多阅片者多病例设计影像诊断试验准确度评价的统计分析方法

Statistical methods in multi-reader multi-case design diagnostic accuracy studies

目的通过公式推导和实例验证,分析多阅片者多病例(multi-reader multi-case,MRMC)设计影像诊断试验准确度评价的统计分析方法。方法本研究包括理论推导和实例验证两个部分。理论部分详细介绍了MRMC统计分析方法,特别是Obuchowski-Rockette(OR)与Dorfman-Berbaum-Metz(DBM)方法的原理和步骤。实例部分研究共纳入了100例受试者,其中67例疾病患者。四名阅片者分别采用传统胶卷影像方法和数字化影像方法进行阅片。通过OR与DBM方法对阅片结果进行分析。结果实例研究显示,OR和DBM方法结果具有较高的一致性。当OR方法采用Jackknife估计协方差矩阵时,其结果与DBM方法完全吻合。结论为准确评估影像诊断试验的临床性能,推荐采用OR和DBM方法进行影像诊断试验准确性评价的统计分析,以确保阅片者因素对评价结果的影响得到充分考虑。OR与DBM方法的结果较为接近,实际应用时应考虑具体数据特点和研究设计选择合适的分析方法。同时,OR与DBM方法的应用目前仍存在一定挑战,如软件实现、缺失数据处理,未来仍需要进一步的探索。

Objective To elaborate on the statistical analysis methods for evaluating the accuracy of imaging diagnostic tests in a multiple-reader multiple-case(MRMC)design through formula derivation and real cases.Methods This study consisted of two parts:theoretical derivation and a real case study.The theoretical part discussed in detail the principles and procedures of MRMC statistical analysis methods,particularly the Obuchowski-Rockette(OR)and Dorfman-Berbaum-Metz(DBM)methods.The real case included 100 subjects,of whom 67 had disease.Four readers interpreted all the cases based on both traditional film imaging methods and digital imaging methods.OR and DBM methods were employed for data analysis.Results The real case showed that the OR and DBM methods had a high degree of consistency,with only slight differences in the confidence intervals.Conclusion It is recommended to use the OR and DBM methods for the statistical analysis of imaging diagnostic test accuracy,ensuring that the impact of reader factors on the evaluation results is fully considered.The results from the OR and DBM methods are relatively similar;when applying these methods in practice,one should consider the specific characteristics of the data and the research design to choose the appropriate analysis method.Besides,there are still challenges when applying the OR and DBM methods,such as software implementation and missing data handling,which require further exploration.