Recommendations For Common Data Elements Research Articles

Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Behavioral Phenotyping.

The recent publication of practice guidelines for management of patients with disorders of consciousness (DoC) in the United States and Europe was a major step forward in improving the accuracy and consistency of terminology, diagnostic criteria, and prognostication in this population. There remains a pressing need for a more precise brain injury classification system that combines clinical semiology with neuroimaging, electrophysiologic, and other biomarker data. To address this need, the National Institute of Neurological Disorders and Stroke launched the Common Data Elements (CDEs) initiative to facilitate systematic collection of high-quality research data in studies involving patients with neurological disease. The Neurocritical Care Society's Curing Coma Campaign expanded this effort in 2018 to develop CDEs for DoC. Herein, we present CDE recommendations for behavioral phenotyping of patients with DoC. The Behavioral Phenotyping Workgroup used a preestablished, five-step process to identify and select candidate CDEs that included review of existing National Institute of Neurological Disorders and Stroke CDEs, nomination and systematic vetting of new CDEs, CDE classification, iterative review, and approval of panel recommendations and development of corresponding case review forms. We identified a slate of existing and newly proposed basic, supplemental, and exploratory CDEs that can be used for behavioral phenotyping of adult and pediatric patients with DoC. The proposed behavioral phenotyping CDEs will assist with international harmonization of DoC studies and allow for more precise characterization of study cohorts, favorably impacting observational studies and clinical trials aimed at improving outcome in this population.

A common language for Gulf War Illness (GWI) research studies: GWI common data elements

AimsThe Gulf War Illness programs (GWI) of the United States Department of Veteran Affairs and the Department of Defense Congressionally Directed Medical Research Program collaborated with experts to develop Common Data Elements (CDEs) to standardize and systematically collect, analyze, and share data across the (GWI) research community. Main methodsA collective working group of GWI advocates, Veterans, clinicians, and researchers convened to provide consensus on instruments, case report forms, and guidelines for GWI research. A similar initiative, supported by the National Institute of Neurologic Disorders and Stroke (NINDS) was completed for a comparative illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and provided the foundation for this undertaking. The GWI working group divided into two sub-groups (symptoms and systems assessment). Both groups reviewed the applicability of instruments and forms recommended by the NINDS ME/CFS CDE to GWI research within specific domains and selected assessments of deployment exposures. The GWI CDE recommendations were finalized in March 2018 after soliciting public comments. Key findingsGWI CDE recommendations are organized in 12 domains that include instruments, case report forms, and guidelines. Recommendations were categorized as core (essential), supplemental-highly recommended (essential for specified conditions, study types, or designs), supplemental (commonly collected, but not required), and exploratory (reasonable to use, but require further validation). Recommendations will continually be updated as GWI research progresses. SignificanceThe GWI CDEs reflect the consensus recommendations of GWI research community stakeholders and will allow studies to standardize data collection, enhance data quality, and facilitate data sharing.

Development of Common Data Elements for Use in Chiari Malformation Type I Clinical Research: An NIH/NINDS Project.

The management of Chiari I malformation (CMI) is controversial because treatment methods vary and treatment decisions rest on incomplete understanding of its complex symptom patterns, etiologies, and natural history. Validity of studies that attempt to compare treatment of CMI has been limited because of variable terminology and methods used to describe study subjects. The goal of this project was to standardize terminology and methods by developing a comprehensive set of Common Data Elements (CDEs), data definitions, case report forms (CRFs), and outcome measure recommendations for use in CMI clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health. A working group, comprising over 30 experts, developed and identified CDEs, template CRFs, data dictionaries, and guidelines to aid investigators starting and conducting CMI clinical research studies. The recommendations were compiled, internally reviewed, and posted online for external public comment. In October 2016, version 1.0 of the CMI CDE recommendations became available on the NINDS CDE website. The recommendations span these domains: Core Demographics/Epidemiology; Presentation/Symptoms; Co-Morbidities/Genetics; Imaging; Treatment; and Outcome. Widespread use of CDEs could facilitate CMI clinical research trial design, data sharing, retrospective analyses, and consistent data sharing between CMI investigators around the world. Updating of CDEs will be necessary to keep them relevant and applicable to evolving research goals for understanding CMI and its treatment.

