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

doi:10.1007/s12028-019-00725-4

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

Neurology

Research output: Contribution to journal › Article › peer-review

33 Scopus citations

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 language	English (US)
Pages (from-to)	46-59
Number of pages	14
Journal	Neurocritical Care
Volume	30
DOIs	https://doi.org/10.1007/s12028-019-00725-4
State	Published - Jun 16 2019

Funding

Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society, and the CHI Baylor St Luke’s Medical Center in Houston, TX. The development of the NINDS SAH CDEs was made possible thanks to the great investment of time and effort of WG members and the members of the NINDS CDE Project and NLM CDE project teams participating from 2015 to 2017. The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS), or the US Government. Dr. Macdonald reports personal fees from Edge Therapeutics and grants from Brain Aneurysm Foundation, outside the submitted work. Dr. Chou reports research grants from National Institute of Health/NINDS (K23‑NS0738060, the University of Pittsburgh Physicians, and the University of Pittsburgh School of Medicine. Outside the submitted work, Dr. Chou received fees from Edge Therapeutics (site principal investigator, consulting), non‑financial support from Merck, consulting fees from the National Institute of Health. Dr. Chou is a co‑inventor on a patent MITOCHONDRIAL BIOMARKERS OF, AND THERAPEU‑ TICS AQ15 FOR, CNS INJURY AND DISEASE filed in the United States Patent and Trademark Office as Application 62/3817. The aim of the National Institute of Health (NIH)/ National Institute of Neurological Disorders and Stroke (NINDS) Unruptured Aneurysms and SAH CDE project has been to provide a common structure for future unruptured intracranial aneurysm and SAH research. This paper describes the recommendations from the SAH Biospecimens and Biomarkers WG.

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

Critical Care and Intensive Care Medicine
Clinical Neurology

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10.1007/s12028-019-00725-4

Cite this

@article{9f6eccaba1a54f918deeb0a2828d96a5,

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{\textquoteright}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",

author = "{the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators} and Chou, {Sherry H.Y.} and Macdonald, {R. Loch} and Emanuela Keller and Suarez, {Jose I.} and Sepideh Amin-Hanjani and Brown, {Robert D.} and {de Oliveira Manoel}, {Airton Leonardo} and Derdeyn, {Colin P.} and Nima Etminan and LeRoux, {Peter D.} and Stephan Mayer and Akio Morita and Gabriel Rinkel and Daniel Rufennacht and Stienen, {Martin N.} and James Torner and Vergouwen, {Mervyn D.I.} and Wong, {George K.C.} and Philippe Bijlenga and Nerissa Ko and McDougall, {Cameron G.} and J. Mocco and Yuuichi Murayama and Werner, {Marieke J.H.} and Rahul Damani and Joseph Broderick and Raj Dhar and Jauch, {Edward C.} and Kirkpatrick, {Peter J.} and Martin, {Renee H.} and Susanne Muehlschlegel and Tatsushi Mutoh and Paul Nyquist and Daiwai Olson and Mejia-Mantilla, {Jorge H.} and {van der Jagt}, Mathieu and Nicholas Bambakidis and Gretchen Brophy and Ketan Bulsara and Jan Claassen and Connolly, {E. Sander} and Hoffer, {S. Alan} and Hoh, {Brian L.} and Holloway, {Robert G.} and Adam Kelly and Peter Nakaji and Alejandro Rabinstein and Peter Vajkoczy and Henry Woo and Zipfel, {Gregory J.}",

note = "Publisher Copyright: {\textcopyright} 2019, Neurocritical Care Society.",

year = "2019",

month = jun,

day = "16",

doi = "10.1007/s12028-019-00725-4",

language = "English (US)",

volume = "30",

pages = "46--59",

journal = "Neurocritical Care",

issn = "1541-6933",

publisher = "Springer",

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TY - JOUR

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.

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 - Zipfel, Gregory J.

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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UR - http://www.scopus.com/inward/citedby.url?scp=85066488619&partnerID=8YFLogxK

U2 - 10.1007/s12028-019-00725-4

DO - 10.1007/s12028-019-00725-4

M3 - Article

C2 - 31144274

AN - SCOPUS:85066488619

SN - 1541-6933

VL - 30

SP - 46

EP - 59

JO - Neurocritical Care

JF - Neurocritical Care

ER -

Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations

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Keywords

ASJC Scopus subject areas

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