BackgroundMulti-Arm Multi-Stage designs aim at comparing several new treatments to a common reference, in order to select or drop any treatment arm to move forward when such evidence already exists based on interim analyses. We redesigned a Bayesian adaptive design initially proposed for dose-finding, focusing our interest in the comparison of multiple experimental drugs to a control on a binary criterion measure.MethodsWe redesigned a phase II clinical trial that randomly allocates patients across three (one control and two experimental) treatment arms to assess dropping decision rules. We were interested in dropping any arm due to futility, either based on historical control rate (first rule) or comparison across arms (second rule), and in stopping experimental arm due to its ability to reach a sufficient response rate (third rule), using the difference of response probabilities in Bayes binomial trials between the treated and control as a measure of treatment benefit. Simulations were then conducted to investigate the decision operating characteristics under a variety of plausible scenarios, as a function of the decision thresholds.ResultsOur findings suggest that one experimental treatment was less efficient than the control and could have been dropped from the trial based on a sample of approximately 20 instead of 40 patients. In the simulation study, stopping decisions were reached sooner for the first rule than for the second rule, with close mean estimates of response rates and small bias. According to the decision threshold, the mean sample size to detect the required 0.15 absolute benefit ranged from 63 to 70 (rule 3) with false negative rates of less than 2 % (rule 1) up to 6 % (rule 2). In contrast, detecting a 0.15 inferiority in response rates required a sample size ranging on average from 23 to 35 (rules 1 and 2, respectively) with a false positive rate ranging from 3.6 to 0.6 % (rule 3).ConclusionAdaptive trial design is a good way to improve clinical trials. It allows removing ineffective drugs and reducing the trial sample size, while maintaining unbiased estimates. Decision thresholds can be set according to predefined fixed error decision rates.Trial registrationClinicalTrials.gov Identifier: NCT01342692.
This article analyzes the methods of teaching Latin medical anatomical terminology in multilingual groups of students, where the language of teaching is Russian. The analysis is carried out on the example of multilingual groups of the Peoples' Friendship University of Russia (RUDN), peculiarity of which is joint training of foreign students and students with Russian as a native language. In such groups, it is difficult for the teacher to rely on the native language of the students (there are too many such languages) or on the language of teaching, which is poorly spoken by the foreign part of the group. The common languages spoken in multilingual groups of the Medical Institute of RUDN University are indicated. The main problematic aspects in the study of Latin terminology for both students speaking different foreign languages and for the teacher conducting lessons in a multilingual group are discussed; the methods of overcoming these problematic aspects are suggested. The relevance of this problematic is substantiated by the increasing number of multilingual groups in Russian universities, including those where the teaching language is Russian. Our methodological recommendations can be used by teachers for preparation of the program and for development of test materials for multilingual groups.
Organization of training for participants in the Tourism Competency championship, who will be able to demonstrate the level of formation of their professional competence in accordance with WS standards. The preparation of championship participants requires a carefully thought-out action plan from the educational organization, which requires the development of goals and objectives. Having studied previous work experience, we have developed the goal and objectives of the preparation. Purpose: to summarize the championship experience and develop a methodology for preparing competitive participants for the WorldSkills Russia championship.
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