Abstract
Background
Clinical studies of subarachnoid hemorrhage (SAH) and unruptured cerebral aneurysms lack uniformity in terms of variables used for assessments and clinical examination of patients which has led to difficulty in comparing studies and performing meta-analyses. The overall goal of the National Institute of Health/National Institute of Neurological Disorders and Stroke Unruptured Intracranial Aneurysms (UIA) and subarachnoid hemorrhage (SAH) Common Data Elements (CDE) Project was to provide common definitions and terminology for future unruptured intracranial aneurysm and SAH research.
Methods
This paper summarizes the recommendations of the subcommittee on SAH Assessments and Clinical Examination. The subcommittee consisted of an international and multidisciplinary panel of experts in UIA and SAH. Consensus recommendations were developed by reviewing previously published CDEs for other neurological diseases including traumatic brain injury, epilepsy and stroke, and the SAH literature. Recommendations for CDEs were classified by priority into “core,” “supplemental—highly recommended,” “supplemental” and “exploratory.”
Results
We identified 248 variables for Assessments and Clinical Examination. Only the World Federation of Neurological Societies grading scale was classified as “Core.” The Glasgow Coma Scale was classified as “Supplemental—Highly Recommended.” All other Assessments and Clinical Examination variables were categorized as “Supplemental.”
Conclusion
The recommended Assessments and Clinical Examination variables have been collated from a large number of potentially useful scales, history, clinical presentation, laboratory, and other tests. We hope that adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data.
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Suarez JI, Sheikh MK, Macdonald RL, Amin-Hanjani S, Brown RD Jr, de Oliveira Manoel AL, Derdeyn C, Etminan N, Keller E, Leroux PD, Mayer SA, Morita A, Rinkel G, Rufennacht D, Stienen, M, Torner J, Vergouwen, MD, Wong GKC, on behalf of the Unruptured Cerebral Aneurysms and SAH CDE Project Investigators. Common data elements for unruptured cerebral aneurysms and subarachnoid hemorrhage clinical research: a National Institute for Neurological Disorders and Stroke, National Library of Medicine, and Neurocritical Care Society Project. Neurocritical Care 2019.
Acknowledgements
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. 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 Cahtolic Health Initiatives 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
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.
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RD, SM, RD, RHM, PN, DMO, JHMM, SM, ECJ, JM, TM, and JIS helped in protocol development and manuscript writing/editing. The corresponding author confirms that authorship requirements have been met, and the final manuscript was approved by ALL authors, and that this manuscript has not been published elsewhere and is not under consideration by another journal. The UIA and SAH CDEs project adhered to ethical guidelines.
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Conflicts of interest
Dr. Damani has nothing to disclose. Dr. Muehlschelegel reports personal fees from American Academy of Neurology, Continuum, during the conduct of the study. Dr. Martin has nothing to disclose. Dr. Mocco reports grants and other from Stryker, grants and other from Penumbra, grants and other from Medtronic, grants and other from Microvention, personal fees and other from Imperative Care, personal fees and other from Cerebrotech, personal fees and other from Viseon, personal fees and other from Endostream, personal fees and other from Rebound Therapeutics, personal fees and other from Vastrax, personal fees and other from Blink TBI, personal fees and other from Serenity, personal fees and other from NTI, personal fees and other from Neurvana, personal fees and other from Cardinal Consulting, outside the submitted work. Dr. Suarez reports being President of the Neurocritical Care Society, a member of the Editorial Board of Stroke Journal, and Chair of the Data and Safety Monitoring Board for the Impact of Fever Prevention in Brain Injured Patients Study sponsored by this is the name of a company, outside of the submitted work. Dr. Mayer reports having received personal consulting fees from Edge Therapeutics and Idorsia Pharmaceuticals outside of the submitted work. Dr. Dhar has nothing to disclose. Dr. Mejia-Matilla has nothing to disclose. Dr. Mutoh has nothing to disclose. Dr. Nyquist has nothing to disclose. Dr. Olson reports Editor, Journal of Neuroscience Nursing, and registry funding from Neuroptics, Inc.
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This project did not involve patient contact or review of patient-related information and thus it was not considered human research.
