The randomized clinical trial provides the strongest study design for the evaluation of a diagnostic technology. An emerging diagnostic technology should first be compared as an adjunct to the existing technology to show it adds value before comparing it alone to the existing technology. Fluorescence and reflectance spectroscopy and quantitative cytology and histopathology are emerging technologies. In this randomized clinical trial, we propose to compare these emerging technologies adjunctively to the existing technologies to show they add value. We plan to compare: 1) colposcopy alone to colposcopy+fluorescence and reflectance spectroscopy, and 2) clinical cytology and histopathology alone to same +quantitative cytology and histopathology in a sample of 600 patients referred with abnormal Papanicoloau smears. An investigational Device Exemption (IDE) will be obtained for the fluorescence and reflectance spectroscopy device and the results of optical spectroscopy will be used to decide which additional areas to biopsy and whether or not to treat the patient at that visit. The patients will also receive the information provided by optical spectroscopy to see if this information reduces anxiety. The cost saved by using Sensitivities, specificities, ROC curves, AUC, and likelihood ratios will be calculated for the colposcopy arm, and for colposcopy and optical spectroscopy in the combined arm. Sensitivities, specificities, ROC curves, AUC, and likelihood ratios will be evaluated for both clinical cytology and quantitative cytology and histopathology using the clinically-read colposcopically-directed biopsy as the gold standard. No IDE is currently planned for the quantitative cytology and histopathology device. Patient satisfaction will therefore be assessed through the use of suppositional questions. Similarly, the information from the quantitative cytology and histopathology will be used synthetically in the cost- effectiveness analysis.
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