JMIR Publications

ABSTRACT

Background:

As researchers are increasingly interested in real-world study (RWS), improving data collection efficiency and data quality has become an important challenge. An electronic source (eSource) generally includes the direct capturing, collecting, and storing of electronic data to simplify clinical research. It can improve data quality and patient safety and reduce clinical trial costs. Although there are already large projects on eSource technology, there is still a lack of experience in using eSource technology to implement RWS. Our team designed and developed an eSource record (ESR) system in China. In a preliminary prospective study, we selected a cosmetic medical device project to evaluate the effect of ESR software on data collection and transcription. Because the previous case verification was simple, we plan to choose more complicated ophthalmology projects to further evaluate ESR.

Objective:

The purpose of this study was to evaluate the data transcription efficiency and quality of ESR software in retrospective studies to verify the feasibility of using eSource as an alternative to traditional manual transcription of data in RWS projects.

Methods:

The approved ophthalmic femtosecond laser project was used for ESR case validation. This study compared the efficiency and quality of data transcription between the eSource method using ESR software and the traditional clinical research model of manually transcribing data. Usability refers to the quality of a user's experience when interacting with products or systems, including websites, software, devices, or applications. To evaluate the system availability of ESR, we used the system usability scale (SUS). The overall questionnaire consisted of two parts: participant information and the SUS evaluation of the electronic medical record (EMR), electronic data capture (EDC) and ESR systems. By accessing log data from the EDC system previously used by the research project, all time spent from the beginning to the end of the study could be counted.

Results:

In terms of transcription time cost per field, the eSource method can save a time cost of 81.8%. Compared with traditional manual data transcription, the eSource method has higher data transcription quality (correct rate of entry of 98.17% vs. 93.32%). A total of 15 questionnaires were received with a response rate of 100%. In terms of usability, the average overall SUS scores of the EMR system, EDC system, and ESR system were 50.3, 51.5, and 63.0, respectively. The Cronbach's alpha for SUS items of the EMR system, EDC system, and ESR system were 0.591 (95% confidence intervals: [-0.012, 0.903]), 0.588 (95% confidence intervals: [-0.288, 0.951]), and 0.785 (95% confidence intervals: [0.576, 0.916]), respectively.

Conclusions:

In real-world ophthalmology studies, the eSource approach based on the ESR system can replace the traditional clinical research model that relies on manual transcription of data.