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

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.

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 C. 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