Department of Health
and Human Services (HHS)
and Human Services (HHS)
January 15, 2021
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is seeking input on common data elements (CDEs) and outcome measures related to lower limb loss. To support this effort, NICHD has been engaged with other NIH Institutes and Centers as well as federal partners, including other Operational Divisions within the Department of Health and Human Services (HHS; Centers for Medicare and Medicaid Services [CMS]; Food and Drug Administration [FDA]; the National Institute for Disability, Independent Living, and Rehabilitation Research [NIDILRR]; the Agency for Healthcare Research and Quality [AHRQ]), the Department of Defense (DoD), and the Department of Veterans Affairs (VA).
One way to improve the yield and impact of research in any area of science is to provide investigators with a common set of tools and resources to facilitate sharing, comparing, and integration of data from multiple sources. NICHD and other federal agencies have worked to establish CDEs for other conditions, such as neurologic disorders. The availability of CDEs allows studies to be aggregated more easily and may enable more meta-analyses or other combined analyses across studies.
Through the use of these elements, researchers will be better able to share, compare, replicate findings, generalize results, and integrate data across studies. By advancing the use of these common data elements and aggregating the data in repositories, NICHD aims to optimize the value of this research and further accelerate and enhance our understanding of those with lower limb loss, while advancing a culture of scientific collaboration.
With this Notice, NICHD announces the availability of a common data elements for review by the public.
Two sets of CDEs are available: measures highly suggested for researchers and clinicians to include in research and practice (referred to as Core variables), and measures that provide additional specificity or variation if a researcher or clinician chooses to use depending on study focus or population (referred to as Supplemental variables).
These elements are intended to promote the collection of comparable data across research studies.
All measures have been defined and curated by reviewing existing CDEs and with significant input from the federal interagency workgroup. For variables from existing CDEs, the data sources are noted, and the exact item wording and response options are used to foster consistency. Data elements are cross-referenced and repeated across various domains where appropriate.
The elements are not intended to be required for all researchers to use, but to serve as a guide to questions or elements that may be best positioned to answer a certain research question.
CDEs for lower limb loss that are included fall into the following domains:
NICHD recognizes that researchers may have longstanding data collection protocols that do not incorporate many of the recommended elements and measures. In such situations, it may be necessary to collect data using more than one element or measure to ensure compatibility with legacy data as well as to allow data from multiple studies to be easily aggregated as the field innovates. Researchers may also want to include additional elements and measures of a construct to best address their hypotheses. This Notice does not preclude the use of elements and measures in addition to other CDEs that have been established.
NICHD invites the public to comment on the draft Common Data Elements for Lower Limb Loss Research. We are seeking guidance from the community of stakeholders involved in this research, specifically NICHD requests feedback on the following:
When developing your comments, we encourage you to read the information provided below and provide any comment you may have by emailing Rehabilitation1@mail.nih.gov. We recommend that organizations coordinate with their members to submit a single response.
The draft collection of common data elements is available here.
Drs. Alison Cernich, NICHD Deputy Director, and Theresa Cruz, Director, National Center for Medical Rehabilitation Research, will host a webinar for the public to further explain and answer any questions related to the research efforts and common data elements. The webinar will be hosted on the following date:
January 19th, 2021, 2-3PM EST [ZoomGov Meeting: https://nih.zoomgov.com/j/1608475606 (Meeting ID: 160 847 5606)].
Theresa Cruz, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: Rehabilitation1@mail.nih.gov