NINDS HD Common Data Elements

The National Institute of Neurological Disorders and Stroke (NINDS), and the National Institutes of Health (NIH) have been working with leading HD scientists and clinicians to create "HD Common Data Elements."

These definitons and guidelines will standardize t\both generic and disease-specific information and methodologies. This will allow clinical researchers to collect, analyze and share data with the same metrics, making it easier for the researchers to compare data, as well as the outcomes of studies and trials.

 

The Committee included many HDSA-affiliated researchers and clinicians, including:

Karen Anderson, MD -- HDSA Center of Excellence at Maryland

Kevin Biglan, MD, HDSA Center of Excellence at University of Rochester

Andrew Feigin, MD - HDSA Center of Excellence at North Shore Hospital

James Gusella, PhD - HDSA Coalition for the Cure

Steven Hersch, MD - HDSA Coalition for the Cure and HDSA Center of Excellence at MGH

Joseph Jankoic, MD - HDSA Center of Excellence at Baylor

Karen Marder, MD, MPH - HDSA Center of Excellence at Columbia University

Jane Paulsen, PhD - HDSA Center of Excellence at University of Iowa

Christopher Ross, MD, PhD, HDSA Coalition for the Cure,  HDSA Center of Excellence at Johns Hopkins

Kathleen Shannon, MD - HDSA Center of Excellence at Rush Medical Center

 

To Review the Draft Document and make comments please follow the instructions below

 

The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), would like to invite the Huntington’s Disease Society of America to comment upon its draft Huntington disease (HD) Common Data Elements (CDEs).  The NINDS recently assembled an external working group of experts, the HD CDE Working Group, to develop “Pre-release Version 0.0” of the Huntington disease CDEs and they are now ready for feedback from the larger HD clinical research community.  

 

HDSA-affiliated researchers and clinicians were members of the committee. 
The NINDS CDE Web site <http://www.commondataelements.ninds.nih.gov/>  fully describes the NINDS CDE Project and its goals.  In summary, the CDE Project aims to develop content standards, both generic and disease-specific, that enable clinical investigators to systematically collect, analyze, and share data across the research community.  The NINDS first convened the HD CDE Working Group in February 2010.  Over the past eleven months, the HD CDE Working Group has identified and defined a catalog of CDEs investigators can choose from when assembling their clinical study materials.  The HD CDE Working Group has not attempted to define the complete universe of variables a clinical study will collect; rather, their goal has been to identify elements that will be most useful across multiple HD clinical studies.
 
The Call for Public Review of the HD CDEs will take place through February 29, 2012.  The Pre-release Version 0.0 of the HD CDEs is now publically available on the NINDS CDE Web site <http://www.commondataelements.ninds.nih.gov/ALS.aspx> .  To access and review the Huntington disease CDE recommendations, please follow the steps below:
1.       Navigate to http://www.commondataelements.ninds.nih.gov/HD.aspx

2.       From the Huntington disease CDE Standards page, scroll to the Data Standards section and download the zip file containing the review package

3.       Unzip the zip file and read the “Overview.doc” document first for tips on how to conduct the review and submit your comments

 
The HD CDE review package is categorized into domains.  Please feel free to provide comments on as many domains as you are comfortable reviewing.  We look forward to your feedback and ask that you please submit your comments by February 29, 2012.  The CDEs will require further refinement and validation and the Call for Public Review is a most important step in that ongoing process.   
 
Thank you in advance for taking the time to review the Huntington disease CDEs.  We hope that you will share this announcement with your colleagues and encourage them to provide feedback as well.
 
Sincerely,
 
Wendy Galpern, M.D., Ph.D.

Office of Clinical Research, NINDS   galpernw@ninds.nih.gov      

                                      

Ira Shoulson, M.D.
Georgetown University
  Ira@irashoulson.org

Julie Stout, Ph.D.

Monash University

Julie. Stout@monash.edu


Joanne Odenkirchen, M.P.H.
CDE Project Officer, NINDS

odenkirj@ninds.nih.gov