Faculty Collaboration Database

Assessment of abdominal pain through global outcomes and recent FDA recommendations in children: are we ready for change? J Pediatr Gastroenterol Nutr 2014 Jan;58(1):46-50

Date

07/17/2013

Pubmed ID

23857339

Pubmed Central ID

PMC4641447

DOI

10.1097/MPG.0b013e3182a20764

Scopus ID

2-s2.0-84893641836 (requires institutional sign-in at Scopus site)   19 Citations

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.

Author List

Mohammad S, Di Lorenzo C, Youssef NN, Miranda A, Nurko S, Hyman P, Saps M

Author

Adrian Miranda MD Adjunct Professor in the Pediatrics department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Abdominal Pain
Activities of Daily Living
Adolescent
Amitriptyline
Analgesics, Non-Narcotic
Child
Disability Evaluation
Female
Humans
Irritable Bowel Syndrome
Male
Patient Satisfaction
Practice Guidelines as Topic
Severity of Illness Index
Surveys and Questionnaires
United States
United States Food and Drug Administration