Shepherd John A, Lu Ying
Department of Radiology, University of California, San Francisco, CA 94143-0946, USA.
J Clin Densitom. 2007 Jul-Sep;10(3):249-58. doi: 10.1016/j.jocd.2007.05.002. Epub 2007 Jul 5.
In this article, we derive a generalized expression for the least significant change (LSC), which we call the generalized LSC (GLSC), to be used when an individual is measured on 2 different systems. The commonly used LSC is defined as the least amount of change between 2 measurements over time that must be exceeded before a change can be considered true (with 95% confidence). The LSC has clinical applications in monitoring disease progression or treatment effects in bone mineral density (BMD) and bone mineral content. Mathematically, the "ideal" LSC (ILSC) is 2.77 times the precision errors for measures on a single system. When BMD values of an individual are measured by 2 different systems, the LSC will depend not only on the precision errors of both systems but also on the calibration relationship between the systems. Like the ILSC, the GLSC is a simple equation applicable for inter machine comparisons. The GLSC can be defined for any 2 systems with measures obtained from cross-calibration and precision studies using the protocols recommended by the International Society for Clinical Densitometry. We validated the GLSC using 10,000 simulated measurements taken between 2 systems and offer several common uses of the GLSC such as system upgrades within a single manufacturer and replacement of 1 manufacturer by another. We found that when upgrading a Hologic QDR-2000 to a QDR-4500, GLSC was twice as large as the QDR-2000 LSC (0.0432 and 0.0215 g/cm2, respectively). The GLSC was 2.6 (spine) to 3.6 (total hip) times larger than the LSC when comparing scans between the Hologic Delphi and the GE Lunar Prodigy. We also explore how the magnitude of the correlation coefficient and sample size change the GLSC and show that a correlation coefficient less than 0.95 increases the %GLSC to above 10%, and that increasing study sample sizes beyond 30 in the cross-calibration studies can only decrease the magnitude of the GLSC accuracy by 4%. We conclude that the GLSC, defined using commonly used clinical cross-calibration and precision assessments, is the most accurate method to compare scans between dual-energy X-ray absorptiometry systems.
在本文中,我们推导出了最小显著变化(LSC)的广义表达式,我们将其称为广义LSC(GLSC),用于在个体于两种不同系统上进行测量时。常用的LSC被定义为两次测量之间随时间变化的最小变化量,在变化被视为真实(具有95%置信度)之前必须超过该量。LSC在监测骨矿物质密度(BMD)和骨矿物质含量的疾病进展或治疗效果方面具有临床应用。从数学上讲,“理想”的LSC(ILSC)是单个系统测量精度误差的2.77倍。当个体的BMD值由两种不同系统测量时,LSC不仅取决于两个系统的精度误差,还取决于系统之间的校准关系。与ILSC一样,GLSC是一个适用于机器间比较的简单公式。GLSC可以针对任何两种系统定义,这些系统通过使用国际临床骨密度测量学会推荐的方案进行交叉校准和精度研究来获取测量值。我们使用在两种系统之间进行的10000次模拟测量验证了GLSC,并提供了GLSC的几种常见用途,例如在单个制造商内部进行系统升级以及由另一个制造商替换一个制造商。我们发现,当将Hologic QDR - 2000升级到QDR - 4500时,GLSC是QDR - 2000 LSC的两倍(分别为0.0432和0.0215 g/cm²)。在比较Hologic Delphi和GE Lunar Prodigy之间的扫描时,GLSC比LSC大了2.6(脊柱)到3.6(全髋)倍。我们还探讨了相关系数的大小和样本量如何改变GLSC,并表明相关系数小于0.95会使%GLSC增加到10%以上,并且在交叉校准研究中,将研究样本量增加到超过30只会使GLSC精度的大小降低4%。我们得出结论,使用常用的临床交叉校准和精度评估定义的GLSC是比较双能X线吸收法系统之间扫描的最准确方法。