Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial

Area of Science:

• Clinical Trials Methodology
• Pain Management Research
• Health Informatics

Background:

• Electronic data collection is emerging for clinical trial data, but its effectiveness and cost compared to traditional methods remain unclear.
• Evaluating electronic versus traditional data collection is crucial for optimizing pain-related clinical trial processes.

Purpose of the Study:

• To compare data quality, protocol adherence, satisfaction, and resource requirements between electronic and traditional data collection in a perioperative pain trial.
• To assess the feasibility of Internet-based electronic submission versus paper diaries and telephone interviews.

Main Methods:

• An open-label, two-arm parallel randomized controlled trial involving women (18-75 years) undergoing breast cancer surgery.
• Participants were randomized to either electronic or traditional data collection for pain-related questionnaires at baseline, post-operation, and 3-month follow-up.
• Data collected included data queries, medication compliance, data completeness, loss to follow-up, patient/research assistant satisfaction, time, and costs.

Main Results:

• The electronic data group had significantly more data queries per patient (4.92 vs. 1.88; P < 0.001).
• No significant differences were found in medication compliance, data completeness, loss to follow-up, or satisfaction.
• Traditional data collection required more research assistant time (42.6 min vs. 9.92 min; P < 0.001), but electronic data collection incurred higher costs ($176.85 vs. $16.33; P < 0.001).

Conclusions:

• Electronic data collection is a feasible method for perioperative pain clinical trials.
• Further trials across different surgical populations are necessary to validate these findings and refine electronic data capture strategies.
• Optimization of electronic data capture methods is recommended for future perioperative pain research.