Preclinical Common Data Elements

Preclinical Traumatic Brain Injury Common Data Elements

Public Review Period Round 2: 12/01/17-02/28/18 (December 2017-February 2018)

Preclinical TBI CDE Round 2 PUBLIC REVIEW ZIP FILE

Email comments to: PreclinicalCDE@nih.gov

Overview

The Traumatic Brain Injury (TBI) Preclinical Working Group brings together experts in preclinical TBI research from academia with the goal of developing TBI common data elements (CDEs) for preclinical research and guidance for CDE utilization. Here we provide materials for a public review of the results of this effort with the hope that you will inform the process, suggest changes, and/or provide further documentation.

The primary objective for developing preclinical CDEs is to produce a well-defined lexicon for describing and reporting how preclinical data are collected with the goal of enhancing rigor, reproducibility and transparency in study performance. The goal of CDE creation is not to standardize how outcomes are performed or collected, but rather to develop a tool to improve standardization of how experimental details and procedures are reported. As such, the working groups (WGs) were asked to determine the level of experimental detail that should be reported in order to improve inter-investigator data harmonization.

The TBI Preclinical Working Groups intended to address the challenge that, while well-validated and standardized animal models of TBI can enhance our understanding of disease and inform therapeutic development, many therapeutics that show promise in preclinical models fail to elicit predicted effects when tested clinically. These meetings explored the relationship between clinical phenotypes of TBI and animal model constructs, and discussed what constitutes a useful translation model system and common data elements for data standardization, particularly in the context of Research and Development decision making.

To develop the Preclinical Traumatic Brain Injury (Preclinical TBI) CDEs, the Preclinical TBI CDE Working Group divided into three sub-working groups to focus on identifying and defining data elements in the domains of:

• SWG1 - General Health Affective Disturbance (Depression/Anxiety/Social Interaction)
• SWG2 - Cognition and Motor (Learning/Memory/Sensory/Motor)
• SWG3 – Large Animal Models (Behavior)

DATA STANDARDS

The Preclinical TBI CDE Working Group, the National Institute of Neurological Disorders and Stroke (NINDS) and the Department of Defense (DOD) CDE Team have released a draft version (Pre-release Version 0.1) of the Preclinical TBI CDE recommendations for Public Review.

Please Note: These recommendations are still in the process of being reviewed, updated, and edited by the Working Group during the public review period. Additional instruments and data will be posted with the final recommendations release in April 2018. We also understand that Preclinical TBI is a relatively new area of data harmonization, specially for large animal models and further clinical investigation is needed.

After the public review period, the Preclinical TBI CDE Working Group will review and revise the recommendations as needed. Version 1.0 of the Preclinical TBI CDE recommendations will be posted by April 2018. Again, please note that changes are still being incorporated and final documents for community use will not be available until April 2018.

Preclinical TBI Common Data Element Public Review Package Overview

The Pre-release Version 0.1 Preclinical TBI Public Review package consists of one zip file (PreclinicalCDE2_v0.1_113017.zip) containing the following documents:

Instructions
1. Instructions on reviewing CDE's and submitting comments
CDE Spreadsheet Guide
1. Description for the CDE spreadsheet columns; please review columns A, B, C, E, F, G, H, I, J, K, L, M, O, P, Q, R
Quick Start Guide
1. Provides a reference for each of the tests/outcomes for the preclinical TBI common data elements (CDEs)
Common Data Elements (CDE) sets for each test/instrument
1. CDE sets are available as excel spreadsheets, which include the CDEs identified and defined by the Preclinical TBI Working Groups. The CDE sets can be used as the building blocks for study data collection forms
Comments form spreadsheet
1. Reviewers should use this spreadsheet to return comments to the working group (PreclinicalCDE@nih.gov)

It is anticipated that many of the CDEs will overlap across outcome measures and study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is maintained in order to ensure the ability to transfer critical medical information electronically from one center to another. This data harmonization also allows for continuity across different disease areas. The goals of the NINDS/DOD CDE initiative are to increase the efficiency and effectiveness of preclinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate investigators who are new to TBI research.

CDE CLASSIFICATION

Each CDE or instrument will be classified according to the definitions below once public review has been completed in April, 2018:

General Core: A data element that is vital to the reporting of all preclinical studies, regardless of disease category.

Disease Core: A data element that collects essential information applicable to any disease-specific study, including all therapeutic areas. The preclinical working groups assign the disease “Core” classification based on a consensus of best research practices from the literature. The disease Core CDEs are a small subset of the available CDEs, and it is anticipated that investigators will need to collect the disease Core CDEs on any type of study since they are vital to the reporting of all disease-specific studies.

