Abstract

INTRODUCTION: The irregular and unpredictable bowel movements (BM) and leakage events makes it challenging for patients with fecal incontinence (FI) to accurately recall, describe or quantify stool habit. Although paper stool diary has been used in clinical trials, patients find these diary entries cumbersome or embarrassing and has not gained popular use. Cell phone apps provides a unique opportunity to instantly record BM and FI events and protect privacy. We developed an electronic FI stool diary app and assessed its reliability/reproducibility and psychometrics and compared this with paper stool diary. METHODS: In a randomized cross-over study, FI patients (≥1 FI episode/week), completed both a paper and app diary for 2 weeks each. The 10-item diary recorded number of bowel movements (BM), FI leakage events, severity and associated symptoms. Also, we assessed functionality and ease of use. Data was assessed and compared for reliability, reproducibility, validity and separately for ease of use (Visual analogue scale, VAS scores 0-10). Intraclass correlation coefficients (ICC) assessed equivalence. RESULTS: Ten patients (18.7 ± 5.9 years, F/M = 9/1) completed assessments for this analysis. The app showed significant correlation between pad use, stool frequency and percentage of BM with urgency (ICC >0.703) between week 1 and week 2, and demonstrated high reliability and test-retest reproducibility (Table 1). The weekly FI episodes trended towards significant correlation between week 1 and week 2 (ICC = 0.676, P = 0.054). The mean stool consistency (ICC = 0.944, P < 0.0001), number of normal (Bristol Stool Form Scale, BSFS type 3-5) and loose stools (BSFS type 6-7) were significantly correlated between week 1 and week 2. The number of FI episodes and use of pads over 2 weeks in app were significantly correlated with paper stool diary (ICC >0.812). Also, stool frequency, percentage of BM with urgency, stool consistency, number of normal and loose stools were significantly correlated with paper diary. The psychometrics parameters were significantly better (P < 0.01) compared to paper diary, but other parameters although better were not significant (Table 3). CONCLUSION: The App is a reliable and reproducible instrument for documenting and assessing FI symptoms, and demonstrates comparable accuracy against paper diary. This user-friendly diary could improve our ability to provide optimal care for FI patients by accurately characterizing their symptoms.

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