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Cantor SB , Yamal JM , Guillaud M , Cox DD , Atkinson EN , Benedet JL , Miller D , Ehlen T , Matisic J , van Niekerk D , Bertrand M , Milbourne A , Rhodes H , Malpica A , Staerkel G , Nader-Eftekhari S , Adler-Storthz K , Scheurer ME , Basen-Engquist K , Shinn E , West LA , Vlastos AT , Tao X , Beck JR , MacAulay C , Follen M
Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia: testing a device as an adjunct to colposcopy
International Journal of Cancer. 2011 Mar;128(5) :1151-1168
PMCID: PMC3015005   
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Abstract
Testing emerging technologies involves the evaluation of biologic plausibility, technical efficacy, clinical effectiveness, patient satisfaction, and cost-effectiveness. The objective of this study was to select an effective classification algorithm for optical spectroscopy as an adjunct to colposcopy and obtain preliminary estimates of its accuracy for the detection of CIN 2 or worse. We recruited 1,000 patients from screening and prevention clinics and 850 patients from colposcopy clinics at two comprehensive cancer centers and a community hospital. Optical spectroscopy was performed, and 4,864 biopsies were obtained from the sites measured, including abnormal and normal colposcopic areas. The gold standard was the histologic report of biopsies, read 2 to 3 limes by histopathologists blinded to the cytologic, histopathologic, and spectroscopic results. We calculated sensitivities, specificities, receiver operating characteristic (ROC) curves, and areas under the ROC curves. We identified a cutpoint for an algorithm based on optical spectroscopy that yielded an estimated sensitivity of 1.00 [95% confidence interval (Cl) = 0.92-1.00] and an estimated specificity of 0.71 [95% Cl = 0.62-0.79] in a combined screening and diagnostic population. The positive and negative predictive values were 0.58 and 1.00, respectively. The area under the ROC curve was 0.85 (95% Cl = 0.81-0.89). The per-patient and per-site performance were similar in the diagnostic and poorer in the screening settings. Like colposcopy, the device performs best in a diagnostic population. Alternative statistical approaches demonstrate that the analysis is robust and that spectroscopy works as well as or slightly better than colposcopy for the detection cif ON 2 to cancer.
Notes
Cantor, Scott B. Yamal, Jose-Miguel Guillaud, Martial Cox, Dennis D. Atkinson, E. Neely Benedet, John L. Miller, Dianne Ehlen, Thomas Matisic, Jasenka van Niekerk, Dirk Bertrand, Monique Milbourne, Andrea Rhodes, Helen Malpica, Anais Staerkel, Gregg Nader-Eftekhari, Shahla Adler-Storthz, Karen Scheurer, Michael E. Basen-Engquist, Karen Shinn, Eileen West, Loyd A. Vlastos, Anne-Therese Tao, Xia Beck, J. Robert MacAulay, Calum Follen, Michele Wiley-blackwell publishing, inc Malden 716hs