痔疾病患者报告临床结局评估量表初探

Development and Assessment of Patient Reported Outcome Assessment Scale for Hemorrhoids

目的:在中医理论指导下研制中医痔疾病患者报告结局(patient reported outcome,PRO)量表,从患者角度出发,为中医痔疾病临床疗效评价提供客观化、标准化的测量工具。方法:根据《中医肛肠科常见病诊疗指南》、PRO研究目标及制作指南,参考社会研究方法学,在医生客观检查、痔患者自评及心理学问卷调查法基础上,结合中医辨证分型,形成基于PRO的痔疾病临床疗效评估量表。调查261例痔患者,运用克隆巴赫系数(Cronbach'sα)法、探索性因素分析、判别分析等统计学方法全面评估量表性能。结果:总量表的Cronbach'sα系数为0.855;Spearman-Browm分半信度为0.691,Guttman分半信度为0.677;各领域之间的相关系数范围为0.261~0.536,各领域与总量表的相关系数范围为0.643~0.758;共提取6个公因子,累计方差贡献率为60.118%。结论:该量表具有较好的信度、效度,可建立判别分析函数,用于痔疾病临床疗效评价、治疗方案筛选和标准优化。

Objective:To provide an objective and standardized measurement tool for the evaluation of the clinical efficacy of TCM hemorrhoidal diseases from the patient's point of view by developing a patient reported outcome(PRO)scale under the guidance of traditional Chinese medicine(TCM)theory.Methods:According to the Guidelines for Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Anorectal Medicine,the objectives of the PRO study and the guidelines,and with reference to the methodology of social research,the PRO-based hemorrhoid efficacy assessment scale was formed on the basis of the objective examination by doctors,self-assessment of hemorrhoid patients and psychological questionnaire method,combined with the traditional Chinese medicine(TCM)syndrome differentiation and typing.261 hemorrhoid patients were investigated using statistical methods such as Cronbach'sαmethod,exploratory factor analysis,and discriminant analysis to comprehensively assess the performance of the scale.Results:The Cronbach'sαcoefficient of the total scale was 0.855;the Spearman-Browm split reliability was 0.691,and the Guttman split reliability was 0.677;the correlation coefficients between the domains ranged from 0.261 to 0.536,and the correlation coefficients between the domains and the total scale ranged from 0.643 to 0.758;a total of six common factors were extracted,and the cumulative variance contribution was 60.118%.Conclusion:The scale with good reliability and validity,can establish discriminant analysis function,which can be used for clinical efficacy evaluation of hemorrhoidal diseases,treatment plan screening and standard optimization.