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

OBJECTIVES: 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.

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

RESULTS: 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).

CONCLUSIONS: 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.