麦克阿瑟临床研究知情同意能力评估工具简体中文版在精神分裂症患者中的信度和效度研究

Reliability and validity of Chinese Mandarin Version of MacArthur Competence Assessment Tool for Clinical Research in patients with schizophrenia

目的 评价麦克阿瑟临床研究知情同意能力评估工具（MacArthur Competence Assessment Tool for Clinical Research，MacCAT-CR）简体中文版在精神分裂症患者中的信度与效度。方法 经原作者同意后，将MacCAT-CR翻译为中文简体版，并对10位研究者进行MacCAT-CR一致性培训；选取100例精神分裂症患者（病例组）中的41例于MacCAT-CR第1次评估后7 d进行MacCAT-CR重测；应用专家共识评估（Expert Commence Rating，ECR）作为金标准，对病例组的MacCAT-CR评分进行校标效度分析；应用主成分分析的方法对病例组进行结构效度分析；同时将病例组MacCAT-CR评估结果与28名对照（对照组）进行区分效度分析。结果 （1）研究者间信度评估，MacCAT-CR总分的组内相关系数值为0.989（P〈0.01）；MacCAT-CR的克朗巴赫系数（α）为0.868，Guttman分半系数为0.803；重测信度的组内相关系数值为0.975（P〈0.01）。（2）MacCAT-CR多数条目评分之间、与4个维度总分之间的相关系数（r）的范围为0.21～0.78（P〈0.05）；MacCAT-CR中4个维度与ECR对应维度评分的相关系数（r）分别为0.87、0.79、0.70、0.51（P〈0.01）；因子分析：MacCAT-CR含有4个因子，总贡献率为61.03%。结论 MacCAT-CR具有良好的信度和效度，可以用于精神分裂症的医学研究，评估受试者知情同意能力。

Objective To evaluate the reliability and validity of Chinese Mandarin Version of MacArthur Competence Assessment Tool for Clinical Research （MacCAT-CR）in patients with schizophrenia. Methods MacCAT-CR was translated into mandarin Chinese with the permission of authors. Inter-rater reliability was assessed by administering the MacCAT-CR to the same patients by 10 independent raters on the same day. The test-retest reliability was assessed in 41 schizophrenia patients between 7 days. Criterion validity analysis was performed by assessing Expert Commence Rating in 100 patients. Construct validity analysis used principal component analysis in the patient group. Discriminant validity was evaluated between patients and controls. Results （ 1 ） Inter-rater reliability was 0. 989 （P 〈 0.01 ）. The coefficient of inter-item consistency （Cronbach＇s or） was 0. 868, and the Guttman split half reliability was 0. 803. Test- retest reliability of MacCAT-CR was 0. 975 （ P 〈 0.01 ）. （ 2 ） Severity of item scores in MacCAT-CR were correlated with each other （ r = 0.21 - 0. 78）. The total scores of MacCAT-CR and three subparts were individually correlated with ECR significantly （ r = 0. 51 - 0. 87, all P 〈0. 01 ）. Correlation Coefficients were 0. 87, 0.79, 0. 70 and 0. 51 （P 〈0. 01） among the 4 subparts and ECR scores. Factor analysis indicated that MacCAT-CR was consisted of 4 factors counting for 61.03% of variance. Conclusion The Chinese mandarin version of MacCAT-CR has good reliability and validity, worthy of using in clinical new drug trials.