Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer - PubMed (original) (raw)
. 2016 Mar 15;122(6):826-39.
doi: 10.1002/cncr.29865. Epub 2016 Feb 1.
Carlo Senore 2, Jack S Mandel 3, James E Allison 4, Wendy S Atkin 5, Robert Benamouzig 6, Patrick M M Bossuyt 7, Mahinda De Silva 8, Lydia Guittet 9, Stephen P Halloran 10, Ulrike Haug 11, Geir Hoff 12, Steven H Itzkowitz 13, Marcis Leja 14, Bernard Levin 15, Gerrit A Meijer 16, Colm A O'Morain 17, Susan Parry 18, Linda Rabeneck 19, Paul Rozen 20, Hiroshi Saito 21, Robert E Schoen 22, Helen E Seaman 23, Robert J C Steele 24, Joseph J Y Sung 25, Sidney J Winawer 26
Affiliations
- PMID: 26828588
- PMCID: PMC5066737
- DOI: 10.1002/cncr.29865
Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer
Graeme P Young et al. Cancer. 2016.
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.
© 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
Figures
Figure 1
This is a conceptualization of the design for testing a new test relative to an existing (comparator) test. Solid lines represent essential paths in the process, and dashed lines represent discretionary paths that are not essential in some phases of evaluation.
References
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