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Members are listed in the Appendix.
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Appendix: SAH Working Group Members
Appendix: SAH Working Group Members
Steering Committee
Jose I Suarez, MD, FNCS, FANA, Johns Hopkins University School of Medicine, Baltimore, MD, co - Chair
R Loch Macdonald, MD, PhD, University of Toronto, Toronto, ON, Canada, co - Chair
Sepideh Amin-Hanjani, MD—University of Illinois at Chicago, Chicago, IL
Robert D. Brown, Jr., MD, MPH—Mayo Clinic, Rochester, MN
Airton Leonardo de Oliveira Manoel, MD, PhD—University of Toronto, Toronto, Ontario, Canada
Colin P Derdeyn, MD, FACR—University of Iowa, Carver College of Medicine, Iowa City, IA
Nima Etminan, MD—University Hospital Mannheim, Mannheim, Germany
Emanuela Keller, MD—University of Zurich, Zurich, Switzerland
Peter D. LeRoux, MD, FACS—Main Line Health, Wynnewood, PA
Stephan Mayer, MD—Henry Ford Hospital, Detroit, MI
Akio Morita, MD, PhD—Nippon Medical School, Tokyo, Japan
Gabriel Rinkel, MD—University Medical Center, Utrecht, The Netherlands
Daniel Rufennacht, MD—Klinik Hirslanden, Zurich, Switzerland
Martin N. Stienen, MD, FEBNS—University of Zurich, Zurich, Switzerland
James Torner, MSc, PhD—University of Iowa, Iowa City, IA
Mervyn D.I. Vergouwen, MD, PhD—University Medical Center, Utrecht, The Netherlands
George K. C. Wong, MD—Chinese University of Hong Kong, Shatin, Hong Kong
Subject Characteristics Working Group
Robert D. Brown, Jr., MD, MPH—Mayo Clinic, Rochester, MN, co-Chair
Akio Morita, MD, PhD—Nippon Medical School, Tokyo, Japan, co-Chair
Philippe Bijlenga, MD, PhD, Geneva University Hospital, Geneva, Switzerland (Superuser)
Nerissa Ko, MD; Cameron G McDougall, MD; J Mocco, MS, MD; Yuuichi Murayama, MD; Marieke J H Werner, MD, PhD
Assessments and Examinations Working Group
Stephan Mayer, MD—Henry Ford Hospital, Detroit, MI, co-Chair
Jose I Suarez, MD, FNCS, FANA, The Johns Hopkins University School of Medicine, Baltimore, MD, co-Chair
Rahul Damani, MD, MPH, Baylor College of Medicine, Houston, TX (Superuser)
Joseph Broderick, MD; Raj Dhar, MD, FRCPC; Edward C Jauch, MD, MS, FACEP, FAHA; Peter J Kirkpatrick; Renee H Martin, PhD; J Mocco, MS, MD; Susanne Muehlschlegel, MD, MPH; Tatsushi Mutoh, MD, DVM, PhD; Paul Nyquist, MD, MPH; Daiwai Olson, RN, PhD; Jorge H Mejia-Mantilla, MD, MSc.
Hospital Course and Acute Therapies Working Group
Sepideh Amin-Hanjani, MD—University of Illinois at Chicago, Chicago, IL, co-Chair
Airton Leonardo de Oliveira Manoel, MD, PhD—University of Toronto, Toronto, Ontario, Canada, co-Chair (Superuser)
Mathieu van der Jagt, MD, PhD, Erasmus Medical Center, Rotterdam, The Netherlands (Superuser)
Nicholas Bambakidis, MD; Gretchen Brophy, PharmD, BCPS, FCCP, FCCM, FNCS; Ketan Bulsara, MD; Jan Claassen, MD, PhD; E Sander Connolly, MD, FACS; S Alan Hoffer, MD; Brian L Hoh, MD, FACS; Robert G Holloway, MD, MPH; Adam Kelly, MD; Stephan Mayer, MD; Peter Nakaji, MD; Alejandro Rabinstein, MD; Jose I Suarez, MD, FNCS, FANA; Peter Vajkoczy, MD; Mervyn D. I. Vergouwen, MD, PhD; Henry Woo, MD; Gregory J Zipfel, MD.
