Factors affecting the reproducibility and validity of colposcopy for product development: review of current literature

Abstract

Colposcopy has been adapted from cervical cytology screening as a tool to assess the tolerance of vaginal products in development for anti-infective and contraceptive indications. As the vagina is poorly enervated, symptoms do not correlate well with visual findings, which increases the importance of secondary assessment. Dysplasia screening has used biopsy liberally to verify the colposcopic diagnostic impression. The few studies that include correlative biopsy with colposcopy performed for product development are reviewed. A recent study of the reproducibility of two observations at a single visit by a single or two different physicians is discussed. The review points to magnification and experience of the observer as factors in improving the agreement between observations. Observers are more likely to agree on areas greater than 1 cm in diameter. Variation is reduced when fewer observers are used and they report findings as dichotomous or categorical data.