Comparison of the conventional cervical smear and liquid-based cytology: results of a controlled, prospective study in the Abruzzo Region of Italy.
OBJECTIVE
To compare conventional cervical testing (CCT) and liquid-based cytology (LBC) within a randomized trial performed during 2001-2002 in the Abruzzo Region of Italy, including a cost-outcome comparative analysis.


METHODS
Study subjects were recruited in the framework of a controlled, randomized study organized in the Abruzzo Region. Women aged 2 6-64 years were randomized to an active arm (LBC) or control arm (CC1). The particip ating laboratories had no previous ex perience with LBC.


RESULTS
The inadequacy rate was 4.3% in CCT and 1.3% in the LBC arm (D < 0.001). Atypical squamous cells of undetermined sign ifi cance and atypical glands of undetermined significance reports were more frequent at CCT vs. LBC. A small, insignificant excess of low grade squamous intraepithelial lesions or high grade squamous epithelial lesions+ reports was observed in the LBC arm. The cervical intraepithelial neoplasia 2+ (CIN2+) detection rate was not statistically different in the 2 arms (CCT=0.54%, LBC= 0.66%, p = 0.28). In the overall series positive predictive value was slightly but not significantly higher in the LBC arm. LBC increased costs by 4.2% per both screened women and CIN2+ detected.


CONCLUSIONS
The study reflects the introductory phase of LBC in laboratories without prior LBC experience. In this setting LBC reduced the inadequacy rate and decreased reading and was at least as sensitive as and more specific than CCT. Utilization of LBC in organized screening programs will be based on local feasibility, considering that the high cost of LBC is only partially compensated for by other benefits, such as residual cellular material, available for molecular testing, including human papillomavirus testing.
Maccallini
Vincenzo
V
Pathology Unit, Annunziata Hospital, Cervical Cancer Screening Program, Abruzzo Region, Sulmona.
Angeloni
Claudio
C
Caraceni
Donatella
D
Fortunato
Carmine
C
Venditti
Maria Antonietta
MA
Di Gabriele
Giannina
G
Antonelli
Chiara
C
Lattanzi
Amedeo
A
Puliti
Donella
D
Ciatto
Stefano
S
Confortini
Massimo
M
Sani
Cristina
C
Zappa
Marco
M
D000328:Adult; D003362:Cost-Benefit Analysis; D003584:Cytological Techniques / Q000191:economics / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology*; D014626:Vaginal Smears / Q000191:economics / Q000379:methods