腰椎管狭窄症疗效评定中国量表的研制与验证  

The development and validation of Chinese scales for the efficacy evaluation of lumbar spinal stenosis

作　　者：姜晓涵 孙涛[1] 李石耀 卞晓恩 陈阳 王珺楠[1] Jiang Xiaohan;Sun Tao;Li Shiyao;Bian Xiaoen;Chen Yang;Wang Junnan(Department of Painology,Shandong Provincial Hospital Affiliated to Shandong University,Jinan City,Shandong Province 250021,China)

机构地区：[1]山东大学附属省立医院疼痛科,济南市250021

出　　处：《中华疼痛学杂志》2023年第3期408-419,共12页Chinese Journal Of Painology

基　　金：国家自然科学基金(81972145);山东省自然科学基金(ZR2020MH283)。

摘　　要：目的制定并验证适合中国国情的腰椎管狭窄症疗效评定中国量表。方法1.构建预量表:根据腰椎管狭窄症的常见临床特征,参照国际量表制作流程,编写量表题项,构建适用于我国疼痛科的腰椎管狭窄症疗效评定中国量表的初始量表,经小范围调查和预试验修订后形成预量表。2.预量表的验证,暂定版量表的形成:采用预量表对148例在山东省立医院疼痛科住院治疗的,已被明确诊断为腰椎管狭窄症的患者进行较大范围临床调查。通过条目分析筛选条目形成暂定版量表,并通过信度、效度、反应度、认可度测评,考评量表的科学性和可行性,并进行诊断性评价。结果量表的信效度良好,其中,标准化后的Cronbach'sα系数为0.794;KMO值为0.667,Bartlett球形检验P<0.05,探索性因子分析共提取出3个公共因子,累计方差贡献率49.978%,各条目因子载荷介于0.431与0.838之间;与瑞士脊柱狭窄问卷的Pearson相关系数的绝对值为0.66,P<0.05;AUC值为0.924,灵敏度为97.7%,特异度为73.7%,截断值为0.45,约登指数0.714;认可度为98.65%;量表在治疗前后效应大小(ES)为2.30,标准化反应均数(SRM)为2.28。结论本研究制定的腰椎管狭窄症疗效评定中国量表信效度良好,量表结构稳定,诊断价值良好,认可度、反应度较高,可进一步在临床上推广应用。Objective To develop and validate a Chinese scale for the efficacy evaluation of lumbar spinal stenosis suitable for China's national conditions.Methods Firstly,designment of a pre-scale:according to the common clinical features and development process of lumbar spinal stenosis,a preliminary scale of the Chinese scale for the efficacy evaluation of lumbar spinal stenosis was constructed after a small range of investigation and pre-test revision.Secondly,validation of the pre-scale and formation of the tentative version of the scale:a large range of clinical investigations were conducted on 148 patients with lumbar spinal stenosis in the Painology Department of Shandong Provincial Hospital.The tentative version of the scale was evaluated by reliability,validity,responsiveness,recognition,and diagnostic evaluation.Results The validity and reliability of the scale were positive,in which the standardized Cronbach's alpha was 0.793;the KMO value was 0.667,the P value of Bartlett spherical test<0.05;the exploratory factor analysis extracting three common factors with a cumulative variance contribution was 49.978% and factor loadings ranging was between 0.431 and 0.838 for each entry;the Pearson correlation coefficients with Swiss Spinal Stenosis Questionnaire was 0.66(P<0.05);the AUC value was 0.924,with a sensitivity of 97.7%,a specificity of 73.7%,a cut-off value of 0.45 and a Youden's index of 0.714;the recognition rate was 98.65%;the effect size and standardized-response means values of the scale 2.30 and 2.28 respectivelybefore and after treatment.Conclusion The Chinese scale for assessment of lumbar spinal stenosis designed in this study has high reliability,validity and stable structure.Moreover,the diagnostic value of the scale is positive,the recognition and responsiveness are high,and the scale can be further popularized and applied in clinical practice.

关 键 词：腰椎骨 椎管狭窄 量表 疼痛科 中国版 疗效评定 

分 类 号：R681.5[医药卫生—骨科学]