Abstract
Introduction
The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations for Unruptured Aneurysms and Aneurysmal Subarachnoid Hemorrhage (SAH) CDEs.
Methods
This paper summarizes the recommendations of the Hospital Course and Acute Therapies after SAH working group. Consensus recommendations were developed by assessment of previously published CDEs for traumatic brain injury, stroke, and epilepsy. Unruptured aneurysm- and SAH-specific CDEs were also developed. CDEs were categorized into “core”, “supplemental—highly recommended”, “supplemental” and “exploratory”.
Results
We identified and developed CDEs for Hospital Course and Acute Therapies after SAH, which included: surgical and procedure interventions; rescue therapy for delayed cerebral ischemia (DCI); neurological complications (i.e. DCI; hydrocephalus; rebleeding; seizures); intensive care unit therapies; prior and concomitant medications; electroencephalography; invasive brain monitoring; medical complications (cardiac dysfunction; pulmonary edema); palliative comfort care and end of life issues; discharge status. The CDEs can be found at the NINDS Web site that provides standardized naming, and definitions for each element, and also case report form templates, based on the CDEs.
Conclusion
Most of the recommended Hospital Course and Acute Therapies CDEs have been newly developed. Adherence to these recommendations should facilitate data collection and data sharing in SAH research, which could improve the comparison of results across observational studies, clinical trials, and meta-analyses of individual patient data.
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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.
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.
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ALdOM, MvdJ, SAH, NCB, GMB, KB, JC, ESC, SAH, BLH, RGH, AGK, SAM, PN, AAR, PV, MDIV, HW, GJZ, JIS contributed to manuscript writing/editing. The corresponding author confirms that authorship requirements have been met, 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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Dr Suarez reports being President of the Neurocritical Care Society, a member of the Editorial Board of Stroke Journal, and Chair of the DSMB for the INTREPID Study sponsored by BARD, 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 Amin-Hanjani, has nothing to disclose. Dr Vergouwen has nothing to disclose. Dr de Oliveira Manoel has nothing to disclose. Dr van der Jagt has nothing to disclose. Dr Bambakidis has nothing to disclose. Dr Brophy has nothing to disclose. Dr Bulsara has nothing to disclose. Dr Claassesn reports grants from Charles A Dana Foundation, grants from James S McDonnell Foundation, from NIH: The Stroke Hyperglycemia Insutlin Network Effort (SHINE) Trial, grants from NIH: I-SPOT, grants from NIH: Established Status Epilepticus Treatment Trial (ESETT), grants from BARD: Intrepid, grants from NIH: Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrhage (I-DEF), grants from NIH/NLM: BIGDATA: Causal Inference in Large-Scale Time Series with Rare and Latent Events, grants from NIH: Rhapsody (ZZ-3K3A-201), other from iCE Neurosystems, outside the submitted work. Dr Connolly has nothing to disclose. Dr Hoffer has nothing to disclose. Dr Hoh has nothing to disclose. Dr Holloway has nothing to disclose. Dr Kelly has nothing to disclose. Dr Nakaji has nothing to disclose. Dr Rabinstein has nothing to disclose. Dr Vajkoczy has nothing to disclose. Dr Woo has nothing to disclose. Dr Zipfel has nothing to disclose.
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Unruptured Aneurysms and SAH − CDE Project Investigators Members are listed in “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 C Bambakidis, MD; Gretchen M 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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de Oliveira Manoel, A.L., van der Jagt, M., Amin-Hanjani, S. et al. Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage: Recommendations from the Working Group on Hospital Course and Acute Therapies—Proposal of a Multidisciplinary Research Group. Neurocrit Care 30 (Suppl 1), 36–45 (2019). https://doi.org/10.1007/s12028-019-00726-3
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DOI: https://doi.org/10.1007/s12028-019-00726-3