PedsQL gastrointestinal symptoms module item development: qualitative methods.
OBJECTIVE
The objective of the present qualitative study was to develop the items and support the content validity for the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for pediatric patients with functional gastrointestinal (GI) disorders and organic GI diseases, hereafter referred to as GI disorders.


METHODS
The iterative process included multiphase qualitative methods. A literature review of GI disorders was conducted to generate domains for the focus interviews. Six pediatric gastroenterologists with extensive clinical experience in GI disorders provided expert opinion regarding the conceptual framework. A total of 98 participants, 46 pediatric patients ages 5 to 18, and 52 parents of patients ages 2 to 18 with physician-diagnosed GI disorders (chronic constipation, functional abdominal pain, irritable bowel syndrome, inflammatory bowel disease [Crohn disease, ulcerative colitis], gastroesophageal reflux disease), participated in the focus interviews and cognitive interviewing phases, including think-aloud and cognitive debriefing protocols.


RESULTS
Eleven domains were derived from the qualitative methods involving patient and parent interviews and expert opinion, with content saturation achieved, resulting in 76 items. The 11 domains consisted of items measuring stomach pain, stomach upset, food and drink limits, trouble swallowing, heartburn and reflux, gas and bloating, constipation, diarrhea, worry, medicines, and communication.


CONCLUSIONS
Qualitative methods involving pediatric patients and their parents in the item generation process support the content validity for the new PedsQL Gastrointestinal Symptoms Module. The PedsQL Gastrointestinal Symptoms Module is undergoing national multisite field testing as the next iterative phase.
Department of Pediatrics, College of Medicine, Texas A&M University, College Station, TX, USA. jvarni@arch.tamu.edu
James W
JW
Varni
Marie T
MT
Kay
Christine A
CA
Limbers
James P
JP
Franciosi
John F
JF
Pohl
D015746:Abdominal Pain / Q000150:complications / Q000503:physiopathology; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000150:complications / Q000503:physiopathology; D005260:Female; D017144:Focus Groups; D005767:Gastrointestinal Diseases / Q000150:complications / Q000503:physiopathology*; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D010290:Parents; D010372:Pediatrics / Q000379:methods*; D036301:Qualitative Research; D011788:Quality of Life; D015203:Reproducibility of Results; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires