NIH Research Festival
Background: Web-based electronic data capture systems (EDCs) of patient-reported outcomes (PROs) continue to gain recognition in clinical care and research. Successful integration of these systems within a research protocol requires several practical considerations. In a longitudinal observational study of informal cancer caregivers, we recorded the challenges of using a web-based electronic-PRO (ePRO) collection system and considerations for solutions. Methods: English- or Spanish-speaking cancer caregivers were asked to complete online questionnaires at three time-points coinciding with the patient’s treatment. Demographic data, psychological constructs, health behaviors, and outcomes were collected through a web-based ePRO system, both onsite and offsite. Instruments included standard measures and short-forms, as well as computerized-adaptive tests (CATs). Issues surrounding implementation of the online system were tracked to assess feasibility of system integration. Results: The baseline response rate for this interim analysis was 94.7%, with 107/113 subjects achieving initial survey completion. Documented complexities included instrument selection, technical capabilities, and study coordination. Online compatibility of measures was assessed and functionality of the ePRO system on different platforms was continually evaluated to improve usability. A transdisciplinary support team was established for technical issues affecting remote access and data collection. Standard operating procedures were routinely updated to reflect the system’s uses and impacts on subject communication. Conclusions: Many considerations arise when integrating an ePRO system into clinical research. Advancements in technology and growth in PRO research, as well as patient-centered care, will enable these considerations to become more systematic. However, more studies using ePRO systems are needed to evaluate their application.
Scientific Focus Area: Research Support Services
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