中医脾胃系疾病PRO量表的研制与条目筛选

目的：在中医理论指导下研制中医脾胃系疾病PRO量表,丰富和发展国际量表体系。方法：遵照国际通用量表研制的程序化方法，在中医理论指导下,结合国际PRO相关概念内涵,建立中医脾胃系疾病PRO量表的理论模型、建立条目池、编制初选量表和临床调查。结果：通过对调查结果进行重要性评分、离散趋势分析、因子分析、逐步回归分析、判别分析法和克朗巴赫系数法等分析方法进一步筛选条目,选择4个以上分析方法选中的条目，最后形成了由4个领域、8个方面和44个条目组成的中医脾胃系疾病PRO量表。结论：中医脾胃系疾病PRO量表是严格按照国际量表研制的操作原则和方法进行，科学性强，结论可信，有利于临床研究中推广应用。

Establishment of the spleen-stomach patients reported outcomes scale in Chinese medicine and the corresponding item selection

Guided by the theories of traditional Chinese medicine, a spleen-stomach patients reported outcomes scale (CM-SSPRO) was established to evaluate the effect of Chinese medicine. According to the routine protocol, in combination with the relevant international PRO concepts, the CM-SSPRO scale was built up step by step as follows: (1) a theoretical model and an item pool of CM-SSPRO were established; (2) the primary scale was edited and piled; (3) the CM-SSPRO scale was put into the clinical trial. After the item selection by a series of statistical analyses, including discrete tendency (coefficient of variation) analysis, principal component analysis, factor analysis, cluster analysis, stepwise regression analysis, discriminant analysis and Cronbach's a, the items which simultaneously satisfied at least 4 analyses mentioned above were picked out and formed the CM-SSPRO scale consisting of 4 domains, 8 facets and 44 items. The establishment of the CM-SSPRO scale strictly conformed to the international rule and protocol. This scale is not only scientifically reliable and has potential application in clinics, but also , enriches and develops the current international scale system