Pediatric Functional Constipation Gastrointestinal Symptom Profile Compared With Healthy Controls.

OBJECTIVES: Patient-reported outcomes are necessary to evaluate the gastrointestinal symptom profile of patients with functional constipation. Study objectives were to compare the gastrointestinal symptom profile of pediatric patients with functional constipation with matched healthy controls with the Pediatric Quality of Life Inventory Gastrointestinal Symptoms and Gastrointestinal Worry Scales and to establish clinical interpretability in functional constipation through identification of minimal important difference (MID) scores. The secondary objective compared the symptom profile of patients with functional constipation with patients with irritable bowel syndrome (IBS). METHODS: Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 116 pediatric patients with functional constipation and 188 parents. Gastrointestinal Symptoms Scales measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea were administered along with Gastrointestinal Worry Scales. A total of 341 families with healthy children and 43 families with patients with IBS completed the scales. RESULTS: A broad profile of gastrointestinal symptoms and worry were reported by patients with functional constipation in comparison with healthy controls (P < 0.001) with large effect sizes (>0.80) across the majority of symptom domains. Patients with IBS manifested a broader symptom profile than functional constipation, with differences for stomach pain, stomach discomfort when eating, and worry about stomachaches, with similar constipation scores. CONCLUSIONS: Pediatric patients with functional constipation report a broad gastrointestinal symptom profile in comparison with healthy controls and only somewhat fewer symptoms than patients with IBS, highlighting the critical need for more efficacious interventions to achieve healthy functioning.

Interpretability of the PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in Pediatric Patients With Functional and Organic Gastrointestinal Diseases.

OBJECTIVE: The present study investigates the clinical interpretability of the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Scales and Worry Scales in pediatric patients with functional gastrointestinal disorders or organic gastrointestinal diseases in comparison with healthy controls. METHODS: The PedsQL™ Gastrointestinal Scales were completed by 587 patients with gastrointestinal disorders/diseases and 685 parents, and 513 healthy children and 337 parents. Minimal important difference (MID) scores were derived from the standard error of measurement (SEM). Cut-points were derived based on one and two standard deviations (SDs) from the healthy reference means. RESULTS: The percentages of patients below the scales' cut-points were significantly greater than the healthy controls (most p values ≤ .001). Scale scores 2 SDs from the healthy reference means were within the range of scores for pediatric patients with a gastrointestinal disorder. MID values were generated using the SEM. CONCLUSIONS: The findings support the clinical interpretability of the new PedsQL™ Gastrointestinal Symptoms Scales and Worry Scales.