and weights

Objective: Existing well-being measures differ in terms of number and format of items, factors being measured, aggregation methods, and are not comparable. A well-being measure involves combining n- number of indicators and quality of the measure depends on properties of combining procedures adopted. The paper proposes two assumption-free aggregation methods to satisfy the desired properties of an index Methods: The paper proposes two indices of well-being in terms of cosine similarity and Geometric mean (GM) avoiding problems associated with scaling of raw data and choosing of weights. Empirical illustration is provided on application of the proposed measures. Results: The proposed indices give better admissibility of operations and satisfy properties like time-reversal test, formation of chain indices, computation of group mean and statistical tests for comparison across time and space. The preferred index can be constructed even for skewed longitudinal data and helps to reflect path of improvement registered by a country/region over time. Conclusions: The index based on GM is preferred due to wider application areas. The index can further be used for classification of countries, sub-groups and even individuals with morbidity in terms of overall wellbeing values. Future studies suggested.

AB0061 ALTERATIONS OF XANTHINE OXIDOREDUCTASE ACTIVITY IN RED BLOOD CELLS AFTER GLUCOCORTICOID TREATMENT IN RHEUMATOID ARTHRITIS

Background:According to modern concepts, rheumatoid arthritis (RA) refers to severe autoimmune rheumatic diseases. The activation of free radical oxidation processes is essential in the development of this disease [1]. Xanthine oxidoreductase is a significant reactive oxygen species source [2]. Despite the great advances in the treatment of rheumatoid arthritis (RA) associated with the introduction of innovative drugs and especially the improvement of the strategy for their use into clinical practice, glucocorticoids still remain an important component of RA pharmacotherapy in actual clinical practice.Objectives:to evaluate the changes in activities of xanthine oxidoreductase interconvertible forms (xanthine oxidase, ЕС 1.17.3.2 and xanthine dehydrogenase, ЕС 1.17.1.4) in lysed red blood cells of RA patients in relation with glucocorticoid treatment.Methods:47 RA patients with verified RA and 30 healthy controls were enrolled in the study. The diagnosis was verified using the 2010 ACR/EULAR criteria 2010. All patients have moderate DAS28 scores. RA patients were randomized into 2 groups comparable in gender, age and the principal clinical manifestations. Methylprednisolone (Metipred, Orion Corp.), average dose 30 mg/day, and betamethasone (Diprospan, Schering-Plough), single dose7 mg, were administered intramuscularly in the respective groups. Хanthine oxidase (XO) and xanthine dehydrogenase (XDG) activities were measured in lysed red blood cells by spectrophotometric method as previously described [3]. The changes of these enzymes activities were studied in RA patients before and after the injection of glucocorticoids. Statistical comparison tests were selected in according to common guidelines, differences were considered significant when p&lt;0.05. Central tendencies were expressed as means±SEM.Results:Mean age of patients in methylprednisolone group was 41.8±1.05 years, and mean RA duration (± SEM) was 7.9±0.21 years. Mean age of patients in diprospan group was 40.9±1.07 years, and mean RA duration was 8.0±0.33 years. Significant decreases of XO activity and increase of XDG activity were observed in lysed red blood cells of RA patients just after the injection of each glucocorticoid drug. Changes of the enzymatic activities in lysed red blood cells were more pronounced in methylprednisolone group. However enzymatic activity did not reach the level of healthy controls. As described previously, decreased XO activity and increased XDG activity were observed in plasma of RA patients just after the injection of the average therapeutic doses of glucocorticoids, as well as in lysed lymphocytes just after the injection of methylprednisolone [4].Conclusion:Treatment with methylprednisolone and betamethasone can affect the balance of XO/XDG activity and increase the antioxidant potential of the blood. This effect can exert beneficial influence on autoimmune inflammation in RA.

Empirical power comparison of statistical tests in contemporary phase III randomized controlled trials with time-to-event outcomes in oncology

More than 95% of recent cancer randomized controlled trials used the log-rank test to detect a treatment difference making it the predominant tool for comparing two survival functions. As with other tests, the log-rank test has both advantages and disadvantages. One advantage is that it offers the highest power against proportional hazards differences, which may be a major reason why alternative methods have rarely been employed in practice. The performance of statistical tests has traditionally been investigated both theoretically and numerically for several patterns of difference between two survival functions. However, to the best of our knowledge, there has been no attempt to compare the performance of various statistical tests using empirical data from past oncology randomized controlled trials. So, it is unknown whether the log-rank test offers a meaningful power advantage over alternative testing methods in contemporary cancer randomized controlled trials. Focusing on recently reported phase III cancer randomized controlled trials, we assessed whether the log-rank test gave meaningfully greater power when compared with five alternative testing methods: generalized Wilcoxon, test based on maximum of test statistics from multiple weighted log-rank tests, difference in t-year event rate, and difference in restricted mean survival time with fixed and adaptive . Using manuscripts from cancer randomized controlled trials recently published in high-tier clinical journals, we reconstructed patient-level data for overall survival (69 trials) and progression-free survival (54 trials). For each trial endpoint, we estimated the empirical power of each test. Empirical power was measured as the proportion of trials for which a test would have identified a significant result (p value < .05). For overall survival, t-year event rate offered the lowest (30.4%) empirical power and restricted mean survival time with fixed offered the highest (43.5%). The empirical power of the other types of tests was almost identical (36.2%-37.7%). For progression-free survival, the tests we investigated offered numerically equivalent empirical power (55.6%-61.1%). No single test consistently outperformed any other test. The empirical power assessment with the past cancer randomized controlled trials provided new insights on the performance of statistical tests. Although the log-rank test has been used in almost all trials, our study suggests that the log-rank test is not the only option from an empirical power perspective. Near universal use of the log-rank test is not supported by a meaningful difference in empirical power. Clinical trial investigators could consider alternative methods, beyond the log-rank test, for their primary analysis when designing a cancer randomized controlled trial. Factors other than power (e.g. interpretability of the estimated treatment effect) should garner greater consideration when selecting statistical tests for cancer randomized controlled trials.

