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Cancer. 2016 Mar 15;122(6):826-39. doi: 10.1002/cncr.29865. Epub 2016 Feb 1.

Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer.

Author information

1
Flinders Center for Innovation in Cancer, Flinders University, Adelaide, South Australia, Australia.
2
Reference Center for Epidemiology and Cancer Prevention, Piedmont Regional Center for Preventive Oncology, City Health and Science University Hospital of Turin, Turin, Italy.
3
Environmental and Occupational Medicine, University of Minnesota, Minneapolis, Minnesota.
4
Division of Gastroenterology, University of California, San Francisco and Kaiser Division of Research, Oakland, California.
5
Gastrointestinal Epidemiology, Imperial College, London, United Kingdom.
6
Gastroenterology Department, Avicenne Hospital, Paris 13 University, Paris, France.
7
Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
8
Department of Gastroenterology, Repatriation General Hospital, Adelaide, South Australia, Australia.
9
Unit 1086, French National Institute for Health and Medical Research, Cancers and Preventions Center, Caen University Hospital, Caen, France.
10
Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.
11
Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology, Bremen, Germany.
12
Telemark Hospital, Skein Cancer Registry of Norway, University of Oslo, Oslo, Norway.
13
Gastrointestinal Division, Icahn School of Medicine at Mount Sinai, New York, New York.
14
Digestive Diseases Center, GASTRO, Faculty of Medicine, University of Latvia, Riga, Latvia.
15
Division of Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas.
16
Netherlands Cancer Institute, Amsterdam, The Netherlands.
17
Faculty of Health Science, Trinity College Dublin, Dublin, Ireland.
18
Ministry of Health Bowel Cancer Program, Auckland Hospital, Auckland, New Zealand.
19
Prevention and Cancer Control, Cancer Care Ontario, and University of Toronto, Toronto, Ontario, Canada.
20
Department of Gastroenterology, Sestopali Fund for Gastrointestinal Cancer Prevention, Tel Aviv, Israel.
21
Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan.
22
Department of Medicine and Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.
23
National Health Service Bowel Cancer Screening Southern Program Hub, Royal Surrey County Hospital, Guildford, United Kingdom.
24
Department of Surgery, University of Dundee, Dundee, Scotland.
25
Office of the Vice Chancellor, The Chinese University of Hong Kong, Shatin, China.
26
Gastroenterology and Nutrition Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.

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.

KEYWORDS:

colonoscopy; colorectal cancer; fecal occult blood test; molecular diagnostics; screening test

PMID:
26828588
PMCID:
PMC5066737
DOI:
10.1002/cncr.29865
[Indexed for MEDLINE]
Free PMC Article

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