Standardizing the Structure of Stroke Clinical and Epidemiologic Research Data: The National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element (CDE) Project

This has only been out there for 5 years so ask your doctor for what your standardized description of your stroke was. You can look at what those Common Data Elements are in the link at the bottom of this post. I didn't have time to make sense of them, but I'm sure your stroke hospital didn't do one damn thing with them.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3493110/

Jeffrey L. Saver, MD, Steven Warach, MD, PhD, Scott Janis, PhD, Joanne Odenkirchen, MPH, Kyra Becker, MD, Oscar Benavente, MD, Joseph Broderick, MD, Alexander W. Dromerick, MD, Pamela Duncan, PhD, Mitchell S. V. Elkind, MD, Karen Johnston, MD, Chelsea S. Kidwell, MD, James F. Meschia, MD, and Lee Schwamm, MD, for the NINDS Stroke Common Data Element Working Group

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Abstract

Background and Purpose

The National Institute of Neurological Disorders and Stroke initiated development of stroke-specific Common Data Elements (CDEs) as part of a project to develop data standards for funded clinical research in all fields of neuroscience. Standardizing data elements in translational, clinical and population research in cerebrovascular disease could decrease study start-up time, facilitate data sharing, and promote well-informed clinical practice guidelines.

Methods

A Working Group of diverse experts in cerebrovascular clinical trials, epidemiology, and biostatistics met regularly to develop a set of Stroke CDEs, selecting among, refining, and adding to existing, field-tested data elements from national registries and funded trials and studies. Candidate elements were revised based on comments from leading national and international neurovascular research organizations and the public.

Results

The first iteration of the NINDS stroke-specific CDEs comprises 980 data elements spanning nine content areas: 1) Biospecimens and Biomarkers; 2) Hospital Course and Acute Therapies; 3) Imaging; 4) Laboratory Tests and Vital Signs; 5) Long Term Therapies; 6) Medical History and Prior Health Status; 7) Outcomes and Endpoints; 8) Stroke Presentation; 9) Stroke Types and Subtypes. A CDE website provides uniform names and structures for each element, a data dictionary, and template case report forms (CRFs) using the CDEs.

Conclusion

Stroke-specific CDEs are now available as standardized, scientifically-vetted variable structures to facilitate data collection and data sharing in cerebrovascular patient-oriented research. The CDEs are an evolving resource that will be iteratively improved based on investigator use, new technologies, and emerging concepts and research findings.

The mission of the National Institute of Neurological Disorders and Stroke (NINDS) is “to reduce the burden of neurologic disease.” Supporting translational, clinical, and population research in stroke is fundamental to this mission, as stroke is the single greatest nervous system cause of death and disability, both in the United States and worldwide.(1, 2) (3)

Accordingly, the NINDS supports a diverse array of translational, clinical trial, epidemiologic, and additional patient-oriented research in cerebrovasular disease, which have had a substantial beneficial effect upon health policy, clinical care, and patient outcomes.(4) However, the fullest potential benefit of these research endeavors has not been realized due to the absence of uniform, widely-accepted formats to characterize demographic, disease, care process, and outcome variables. Data elements are often characterized in varying manners in different studies, hampering cross-study comparisons, recognition of population differences, data-sharing, and pooled analyses.

To harmonize data collected across diverse translational, clinical, and population studies, NINDS began the Common Data Element (CDE) Project in 2006.(5) The project aims to standardize naming, definitions, data structure, and response options for all variables commonly employed in NINDS-funded patient and population research. The CDE project complements study-level guidelines from the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network.(6) However, where EQUATOR guidelines focus on the reporting of study level results, the CDE Project focuses on the collection and reporting of individual variable level results, providing guidance for data collection, and facilitating data sharing, at a more granular, patient level.

