This paper presents the second edition of our multicast protocol designed to enable shared virtual worlds.This second release was undertaken to provide an interaction methodology with other participants of a shared virtual world. These virtual world participants can be either human-controlled, or algorithmically controlled content delivery avatars.
8067 Background: Improving survival, QL, and PROs are key goals in cancer treatment. Valid QL instruments are available; however, low feasibility in treatment settings remains a barrier to QL assessment. The LCSS was converted into a computerized format for inexpensive hand-held devices (pocket pc), providing an immediate graphic report of current scores and change over time. All data are automatically recorded without transcription. This study documents ease of use and psychometrics with this new approach, comparing the LCSS paper form with the electronic (LCSS-QL). The objectives were to: a) determine correlation of the LCSS-QL with the paper version; b) measure completion times; and c) assess acceptability of the LCSS-QL by patients, nurses, and physicians. Methods: Patients were entered at 9 COMET clinics in Ontario. All had: a) stage III or IV NSCLC, b) KPS ≥ 60, 3) no prior chemotherapy, and 4) received initial courses of docetaxel + platinum. 48 patients completed both the paper and electronic forms (pretreatment, and with the next 4 chemotherapy cycles - paper version with every other cycle). Characteristics: 58% men; KPS (median 80%; range 60% - 100%); age (median 71; range 47–81); Stage IV: 73%. Results: The LCSS-QL had excellent acceptance by patients, nurses, and physicians. Patients required a mean of only 2.1 minutes (SD 1.58 min) to complete the LCSS-QL. Reliability coefficients using Cronbach’s alpha were high for the paper (0.83) and electronic (0.88) versions. Correlation coefficients between paper and electronic forms were in near agreement (0.93, 0.92, 0.92 for each of 3 methods used: Pearson r, Intraclass Correlation Coefficient, Lin’s concordance, respectively) for the total score. Conclusions: 1) The high acceptance rate by patients and professionals, the rapid completion time, good feasibility, reliability, and validity confirm that the electronic LCSS is practical for evaluating QL and PRO endpoints in clinical trials and in patient management; and 2) both the paper and electronic LCSS versions provide the same score for quality of life. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis Aventis Aventis Aventis Aventis
Abstract Aim To evaluate the safety of efpeglenatide, a long‐acting glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), and its effects on body weight management in adults without diabetes. Materials and methods In this phase II, randomized, placebo‐controlled, double‐blind trial, participants with a body mass index (BMI) ≥30 kg/m 2 or ≥27 kg/m 2 with comorbidity were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet. The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed‐effect model with repeated measures with an unstructured covariance matrix over all post‐screening visits; treatment comparisons were based on least squares mean estimates. Results Over 20 wk, all doses of efpeglenatide significantly reduced body weight from baseline versus placebo ( P < 0.0001), with placebo‐adjusted reductions ranging between −6.3 kg (6 mg once every 2 wk) and −7.2 kg (6 mg once weekly). Greater proportions of efpeglenatide‐treated participants had body weight loss of ≥5% or ≥10% versus placebo ( P < 0.01, all comparisons). Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo. Rates of study discontinuations as a result of adverse events ranged from 5% to 19% with efpeglenatide. Gastrointestinal effects were the most common treatment‐emergent adverse events. Conclusions Efpeglenatide once weekly and once every 2 wk led to significant body weight reduction and improved glycaemic and lipid variables versus placebo. It was also well tolerated for weight management in adults without diabetes.
Abstract Aims To assess satisfaction with treatment and psychological well‐being associated with insulin glargine and Neutral Protamine Hagedorn (NPH). Insulin glargine, a new long‐acting insulin analogue, provides constant, peakless insulin release following once‐daily administration and is associated with fewer hypoglycaemic episodes, despite metabolic control equivalent to that achieved with NPH human basal insulin. Methods The Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Well‐being Questionnaire (W‐BQ) were completed at baseline and at weeks 8, 20 or 28 by 517 patients with Type 1 diabetes participating in a randomized, controlled European trial comparing insulin glargine and NPH. Analysis of covariance was performed on change from baseline scores (main effects: treatment and pooled site; covariate: baseline scores). Results Treatment satisfaction improved with insulin glargine at all time points, including endpoint, but deteriorated slightly with NPH. These differences were significant throughout the study (change from baseline to endpoint: +1.27 vs. −0.56; P = 0.0001). Outcomes were better with insulin glargine for the DTSQ items, Perceived Frequency of Hyperglycaemia and Hypoglycaemia, with statistically significant differences at week 28 and endpoint for hyperglycaemia ( P = 0.0373 and 0.0379) and at week 20 for hypoglycaemia ( P = 0.0024). There was no difference in psychological well‐being between the treatment groups, with mean scores increasing in both. Conclusions Study participants had treatment‐independent improvements in General Well‐being. Advantages for insulin glargine were seen in significantly improved Treatment Satisfaction throughout the study, together with lower Perceived Frequency of Hyperglycaemia than for patients on NPH, without a significant increase in Perceived Frequency of Hypoglycaemia.
