Abstract
Because most traumatic brain injuries (TBIs) do not present with objective indicators (e.g., neuroimaging findings) to confirm the diagnosis, clinicians often rely on self- or observer-reporting of alteration of consciousness (AOC; e.g., loss of consciousness [LOC], amnesia, other signs of altered mental status), and symptoms to make diagnoses. Moreover, there is no universal agreement on signs and symptoms to sufficiently diagnose TBI, which leads to variability and ambiguity in how TBI is diagnosed in clinical and research settings. The lack of standardized procedures for the diagnosis of acute TBI is a major challenge that hampers the ability to evaluate and compare TBI studies and advance the science and treatment of TBI. We present a new semi-structured TBI Diagnostic Interview (TBI-DI), developed for prospective TBI research to collect injury information important to verifying eligibility for the diagnosis of TBI. Specifically, the TBI-DI collects patient (and/or witness) reports of head trauma, AOC (including LOC and amnesia), and TBI-related symptomology. We describe the protocol, interrater reliability of the TBI-DI items to the same audio-recorded interview, and observed injury characteristics for interviews conducted at 2 weeks post-injury. The sample comprised 335 interviews (320 self-reported, 10 informant-reported, and 5 both) collected on individuals with TBI who were prospectively recruited from 4 U.S. level 1 trauma centers from 2019 to 2023. Cohen’s kappa was calculated to summarize interrater reliability n = 288 interviews. UpSet plots were created to illustrate the prevalence of distinct profiles of signs of AOC and symptom reporting. Overall, there was a near-perfect agreement between raters for all AOC descriptors (κ = 0.85–0.92) and symptom items (κ ranging from 0.92 to 0.99). We observed diverse profiles of AOC, with 45% manifesting witnessed LOC, post-traumatic amnesia, or other altered mental status. Patients (n = 325) self-reported 256 different combinations of the 14 acute symptoms included in the interview (most commonly experiencing headache, dizziness, fatigue, and difficulty concentrating). The TBI-DI and associated SOP appear well-suited for use in a multicenter prospective study of TBI. Future research should examine the stability of reporting by respondents and the alignment between interview and objective clinical information. The TBI-DI solicits diverse acute diagnostic information that, when combined with clinical information (including confounding factors) and objective injury indicators, may inform more rigorous scientific reporting and evidence-based TBI diagnostic practices.
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