Thematische Bibliographien / Bioavailability – Research – Statistical methods

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Auswahl der wissenschaftlichen Literatur zum Thema „Bioavailability – Research – Statistical methods“

Autor: Grafiati

Veröffentlicht am 30. Juni 2021

Zuletzt aktualisiert am 6. Februar 2022

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Zeitschriftenartikel zum Thema "Bioavailability – Research – Statistical methods"

Kruijtzer, C. M. F., J. H. Beijnen, H. Rosing, W. W. ten Bokkel Huinink, M. Schot, R. C. Jewell, E. M. Paul und J. H. M. Schellens. „Increased Oral Bioavailability of Topotecan in Combination With the Breast Cancer Resistance Protein and P-Glycoprotein Inhibitor GF120918“. Journal of Clinical Oncology 20, Nr. 13 (01.07.2002): 2943–50. http://dx.doi.org/10.1200/jco.2002.12.116.

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PURPOSE: We discovered that breast cancer resistance protein (BCRP), a recently identified adenosine triphosphate–binding cassette drug transporter, substantially limits the oral bioavailability of topotecan in mdr1a/1b(−/−) P-glycoprotein (P-gp) knockout and wild-type mice. GF120918 is a potent inhibitor of BCRP and P-gp. The aim was to increase the bioavailability of topotecan by GF120918. PATIENTS AND METHODS: In cohort A, eight patients received 1.0 mg/m2 oral topotecan with or without coadministration of one single oral dose of 1,000 mg GF120918 (day 1 or day 8). In cohort B, eight other patients received 1.0 mg/m2 intravenous topotecan with or without 1,000 mg oral GF120918 to study the effect of GF120918 on the systemic clearance of topotecan. RESULTS: After oral topotecan, the mean area under the plasma concentration-time curve (AUC) of total topotecan increased significantly from 32.4 ± 9.6 μg·h/L without GF120918 to 78.7 ± 20.6 μg·h/L when GF120918 was coadministered (P = .008). The mean maximum plasma concentration of total topotecan increased from 4.1 ± 1.5 μg/L without GF120918 to 11.5 ± 2.4 μg/L with GF120918 (P = .008). The apparent bioavailability in this cohort increased significantly from 40.0% (range, 32% to 47%) to 97.1% (range, 91% to 120%) (P = .008). Interpatient variability of the apparent bioavailability was 17% without and 11% with GF120918. After intravenous administration of topotecan, coadministration of oral GF120918 had a small but statistically significant effect on the AUC and systemic clearance of total topotecan but no statistically significant effect on maximum plasma concentration and terminal half-life of total topotecan. CONCLUSION: Coadministration of the BCRP and P-gp inhibitor GF120918 resulted in a significant increase of the systemic exposure of oral topotecan. The apparent oral bioavailability increased from 40.0% without to 97.1% with GF120918.

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van Leeuwen, Roelof W. F., Robert Peric, Koen G. A. M. Hussaarts, Emma Kienhuis, Nikki S. IJzerman, Peter de Bruijn, Cor van der Leest et al. „Influence of the Acidic Beverage Cola on the Absorption of Erlotinib in Patients With Non–Small-Cell Lung Cancer“. Journal of Clinical Oncology 34, Nr. 12 (20.04.2016): 1309–14. http://dx.doi.org/10.1200/jco.2015.65.2560.

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Purpose Erlotinib depends on stomach pH for its bioavailability. When erlotinib is taken concurrently with a proton pump inhibitor (PPI), stomach pH increases, which results in a clinically relevant decrease of erlotinib bioavailability. We hypothesized that this drug-drug interaction is reversed by taking erlotinib with the acidic beverage cola. The effects of cola on erlotinib bioavailability in patients not treated with a PPI were also studied. Patients and Methods In this randomized, cross-over, pharmacokinetic study in patients with non–small-cell lung cancer, we studied intrapatient differences in absorption (area under the plasma concentration time curve [AUC0-12h]) after a 7-day period of concomitant treatment with erlotinib, with or without esomeprazole, with either cola or water. At the 7th and 14th day, patients were hospitalized for 1 day for pharmacokinetic sampling. Results Twenty-eight evaluable patients were included in the analysis. In patients treated with erlotinib and esomeprazole with cola, the mean AUC0-12h increased 39% (range, −12% to 136%; P = .004), whereas in patients not treated with the PPI, the mean AUC0-12h was only slightly higher (9%; range, −10% to +30%; P = .03) after erlotinib intake with cola. Conclusion Cola intake led to a clinically relevant and statistically significant increase in the bioavailability of erlotinib during esomeprazole treatment. In patients not treated with the PPI, the effects of cola were marginal. These findings can be used to optimize the management of drug-drug interactions between PPIs and erlotinib.

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Selvaraj, Brito R., Seshaiah K. Sridhar, Bhaskar R. Kesavan und Sucharitha Palagati. „Application of Statistical Tooling Techniques for Designing of Carvedilol Nanolipid Transferosomes and its Dermatopharmacokinetic and Pharmacodynamic Studies“. Pharmaceutical Nanotechnology 8, Nr. 6 (28.12.2020): 452–70. http://dx.doi.org/10.2174/2211738508666200928164820.

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Background: The hypothesis is to augment the bioavailability and therapeutic potential of low bioavailable Carvedilol (25-35%) through Nanostructured Lipid Carrier (NLC) loaded Transdermal patch (Nanolipid Transferosomes). Methods: Box-Behnken design was designed to formulate NLC through a hot homogenization technique. About 17 formulations (C1-C17) were formulated by varying the critical material attribute and critical process parameter. Optimization was done based on its critical quality attributes like particle size, zeta potential and entrapment efficiency. Selected NLC (C16) has been fabricated into a transdermal patch through solvent evaporation technique and estimated for thickness, weight variation, moisture content, folding endurance, drug content, in vitro drug release, ex vivo skin permeation studies 48 hrs, in vitro drug release kinetic studies and skin irritation studies. In vivo pharmacokinetics and pharmacodynamic study parameters were compared between carvedilol loaded NLC transdermal patch and a conventional formulation (Coreg CR). Results: NLC (C16) was selected as the best formulation based on desirable, less particle size (201.1 ± 2.02 nm), more zeta potential (-37.2 ± 1.84mV) and maximum entrapment efficiency (87.54 ± 1.84%). Experimental investigations of in vivo dermatopharmacokinetic data shown statistically significant changes (p<0.05) in the parameter (increased AUC0-α, MRT with decreased Cmax, Tmax) when administered through the transdermal patch and on compared to the conventional dosage form. It was observed that there was a significant change with p<0.05 among the pharmacokinetic factors of conventional Carvedilol formulation, Carvedilol NLC and Carvedilol NLC loaded Transdermal patch with a maximum time of peak plasma concentration (Tmax) of 4 hrs, 8 hrs and 8 hrs; maximum peak plasma concentration (Cmax) of 0.258 μg/ml, 0.208 μg/ml and 0.108 μg/ml. Area Under Curve (AUC0-α) was established to be 125.127 μg/ml/h, 132.576 μg/ml.h and 841.032 μg/ml.h. Mean Residence Time (MRT0- α) of the drug was established to be 17 hrs, 19 hrs and 82 hrs, respectively. This data reveals the impact of NLC on the enhancement of bioavailability through a transdermal patch. In vivo pharmacodynamic studies confirm that NLC loaded transdermal patch (Nanolipid Transferosomes) shows a significant control in blood pressure for 48 hrs when compared to the conventional dosage form. Conclusion: This research data concludes that NLC loaded transdermal patch (Nanolipid Transferosomes) was a suitable candidate to enhance the bioavailability of low bioavailable drug-like Carvedilol. Lay Summary: It was inferred from the literature that NLC filled transdermal patches were a novel strategy to increase the solubility and permeability of Carvedilol, which has less bioavailability. It reveals that there was no reproducible preparation for the NLC. It also reveals that the option of formulation and process parameters for the formation of NLC is not clearly justified. On account of this, an uniquely validated and optimized formulation technique was developed for NLC with low soluble and poorly bioavailable carvedilol, tested in Albino wistar rats for enhancement of bioavailability, the same study has been performed and proved.

