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


METHODS
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.
Nieminen
Pekka
P
Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Box 140, FIN-00029, Helsinki, Finland. pekka.nieminen@hus.fi
Kotaniemi-Talonen
Laura
L
Hakama
Matti
M
Tarkkanen
Jussi
J
Martikainen
Jorma
J
Toivonen
Terttu
T
Ikkala
Jorma
J
Anttila
Ahti
A
D000328:Adult; D000368:Aged; D001331:Automation; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*