痰浊证中医疗效评价量表的考评

Evaluation of the medical efficacy evaluation scale in phlegm turbidity syndrome

目的:对痰浊证中医疗效患者自评量表的信度、效度及反应度进行考评。方法:采用本课题组前期研制的痰浊证中医疗效患者自评量表,现场调查痰浊证患者及体检健康者,对量表的可行性(量表完成率、接受率及完成时间)、信度(重测信度、内部一致性信度)、效度(内容效度、结构效度、效标效度)及反应度进行考评。结果:本研究共纳入受试者201例,其中痰浊证患者115例,正常健康者86例。量表的接受率为96.63%,完成率为100%,完成时间中位数为2min。量表总分的重测信度为0.896,各维度和各条目的重测信度均>0.7。总表的克朗巴赫系数为0.643,9个条目依次删除后,克朗巴赫系数均降低,且各条目、维度与量表总分的相关系数均>0.4。因子分析提取3个公因子,累计贡献率为54.463%,因子的条目组成与设定的理论框架有一定差异,结合专家讨论进一步调整量表结构。量表总分与TC、TG、HDL-C及LDL-C无明显相关性。量表条目能够较好地区分出健康人群及不同疾病类型。结论:量表具有较好的可行性、信度、效度和反应度,适用于中医药治疗痰浊证患者的疗效评估,可进一步推广应用。

Objective: To evaluate the reliability, validity and responsiveness of the patients’ self-rating scale for medical efficacy of phlegm turbidity syndrome. Methods: Using the self-evaluation scale of medical efficacy patients with the phlegm turbidity syndrome developed in the previous stage, the subjects of patients with phlegm syndrome and healthy subjects were asked to complete the scale, the feasibility of the scale(completion rate, acceptance rate and completion time of the scale), reliability(test-retest reliability, internal consistency reliability), validity(content validity, construct validity, criterion validity) and reactivity of the scale were evaluated. Results: A total of 201 subjects of 115 patients with phlegm turbidity syndrome and 86 healthy subjects were asked to complete the scale. The acceptance rate of the scale was 96.63%, the completion rate was 100%, and the median completion time was 2 min. The test-retest reliability of total score of the scale was 0.896, and the test-retest reliability of each entry was greater than 0.7. Cronbach’s α coefficient of the total scale was 0.643, after deleting the 9 items, the α coefficient was reduced, and the Spearman correlation coefficient of each item, dimension and scale total score were greater than 0.4. Three common factors extracted by factor analysis, and the cumulative contribution rate was 54.463%, the composition of the factors had a certain difference with the theoretical framework. Combined with experts discussion, the structure of the scale was adjusted further. The total scores were not significantly correlated with TC, TG, HDL-C and LDL-C. The scale entries can be used to better distinguish the healthy population and different diseases. Conclusion: The scale has good feasibility, reliability, validity and reactivity. It is suitable for the evaluation of the efficacy of the patients with phlegm turbidity syndrome, and it can be further promoted and applied.