title: Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer.
abstract: BACKGROUND
  New screening tests for colorectal cancer continue to emerge, but the evidence needed to justify their adoption in screening programs remains uncertain.
  
  
  METHODS
  A review of the literature and a consensus approach by experts was undertaken to provide practical guidance on how to compare new screening tests with proven screening tests.
  
  
  RESULTS
  Findings and recommendations from the review included the following: Adoption of a new screening test requires evidence of effectiveness relative to a proven comparator test. Clinical accuracy supported by programmatic population evaluation in the screening context on an intention-to-screen basis, including acceptability, is essential. Cancer-specific mortality is not essential as an endpoint provided that the mortality benefit of the comparator has been demonstrated and that the biologic basis of detection is similar. Effectiveness of the guaiac-based fecal occult blood test provides the minimum standard to be achieved by a new test. A 4-phase evaluation is recommended. An initial retrospective evaluation in cancer cases and controls (Phase 1) is followed by a prospective evaluation of performance across the continuum of neoplastic lesions (Phase 2). Phase 3 follows the demonstration of adequate accuracy in these 2 prescreening phases and addresses programmatic outcomes at 1 screening round on an intention-to-screen basis. Phase 4 involves more comprehensive evaluation of ongoing screening over multiple rounds. Key information is provided from the following parameters: the test positivity rate in a screening population, the true-positive and false-positive rates, and the number needed to colonoscope to detect a target lesion.
  
  
  CONCLUSIONS
  New screening tests can be evaluated efficiently by this stepwise comparative approach.
authors.affiliation: Flinders Center for Innovation in Cancer, Flinders University, Adelaide, South Australia, Australia.
authors.forename: Graeme P
authors.initials: GP
authors.lastname: Young
authors.affiliation: Reference Center for Epidemiology and Cancer Prevention, Piedmont Regional Center for Preventive Oncology, City Health and Science University Hospital of Turin, Turin, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Senore
authors.affiliation: Environmental and Occupational Medicine, University of Minnesota, Minneapolis, Minnesota.
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authors.initials: JS
authors.lastname: Mandel
authors.affiliation: Division of Gastroenterology, University of California, San Francisco and Kaiser Division of Research, Oakland, California.
authors.forename: James E
authors.initials: JE
authors.lastname: Allison
authors.affiliation: Gastrointestinal Epidemiology, Imperial College, London, United Kingdom.
authors.forename: Wendy S
authors.initials: WS
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authors.affiliation: Gastroenterology Department, Avicenne Hospital, Paris 13 University, Paris, France.
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authors.lastname: Benamouzig
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Patrick M M
authors.initials: PM
authors.lastname: Bossuyt
authors.affiliation: Department of Gastroenterology, Repatriation General Hospital, Adelaide, South Australia, Australia.
authors.forename: Mahinda De
authors.initials: MD
authors.lastname: Silva
authors.affiliation: Unit 1086, French National Institute for Health and Medical Research, Cancers and Preventions Center, Caen University Hospital, Caen, France.
authors.forename: Lydia
authors.initials: L
authors.lastname: Guittet
authors.affiliation: Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Halloran
authors.affiliation: Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology, Bremen, Germany.
authors.forename: Ulrike
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authors.lastname: Haug
authors.affiliation: Telemark Hospital, Skein Cancer Registry of Norway, University of Oslo, Oslo, Norway.
authors.forename: Geir
authors.initials: G
authors.lastname: Hoff
authors.affiliation: Gastrointestinal Division, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Steven H
authors.initials: SH
authors.lastname: Itzkowitz
authors.affiliation: Digestive Diseases Center, GASTRO, Faculty of Medicine, University of Latvia, Riga, Latvia.
authors.forename: Marcis
authors.initials: M
authors.lastname: Leja
authors.affiliation: Division of Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Bernard
authors.initials: B
authors.lastname: Levin
authors.affiliation: Netherlands Cancer Institute, Amsterdam, The Netherlands.
authors.forename: Gerrit A
authors.initials: GA
authors.lastname: Meijer
authors.affiliation: Faculty of Health Science, Trinity College Dublin, Dublin, Ireland.
authors.forename: Colm A
authors.initials: CA
authors.lastname: O'Morain
authors.affiliation: Ministry of Health Bowel Cancer Program, Auckland Hospital, Auckland, New Zealand.
authors.forename: Susan
authors.initials: S
authors.lastname: Parry
authors.affiliation: Prevention and Cancer Control, Cancer Care Ontario, and University of Toronto, Toronto, Ontario, Canada.
authors.forename: Linda
authors.initials: L
authors.lastname: Rabeneck
authors.affiliation: Department of Gastroenterology, Sestopali Fund for Gastrointestinal Cancer Prevention, Tel Aviv, Israel.
authors.forename: Paul
authors.initials: P
authors.lastname: Rozen
authors.affiliation: Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.affiliation: Department of Medicine and Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Schoen
authors.affiliation: National Health Service Bowel Cancer Screening Southern Program Hub, Royal Surrey County Hospital, Guildford, United Kingdom.
authors.forename: Helen E
authors.initials: HE
authors.lastname: Seaman
authors.affiliation: Department of Surgery, University of Dundee, Dundee, Scotland.
authors.forename: Robert J C
authors.initials: RJ
authors.lastname: Steele
authors.affiliation: Office of the Vice Chancellor, The Chinese University of Hong Kong, Shatin, China.
authors.forename: Joseph J Y
authors.initials: JJ
authors.lastname: Sung
authors.affiliation: Gastroenterology and Nutrition Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Sidney J
authors.initials: SJ
authors.lastname: Winawer
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D016022:Case-Control Studies; D002986:Clinical Trials as Topic; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D055088:Early Detection of Cancer / Q000379:methods*; D005069:Evaluation Studies as Topic; D005189:False Positive Reactions; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D009780:Occult Blood; D017410:Practice Guidelines as Topic / Q000592:standards; D015203:Reproducibility of Results; D012107:Research Design; D018401:Sample Size
chemical_list: D014408:Biomarkers, Tumor
keywords: colonoscopy; colorectal cancer; fecal occult blood test; molecular diagnostics; screening test
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