基于慢性胃肠疾病患者报告临床结局测量量表的编制及信度、效度分析

Development and Analysis of a Patient Reported Outcome Instrument for Chronic Gastrointestinal Diseases

目的编制普遍适用于慢性胃肠疾病的基于患者报告临床结局(PRO)评价量表,并对其信度、效度进行分析。方法通过典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法,形成量表条目池,筛选优化条目,小样本反复预调查,形成初步量表,在北京地区进行多中心量表测试,并对274份有效数据进行信度、效度分析。结果初步形成具有6个维度、35个条目的基于慢性胃肠疾病患者报告临床结局评价量表,该量表总克朗巴赫α系数为0.8862,标化α系数为0.8876,各维度α系数均在0.65以上;折半信度分别为0.8113和0.8070,两部分相关系数为0.7058。区分效度检验以t检验法比较高分组和低分组各条目得分,结果均有统计学意义;结构效度采用主成分方法进行因子分析,并进行最大方差正交旋转,提取特征根值>1的6个公因子,累计贡献率为52.14%,分别解释为反流、消化不良、全身状况、社会功能、排便、心理,与理论构想和慢性胃肠疾病临床特点相符。结论该量表具有较好的信度、效度,可尝试作为慢性胃肠疾病临床疗效评价研究的工具。

Objective To develop a patient reported outcome instrument for chronic gastrointestinal diseases and to investigate its reliability and validity. Methods The instrument was developed by establishing item pool through interviewing typical cases, focus group discussion, expert consulting, referring to related instruments, and etc, selecting and optimizing items, small sample pilot survey, formation of primary instrument, then a multi-centered clinical investigation was conducted in Beijing, the data of 274 effective respondents of which was analyzed to assess reliability and validity using SPSS 11.5 software. Result A 6-dimention, 35-item instrument was developed, which has satisfying internal consistency reliability, Cronbach＇s α coefficient was 0. 8876, and those of all domains were more than 0. 65; split-half reliability was 0. 8113 and 0. 8070 respectively, the correlation of two parts was 0. 7058. For validity, the instrument has good discriminate validity, construct validity tested by factor analysis resulted in 6 factors with eigenvalue 1 ,which contributed to 52.14% of total variance,these factors can be explained as regurgitation, dyspepsia, general condition, social function, defecation and psychology. Conclusion The instrument has a good internal reliability and validity, which can be applied for the therapeutic evaluation of chronic gastrointestinal diseases, but still need further investigation and modification.