炎症性肠病患者报告结局测定量表的测量学特性分析

Analysis of the Measurement Characteristics of Inflammatory Bowel Disease Patient-reported Outcomes Measurement Scale

背景炎症性肠病(IBD)患者报告结局水平受到关注,目前少有成熟且具有我国文化特点的IBD患者报告结局量表,已开发出的量表需要经过严格的考评。目的对炎症性肠病患者报告结局测定量表[PROISCD-IBD(V1.0)]的测量学特性进行分析评价,为科学测评IBD患者报告结局提供依据。方法使用PROISCD-IBD(V1.0)对2020年10月—2022年1月在昆明医科大学第一附属医院和广东医科大学附属医院消化门诊及住院部就诊的274例IBD患者的报告结局进行测定。PROISCD-IBD(V1.0)包括1个共性模块和1个IBD特异模块(TIBD)。共性模块共有30个条目,条目又分为4个领域:身体健康(PHD)、心理健康(MHD)、社会健康(SHD)、精神/信仰健康(SBD)。TIBD涵盖4个侧面,依次为消化系统症状(DSS)、肠外症状(EXS)、特殊心理(SPP)、治疗副作用(TSE)。全量表共有44个条目。采用Cronbach’sα系数和分半系数对信度进行测定;采用相关系数法、探索性因子分析法和结构方程模型分析结构效度;采用t检验分析各领域的临床效度。结果PROISCD-IBD(V1.0)的PHD、MHD、SHD、SBD以及TIBD 5个领域的Cronbach’sα系数分别为0.732、0.838、0.781、0.673、0.884,总量表的Cronbach’sα系数为0.932;PHD、MHD、SHD、SBD以及TIBD 5个领域的分半系数分别为0.669、0.859、0.610、0.494、0.795,总量表的分半信度为0.879。相关性分析显示,PHD、MHD、SHD和SBD领域得分与共性模块得分的相系数均>0.6(P<0.05)。探索性因子分析共提取出3个主成分,累积方差贡献率为58.047%。结构方程模型显示,χ2/df=2.568,近似误差均方(RMSEA)=0.076,规范拟合指数(NFI)=0.677,不规范拟合指数(NNFI)=0.774,比较拟合指数(CFI)=0.772,增值拟合指数(IFI)=0.774,标准化根均方残差(SRMR)=0.1031。IBD患者按照临床分期分为活动期(n=90)和缓解期(n=184),缓解期患者各领域、共性模块、TIBD以及量表总分均高于活动期患者(P<0.05)。结论PROISCDIBD(V1.0)的信度和效度较好,可用于IBD患者报告结局测定。

Background The reported outcome level of patients with inflammatory bowel disease(IBD)has received attention.There are few mature outcome scales with Chinese cultural characteristics for patients with IBD,and the developed scales need strict evaluation.Objective To analyze and evaluate the measurement properties of the Inflammatory Bowel Disease Patient-Reported Outcome Measurement Scale〔PROISCD-IBD(V1.0)〕,to provide basis for scientific evaluation of reported outcomes in patients with IBD.Methods From October 2020 to January 2022,PROISCD-IBD(V1.0)was used to detect 274 IBD patients who were treated in the Outpatient and Inpatient Departments of Gastroenterology in the First Affiliated Hospital of Kunming Medical University and the Affiliated Hospital of Guangdong Medical University.PROISCD IBD(V1.0)consisted of 1 commonality module and 1 IBD specific module(TIBD).The commonality module had 30 items,which were divided into 4 domains of physical health(PHD),mental health(MHD),social health(SHD),and spiritual/belief health(SBD).TIBD covered four aspects of digestive system symptoms(DSS),extraintestinal symptom(EXS),special psychological symptoms(SPP),and treatment side effects(TSE).Cronbach'sαcoefficient and split-half coefficient were used to test the reliability.Correlation coefficient method,exploratory factor analysis and structural equation model were used to analyze the structural validity.Clinical validity of each domain was analyzed using t test.Results The Cronbach'sαcoefficients of PHD,MHD,SHD,SBD and TIBD of PROISCD-IBD(V1.0)were 0.732,0.838,0.781,0.673 and 0.884,respectively.Cronbach'sαcoefficient of total scale was 0.932.The half-score coefficients of PHD,MHD,SHD,SBD and TIBD were 0.669,0.859,0.610,0.494 and 0.795,respectively,and the half-score reliability of the total scale was 0.879.Correlation analysis showed that the phase coefficients of PHD,MHD,SHD and SBD scores and commonality module score were all>0.6(P<0.05).Three principal components were extracted from exploratory factor analysis,and the cumulative variance contribution rate was 58.05%.Structural equation model showed thatχ2/df=2.568,root-mean-square error of approximation(RMSEA)=0.076,normed fit index(NFI)=0.677,non-normed fit index(NNFI)=0.774,comparative fit index(CFI)=0.772,incremental fit index(IFI)=0.774,SRMR=0.1031.IBD patients were divided into active stage(n=90)and remission stage(n=184)according to clinical stages.The total scores of various domains,common modules,TIBD and scale in remission stage were higher than those in active stage(P<0.05).Conclusion PROISCD-IBD(V1.0)has good reliability and validity for reporting outcome measures in patients with IBD.