PedsQL gastrointestinal symptoms scales and gastrointestinal worry scales in pediatric patients with inflammatory bowel disease in comparison with healthy controls

Authors: VARNI, JAMES - Texas A&M University; FRANCIOSI, JAMES - Cincinnati Children'S Research Hospital; SHULMAN, ROBERT - Children'S Nutrition Research Center (CNRC); SAEED, SHEHZAD - Cincinnati Children'S Research Hospital; NURKO, SAMUEL - Boston Children'S Hospital; NEIGUT, DEBORAH - Children'S Hospital - Denver, Colorado; BENDO, CRISTIANE - Federal University Of Minas Gerais; PATEL, ASHISH - University Of Texas Southwestern Medical Center; SELF, MARIELLA - Baylor College Of Medicine; SAPS, MIGUEL - Northwestern University; ZACUR, GEORGE - Cincinnati Children'S Research Hospital; DENHAM, JOLANDA - Ohio University; DARK, CHELSEA - Texas A&M University; POHL, JOHN - Primary Children'S Medical Center

Submitted to: Inflammatory Bowel Diseases
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/22/2015
Publication Date: 5/19/2015
Citation: Varni, J.W., Franciosi, J.P., Shulman, R.J., Saeed, S., Nurko, S., Neigut, D.A., Bendo, C.B., Patel, A.S., Self, M.M., Saps, M., Zacur, G.M., Denham, J., Dark, C.V., Pohl, J.F. 2015. PedsQL gastrointestinal symptoms scales and gastrointestinal worry scales in pediatric patients with inflammatory bowel disease in comparison with healthy controls. Inflammatory Bowel Diseases. (5)21:1115-1124.

Interpretive Summary: It is becoming more and more important to let patients describe how they do or do not respond to a treatment of gastrointestinal symptoms; these are called patient reported outcomes (PROs). In this study, we tested whether a questionnaire we developed could be used for PROs in children with chronic inflammatory bowel diseases – Crohn's disease and ulcerative colitis. Our results showed that the questionnaire could be used for PROs in this group of children and the results could be compared to those of healthy children. This tool will help clinicians have a better understanding of the health and well-being of children.

Technical Abstract: Patient-reported outcomes are essential in determining the broad impact of inflammatory bowel disease (IBD) and treatments from the patient's perspective. The primary study objectives were to compare the gastrointestinal symptoms and worry of pediatric patients with IBD with matched healthy controls and to compare Crohn's disease and ulcerative colitis with each other using the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms and Gastrointestinal Worry Scales. PedsQL Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 256 pediatric patients with IBD and 259 parents of patients (263 families; Crohn's disease [n = 195], ulcerative colitis [n = 68]). Ten 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 2 Gastrointestinal Worry Scales. A matched group of 384 healthy children families completed the PedsQL in an Internet survey. PedsQL Gastrointestinal Symptoms and Worry Scales distinguished between pediatric patients with IBD in comparison with healthy controls (P < 0.001), with larger effect sizes for symptoms indicative of IBD, supporting known-groups validity and clinical interpretability including minimal important difference scores. Patients with Crohn's disease or ulcerative colitis did not demonstrate significantly different gastrointestinal symptoms or worry in comparison with each other. The PedsQL Gastrointestinal Symptoms and Worry Scales may be used as common metrics across pediatric patients with IBD, including Crohn's disease and ulcerative colitis separately to measure gastrointestinal-specific symptoms in clinical research and practice.