Ninds/nih And Dod Sport-related Concussion Common Data Elements

PURPOSE: In 2016, the National Institute of Neurological Disorders and Stroke (NINDS)/National Institutes of Health (NIH) and the Department of Defense (DOD) began development of Sport-related Concussion (SRC) Common Data Elements (CDEs) to develop data standards for all funded clinical research in neuroscience with goal of increasing the effectiveness of clinical research studies and treatment by facilitating data sharing across studies. The purpose of this abstract is to report the findings from the SRC-CDEs. METHODS: The initial NINDS Traumatic Brain Injury (TBI) CDE recommendations created in 2010 included limited sport-related brain injury recommendations. In August 2016, a new SRC-specific CDE working group (WG) began developing and identifying CDEs, template case report forms (CRFs), data dictionaries and guidelines to assist investigators initiating and conducting SRC-specific clinical research studies. Comprised of 34 experts from around the world, the WG met regularly to review current collection of SRC data. The WG was divided into three subgroups to examine SRC over time: (1) Acute Subgroup (time of injury until 72 hours); (2) Subacute Subgroup (after 72 hours to 3 months); and, (3) Persistent/Chronic Subgroup (3 months and greater post-concussion). RESULTS: The SRC CDEs were released to the NINDS CDE website in June 2017. The recommendations include Core and Supplemental - Highly Recommended CDEs for cognitive measures and symptom checklists, as well as other outcomes and endpoints (e.g., vestibular, oculomotor, balance, anxiety, depression) and sample case report forms (e.g., injury reporting, demographics, history of concussion, concussion history) across acute, sub-acute and persistent/chronic. CONCLUSION: NINDS encourages the use of SRC CDEs by the clinical research community to standardize data collection and reporting. The NINDS CDEs are a continually evolving resource, and these newly developed SRC CDEs serve as valuable starting points for investigators to streamline research that informs treatments for SRC. This material is based upon work supported by the U.S Army Medical Research and Materiel Command’s Combat Casualty Care Research Program and funded by NIH contracts HHSN271201700064C and HHSN271201200034C.

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

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.

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.

Progress in Developing Common Data Elements for Traumatic Brain Injury Research: Version Two – The End of the Beginning

To accelerate data sharing and research on traumatic brain injury (TBI), several federal agencies have been collaborating to support the development and implementation of common data elements (CDEs). The first recommendations for CDEs were made in 2010, and were well suited for hospital-based studies of acute TBI in adults. To broaden the utility of the TBI CDEs, experts were asked to update the recommendations to make them relevant to all ages, levels of injury severity, and phases of recovery. The second version of the TBI CDEs (v.2) was organized around four major study types: 1) epidemiological research; 2) studies on acute, hospitalized patients; 3) studies of the rehabilitation for moderate/severe TBI; and 4) mild TBI/concussion research. Given the heterogeneity of TBI, only a small set of core CDEs were found to be relevant across all study types. However, within groups, a much larger set of highly relevant CDEs were identified, and these were called basic CDEs. In addition, an expanded number of supplemental CDEs were specified and recommended for use depending upon the study goals. Version 2 provides a rich data dictionary for TBI research with about 900 CDEs. Many of the CDEs overlap across the study types, which will facilitate comparisons and meta-analysis across studies. Further modifications of the CDEs should be based on evaluation of their usefulness following implementation across a range of studies.

Common Data Elements for Research on Traumatic Brain Injury: Pediatric Considerations

Traumatic brain injury (TBI) is a significant global health problem, with a notably high incidence in children and adolescents. Despite the prevalence of TBI and the disabilities that often follow, research on which to base effective treatment is limited by several challenges, including but not limited to the complexity and heterogeneity of TBI. Even when rigorous methods are employed, the utility of the research may be limited by difficulties in comparing findings across studies resulting from the use of different measures to assess similar TBI study variables. Standardization of definitions and data elements is an important step toward accelerating the process of data sharing that will ultimately lead to a stronger evidence base for treatment advances. To address this need, recommendations for common data elements (CDEs) for research on TBI were developed through a 2009 national initiative. To ensure that the TBI CDE recommendations are relevant to pediatric populations, the National Institute on Disability and Rehabilitation Research (NIDRR) and the National Institute of Neurological Disorders and Stroke (NINDS) called for a review of the original recommendations. Following the process used for the original initiative, multidisciplinary work groups composed of pediatric TBI experts were formed (Demographics and Clinical Assessment; Biomarkers; Neuroimaging; and Outcomes Assessment). Recommendations for modifications and additions to the original CDEs were developed by the work groups, vetted at a 2010 workshop and further refined in preparation for publication. The pediatric considerations for TBI CDEs are described in a series of articles in this journal. This article describes the efforts leading to this pediatric CDE initiative and the CDE review and development process. It concludes with general recommendations for future iterations of the CDE initiative.

