Assessment of Abdominal Pain Through Global Outcomes and Recent FDA Recommendations in Children

Objectives: Irritable bowel syndrome is a multisymptom construct, with abdominal pain (AP) acting as the driving symptom of patient‐reported severity. The Food and Drug Administration considers a >30% decrease in AP as satisfactory improvement, but this has not been validated in children. We investigated the correspondence of 2 measures for AP assessment, ≥30% improvement in AP and global assessment of improvement. Methods: Secondary analysis of data from 72 children who completed a randomized clinical trial for abdominal pain–associated functional gastrointestinal disorders. Children completed daily assessment of AP intensity, functional disability inventory (FDI), question regarding pain's interference with activities, and 2 global assessment questions. We measured the extent to which ≥30% improvement of AP and global assessment questions correlated with each other and with disability. Results: The global questions correlated with each other ( r = 0.74; P < 0.0001) and with a ≥30% improvement in AP ( P < 0.01). Global outcomes were satisfaction with treatment was inversely related to the child's report of interference with activities ( P < 0.01) and symptom relief was positively associated with ≥30% improvement in FDI scores ( P < 0.009). A 30% change in FDI scores was associated with global questions of symptom relief ( P = 0.009) but not with satisfaction with treatment ( P = 0.07). The association of AP improvement with interference with activities ( P = 0.14) or change in FDI scores ( P = 0.27) did not reach significance. Conclusions: Currently used global assessments are significantly associated with decreased pain intensity, decreased interference with daily activities, and a ≥30% change in FDI scores, whereas recommended 30% improvement in pain intensity is not as comprehensive.