Perceptions locales des services écosystémiques des aires protégées à l’Est du Burkina Faso

Background: Ecosystems provide countless services to humans. However, the source of ecosystem services is poorly understood, leading to serious conservation problems. This study aims to assess local perceptions of ecosystem services and their source of supply.Methods: It was carried out in three protected areas and their surrounding areas in eastern Burkina Faso. Semi-structured individual interviews were conducted with nearly 148 people to identify the benefits they derive from protected areas (PA) and local strategies for their sustainability. The benefits have been classified between the four categories of ecosystem services (provisioning, regulation, cultural and support) and another category called “other services”. Citation percentages were calculated and a statistical comparison test was performed. A Principal Component Analysis was also conducted to distribute the different benefits by PA.Results: The local populations listed eight protected areas offering 39 types of benefits, distributed among the different categories. The procurement services category and the "other services" category provide the maximum number of services. The benefits offered vary from one area to another. The W national park offers the most benefits (64.10%). The conservation status of each protected area influences the provision of services. Thus, most of the services classified by the Millennium Ecosystem Assessment are provided by parks while those in the “other services” category are provided by hunting areas. People recognize ecosystem services with their sources of supply and have proposed 25 solutions to ensure their sustainability.Conclusion: Local people have provided important data that can help in the development of reliable management plans taking into account their cultural knowledge and aspirations.Keywords: Conservation, Local populations, Sustainable management of natural resources, Ecosystem services, Local strategies

Investigation of the Environmental and Socio-Economic Characteristics of Counties with a High Asthma Burden to Focus Asthma Action in Utah

Rising adult asthma prevalence (AAP) rates and asthma emergency room (AER) visits constitute a large burden on public health in Utah (UT), a high-altitude state in the Great Basin Desert, USA. This warrants an investigation of the characteristics of the counties with the highest asthma burden within UT to improve allocation of health resources and for planning. The relations between several predictor environmental, health behavior and socio-economic variables and two health outcome variables, AAP and AER visits, were investigated for UT’s 29 counties. Non-parametric statistical comparison tests, correlation and linear regression analysis were used to determine the factors significantly associated with AER visits and AAP. Regression kriging with Utah small area data (USAD) as well as socio-economic and pollution data enabled local Moran’s I cluster analysis and the investigation of moving correlations between health outcomes and risk factors. Results showed the importance of desert/mining dust and socio-economic status as AAP and AER visits were greatest in the south of the state, highlighting a marked north–south divide in terms of these factors within the state. USAD investigations also showed marked differences in pollution and socio-economic status associated with AAP within the most populous northern counties. Policies and interventions need to address socio-economic inequalities within counties and between the north and south of the state. Fine (PM2.5) and coarse (PM10) particulate matter monitors should be installed in towns in central and southern UT to monitor air quality as these are sparse, but in the summer, air quality can be worse here. Further research into spatiotemporal variation in air quality within UT is needed to inform public health interventions such as expanding clean fuel programs and targeted land-use policies. Efforts are also needed to examine barriers to routine asthma care.

Characterization of New Optical Imaging Biomarkers of Peripheral Nerve Overstimulation

