Common data elements for clinical research in mitochondrial disease: a National Institute for Neurological Disorders and Stroke project

Objective: The National Institute of Neurological Disorders and Stroke (NINDS) initiated the Common Data Element (CDE) project to provide standardized clinical research data collection formats that increase the efficiency and effectiveness of studies and reduce start-up time, as well as improve data quality and facilitate and accelerate data sharing. In 2010, Stroke-specific CDEs were posted on the NINDS CDE website. The Stroke Oversight Committee (OC) reviewed Core CDEs in 2015; and in 2018, recommended that Stroke CDEs undergo a comprehensive review and update to Version 2.0. Background: In August 2018, a Stroke V2.0 Working Group (WG) consisting of over 50 worldwide subject matter experts was convened by NINDS. The WG was asked to review all current Stroke CDEs and subarachnoid hemorrhage and unruptured cerebral aneurysms (SAH) CDEs (developed in 2017) for harmonization and inclusion within Stroke V2.0. Methods: The Stroke V2.0 WG divided into eight domain-specific subgroups: Biospecimens, Biomarkers, and Laboratory Tests; Hospital Course and Acute Therapies; Imaging; Long Term Therapies; Medical History and Prior Health Status; Outcomes and Endpoints; Stroke Presentation and Vital Signs; and Stroke Types and Subtypes. Subgroups met regularly to review, revise and add to the existing Stroke CDEs based on developments in stroke research. Following an internal WG review, a public review of the draft updates will be held. The WG will consider public feedback before V2.0 is finalized. The Stroke OC plans to review the project status at the 2020 International Stroke Conference. Results: The Stroke V2.0 CDE recommendations will include updated and new template case report forms, data dictionaries, instrument informational documents and guideline documents. The updates will reflect the current state of science, streamline CDE recommendations, and incorporate SAH CDEs. Stroke V2.0 CDEs will be available on the NINDS CDE website in 2020. Conclusions: The NINDS CDEs are periodically revised as research progresses. Through the update of the Stroke CDEs to V2.0, the initiative strives to maintain the utility of CDEs as a valuable clinical research resource. NINDS encourages use of CDEs to standardize research data collection across studies.

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Abstract WP332: Updating the Structure of Stroke Clinical Research Data: Version 2 of the Stroke Common Data Elements From the National Institutes of Health/National Institute of Neurological Disorders and Stroke

Stroke ◽

10.1161/str.47.suppl_1.wp332 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Joy R Esterlitz ◽

Jeffrey L Saver ◽

Steven Warach ◽

Thomas G Brott ◽

Ralph L Sacco ◽

...

Keyword(s):

Clinical Research ◽

Data Sharing ◽

Neurological Disorders ◽

National Institutes Of Health ◽

Common Data Elements ◽

Start Up ◽

Efficiency And Effectiveness ◽

Data Elements ◽

Study Type

Introduction: In order to increase the efficiency and effectiveness of neurovascular clinical research studies, increase data quality, facilitate data sharing, help educate new clinical investigators and reduce study start-up time, the National Institute of Neurological Disorders and Stroke (NINDS) convened a Working Group (WG) that developed Version 1.0 (published 2010) Stroke-specific Common Data Elements (CDEs). Since their initial publication, intervening advances in science and initial experience with the CDEs identified a need to update them and refine guidance on their deployment. Hypothesis/Objective: The NINDS has updated guidance on uniform data structures for use in cerebrovascular research in epidemiology, clinical trials and imaging studies in order to advance the prevention, acute treatment and recovery from cerebrovascular disease. Methods: The NINDS convened experts in research and data element design drawing strongly from investigators in the NIH StrokeNet and other NINDS clinical research projects. Results: Stroke CDE leadership developed a revised process for classifying Stroke CDEs among the four hierarchical categories of Core, Supplemental - Highly Recommended, Supplemental and Exploratory. Due to the heterogeneity of stroke conditions and study types, the classification of Supplemental - Highly Recommended was used for study type (clinical trial or observational), disease type (e.g., ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage) and disease phase (primary prevention, acute, recovery and secondary prevention). Conclusion: The second iteration of NINDS CDE recommendations for neurovascular disease is an important step towards more efficient study start-up time and improved data sharing. The updated CDEs were released on the NINDS CDE website in May 2015. The information at this meeting will include examples of how the Stroke CDEs may be used by a research study, an explanation of the new CDE classifications, and examples of navigating and selecting CDEs from the NINDS CDE website. Support: This project was funded by HHSN271201200034C.

