Sources of variability in fluorescence spectroscopic measurements in a Phase II clinical trial of 850 patients.
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.


CONCLUSIONS
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.
Lee
Jong Soo
JS
Carnegie Mellon University, Department of Statistics, Pittsburgh, PA 15213, USA.
Follen
Michele
M
MacAulay
Calum
C
Pikkula
Brian
B
Serachitopol
Dan
D
Price
Roderick
R
Cox
Dennis
D
D000328:Adult; D005260:Female; D006801:Humans; D008875:Middle Aged; D013050:Spectrometry, Fluorescence / Q000295:instrumentation / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*