Objective: This study was done to evaluate the efficacy of the Pap smear, speculoscopy, and a combination of Pap smear and speculoscopy (PapSure examination) in pre- and postmenopausal women.
Study design: All women were screened using the Pap smear and speculoscopy and combination of both (PapSure examination) in the multicenter trial. Final diagnosis of each patient was based on a histological evaluation of the colposcopic target biopsy. Results were analyzed using a proportional comparison test, sensitivity, specificity, and predictive value with significance determined at p<0.05.
Results: Of 1813 women screened, 1701 were eligible for analysis. Two hundred and fourteen women (12.6%) received at least one positive screening test result. Of the 1084 colposcopic biopsy specimens obtained, 24 showed low-grade squamous intraepithelial lesion (LSIL) and 19 high-grade SIL (HSIL). HSIL were considered test-positive. Rate of colposcopy was 21.5% (125/582) in the premenopausal group and 63.9% (321/502) in the postmenopausal group (p<0.001). For premenopausal women, speculoscopy (75.0%) or PapSure (91.7%) provided higher sensitivity than Pap smear (50%) (p<0.05). In postmenopausal women, no statistical significance in sensitivity existed between PapSure (85.7%) and Pap smear (57.1%). Speculoscopy (96.8%) or PapSure (96.5%) had lower specificity than Pap smear (99.6%) (p<0.001).
Conclusion: PapSure was an accurate alternative screening method to Pap smear or speculoscopy for cervical intraepithelial lesions because of a significantly higher sensitivity along with adequate specificity for premenopausal women; however, PapSure was not a more effective cervical screening method for postmenopausal women.