Common Data Elements for Pediatric Traumatic Brain Injury: Recommendations from the Working Group on Demographics and Clinical Assessment

The Common Data Elements (CDEs) initiative is a National Institutes of Health (NIH) interagency effort to standardize naming, definitions, and data structure for clinical research variables. Comparisons of the results of clinical studies of neurological disorders have been hampered by variability in data coding, definitions, and procedures for sample collection. The CDE project objective is to enable comparison of future clinical trials results in major neurological disorders, including traumatic brain injury (TBI), stroke, multiple sclerosis, and epilepsy. As part of this effort, recommendations for CDEs for research on TBI were developed through a 2009 multi-agency initiative. Following the initial recommendations of the Working Group on Demographics and Clinical Assessment, a separate workgroup developed recommendations on the coding of clinical and demographic variables specific to pediatric TBI studies for subjects younger than 18 years. This article summarizes the selection of measures by the Pediatric TBI Demographics and Clinical Assessment Working Group. The variables are grouped into modules which are grouped into categories. For consistency with other CDE working groups, each variable was classified by priority (core, supplemental, and emerging). Templates were produced to summarize coding formats, guide selection of data points, and provide procedural recommendations. This proposed standardization, together with the products of the other pediatric TBI working groups in imaging, biomarkers, and outcome assessment, will facilitate multi-center studies, comparison of results across studies, and high-quality meta-analyses of individual patient data.

Consensus Recommendations for Common Data Elements for Operational Stress Research and Surveillance: Report of a Federal Interagency Working Group

Nash WP, Vasterling J, Ewing-Cobbs L, Horn S, Gaskin T, Golden J, Riley WT, Bowles SV, Favret J, Lester P, Koffman R, Farnsworth LC, Baker DG. Consensus recommendations for common data elements for operational stress research and surveillance: report of a federal interagency working group. Empirical studies and surveillance projects increasingly assess and address potentially adverse psychological health outcomes from the stress of military operations, but no standards yet exist for common concept definitions, variable categories, and measures. This article reports the consensus recommendations of the federal interagency Operational Stress Working Group for common data elements to be used in future operational stress research and surveillance with the goal of improving comparability across studies. Operational stress encompasses more than just combat; it occurs everywhere service members and their families live and work. Posttraumatic stress is not the only adverse mental or behavioral health outcome of importance. The Operational Stress Working Group contends that a primary goal of operational stress research and surveillance is to promote prevention of adverse mental and behavioral outcomes, especially by recognizing the preclinical and subclinical states of distress and dysfunction that portend a risk for failure of role performance or future mental disorders. Recommendations for data elements are divided into 3 tiers: core, supplemental, and emerging, including variable domains and specific measures for assessing operational stressor exposures, stress outcomes, moderating factors, and mediating processes. Attention is drawn to the emerging construct of stress injury as a generic term for subclinical operational stress, and to emerging data elements addressing biological, psychological, and spiritual mediators of risk. Methodologies are needed for identifying preclinical and subclinical states of distress or dysfunction that are markers of risk for failure of role performance and future clinical mental disorders, so that targeted prevention interventions can be developed and evaluated.

Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements

Thurmond VA, Hicks R, Gleason T, Miller AC, Szuflita N, Orman J, Schwab K. Advancing integrated research in psychological health and traumatic brain injury: common data elements. In civilian, military, and veteran populations, there is increased recognition of the interrelationship between traumatic brain injury (TBI) and some psychological health (PH) disorders and the need to better understand the relationships by integrating research for these topics. The use of different measures to assess similar study variables and/or assess outcomes may limit important advances in PH and TBI research. Without a set of common data elements (CDEs; to include variable definitions and recommended measures for the purpose of this discussion), comparison of findings across studies is challenging. The federal agencies involved in PH and TBI research, the National Institute of Neurological Disorders and Stroke, Department of Veterans Affairs, National Institute on Disability and Rehabilitation Research, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, and Defense and Veterans Brain Injury Center, therefore cosponsored a scientific initiative to develop CDEs for PH and TBI research. Scientific experts were invited to participate in 1 of 8 working groups to develop recommendations for specific topic-driven CDEs. Draft recommendations were presented and discussed in the workshop “Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements (CDE)” held on March 23–24, 2009, in Silver Spring, MD. The overall process leading to the workshop and subsequent recommendations by the working groups are presented in this article. Topic-driven recommendations for CDEs are presented in individual reports in this edition.