MRMC方差分析在影像诊断试验多阅片者多病例研究设计中的应用  

The Application of MRMC ANOVA Method in Multireader Multicase Design of Radiological Diagnostic Study

作　　者：尚美霞 姚晨[1] 康晓平[2] 阎小妍[3] 

机构地区：[1]北京大学第一医院医学统计室,100034 [2]北京大学公共卫生学院流行病与卫生统计系 [3]北京大学临床研究所

出　　处：《中国卫生统计》2017年第5期705-709,712,共6页Chinese Journal of Health Statistics

摘　　要：目的探索MRMC方差分析方法对多阅片者多病例(MRMC)研究设计的数据结果处理的统计效能,并与传统ROC曲线分析法比较,为分析该类数据选择合适的统计方法提供依据。方法采集经金标准诊断为良性和恶性乳腺肿瘤患者96例,由12名有代表性的阅片者认读两种不同诊断技术(2D和3D断层成像)下的影像图片,分别采用MRMC方差分析和传统ROC曲线分析法对两种诊断技术的读片数据进行统计分析;MRMC方差分析应用SAS 9.2软件,结合MRMC_DBM程序实现;传统ROC曲线分析应用软件ROCKITβ0.8进行参数估计。结果经12名阅片者对46例良性患者(2例缺失)和48例恶性患者的读片结果比较,3D断层成像技术的诊断一致率(72.87%)明显高于常规2D成像技术(62.59%),其中阳性一致率分别为71.01%和65.45%,阴性一致率分别为69.38%和59.60%;利用MRMC方差分析方法可以分别估计并比较两种诊断技术的ROC曲线下面积(2D:0.7505,3D:0.8500),另外还能同时考虑不同水平阅片者读片可能产生的偏倚并将其量化,估计各种随机效应的方差分量大小(σ_r^2=0.0009,σ_p^2=0.0953,σ_(tr)~2=0.0001,σ_(tp)~2=0.0185,σ_(rp)~2=0.0405,σ_(trp)~2=0.1212,总随机误差为0.2765);而采用传统ROC曲线分析法仅可得到两种诊断技术的ROC曲线下面积(2D:0.7368,3D:0.8328)。结论 MRMC方差分析方法较传统ROC曲线分析法更适合用于分析影像诊断试验中多阅片者多病例研究设计的统计数据,前者不仅可比较影像诊断试验中诊断技术的准确性大小,而且还可以对诊断技术和诊断者的可靠性作出评价。Objective To explore the statistical power of the MRMC ANOVA method evaluating the results between different diagnostic technologies in multireader multicase study design;and to provide the theory basis for the usage of mutiread-er muticase design in radiological diagnostic study. Methods Collect 96 image pictures of suspected breast cancer subjects tak-ing in 2D and 3D tomographic these two different imaging diagnostic techniques,select 12 representative readers randomly,and analyze the data about the reading results with MRMC ANOVA method and traditional ROC curve method separately; MRMC ANOVA method apples software SAS 9. 2 accompanied with MRMC DBM Macro programme written by Hillis SL. and param-eter estimations of traditional ROC curve method apples software ROCKITβ0. 8. Results The consistency rate of 3D tomo-graphic imaging diagnostic technique is much more bigger than that of 2D imaging diagnostic technique（2D：62. 59%,3D：72. 87%） ,and the positive consistency rate is 65. 45% and 71. 01% while the negative consistency rate is 59. 60% and 69. 38%respectively;MRMC ANOVA method can estimate and compare the diagnostic accuracy of 2D diagnostic technique and 3D to-mographic imaging diagnostic technique（2D：0. 7505,3D：0. 8500,3D-2D：0. 0994）; Besides it can also consider the probable biases resulting from different readers and quantify them,then estimate the variance components of all possible random effects （,total random error is 0. 2765）;But the traditional ROC method can only figure out the accuracy of the two technologies（2D：0. 7368,3D：0. 8328,3D-2D：0. 0960）. Conclusions Compared with the traditional ROC curve method,MRMC ANOVA meth-od is much more comprehensive and accurate when assessing the diagnostic power of mutireader muticase radiological diagnostic study,which can not only compare the accuracy but also evaluate the reliability.

关 键 词：影像诊断试验 多阅片者多病例 MRMC方差分析 方差分量 

分 类 号：R195.1[医药卫生—卫生统计学]