title: Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia: Testing a device as an adjunct to colposcopy.
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 times 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 (CI) = 0.92-1.00] and an estimated specificity of 0.71 [95% CI = 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% CI = 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 of CIN 2 to cancer.
authors.affiliation: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. sbcantor@mdanderson.org
authors.forename: Scott B
authors.initials: SB
authors.lastname: Cantor
authors.forename: Jose-Miguel
authors.initials: JM
authors.lastname: Yamal
authors.forename: Martial
authors.initials: M
authors.lastname: Guillaud
authors.forename: Dennis D
authors.initials: DD
authors.lastname: Cox
authors.forename: E Neely
authors.initials: EN
authors.lastname: Atkinson
authors.forename: John L
authors.initials: JL
authors.lastname: Benedet
authors.forename: Dianne
authors.initials: D
authors.lastname: Miller
authors.forename: Thomas
authors.initials: T
authors.lastname: Ehlen
authors.forename: Jasenka
authors.initials: J
authors.lastname: Matisic
authors.forename: Dirk
authors.initials: D
authors.lastname: van Niekerk
authors.forename: Monique
authors.initials: M
authors.lastname: Bertrand
authors.forename: Andrea
authors.initials: A
authors.lastname: Milbourne
authors.forename: Helen
authors.initials: H
authors.lastname: Rhodes
authors.forename: Anais
authors.initials: A
authors.lastname: Malpica
authors.forename: Gregg
authors.initials: G
authors.lastname: Staerkel
authors.forename: Shahla
authors.initials: S
authors.lastname: Nader-Eftekhari
authors.forename: Karen
authors.initials: K
authors.lastname: Adler-Storthz
authors.forename: Michael E
authors.initials: ME
authors.lastname: Scheurer
authors.forename: Karen
authors.initials: K
authors.lastname: Basen-Engquist
authors.forename: Eileen
authors.initials: E
authors.lastname: Shinn
authors.forename: Loyd A
authors.initials: LA
authors.lastname: West
authors.forename: Anne-Therese
authors.initials: AT
authors.lastname: Vlastos
authors.forename: Xia
authors.initials: X
authors.lastname: Tao
authors.forename: J Robert
authors.initials: JR
authors.lastname: Beck
authors.forename: Calum
authors.initials: C
authors.lastname: Macaulay
authors.forename: Michele
authors.initials: M
authors.lastname: Follen
mesh_terms: D000465:Algorithms; D052685:Alphapapillomavirus / Q000302:isolation & purification; D003127:Colposcopy; D005260:Female; D006801:Humans; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013057:Spectrum Analysis / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology