Chronic TBI-related neurodegeneration CDEs

To promote broad and effective data sharing of research on chronic traumatic brain injury (TBI)-related neurodegeneration, NINDS convened two working groups to recommend common data elements (CDEs) for the post-mortem assessment of chronic TBI including Chronic Traumatic Encephalopathy (CTE).

• The Neuropathology Working Group developed recommendations for neuropathological assessment, including gross pathology, microscopic evaluation, and diagnostic criteria.
• The Clinical History Working Group developed recommendations for the accompanying informant-based measures of a subject’s clinical history, including the domains of TBI exposure, medical history, demographics, and cognition/mood/behavior.

Working groups followed the classification standards of NINDS CDEs, recommending data elements as either Core, Supplemental Highly Recommended, or Supplemental. Core CDEs are considered essential to an assessment, the minimum required data for characterizing a disease or process. Supplemental Highly Recommended CDEs are not required but are viewed as highly informative, with data collection strongly encouraged. Supplemental CDEs are not required and are viewed as optional, e.g., elements that are likely to be study specific.

The working groups reached consensus on recommended CDEs in fall of 2021; a pdf collection of the recommended forms can be found in the Documents tab below. The CDEs were available for public review in Nov-Dec 2021, and final revisions were made in early 2022 to optimize the form structures, in collaboration with data-submission testing teams. FITBIR users who wish to explore the form structures may do so by visiting the FITBIR Data Dictionary, clearing search filters, and selecting the label ‘Neuropath assessments’.

This collection contains the following documents:

• Guide to forms: this file lists the recommended forms for each domain, with reference to associated questionnaires and data dictionaries
• Questionnaires: these pdf documents represent the instruments/questionnaires used to acquire the recommended CDEs. In some cases, the clinical history group recommended existing instruments, with modifications where needed for postmortem data collection. In other cases (demographics, medical history, and neuropathological assessment), working groups created new forms; the pdf documents offer examples of potential data capture forms.
• Data Dictionaries: these can be exported on each form structure's page in the FITBIR Data Dictionary.

NOTE: due to data structure issues that are beyond the scope of this review, there is not always a 1:1 correspondence between a question on the instrument/questionnaire and a data element in the data dictionary. This lack of correspondence reflects the fact that individual data elements may be re-used to characterize multiple events or processes of interest. Example: in a TBI exposure form such as the BISQ, a single data element encodes the frequency of an exposure, regardless of exposure type. In this example, the type of exposure does not appear as an individual data element but is represented as a grouping element in the FITBIR form data structure.

Neuropathology Working Group

• John Crary, MD, PhD, (co-chair), Icahn School of Medicine at Mt. Sinai
• Rebecca Folkerth, MD (co-chair), NYC Office of the Chief Medical Examiner
• C. Dirk Keene, MD, PhD (co-chair), University of Washington
• Russ Huber, MD, PhD, Boston University
• Julia Kofler, MD, University of Pittsburgh
• Gabor Kovacs, MD, PhD, University of Toronto
• Ann McKee, MD, Boston University
• Thor Stein, MD, PhD, Boston University
• William Stewart, PhD, Glasgow University
• Douglas Wiebe, PhD, University of Pennsylvania

Clinical History Working Group

• Kristen Dams-O’Connor, PhD (co-chair), Icahn School of Medicine at Mt. Sinai
• Jesse Mez, MD (co-chair), Boston University
• Michael Alosco, PhD, Boston University
• Abigail Bretzin, PhD, University of Pennsylvania
• Julia Culhane, BA, Boston University (from Aug. 2020)
• Col. Sidney Hinds, MD, Wounded Warrior Project
• Julia Kofler, MD, University of Pittsburgh
• Caitlin Liddiard, BS, Boston University (to Aug. 2020)
• Enna Selmanovic, BS, Icahn School of Medicine at Mt. Sinai
• Douglas Wiebe, PhD, University of Pennsylvania
• Kristine Yaffe, MD, University of California San Francisco

Data Submission Testing Team

• Abigail Bretzin, PhD, University of Pennsylvania
• Kaitlyn Hartlage, MPH, Boston University
• Joseph Palmisano, MA, MPH, Boston University
• Douglas Wiebe, PhD, University of Pennsylvania

NIH/FITBIR

• Deborah Babcock, PhD, NINDS
• Patrick Bellgowan, PhD, NINDS
• Rebecca Berman, PhD, NINDS
• Rashida Kamara, BS, NINDS
• Kevin Armengol, MS, FITBIR data curator June 2021+
• Olga Vovk, PhD, FITBIR data curator to June 2021