Outcomes and statistical analyses
cancer, CIN3/AIS
CANCER
The primary outcomes in the two groups were the proportion of tested women, the number of CIN2+ lesions detected per 1,000 women who were eligible for the intervention, reflecting an intention-to-treat analysis, and the benefit–harm ratio. CIN2+ was chosen as main clinical outcome since it is the treatable threshold for older women. The CIN2+ detection in the intervention group was also reported using the total number of HPV–positive women with histology as denominator and according to HPV genotype (HPV16/18 versus HPV other types). The proportion of tested women was calculated as the number of cervical cytology samples or vaginal self-samples (defined as index test) registered within 12 months from the date of eligibility for study inclusion divided by the number of women eligible for the screening offer. This outcome was tabulated by screening modality, age group, and screening history. We evaluated the benefit–harm ratio of the intervention and standard practice by estimating the number of colposcopies required to detect a single case of CIN2+/ CIN3+ (CIN3/AIS and cancer) as previously described [