The overall CDE Project has four primary goals: 1) disseminate standards for the collection of data from participants enrolled in studies of neurological diseases; 2) create easily accessible data-collection tools for investigators that are ready to use “off the shelf”; 3) encourage focused and simplified data collection to reduce burden on investigators and practice-based clinicians to increase clinical research participation; and 4) improve study quality and reduce cost of data entry, cleaning and analysis by providing uniform data descriptions and tools across NINDS-funded clinical studies of treatment for neurological diseases.(5, 7) The anticipated benefits of the CDE Project are multiple, and include: 1) rapid and efficient study start-up by allowing investigators access to appropriate data elements, definitions, and case report form templates; 2) improved patient safety by facilitating development of common report templates that can be submitted to oversight committees such as Data and Safety Monitoring Boards (DSMBs); 3) enriched data sharing and data aggregation by employing standard definitions and common forms; and 4) wide adoption of common outcome measures (e.g., functional, cognitive) that may be relevant across the neurological diseases.(5, 7)

The CDE Project first developed a set of General CDEs commonly collected in all neuroscience clinical studies, including demographic information, medical history data, medication use, and data needed for safety reporting.(8) Next, development of disease-specific CDEs was undertaken. This paper describes the process and outcome for the development of Stroke CDEs.

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Methods

NINDS convened a Stroke CDE Working Group consisting of 52 experts with experience in NIH-funded cerebrovascular disease clinical and population research or international initiatives in stroke data integration. The Working Group comprised extramural clinical scientists, intramural NINDS researchers, and the NINDS CDE team, supported by a contracted clinical research organization, KAI Research Inc. (Rockville, MD). Participants represented a broad spectrum of specialties and research domains, including: adult and pediatric stroke; acute care and prevention; outpatient, prehospital, emergency department, inpatient, and neurointensive care; neurology, neurosurgery, emergency medicine, radiology, and hematology; nursing, physicians, biostatisticians, public health, and epidemiologists. The input of experienced research coordinators and scientists involved with the creation of data and specimen repositories and of an industry scientist was also solicited. Members from diverse institutions were selected to ensure the inclusion of different perspectives and experience. Specific federal agencies, such as the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), were requested to appoint representatives. The CRO was responsible for scheduling the Working Group conference calls and working on administrative action items such as development of the CDE data dictionaries based on the Working Group’s content recommendations. Wherever possible efforts were made to harmonize the Stroke CDE work product with existing data structure recommendations, including from the Specialized Program of Translational Research in Acute Ischemic Stroke (SPOTRIAS) Common Clinical Database, the Centers for Disease Control and Prevention’s Paul Coverdell National Acute Stroke Registry (Coverdell), and the American Heart Association/American Stroke Association Get With the Guidelines (GWTG) – Stroke national quality improvement registry.

The final CDE products were to include:

1. Listing of standardized data elements that can be incorporated into any data system
2. Data Dictionary with data specifications for each element, including definition, format of response (numeric vs multiple choice vs free text), recommended response options (for multiple choice), explanations, and references
3. Template study forms in Microsoft WORD and PDF format
4. Manuals of Procedures (MOPs), as appropriate
5. Website that facilitates access to the CDE data elements, data dictionary, forms, and MOPS (http://www.commondataelements.ninds.nih.gov/Stroke.aspx).

