USE OF A NOVEL ELECTRONIC DATA-COLLECTION SYSTEM IN MULTICENTER STUDIES OF IRRITABLE-BOWEL-SYNDROME

Background: The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper a ssessment of potential therapeutic agents. Historically, data have bee n collected on paper diary cards, which patients were requested to fil l out at a specified interval. However, with paper diary cards it is n ot possible to determine whether the cards are filled out as required, or at random times. To circumvent this problem, a novel electronic da ta collection system that ensures the reliability and security of data entry was used. Methods: Data were collected from 640 patients during the 2-week screening and 12-week treatment phases of two multicentre trials of IBS. The electronic data collection system used was based up on a touchtone telephone system. Results: The electronic data collecti on system had a potential 8135 up-time hours during the study. An upti me of 8040 h and down-time of 95 h was observed. This corresponds to a n up-time of approximately 99%. Patient compliance for data entry in t he two studies was 81% and 83%, respectively. On a single random day d uring their daily telephone call, patients were asked questions to ass ess satisfaction with the system. On aggregate, 79% of patients were s atisfied or very satisfied with the system, only 10% were dissatisfied or very dissatisfied. Conclusion: A unique electronic data collection system was tested for use in clinical studies in IBS. This system pro vided 100% reliability as to the date of data entry, and data were not subject to modification once entered. This methodology represents a m arked advancement in clinical studies of IBS.