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Randomized Controlled Trial
. 2007 Jul 7;335(7609):28.
doi: 10.1136/bmj.39196.740995.BE. Epub 2007 May 21.

Accuracy of liquid based versus conventional cytology: overall results of new technologies for cervical cancer screening: randomised controlled trial

Guglielmo Ronco  1 , Jack Cuzick, Paola Pierotti, Maria Paola Cariaggi, Paolo Dalla Palma, Carlo Naldoni, Bruno Ghiringhello, Paolo Giorgi-Rossi, Daria Minucci, Franca Parisio, Ada Pojer, Maria Luisa Schiboni, Catia Sintoni, Manuel Zorzi, Nereo Segnan, Massimo Confortini
Affiliations
Randomized Controlled Trial

Accuracy of liquid based versus conventional cytology: overall results of new technologies for cervical cancer screening: randomised controlled trial

Guglielmo Ronco et al. BMJ. .

Abstract

Objective: To compare the accuracy of conventional cytology with liquid based cytology for primary screening of cervical cancer.

Design: Randomised controlled trial.

Setting: Nine screening programmes in Italy.

Participants: Women aged 25-60 attending for a new screening round: 22 466 were assigned to the conventional arm and 22 708 were assigned to the experimental arm.

Interventions: Conventional cytology compared with liquid based cytology and testing for human papillomavirus.

Main outcome measure: Relative sensitivity for cervical intraepithelial neoplasia of grade 2 or more at blindly reviewed histology, with atypical cells of undetermined significance or more severe cytology considered a positive result.

Results: In an intention to screen analysis liquid based cytology showed no significant increase in sensitivity for cervical intraepithelial neoplasia of grade 2 or more (relative sensitivity 1.17, 95% confidence interval 0.87 to 1.56) whereas the positive predictive value was reduced (relative positive predictive value v conventional cytology 0.58, 0.44 to 0.77). Liquid based cytology detected more lesions of grade 1 or more (relative sensitivity 1.68, 1.40 to 2.02), with a larger increase among women aged 25-34 (P for heterogeneity 0.0006), but did not detect more lesions of grade 3 or more (relative sensitivity 0.84, 0.56 to 1.25). Results were similar when only low grade intraepithelial lesions or more severe cytology were considered a positive result. No evidence was found of heterogeneity between centres or of improvement with increasing time from start of the study. The relative frequency of women with at least one unsatisfactory result was lower with liquid based cytology (0.62, 0.56 to 0.69).

Conclusion: Liquid based cytology showed no statistically significant difference in sensitivity to conventional cytology for detection of cervical intraepithelial neoplasia of grade 2 or more. More positive results were found, however, leading to a lower positive predictive value. A large reduction in unsatisfactory smears was evident.

Trial registration: Current Controlled Trials ISRCTN81678807 [controlled-trials.com].

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Conflict of interest statement

Competing interests: JC is a member of the speaker's bureau for Digene. His institution (Cancer Research UK) has received research funding from Roche Diagnostics for a different study. MC is the principal recipient of a grant to the Scientific Institute for Cancer Prevention of Tuscany Region from Menarini Diagnostics. This grant is for another study.

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References

    1. Davey E, Barrat A, Irwig L, Chan SF, Macaskill P, Mannes P, et al. Effect of study design and quality on unsatisfactory rates, cytological classification, and accuracy in liquid-based versus conventional cervical cytology: a systematic review. Lancet 2006;367:122-32. - PubMed
    1. Ronco G, Segnan N, Giorgi-Rossi P, Zappa M, Casadei GP, Carozzi F, et al. Human papillomavirus testing and liquid-based cytology: results at recruitment from the New Technologies for Cervical Cancer randomized controlled trial. J Natl Cancer Inst 2006;98:765-74. - PubMed
    1. Ronco G, Giorgi-Rossi P, Carozzi F, Dalla Palma P, Del Mistro A, De Marco L, et al. Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial. Lancet Oncol 2006;7:547-55. - PubMed
    1. Nanda K, McCrory DC, Myers ER, Bastina LA, Hasselblad V, Hickey JD, et al. Accuracy of the Papanicolau test in screening and follow-up of cervical cytologic abnormalities: a systematic review. Ann Intern Med 2000;132:810-9. - PubMed
    1. Bernstein SJ, Sanchez-Ramos L, Ndubisi B. Liquid-based cervical cytologic smear study and conventional Papanicolau smears: a meta analysis of prospective studies comparing cytologic diagnosis and sample adequacy. Am J Obstet Gynecol 2001;185:308-17. - PubMed

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