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An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles

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dc.contributor.authorRobert S Bresalier, Robert S.
dc.contributor.authorSenore, Carlo
dc.contributor.authorYoung, Graeme P.
dc.contributor.authorAllison, James
dc.contributor.authorBenamouzig, Robert
dc.contributor.authorBenton, Sally
dc.contributor.authorBossuyt, Patrick M.
dc.contributor.authorCaro, Luis
dc.contributor.authorCarvalho, Beatriz
dc.contributor.authorChiu, Han-Mo
dc.contributor.authorCoupé, Veerle M. H.
dc.contributor.authorKlaver, Willemijn de
dc.contributor.authorKlerk, Clasine Maria de
dc.contributor.authorDekker, Evelien
dc.contributor.authorDolwani, Sunil
dc.contributor.authorFraser, Callum G.
dc.contributor.authorGrady, William
dc.contributor.authorGuittet, Lydia
dc.contributor.authorGupta, Samir
dc.contributor.authorHalloran, Stephen P.
dc.contributor.authorHaug, Ulrike
dc.contributor.authorHoff, Geir
dc.contributor.authorItzkowitz, Steven
dc.contributor.authorKortlever, Tim
dc.contributor.authorKoulaouzidis, Anastasios
dc.contributor.authorLadabaum, Uri
dc.contributor.authorLauby-Secretan, Beatrice
dc.contributor.authorLevin, Bernard
dc.contributor.authorLevin, Theodore Robert
dc.contributor.authorMeijer, Gerrit A.
dc.contributor.authorMacrae, Finlay
dc.contributor.authorMelson, Joshua
dc.contributor.authorO'Morain, Colm
dc.contributor.authorParry, Susan
dc.contributor.authorRabeneck, Linda
dc.contributor.authorRansohoff, David F.
dc.contributor.authorSaenz Fuenzalida, Roque Luis
dc.contributor.authorSaito, Hiroshi
dc.contributor.authorSanduleanu-Dascalescu, Silvia
dc.date.accessioned2024-06-03T14:51:20Z
dc.date.available2024-06-03T14:51:20Z
dc.date.issued2023
dc.descriptionRobert E Schoen ,42 Kevin Selby,43 Harminder Singh Erin Leigh Symonds ,44 Robert J C Steele ,45 Joseph J Y Sung ,46 ,47 Sidney J Winawer,48 Members of the World Endoscopy Colorectal Cancer Screening New Test Evaluation Expert Working Group
dc.description.abstractObjective New screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re- examined the principles underlying evaluation of new non- invasive tests in view of technological developments and identification of new biomarkers. Design A formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles. results Twelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non- invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, f lexibility to adjust its positivity threshold is desirable. A rigorous and efficient four- phased approach is proposed, commencing with small studies assessing the test’s ability to discriminate between CRC and non- cancer states (phase I), followed by prospective estimation of accuracy across the continuum of neoplastic lesions in neoplasia- enriched populations (phase II). If these show promise, a provisional test positivity threshold is set before evaluation in typical screening populations. Phase III prospective studies determine single round intention- to- screen programme outcomes and confirm the test positivity threshold. Phase IV studies involve evaluation over repeated screening rounds with monitoring for missed lesions. Phases III and IV findings will provide the real- world data required to model test impact on CRC mortality and incidence. Conclusion New non- invasive tests can be efficiently evaluated by a rigorous phased comparative approach, generating data from unbiased populations that inform predictions of their health impact.
dc.description.versionVersión publicada
dc.format.extent15 p.
dc.identifier.citationBresalier RS, Senore C, Young GP, et al. Gut 2023;72:1904–1918.
dc.identifier.doihttps://doi.org/10.1136/gutjnl-2023-329701
dc.identifier.urihttps://hdl.handle.net/11447/8983
dc.language.isoen
dc.rightsAtribución-NoComercial-CompartirIgual 3.0 Chile (CC BY-NC-SA 3.0 CL)
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/3.0/cl/
dc.subjectColorectal cancer
dc.titleAn efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles
dc.typeArticle
dcterms.accessRightsAcceso abierto
dcterms.sourceGut
dspace.entity.typePublication
relation.isAuthorOfPublicationc2aa7028-9fa8-4068-9acc-fca05b7a5d17
relation.isAuthorOfPublication.latestForDiscoveryc2aa7028-9fa8-4068-9acc-fca05b7a5d17

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