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Urminská, Jana, Tomáš Tóth, Renáta Benda Prokeinová und Peter Ondrišík. „The effect of the selected remediation medium on the cadmium bioavailability in the selected ecosystem in the Southwestern locality of Slovakia“. Ekológia (Bratislava) 38, Nr. 3 (01.09.2019): 214–24. http://dx.doi.org/10.2478/eko-2019-0017.

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AbstractSoil is a sensitive ecological factor. Biodegradable materials from the environment can also be used to deal with serious ecological problems. Soil affecting by remediation medium - garden compost - was analysed for toxic cadmium (Cd) in terms of environmental protection. The objective of this research was to analyse soil and compost at foothill locality of the Tribeč Mountains (Southwestern Slovakia) in the years 2015−2017 to determine Cd contents in soil and compost, pH and to assess Cd bioavailability. The analyses were carried out using the Atomic Absorption Spectrometry with seven-step Selective Sequential Extraction methods. The results obtained were evaluated statistically using the SAS 9.4 software method by Spearman’s correlation coefficient. The results showed that Cd contents in soil had reached 2.96 mg kg−1 and soil with compost (the ratio 1:1) 2.71 mg kg−1 dry matter. Cd contents in the soil exceeded maximum allowed limit of 196%. And deceased by 25% after adding compost. The pH in soil with compost varied from 6.78 to 7.98. The pH prevented the mobility of Cd about 8.3% in average. Statistical dependence was high, which was demonstrated for relationship between Cd in soil, pH and compost. Available Cd forms in soil were 53.3% and soil with compost were 45% in average. The garden compost as a remediation medium reduced Cd bioavailability.

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Zhang, Xuhuiqun, Amandeep Sandhu, Jiayi Fan, Di Xiao, Indika Edirisinghe und Britt Burton-Freeman. „Metabolic Status and Gender Affect the Absorption and Metabolism of Red Raspberry (Poly)phenols“. Current Developments in Nutrition 5, Supplement_2 (Juni 2021): 385. http://dx.doi.org/10.1093/cdn/nzab037_095.

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Abstract Objectives Red raspberries are rich in bioactive (poly)phenols, particularly anthocyanins and ellagitannins. A substantial amount of variability is observed in the bioavailability and metabolism of (poly)phenols in humans. This study aimed to investigate the potential factors, i.e., metabolic status, body mass index (BMI), age, gender and race, on (poly)phenol metabolism in individuals with different health statuses. Methods After 3-day wash-in and overnight fasting, subjects (n = 65, male: female 32:33, age 34 ± 1 years, BMI 27 ± 1 kg/m2, mean ± SEM) consumed 250 g red raspberries (2 cups equivalence). Plasma samples collected over 24 h were quantified for (poly)phenolic metabolites using an ultra-high performance liquid chromatography coupled with triple quadrupole (UHPLC-QQQ). Statistical analysis was performed using PC-SAS. Results Individuals with prediabetes and insulin-resistance (n = 45) had significantly higher bioavailability of cyanidin sophoroside (0.21 ± 0.02% vs. 0.14 ± 0.03%, P = 0.04) and cyanidin 3-O-glucoside (0.12 ± 0.01% vs. 0.09 ± 0.01%, P = 0.02), and lower area under the 24 h curve (AUC0–24h) of hippuric acid glucuronide (435 ± 123 nmol/L × h vs. 1011 ± 184 nmol/L × h, P = 0.01) compared to healthy individuals (n = 20). Females (n = 33) had significantly lower bioavailability of cyanidin 3-O-glucoside (0.09 ± 0.01% vs. 0.13 ± 0.01%, P = 0.04) compared to males (n = 32). Correlation analysis on all subjects (n = 65) identified that bioavailability of cyanidin sophoroside and cyanidin 3-O-glucoside negatively correlated with fasting plasma triglyceride and positively correlated with HOMA-IR, HOMA-β, and fasting insulin concentration (P < 0.05). The AUC0–24h of hippuric acid glucuronide negatively correlated with fasting plasma glucose and triglyceride concentrations. Conclusions Individuals with different metabolic status and gender have different capacity to absorb and metabolize red raspberry (poly)phenols. The data provide insight for personalized nutrition for optimal health benefits and suggest further research on possible mechanisms involved. Funding Sources This project was funded by the National Processed Raspberry Council and various donor funds to the Center for Nutrition Research, Illinois Institute of Technology.

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Hussaini, Azra, Anthony J. Olszanski, Cy Aaron Stein, Bill Bosch und Paul Nemeth. „Relative bioavailability (BA) and bioequivalence (BE) study of abiraterone acetate (AA) fine particle (AAFP) with methylprednisolone (MP) and a reference formulation with prednisone (PN) in healthy male subjects.“ Journal of Clinical Oncology 35, Nr. 15_suppl (20.05.2017): e16538-e16538. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e16538.

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e16538 Background: AA is approved for treatment of metastatic castration-resistant prostate cancer when taken in combination with PN. The originator AA (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic (PK) variability. AAFP is a proprietary formulation (utilizing SoluMatrix Fine-Particle Technology™) that was designed to provide improved BA. In a prior study in healthy subjects, AAFP 500 mg was established as bioequivalent to OAA 1000 mg when given in the fasted state. In this study, AAFP was evaluated in subjects in a fasted state with steady state (SS) MP, an alternative steroid to PN. Methods: Subjects aged 18–50 years were randomized in a crossover design to receive MP (4 mg BID) or PN (5 mg BID) for 12 days in Period 1. On Day 11 of Period 1, subjects given MP received a single dose of AAFP 500 mg (test) and subjects given PN received a single dose of OAA 1000 mg (reference). After a 2-week steroid washout period, subjects received the alternate treatments in Period 2. Results: There were no statistical differences with regard to abiraterone AUC ( P≥0.38) and Cmax ( P= 0.22) between AAFP 500 mg and OAA 1000 mg (Table). Geometric mean ratio (GMR), a measure of BE, was 95.9% (90% CI: 86.0–106.9%) for AUC0-∞, 99.2% (90% CI: 88.7–110.9%) for AUC0-t, and 116.8% (90% CI: 102.2–133.4%) for Cmax. GMR of AUC0-∞ and AUC0-t, fell within the 80–125% range for BE, and Cmax 90% CI was just outside the upper limit. The coefficient of variance (CV) for both AUC and Cmaxwas smaller for AAFP compared with OAA. Both treatments were safe and well tolerated. Conclusions: AAFP 500 mg with MP gave comparable exposure to OAA 1000 mg with PN with respect to Cmaxand AUC. Less drug exposure variability was observed with AAFP compared with OAA. Reduced PK variability could improve clinical outcomes and warrants further study. [Table: see text]

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Morris, Claudia R., Frans Kuypers, Robert W. Hagar, Michael Ansari, Sandra K. Larkin, Lisa Lavrisha, Meghan Wardlaw, Alicia Zhou, Elliott Vichinsky und Jung H. Suh. „Metabolic Fate of Oral Glutamine Supplementation within Plasma and Erythrocytes of Patients with Sickle Cell Disease: Preliminary Pharmacokinetics Results“. Blood 116, Nr. 21 (19.11.2010): 1636. http://dx.doi.org/10.1182/blood.v116.21.1636.1636.

