The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update.
The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update.
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DOI：
10.1007/s00259-020-05120-2
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发表时间：
2021-07
影响因子：
9.1
通讯作者：
Garibotto V
中科院分区：
文献类型：
--
作者：
Boccardi M;Dodich A;Albanese E;Gayet-Ageron A;Festari C;Ashton NJ;Bischof GN;Chiotis K;Leuzy A;Wolters EE;Walter MA;Rabinovici GD;Carrillo M;Drzezga A;Hansson O;Nordberg A;Ossenkoppele R;Villemagne VL;Winblad B;Frisoni GB;Garibotto V
2017年阿尔茨海默病（AD）战略生物标志物路线图（SBR）将AD诊断生物标志物的验证分为5个阶段，通过主要和次要目标系统评估分析有效性（第1-2阶段），临床有效性（第3-4阶段）和临床实用性（第5阶段）。该框架允许绘制知识差距和研究优先事项，加速临床实施的路线。在一项旨在评估tau病理学生物标志物发展的计划中，我们根据AD研究的进展修改了该方法。我们严格评估了2017年生物标志物路线图在当前诊断框架内的充分性，在阿尔茨海默病协会和8个领先的AD生物标志物研究小组的研讨会上讨论了更新，并详细介绍了允许一致评估tau和其他AD诊断生物标志物目标实现的方法。2020年更新适用于所有AD诊断生物标志物。在第2-3阶段，我们接受了更多种类的研究设计（例如，除了纵向之外的横截面）和参考标准（例如，生物标志物确认以及临床进展）。我们构建了一个系统的数据提取，以实现透明和正式的证据评估程序。最后，我们澄清了需要解决的问题，以生成符合证据到决策程序的数据。这一修订允许对现有证据进行更通用和精确的评估，跟上理论发展，并帮助临床研究人员制作适合证据决策程序的证据。遵守这种方法对于在临床研究和诊断中有效实施AD生物标志物至关重要。
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. 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. 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. 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.
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影响因子：
4.2
作者：
Chiotis, Konstantinos;Saint-Aubert, Laure;Nordberg, Agneta
通讯作者：
Nordberg, Agneta
影响因子：
5.1
作者：
Boccardi, M.;Nicolosi, V.;Frisoni, G. B.
通讯作者：
Frisoni, G. B.
DOI：
10.1016/j.jalz.2011.03.008
发表时间：
2011-05
期刊：
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子：
--
作者：
Albert MS;DeKosky ST;Dickson D;Dubois B;Feldman HH;Fox NC;Gamst A;Holtzman DM;Jagust WJ;Petersen RC;Snyder PJ;Carrillo MC;Thies B;Phelps CH
通讯作者：
Phelps CH
影响因子：
82.9
作者：
Dujardin S;Commins C;Lathuiliere A;Beerepoot P;Fernandes AR;Kamath TV;De Los Santos MB;Klickstein N;Corjuc DL;Corjuc BT;Dooley PM;Viode A;Oakley DH;Moore BD;Mullin K;Jean-Gilles D;Clark R;Atchison K;Moore R;Chibnik LB;Tanzi RE;Frosch MP;Serrano-Pozo A;Elwood F;Steen JA;Kennedy ME;Hyman BT
通讯作者：
Hyman BT
影响因子：
14
作者：
Bocchetta, Martina;Galluzzi, Samantha;Frisoni, Giovanni B.
通讯作者：
Frisoni, Giovanni B.