Ho Leonard Tf, Chung Vincent Ch, Wong Charlene Hl, Wu Irene Xy, Lan Kun Chan, Wu Darong, Yeung Jerry Wf, Zhang Nevin L, Leung Ting Hung, Wu Justin Cy
School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.
The Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.
Integr Med Res. 2021 Sep;10(3):100713. doi: 10.1016/j.imr.2020.100713. Epub 2020 Dec 24.
in Traditional Chinese Medicine (TCM) has been recognised by the eleventh revision of the International Classification of Diseases (ICD-11). Accurate pattern diagnosis requires reliable and valid diagnostic instruments that guide the collection of TCM clinical data without bias. This study synthesised the existing TCM diagnostic instruments for functional dyspepsia (FD) and appraised their quality regarding their development process and measurement properties.
Seven electronic databases were searched for validation studies on TCM diagnostic instruments for FD. Synthesis and appraisal of the included studies were performed following the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) Initiative guidelines adapted for TCM diagnostic instruments. Risk of bias assessment was conducted using the .
Five studies were included, with five unique TCM diagnostic instruments for FD identified. All five diagnostic instruments were of inadequate quality in terms of their development process, implying a shortcoming in their relevance, comprehensibility, and comprehensiveness. Only the criterion validity of was of sufficient quality and had no risk of bias in its validation.
The quality of TCM diagnostic instruments for FD warrants urgent improvements. None of them was considered reliable or valid for guiding TCM pattern diagnosis. To support the evidence base of the standardization of TCM patterns in ICD-11, TCM diagnostic instruments should be developed and validated rigorously under the COSMIN guidelines. Amendments should be made on the guidelines to accommodate the features and uniqueness of TCM diagnostic process.
中医已被《国际疾病分类》（ICD - 11）第十一次修订版认可。准确的证型诊断需要可靠且有效的诊断工具，以无偏倚地指导中医临床数据的收集。本研究综合了现有的功能性消化不良（FD）中医诊断工具，并对其在开发过程和测量属性方面的质量进行了评估。
检索了七个电子数据库，以查找关于FD中医诊断工具的验证研究。按照适用于中医诊断工具的COSMIN（基于共识的健康测量工具选择标准）倡议指南，对纳入研究进行综合和评估。使用……进行偏倚风险评估。
纳入了五项研究，确定了五种用于FD的独特中医诊断工具。所有这五种诊断工具在其开发过程方面质量均不足，这意味着它们在相关性、可理解性和全面性方面存在缺陷。只有……的效标效度质量足够，且在其验证过程中无偏倚风险。
FD中医诊断工具的质量亟待提高。它们中没有一个被认为对于指导中医证型诊断是可靠或有效的。为了支持ICD - 11中中医证型标准化的证据基础，应在COSMIN指南下严格开发和验证中医诊断工具。应修订指南以适应中医诊断过程的特点和独特性。
