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

Objectives The common data elements (CDE) project was developed by the National Institute of Neurological Disorders and Stroke (NINDS) to provide clinical researchers with tools to improve data quality and allow for harmonization of data collected in different research studies. CDEs have been created for several neurological diseases; the aim of this project was to develop CDEs specifically curated for mitochondrial disease (Mito) to enhance clinical research. Methods Nine working groups (WGs), composed of international mitochondrial disease experts, provided recommendations for Mito clinical research. They initially reviewed existing NINDS CDEs and instruments, and developed new data elements or instruments when needed. Recommendations were organized, internally reviewed by the Mito WGs, and posted online for external public comment for a period of eight weeks. The final version was again reviewed by all WGs and the NINDS CDE team prior to posting for public use

Using the Spinal Cord Injury Common Data Elements

International Spinal Cord Injury (SCI) Data Sets include core, basic, and extended data sets. To date, 13 data sets have been published on the Web site of the International Spinal Cord Injury Society (ISCoS; www.iscos.org.uk), and several more are forthcoming. The data sets are constituted of data elements, which may be appropriate to use in trials conducted to test novel therapeutic candidates including neuroprotective drugs, various cell types, and rehabilitative strategies and devices. The National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health (NIH), embarked on a Common Data Element (CDE) Project 5 years ago. The mission of the NINDS CDE Project is to develop data standards for clinical research. The NINDS CDE team has since developed variable names and database structures for the International SCI Data Sets (ie, the SCI CDEs; http://www.commondataelements.ninds.nih.gov/SCI.aspx). Dataset variable names and database structure are exemplified with the International SCI Core Data Set and the International SCI Cardiovascular Function Basic Data Set. The consistency of the data sets and the CDE format may improve the ability to transfer critical medical information electronically from one center to another. The goals of the SCI CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators. Pilot testing the SCI CDEs is an important step to ensure the SCI CDE effort achieves its goals

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

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

Immersion in ESL culture: Oral output through acting

BACKGROUND: To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich ataxia, a neurological disorder that involves multiple organ systems. METHODS: To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: Ataxia and Performance Measures; Biomarkers; Cardiac and Other Clinical Outcomes; and Demographics, Laboratory Tests and Medical History. The basic development process included: Identification of international experts in Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment. RESULTS: The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The Subgroups’ recommendations are classified as core, supplemental or exploratory. Template case report forms were created for many of the core tests. CONCLUSIONS: The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia