Tag: statistics

Ophthalmic Physiol Opt. 2023 Dec 22. doi: 10.1111/opo.13261. Online ahead of print.

ABSTRACT

PURPOSE: (1) To assess the feasibility of conducting tablet-based vision tests in hospital clinic waiting areas; (2) To test the hypothesis that increasing severity of diabetic macular oedema (DME) is associated with the performance of tablet-based surrogates of everyday tasks and self-reported visual function.

METHODS: Sixty-one people with mild (n = 28), moderate (n = 24) or severe (n = 9) DME performed two tablet-based tests of ‘real-world’ visual function (visual search and face recognition) while waiting for appointments in a hospital outpatient clinic. Participants also completed a tablet-based version of a seven-item, visual-functioning (VF-7) patient-reported outcome measure. Test performance was compared to previously published 99% normative limits for normally sighted individuals.

RESULTS: Thirty-four participants (56%; 95% confidence interval [CI] 43%-68%) exceeded normative limits for visual search, while eight (13%; 95% CI 65%-24%) exceeded normative limits for face discrimination. Search duration was significantly longer for people with severe DME than those with mild and moderate DME (p = 0.01). Face discrimination performance was not significantly associated with DME severity. VF-7 scores were statistically similar across DME severity groups. Median time to complete all elements (eligibility screening, both tablet-based tasks and the VF-7) was 22 (quartiles 19, 25) min. Further, 98% and 87% of participants, respectively, reported the search task and face discrimination task to be enjoyable, while 25% and 97%, respectively, reported finding the two tasks to be difficult.

CONCLUSIONS: Portable tablet-based tests are quick, acceptable to patients and feasible to be performed in a clinic waiting area with minimal supervision. They have the potential to be piloted in patients’ homes for self-monitoring.

PMID:38131130 | DOI:10.1111/opo.13261

Pharmacotherapy. 2023 Dec 22. doi: 10.1002/phar.2902. Online ahead of print.

ABSTRACT

INTRODUCTION: Studies have demonstrated that sodium-glucose cotransporter-2 (SGLT2) inhibitors are kidney protective; however, their ability to cause hemodynamic changes may predispose patients to acute kidney injury (AKI). A United States Food and Drug Administration warning recommends evaluating for factors that predispose patients to AKI before initiating a SGLT2 inhibitor.

OBJECTIVE: To identify risk factors that may predispose persons with diabetes to AKI when initiating SGLT2 inhibitor therapy.

METHODS: This was a multi-center retrospective cohort chart review of patients with type 2 diabetes prescribed a SGLT2 inhibitor from January 2013 to September 2019. Patients were included if they were receiving care at Advocate Medical Group and were confirmed to have taken one of the four SGLT2 inhibitors available at the time of study approval, canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin, for at least 7 days. Patients were excluded if they did not have a basic metabolic panel or comprehensive metabolic panel recorded 1 year prior to or 6 months after SGLT2 inhibitor therapy initiation.

RESULTS: Data extraction from the electronic medical record identified 6425 patients receiving a SGLT2 inhibitor, of which 1962 met inclusion criteria and were included for analysis. Thirty-five (1.8%) patients experienced an AKI after SGLT2 inhibitor therapy initiation. There was no statistically significant difference between groups based on background medication use (p = 0.325). At baseline, patients experiencing an AKI after SGLT2 inhibitor initiation were more likely to be older in age (p=0.010), have a higher serum potassium (p< 0.001), blood glucose (p=0.018), SCr (p=0.009) and UACR (p<0.001), and a lower eGFR (p=0.028) compared to those who did not experience AKI.

CONCLUSIONS: The transient eGFR decline with SGLT2 inhibitor initiation should be expected and is generally not an indication to discontinue therapy. Future initiatives should be directed at increasing knowledge of monitoring recommendations for these agents.

PMID:38131129 | DOI:10.1002/phar.2902

J Int Soc Sports Nutr. 2024 Dec;21(1):2296888. doi: 10.1080/15502783.2023.2296888. Epub 2023 Dec 22.

