Lessons Learned In Collecting Participant Reported Outcome Data via Web-Based Data Systems
Year of Publication
Yesko, L; Hoehn, A; Van Veldhuisen, P; Schwartz, R; McNeely, J; Wu, L; Sherritt, L; Subramaniam, G
Society for Clinical Trials (SCT) 37th Annual Meeting
Montreal, Quebec, Canada
EDC; ePro; iPad; Primary Care Screening; Self-Adminstered
In clinical trials, it has become increasingly common to collect research data directly from study participants without intervention by the study coordinator. Electronic participant reported outcome (ePro) systems are typically developed for participant daily diaries or self-administered questionnaires. Participants can use assigned usernames and passwords to access the systems via the internet and are able to complete assessments on study computers or other portable devices. Data collection from study participants via an ePRO system can be used to identify adverse events, track adherence to study procedures, and to mask study staff to responses to questions. The latter is particularly beneficial for sensitive questions or responses to questions that might be influenced by social desirability. Assessments can be customized based on the participant’s characteristics (e.g., gender-specific questions can be tailored within ePRO using the information from the participants’ responses to demographic items). Studies conducted by the National Institute on Drug Abuse (NIDA)-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN) use questionnaires to collect data on participant characteristics and outcome measures. The Emmes Corporation, which serves as the Data and Statistical Center for the CTN, developed an ePro system within its web-based data collection system to collect research data directly from participants. In designing an ePRO platform, there are various aspects of the system that need to be assessed and validated before launching, including regulatory requirements, training of study participants, backup plans for system down-time or internet connectivity, and data quality and monitoring. These aspects of ePRO system design will be discussed in the context of a recently completed CTN study which had the primary goal of validating an electronic screening instrument for tobacco, alcohol, and other substance use. Data on participant acceptability feedback, including assistance required and time to complete the screening instrument, from this study will be presented.