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Abstract Abstract 1636 Introduction: The erythrocyte redox environment may contribute to increased hemolysis and decreased nitric oxide (NO) bioavailability in pulmonary hypertension (PH) of sickle cell disease (SCD). Glutathione (GSH) is the principal thiol redox buffer in erythrocytes and its depletion has been linked to hemolysis. Glutamine plays an additional anti-oxidant role through preservation of the intracellular nicotinamide adenine dinucleotide (NAD) levels, required for reducing GSSG back to GSH. Altered GSH and glutamine metabolism will promote hemolysis and contribute to altered redox homeostasis. Glutamine depletion and low levels of the obligate NO substrate L-arginine are associated with pulmonary hypertension (PH) in SCD. Low arginine bioavailability is also associated with increased mortality risk. Pilot data of L-glutamine therapy has been associated with improved vasculopathy and increased NAD redox potential in SCD. Targeting these deficiencies in SCD has generated interest, however, little information on the pharmacokinetics (pK) is currently available. Methods: We performed pK studies to determine the metabolic fate of glutamine supplementation on plasma and erythrocyte amino acids in patients with SCD. Patients fasting for > 8 hours received 10 grams of L-glutamine powder mixed with Gatorade. Blood was analyzed at baseline, 30, 60, 90, 2hr, 3hr, 4hr and 8hrs after ingesting study drug. A standardized diet was administered to all participants at 3 established time-points (after 2hr, 5hr and 7 hrs). A subset of patients also had pK studies performed without study drug to follow normal diurnal fluctuations in amino acids. Results: We report data on 5 patients with SCD, three of whom performed pK studies both with and without glutamine supplementation. Average age was 50.6 ±5.6 years, 60% were female, 40% SS, 60% SC, and 4 had PH (mean TRV=3.4±0.8m/s, range 3.0–4.6m/s) while one patient had a TRV=2.25 and no history of PH. Diurnal variations in many amino acids were observed. However plasma glutamine levels more than doubled after oral glutamine supplementation, compared to minimal fluctuations with diet. Plasma glutamine concentration peaked within 30 minutes of ingestion (p=0.01) before decreasing to a plateau by 2 hours that remained higher than baseline by 8 hours. Oral glutamine also increased plasma arginine concentration, which peaked by 4 hrs (p=0.03) and remained elevated through 8 hrs (FigB). Global arginine bioavailability (plasma arginine/(ornithine+ citrulline) also increased (0.67± 0.2 to 1.83±0.6, p=0.02). Erythrocyte glutamine levels began to increase by 8 hours, (Fig 1C), while erythrocyte arginine concentration peaked at 4 hours. Anecdotally, the greatest improvement in intracellular arginine bioavailability occurred in our patient with severe PH and a TRV=4.6 (Fig 1D). The erythrocyte glutamine/glutamate ratio peaked at 1–2 hrs, as did the erythrocyte glutathione concentration, although these trends did not reach statistical significance. Conclusions: Oral glutamine supplementation (10 gm) acutely improves glutamine and arginine bioavailability in both plasma and erythrocytes. The clinical implications of these observations remain to be determined, however this represents a promising novel therapy for hemoglobinopathies. Phase II studies of glutamine supplementation targeting PH patients with SCD or thalassemia are ongoing at Children's Hospital & Research Center Oakland. Disclosures: Off Label Use: L-glutamine - an amino acid that may improve arginine bioavailability. IND held by C. Morris.

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Dhillon, N., B. B. Aggarwal, R. A. Newman, R. A. Wolff, A. B. Kunnumakkara, J. L. Abbruzzese, D. S. Hong, L. H. Camacho, C. Ng und R. Kurzrock. „Curcumin and pancreatic cancer: Phase II clinical trial experience“. Journal of Clinical Oncology 25, Nr. 18_suppl (20.06.2007): 4599. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.4599.

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4599 Background: Pancreatic cancer is virtually always lethal, and the only FDA-approved therapies–gemcitabine and erlotinib–produce objective responses in less than 10% of patients. Curcumin (diferuloyl methane) is a plant-derived dietary ingredient that suppresses NF-κB and numerous other pathways relevant to pancreatic cancer and has potent preclinical anti-tumor activity. Herein, we evaluated the safety and potential antitumor activity of curcumin against advanced pancreatic cancer, and its impact on biologic correlates. Methods: Patients received 8 grams of curcumin by mouth daily for two months and were then restaged. Maintenance therapy was continued at the same dose and schedule until disease progression. Results: Twenty-five patients were enrolled as of the date of analysis, with 21 evaluable for response. Circulating curcumin was detectable, albeit at low steady-state levels (about 31 ng/ml), suggesting poor oral bioavailability. To date, two patients have had prolonged stable disease (8 and 12+ months). Interestingly, one patient had a brief, but marked tumor regression (73%) (accompanied by significant increases (4–35-fold) in serum cytokine (interleukin-6 (IL-6), IL-8, IL-10, and IL-1 receptor antagonist (IL-1RA) levels). No toxicities have been observed. Curcumin down-regulated expression of NF-κB, COX-2 and phosphorylated STAT3 in peripheral blood mononuclear cells (PBMC) from patients (most of whom had baseline levels considerably higher than those found in healthy volunteers)although the decrease did not reach statistical significance for p65. Curcumin was determined in patient plasma samples after enzymatic digestion with glucuronidase enzyme. While there was considerable variation in plasma curcumin levels from patient to patient, drug levels peaked at 22–41 ng/ml and remained relatively constant over the entire 4 week experimental period. Conclusions: We conclude that oral curcumin is well tolerated and, despite its limited absorption, has biologic activity in patients with pancreatic cancer. [Table: see text] No significant financial relationships to disclose.

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Lalani, Aly-Khan A., Rana R. McKay, Xun Lin, Ronit Simantov, Marina D. Kaymakcalan und Toni K. Choueiri. „Proton pump inhibitors (PPIs) and survival outcomes in patients with metastatic renal cell carcinoma (mRCC).“ Journal of Clinical Oncology 35, Nr. 6_suppl (20.02.2017): 493. http://dx.doi.org/10.1200/jco.2017.35.6_suppl.493.

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493 Background: PPIs are potent inhibitors of gastric acid secretion and can affect the bioavailability of orally administered cancer targeting therapies, such as vascular endothelial growth factor tyrosine-kinase inhibitors (VEGF-TKIs). Smaller preclinical and clinical studies have attempted to assess the interaction between VEGF-TKIs and PPIs in patients with advanced cancers; however, these studies are limited and larger analyses from rigorous datasets have been lacking. We investigate the impact of PPI use on survival in patients with mRCC treated with oral VEGF-TKIs. Methods: A pooled analysis of mRCC patients treated on phase II and III clinical trials was conducted. The primary outcome was to assess overall survival (OS) between PPI users, defined as patients receiving a PPI at baseline, compared to non-PPI users. Secondary outcomes included progression-free survival (PFS), objective response rates (ORR), and adverse events. Statistical analyses were performed using Cox regression adjusted for several risk factors and the Kaplan-Meier method. Results: Our cohort consisted of 2,188 patients treated with sunitinib (n = 952), axitinib (n = 626), or sorafenib (n = 610), of whom 120 were PPI users. Overall, PPI users demonstrated similar OS compared to non-PPI users (median 24.1 vs. 21.3 months, adjusted hazard ratio [aHR] 1.051, 95% confidence interval (CI) 0.769-1.438, p = 0.754). Similarly, PFS (5.5 vs. 8.0 months, aHR 1.016, 95% CI 0.793-1.301, p = 0.902) and ORR (23.3% versus 27.4%, p = 0.344) were not different between PPI users and non-users. These findings were consistent across International mRCC Database Consortium risk groups and by line of therapy. Adverse events were also similar between both groups. Conclusions: In this analysis, we demonstrate that PPI use does not appear to negatively impact the efficacy of VEGF-TKIs in mRCC patients treated in the targeted therapy era. Given the current landscape expanding to include more self-administered treatments, documentation of concomitant medications, and patient education on potential drug interactions are critical for optimizing the utilization of oral cancer targeting therapy.

