Apply response adaptive randomization to group sequential with early stopping

Group sequential methods and response adaptive randomization (RAR) procedures have been applied in clinical trials due to economical and ethical considerations. Group sequential methods are able to reduce the average sample size by inducing early stopping, but patients are equally allocated with half of chance to inferior arm. RAR procedures incline to allocate more patients to better arm; however it requires more sample size to obtain a certain power. This study intended to combine these two procedures. We applied the Bayesian decision theory approach to define our group sequential stopping rules and evaluated the operating characteristics under RAR setting. The results showed that Bayesian decision theory method was able to preserve the type I error rate as well as achieve a favorable power; further by comparing with the error spending function method, we concluded that Bayesian decision theory approach was more effective on reducing average sample size.^

Assessing fun in serious games: Formative evaluation of games from two diabetes prevention interventions

Purpose. To determine the usability of two video games to prevent type 2 diabetes and obesity among youth through analysis of data collected during alpha-testing. ^ Subjects. Ten children aged 9 to 12 were selected for three 2-hour alpha testing sessions.^ Methods. "Escape from Diab" and "Nanoswarm" were designed to change dietary and physical inactivity behaviors, based on a theoretical framework of mediating variables obtained from social cognitive theory, self-determination theory, elaboration likelihood model, and behavioral inoculation theory. Thirteen mini-games developed by the software company were divided into 3 groups based on completion date. Children tested 4-5 mini-games in each of three sessions. Observed game play was followed by a scripted interview. Results from observation forms and interview transcripts were tabulated and coded to determine usability. Suggestions for game modifications were delivered to the software design firm, and a follow-up table reports rationale for inclusion or exclusion of such modifications.^ Results. Participants were 50% frequent video game players and 20% non game-players. Most (60%) were female. The mean grade (indicating likeability as a subset of usability) across all games given by children was significantly greater than a neutral grade of 80% (89%, p < 0.01), indicating a positive likeability score. The games on average also received positive ratings for fun, helpfulness of instructions and length compared to neutral values (midpoint on likert scales) (all p < 0.01). Observation notes indicated that participants paid attention to the instructions, did not appear to have much difficulty with the games, and were "not frustrated", "not bored", "very engaged", "not fidgety" and "very calm" (all p < 0.01). The primary issues noted in observations and interviews were unclear instructions and unclear purpose of some games. Player suggestions primarily involved ways to make on screen cues more visible or noticeable, instructions more clear, and games more elaborate or difficult.^ Conclusions. The present study highlights the importance of alpha testing video game components for usability prior to completion to enhance usability and likeability. Results indicate that creating clear instructions, making peripheral screen cues more eye-catching or noticeable, and vigorously stating the purpose of the game to improve understandability are important elements. However, future interventions will each present unique materials and user-interfaces and should therefore also be thoroughly alpha-tested. ^