The International Common Data Elements Project for TBI – Getting Further, Faster

This is precisely what we need for stroke, because if we can't even competently and accurately describe the problems we will never be able to solve them. I don't expect either the the NSA, ASA or WSO to take on this challenging task because that would entail hard work. Prove me wrong!
http://www.ninds.nih.gov/research/tbi/intl_CDE_project.htm
The brain is the most complex organ of the body and repairing it after injury is challenging. To address this challenge, research scientists are working to increase our understanding of brain function and to develop better diagnostic tools and treatments for the millions of people worldwide living with traumatic brain injury (TBI). The National Institute of Neurological Disorders and Stroke (NINDS) is the lead institute at the National Institutes of Health (NIH) for TBI research and supports a range of high quality research on this topic.
Understanding reasons for good and poor recoveries after TBI is an important step toward developing better treatments, and several years ago NINDS supported a study to address this question. The study was unusual in that it evaluated thousands of cases of severe TBI by combining data retrospectively from several clinical trials. Such large data sets were previously unavailable, and the study successfully identified several major factors associated with recovery. However, some research questions could not be fully addressed because the original studies did not include the data needed to answer them. It became clear that many important questions about recovery after TBI would need to be addressed in new studies. Moreover, investigators also discovered that retrospectively comparing data from multiple studies was excruciatingly difficult and time consuming because the same types of information were coded in different ways. For example, some studies reported a subject’s educational status as “none, grade school, high school, college, or graduate school” while other studies reported “total years of school.” Hundreds of these types of examples existed, and investigators spent years figuring out ways to make the studies comparable and then reformatting the data. There had to be a better way to combine information from multiple studies!
The better way is the International TBI Common Data Elements Project, a collaboration among the NIH, Department of Defense (DOD), National Institute on Disability and Rehabilitation Research, Department of Veterans Affairs, and Centers for Disease Control and Prevention to standardize definitions and protocols for TBI research. Rather than retrospectively reformatting and harmonizing data after a study ends, the goal of the International TBI Common Data Elements Project is to standardize data collection at the beginning. The project includes hundreds of scientific experts from around the world who serve on working groups and steering committees to develop recommendations for collecting data in a uniform manner. The standardized data recommendations are referred to as common data elements (CDEs).
Currently, more than 900 CDEs for TBI research (Hicks et al., 2013) exist, and are available on multiple websites, including the NINDS Common Data Elements website. A small number of the CDEs are so commonly used that they are called “CORE CDEs” and recommended for use in virtually all TBI research studies. Other CDEs are recommended for use depending on the type of study, such as epidemiology, acute-hospital, rehabilitation, or mild TBI/concussion. Some of the CDEs are relevant to subjects of all ages, and others are specific to children or adults.  
Following the development of the TBI CDEs, the next major step was to try them out to see if they could actually work in a research study conducted across multiple centers on a wide range of subjects. To give them a test-run, four TBI hospitals collaborated to collect data on more than 650 subjects with TBI, with injuries ranging from mild to severe, in a study called TRACK-TBI. The TRACK-TBI study revealed that the TBI CDEs had a few minor issues, but overall they were useable. In addition, the CDEs accelerated the research as the data were collected in just two years. Most of the data are still being analyzed; one early publication demonstrated that an MRI of the brain was more predictive of recovery outcomes at 3 months than a conventional CT scan (Yuh et al., 2013). Although previous smaller studies had shown similar findings, the large number of subjects in the TRACK-TBI study greatly increased the clinical significance and impact. 
Lastly, there is the question of how to put the TBI CDEs into practice. It’s one thing to develop CDEs and another thing to actually use them. Fortunately, there are two major activities underway to promote the use of the TBI CDEs and data sharing. One is the NIH and DOD collaboration to provide a Federal Interagency TBI Research (FITBIR) Informatics System. FITBIR provides a database for TBI research at no cost to the research scientists, as well as an electronic data capture tool, and a platform for collaboration and data sharing. FITBIR uses the TBI CDEs for its data dictionary. The second major activity is the International TBI Research (InTBIR) Initiative (Tosetti et al., 2013). InTBIR is a collaboration among the NIH, European Union Research Directorate and Canadian Institutes of Health Research to support international team science to study 10,000 children and adults with TBI. InTBIR researchers will use the TBI CDEs in their studies to facilitate data sharing and analysis toward the development of better diagnostic tools and more effective treatments.
In summary, the International TBI Common Data Elements Project built a foundation for the FITBIR Informatics System and the InTBIR Initiative, and together all of these projects will help us to get further, faster on understanding TBI and identifying ways to promote recovery.