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

Objectives: To investigate the use of the digital pen (DP) system to collect data in a clinical trial. To assess the accuracy of the system in this setting.

Design: Qualitative study based on semistructured interviews and a focus group. Quantitative study comparing the DP system and a double manual data-entry system in accuracy of acquiring data by variable type (tick boxes, dates, numbers, letters).

Setting: An ongoing randomised multicentric clinical trial in tertiary care in France.

Participants: 27 investigators involved in the trial (anaesthetists) who did or did not include patients, 4 study monitors and the study coordinator.

Results: Six key findings emerged: 1) the DP system was easy to use; its utilisation was intuitive, even for investigators inexperienced in informatics; 2) despite its portability, the DP was not always used in front of patients; 3) the DP system did not affect patient recruitment; 4) most of the technical problems of the system occurred during setup (compatibility, password access, antivirus software); 5) the main advantage was quickness of data availability for the study coordination staff and the main hindrance was the extra time required for online verification; and 6) all investigators were ready to use the system again. The investigators had to check 16% of data obtained by the DP system during the verification step. There is no relevant difference between the number of errors for the DP and the double manual data-entry systems: 8/5022 versus 6/5022 data entries. 5 out of 8 DP-system failures were due to the intelligent character recognition system.

Conclusion: The DP system has a good acceptability among all investigators in a clinical setting, whether they are experienced with computers or not, and a good accuracy, as compared with double manual data entry.