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Nagler, Arnon, Vanderson Rocha, Myriam Labopin, Ali Unal, Tarek Ben Othman, Antonio Campos, Liisa Volin et al. „Allogeneic Hematopoietic Stem-Cell Transplantation for Acute Myeloid Leukemia in Remission: Comparison of Intravenous Busulfan Plus Cyclophosphamide (Cy) Versus Total-Body Irradiation Plus Cy As Conditioning Regimen—A Report From the Acute Leukemia Working Party of the European Group for Blood and Marrow Transplantation“. Journal of Clinical Oncology 31, Nr. 28 (01.10.2013): 3549–56. http://dx.doi.org/10.1200/jco.2013.48.8114.

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Purpose Cyclophosphamide (Cy) combined with total-body irradiation (TBI) or with busulfan (Bu) are currently the most common myeloablative regimens used in allogeneic stem-cell transplantation (alloSCT) in adults with acute myelogenous leukemia (AML). Intravenous (IV) Bu has more predictable bioavailability and a safer toxicity profile than the oral formulation. Comparative studies of outcomes have been performed between oral Bu/Cy and Cy/TBI, but there have been no comparative trials in the era of IV Bu. Patients and Methods We performed a retrospective registry-based study comparing outcomes of patients with AML in first or second remission after alloSCT from sibling donors who underwent IV Bu/Cy (n = 795) or Cy/TBI (n = 864) conditioning. Results Engraftment rate was 98% and 99% after IV Bu/Cy and Cy/TBI, respectively. Grade 2 to 4 acute graft-versus-host disease (GVHD) was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P < .001). Similarly, chronic GVHD was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P = .003). Cumulative incidence of 2-year nonrelapse mortality (NRM; ± standard deviation [SD]) was 12% ± 1% in the IV Bu/Cy group and 15% ± 2% in the Cy/TBI group (P = .14), and 2-year relapse incidence (RI; ± SD) was 26% ± 3% and 21% ± 1%, respectively (P = .012). Leukemia-free survival (LFS) rate (± SD) was 61% ± 2% after IV Bu/Cy and 64% ± 2% after Cy/TBI (P = .27). In multivariable analysis, adjusting for differences between both groups, patients who received IV Bu/Cy had lower acute and chronic GVHD, higher RI, and a trend toward lower NRM. LFS was not statistically different between the two conditioning regimens. Conclusion This retrospective study shows that final outcomes after myeloablative conditioning using IV Bu/Cy were not statistically different from those after Cy/TBI.

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Dissertationen zum Thema "Bioavailability – Research – Statistical methods"

Corrado, Charles J. „Nonparametric statistical methods in financial market research“. Diss., The University of Arizona, 1988. http://hdl.handle.net/10150/184608.

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This dissertation presents an exploration of the use of nonparametric statistical methods based on ranks for use in financial market research. Applications to event study methodology and the estimation of security systematic risk are analyzed using a simulation methodology with actual daily security return data. The results indicate that procedures based on ranks are more efficient than normal theory procedures currently in common use.

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Richaud, de Minzi María Cristina. „New statistical methods for research in personality assessment“. Pontificia Universidad Católica del Perú, 2013. http://repositorio.pucp.edu.pe/index/handle/123456789/99784.

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In the present work a review of the new multivariate techniques and why they appear especiallysuited to the personality research is presented. Emerging models of personality and advances in the measurement of personality and psychopathology suggest that research in this field has ente red a stage of advanced development. The past two decades have shown importan! developments in statistics and measurement. Refinement of multivariate statistics has been especially importan! in personality assessment because of the complexity of relations among personality variables. Multivariate procedures provide the opportunity to examine the complexity of these interactions by providing methods of analysis for multiple variables. On the other hand, structural equation modeling and multivariate techniques for analyzing categorical variables have been developed. Multidimensional scaling and item response theory are the last developments.
En este trabajo se realiza una revisión de las nuevas técnicas estadísticas y de su utilidad para la investigación en personalidad. Los nuevos modelos y los avances en la medición de la personalidad y la psicopatología sugieren que la investigación en este campo y en su evaluación han entrado en un estadio avanzado de desarrollo. En las dos últimas décadas se han producido importantes desarrollos en estadística y medición. El refinamiento de las técnicas de análisis multivariado ha sido fundamental en la evaluación de la personalidad debido a la complejidad de las relaciones entre sus variables. Los procedimientos de análisis multivariado proveen la oportunidad de examinar la complejidad de esas interacciones a través de métodos de análisis para variables múltiples. Por otra parte, se han desarrollado los modelos de ecuaciones estructurales y técnicas multivariadas para analizar variables categóricas. Los últimos desarrollos corresponden al escalamiento multidimensional y a la teoría de la respuesta al ítem.

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Grigas, Paul (Paul Edward). „Methods for convex optimization and statistical learning“. Thesis, Massachusetts Institute of Technology, 2016. http://hdl.handle.net/1721.1/106683.

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Thesis: Ph. D., Massachusetts Institute of Technology, Sloan School of Management, Operations Research Center, 2016.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Cataloged from student-submitted PDF version of thesis.
Includes bibliographical references (pages 219-225).
We present several contributions at the interface of first-order methods for convex optimization and problems in statistical machine learning. In the first part of this thesis, we present new results for the Frank-Wolfe method, with a particular focus on: (i) novel computational guarantees that apply for any step-size sequence, (ii) a novel adjustment to the basic algorithm to better account for warm-start information, and (iii) extensions of the computational guarantees that hold in the presence of approximate subproblem and/or gradient computations. In the second part of the thesis, we present a unifying framework for interpreting "greedy" first-order methods -- namely Frank-Wolfe and greedy coordinate descent -- as instantiations of the dual averaging method of Nesterov, and we discuss the implications thereof. In the third part of the thesis, we present an extension of the Frank-Wolfe method that is designed to induce near-optimal low-rank solutions for nuclear norm regularized matrix completion and, for more general problems, induces near-optimal "well-structured" solutions. We establish computational guarantees that trade off efficiency in computing near-optimal solutions with upper bounds on the rank of iterates. We then present extensive computational results that show significant computational advantages over existing related approaches, in terms of delivering low rank and low run-time to compute a target optimality gap. In the fourth part of the thesis, we analyze boosting algorithms in linear regression from the perspective modern first-order methods in convex optimization. We show that classic boosting algorithms in linear regression can be viewed as subgradient descent to minimize the maximum absolute correlation between features and residuals. We also propose a slightly modified boosting algorithm that yields an algorithm for the Lasso, and that computes the Lasso path. Our perspective leads to first-ever comprehensive computational guarantees for all of these boosting algorithms, which provide a precise theoretical description of the amount of data-fidelity and regularization imparted by running a boosting algorithm, for any dataset. In the fifth and final part of the thesis, we present several related results in the contexts of boosting algorithms for logistic regression and the AdaBoost algorithm.
by Paul Grigas.
Ph. D.

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Snell, Kym Iris Erika. „Development and application of statistical methods for prognosis research“. Thesis, University of Birmingham, 2015. http://etheses.bham.ac.uk//id/eprint/6259/.

