Leveraging the functionality of Research Electronic Data Capture (REDCap) to enhance data collection and quality in the Opioid Analgesic Reduction Study.

Abstract

Background: The Opioid Analgesic Reduction Study is a double-blind, prospective, clinical trial investigating analgesic effectiveness in the management of acute post-surgical pain after impacted third molar extraction across five clinical sites. Specifically, Opioid Analgesic Reduction Study examines a commonly prescribed opioid combination (hydrocodone/acetaminophen) against a non-opioid combination (ibuprofen/acetaminophen). The Opioid Analgesic Reduction Study employs a novel, electronic infrastructure, leveraging the functionality of its data management system, Research Electronic Data Capture, to not only serve as its data reservoir but also provide the framework for its quality management program.

Methods: Within the Opioid Analgesic Reduction Study, Research Electronic Data Capture is expanded into a multi-function management tool, serving as the hub for its clinical data management, project management and credentialing, materials management, and quality management. Research Electronic Data Capture effectively captures data, displays/tracks study progress, triggers follow-up, and supports quality management processes.

Results: At 72% study completion, over 12,000 subject data forms have been executed in Research Electronic Data Capture with minimal missing (0.15%) or incomplete or erroneous forms (0.06%). Five hundred, twenty-three queries were initiated to request clarifications and/or address missing data and data discrepancies.

Conclusion: Research Electronic Data Capture is an effective digital health technology that can be maximized to contribute to the success of a clinical trial. The Research Electronic Data Capture infrastructure and enhanced functionality used in Opioid Analgesic Reduction Study provides the framework and the logic that ensures complete, accurate, data while guiding an effective, efficient workflow that can be followed by team members across sites. This enhanced data reliability and comprehensive quality management processes allow for better preparedness and readiness for clinical monitoring and regulatory reporting.