Abstract
BackgroundThe choice between paper data collection methods and electronic data collection (EDC) methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study.MethodsA computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859), at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR) system was developed using a modified version of the EDC.ResultsAutomation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites.ConclusionAutomated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved.
Highlights
The choice between paper data collection methods and electronic data collection (EDC) methods has become a key question for clinical researchers
We report on our experience with an EDC system designed to collect data for a multi center breast cancer study, and an innovative method to assess cross-site data consistency with a subsequent system automating interrater/intra-rater reliability strategy
We describe the variability in electronically available data across six sites and report efficiencies gained from implementing an electronic data collection (EDC) instead of the originally proposed paper-based data collection
Summary
The choice between paper data collection methods and electronic data collection (EDC) methods has become a key question for clinical researchers. The choice between paper data collection methods or automated electronic data collection (EDC) methods has become a key design question for clinical researchers. [1,2,3,4,5,6,7,8] The disadvantages are: (1) extensive time and programming needed to develop EDC systems; (2) equipment costs; and (3) lack of ability to verify miscoded data against paper records, once data have been entered. [1,2,3,4,5,6,7,8] Despite these disadvantages, EDC offers promise for integrating existing data for multi-site longitudinal studies with flexibility, innovation, and less effort than that required by traditional paper methods. Subsequent systems can be developed from the first system more efficiently and at lower cost.[8]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
