基于中医证候要素的消渴目病患者报告结局量表条目池设置及考评

Establishing and Evaluation of the Item Pool of Xiaoke Eye Disease Patients Reported Outcomes Scale Based on TCM Syndrome Elements

目的制定基于中医证候要素的消渴目病(糖尿病视网膜病变)患者报告结局(PRO)量表,并对其进行初步考评。方法系统检索2006年1月—2015年12月中国知网和维普网中与消渴目病证候类型有关的文献,整理和归纳其中的消渴目病证型,并将复合证候分解为单一证素;于2015年7—10月在山东省中医院内分泌科病房对糖尿病视网膜病变患者30例、患者家属5例、内分泌科医护人员5例进行半结构化深度访谈。将文献研究结果与访谈结果相结合,设置消渴目病PRO量表初始条目池。采用抽签法,选取2014年3月—2015年11月山东中医药大学第一附属医院内分泌科和眼科、山东中医药大学第二附属医院内分泌科和眼科、济南市中医院内分泌科和眼科收治的糖尿病视网膜病变患者280例,采用初步设置的消渴目病PRO量表条目池对其进行调查,以对量表进行考评。共发放问卷280份,回收有效问卷270份,问卷有效回收率为96.4%。结果文献检索共纳入合格文献42篇,拆分出证素15种,结合访谈结果,初步设置成的消渴目病PRO量表共31个条目,其中生理维度18个条目(证候效应指标9个、特有症状指标9个),心理维度6个条目,社会维度5个条目,满意度维度2个条目。不同病情分级患者的生理维度证候效应指标、生理维度特有症状指标、心理维度、社会维度得分及总分比较,差异均有统计学意义(P<0.05)。总量表的Cronbach'sα系数为0.944,其中生理维度证候效应指标、生理维度特有症状指标、心理维度、社会维度的Cronbach'sα系数分别为0.909、0.901、0.890、0.857。因子分析共获得5个公因子,累计方差贡献率为66.755%。结论初步设置的消渴目病PRO量表信效度较好,可以用于中医药治疗消渴目病的疗效评估,建议在临床上推广应用。

Objective To establish and preliminarily evaluate Xiaoke Eye Disease（ diabetic retinopathy） Patients Reported Outcomes（ PRO） Scale based on TCM syndrome elements. Methods The literatures related to the syndromes of Xiaoke eye disease were retrieved systematically from January 2006 to December 2015 from China National Knowledge Infrastructure and VIP Network, and the types of Xiaoke eye disease were collected and summarized, and the composite syndromes were decomposed into single syndrome factor. From July to October 2015, semi- structured depth interview was conducted to the 30 patients with diabetic retinopathy,5 relatives of patients,and 5 medical workers in endocrinology department in endocrinological ward of Shandong Provincial Hospital of Traditional Chinese Medicine. Combining the research results of literatures with the interviewed results,we established the initial item pool of the PRO scale of Xiaoke eye disease. By the lottery method,280 patients with diabetic retinopathy who were admitted to the Department of Endocrinology and Ophthalmology of Shandong University of Traditional Chinese Medicine,Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine and Ji＇nan Municipal Hospital of Traditional Chinese Medicine were selected in the study. In order to assess the scale,the initial item pool of PRO scale of Xiaoke eye disease was used to investigate the subjects. A total of 280 questionnaires were sent out and 270 valid questionnaires were recovered. The effective response rate was 96. 4%. Results A total of 42 qualified articles were included through literature retrieval,and 15 kinds of syndrome elements were separated, combined with the interviewed results,31 items,including 18 items of physical dimension（ 9 syndrome effect indicators,9 specific symptom indicators）,6items of psychological dimension,5 items of social dimension,2 items of satisfaction dimension were in the initial PRO scale of eye disease. There were significant differences in syndrome effect indicators and specific symptom indicators in physiology dimension,psychological dimension,social dimension and total scores among patients with different disease classification（ P〈0. 05）. The Cronbach＇ s α coefficient of the total scale was 0. 944, and the Cronbach＇ s α coefficients of syndrome effect indicators and specific symptom indicators in physiology dimension,psychological dimension and social dimension were 0. 909,0. 901,0. 890 and 0. 857 respectively. Five common factors were obtained by factor analysis, and the cumulative variance contribution rate was 66. 755%. Conclusion The preliminarily established PRO scale of Xiaoke eye disease has good reliability and validity,and can be used in the evaluation of curative effects of traditional Chinese medicine on Xiaoke eye disease. It is recommended to be applied in clinic.