ARTISTIC: a randomised trial of human papillomavirus (HPV) testing in primary cervical screening

作者：HC Kitchener, Maribel Almonte, Clare Gilham, Robin Dowie, Boyka Stoykova, Alexandra Sargent, Caleb Roberts, M. Desai, Julian Peto · 发表于：Health Technology Assessment · 年份：2009 · DOI：10.3310/hta13510 · 被引用次数：188 · 研究领域：Cervical Cancer and HPV Research、Global Cancer Incidence and Screening、Reliability and Agreement in Measurement

OBJECTIVES: Primary cervical screening uses cytology to detect cancer precursor lesions [cervical intraepithelial neoplasia stage 3 or beyond (CIN3+)]. Human papillomavirus (HPV) testing could add sensitivity as an adjunct to cytology or as a first test, reserving cytology for HPV-positive women. This study addresses the questions: Does the combination of cytology and HPV testing achieve a reduction in incident CIN3+?; Is HPV testing cost-effective in primary cervical screening?; Is its use associated with adverse psychosocial or psychosexual effects?; and How would it perform as an initial screening test followed by cytology for HPV positivity? DESIGN: ARTISTIC was a randomised trial of cervical cytology versus cervical cytology plus HPV testing, evaluated over two screening rounds, 3 years apart. Round 1 would detect prevalent disease and round 2 a combination of incident and undetected disease from round 1. SETTING: Women undergoing routine cervical screening in the NHS programme in Greater Manchester. PARTICIPANTS: In total 24,510 women aged 20-64 years were enrolled between July 2001 and September 2003. INTERVENTIONS: HPV testing was performed on the liquid-based cytology (LBC) sample obtained at screening. Women were randomised in a ratio of 3:1 to have the HPV test result revealed and acted upon if persistently positive in cytology-negative cases or concealed. A detailed health economic evaluation and a psychosocial and psychosexual assessment were also performed. MAIN...