Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies

Common Data Elements and Standard Reporting Recommendations

the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Introduction: Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints. Methods: A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel’s recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers. Results: No cellular or molecular biomarker has been validated for inclusion as “core” recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms. Conclusion: Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative biomarkers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.

Original languageEnglish (US)
Pages (from-to)46-59
Number of pages14
JournalNeurocritical care
Volume30
DOIs
StatePublished - Jun 16 2019

Fingerprint

Subarachnoid Hemorrhage
Biomarkers
Meta-Analysis
Guidelines
Practice Guidelines
Common Data Elements

Keywords

  • Apolipoprotein E
  • B-type natriuretic peptide, common data elements
  • Biomarkers
  • Biospecimens
  • Cardiac troponin I
  • Cerebrospinal fluid
  • Plasma-type gelsolin
  • S100β
  • Standard operating procedure
  • Subarachnoid hemorrhage
  • Tumor necrosis factor alpha, interleukin-6, metalloproteinase-9

ASJC Scopus subject areas

  • Clinical Neurology
  • Critical Care and Intensive Care Medicine

Cite this

Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies : Common Data Elements and Standard Reporting Recommendations. / the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators.

In: Neurocritical care, Vol. 30, 16.06.2019, p. 46-59.

Research output: Contribution to journalArticle

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title = "Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations",
abstract = "Introduction: Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints. Methods: A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel’s recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers. Results: No cellular or molecular biomarker has been validated for inclusion as “core” recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms. Conclusion: Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative biomarkers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.",
keywords = "Apolipoprotein E, B-type natriuretic peptide, common data elements, Biomarkers, Biospecimens, Cardiac troponin I, Cerebrospinal fluid, Plasma-type gelsolin, S100β, Standard operating procedure, Subarachnoid hemorrhage, Tumor necrosis factor alpha, interleukin-6, metalloproteinase-9",
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T1 - Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies

T2 - Common Data Elements and Standard Reporting Recommendations

AU - the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

AU - Chou, Sherry H.Y.

AU - Macdonald, R. Loch

AU - Keller, Emanuela

AU - Suarez, Jose I.

AU - Amin-Hanjani, Sepideh

AU - Brown, Robert D Jr.

AU - de Oliveira Manoel, Airton Leonardo

AU - Derdeyn, Colin P.

AU - Etminan, Nima

AU - LeRoux, Peter D.

AU - Mayer, Stephan

AU - Morita, Akio

AU - Rinkel, Gabriel

AU - Rufennacht, Daniel

AU - Stienen, Martin N.

AU - Torner, James

AU - Vergouwen, Mervyn D.I.

AU - Wong, George K.C.

AU - Bijlenga, Philippe

AU - Ko, Nerissa

AU - McDougall, Cameron G.

AU - Mocco, J.

AU - Murayama, Yuuichi

AU - Werner, Marieke J.H.

AU - Damani, Rahul

AU - Broderick, Joseph

AU - Dhar, Raj

AU - Jauch, Edward C.

AU - Kirkpatrick, Peter J.

AU - Martin, Renee H.

AU - Muehlschlegel, Susanne

AU - Mutoh, Tatsushi

AU - Nyquist, Paul

AU - Olson, Daiwai

AU - Mejia-Mantilla, Jorge H.

AU - van der Jagt, Mathieu

AU - Bambakidis, Nicholas

AU - Brophy, Gretchen

AU - Bulsara, Ketan

AU - Claassen, Jan

AU - Connolly, E. Sander

AU - Hoffer, S. Alan

AU - Hoh, Brian L.

AU - Holloway, Robert G.

AU - Kelly, Adam

AU - Nakaji, Peter

AU - Rabinstein, Alejandro

AU - Vajkoczy, Peter

AU - Woo, Henry

AU - Huston, John III

PY - 2019/6/16

Y1 - 2019/6/16

N2 - Introduction: Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints. Methods: A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel’s recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers. Results: No cellular or molecular biomarker has been validated for inclusion as “core” recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms. Conclusion: Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative biomarkers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.

AB - Introduction: Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints. Methods: A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel’s recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers. Results: No cellular or molecular biomarker has been validated for inclusion as “core” recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms. Conclusion: Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative biomarkers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.

KW - Apolipoprotein E

KW - B-type natriuretic peptide, common data elements

KW - Biomarkers

KW - Biospecimens

KW - Cardiac troponin I

KW - Cerebrospinal fluid

KW - Plasma-type gelsolin

KW - S100β

KW - Standard operating procedure

KW - Subarachnoid hemorrhage

KW - Tumor necrosis factor alpha, interleukin-6, metalloproteinase-9

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U2 - 10.1007/s12028-019-00725-4

DO - 10.1007/s12028-019-00725-4

M3 - Article

VL - 30

SP - 46

EP - 59

JO - Neurocritical Care

JF - Neurocritical Care

SN - 1541-6933

ER -