Disease Supplemental - Highly Recommended: A data element which is essential based on certain conditions or experimental designs to test the outcome in a particular domain. In most cases, these are well-established experimental factors that are known to influence the measured outcome. These data elements are highly recommended for the specified disease condition, study type or design.

Disease Supplemental: A data element which is commonly collected in pre-clinical research studies. Use depends upon the study design, protocol or type of research involved. These are recommended, but not vital, for studies.

Disease Exploratory: A data element that requires further validation, but may fill current gaps in the CDEs and/or substitute for an existing CDE once validation is complete. Such data elements show great promise, but require further validation before they are ready for prime-time use. They are reasonable to use with the understanding of their limited validation.

HISTORY AND ACKNOWLEDGEMENTS

Chairs and co-chairs were appointed to lead and the three individual pre-clinical TBI sub-working groups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The Preclinical TBI CDE Working Groups were supported by the NINDS/DOD CDE Team.

The rosters for the Preclinical TBI CDE subgroups are shown below:

SWG1 - General Health /Affective Disturbance (Depression/Anxiety/Social Interaction)

Name	Affiliation
Adam Bachstetter, PhD	University of Kentucky
Chantelle Ferland-Beckham, PhD	Cohen Veterans Bioscience
Candace Floyd, PhD [Co-Chair]	University of Alabama at Birmingham
Aristea Galanopoulou, MD, PhD	Albert Einstein College of Medicine
Patricia Kabitzke, PhD	Cohen Veterans Bioscience
Michelle LaPlaca, PhD [Chair]	Biomedical Engineering Georgia Tech
Vance Lemmon, PhD	University of Miami Miller School of Medicine
Jonathan Lifshitz, PhD	University of Arizona
Helen Scharfman, PhD	Nathan S. Kline Institute for Psychiatric Research
Doug Smith, MD	University of Pennsylvania

SWG2 - Cognition and Motor (Learning/Memory/Sensory/Motor)

Name	Affiliation
Adam Bachstetter, PhD	University of Kentucky
Hulya Bayir, MD	University of Pittsburg Medical Center
Ed Dixon, PhD [Chair]	University of Pittsburg Medical Center
Adam Ferguson, PhD	University of California San Francisco
Stuart Friess, MD	Washington University in St.Louis
Aristea Galanopoulou, MD, PhD	Albert Einstein College of Medicine
Ed Hall, PhD [Co-Chair]	University of Kentucky
Neil Harris, PhD	University of California Los Angeles
Ramona Hicks, PhD	One Mind for Research
Patricia Kabitzke, PhD	Cohen Veterans Bioscience
Michelle LaPlaca, PhD	Biomedical Engineering Georgia Tech
Jonathan Lifshitz, PhD	University of Arizona
David Loane, PhD	University of Maryland Medical Center
Linda Noble, PhD	University of California San Francisco
Helen Scharfman, PhD	Nathan S. Kline Institute for Psychiatric Research

SWG3 – Large Animal Models (Behavior)

Name	Affliliation
Hasan Alam, MD [Chair]	University of Michigan
Candace Floyd, PhD	University of Alabama at Birmingham
Ed Hall, PhD	University of Kentucky
Ramona Hicks, PhD	One Mind
Lindsey Hulbert, PhD [Co-Chair]	Kansas State University
Victoria Johnson, MBChB, PhD	University of Pennsylvania
Susan Margulies, PhD	University of Pennsylvania
Vahagn Nikolian, MD	University of Michigan
Laila Zai, PhD	Applied Research Associates, Inc.

NINDS/DOD/FITBIR

Name	Affiliation
Pat Bellgowan, PhD	National Institute of Neurological Disorders and Stroke (NINDS)
Alicia Tammy Crowder, PhD	Department of Defense (DOD)
Nsini Umoh, PhD	Department of Defense (DOD)
Diana Cummings, PhD	National Institute of Neurological Disorders and Stroke (NINDS)
Carol Taylor-Burds, PhD	National Institute of Neurological Disorders and Stroke (NINDS)
Matt McAuliffe,PhD	Federal Interagency Traumatic Brain Injury Research (FITBIR)
Olga Vovk, PhD	Federal Interagency Traumatic Brain Injury Research (FITBIR)
Leonie Misquitta, PhD	Federal Interagency Traumatic Brain Injury Research (FITBIR)