ABSTRACT

OBJECTIVE: The purpose of this study was to examine the acute effects of a multi-ingredient, low calorie dietary supplement (MIDS, XTEND® Healthy Hydration) on 5-kilometer (5-km) time trial performance and blood electrolyte concentrations compared to a carbohydrate-electrolyte beverage (CE, GATORADE® Thirst Quencher) and distilled water (W).

METHODS: During visit 1 (V1), participants (10 men and 10 women, 20-35 years old, BMI ≤ 29 kg/m², recreationally active) reported to the laboratory whereby the following tests were performed: i) height and weight measurements, ii) body composition analysis, iii) treadmill testing to measure maximal aerobic capacity, and iv) 5-km time trial familiarization. The second visit (V2) was one week after V1 in the morning (0600 – 0900) and participants arrived 12-14 h fasted (no food or drink). The first battery of assessments (V2-T1) included nude body mass, urine specific gravity (USG), a profile of mood states (POMS) questionnaire, and the completion of a visual analogue scale (VAS) questionnaire to quantify cramping. Then heart rate (HR), blood pressure (BP), total body hydration (via bioelectrical impedance spectroscopy [BIS]) were examined. Finally, a measurement of blood markers via finger stick was performed. Participants consumed a randomized beverage (16 fl. oz. of MIDS, 16 fl. oz. of W, or 16 fl. oz. of CE) within 3 min followed by a 45-min rest. Following the rest period, a second battery (V2-T2) was performed whereby participants’ USG was assessed and they completed the POMS and VAS questionnaires, and HR, BP, and blood markers were measured. The participants then performed a 5-km treadmill time trial. Immediately following the 5-km time trial, participants completed a third testing battery (V2-T3) that began with blood markers, HR and BP assessments, followed by nude body weight assessment, and the POMS and VAS questionnaires. After 60 min, a fourth battery (V2-T4) was performed that included HR, BP, and blood markers. After sitting quietly for another 60 min a fifth battery assessment was performed (V2-T5) that included participants’ USG, POMS and VAS questionnaires, HR, BP, blood markers, and total body hydration. Visits 3 (V3) and 4 (V4) followed the same protocol except a different randomized drink (16 oz. of CE, MIDS, or W) was consumed; all of which were separated by approximately one week.

RESULTS: No differences occurred between conditions for 5-km time trial completion, indirect calorimetry outcomes during 5-km time trials, USG, or nude mass measurements (p > 0.05 for all relevant statistical tests). However, blood potassium and the sodium/potassium ratio displayed significant interactions (p < 0.05), and post hoc testing indicated these values were better maintained in the MIDS versus other conditions. Post-exercise cramp prevalence was greater in the CE (p < 0.05) and trended higher with W (p = 0.083) compared to the MIDS condition. Post-exercise cramp severity was also elevated with the W and CE beverages (p < 0.05) but not the MIDS (p = 0.211).

CONCLUSIONS: The MIDS did not affect 5-km time trial performance but exhibited favorable effects on blood electrolyte and post-exercise self-reporting cramp outcomes compared to the CE and W drinks.

PMID:38131124 | DOI:10.1080/15502783.2023.2296888

J Biopharm Stat. 2023 Dec 22:1-20. doi: 10.1080/10543406.2023.2292209. Online ahead of print.

ABSTRACT

The goal of phase II clinical trials is to evaluate the therapeutic efficacy of a new drug. Some investigators want to use the time-to-event endpoint as the primary endpoint of the phase II study to see the improvement of the therapeutic efficacy of a new drug in median survival time. Recently, median event time test (METT) has been proposed to provide a simple and straightforward rule which compares the observed median survival time with the prespecified threshold. However, median survival time would not be observed during the trial if the drug performs well and indeed cures most patients or if the accrual rate is so fast. To address the issues in clinical practice, we first propose a percentile event time test (PETT), which generalizes METT to any percentile of the survival time, and develop data-driven monitoring for phase II clinical trial designs based on PETT. We evaluate the performance of the method through simulations and illustrate the proposed method with a trial example.

