Steps to standardization and validation of hippocampal volumetry as a biomarker in clinical trials and diagnostic criterion for Alzheimer’s disease

Abstract Background The promise of Alzheimer’s disease biomarkers has led to their incorporation in new diagnostic criteria and in therapeutic trials; however, significant barriers exist to widespread use. Chief among these is the lack of internationally accepted standards for quantitative metrics....

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Published in:Alzheimer's & dementia 2011-07, Vol.7 (4), p.474-485.e4
Main Authors: Jack, Clifford R, Barkhof, Frederik, Bernstein, Matt A, Cantillon, Marc, Cole, Patricia E, DeCarli, Charles, Dubois, Bruno, Duchesne, Simon, Fox, Nick C, Frisoni, Giovanni B, Hampel, Harald, Hill, Derek L.G, Johnson, Keith, Mangin, Jean-François, Scheltens, Philip, Schwarz, Adam J, Sperling, Reisa, Suhy, Joyce, Thompson, Paul M, Weiner, Michael, Foster, Norman L
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Alzheimer Disease - diagnosis
Alzheimer's disease
Biological markers
Biomarker standards
Biomarkers
Biomarkers - analysis
Europe
Female
Hippocampus
Hippocampus - pathology
Humans
Image Processing, Computer-Assisted
Magnetic resonance imaging
Magnetic Resonance Imaging - methods
Magnetic Resonance Imaging - standards
Male
Neuroimaging
Neurology
Reference Values
Reproducibility of Results
ROC Curve
Standardization
Validation
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cited_by cdi_FETCH-LOGICAL-c6437-fc659be1703e16684ca3ffbfa9854b3021e6c677e01da36d732cc9e5e37d1fd03
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container_title Alzheimer's & dementia
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creator Jack, Clifford R
Barkhof, Frederik
Bernstein, Matt A
Cantillon, Marc
Cole, Patricia E
DeCarli, Charles
Dubois, Bruno
Duchesne, Simon
Fox, Nick C
Frisoni, Giovanni B
Hampel, Harald
Hill, Derek L.G
Johnson, Keith
Mangin, Jean-François
Scheltens, Philip
Schwarz, Adam J
Sperling, Reisa
Suhy, Joyce
Thompson, Paul M
Weiner, Michael
Foster, Norman L
description Abstract Background The promise of Alzheimer’s disease biomarkers has led to their incorporation in new diagnostic criteria and in therapeutic trials; however, significant barriers exist to widespread use. Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging measure in Alzheimer’s disease and thus represents the most rational target for an initial effort at standardization. Methods and Results The authors of this position paper propose a path toward this goal. The steps include the following: (1) Establish and empower an oversight board to manage and assess the effort, (2) adopt the standardized definition of anatomic hippocampal boundaries on magnetic resonance imaging arising from the European Alzheimer’s Disease Centers–Alzheimer’s Disease Neuroimaging Initiative hippocampal harmonization effort as a reference standard, (3) establish a scientifically appropriate, publicly available reference standard data set based on manual delineation of the hippocampus in an appropriate sample of subjects (Alzheimer’s Disease Neuroimaging Initiative), and (4) define minimum technical and prognostic performance metrics for validation of new measurement techniques using the reference standard data set as a benchmark. Conclusions Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent was to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. The standardization and assay validation process outlined for hippocampal volumetry was envisioned as a template that could be applied to other imaging biomarkers.
