Assessment of abdominal pain through global outcomes and recent FDA recommendations in children: are we ready for change?

Mohammad, S.; Di Lorenzo, C.; Youssef, N. N.; Miranda, A.; Nurko, S.; Hyman, P.; Saps, M.

J Pediatr Gastroenterol Nutr. 2013 Jul 17; 58(1):46-50

Abstract

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.

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