PATIENTS CONSIDER TRAINING A NECESSARY PART OF CLINICAL TRIALS, PREFERRING READILY-ACCESSIBLE INTERACTIVE ELECTRONIC TRAINING

• Published in: Value in health Vol. 20; no. 5; p. A54
• Main Authors: Ly, JJ, Durand, EM, Gary, ST, Tuller, JM, Dallabrida, SM
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01-05-2017
• Subjects: Access; Clinical research; Clinical training; Clinical trials; Data quality; Educational materials; Electronic equipment; Human subjects; Inconsistency; Internet; Patient satisfaction; Questionnaires; Training; Variability
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: As patient-reported outcomes (PROs) are often primary or secondary endpoints in clinical trials, regulatory PRO guidance recommend patient training to improve data quality and reduce variability. This study explored patients' views on the importance of training and their preferred mode for training. METHODS: 437 Participants reported on an online survey their opinions regarding 1) the necessity of training during clinical trials, 2) preferred training material format, and 3) accessibility of materials for the duration of the trial. Participants were also asked how they would handle questions that may arise when completing questionnaires. Demographic information, including age, education level, and household income were recorded. RESULTS: 95.4% of participants indicated that educational materials and training were "definitely needed" (75.5%) or "somewhat needed" (19.9%). With modes of training, 71.6% of participants reported they preferred completing interactive training on mobile electronic devices or the internet as opposed to 27% who preferred paper guides to take home. 89.9% of respondent considered accessibility to the training to refresh on the information during the trial "definitely needed" (58.2%) or "somewhat needed" (31.7%). Should they have questions completing a questionnaire, 46.2% stated they would ask the trial doctor, 40.5% would look up information online or in reference materials, and 12.6% would try to pick the best answer. CONCLUSIONS: Our study found that the vast majority of participants considered educational materials and training a necessary part of clinical trial participation. Moreover, most participants preferred electronic modes of training and the ability to refresh on training materials. Less than half of the respondent would ask site staff to clarify questions, which may introduce inconsistency in PRO measures unless training is used to provide standardize instructions and key definitions. Our findings are consistent with regulatory PRO guidance and suggest that electronic interactive training could be used as an approach to improve data quality.