A Common Data Element-Based Adjudication Process for mTBI Clinical Profiles: A Targeted Multidomain Clinical Trial Preliminary Study

Introduction: The primary purpose of this study was to examine the prevalence and percent agreement of clinician-identified mild traumatic brain injury (mTBI) clinical profiles and cutoff scores for selected Federal Interagency Traumatic Brain Injury Research common data elements (CDEs). A secondary purpose was to investigate the predictive value of established CDE assessments in determining clinical profiles in adults with mTBI.

Materials and methods: Seventy-one (23 males; 48 females) participants (M = 29.00, SD = 7.60, range 18-48 years) within 1-5 months (M = 24.20, SD = 25.30, range 8-154 days) of mTBI completed a clinical interview/exam and a multidomain assessment conducted by a licensed clinician with specialized training in concussion, and this information was used to identify mTBI clinical profile(s). A researcher administered CDE assessments to all participants, and scores exceeding CDE cutoffs were used to identify an mTBI clinical profile. The clinician- and CDE-identified clinical profiles were submitted to a multidisciplinary team for adjudication. The prevalence and percent agreement between clinician- and CDE-identified clinical profiles was documented, and a series of logistic regressions with adjusted odds ratios were performed to identify which CDE assessments best predicted clinician-identified mTBI clinical profiles.

Results: Migraine/headache, vestibular, and anxiety/mood mTBI clinical profiles exhibited the highest prevalence and overall percent agreement among CDE and clinician approaches. Participants exceeding cutoff scores for the Global Severity Index and Headache Impact Test-6 assessments were 3.90 and 8.81 times more likely to have anxiety/mood and migraine/headache profiles, respectively. The Vestibular/Ocular Motor Screening vestibular items and the Pittsburgh Sleep Quality Index total score were predictive of clinician-identified vestibular and sleep profiles, respectively.

Conclusions: The CDEs from migraine/headache, vestibular, and anxiety/mood domains, and to a lesser extent the sleep modifier, may be clinically useful for identifying patients with these profiles following mTBI. However, CDEs for cognitive and ocular may have more limited clinical value for identifying mTBI profiles.