一项针对850名患者的II期临床试验中荧光光谱测量的变异性来源。
Sources of variability in fluorescence spectroscopic measurements in a Phase II clinical trial of 850 patients.
作者信息
Lee Jong Soo, Follen Michele, MacAulay Calum, Pikkula Brian, Serachitopol Dan, Price Roderick, Cox Dennis
机构信息
Carnegie Mellon University, Department of Statistics, Pittsburgh, PA 15213, USA.
出版信息
Gynecol Oncol. 2007 Oct;107(1 Suppl 1):S260-9. doi: 10.1016/j.ygyno.2007.07.012. Epub 2007 Sep 7.
BACKGROUND
Devices using fluorescence spectroscopy to differentiate high grade squamous intraepithelial lesions from normal tissue in the cervix have shown some diagnostic efficacy. Measurements from these devices produce large amounts of complex, multi-factored data. The purpose of this study is to isolate the effects of the particular care providers and equipment operators who are involved in taking measurements.
METHODS
Data from spectroscopic measurements of the Phase II study of 850 patients with abnormal Papancicolau smears were used. The data were subject to a Principal Components Analysis and to MANOVA to control for variables that are known to affect outcomes.
RESULTS
The analysis showed significant provider effects from both devices and significant operator effects from one device.
CONCLUSION
We will repeat a similar analysis on data from a screening trial, on the combined diagnostic and screening study, and on the reflectance data. In the future, we hope to be able to design devices that address provider and operator effects.
背景
利用荧光光谱法区分宫颈高级别鳞状上皮内病变与正常组织的设备已显示出一定的诊断效能。这些设备的测量会产生大量复杂的、多因素的数据。本研究的目的是分离参与测量的特定医护人员和设备操作人员的影响。
方法
使用了来自850例巴氏涂片异常患者II期研究的光谱测量数据。对数据进行主成分分析和多变量方差分析，以控制已知会影响结果的变量。
结果
分析显示，两种设备均存在显著的医护人员影响，一种设备存在显著的操作人员影响。
结论
我们将对筛查试验数据、联合诊断与筛查研究数据以及反射率数据重复进行类似分析。未来，我们希望能够设计出可解决医护人员和操作人员影响的设备。
Zotero 插件