机构地区:[1]广州中医药大学第二临床医学院,广东广州510006 [2]广东省中医院皮肤科,广东广州510120 [3]广东省中医皮肤临床医学研究中心,广东广州510120 [4]省部共建中医湿证国家重点实验室(广州中医药大学第二附属医院),广东广州510120 [5]粤港澳中医药与免疫疾病研究联合实验室,广东广州510120 [6]广东省中医证候临床研究重点实验室,广东广州510120
出 处:《中国皮肤性病学杂志》2024年第12期1333-1340,共8页The Chinese Journal of Dermatovenereology
基 金:广东省科学技术厅项目协同创新与平台环境建设项目(2020B1111170012);广州市科技计划项目基础研究计划“市校(院)联合资助项目”(202102010335)。
摘 要:目的为进一步优化构建中医药治疗银屑病的疗效评价工具并提高其在中医临床疗效评价中的测量精度,采用项目反应理论Rasch分析技术分析评价寻常型银屑病主症量表,为量表优化提供依据。方法通过Winsteps5.32.0软件对寻常型银屑病主症量表在临床试验中的数据构建Rasch模型并从信度、效度、评定尺度和条目-被试匹配性方面对量表从整体及条目层面进行考评。其中,信度分析主要采用信度指数和分离指数测量量表的一致性和可靠性,效度分析主要包括拟合度分析、单维性检验、项目功能差异分析。结果寻常型银屑病主症量表信度良好,效度方面整体拟合度、单维性良好,且不存在性别和治疗前后的项目功能差异。但条目拟合度分析中,量表Q5的加权残差均方Infit MNSQ>1.50,稍高于正常范围;评定尺度分析方面,量表1中计分3和计分4的阈值差值为0.97个logit,略低于推荐标准;量表2计分3与计分4的阈值差值为0.89以及计分4与计分5的阈值差值为0.71,均低于标准。条目-被试匹配性方面,怀特图中量表1及量表2的患者平均病情严重程度均在条目难度平均水平下,t检验结果提示量表1及量表2条目难度高于患者的病情严重程度,差异有统计学意义(P<0.0001)。结论Rasch分析表明该量表具有良好的信度及效度,具备测量目标人群健康水平改变的能力。但量表计分方式不太合理且条目难度偏高,在后续的修订中,应增加一些难度较低的题目并调整计分方式以进一步优化量表。Objective In order to further optimize and construct the evaluation tool for the treatment of psoriasis by traditional Chinese medicine and improve its measurement accuracy in the evaluation of the clinical efficacy,the Rasch analysis technique was empolyed to analyze and evaluate the Main Syndrome Scale for Psoriasis Vulgaris,providing a basis for the optimization of the scale.Methods Winsteps 5.32.0 software was used to perform Rasch analysis,with the data of the Main Symptom Scale for Psoriasis Vulgaris in clinical trials.The psychometric properties of the Patient-Reported Outcome Scale were tested,including reliability,validity,response categories and item-person matching test.We used reliability index and separate index to measure the consistency and reliability of the Scale.Validity analysis included the fit analysis,unidimensionality assessment and differential item functioning analysis.Results The reliability of the Main Symptom Scale for Psoriasis Vulgaris tested good.In terms of validity,the overall fit and unidimensionality of the Scale showed good as well,with no differential item functioning(DIF)by gender and treatment.However,in the aspect of the item fit analysis,the infit MNSQ(mean square)of Q5 on the Scale was higher than 1.50,which exceeded normal range slightly.According to the response categories analysis,the threshold from score 3 to score 4 in Scale 1 was 0.97 logit,which was slightly less than the recommended standard.The threshold from score 3 to score 4 and from score 4 to score 5 in Scale 2 were 0.89 logit and 0.71 logit respectively,which were below the standard.According to the item-person matching test,in the Wright map,the average severity of the illness of patients(M)on Scale 1 and Scale 2 both were below the average difficulty of items(M),and the t-test results also showed that the difficulty of items in Scale 1 and Scale 2 were higher than patient′s severity,and the difference were statistically significant(P<0.0001).Conclusion The Rasch analysis of the Main Symptom Scale for Ps
关 键 词:结局 银屑病 寻常性 主症量表 RASCH 项目反应理论
分 类 号:R758.63[医药卫生—皮肤病学与性病学]
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