Kitchener, H. C., Blanks, R., Dunn, G., Gunn, L., Desai, M., Albrow, R., Mather, J., Rana, D. N., Cubie, H., Moore, C., Legood, R., Gray, A., Moss, S. (2011) Automation-assisted versus manual reading of cervical cytology (MAVARIC): a randomised controlled trial. LANCET ONCOLOGY, 12 (1). pp. 56-64. ISSN 1470-2045

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Abstract

Background The standard for reading cervical cytology is for a cytoscreener to manually search across an entire slide for abnormal cells using a conventional microscope. Automated technology can select fields of view to assess abnormal cells, which allows targeted reading by cytoscreeners. In the Manual Assessment Versus Automated Reading In Cytology (MAVARIC) trial, we compared the accuracy of these techniques for the detection of underlying disease. Methods For this randomised controlled trial, women aged 25-64 years undergoing primary cervical screening in Manchester, UK, were randomly assigned (1:2) to receive either manual reading only or paired reading (automation. assisted reading and manual reading), between March 1, 2006, and Feb 28, 2009. In the paired arm, two automated systems were used the ThinPrep Imaging System and the FocalPoint GS Imaging System. General practices and community clinics were randomised to either ThinPrep or to SurePath (for the FocalPoint system) liquid-based cytology with block randomisation stratified by deprivation index. Samples were then individually randomised to manual reading only or paired reading only. Laboratory staff were unaware of the allocation of each slide and concealment was maintained until the end of the reporting process. The primary outcome was sensitivity of automation-assisted reading relative to manual reading for the detection of underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in the paired arm. This trial is registered, number ISRCTN66377374. Findings 73 266 liquid-based cytology samples were obtained from women undergoing primary cervical screening; 24 688 allocated to the manual-only arm and 48 578 to the paired-reading arm. Automation-assisted reading was 8% less sensitive than manual reading (relative sensitivity 0.92, 95% CI 0.89-0.95), which was equivalent to an absolute reduction in sensitivity of 6.3%, assuming the sensitivity of manual reading to be 79%. Specificity of automation-assisted reading relative to manual reading increased by 0.6% (1.006, 95% CI 1.005-1.007). Interpretation The inferior sensitivity of automation-assisted reading for the detection of CIN2+, combined with an inconsequential increase in specificity, suggests that automation-assisted reading cannot be recommended for primary cervical screening.

Item Type:	Article
Authors (ICR Faculty only):	Blanks, Roger and Moss, sue
All Authors:	Kitchener, H. C., Blanks, R., Dunn, G., Gunn, L., Desai, M., Albrow, R., Mather, J., Rana, D. N., Cubie, H., Moore, C., Legood, R., Gray, A., Moss, S.
Additional Information:	ISI Document Delivery No.: 708LA Times Cited: 0 Cited Reference Count: 18 Kitchener, Henry C. Blanks, Roger Dunn, Graham Gunn, Lionel Desai, Mina Albrow, Rebecca Mather, Jean Rana, Durgesh N. Cubie, Heather Moore, Catherine Legood, Rosa Gray, Alastair Moss, Sue National Institute for Health Research Health Technology Assessment [03/04/02]; Abbott Diagnostics ; Qiagen ; NIHR Manchester Biomedical Research Centre National Institute for Health Research Health Technology Assessment programme. All authors' institutions received funding from the National Institute for Health Research Health Technology Assessment programme (NIHR HTA) to do the study. SM, RB, and CM received NIHR HTA funding to attend trial management group meetings. HC's institute received an M2000 system on loan from Abbott Diagnostics, and money from Abbott Diagnostics and Qiagen to reimburse travel expenses to scientific meetings. HCK received reimbursement for travel expenses from the International Academy of Cytology to present the results of this study at their 2010 scientific meeting. This study was done under the guidance of an independent trial steering committee (David Torgerson, Maggie Cruickshank, and Karin Denton) and a data monitoring and ethics committee (Paula Williamson, John Smith, and Patrick Walker). We are grateful to Yvonne Hughes and the staff at the Manchester Cytology Centre for their cooperation and effort in accommodating the MAVARIC study. We acknowledge the use of a BD FocalPoint GS Imaging System provided free of charge by Medical Solutions for the initial 2 years of the study. We thank Qiagen for providing substantially discounted Hybrid Capture 2 kits. This project was funded by the National Institute for Health Research Health Technology Assessment programme (NIHR HTA; project number 03/04/02). The views and opinions expressed in this study are those of the authors and do not necessarily reflect those of the Department of Health. This work was supported by the NIHR Manchester Biomedical Research Centre. Elsevier science inc New york
Uncontrolled Keywords:	thinprep imaging-system human-papillomavirus intraepithelial neoplasia cancer metaanalysis sensitivity lesions
Research teams:	Closed research groups > Cancer Screening Evaluation Unit (DoH)
Depositing User:	Barry Jenkins
Date Deposited:	07 Apr 2011 11:30
Last Modified:	10 Oct 2011 12:51
URI:	http://publications.icr.ac.uk/id/eprint/10571

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