A comparative effectiveness study of eSource used for data capture for a clinical research registry

Area of Science:

• Clinical Informatics
• Health Data Management
• Medical Registries

Background:

• Traditional manual data transcription in clinical registries is time-consuming and prone to errors.
• Adoption of electronic source (eSource) data capture methods is increasing, but empirical evidence on its efficiency and accuracy is needed.
• Understanding the impact of eSource on workflow and data quality is crucial for its widespread implementation.

Purpose of the Study:

• To compare the time efficiency of eSource-enabled versus traditional manual data transcription for clinical registry data collection.
• To evaluate the impact of eSource on data quality, specifically transcription errors.
• To assess the flexibility of workflows associated with eSource data capture.

Main Methods:

• A pilot study utilizing time and motion methods was conducted for a single-center OB/GYN registry.
• Industrial engineers used specialized software to record keystrokes, mouse clicks, and video data during real-time data collection.
• Direct observation captured workflow activities for both eSource and non-eSource (traditional) data capture methods.

Main Results:

• Overall average data capture time was reduced by 151 seconds per case with eSource (1603s) compared to non-eSource (1754s) (p=0.051).
• Demographic data capture time saw a significant reduction of 79 seconds per case (eSource: 133s; non-eSource: 213s; p<0.001), representing a 37% time saving.
• eSource data capture resulted in zero transcription errors, a significant improvement over the 9% error rate observed with non-eSource methods.

Conclusions:

• The implementation of eSource in clinical registry data collection is associated with substantial reductions in data entry time.
• eSource methods significantly improve data quality by minimizing transcription errors.
• Further validation studies in diverse settings are recommended to confirm these findings.