The "Measuring Outcomes of Clinical Connectivity" (MOCC) trial: Investigating data entry errors in the electronic Primary Care Research Network (ePCRN)

Introduction: The electronic Primary Care Research Network (ePCRN) enrolled PBRN researchers in a feasibility trial to test the functionality of the network's electronic architecture and investigate error rates associated with two data entry strategies used in clinical trials. Methods: PBRN physicians and research assistants who registered with the ePCRN were eligible to participate. After online consent and randomization, participants viewed simulated patient records, presented as either abstracted data (short form) or progress notes (long form). Participants transcribed 50 data elements onto electronic case report forms (CRFs) without integrated field restrictions. Data errors were analyzed. Results: Ten geographically dispersed PBRNs enrolled 100 members and completed the study in less than 7 weeks. The estimated overall error rate if field restrictions had been applied was 2.3%. Participants entering data from the short form had a higher rate of correctly entered data fields (94.5% vs 90.8%, P = .004) and significantly more error-free records (P = .003). Conclusions: Feasibility outcomes integral to completion of an Internet-based, multisite study were successfully achieved. Further development of programmable electronic safeguards is indicated. The error analysis conducted in this study will aid design of specific field restrictions for electronic CRFs, an important component of clinical trial management systems.