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A pivotal component of prognosis research is the prediction of future outcome risk. This thesis applies, develops and evaluates novel statistical methods for development and validation of risk prediction (prognostic) models. In the first part, a literature review of published prediction models shows that the Cox model remains the most common approach for developing a model using survival data; however, this avoids modelling the baseline hazard and therefore restricts individualised predictions. Flexible parametric survival models are shown to address this by flexibly modelling the baseline hazard, thereby enabling individualised risk predictions over time. Clinical application reveals discrepant mortality rates for different hip replacement procedures, and identifies common issues when developing models using clinical trial data. In the second part, univariate and multivariate random-effects meta-analyses are proposed to summarise a model’s performance across multiple validation studies. The multivariate approach accounts for correlation in multiple statistics (e.g. C-statistic and calibration slope), and allows joint predictions about expected model performance in applied settings. This allows competing implementation strategies (e.g. regarding baseline hazard choice) to be compared and ranked. A simulation study also provides recommendations for the scales on which to combine performance statistics to best satisfy the between-study normality assumption in random-effects meta-analysis.

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Ho, Lai Ping. „Application of statistical methods to problems in epidemiological research“. HKBU Institutional Repository, 2003. http://repository.hkbu.edu.hk/etd_ra/454.

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Kunz, Lauren Margaret. „Statistical Methods for Comparative Effectiveness Research of Medical Devices“. Thesis, Harvard University, 2014. http://nrs.harvard.edu/urn-3:HUL.InstRepos:14226082.

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A recent focus in health care policy is on comparative effectiveness of treatments--from drugs to behavioral interventions to medical devices. Medical devices bring a unique set of challenges for comparative effectiveness research. In this dissertation, I develop statistical methods for comparative effectiveness estimation and illustrate the methodology in the context of three different medical devices. In chapter 2, I review approaches for causal inference in the context of observational cohort studies, utilizing a potential outcomes framework demonstrated using data for patients undergoing revascularization surgery with radial versus femoral artery access. Propensity score methods; G-computation; augmented inverse probability of treatment weighting; and targeted maximum likelihood estimation are implemented and their causal and statistical assumptions evaluated. In chapter 3, I undertake a theoretical and simulation-based assessment of differential follow-up information per treatment arm on inference in meta-analysis where applied researchers commonly assume similar follow-up duration across treatment groups. When applied to the implantation of cardiovascular resynchronization therapies to examine comparative survival, only 3 of 8 studies report arm-specific follow-up. I derive the bias of the rate ratio for an individual study using the number of deaths and total patients per arm and show that the bias can be large, even for modest violations of the assumption that follow-up is the same in the two arms. Furthermore, when pooling multiple studies with Bayesian methods for random effects meta-analysis, the direction and magnitude of the bias is unpredictable. In chapter 4, I examine the statistical power for designing a study of devices when it is difficult to blind patients and providers, everyone wants the device, and clustering by hospitals where the devices are implanted needs to be taken into account. In these situations, a stepped wedge design (SWD) cluster randomized design may be used to rigorously assess the roll-out of novel devices. I determine the exact asymptotic theoretical power using Romberg integration over cluster random effects to calculate power in a two-treatment, binary outcome SWD. Over a range of design parameters, the exact method is from 9% to 2.4 times more efficient than designs based on the existing method.

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Vähänikkilä, H. (Hannu). „Statistical methods in dental research, with special reference to time-to-event methods“. Doctoral thesis, Oulun yliopisto, 2015. http://urn.fi/urn:isbn:9789526207933.

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Abstract Statistical methods are an essential part of the published dental research. It is important to evaluate the use of these methods to improve the quality of dental research. In the first part, the aim of this interdisciplinary study is to investigate the development of the use of statistical methods in dental journals, quality of statistical reporting and reporting of statistical techniques and results in dental research papers, with special reference to time-to-event methods. In the second part, the focus is specifically on time-to-event methods, and the aim is to demonstrate the strength of time-to-event methods in collecting detailed data about the development of oral health. The first part of this study is based on an evaluation of dental articles from five dental journals. The second part of the study is based on empirical data from 28 municipal health centres in order to study variations in the survival of tooth health. There were different profiles in the statistical content among the journals. The quality of statistical reporting was quite low in the journals. The use of time-to-event methods has increased from 1996 to 2007 in the evaluated dental journals. However, the benefits of these methods have not been fully adopted in dental research. The current study added new information regarding the status of statistical methods in dental research. Our study also showed that complex time-to-event analysis methods can be utilized even with detailed information on each tooth in large groups of study subjects. Authors of dental articles might apply the results of this study to improve the study protocol/planning as well as the statistical section of their research article
Tiivistelmä Tilastolliset tutkimusmenetelmät ovat olennainen osa hammaslääketieteellistä tutkimusta. Menetelmien käyttöä on tärkeä tutkia, jotta hammaslääketieteen tutkimuksen laatua voitaisiin parantaa. Tämän poikkitieteellisen tutkimuksen ensimmäisessä osassa tavoite on tutkia erilaisten tilastomenetelmien ja tutkimusasetelmien käyttöä, raportoinnin laatua ja tapahtumaan kuluvan ajan analysointimenetelmien käyttöä hammaslääketieteellisissä artikkeleissa. Toisessa osassa osoitetaan analysointimenetelmien vahvuus isojen tutkimusjoukkojen analysoinnissa. Ensimmäisen osan tutkimusaineiston muodostavat viiden hammaslääketieteellisen aikakauslehden artikkelit. Toisen osan tutkimusaineiston muodostivat 28 terveyskeskuksessa eri puolella Suomea hammashoitoa saaneet potilaat. Lehdet erosivat toisistaan tilastomenetelmien käytön ja tulosten esittämisen osalta. Tilastollisen raportoinnin laatu oli lehdissä puutteellinen. Tapahtumaan kuluvan ajan analysointimenetelmien käyttö on lisääntynyt vuosien 1996–2007 aikana. Tapahtumaan kuluvan ajan analysointimenetelmät mittaavat seuranta-ajan tietystä aloituspisteestä määriteltyyn päätepisteeseen. Tämän väitöksen tutkimukset osoittivat, että tapahtumaan kuluvan ajan analysointimenetelmät sopivat hyvin isojen tutkimusjoukkojen analysointiin. Menetelmien hyötyä ei ole kuitenkaan vielä saatu täysin esille hammaslääketieteellisissä julkaisuissa. Tämä tutkimus antoi uutta tietoa tilastollisten tutkimusmenetelmien käytöstä hammaslääketieteellisessä tutkimuksessa. Artikkelien kirjoittajat voivat hyödyntää tämän tutkimuksen tuloksia suunnitellessaan hammaslääketieteellistä tutkimusta

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Elia, Eleni. „Statistical methods in prognostic factor research : application, development and evaluation“. Thesis, University of Birmingham, 2017. http://etheses.bham.ac.uk//id/eprint/7259/.

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In patients with a particular disease or health condition, prognostic factors are characteristics (such as age, biomarkers) that are associated with different risks of a future clinical outcome. Research is needed to identify prognostic factors, but current evidence suggests that primary research is of low quality and poorly/selectively reported, which limits subsequent systematic reviews and meta-analysis. This thesis aims to improve prognostic factor research, through the application, development and evaluation of statistical methods to quantify the effect of potential prognostic factors. Firstly, I conduct a new prognostic factor study in pregnant women. The findings suggest that the albumin/creatinine ratio (ACR) is an independent prognostic factor for neonatal and, in particular, maternal composite adverse outcomes; thus ACR may enhance individualised risk prediction and clinical decision-making. Then, a literature review is performed to flag challenges in conducting meta-analysis of prognostic factor studies in the same clinical area. Many issues are identified, especially between-study heterogeneity and potential bias in the thresholds (cut-off points) used to dichotomise continuous factors, and the set of adjustment factors. Subsequent chapters aim to tackle these issues by proposing novel multivariate meta-analysis methods to ‘borrow strength’ across correlated thresholds and/or adjustment factors. These are applied to a variety of examples, and evaluated through simulation, which show how the approach can reduce bias and improve precision of meta-analysis results, compared to traditional univariate methods. In particular, the percentage reduction in the variance is of a similar magnitude to the percentage of data missing at random.

