Contributed by Wendy R. Galpern, MD, PhD, NINDS; Julie C. Stout, PhD, Monash University; Ira Shoulson, MD, Georgetown University
Background on the CDE Project
In 2011, the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, released the Parkinson's disease Common Data Elements (CDEs), and the Institute is pleased to announce that the development of CDEs for Huntington's disease (HD) is now complete.
The CDE Project is aimed at developing content standards that enable clinical investigators to systematically collect, analyze, and share data across clinical studies. Study start-up can be a time-consuming effort, and often investigators develop their own data collection tools. The availability of CDEs will facilitate the initiation of a study, promote data collection in a consistent format, and enable comparisons between studies. Twelve disorders are currently included in the CDE Project (www.commondataelements.ninds.nih.gov), with PD, HD, and Friedreich's ataxia being of particular interest to the Movement Disorders community.
Huntington's Disease CDEs
Process and products
For the HD CDEs, an external Working Group of nearly 60 HD experts world-wide was assembled and divided into 11 Subgroups, with Julie Stout, PhD (Monash University, Melbourne, Australia) and Ira Shoulson, MD (Georgetown University, Washington, DC) serving as the Working Group Chairs.
A listing of the HD CDE Working Group Members is available on the HD CDE website.
The HD Subgroups met over a 15-month period to develop their recommendations. Following an internal Working Group review period, the recommendations were posted for public comment. The feedback was incorporated, and the HD CDEs are now publicly available for use.
On the website, you will find a listing of standardized instruments with recommendations regarding their use. There is a catalog of HD CDEs, template case report forms, and data dictionaries. Subgroups gave particular attention to differences in recommendations for manifest versus pre-manifest HD.
It was recommended that the following instruments be collecting in all HD studies:
In addition, as addressed in detail on the website, several other instruments can be considered for use in various types of HD studies.
How to find the CDEs
1. Search the internet for "NINDS HD CDE"
2. Click "Tools" to access the CDE Catalog, CRF Library, and Form Builder
Impact of the CDEs
Rapid adoption of the HD CDEs will translate into improved efficiencies across clinical research activities. The CDEs provide a library of assessments and measurement standards that have been vetted by experts in the field, which will make it increasingly possible to choose measures with confidence even for aspects of HD that are outside of a given investigator's direct areas of expertise. The longer-term benefits of using the HD CDEs will include the ability to create large datasets by combining several studies that share common elements. Such large datasets are required, for example, to be able to detect the very smallest effects that HD has in people many years before onset, and to examine more subtle genetic variability. The HD CDEs will provide investigators, both experienced and new to field, with a valuable research tool to access and make use of informative data elements that have stood the test of time in assessing individuals affected by HD.
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