Chronic TBI-related neurodegeneration CDEs

CDEs for the assessment of chronic TBI-related neurodegeneration including Chronic Traumatic Encephalopathy




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OVERVIEW

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.

PUBLIC REVIEW

The Working Groups have released a draft version of the chronic TBI/CTE common data elements for public review. We are in the process of finalizing these data elements, and request your expertise in providing feedback during this public review period. Data elements have been implemented in draft form structures in the FITBIR informatics platform. Corresponding questionnaires and data dictionaries are available as part of the review package documents, described below.

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.

Please review the CDEs by evaluating the Questionnaires and Data Dictionaries described below. Feedback / comments on the CDEs should be provided at https://forms.gle/ga8e6bLY7qWKtYyZ9 This public review period will close after 30 days, on December 1st, 2021. The working groups will review and revise the recommendations for final release in January 2022.

REVIEW DOCUMENTS

This pre-release review package contains the following documents:

  • Instructions with a link to the feedback form
  • 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 reviewable pdf documents offer examples of potential data capture forms.
  • Data Dictionaries: these xlsx documents show the properties of individual data elements in the FITBIR form structure, including variable names, permissible values, and instructions.
  • CDE Data Dictionary Guide: this pdf document summarizes the key columns in the data dictionaries that are relevant for the review process

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. In these situations, we have added the grouping elements to the data dictionary spreadsheet, to clarify that these elements are captured in the data structure. 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.

WORKING GROUP ROSTER

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