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Roloff, Verena Sandra. „Statistical methods for using meta-analysis to plan future research“. Thesis, University of Cambridge, 2012. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.610859.

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Chiu, Jing-Er. „Applications of bayesian methods to arthritis research /“. free to MU campus, to others for purchase, 2001. http://wwwlib.umi.com/cr/mo/fullcit?p3036813.

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Bücher zum Thema "Bioavailability – Research – Statistical methods"

Chow, Shein-Chung. Design and analysis of bioavailability and bioequivalence studies. 2. Aufl. New York: M. Dekker, 2000.

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Chow, Shein-Chung. Design and analysis of bioavailability and bioequivalence studies. 3. Aufl. Boca Raton: Chapman & Hall/CRC, 2009.

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Chow, Shein-Chung. Design and analysis of bioavailability and bioequivalence studies. New York: M. Dekker, 1992.

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Sabo, Roy, und Edward Boone. Statistical Research Methods. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1.

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G, Berry, Hrsg. Statistical methods in medical research. 3. Aufl. Oxford: Blackwell Scientific Publications, 1994.

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Armitage, P. Statistical methods in medical research. 2. Aufl. Oxford ; Boston: Blackwell Scientific ; Chicago, Ill. : Distributors, USA, Year Book Medical Publishers, 1987.

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1971-, Shmueli Galit, Hrsg. Statistical methods in ecommerce research. Hoboken, N.J: Wiley, 2008.

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G, Berry, und Matthews J. N. S, Hrsg. Statistical methods in medical research. 4. Aufl. Malden, MA: Blackwell Science, 2001.

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Armitage, P. Statistical methods in medical research. 4. Aufl. Oxford: Blackwell Scientific Publications, 2002.

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Armitage, Peter. Statistical methods in medical research. 2. Aufl. Oxford: Blackwell Scientific, 1987.

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Buchteile zum Thema "Bioavailability – Research – Statistical methods"

Malim, Tony, und Ann Birch. „Statistical Tests“. In Research Methods and Statistics, 107–34. London: Macmillan Education UK, 1997. http://dx.doi.org/10.1007/978-1-349-13865-4_4.

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Sabo, Roy, und Edward Boone. „Introduction“. In Statistical Research Methods, 1–12. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_1.

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Sabo, Roy, und Edward Boone. „Association and Regression“. In Statistical Research Methods, 181–209. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_10.

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Sabo, Roy, und Edward Boone. „One-Sample Proportions“. In Statistical Research Methods, 13–35. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_2.

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Sabo, Roy, und Edward Boone. „Two-Sample Proportions“. In Statistical Research Methods, 37–57. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_3.

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Sabo, Roy, und Edward Boone. „Multi-category Data“. In Statistical Research Methods, 59–78. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_4.

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Sabo, Roy, und Edward Boone. „Summarizing Continuous Data“. In Statistical Research Methods, 79–99. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_5.

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Sabo, Roy, und Edward Boone. „One-Sample Means“. In Statistical Research Methods, 101–20. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_6.

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Sabo, Roy, und Edward Boone. „Two-Sample Means“. In Statistical Research Methods, 121–45. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_7.

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Sabo, Roy, und Edward Boone. „Analysis of Variance“. In Statistical Research Methods, 147–65. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8708-1_8.

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Konferenzberichte zum Thema "Bioavailability – Research – Statistical methods"

Miroshnyk, Marina, und Viktoriya Krylova. „Communication channel statistical characteristics research methods“. In 2016 13th International Conference on Modern Problems of Radio Engineering, Telecommunications and Computer Science (TCSET). IEEE, 2016. http://dx.doi.org/10.1109/tcset.2016.7452116.

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Yuan, Lichi. „Research on Statistical Word Clustering Methods“. In 2019 International Conference on Machine Learning, Big Data and Business Intelligence (MLBDBI). IEEE, 2019. http://dx.doi.org/10.1109/mlbdbi48998.2019.00072.

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Kaminskyi, Roman, Nataliia Kunanets, Antonii Rzheuskyi und Andrii Khudyi. „Methods of Statistical Research for Information Managers“. In 2018 IEEE 13th International Scientific and Technical Conference on Computer Sciences and Information Technologies (CSIT). IEEE, 2018. http://dx.doi.org/10.1109/stc-csit.2018.8526588.

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Kar, Reshma, Mandakranta Chakraborty und Diptendu Bhattacharya. „Statistical Methods for Reducing Uncertainty and Eliminating Distortion in Type2 Fuzzy Sets“. In Student Research Symposium 2012. Research Publishing Services, 2012. http://dx.doi.org/10.3850/978-981-07-3043-7_017.

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Ndong, Joseph, und Kavé Salamatian. „A Robust Anomaly Detection Technique Using Combined Statistical Methods“. In 2011 9th Annual Communication Networks and Services Research Conference (CNSR). IEEE, 2011. http://dx.doi.org/10.1109/cnsr.2011.23.

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Gren, Lucas, und Alfredo Goldman. „Useful statistical methods for human factors research in software engineering“. In ICSE '16: 38th International Conference on Software Engineering. New York, NY, USA: ACM, 2016. http://dx.doi.org/10.1145/2897586.2897588.

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Das, Nandini. „Supplier Selection Criteria and Methods in Supply Chain (A Statistical Approach)“. In 3rd Asia Pacific Management Research Conference (APMRC 2019). Paris, France: Atlantis Press, 2020. http://dx.doi.org/10.2991/aebmr.k.200812.002.

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Eismann, Michael, Jacob Martin, Joseph Meola, Kevin Gross und Nicholas Westing. „Hyperspectral data exploitation: Progress from statistical methods toward machine learning“. In 2019 IEEE Research and Applications of Photonics in Defense Conference (RAPID). IEEE, 2019. http://dx.doi.org/10.1109/rapid.2019.8864242.

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Wu, Guoshi, und Kaiping Liu. „Research on Text Classification Algorithm by Combining Statistical and Ontology Methods“. In 2009 International Conference on Computational Intelligence and Software Engineering. IEEE, 2009. http://dx.doi.org/10.1109/cise.2009.5363406.

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B. M. Barbosa, Eduardo, und Edson L. F. Senne. „A Heuristic for Optimization of Metaheuristics by Means of Statistical Methods“. In 6th International Conference on Operations Research and Enterprise Systems. SCITEPRESS - Science and Technology Publications, 2017. http://dx.doi.org/10.5220/0006106402030210.

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Berichte der Organisationen zum Thema "Bioavailability – Research – Statistical methods"

Utley, Dawn R. A Research and Analysis of Technology Trends, Engineering Management, and Statistical Methods. Fort Belvoir, VA: Defense Technical Information Center, Februar 2002. http://dx.doi.org/10.21236/ada399686.

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McCulloch, Charles, und John Neuhaus. Statistical Methods for Reducing Bias in Comparative Effectiveness Research When Using Patient Data from Doctor Visits. Patient-Centered Outcomes Research Institute® (PCORI), Juni 2019. http://dx.doi.org/10.25302/6.2019.me.130601466.

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Kennedy, Alan, Mark Ballentine, Andrew McQueen, Christopher Griggs, Arit Das und Michael Bortner. Environmental applications of 3D printing polymer composites for dredging operations. Engineer Research and Development Center (U.S.), Januar 2021. http://dx.doi.org/10.21079/11681/39341.

