Deans' stroke musings

Changing stroke rehab and research worldwide now.Time is Brain!Just think of all the trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 493 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It's quite disgusting that this information is not available from every stroke association and doctors group.
My back ground story is here:

Tuesday, July 18, 2017

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.
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


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.


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.


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.


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.


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 (

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