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Common Data Elements for Subarachnoid Hemorrhage and Unruptured Intracranial Aneurysms: Recommendations from the Working Group on Subject Characteristics

Abstract

Background

The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) have been generated to standardize and define terms used by the scientific community. The widespread use of these CDEs promotes harmonized data collection in clinical research. The aim of the NINDS Unruptured Intracranial Aneurysms (UIA) and Subarachnoid Hemorrhage (SAH), and Subject Characteristics working group (WG) was to identify, define, and classify CDEs describing the characteristics of patients diagnosed with an UIA and SAH. Thus, “Participant/Subject characteristics” is a set of factors defining a population of selected individuals and allowing comparisons with a reference population and overtime.

Methods

Based on standard terms defined by the United States’ Census Bureau, CDEs previously defined by several (Stroke, Epilepsy and Traumatic Brain Injury) NINDS CDE working groups literature and expert opinion of the WG, the “Participant/Subject characteristics” domain has been defined.

Results

A set of 192 CDEs divided in 7 subsections: demographics (8 CDEs), social status (8 CDEs), behavioral status (22 CDEs), family and medical history (144 CDEs), pregnancy and perinatal history (8 CDEs), history data source reliability (3 CDEs), and prior functional status (3 CDEs) was defined. SAH is characterized by 6 core elements, all classified in the “Participant/Subject characteristics” domain. Four exploratory elements out of the 39 for SAH overall are in the “Participant/Subject characteristics” domain, and all remaining 182 CDEs in the “Participant/Subject characteristics” domain are classified as Supplemental-Highly Recommended elements.

Conclusions

These CDEs would allow the development of best practice guidelines to standardize the assessment and reporting of observations concerning UIA and SAH.

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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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Contributions

PB, AM, NUK, JM, SM, YM, MJHW, and RDBJr were involved in protocol development and 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.

Corresponding author

Correspondence to Philippe Bijlenga.

Ethics declarations

Conflicts of interest

Dr. Bijlenga and Dr. Morel have received research grants from SystemsX.ch a Swiss initiative for Systems Biology and evaluated by the Swiss National Science Foundation. Dr Morita has nothing to disclose. Dr Brown 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 Wermer has nothing to disclose. Dr Ko reports grants from National Institutes of Health/NINDS, other from Edge Therapeutics, during the conduct of the study. Dr Murayama reports grants and personal fees from Stryker Neurovascular, grants from Siemens Healthcare, and personal fees from Kaneka Medics, during the conduct of the study.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Unruptured Cerebral Aneurysms and SAH CDE Project Investigators members are listed in Appendix.

Appendix: UIA and SAH Working Group Members

Appendix: UIA and 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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Bijlenga, P., Morita, A., Ko, N.U. et al. Common Data Elements for Subarachnoid Hemorrhage and Unruptured Intracranial Aneurysms: Recommendations from the Working Group on Subject Characteristics. Neurocrit Care 30 (Suppl 1), 20–27 (2019). https://doi.org/10.1007/s12028-019-00724-5

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Keywords

  • Intracranial aneurysm
  • Subarachnoid Hemorrhage
  • Common Data Elements
  • Participant/Subject characteristics