BACKGROUND: Self-report items from the Crohn's Disease Activity Index (CDAI) are completed using a 7-day paper diary; however, there are reports of protocol deviations by both patients and researchers/clinicians. The self-report literature has demonstrated these deviations can distort the information collected by introducing recall bias, especially for subjective measures like pain and well-being. PURPOSE: The purpose of this pilot study is to evaluate the feasibility of using an electronic diary to collect symptom self-reports. METHODS: Sixteen patients with Inflammatory Bowel Disease completed entries on the diary 12 times per day for 3 weeks. The diary included "user-friendly" features that made it easier to incorporate into their daily lives. RESULTS: Despite 2 compliance outliers, the overall compliance was 88%; when these outliers were removed compliance increased to 92%. Participants used the diary features appropriately and completed a substantial number of assessments per day. Although overall compliance declined significantly over the 3-week study period, the number of prompts completed did not change significantly over time. CONCLUSIONS: Limitations include the small sample size, but despite this limitation this report supports the feasibility of collecting symptom information using an electronic diary. Future studies are needed to evaluate the possibility of using an electronic diary to collect the CDAI self-report information in both clinical and research settings.
BACKGROUND: Self-report items from the Crohn's Disease Activity Index (CDAI) are completed using a 7-day paper diary; however, there are reports of protocol deviations by both patients and researchers/clinicians. The self-report literature has demonstrated these deviations can distort the information collected by introducing recall bias, especially for subjective measures like pain and well-being. PURPOSE: The purpose of this pilot study is to evaluate the feasibility of using an electronic diary to collect symptom self-reports. METHODS: Sixteen patients with Inflammatory Bowel Disease completed entries on the diary 12 times per day for 3 weeks. The diary included "user-friendly" features that made it easier to incorporate into their daily lives. RESULTS: Despite 2 compliance outliers, the overall compliance was 88%; when these outliers were removed compliance increased to 92%. Participants used the diary features appropriately and completed a substantial number of assessments per day. Although overall compliance declined significantly over the 3-week study period, the number of prompts completed did not change significantly over time. CONCLUSIONS: Limitations include the small sample size, but despite this limitation this report supports the feasibility of collecting symptom information using an electronic diary. Future studies are needed to evaluate the possibility of using an electronic diary to collect the CDAI self-report information in both clinical and research settings.
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