Large between-center differences in outcome after moderate and severe traumatic brain injury in the international mission on prognosis and clinical trial design in traumatic brain injury (IMPACT) study

Abstract

Background: Differences between centers in patient outcome after traumatic brain injury are of importance for multicenter studies and have seldom been studied.

Objective: To quantify the differences in centers enrolling patients in randomized clinical trials (RCTs) and surveys.

Methods: We analyzed individual patient data from 9578 patients with moderate and severe traumatic brain injury enrolled in 10 RCTs and 3 observational studies. We used random-effects logistic regression models to estimate the between-center differences in unfavorable outcome (dead, vegetative state, or severe disability measured with the Glasgow Outcome Scale) at 6 months adjusted for differences in patient characteristics. We calculated the difference in odds of unfavorable outcome between the centers at the higher end vs those at the lower end of the outcome distribution. We analyzed the total database, Europe and the United States separately, and 4 larger RCTs.

Results: The 9578 patients were enrolled at 265 centers, and 4629 (48%) had an unfavorable outcome. After adjustment for patient characteristics, there was a 3.3-fold difference in the odds of unfavorable outcome between the centers at the lower end of the outcome distribution (2.5th percentile) vs those at the higher end of the outcome distribution (97.5th percentile; P<.001). In the 4 larger RCTs, the differences between centers were similar. However, differences were smaller between centers in the United States (2.4-fold) than between centers in Europe (3.8-fold).

Conclusion: Outcome after traumatic brain injury differs substantially between centers, particularly in Europe. Further research is needed to study explanations for these differences to suggest where quality of care might be improved.