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This Dredging Operations Environmental Research (DOER) technical note disseminates novel methods to monitor and reduce contaminant mobility and bioavailability in water, sediments, and soils. These method advancements are enabled by additive manufacturing (i.e., three-dimensional [3D] printing) to deploy and retrieve materials that adsorb contaminants that are traditionally applied as unbound powders. Examples of sorbents added as amendments for remediation of contaminated sediments include activated carbon, biochar, biopolymers, zeolite, and sand caps. Figure 1 provides examples of sorbent and photocatalytic particles successfully compounded and 3D printed using polylactic acid as a binder. Additional adsorptive materials may be applicable and photocatalytic materials (Friedmann et al. 2019) may be applied to degrade contaminants of concern into less hazardous forms. This technical note further describes opportunities for U.S. Army Corps of Engineers (USACE) project managers and the water and sediment resource management community to apply 3D printing of polymers containing adsorptive filler materials as a prototyping tool and as an on-site, on-demand manufacturing capability to remediate and monitor contaminants in the environment. This research was funded by DOER project 19-13, titled “3D Printed Design for Remediation and Monitoring of Dredged Material.”

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Mirel, Lisa, Cindy Zhang, Christine Cox, Ye Yeats, Félix Suad El Burai und Golden Cordell. Comparative analysis of the National Health and Nutrition Examination Survey public-use and restricted-use linked mortality files. Centers for Disease Control and Prevention (U.S.), Mai 2021. http://dx.doi.org/10.15620/cdc:104744.

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"Objectives—Linking national survey data with administrative data sources enables researchers to conduct analyses that would not be possible with each data source alone. Recently, the Data Linkage Program at the National Center for Health Statistics (NCHS) released updated Linked Mortality Files, including the National Health and Nutrition Examination Survey data linked to the National Death Index mortality files. Two versions of the files were released: restricted-use files available through NCHS and Federal Statistical Research Data Centers and public-use files. To reduce the reidentification risk, statistical disclosure limitation methods were applied to the public-use files before they were released. This included limiting the amount of mortality information available and perturbing cause of death and follow-up time for select records. Methods—To assess the comparability of the restricted-use and public-use files, relative hazard ratios for all-cause and cause-specific mortality using Cox proportional hazards models were estimated and compared. Results—The comparative analysis found that the two data files yield similar descriptive and model results. Suggested citation: Mirel LB, Zhang C, Cox CS, Ye Y, El Burai Félix S, Golden C. Comparative analysis of the National Health and Nutrition Examination Survey public-use and restricted-use linked mortality files. National Health Statistics Reports; no 155. Hyattsville, MD: National Center for Health Statistics. 2021. DOI: https://doi.org/10.15620/cdc:104744. CS323656 nhsr155-508.pdf"

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Wraight, Sarah, Julia Hofmann, Justine Allpress und Brooks Depro. Environmental justice concerns and the proposed Atlantic Coast Pipeline route in North Carolina. RTI Press, März 2018. http://dx.doi.org/10.3768/rtipress.2018.mr.0037.1803.

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This report describes publicly available data sets and quantitative analysis that local communities can use to evaluate environmental justice concerns associated with pipeline projects. We applied these data and analytical methods to two counties in North Carolina (Northampton and Robeson counties) that would be affected by the proposed Atlantic Coast Pipeline (ACP). We compared demographic and vulnerability characteristics of census blocks, census block groups, and census tracts that lie within 1 mile of the proposed pipeline route with corresponding census geographies that lie outside of the 1-mile zone. Finally, we present results of a county-level analysis of race and ethnicity data for the entire North Carolina segment of the proposed ACP route. Statistical analyses of race and ethnicity data (US Census Bureau) and Social Vulnerability Index scores (University of South Carolina’s Hazards & Vulnerability Research Institute) yielded evidence of significant differences between the areas crossed by the pipeline and reference geographies. No significant differences were found in our analyses of household income and cancer risk data.

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Kodupuganti, Swapneel R., Sonu Mathew und Srinivas S. Pulugurtha. Modeling Operational Performance of Urban Roads with Heterogeneous Traffic Conditions. Mineta Transportation Institute, Januar 2021. http://dx.doi.org/10.31979/mti.2021.1802.

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The rapid growth in population and related demand for travel during the past few decades has had a catalytic effect on traffic congestion, air quality, and safety in many urban areas. Transportation managers and planners have planned for new facilities to cater to the needs of users of alternative modes of transportation (e.g., public transportation, walking, and bicycling) over the next decade. However, there are no widely accepted methods, nor there is enough evidence to justify whether such plans are instrumental in improving mobility of the transportation system. Therefore, this project researches the operational performance of urban roads with heterogeneous traffic conditions to improve the mobility and reliability of people and goods. A 4-mile stretch of the Blue Line light rail transit (LRT) extension, which connects Old Concord Rd and the University of North Carolina at Charlotte’s main campus on N Tryon St in Charlotte, North Carolina, was considered for travel time reliability analysis. The influence of crosswalks, sidewalks, trails, greenways, on-street bicycle lanes, bus/LRT routes and stops/stations, and street network characteristics on travel time reliability were comprehensively considered from a multimodal perspective. Likewise, a 2.5-mile-long section of the Blue Line LRT extension, which connects University City Blvd and Mallard Creek Church Rd on N Tryon St in Charlotte, North Carolina, was considered for simulation-based operational analysis. Vissim traffic simulation software was used to compute and compare delay, queue length, and maximum queue length at nine intersections to evaluate the influence of vehicles, LRT, pedestrians, and bicyclists, individually and/or combined. The statistical significance of variations in travel time reliability were particularly less in the case of links on N Tryon St with the Blue Line LRT extension. However, a decrease in travel time reliability on some links was observed on the parallel route (I-85) and cross-streets. While a decrease in vehicle delay on northbound and southbound approaches of N Tryon St was observed in most cases after the LRT is in operation, the cross-streets of N Tryon St incurred a relatively higher increase in delay after the LRT is in operation. The current pedestrian and bicycling activity levels seemed insignificant to have an influence on vehicle delay at intersections. The methodological approaches from this research can be used to assess the performance of a transportation facility and identify remedial solutions from a multimodal perspective.

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Halych, Valentyna. SERHII YEFREMOV’S COOPERATION WITH THE WESTERN UKRAINIAN PRESS: MEMORIAL RECEPTION. Ivan Franko National University of Lviv, Februar 2021. http://dx.doi.org/10.30970/vjo.2021.49.11055.

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The subject of the study is the cooperation of S. Efremov with Western Ukrainian periodicals as a page in the history of Ukrainian journalism which covers the relationship of journalists and scientists of Eastern and Western Ukraine at the turn of the XIX-XX centuries. Research methods (biographical, historical, comparative, axiological, statistical, discursive) develop the comprehensive disclosure of the article. As a result of scientific research, the origins of Ukrainocentrism in the personality of S. Efremov were clarified; his person as a public figure, journalist, publisher, literary critic is multifaceted; taking into account the specifics of the memoir genre and with the involvement of the historical context, the turning points in the destiny of the author of memoirs are interpreted, revealing cooperation with Western Ukrainian magazines and newspapers. The publications ‘Zoria’, ‘Narod’, ‘Pravda’, ‘Bukovyna’, ‘Dzvinok’, are secretly got into sub-Russian Ukraine, became for S. Efremov a spiritual basis in understanding the specifics of the national (Ukrainian) mass media, ideas of education in culture of Ukraine at the end of XIX century, its territorial integrity, and state independence. Memoirs of S. Efremov on cooperation with the iconic Galician journals ‘Notes of the Scientific Society after the name Shevchenko’ and ‘Literary-Scientific Bulletin’, testify to an important stage in the formation of the author’s worldview, the expansion of the genre boundaries of his journalism, active development as a literary critic. S. Yefremov collaborated most fruitfully and for a long time with the Literary-Scientific Bulletin, and he was impressed by the democratic position of this publication. The author’s comments reveal a long-running controversy over the publication of a review of the new edition of Kobzar and thematically related discussions around his other literary criticism, in which the talent of the demanding critic was forged. S. Efremov steadfastly defended the main principles of literary criticism: objectivity and freedom of author’s thought. The names of the allies of the Ukrainian idea L. Skochkovskyi, O. Lototskyi, O. Konyskyi, P. Zhytskyi, M. Hrushevskyi in S. Efremov’s memoirs unfold in multifaceted portrait descriptions and function as historical and cultural facts that document the pages of the author’s biography, record his activities in space and time. The results of the study give grounds to characterize S. Efremov as the first professional Ukrainian-speaking journalist.