PMID:38131110 | DOI:10.1080/10543406.2023.2292209

J Dev Econ. 2024 Mar;167:103215. doi: 10.1016/j.jdeveco.2023.103215. Epub 2023 Nov 27.

ABSTRACT

We study how human capital and economic conditions causally affect the choice of religious denomination. We utilize a longitudinal dataset monitoring the religious history of more than 5,000 Kenyans over twenty years, in tandem with a randomized experiment (deworming) that has exogenously boosted education and living standards. The main finding is that the program reduces the likelihood of membership in a Pentecostal denomination up to 20 years later when respondents are in their mid-thirties, while there is a comparable increase in membership in traditional Christian denominations. The effect is concentrated and statistically significant among a sub-group of participants who benefited most from the program in terms of increased education and income. The effects are unlikely due to increased secularization, because the program does not reduce measures of religiosity. The results help explain why the global growth of the Pentecostal movement, sometimes described a “New Reformation”, is centered in low-income communities.

PMID:38131098 | PMC:PMC10732350 | DOI:10.1016/j.jdeveco.2023.103215

Chem Sci. 2023 Dec 6;15(1):250-258. doi: 10.1039/d3sc04861f. eCollection 2023 Dec 20.

ABSTRACT

Using a highly active permethylindenyl-phenoxy (PHENI*) titanium catalyst, high to ultra-high molecular weight ethylene-linear-α-olefin (E/LAO) copolymers are prepared in high yields under mild conditions (2 bar, 30-90 °C). Controllable, efficient, and predictable comonomer enchainment provides access to a continuum of copolymer compositions and a vast range of material properties using a single monomer-agnostic catalyst. Multivariate statistical tools are employed that combine the tuneability of this system with the analytical and predictive power of data-derived models, this enables the targeting of polyolefins with designer properties directly through predictive alteration of reaction conditions.

PMID:38131091 | PMC:PMC10731910 | DOI:10.1039/d3sc04861f

Chem Sci. 2023 Nov 29;15(1):389-398. doi: 10.1039/d3sc03685e. eCollection 2023 Dec 20.

ABSTRACT

Supramolecular dimers are elementary units allowing the build-up of multi-molecule architectures. New among these are cyanostar-stabilized dimers of phosphate and phosphonate anions. While the anion dimerization at the heart of these assemblies is reliable, the covalent synthesis leading to this class of designer anions serves as a bottleneck in the pathway to supramolecular assemblies. Herein, we demonstrate the reliable synthesis of 14 diverse anionic monomers by Heck coupling between vinyl phosphonic acid and aryl bromide compounds. When this synthesis is combined with reliable anion dimerization, we show formation of supramolecular dimers and polymers by co-assembly with cyanostar macrocycles. The removal of the covalent bottleneck opened up a seamless synthetic route to iterate through three monomers affording the solubility needed to characterize the mechanism of supramolecular polymerization. We also test the idea that the small size of these vinyl phosphonates provide identical dimer stabilities across the library by showing how mixtures of anions undergo statistical (social) self-sorting. We exploit this property by preparing soluble copolymers from the mixing of different monomers. This multi-anion assembly shows the utility of a library for programming properties.

PMID:38131081 | PMC:PMC10732014 | DOI:10.1039/d3sc03685e

Clin Oral Investig. 2023 Dec 22;28(1):13. doi: 10.1007/s00784-023-05421-4.

ABSTRACT

OBJECTIVES: Statistics on the rate of unconventional lymph node metastases (ULNM) at the time of one-stage radical surgery in tongue cancer patients. To assess whether an extended neck dissection group with additional removal of ULNs has a lower rate of neck recurrence compared to the traditional neck dissection group.

MATERIALS AND METHODS: A total of 336 patients with TSCC who underwent radical surgery were recruited and underwent traditional or extended neck dissection. Compared to traditional neck dissection, the aim of extended neck dissection is designed to additional resect ULNs.

RESULTS: In total, 180 patients underwent extended neck dissection, while 156 underwent traditional neck dissection. The incidence of ULNM was 11.67% (21/180) in patients treated with extended neck dissection. The incidence of ipsilateral neck recurrence was 9.49% and 0.56% in patients who underwent traditional and extended neck dissection, respectively (p = 0.0001).

