*2.11. Statistical Methods*

Patients' characteristics were summarized by count and percent or mean and standard deviation (SD) for categorical and continuous variables, respectively. HPV test agreement, at both baseline and at follow-up, were estimated by the proportion of concordant cases. In order to take into account the low prevalence of negative and positive cases at baseline and at follow-up, respectively, concordance was estimated by the prevalence-adjusted and bias-adjusted kappa (PABAK) [14] statistic. Point estimates were tabulated alongside 95% confidence interval and the significance of the agreement between each HPV test with the HC2 test was determined by using the McNemar test. Sensitivity and specificity of each test at baseline and at follow-up were plotted in a forest-like plot for all patients and tabulated for the CIN2+ patients only. All tests were two-tailed and considered significant at the 5% level. The HC2 test was used as the reference test. All analyses were conducted using SAS 9.4 (N.C, Cary) and STATA (StataCorp. 2021. *Stata Statistical Software: Release 17*. College Station, TX, USA: StataCorp LLC).
