基于类风湿关节炎患者报告的临床结局测量量表的初步构建

Preliminary Construction of Questionnaire Based on Rheumatoid Arthritis Patients-Reported Outcomes

目的建立基于类风湿关节炎(RA)患者报告的临床结局(PRO)测量量表,从患者报告的角度为RA临床疗效评价提供一个新的方法。方法采用文献资料查询、病历回顾、临床访谈、头脑风暴法、专家咨询等构建量表条目,确立躯体状态、心理状态及社会健康3方面域体系,并确立量表条目;参考患者日常就诊时描述的常用语言,结合国内外成熟的中文版量表的条目,形成PRO量表;现场调查获得137例有效测试数据,对量表信度、效度进行统计分析。结果信度分析中内部一致性信度克朗巴赫系数α为0.878,折半信度系数为0.793;效度分析中,利用主成分的方法进行因子分析,得出躯体功能和社会健康、心理状态、躯体功能及躯体感觉4个领域。条目分析中,各条目区分度较好,能区分所调查条目的不同程度。结论本量表信度、效度较高,可用于类风湿关节炎患者报告的临床疗效评价。

Objective To compile the measurement scale based on patient-reported outcomes （PRO） of rheumatoid arthritis（RA） patients to provide a new way of evaluation of clinical effect from the viewpoint of patients＇ report. Methods Literature consulting, case reviewing, talking with patients, brain storming, and consulting to experts were adopted to establish domain system containing body status, mental status and social health and then set up the items. The patients＇ language was taken as reference and the mature items used in China and abroad were taken in combination for the compilation of PRO Scale. We obtained the valid data from 137 patients in the field investigation and did the statistical analysis on the reliability and validity of the scale. Results In the reliability, the Cronbach＇s Alpha coeffecient was 0. 878, and the coeffecient of split-hall reliability was0. 793. In the validity, the main ingredients were used for the factor analysis and the four fields were obtained, including body function, social health, mental status, and body function and somatosensory. The item analysis showed a good item discrimination, able to distinguish the different degrees of investigated items. Conclusion The very PRO Scale is high in reliability and validity and can be used to evaluate the therapeutic effect of RA patients.