中国全科医学 ›› 2022, Vol. 25 ›› Issue (29): 3672-3677.DOI: 10.12114/j.issn.1007-9572.2022.0038

所属专题: 中医最新文章合集 患者报告结局最新文章合集

• 论著·中医研究 • 上一篇    下一篇

基于中医理论构建炎症性肠病患者报告结局量表及条目筛选研究

罗建峰1, 侯江涛2, 侯政昆2, 彭彬3, 李辉标2, 刘诗颖1, 何镇帆1, 钟嘉敏1, 张诗静1, 刘凤斌2,*(), 陈新林1,*()   

  1. 1.510006 广东省广州市,广州中医药大学基础医学院
    2.510405 广东省广州市,广州中医药大学第一附属医院
    3.510405 广东省广州市,广州中医药大学第一临床医学院
  • 收稿日期:2021-12-16 修回日期:2022-02-10 出版日期:2022-10-15 发布日期:2022-04-28
  • 通讯作者: 刘凤斌, 陈新林
  • 罗建峰,侯江涛,侯政昆,等.基于中医理论构建炎症性肠病患者报告结局量表及条目筛选研究[J].中国全科医学,2022,25(29):3672-3677. [www.chinagp.net]
    作者贡献:罗建峰参与研究的设计、实施、统计分析并承担论文的写作;侯江涛、侯政昆、彭彬、李辉标、刘诗颖、张诗静参与研究的设计、调查开展;何镇帆、钟嘉敏负责数据的录入与管理;刘凤斌、陈新林提出研究概念,设计并承担项目管理、监督,负责论文的审查及校对,对文章整体负责。
  • 基金资助:
    国家自然科学基金面上项目(81774451); 国家自然科学基金青年科学基金项目(82104501); 广州中医药大学"薪火计划"(XH20190102)

Development and Item Selection of the Inflammatory Bowel Disease Patient-reported Outcomes Scale Based on Theories of Traditional Chinese Medicine

Jianfeng LUO1, Jiangtao HOU2, Zhengkun HOU2, Bin PENG3, Huibiao LI2, Shiying LIU1, Zhenfan HE1, Jiamin ZHONG1, Shijing ZHANG1, Fengbin LIU2,*(), Xinlin CHEN1,*()   

  1. 1. School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou 510006, China
    2. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China
    3. The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, China
  • Received:2021-12-16 Revised:2022-02-10 Published:2022-10-15 Online:2022-04-28
  • Contact: Fengbin LIU, Xinlin CHEN
  • About author:
    LUO J F, HOU J T, HOU Z K, et al. Development and item selection of the inflammatory bowel disease patient-reported outcomes scale based on theories of traditional Chinese medicine[J]. Chinese General Practice, 2022, 25 (29) : 3672-3677.

摘要: 背景 我国炎症性肠病(IBD)患病人数逐年增加,中西医结合治疗有助于缓解和控制患者的症状。生存质量是IBD临床疗效评价的重要指标,但少见文献报道基于中医理论研发的IBD患者报告结局(PROs)量表。 目的 基于中医理论构建IBD PROs量表,确定IBD PROs量表的概念框架和条目。 方法 遵循国际量表研发流程与规范研制IBD PROs量表。以中医理论"形神合一、天人相应"为指导,采用文献研究、核心小组讨论、专家咨询等方法,构建IBD PROs量表的概念框架,产生条目池,确立条目,形成初始量表。使用初始量表对2021年1—6月就诊于广州中医药大学第一附属医院脾胃病科的IBD患者进行预调查。应用离散趋势法、克朗巴赫系数法、相关系数法对初始量表进行条目筛选。 结果 IBD PROs量表由"形神合一""天人相应"两个维度组成,其中"形神合一"的"形体"方面纳入12个条目,"情志"方面纳入9个条目,"天人相应"维度纳入6个条目。 结论 基于中医理论构建的IBD PROs量表,可用于评价IBD患者的生存质量,仍需进一步开展临床研究验证该量表的信效度。

关键词: 炎症性肠病, 患者报告结局, 中医理论, 生存质量, 条目筛选, 量表构建

Abstract:

Background

The prevalence of inflammatory bowel disease (IBD) increases annually in China. The integrated traditional Chinese and western medicine is helpful to alleviate and control symptoms of IBD. Quality of life (QoL) is an important index to evaluate the clinical efficacy of IBD. However, there are few studies about IBD patient-reported outcomes (PROs) based on TCM theories.

Objective

To determine the framework and items, and then use them to develop the IBD PROs scale using TCM theories.

Methods

Under the guidance of the TCM theory of "body and mind harmony, and man's adaptation to his total environment" , literature review, core-group discussion and expert consultation were carried out. The conceptual framework and item pool of the draft of an IBD PROs scale were developed, then the corresponding items were determined, forming the draft of the IBD PROs scale. Then the draft scale was pre-tested in IBD patients treated in Department of Spleen and Stomach Diseases, the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January to June 2021. The dispersion tendency, Cronbach's α and correlation analysis were used for further item selection.

Results

The final IBD PROs scale is composed of two domains: body and mind harmony (12 body-related items, and 9 mind-related items) and man's adaptation to his total environment (6 items) .

Conclusion

The IBD PROs scale developed based on theories of TCM could be used to evaluate the QoL of IBD patients. But further clinical research is still needed to verify its reliability and validity.

Key words: Inflammatory bowel disease, Patient-reported outcomes, TCM theories, Quality of life, Item selection, Construction of scale