Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project

Jose I Suarez¹, Muniza K Sheikh², R Loch Macdonald³, Sepideh Amin-Hanjani⁴, Robert D Brown Jr⁵, Airton Leonardo de Oliveira Manoel³, Colin P Derdeyn⁶, Nima Etminan⁷, Emanuela Keller⁸, Peter D Leroux⁹, Stephan A Mayer¹⁰, Akio Morita¹¹, Gabriel Rinkel¹², Daniel Rufennacht¹³, Martin N Stienen⁸, James Torner⁶, Mervyn D I Vergouwen¹², George K C Wong¹⁴; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

Collaborators, Affiliations

Collaborators

Unruptured Intracranial Aneurysms and SAH CDE Project Investigators:
Jose I Suarez, R Loch Macdonald, Sepideh Amin-Hanjani, Robert D Brown Jr, Airton Leonardo de Oliveira Manoel, Colin P Derdeyn, Nima Etminan, Emanuela Keller, Peter D LeRoux, Stephan Mayer, Akio Morita, Gabriel Rinkel, Daniel Rufennacht, Martin N Stienen, James Torner, Mervyn D I Vergouwen, George K C Wong, Philippe Bijlenga, Nerissa Ko, Cameron G McDougall, J Mocco, Yuuichi Murayama, Marieke J H Werner, Joseph Broderick, Raj Dhar, Edward C Jauch, Peter J Kirkpatrick, Renee H Martin, J Mocco, Susanne Muehlschlegel, Tatsushi Mutoh, Paul Nyquist, Daiwai Olson, Jorge H Mejia-Mantilla, Mathieu van der Jagt, Nicholas C Bambakidis, Gretchen Brophy, Ketan Bulsara, Jan Claassen, E Sander Connolly, S Alan Hoffer, Brian L Hoh, Robert G Holloway, Adam Kelly, Peter Nakaji, Alejandro Rabinstein, Peter Vajkoczy, Henry Woo, Gregory J Zipfel, Sherry Chou, Sylvain Doré, Aaron S Dumont, Murat Gunel, Hidetoshi Kasuya, Alexander Roederer, Ynte Ruigrok, Paul M Vespa, Asita Simone Sarrafzadeh-Khorrasani, Katharina Hackenberg, John Huston 3rd, Timo Krings, Giuseppe Lanzino, Philip M Meyers, Max Wintermark, Janis Daly, Christopher Ogilvy, Denise H Rhoney, Y B Roos, Adnan Siddiqui, Ale Algra, Juhanna Frösen, David Hasan, Seppo Juvela, David J Langer, Rustam Al-Shahi Salman, Daniel Hanggi, Tom Schweizer, Johanna Visser-Meily, Liz Amos, Christophe Ludet, Claudia Moy, Joanne Odenkirchen, Sherita Ala'i, Joy Esterlitz, Kristen Joseph, Muniza Sheikh

Affiliations

¹ Division of Neurosciences Critical Care, The Johns Hopkins University School of Medicine, 1800 Orleans Street, Sheikh Zayed Building, 3014C, Baltimore, MD, 21287, USA. jsuarez5@jhmi.edu.
² The Emmes Corporation, Rockville, MD, USA.
³ University of Toronto, Toronto, ON, Canada.
⁴ University of Illinois at Chicago, Chicago, IL, USA.
⁵ Mayo Clinic, Rochester, MN, USA.
⁶ University of Iowa, Iowa City, IA, USA.
⁷ University of Duesseldorf, Düesseldorf, Germany.
⁸ University of Zurich, Zurich, Switzerland.
⁹ Main Line Health Care, Wynnewood, PA, USA.
¹⁰ Henry Ford Hospital, Detroit, MI, USA.
¹¹ Nippon Medical School, Tokyo, Japan.
¹² University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
¹³ Klinik Hirslanden, Zurich, Switzerland.
¹⁴ Chinese University of Hong Kong, Shatin, Hong Kong.

PMID: 31087257
DOI: 10.1007/s12028-019-00723-6

Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project

Jose I Suarez et al. Neurocrit Care. 2019 Jun.

. 2019 Jun;30(Suppl 1):4-19.

doi: 10.1007/s12028-019-00723-6.

