Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial. Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Results Participants have been enrolled in the streamlined and traditional trials and recuitment is ongoing. Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.

Objective Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. Materials and methods A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-minute video and website material that describes a clinical research trial. Results A diverse team collaborated extensively over 15 months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Discussion Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. Conclusion New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials.

Word prediction systems can reduce the number of keystrokes required to form a message in a letter-based AAC system. It has been questioned however, whether such savings translate into an enhanced communication rate due to the additional cognitive load (e.g., shifting of focus and scanning of a prediction list) required in using such a system. Our hypothesis is that word prediction has great potential in enhancing communication rate, but the amount is dependent on the accuracy of the word prediction system. Due to significant user interface variations in AAC systems and significant differences between communication rates achieved by different users on even the same device, this hypothesis is difficult to verify. We present a study of communication rate and word prediction systems using "pseudo-impaired" participants and two different word prediction systems compared against letter-by-letter entry. We find that word prediction systems can in fact speed communication rate, and that a more accurate word prediction system can raise communication rate higher than is explained by the additional accuracy of the system alone.

Word prediction can be used for enhancing the communication ability of persons with speech and language impairments. In this work, we explore two methods of adapting a language model to the topic of conversation, and apply these methods to the prediction of fringe words.

This study examined the conditions under which action representations - presented in both static and dynamic formats - were most readily identified. Preschoolers without disabilities selected graphics corresponding to a spoken word from a computerized four-choice array. Although pre-tests confirmed that the children had all of the stimulus words in their lexical repertoires, their demonstration of that knowledge when the stimuli were presented in graphical form was less robust. The children were generally more challenged by the static representations than the dynamic ones, and their performances were most accurate with the most realistic dynamic representations. A developmental effect was noted, as children's symbol identification became more accurate across the range of representational forms as they got older.