An animal study was designed to explore the potentially damaging effects of electrical overstimulation on peripheral nerves using a polarization‐sensitive optical coherence tomography (PS‐OCT) imaging and stimulation platform. Lewis rats (n = 15) were divided into 3 groups with 2 different levels of stimulation applied to the exposed sciatic nerve: Group 1 (sham control): 0.0 mA/0 Hz, Group 2: 3.4 mA/50 Hz, and Group 3: 6.8 mA/100 Hz. On day 1, the protocol contains Von Frey and walking track behavioral tests, followed by sciatic nerve exposure surgery (left leg). Electrical stimulation of the nerve was performed for one hour, with a one‐hour recovery period. PS‐OCT and optical coherence tomography angiography (OCT‐A) imaging were performed both prior to and during these periods. On day 7, this protocol was repeated without stimulation. OCT imaging was performed along a 5‐mm length of the sciatic nerve, including sites proximal and distal to injury. Both the stimulated and contralateral sciatic nerves were then resected and processed for histology.Image analysis quantified the effects of electrical stimulation at the two time points and allows comparison between stimulation levels. In all cohort groups, PS‐OCT image features remained consistent on day 1. On day 7, we observed relatively few PS‐OCT or OCT‐A changes compared to day 1 in the sham control animals. Groups 2 and 3 showed a clear increase in OCT‐A perfusion in the stimulated region, while there is a drop in PS‐OCT signal in the same area. The PS‐OCT signal drop‐out appears more pronounced in Group 2 compared to Group 3. It is not yet clear if the PS‐OCT signal drop‐out is related to demyelination or from shadowing from hyperperfused tissue. Walking track video was analyzed frame‐by‐frame for animal foot spread to determine sciatic and tibial function indices. This data, along with Von Frey withdrawal forces, were analyzed with statistical comparison tests (ANOVA) and indicated no significant differences between the groups nor significant interactions when compared across stimulation group, pre‐ and post‐exposure, and ipsilateral‐contralateral leg. Histological samples were processed for histomorphometry and axonal damage proximal and distal to the injury, as well as for immunohistochemistry of axons, macrophages, and nuclei in the stimulated and unstimulated regions in all groups.PS‐OCT and OCT‐A proffer real‐time observation of nerve changes with overstimulation that are undetectable by behavioral testing.Support or Funding InformationNIH SPARC

PD37-09 PREVALENCE OF COGNITIVE IMPAIRMENT AND SPHINCTER MISUSE AMONG MEN WITH ARTIFICIAL URINARY SPHINCTERS

INTRODUCTION AND OBJECTIVE: As the population ages, a growing number of patients will suffer progressive cognitive decline, both normal and pathological. The association between cognitive impairment and loss of independence in activities of daily living is well documented and relates to both memory loss and functional decline in abilities like manual dexterity. These deficits can be particularly problematic for patients with artificial urinary sphincters (AUS). We aimed to define the prevalence of cognitive impairment and sphincter misuse among our institutional cohort of AUS patients. METHODS: Men who had undergone primary AUS placement or revision surgery at our institution from 2004-2019 were invited to participate in telephone surveys. Patients answered questions regarding current urinary symptoms, quality of life, medical history, AUS use, and urologic follow-up. Validated telephone mini-mental status exams (T-MMSE) were completed to assess cognitive function. Patients were categorized by degree of cognitive impairment and analyzed using appropriate statistical comparison tests. RESULTS: A total of 142 unique patients were identified; 74 participated in the study (61% response rate, excluding 20 deceased patients). Median age and follow-up since AUS implantation were 76 [69, 81] and 7 [4, 11] years, respectively. Some degree of cognitive impairment was seen in 18 (24%) patients: 13 (18%) mild, 2 (3%) moderate, and 3 (4%) severe. Table 1 compares patient characteristics, revision and continence rates, and sphincter usage patterns in those with normal versus impaired cognition. Twenty-three (31%) patients reported they did not cycle their device with every void, and 11 (15%) reported they were no longer using their AUS. Notably, 50% of patients with impaired cognition were not cycling their device with every void compared to 25% among those with normal cognition. Over half of all patients with impaired cognition had not seen a urologist in the last year. CONCLUSIONS: Our study revealed significant rates of cognitive impairment and sphincter misuse among men with artificial urinary sphincters. These data suggest there may be a role for monitoring cognitive function and long-term follow-up in these patients. Further prospective study of cognitive decline and related outcomes in AUS patients is warranted.Source of Funding: No source of funding

MULTIVARIATE ANALYSIS OF DIGITAL IMAGES AS AN ALTERNATIVE TO MONITOR DYE DEGRADATION BY THE FENTON PROCESS

The present work proposed the application of a multivariate regression model based on image data to monitor the decolorization process. Thus, a PLS regression based on the color histogram was applied to monitor the methylene blue degradation by the Fenton reaction. The results obtained by the digital imaging and UV-Vis methods were compared and the initial (Co) and final (C) methylene blue concentrations, as well as the kinetic parameters, coefficients of determination (R2), half time degradation (t½), intercept (ρ), and slope (σ), were evaluated. From our results, the digital imaging and UV-Vis methods have equivalent potential to monitor the color removal profile, similar kinetic term, and low measurement errors. While the coefficient of determination (R(2)) of all PLS models and kinetics curves are close to 1.00, the half time degradation (t½) parameter ranged between 0.29 to 1.39 min for the UV-Vis model, and 0.80 min to 2.17 min for the digital imaging model. Furthermore, the efficiency of methylene blue removal ranged between 92.04% and 97.78% for the UV-Vis model and 91.30% to 93.72% for the digital imaging model. Then, based on statistical comparison tests, it was concluded that the digital imaging method is an alternative to monitor dye degradation processes.