Assessment of Abdominal Pain Through Global Outcomes and Recent FDA Recommendations in Children: Are We Ready for Change?

作者:Mohammad Saeed*; Di Lorenzo Carlo; Youssef Nader N; Miranda Adrian; Nurko Samuel; Hyman Paul; Saps Miguel
来源:Journal of Pediatric Gastroenterology and Nutrition, 2014, 58(1): 46-50.
DOI:10.1097/MPG.0b013e3182a20764

摘要

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 %26gt;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%26apos;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%26lt;0.0001) and with a 30% improvement in AP (P%26lt;0.01). Global outcomes were satisfaction with treatment was inversely related to the child%26apos;s report of interference with activities (P%26lt;0.01) and symptom relief was positively associated with 30% improvement in FDI scores (P%26lt;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.