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DIAGNOSTIC COLPOSCOPIC ACCURACY BY THE GYNOCULAR AND A STATIONARY COLPOSCOPE

Published online by Cambridge University Press:  11 June 2015

Helena Kopp Kallner ,
Maria Persson ,
Marcus Thuresson ,
Daniel Altman ,
Isaac Shemer ,
Malin Thorsell  and
Elisabeth Andrea Wikström Shemer
Helena Kopp Kallner
Affiliation:
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet
Maria Persson
Affiliation:
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet
Marcus Thuresson
Affiliation:
Statisticon
Daniel Altman
Affiliation:
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet
Isaac Shemer
Affiliation:
Department of Neurophysiology, Karolinska Institutet
Malin Thorsell
Affiliation:
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet
Elisabeth Andrea Wikström Shemer
Affiliation:
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet; Department of Women's and Children's Health, Uppsala Universityelisabeth@gynocular.com
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Abstract

Objectives: The aim of this study was to evaluate the diagnostic accuracy of sensitivity and specificity of cervical lesions by the low-cost, portable Gynocular colposcope and a stationary colposcope, in women referred for colposcopy with abnormal cervical cytology.

Methods: A randomized cross-over clinical trial for evaluating the diagnostic accuracy in detecting cervical lesions by the Gynocular and a stationary colposcope. The Swede score systematic colposcopy system was used for evaluation of colposcopic abnormalities. Directed punch biopsy and excisional cone biopsy were used as the “gold-standard” by histologically confirmed high grade cervical lesions CIN2+ (CIN2, CIN3, CIN3+). In total, 123 women referred for colposcopy due to abnormal cervical cytology were recruited at the Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden. The percentage agreement and the kappa statistic were calculated for Swede score by the Gynocular and a stationary colposcope. Swede scores were compared with the results from directed punch biopsy and excisional cone biopsy.

Results: The Gynocular and the stationary colposcope had a high agreement of Swede scores with a Kappa statistic of 0.947, p < .0001. Punch biopsy diagnosed CIN2+ (CIN2, CIN3, and invasive cancer) in 44 (35.7 percent) women while cytology detected CIN2+ in 34 (27.6 percent) women. There were no significant differences of the sensitivity and specificity for different Swede scores by the Gynocular or a stationary colposcope in detecting CIN 2+.

Conclusions: There were no significant differences in sensitivity or specificity in detecting cervical lesions by the Gynocular or stationary colposcope. The Gynocular is as accurate in diagnosing cervical lesions as a stationary colposcope.

Keywords

Diagnostic accuracyColposcopyGynocularCervixCIN
Type
Assessments
Information
International Journal of Technology Assessment in Health Care , Volume 31 , Issue 3 , 2015 , pp. 181 - 187
Copyright
Copyright © Cambridge University Press 2015 

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