Biospecimens and Biomarkers Working Group
Emanuela Keller, MD—University of Zurich, Zurich, Switzerland, co-Chair (Superuser)
R Loch Macdonald, MD, PhD, University of Toronto, Toronto, ON, Canada, co-Chair
Sherry Chou, MD, MMSc; Sylvain Doré, PhD, FAHA; Aaron S Dumont, MD; Murat Gunel, MD, FACS, FAHA; Hidetoshi Kasuya, MD; Alexander Roederer, PhD; Ynte Ruigrok, MD; Paul M Vespa, MD, FCCM, FAAN, FANA, FNCS; Asita Simone Sarrafzadeh-Khorrasani, PhD.
Imaging Working Group
Colin P Derdeyn, MD, FACR—University of Iowa, Carver College of Medicine, Iowa City, IA, co-Chair
Nima Etminan, MD University Hospital Mannheim, Mannheim, Germany, co-Chair
Katharina Hackenberg, MD, University Hospital Mannheim, Mannheim, Germany (Superuser)
John Huston, III, MD; Timo Krings, MD, PhD, FRCPC; Giuseppe Lanzino, MD; Philip M Meyers, MD, FACR, FSIR, FAHA; Gabriel Rinkel, MD; Daniel Rufennacht, MD; Max Wintermark, MD.
Long-Term Therapies Working Group
James Torner, MSc, PhD—University of Iowa, Iowa City, IA, co-Chair (Superuser)
George K. C. Wong, MD—Chinese University of Hong Kong, Shatin, Hong Kong, co-Chair (Superuser)
Joseph Broderick, MD; Janis Daly, PhD, MS; Christopher Ogilvy, MD; Denise H Rhoney, PharmD, FCCP, FCCM, FNCS; YB Roos, PhD; Adnan Siddiqui, MD, PhD, FAHA.
Unruptured Intracranial Aneurysms Working Group
Nima Etminan, MD—University Hospital Mannheim, Mannheim, Germany, co-Chair
Gabriel Rinkel, MD—University Medical Center, Utrecht, The Netherlands, co-Chair
Katharina Hackenberg, MD, University Hospital Mannheim, Mannheim, Germany (Superuser)
Ale Algra, MD, FAHA; Juhanna Frösen, MD; David Hasan, MD; Seppo Juvela, MD, PhD; David J Langer, MD; Philip M Meyers, MD, FACR, FSIR, FAHA; Akio Morita, MD, PhD; Rustam Al-Shahi Salman, MA, PhD, FRCP.
Outcomes and Endpoints Working Group
Martin N. Stienen, MD, FEBNS—University of Zurich, Zurich, Switzerland, co-Chair (Superuser)
Mervyn D.I. Vergouwen, MD, PhD—University Medical Center, Utrecht, The Netherlands, co-Chair
Daniel Hanggi, MD; R Loch Macdonald, MD, PhD; Tom Schweizer, PhD; Johanna Visser-Meily, MD, PhD.
National Library of Medicine CDE Team
Liz Amos, MLIS, National Information Center on Health Services Research and Health Care Technology, National Library of Medicine
Christophe Ludet, MS, National Library of Medicine, Bethesda, MD
NINDS CDE Team
Claudia Moy, PhD, NINDS, Bethesda, MD
Joanne Odenkirchen, MPH, NINDS, Bethesda, MD
Sherita Ala’i, MS, The Emmes Corporation, Rockville, MD
Joy Esterlitz, MS, The Emmes Corporation, Rockville, MD
Kristen Joseph, MA, The Emmes Corporation, Rockville, MD
Muniza Sheikh, MS, MBA, The Emmes Corporation, Rockville, MD
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Damani, R., Mayer, S., Dhar, R. et al. Common Data Element for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage: Recommendations from Assessments and Clinical Examination Workgroup/Subcommittee. Neurocrit Care 30 (Suppl 1), 28–35 (2019). https://doi.org/10.1007/s12028-019-00736-1
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DOI: https://doi.org/10.1007/s12028-019-00736-1