Department of Pediatrics, College of Medicine, Texas A&M University, College Station, TX, USA.
J Pediatr Gastroenterol Nutr. 2012 May;54(5):664-71. doi: 10.1097/MPG.0b013e31823c9b88.
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.
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.
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.
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.
本定性研究的目的是为功能性胃肠病（FGID）和器质性胃肠病（OGID）患儿的儿科生活质量量表（PedsQL）胃肠道症状模块开发项目并提供其内容效度。
迭代过程包括多阶段定性方法。对胃肠道疾病进行文献回顾，为重点访谈生成领域。6 位在胃肠道疾病方面具有丰富临床经验的儿科胃肠病专家就概念框架提供了专家意见。共有 98 名参与者，包括 46 名年龄在 5 至 18 岁的儿科患者和 52 名年龄在 2 至 18 岁的患儿家长，他们均经医生诊断患有胃肠道疾病（慢性便秘、功能性腹痛、肠易激综合征、炎症性肠病[克罗恩病、溃疡性结肠炎]、胃食管反流病），参与了重点访谈和认知访谈阶段，包括出声思维和认知剖析协议。
从涉及患者和家长访谈以及专家意见的定性方法中得出了 11 个领域，内容达到了饱和，产生了 76 个项目。这 11 个领域包括测量胃痛、胃部不适、饮食限制、吞咽困难、烧心和反流、气体和腹胀、便秘、腹泻、担忧、药物和沟通的项目。
在项目生成过程中纳入儿科患者及其父母的定性方法支持了新的 PedsQL 胃肠道症状模块的内容效度。PedsQL 胃肠道症状模块正在作为下一迭代阶段进行全国多地点现场测试。
