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

Graeme P. Young; Carlo Senore; Jack S. Mandel; James E. Allison; Wendy S. Atkin; Robert Benamouzig; Patrick M. M. Bossuyt; Mahinda De Silva; Lydia Guittet; Stephen P. Halloran; Ulrike Haug; Geir Hoff; Steven H. Itzkowitz; Marcis Leja; Bernard Levin; Gerrit A. Meijer; Colm A. O'Morain; Susan Parry; Linda Rabeneck; Paul Rozen; Hiroshi Saito; Robert E. Schoen; Helen E. Seaman; Robert J. C. Steele; Joseph J. Y. Sung; Sidney J. Winawer

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 (Lead / Corresponding author), Carlo Senore, Jack S. Mandel, James E. Allison, Wendy S. Atkin, Robert Benamouzig, Patrick M. M. Bossuyt, Mahinda De Silva, Lydia Guittet, Stephen P. Halloran, Ulrike Haug, Geir Hoff, Steven H. Itzkowitz, Marcis Leja, Bernard Levin, Gerrit A. Meijer, Colm A. O'Morain, Susan Parry, Linda Rabeneck, Paul RozenHiroshi Saito, Robert E. Schoen, Helen E. Seaman, Robert J. C. Steele, Joseph J. Y. Sung, Sidney J. Winawer

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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. Cancer 2016;122:826-39. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

Original language	English
Pages (from-to)	826-839
Number of pages	14
Journal	Cancer
Volume	122
Issue number	6
Early online date	1 Feb 2016
DOIs	https://doi.org/10.1002/cncr.29865
Publication status	Published - 15 Mar 2016

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© 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Final published version, 183 KBLicence: CC BY

Steele, Bob
- Population Health and Genomics - Emeritus Professor
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Young, G. P., Senore, C., Mandel, J. S., Allison, J. E., Atkin, W. S., Benamouzig, R., Bossuyt, P. M. M., Silva, M. D., Guittet, L., Halloran, S. P., Haug, U., Hoff, G., Itzkowitz, S. H., Leja, M., Levin, B., Meijer, G. A., O'Morain, C. A., Parry, S., Rabeneck, L., ... Winawer, S. J. (2016). Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer. Cancer, 122(6), 826-839. https://doi.org/10.1002/cncr.29865

@article{7627af72728b49b4950e4b6b003e3863,

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. Cancer 2016;122:826-39. {\textcopyright} 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.",

author = "Young, {Graeme P.} and Carlo Senore and Mandel, {Jack S.} and Allison, {James E.} and Atkin, {Wendy S.} and Robert Benamouzig and Bossuyt, {Patrick M. M.} and Silva, {Mahinda De} and Lydia Guittet and Halloran, {Stephen P.} and Ulrike Haug and Geir Hoff and Itzkowitz, {Steven H.} and Marcis Leja and Bernard Levin and Meijer, {Gerrit A.} and O'Morain, {Colm A.} and Susan Parry and Linda Rabeneck and Paul Rozen and Hiroshi Saito and Schoen, {Robert E.} and Seaman, {Helen E.} and Steele, {Robert J. C.} and Sung, {Joseph J. Y.} and Winawer, {Sidney J.}",

note = "{\textcopyright} 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.",

year = "2016",

month = mar,

day = "15",

doi = "10.1002/cncr.29865",

language = "English",

volume = "122",

pages = "826--839",

journal = "Cancer",

issn = "0008-543X",

publisher = "Wiley",

number = "6",

}

Young, GP, Senore, C, Mandel, JS, Allison, JE, Atkin, WS, Benamouzig, R, Bossuyt, PMM, Silva, MD, Guittet, L, Halloran, SP, Haug, U, Hoff, G, Itzkowitz, SH, Leja, M, Levin, B, Meijer, GA, O'Morain, CA, Parry, S, Rabeneck, L, Rozen, P, Saito, H, Schoen, RE, Seaman, HE, Steele, RJC, Sung, JJY & Winawer, SJ 2016, 'Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer', Cancer, vol. 122, no. 6, pp. 826-839. https://doi.org/10.1002/cncr.29865

TY - JOUR

T1 - Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer

AU - Young, Graeme P.

AU - Senore, Carlo

AU - Mandel, Jack S.

AU - Allison, James E.

AU - Atkin, Wendy S.

AU - Benamouzig, Robert

AU - Bossuyt, Patrick M. M.

AU - Silva, Mahinda De

AU - Guittet, Lydia

AU - Halloran, Stephen P.

AU - Haug, Ulrike

AU - Hoff, Geir

AU - Itzkowitz, Steven H.

AU - Leja, Marcis

AU - Levin, Bernard

AU - Meijer, Gerrit A.

AU - O'Morain, Colm A.

AU - Parry, Susan

AU - Rabeneck, Linda

AU - Rozen, Paul

AU - Saito, Hiroshi

AU - Schoen, Robert E.

AU - Seaman, Helen E.

AU - Steele, Robert J. C.

AU - Sung, Joseph J. Y.

AU - Winawer, Sidney J.

PY - 2016/3/15

Y1 - 2016/3/15

N2 - 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. Cancer 2016;122:826-39. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

AB - 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. Cancer 2016;122:826-39. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

U2 - 10.1002/cncr.29865

DO - 10.1002/cncr.29865

M3 - Comment/debate

C2 - 26828588

SN - 0008-543X

VL - 122

SP - 826

EP - 839

JO - Cancer

JF - Cancer

IS - 6

ER -

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

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