Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations
Chou, Sherry H-Y; Macdonald, R Loch; Keller, Emanuela; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators
(2019) Neurocritical Care, volume 30, issue Suppl 1, pp. 46 - 59
(Article)
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
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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.
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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, interleukin-6, common data elements, B-type natriuretic peptide, Tumor necrosis factor alpha, S100, metalloproteinase-9, Clinical Neurology, Critical Care and Intensive Care Medicine, Research Support, Non-U.S. Gov't, Research Support, N.I.H., Intramural, Journal Article
ISSN: 1541-6933
Publisher: Humana Press
Note: Funding Information: 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. Funding Information: 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. Funding Information: 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. Funding Information: 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. Publisher Copyright: © 2019, Neurocritical Care Society.
(Non peer reviewed)