Suppr超能文献

《加利福尼亚大学洛杉矶分校硬皮病临床试验联盟胃肠道仪器日本版的可靠性、有效性和敏感性:在静脉注射免疫球蛋白给药疗效评估中的应用》

Reliability, validity, and sensitivity of the Japanese version of the University of California Los Angeles scleroderma clinical trial consortium gastrointestinal tract instrument: Application to efficacy assessment of intravenous immunoglobulin administration.

机构信息

Department of Dermatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Department of Clinical Cannabinoid Research, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

出版信息

J Dermatol. 2024 Jun;51(6):741-751. doi: 10.1111/1346-8138.17202. Epub 2024 Apr 1.

Abstract

This study aimed to develop and assess the reliability, validity, and sensitivity of the Japanese version of the University of California Los Angeles Scleroderma Clinical Trial Consortium gastrointestinal tract (GIT) Instrument 2.0 (the GIT score), as an evaluation tool for GIT symptoms in systemic sclerosis (SSc). The Japanese version of the GIT score was constructed using the forward-backward method. The reliability and validity of this instrument were evaluated in a cohort of 38 SSc patients. Correlation analysis was conducted to assess the relationship between the GIT score and existing patient-reported outcome measures. Additionally, the sensitivity of the GIT score was examined by comparing GIT scores before and after intravenous immunoglobulin (IVIG) administration in 10 SSc-myositis overlap patients, as IVIG has recently demonstrated effectiveness in alleviating GIT symptoms of SSc. As a result, the Japanese version of the GIT score exhibited internal consistency and a significant association with the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease. Furthermore, the total GIT score, as well as the reflux and distention/bloating subscales, displayed moderate correlations with the EuroQol 5 dimensions (EQ-5D) pain/discomfort subscale and the Short Form-36 body pain subscale. Notably, following IVIG treatment, there was a statistically significant reduction in the total GIT score and multiple subscales. We first validated the Japanese version of the GIT score in Japanese SSc patients in real-world clinical settings. This instrument holds promise for application in future clinical trials involving this patient population.

摘要

本研究旨在开发和评估日本版加利福尼亚大学洛杉矶硬皮病临床试验联盟胃肠道(GIT)工具 2.0(GIT 评分)的可靠性、有效性和敏感性,作为系统性硬化症(SSc)GIT 症状的评估工具。使用前后向翻译法构建了 GIT 评分的日语版。在 38 名 SSc 患者的队列中评估了该工具的可靠性和有效性。通过分析 GIT 评分与现有患者报告结局测量之间的相关性,评估了该仪器的有效性。此外,在 10 名 SSc-肌炎重叠患者中比较了 GIT 评分在静脉注射免疫球蛋白(IVIG)治疗前后的变化,以评估 GIT 评分的敏感性,因为 IVIG 最近已被证明可有效缓解 SSc 的 GIT 症状。结果表明,GIT 评分的日语版具有内部一致性,并与胃食管反流病症状频率量表显著相关。此外,总 GIT 评分以及反流和扩张/腹胀子量表与欧洲五维健康量表(EQ-5D)疼痛/不适子量表和健康调查简表 36 项身体疼痛子量表具有中度相关性。值得注意的是,在 IVIG 治疗后,总 GIT 评分和多个子量表均显著降低。我们首次在现实临床环境中验证了日本版 GIT 评分在日本 SSc 患者中的适用性。该工具有望在未来涉及该患者群体的临床试验中得到应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1301/11483899/61bc456bad7a/JDE-51--g002.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验