Randomized evaluation trial on automation-assisted screening for cervical cancer: results after 777,000 invitations

New cervical screening methods have been developed. They seem to become accepted in routine use without randomized trials, within existing screening programmes. Our aim was to evaluate, in a randomized setting, the performance of automation-assisted cytological screening in routine use compared with conventional Papanicoalou (Pap) screening.

This prospective study was based on a 1:2 individually randomized design. Altogether 777,144 women were invited to attend the routine screening programme.

Automation-assisted screening found more Pap class III (LSIL+) findings compared with conventional study arm, relative risk (RR) 1.08 (confidence interval 1.01-1.15). Also, detection rates of verified pre-cancers were more common in automation-assisted arm, RR 1.11 (1.02-1.21).

Automation-assisted screening performed well compared with conventional screening. The difference was smaller than reported in non-randomized studies. A new technique may assume several years to reach the ultimate quality and can add costs without improving efficacy. Follow-up of prevented cervical cancers is required.