Authors

Collaborators

Unruptured Intracranial Aneurysms and SAH CDE Project Investigators:
Jose I Suarez, R Loch Macdonald, Sepideh Amin-Hanjani, Robert D Brown Jr, Airton Leonardo de Oliveira Manoel, Colin P Derdeyn, Nima Etminan, Emanuela Keller, Peter D LeRoux, Stephan Mayer, Akio Morita, Gabriel Rinkel, Daniel Rufennacht, Martin N Stienen, James Torner, Mervyn D I Vergouwen, George K C Wong, Philippe Bijlenga, Nerissa Ko, Cameron G McDougall, J Mocco, Yuuichi Murayama, Marieke J H Werner, Joseph Broderick, Raj Dhar, Edward C Jauch, Peter J Kirkpatrick, Renee H Martin, J Mocco, Susanne Muehlschlegel, Tatsushi Mutoh, Paul Nyquist, Daiwai Olson, Jorge H Mejia-Mantilla, Mathieu van der Jagt, Nicholas C Bambakidis, Gretchen Brophy, Ketan Bulsara, Jan Claassen, E Sander Connolly, S Alan Hoffer, Brian L Hoh, Robert G Holloway, Adam Kelly, Peter Nakaji, Alejandro Rabinstein, Peter Vajkoczy, Henry Woo, Gregory J Zipfel, Sherry Chou, Sylvain Doré, Aaron S Dumont, Murat Gunel, Hidetoshi Kasuya, Alexander Roederer, Ynte Ruigrok, Paul M Vespa, Asita Simone Sarrafzadeh-Khorrasani, Katharina Hackenberg, John Huston 3rd, Timo Krings, Giuseppe Lanzino, Philip M Meyers, Max Wintermark, Janis Daly, Christopher Ogilvy, Denise H Rhoney, Y B Roos, Adnan Siddiqui, Ale Algra, Juhanna Frösen, David Hasan, Seppo Juvela, David J Langer, Rustam Al-Shahi Salman, Daniel Hanggi, Tom Schweizer, Johanna Visser-Meily, Liz Amos, Christophe Ludet, Claudia Moy, Joanne Odenkirchen, Sherita Ala'i, Joy Esterlitz, Kristen Joseph, Muniza Sheikh

Affiliations

¹ Division of Neurosciences Critical Care, The Johns Hopkins University School of Medicine, 1800 Orleans Street, Sheikh Zayed Building, 3014C, Baltimore, MD, 21287, USA. jsuarez5@jhmi.edu.
² The Emmes Corporation, Rockville, MD, USA.
³ University of Toronto, Toronto, ON, Canada.
⁴ University of Illinois at Chicago, Chicago, IL, USA.
⁵ Mayo Clinic, Rochester, MN, USA.
⁶ University of Iowa, Iowa City, IA, USA.
⁷ University of Duesseldorf, Düesseldorf, Germany.
⁸ University of Zurich, Zurich, Switzerland.
⁹ Main Line Health Care, Wynnewood, PA, USA.
¹⁰ Henry Ford Hospital, Detroit, MI, USA.
¹¹ Nippon Medical School, Tokyo, Japan.
¹² University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
¹³ Klinik Hirslanden, Zurich, Switzerland.
¹⁴ Chinese University of Hong Kong, Shatin, Hong Kong.

PMID: 31087257
DOI: 10.1007/s12028-019-00723-6

Abstract

Objectives: The goal for this project was to develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in unruptured intracranial aneurysm (UIA) and subarachnoid hemorrhage (SAH) clinical research, as part of a new joint effort between the National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine of the US National Institutes of Health. These UIA and SAH CDEs will join several other neurological disease-specific CDEs that have already been developed and are available for use by research investigators.

Methods: A Working Group (WG) divided into eight sub-groups and a Steering Committee comprised of international UIA and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed and provided recommendations for UIA and SAH clinical research. The recommendations were compiled, internally reviewed by the entire UIA and SAH WG and posted online for 6 weeks for external public comments. The UIA and SAH WG and the NINDS CDE team reviewed the final version before posting the SAH Version 1.0 CDE recommendations.

Results: The NINDS UIA and SAH CDEs and supporting documents are publicly available on the NINDS CDE ( https://www.commondataelements.ninds.nih.gov/#page=Default ) and NIH Repository ( https://cde.nlm.nih.gov/home ) websites. The recommendations are organized into domains including Participant Characteristics and Outcomes and Endpoints.

Conclusion: Dissemination and widespread use of CDEs can facilitate UIA and SAH clinical research and clinical trial design, data sharing, and analyses of observational retrospective and prospective data. It is vital to maintain an international and multidisciplinary collaboration to ensure that these CDEs are implemented and updated when new information becomes available.

Keywords: Clinical trials; Common data elements; Observational studies; Outcomes; Subarachnoid hemorrhage; Unruptured intracranial aneurysms.

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References

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1. Sheehan J, Hirschfeld S, Foster E, Ghitza U, Goetz K, Karpinski J, et al. Improving the value of clinical research through the use of common data elements (CDEs). Clin Trials. 2016;13(6):671–9. - DOI
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1. Yue JK, Vassar MJ, Lingsma HF, Cooper SR, Okonkwo DO, Valadka AB, et al. Transforming research and clinical knowledge in traumatic brain injury pilot: multicenter implementation of the common data elements for traumatic brain injury. J Neurotrauma. 2013;30(22):1831–44. - DOI

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Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project

Collaborators

Affiliations

Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project

Authors

Collaborators

Affiliations

Abstract

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Molecular Biology Databases