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Tucker-Blackmon, Angelicque. Engagement in Engineering Pathways “E-PATH” An Initiative to Retain Non-Traditional Students in Engineering Year Three Summative External Evaluation Report. Innovative Learning Center, LLC, Juli 2020. http://dx.doi.org/10.52012/tyob9090.

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The summative external evaluation report described the program's impact on faculty and students participating in recitation sessions and active teaching professional development sessions over two years. Student persistence and retention in engineering courses continue to be a challenge in undergraduate education, especially for students underrepresented in engineering disciplines. The program's goal was to use peer-facilitated instruction in core engineering courses known to have high attrition rates to retain underrepresented students, especially women, in engineering to diversify and broaden engineering participation. Knowledge generated around using peer-facilitated instruction at two-year colleges can improve underrepresented students' success and participation in engineering across a broad range of institutions. Students in the program participated in peer-facilitated recitation sessions linked to fundamental engineering courses, such as engineering analysis, statics, and dynamics. These courses have the highest failure rate among women and underrepresented minority students. As a mixed-methods evaluation study, student engagement was measured as students' comfort with asking questions, collaboration with peers, and applying mathematics concepts. SPSS was used to analyze pre-and post-surveys for statistical significance. Qualitative data were collected through classroom observations and focus group sessions with recitation leaders. Semi-structured interviews were conducted with faculty members and students to understand their experiences in the program. Findings revealed that women students had marginalization and intimidation perceptions primarily from courses with significantly more men than women. However, they shared numerous strategies that could support them towards success through the engineering pathway. Women and underrepresented students perceived that they did not have a network of peers and faculty as role models to identify within engineering disciplines. The recitation sessions had a positive social impact on Hispanic women. As opportunities to collaborate increased, Hispanic womens' social engagement was expected to increase. This social engagement level has already been predicted to increase women students' persistence and retention in engineering and result in them not leaving the engineering pathway. An analysis of quantitative survey data from students in the three engineering courses revealed a significant effect of race and ethnicity for comfort in asking questions in class, collaborating with peers outside the classroom, and applying mathematical concepts. Further examination of this effect for comfort with asking questions in class revealed that comfort asking questions was driven by one or two extreme post-test scores of Asian students. A follow-up ANOVA for this item revealed that Asian women reported feeling excluded in the classroom. However, it was difficult to determine whether these differences are stable given the small sample size for students identifying as Asian. Furthermore, gender differences were significant for comfort in communicating with professors and peers. Overall, women reported less comfort communicating with their professors than men. Results from student metrics will inform faculty professional development efforts to increase faculty support and maximize student engagement, persistence, and retention in engineering courses at community colleges. Summative results from this project could inform the national STEM community about recitation support to further improve undergraduate engineering learning and educational research.

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Treadwell, Jonathan R., James T. Reston, Benjamin Rouse, Joann Fontanarosa, Neha Patel und Nikhil K. Mull. Automated-Entry Patient-Generated Health Data for Chronic Conditions: The Evidence on Health Outcomes. Agency for Healthcare Research and Quality (AHRQ), März 2021. http://dx.doi.org/10.23970/ahrqepctb38.

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Background. Automated-entry consumer devices that collect and transmit patient-generated health data (PGHD) are being evaluated as potential tools to aid in the management of chronic diseases. The need exists to evaluate the evidence regarding consumer PGHD technologies, particularly for devices that have not gone through Food and Drug Administration evaluation. Purpose. To summarize the research related to automated-entry consumer health technologies that provide PGHD for the prevention or management of 11 chronic diseases. Methods. The project scope was determined through discussions with Key Informants. We searched MEDLINE and EMBASE (via EMBASE.com), In-Process MEDLINE and PubMed unique content (via PubMed.gov), and the Cochrane Database of Systematic Reviews for systematic reviews or controlled trials. We also searched ClinicalTrials.gov for ongoing studies. We assessed risk of bias and extracted data on health outcomes, surrogate outcomes, usability, sustainability, cost-effectiveness outcomes (quantifying the tradeoffs between health effects and cost), process outcomes, and other characteristics related to PGHD technologies. For isolated effects on health outcomes, we classified the results in one of four categories: (1) likely no effect, (2) unclear, (3) possible positive effect, or (4) likely positive effect. When we categorized the data as “unclear” based solely on health outcomes, we then examined and classified surrogate outcomes for that particular clinical condition. Findings. We identified 114 unique studies that met inclusion criteria. The largest number of studies addressed patients with hypertension (51 studies) and obesity (43 studies). Eighty-four trials used a single PGHD device, 23 used 2 PGHD devices, and the other 7 used 3 or more PGHD devices. Pedometers, blood pressure (BP) monitors, and scales were commonly used in the same studies. Overall, we found a “possible positive effect” of PGHD interventions on health outcomes for coronary artery disease, heart failure, and asthma. For obesity, we rated the health outcomes as unclear, and the surrogate outcomes (body mass index/weight) as likely no effect. For hypertension, we rated the health outcomes as unclear, and the surrogate outcomes (systolic BP/diastolic BP) as possible positive effect. For cardiac arrhythmias or conduction abnormalities we rated the health outcomes as unclear and the surrogate outcome (time to arrhythmia detection) as likely positive effect. The findings were “unclear” regarding PGHD interventions for diabetes prevention, sleep apnea, stroke, Parkinson’s disease, and chronic obstructive pulmonary disease. Most studies did not report harms related to PGHD interventions; the relatively few harms reported were minor and transient, with event rates usually comparable to harms in the control groups. Few studies reported cost-effectiveness analyses, and only for PGHD interventions for hypertension, coronary artery disease, and chronic obstructive pulmonary disease; the findings were variable across different chronic conditions and devices. Patient adherence to PGHD interventions was highly variable across studies, but patient acceptance/satisfaction and usability was generally fair to good. However, device engineers independently evaluated consumer wearable and handheld BP monitors and considered the user experience to be poor, while their assessment of smartphone-based electrocardiogram monitors found the user experience to be good. Student volunteers involved in device usability testing of the Weight Watchers Online app found it well-designed and relatively easy to use. Implications. Multiple randomized controlled trials (RCTs) have evaluated some PGHD technologies (e.g., pedometers, scales, BP monitors), particularly for obesity and hypertension, but health outcomes were generally underreported. We found evidence suggesting a possible positive effect of PGHD interventions on health outcomes for four chronic conditions. Lack of reporting of health outcomes and insufficient statistical power to assess these outcomes were the main reasons for “unclear” ratings. The majority of studies on PGHD technologies still focus on non-health-related outcomes. Future RCTs should focus on measurement of health outcomes. Furthermore, future RCTs should be designed to isolate the effect of the PGHD intervention from other components in a multicomponent intervention.

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