Standardizing data collection in traumatic brain injury

Abstract

Collaboration among investigators, centers, countries, and disciplines is essential to advancing the care for traumatic brain injury (TBI). It is thus important that we "speak the same language." Great variability, however, exists in data collection and coding of variables in TBI studies, confounding comparisons between and analysis across different studies. Randomized controlled trials can never address the many uncertainties concerning treatment approaches in TBI. Pooling data from different clinical studies and high-quality observational studies combined with comparative effectiveness research may provide excellent alternatives in a cost-efficient way. Standardization of data collection and coding is essential to this end. Common data elements (CDEs) are presented for demographics and clinical variables applicable across the broad spectrum of TBI. Most recommendations represent a consensus derived from clinical practice. Some recommendations concern novel approaches, for example assessment of the intensity of therapy in severely injured patients. Up to three levels of detail for coding data elements were developed: basic, intermediate, and advanced, with the greatest level of detail attained in the advanced version. More detailed codings can be collapsed into the basic version. Templates were produced to summarize coding formats, explanation of choices, and recommendations for procedures. Endorsement of the recommendations has been obtained from many authoritative organizations. The development of CDEs for TBI should be viewed as a continuing process; as more experience is gained, refinement and amendments will be required. This proposed process of standardization will facilitate comparative effectiveness research and encourage high-quality meta-analysis of individual patient data.

FIG. 1.

Structure of common data elements. Related elements are combined in modules (blue), which are grouped together in categories (orange). A full listing of the common data elements, including codings and templates as well as explanations of the abbreviations can be found at www.tbi-impact.org.

FIG. 2.

Example of the three levels for coding a data element, with the greatest level of detail in the advanced format.

FIG. 3.

Example of how data elements can be used to design a case report form for an acute care study on severe TBI (TBI, traumatic brain injury; GCS, Glasgow Coma Scale; ICP, intracranial pressure; CT, computed tomography; PTA, post-traumatic amnesia; GOSE-E, Glasgow Outcome Scale-Extended; ICU, intensive care unit; MRI, magnetic resonance imaging; ER, emergency room; AIS, Abbreviated Injury Scale; ISS, Injury Severity Scale.