doi_str_mv 10.1016/j.jalz.2011.04.007
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Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging measure in Alzheimer’s disease and thus represents the most rational target for an initial effort at standardization. Methods and Results The authors of this position paper propose a path toward this goal. The steps include the following: (1) Establish and empower an oversight board to manage and assess the effort, (2) adopt the standardized definition of anatomic hippocampal boundaries on magnetic resonance imaging arising from the European Alzheimer’s Disease Centers–Alzheimer’s Disease Neuroimaging Initiative hippocampal harmonization effort as a reference standard, (3) establish a scientifically appropriate, publicly available reference standard data set based on manual delineation of the hippocampus in an appropriate sample of subjects (Alzheimer’s Disease Neuroimaging Initiative), and (4) define minimum technical and prognostic performance metrics for validation of new measurement techniques using the reference standard data set as a benchmark. Conclusions Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent was to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. The standardization and assay validation process outlined for hippocampal volumetry was envisioned as a template that could be applied to other imaging biomarkers.</description><identifier>ISSN: 1552-5260</identifier><identifier>EISSN: 1552-5279</identifier><identifier>DOI: 10.1016/j.jalz.2011.04.007</identifier><identifier>PMID: 21784356</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Aged, 80 and over ; Alzheimer Disease - diagnosis ; Alzheimer's disease ; Biological markers ; Biomarker standards ; Biomarkers ; Biomarkers - analysis ; Europe ; Female ; Hippocampus ; Hippocampus - pathology ; Humans ; Image Processing, Computer-Assisted ; Magnetic resonance imaging ; Magnetic Resonance Imaging - methods ; Magnetic Resonance Imaging - standards ; Male ; Neuroimaging ; Neurology ; Reference Values ; Reproducibility of Results ; ROC Curve ; Standardization ; Validation</subject><ispartof>Alzheimer's &amp; dementia, 2011-07, Vol.7 (4), p.474-485.e4</ispartof><rights>The Alzheimer's Association</rights><rights>2011 The Alzheimer's Association</rights><rights>Copyright © 2011 The Alzheimer's Association. 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Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging measure in Alzheimer’s disease and thus represents the most rational target for an initial effort at standardization. Methods and Results The authors of this position paper propose a path toward this goal. The steps include the following: (1) Establish and empower an oversight board to manage and assess the effort, (2) adopt the standardized definition of anatomic hippocampal boundaries on magnetic resonance imaging arising from the European Alzheimer’s Disease Centers–Alzheimer’s Disease Neuroimaging Initiative hippocampal harmonization effort as a reference standard, (3) establish a scientifically appropriate, publicly available reference standard data set based on manual delineation of the hippocampus in an appropriate sample of subjects (Alzheimer’s Disease Neuroimaging Initiative), and (4) define minimum technical and prognostic performance metrics for validation of new measurement techniques using the reference standard data set as a benchmark. Conclusions Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent was to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. 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dementia</jtitle><addtitle>Alzheimers Dement</addtitle><date>2011-07</date><risdate>2011</risdate><volume>7</volume><issue>4</issue><spage>474</spage><epage>485.e4</epage><pages>474-485.e4</pages><issn>1552-5260</issn><eissn>1552-5279</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>ObjectType-Article-2</notes><notes>ObjectType-Feature-1</notes><abstract>Abstract Background The promise of Alzheimer’s disease biomarkers has led to their incorporation in new diagnostic criteria and in therapeutic trials; however, significant barriers exist to widespread use. Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging measure in Alzheimer’s disease and thus represents the most rational target for an initial effort at standardization. Methods and Results The authors of this position paper propose a path toward this goal. The steps include the following: (1) Establish and empower an oversight board to manage and assess the effort, (2) adopt the standardized definition of anatomic hippocampal boundaries on magnetic resonance imaging arising from the European Alzheimer’s Disease Centers–Alzheimer’s Disease Neuroimaging Initiative hippocampal harmonization effort as a reference standard, (3) establish a scientifically appropriate, publicly available reference standard data set based on manual delineation of the hippocampus in an appropriate sample of subjects (Alzheimer’s Disease Neuroimaging Initiative), and (4) define minimum technical and prognostic performance metrics for validation of new measurement techniques using the reference standard data set as a benchmark. Conclusions Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent was to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. The standardization and assay validation process outlined for hippocampal volumetry was envisioned as a template that could be applied to other imaging biomarkers.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>21784356</pmid><doi>10.1016/j.jalz.2011.04.007</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Aged, 80 and over
Alzheimer Disease - diagnosis
Alzheimer's disease
Biological markers
Biomarker standards
Biomarkers
Biomarkers - analysis
Europe
Female
Hippocampus
Hippocampus - pathology
Humans
Image Processing, Computer-Assisted
Magnetic resonance imaging
Magnetic Resonance Imaging - methods
Magnetic Resonance Imaging - standards
Male
Neuroimaging
Neurology
Reference Values
Reproducibility of Results
ROC Curve
Standardization
Validation
title Steps to standardization and validation of hippocampal volumetry as a biomarker in clinical trials and diagnostic criterion for Alzheimer’s disease
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