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Common Data Elements for Traumatic Brain Injury: Recommendations From the Interagency Working Group on Demographics and Clinical Assessment

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Abstract

Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, Engel DC, Gordon W, Langlois Orman J, Lew HL, Robertson C, Temkin N, Valadka A, Verfaellie M, Wainwright M, Wright DW, Schwab K. Common data elements for traumatic brain injury: recommendations from the Interagency Working Group on Demographics and Clinical Assessment.

Comparing results across studies in traumatic brain injury (TBI) has been difficult because of the variability in data coding, definitions, and collection procedures. The global aim of the Working Group on Demographics and Clinical Assessment was to develop recommendations on the coding of clinical and demographic variables for TBI studies applicable across the broad spectrum of TBI, and to classify these as core, supplemental, or emerging. The process was consensus driven, with input from experts over a broad range of disciplines. Special consideration was given to military and pediatric TBI. Categorizing clinical elements as core versus supplemental proved difficult, given the great variation in types of studies and their interests. The data elements are contained in modules, which are grouped together in categories. Three levels of detail for coding data elements were developed: basic, intermediate, and advanced, with the greatest level of detail in the advanced version. In every case, the more detailed coding can be collapsed into the basic version. Templates were produced to summarize coding formats, motivation of choices, and recommendations for procedures. Work is ongoing to include more international participation and to provide an electronic data entry format with pull-down menus and automated data checks. This proposed standardization will facilitate comparison of research findings across studies and encourage high-quality meta-analysis of individual patient data.

Section snippets

Aim

The global aim of the Working Group on Demographics and Clinical Assessment of the larger multiagency effort described by Thurmond et al3 was to develop recommendations on coding of demographics and clinical assessments for studies across the broad spectrum of TBI. We strived to make the elements applicable both to milder and more severe injuries, to acute and long-term studies, to studies including patients early after injury, to those enrolling patients at later periods, and to studies in the

Approach

These aims posed a formidable challenge to the working group. The wide range of expertise, affiliation to many agencies and organizations, and the tremendous commitment of all working group members, however, provided optimal conditions to meet these challenges. Collectively, the working group had access to a wide range of data collection forms as examples. These included the codings developed by the IMPACT study group, the data collection forms of the National Institute on Disability and

The Product: Common Data Elements for Traumatic Brain Injury Demographics and Clinical Assessments

We successfully managed to develop general consensus on the coding of data elements for use across the broad spectrum of TBI. The data elements are contained in modules, which are grouped together in categories. For example, the data elements “age, gender, and race” are contained in the module “demographics,” under the category “subject characteristics.” The main categories relevant to this article are as follows:

  • •

    Participant/Subject Characteristics

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    Participant/Subject and Family History

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Age

Recording age in TBI studies is of great importance. Causes of injury differ per age group and lead to different types of injury. Age is one of the strongest predictors of outcome in TBI, with older patients faring more poorly than younger patients.6, 7

The choice for recording age or date of birth was discussed extensively. Although date of birth is commonly recorded in TBI studies and provides the most detailed and source-verifiable information, it was thought that date of birth might be

Subject and Family History

Details on medical history and use of medication are collected in nearly every TBI clinical study. However, medical history data are typically the least reliable data collected and are almost universally collected in a free text format, thus prohibiting any meaningful analysis. Nevertheless, preexisting conditions may influence the disease course and chances of recovery, and information on medical history is essential for interpretation of adverse events occurring during clinical trials. It is

Type and Cause of Injury

Recording details on the type, place, nature, and mechanism of injury is highly relevant, both from an epidemiologic perspective (with implications for prevention programs) and because different pathophysiologic mechanisms occur in different types of injury. After much debate, we recommend a broad classification of type of injury into 4 categories: closed, penetrating, blast, and crush. Blast injuries are defined by any form of TBI occurring in association with a blast explosion. Worldwide,

Vital Signs

Documentation of blood pressure, heart rate, temperature, and oxygen saturation is recommended for all patients with TBI who are admitted to the hospital directly after injury. This is important for 2 reasons. First, therapeutic interventions in a trial may increase the incidence of abnormal physiology, and such adverse effects need to be recorded on safety grounds. Second, regardless of whether or not physiologic insults are due to trial interventions, systemic hypotension, low cerebral

Military TBI

A critical question is how, and the extent to which, the nature and severity of TBI sustained by military personnel may differ from TBI sustained by civilians in nonmilitary environments. Injuries in military personnel including TBI are common in peacetime, as well as during combat, because they routinely engage in risky activities.28 Clearly though, soldiers in the combat environment are more likely to sustain such injuries through exposure to blast overpressure or to sustain penetrating

Next Steps

We consider the initiative toward standardization of data collection across TBI studies of great importance. It should be realized, however, that this is an ongoing process. Despite the broad and expert input with representation from different disciplines and stakeholder organizations, the current proposals represent only a beta version, which will require further refinement and validation in clinical practice. Furthermore, we consider it essential to obtain broad support and acceptance of the

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    Support for the meetings and activities of the Working Group on Demographics and Clinical Assessment was funded in the context of the interagency initiative toward “an integrated approach to Research in Psychological Health and Traumatic Brain Injury” (National Institutes of Health-National Institute of Neurological Disorders and Stroke [NIH-NINDS]; the National Institute on Disability and Rehabilitation Research; the Department of Veterans Affairs; the Defense and Veterans Brain Injury Center and the Defense Centers of Excellence). The development of CDEs was further supported by a supplemental grant from NIH-NINDS (grant no. NS 042691).

    Views expressed are those of the authors and do not necessarily reflect those of the agencies or institutions with which they are affiliated, including the U.S. Department of Veterans Affairs, the U.S. Department of Defense, the U.S. Department of Health and Human Services, the National Institutes of Health, the National Institute of Mental Health, or the Uniformed Services University of the Health Sciences. This work is not an official document, guidance, or policy of the U.S. Government, nor should any official endorsement be inferred.

    No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

    Reprints are not available from the author.

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    Copyright © 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.