title: Disease detection and resource use in the safety and control arms of the HPV FOCAL cervical cancer screening trial.
abstract: BACKGROUND
  The HPV FOCAL Trial is a RCT comparing human papilloma virus (HPV) with Liquid Based Cytology (LBC) screening for cervical cancer. Results are presented for the comparison of the Safety and Control arms after two rounds.
  
  
  METHODS
  HPV FOCAL included randomisation of women aged 25-65 into the Safety arm, where they were initially screened with HPV and the Control arm, where they received entry screening with LBC, with both arms screened again with LBC at 24 months.
  
  
  RESULTS
  There are 6203 (Safety) and 6075 (Control) women included in this analysis. For the Safety vs Control arms, Round 1 screening resulted in increased detection of cervical intraepithelial neoplasia 2 or worse (CIN2+),15.3 vs 10.4 per 1000, RR=1.48 (95%CI=1.08-2.03) and higher colposcopy referral rates, 5.6% vs 3.2%. LBC screening at 24 months resulted in similar colposcopy referral rates, 1.5% vs 1.9%, and decreased CIN2+ detection, 2.0 vs 4.7 per 1000, RR=0.43 (95%CI=0.21-0.88) in the Safety vs Control arms. CIN2+ detection and colposcopy referral rates declined with increasing age in both arms. One round of HPV screening detected similar levels of CIN2+ as two rounds of LBC screening.
  
  
  CONCLUSIONS
  CIN2+ detection at 2 years was lower in those screened by HPV, indicating an improved 2-year negative predictive value of the HPV test.
authors.affiliation: Cancer Control Research, BC Cancer Research Centre, 675W 10th Ave, Vancouver, British Columbia, V5Z 1L3 Canada.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Coldman
authors.affiliation: Cancer Control Research, BC Cancer Research Centre, 675W 10th Ave, Vancouver, British Columbia, V5Z 1L3 Canada.
authors.forename: Lovedeep
authors.initials: L
authors.lastname: Gondara
authors.affiliation: Cancer Control Research, BC Cancer Research Centre, 675W 10th Ave, Vancouver, British Columbia, V5Z 1L3 Canada.
authors.forename: Laurie W
authors.initials: LW
authors.lastname: Smith
authors.affiliation: Cervical Cancer Screening Program, BC Cancer Agency, 650W 10th Ave, Vancouver, British Columbia, V5Z 4E6 Canada.
authors.forename: Dirk
authors.initials: D
authors.lastname: van Niekerk
authors.affiliation: Cervical Cancer Screening Program, BC Cancer Agency, 650W 10th Ave, Vancouver, British Columbia, V5Z 4E6 Canada.
authors.forename: Kathy
authors.initials: K
authors.lastname: Ceballos
authors.affiliation: Clinical Prevention Services, BC Centre for Disease Control, 655W 12th Ave, Vancouver, British Columbia, V5Z 4R4 Canada.
authors.forename: Mel
authors.initials: M
authors.lastname: Krajden
authors.affiliation: Cancer Control Research, BC Cancer Research Centre, 675W 10th Ave, Vancouver, British Columbia, V5Z 1L3 Canada.
authors.forename: Darrel
authors.initials: D
authors.lastname: Cook
authors.affiliation: Department of Obstetrics and Gynecology, University of British Columbia, 1190 Hornby Street, Vancouver, British Columbia, V6Z 2K5 Canada.
authors.forename: David J
authors.initials: DJ
authors.lastname: Quinlan
authors.affiliation: Department of Obstetrics and Gynecology, University of British Columbia, 1190 Hornby Street, Vancouver, British Columbia, V6Z 2K5 Canada.
authors.forename: Marette
authors.initials: M
authors.lastname: Lee
authors.affiliation: Department of Obstetrics and Gynecology, University of British Columbia, 1190 Hornby Street, Vancouver, British Columbia, V6Z 2K5 Canada.
authors.forename: Gavin Ce
authors.initials: GC
authors.lastname: Stuart
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, BC Cancer Research Centre, 675W 10th Ave, Vancouver, British Columbia, V5Z 1L3 Canada.
authors.forename: Stuart
authors.initials: S
authors.lastname: Peacock
authors.affiliation: School of Public Health, University of British Columbia, 2206 E Mall, Vancouver, British Columbia, V6T 1Z9 Canada.
authors.forename: Ruth Elwood
authors.initials: RE
authors.lastname: Martin
authors.affiliation: Cervical Cancer Screening Program, BC Cancer Agency, 650W 10th Ave, Vancouver, British Columbia, V5Z 4E6 Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: Gentile
authors.affiliation: Division of Cancer Epidemiology, McGill University, 546 Pine Ave West, Montreal, Quebec, H2W 1S6 Canada.
authors.forename: Eduardo L
authors.initials: EL
authors.lastname: Franco
authors.affiliation: School of Public Health, University of British Columbia, 2206 E Mall, Vancouver, British Columbia, V6T 1Z9 Canada.|Women's Health Research Institute, Women's Hospital, Vancouver, British Columbia, V6H 3N1 Canada.
authors.forename: Gina S
authors.initials: GS
authors.lastname: Ogilvie
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*