The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), recently assembled external working groups of nearly 50 international experts to develop a set of Spinal Cord Injury (SCI) Common Data Elements (CDEs) for use in clinical research.
The Rick Hansen Institute was pleased to be a member of the Care and Demographic working groups. RHI's Director of Research & Best Practice Implementation, Dr. Vanessa Noonan, served as RHI's representative in both working groups. Several other members of RHI's network were also involved in this project. To see a full list of working group members, please click here.
The NINDS CDE website describes the CDE Project and its goals. In summary, the CDE Project is intended to provide a resource with content standards, both generic and disease-specific, to enable clinical investigators to systematically collect, analyze and share data across the neurological research community. Over the past 10 months, SCI CDE working groups have identified and defined a catalog of CDEs, written guidance documents and recommendations for their use, and identified relevant references, which investigators can choose from when designing clinical studies and clinical trials for SCI. The SCI CDE working groups have deliberated with the overarching objective to examine the wide range of currently available tools, and then choose those elements and instruments that will be most useful across clinical studies.
These documents are now ready for feedback from the larger SCI research and practice community.
The public review period for the SCI CDEs will take place from May 12, 2014 through June 16, 2014. During this time, Pre-release Version 0.0 of the SCI CDEs will be publically available on the NINDS CDE Website. To access and review the SCI CDE recommendations, please follow the steps below:
1. Navigate to http://www.commondataelements.ninds.nih.gov/SCI.aspx
2. From the SCI CDE Data Standards tab, find the zip file near the top of the page containing the SCI Public Review package.
3. Download and unzip the zip file
4. Read the “instructions.doc” first for an introduction and tips on how to conduct the review and submit your comments.
5. The unzipped Pre-release Version 0.0 SCI Public Review Package contains 2 files containing instructions and the roster of contributors, and 9 folders containing materials prepared by each of the working groups: (1) Demographics; (2) Care History/Comorbidity; (3) Electrodiagnostics; (4) Functional; (5) Imaging; (6) Neurological; (7) Pain; (8) Participation/Quality of Life; and (9) Psychological. Please feel free to review and provide comments on as many domains as you wish.
We encourage researcher and public feedback. Comments will be accepted until June 16, 2014.
Please note, the review package represents only a beta version of the SCI CDEs. These CDEs will require refinement and eventual validation, and the Call for Public Review is an important step in this process.