The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update

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Fältnamn	Indikatorer	Metadata
000		06845naa a2200781 4500
001		oai:gup.ub.gu.se/306426
003		SwePub
008		240528s2021 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
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024	7	a https://gup.ub.gu.se/publication/3064262 URI
024	7	a https://doi.org/10.1007/s00259-020-05120-22 DOI
024	7	a https://lup.lub.lu.se/record/98224d39-1a6f-4015-921d-f5be6e2d9b8d2 URI
024	7	a http://kipublications.ki.se/Default.aspx?queryparsed=id:1462543352 URI
040		a (SwePub)gud (SwePub)lud (SwePub)ki
041		a eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Boccardi, M.u German Center for Neurodegenerative Diseases (DZNE), Greifswald,University of Geneva4 aut
245	1 0	a The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update
264		c 2021-03-10
264	1	b Springer Science and Business Media LLC,c 2021
520		a Background The 2017 Alzheimer's disease (AD) Strategic Biomarker Roadmap (SBR) structured the validation of AD diagnostic biomarkers into 5 phases, systematically assessing analytical validity (Phases 1-2), clinical validity (Phases 3-4), and clinical utility (Phase 5) through primary and secondary Aims. This framework allows to map knowledge gaps and research priorities, accelerating the route towards clinical implementation. Within an initiative aimed to assess the development of biomarkers of tau pathology, we revised this methodology consistently with progress in AD research. Methods We critically appraised the adequacy of the 2017 Biomarker Roadmap within current diagnostic frameworks, discussed updates at a workshop convening the Alzheimer's Association and 8 leading AD biomarker research groups, and detailed the methods to allow consistent assessment of aims achievement for tau and other AD diagnostic biomarkers. Results The 2020 update applies to all AD diagnostic biomarkers. In Phases 2-3, we admitted a greater variety of study designs (e.g., cross-sectional in addition to longitudinal) and reference standards (e.g., biomarker confirmation in addition to clinical progression) based on construct (in addition to criterion) validity. We structured a systematic data extraction to enable transparent and formal evidence assessment procedures. Finally, we have clarified issues that need to be addressed to generate data eligible to evidence-to-decision procedures. Discussion This revision allows for more versatile and precise assessment of existing evidence, keeps up with theoretical developments, and helps clinical researchers in producing evidence suitable for evidence-to-decision procedures. Compliance with this methodology is essential to implement AD biomarkers efficiently in clinical research and diagnostics.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicin0 (SwePub)3022 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicine0 (SwePub)3022 hsv//eng
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Neurologi0 (SwePub)302072 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Neurology0 (SwePub)302072 hsv//eng
653		a Biomarker
653		a Alzheimer’
653		a s disease
653		a Dementia
653		a MCI
653		a Mild cognitive
653		a impairment
653		a Validation methodology
653		a Radiology
653		a Nuclear Medicine & Medical Imaging
653		a Alzheimer’s disease
653		a Mild cognitive impairment
700	1	a Dodich, A.u University of Trento,University of Geneva4 aut
700	1	a Albanese, E.u Università della Svizzera Italiana4 aut
700	1	a Gayet-Ageron, A.u University of Geneva,Geneva University Hospital4 aut
700	1	a Festari, C.u Centro San Giovanni di Dio Fatebenefratelli4 aut
700	1	a Ashton, Nicholas J.u University of Gothenburg,Gothenburg University,Göteborgs universitet,Wallenberg Centre for Molecular and Translational Medicine,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry,South London and Maudsley NHS Foundation Trust,King's College London4 aut0 (Swepub:gu)xashtn
700	1	a Bischof, G. N.u University Hospital of Cologne4 aut
700	1	a Chiotis, K.u Karolinska Institutet,Karolinska Institute,Karolinska University Hospital4 aut
700	1	a Leuzy, Antoineu Karolinska Institute4 aut0 (Swepub:lu)an3415le
700	1	a Wolters, E. E.u Amsterdam UMC - Vrije Universiteit Amsterdam,Vrije Universiteit Amsterdam4 aut
700	1	a Walter, M. A.u Geneva University Hospital4 aut
700	1	a Rabinovici, G. D.u University of California, San Francisco4 aut
700	1	a Carrillo, M.u Alzheimer's Association: Alzheimer's Disease and Dementia4 aut
700	1	a Drzezga, A.u University of Cologne,German Center for Neurodegenerative Diseases (DZNE), Bonn,Jülich Research Centre4 aut
700	1	a Hansson, Oskaru Lund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Skåne University Hospital4 aut0 (Swepub:lu)mphy-ohn
700	1	a Nordberg, A.u Karolinska Institutet,Karolinska Institute,Karolinska University Hospital4 aut
700	1	a Ossenkoppele, Riku Lund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Vrije Universiteit Amsterdam,Amsterdam UMC - Vrije Universiteit Amsterdam4 aut0 (Swepub:lu)ri1513os
700	1	a Villemagne, V. L.u Austin Health,University of Pittsburgh4 aut
700	1	a Winblad, B.u Karolinska Institute,Karolinska University Hospital4 aut
700	1	a Frisoni, G. B.u University of Geneva,Geneva University Hospital4 aut
700	1	a Garibotto, V.u University of Geneva,Geneva University Hospital4 aut
710	2	a German Center for Neurodegenerative Diseases (DZNE), Greifswaldb University of Geneva4 org
773	0	t European Journal of Nuclear Medicine and Molecular Imagingd : Springer Science and Business Media LLCg 48, s. 2070-2085q 48<2070-2085x 1619-7070x 1619-7089
856	4	u https://link.springer.com/content/pdf/10.1007/s00259-020-05120-2.pdf
856	4	u http://dx.doi.org/10.1007/s00259-020-05120-2x freey FULLTEXT
856	4 8	u https://gup.ub.gu.se/publication/306426
856	4 8	u https://doi.org/10.1007/s00259-020-05120-2
856	4 8	u https://lup.lub.lu.se/record/98224d39-1a6f-4015-921d-f5be6e2d9b8d
856	4 8	u http://kipublications.ki.se/Default.aspx?queryparsed=id:146254335

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin

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