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether enteric-coated aspirin results in a lower incidence of gastrointestinal complications compared to normal aspirin in CABG surgery. Using the reported search, 340 papers were identified. Nine papers represented the best evidence on the subject. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, weaknesses, results and study comments were tabulated. Five randomised controlled trials of healthy volunteers undergoing endoscopy after a period of either enteric-coated aspirin or plain aspirin administration all demonstrated a clear reduction of gastric mucosal injury. However, these trials on healthy volunteers taking short-term aspirin have not been supported by clinical studies in older age-group adults taking lower doses of aspirin for long periods. No clinical benefits in terms of reduction of gastrointestinal bleeding or ulceration with enteric coating have, therefore, been successfully demonstrated, although the endoscopic studies show that potentially these benefits could exist.
To compare the efficacy and safety of a simple daily titration algorithm compared with a weekly dose adjustment of iGlarLixi in people with type 2 diabetes.LixiLan ONE CAN (NCT03767543), a randomized, 26-week, open-label, multicentre phase 3 trial conducted in Canada, involved 265 people with type 2 diabetes and an HbA1c of ≥7.5% to ≤ 10.5% or less (≥58 to ≤91 mmol/mol) on basal insulin for 6 months or longer. Participants were randomized 1:1 with instructions to self-titrate iGlarLixi daily (1 unit/day) or once weekly (2 or 4 units/week) to a common target fasting plasma glucose of 4.4 to 5.6 mmol/L (79 to 101 mg/dl). The primary objective was to show non-inferiority of the daily versus weekly titration algorithm.At 26 weeks, daily titration of iGlarLixi was not inferior to a weekly titration for both the prespecified primary endpoint of change in HbA1c from baseline (least square [LS] mean change: -1.24% vs. -0.92%, respectively; LS mean difference: 0.32%; 95% CI [0.07, 0.57]; P < .0001) and for the secondary endpoint of change in weight from baseline (LS mean change: -0.22 vs. +0.81 kg, respectively; LS mean difference: 1.03 kg; 95% CI [0.01, 2.06]; P < .0001). Indeed, for both the primary and secondary outcome, the daily titration of iGlarLixi was superior. There were no statistically significant differences in hypoglycaemia incidence between the two titration strategies during the 26-week study.A daily titration algorithm for switching basal insulin to iGlarLixi was shown to be non-inferior and superior for glycaemic control and weight compared with weekly titration.
Most studies in the sociology of science have used individuals or organizations as their units of analysis. Using scientific articles provides an alternative method for studying the distribution of recognition or influence in science. The study of citations to articles not only permits a better examination of the functionalist distinction between achievement and ascriptive processes (relying on universalistic and “Matthew effect” criteria, respectively) but also considers intellectual factors in scientific communications-some of the major concerns of the critics of functionalism. This paper develops a method for the study of citations and applies it to a sample of geoscience articles. The results indicate that achievement processes are more important than ascriptive processes in the distribution of scientific influence.
Introduction Efpeglenatide is a long-acting glucagon-like peptide-1 receptor agonist being developed to improve glycemic control in type 2 diabetes (T2D). In the BALANCE 205 study ( NCT02075281 ), efpeglenatide significantly reduced body weight versus placebo in patients with obesity, or overweight with comorbidities, and without T2D. These subanalyses explore the efficacy and safety of efpeglenatide in subgroups of patients with pre-diabetes and stratified by body mass index (BMI) or age from the BALANCE study. Research design and methods The 20-week BALANCE study randomized patients with BMI ≥30 kg/m 2 or ≥27 kg/m 2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo. For these subanalyses, patients were stratified by pre-diabetes status (glycated hemoglobin (HbA 1c ) 5.7%−6.4% (39–46 mmol/mol) or fasting plasma glucose (FPG) 100–125 mg/dL) and by BMI or age < or ≥ median values (34.9 kg/m 2 and 44 years, respectively) at baseline. Results In patients with pre-diabetes at baseline, all efpeglenatide doses led to greater proportions of patients reverting to normoglycemia (40.6%–64.3%) versus placebo (10.0%), and greater reductions in HbA 1c (0.30%–0.38%), FPG (7.7–14.1 mg/dL), and weight (5.6–7.3 kg) versus placebo (nominal p<0.05 for all). In patients with BMI or age < or ≥ median, greater reductions in weight were observed with all efpeglenatide doses versus placebo (nominal p<0.01 for all). The most common adverse events in patients receiving efpeglenatide across patient subgroups were gastrointestinal adverse events. Conclusions These results are consistent with the overall BALANCE population and suggest beneficial effects of efpeglenatide on glycemic control and body weight regardless of pre-diabetes status, age, or BMI at baseline. The effects of efpeglenatide on glycemic control in patients with pre-diabetes suggest it might help reduce the likelihood of at-risk patients developing diabetes.
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