CONCLUSIONS: Extended neck dissection is effective for preventing neck recurrence in TSCC patients with ULNs.

CLINICAL RELEVANCE: ULNM may be the main cause of neck recurrence after neck dissection in patients with tongue cancer. A better prognosis may be achieved by additional resection of ULNs on the basis of traditional neck dissection.

PMID:38129547 | DOI:10.1007/s00784-023-05421-4

Sci Rep. 2023 Dec 21;13(1):22919. doi: 10.1038/s41598-023-50128-x.

ABSTRACT

Health professionals need a strong prediction system to reach appropriate disease diagnosis, particularly for under-five child with health problems like anemia. Diagnosis and treatment delay can potentially lead to devastating disease complications resulting in childhood mortality. However, the application of machine learning techniques using a large data set provides scientifically sounded information to solve such palpable critical health and health-related problems. Therefore, this study aimed to determine the predictors of anemia among under-5 year’s age children in Ethiopia using a machine learning approach. A cross-sectional study design was done using the Ethiopian Demographic and Health Survey 2016 data set. A two-stage stratified cluster sampling technique was employed to select the samples. The data analysis was conducted using Statistical Package for Social Sciences/SPSS version 25 and R-software. Data were derived from Ethiopian Demographic and Health Survey. Boruta algorism was applied to select the features and determine the predictors of anemia among under-5 years-old children in Ethiopia. The machine learning algorism showed that number of children, distance to health facilities, health insurance coverage, youngest child’s stool disposal, residence, mothers’ wealth index, type of cooking fuel, number of family members, mothers’ educational status and receiving rotavirus vaccine were the top ten important predictors for anemia among under-five children. Machine-learning algorithm was applied to determine the predictors of anemia among under- 5 year’s age children in Ethiopia. We have identified the determinant factors by conducting a feature importance analysis with the Boruta algorithm. The most significant predictors were number of children, distance to health facility, health insurance coverage, youngest child’s stool disposal, residence, mothers’ wealth index, and type of cooking fuel. Machine learning model plays a paramount role for policy and intervention strategies related to anemia prevention and control among under-five children.

PMID:38129535 | DOI:10.1038/s41598-023-50128-x

Br J Cancer. 2023 Dec 21. doi: 10.1038/s41416-023-02542-1. Online ahead of print.

ABSTRACT

BACKGROUND: Berzosertib (M6620) is a highly potent (IC50 = 19 nM) and selective, first-in-class ataxia telangiectasia-mutated and Rad3-related protein kinase (ATR) inhibitor. This trial assessed the safety, preliminary efficacy, and tolerance of berzosertib in oesophageal cancer (A1 cohort) with RT and advanced solid tumours (A2 cohort) with cisplatin and capecitabine.

METHODS: Single-arm, open-label dose-escalation (Time-to-Event Continual Reassessment Method) trial with 16 patients in A1 and 18 in A2. A1 tested six dose levels of berzosertib with RT (35 Gy over 15 fractions in 3 weeks).

RESULTS: No dose-limiting toxicities (DLTs) in A1. Eight grade 3 treatment-related AEs occurred in five patients, with rash being the most common. The highest dose (240 mg/m²) was determined as the recommended phase II dose (RP2D) for A1. Seven DLTs in two patients in A2. The RP2D of berzosertib was 140 mg/m² once weekly. The most common grade ≥3 treatment-related AEs were neutropenia and thrombocytopenia. No treatment-related deaths were reported.

CONCLUSIONS: Berzosertib combined with RT is feasible and well tolerated in oesophageal cancer patients at high palliative doses. Berzosertib with cisplatin and capecitabine was well tolerated in advanced cancer. Further investigation is warranted in a phase 2 setting.

CLINICAL TRIALS IDENTIFIER: EU Clinical Trials Register (EudraCT) – 2015-003965-27 ClinicalTrials.gov – NCT03641547.

PMID:38129525 | DOI:10.1038/s41416-023-02542-1