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1.003 FACILITATING CLINICAL RESEARCH: THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS (NINDS) AND STROKE PARKINSON'S DISEASE COMMON DATA ELEMENTS PROJECT

Parkinsonism & Related Disorders ◽

10.1016/s1353-8020(11)70117-1 ◽

2012 ◽

Vol 18 ◽

pp. S10-S11 ◽

Cited By ~ 1

Author(s):

C.M. Tanner ◽

K. Kieburtz ◽

W. Galpern ◽

M. Delong ◽

D. Dickson ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Clinical Research ◽

Neurological Disorders ◽

Common Data Elements ◽

Data Elements

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NINDS Common Data Elements for Congenital Muscular Dystrophy Clinical Research: A National Institute for Neurological Disorders and Stroke Project

Journal of Neuromuscular Diseases ◽

10.3233/jnd-170248 ◽

2018 ◽

Vol 5 (1) ◽

pp. 75-84

Author(s):

Michael W. Lawlor ◽

Susan T. Iannaccone ◽

Katherine Mathews ◽

Francesco Muntoni ◽

Sherita Alai-Hansen ◽

...

Keyword(s):

Muscular Dystrophy ◽

Clinical Research ◽

Neurological Disorders ◽

Congenital Muscular Dystrophy ◽

Common Data Elements ◽

Data Elements

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Abstract TP419: A Common Data Language for Clinical Research Studies: The National Institute of Neurological Disorders and Stroke and National Library of Medicine Cerebral Aneurysms and Subarachnoid Hemorrhage Common Data Elements Version 1.0 Recommendations

Stroke ◽

10.1161/str.48.suppl_1.tp419 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Joanne Odenkirchen ◽

Liz Amos ◽

Christophe Ludet ◽

Muniza Sheikh ◽

Sherita Ala’i ◽

...

Keyword(s):

Subarachnoid Hemorrhage ◽

Clinical Research ◽

Neurological Disorders ◽

Working Group ◽

Cerebral Aneurysms ◽

National Library ◽

Data Standards ◽

Common Data Elements ◽

Unruptured Intracranial Aneurysms ◽

Data Elements

Introduction: The National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine (NLM) initiated development of cerebral aneurysms and subarachnoid hemorrhage (SAH)-specific Common Data Elements (CDEs) in 2015 as part of a joint project to develop data standards for funded clinical research in neuroscience. Objective: Through the development of these data standards for clinical research, the NINDS and NLM SAH joint CDE initiative strives to improve SAH data collection by increasing efficiency, improving data quality, reducing study start-up time, facilitating data sharing/meta-analyses and helping educate new clinical investigators. Methods: The working group consisted of international members with varied fields of expertise related to SAH and was divided into domains such as subject characteristics and assessments and exams. They developed a set of SAH-specific CDE recommendations by selecting among, refining and adding to existing field-tested data elements. Recommendations, based on reviewing the established Stroke CDEs as well as other disease-specific CDEs, were uploaded to the NIH CDE Repository. Following an internal working group review of recommendations, the SAH CDEs will be vetted during a public review on the NINDS website. Results: Version 1.0 of the SAH CDEs will be available in early 2017. New SAH CDEs and recommendations will include those developed for unruptured intracranial aneurysms and long-term therapies. The NINDS CDE website provides uniform names and structures for each data element, as well as guidance documents and template case report forms using the CDEs. Conclusion: The NINDS encourages the use of CDEs by the clinical research community in order to standardize the collection of research data across studies. The NINDS CDEs are a continually evolving resource, requiring updates as research advancements indicate. These newly developed SAH CDEs will serve to be a valuable starting point for researchers and facilitate streamlining and sharing data. Information provided at this meeting will include examples of how the SAH CDEs may be used by a research study, demonstrations of navigating the NINDS CDE and NIH CDE Repository websites and how users can submit feedback.

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