Department of Pediatrics, College of Medicine, Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, College Station, TX.
Department of Pediatrics, Baylor College of Medicine, Children's Nutrition Research Center, Texas Children's Hospital, Houston, TX.
J Pediatr Gastroenterol Nutr. 2021 Aug 1;73(2):192-196. doi: 10.1097/MPG.0000000000003146.
Like adults, children suffer from gastroparesis; however, there are currently no validated instruments to determine the impact of gastroparesis in pediatric patients. The objective of this study was to develop the items and domains to support the content validity of the new Pediatric Quality of Life Inventory (PedsQL™) Gastroparesis Symptoms Module.
Patients were recruited from the National Institute of Diabetes and Digestive and Kidney Diseases Pediatric Gastroparesis Registry. The qualitative methods involved an iterative process comprising a literature review of existing questionnaires and gastroparesis clinical research, an expert review panel of pediatric gastroenterologists who provided feedback on the conceptual framework in developing the semi-structured interview, and in-depth focus interviews with six pediatric patients with gastroparesis and five of their parents (one did not participate) in developing relevant domains and item content. In the subsequent cognitive interviews phase, five additional patients with gastroparesis and their parents provided detailed feedback on item content, relevance, importance, and understandability of the domains and items.
Ten domains/scales were derived from the qualitative methods, with item content saturation achieved at 67 items, with no further themes or content identified during the final cognitive interviews. The Module is comprised of 10 individual scales measuring nausea, stomach fullness when eating, vomiting, dry heaves, heartburn and reflux, stomach pain and hurt, food and drink limits, bloating, appetite, and worry.
Our study supports the content validity of the new PedsQL Gastroparesis Symptoms Module. The Module field test study will be conducted in a multisite national study.
与成人一样，儿童也会患有胃轻瘫；然而，目前尚无经过验证的工具来确定胃轻瘫对儿科患者的影响。本研究的目的是开发项目和领域，以支持新的儿科生活质量问卷（PedsQL™）胃轻瘫症状模块的内容效度。
患者从美国国立卫生研究院糖尿病、消化和肾脏疾病研究所儿科胃轻瘫登记处招募。定性方法包括一个迭代过程，包括对现有问卷和胃轻瘫临床研究的文献回顾、儿科胃肠病专家的专家审查小组对制定半结构化访谈的概念框架提供反馈，以及对 6 名患有胃轻瘫的儿科患者及其 5 名家长（其中 1 名家长未参与）进行深入焦点访谈，以制定相关领域和项目内容。在随后的认知访谈阶段，另外 5 名患有胃轻瘫的患者及其家长对领域和项目的内容、相关性、重要性和可理解性提供了详细的反馈。
从定性方法中得出了 10 个领域/量表，通过 67 个项目实现了项目内容的饱和，在最后的认知访谈中没有发现进一步的主题或内容。该模块由 10 个单独的量表组成，用于测量恶心、进食时饱腹感、呕吐、干呕、烧心和反流、胃痛和疼痛、食物和饮料限制、腹胀、食欲和担忧。
我们的研究支持新的 PedsQL 胃轻瘫症状模块的内容效度。该模块的现场测试研究将在一项多地点的全国性研究中进行。
