Accuracy of optical spectroscopy for the detection of cervical intraepithelial neoplasia: Testing a device as an adjunct to colposcopy.
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.
Cantor
Scott B
SB
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. sbcantor@mdanderson.org
Yamal
Jose-Miguel
JM
Guillaud
Martial
M
Cox
Dennis D
DD
Atkinson
E Neely
EN
Benedet
John L
JL
Miller
Dianne
D
Ehlen
Thomas
T
Matisic
Jasenka
J
van Niekerk
Dirk
D
Bertrand
Monique
M
Milbourne
Andrea
A
Rhodes
Helen
H
Malpica
Anais
A
Staerkel
Gregg
G
Nader-Eftekhari
Shahla
S
Adler-Storthz
Karen
K
Scheurer
Michael E
ME
Basen-Engquist
Karen
K
Shinn
Eileen
E
West
Loyd A
LA
Vlastos
Anne-Therese
AT
Tao
Xia
X
Beck
J Robert
JR
Macaulay
Calum
C
Follen
Michele
M
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