Data capture by digital pen in clinical trials: a qualitative and quantitative study

Area of Science:

• Clinical research methodology
• Health informatics
• Data management in clinical trials

Background:

• Clinical trials require accurate and efficient data collection methods.
• Traditional data entry systems can be time-consuming and prone to errors.
• Digital Pen (DP) systems offer a potential alternative for data capture in healthcare settings.

Purpose of the Study:

• To evaluate the usability and accuracy of a digital pen (DP) system for data collection in a clinical trial setting.
• To compare the DP system's data acquisition accuracy against a double manual data-entry system.

Main Methods:

• A qualitative study involving semistructured interviews and a focus group with trial investigators.
• A quantitative study comparing the DP system with double manual data entry for various data types (tick boxes, dates, numbers, letters).
• The study was conducted within a randomized multicentric clinical trial in tertiary care in France.

Main Results:

• The DP system was rated as easy to use and intuitive, even for users with limited computer experience.
• Data accuracy was comparable to double manual data entry, with no significant difference in error rates (8/5022 for DP vs. 6/5022 for manual).
• Technical issues primarily occurred during setup; however, investigators expressed willingness to use the system again.

Conclusions:

• The digital pen system demonstrates good acceptability and ease of use among clinical trial investigators.
• The DP system offers comparable accuracy to double manual data entry, making it a viable option for clinical trial data collection.
• The system's quick data availability is a key advantage for study coordination.