Search

Purpose Research pharmacy effort required to safely and compliantly manage investigational products (IP) varies between studies. No validated tool exists in the United States to evaluate these differences in effort. The Vizient Pharmacy Research Committee Investigational Drug Services (IDS) Subcommittee previously developed a systematic complexity scoring tool (CST) through expert consensus to assign a complexity score for pharmacy effort. This project seeks to develop and validate complexity categories based on CST scores. Methods Vizient member institutions in IDS assigned a CST complexity score and a perceived complexity category (low, medium, or high) for study initiation and maintenance. Receiver operating characteristic (ROC) curve analysis defined the best CST score cutoff points for each complexity category. Comparing the CST-assigned to the user-perceived complexity category determined whether the CST-assigned complexity category aligned with practitioner assignment. Results A total of 322 responses were used to determine complexity score categories. The AUC values for study initiation and maintenance were 0.79 (P < 0.001) for the low/medium boundary and 0.80 (P < 0.001) for the medium/high boundary, suggesting the performance of the CST is good. The agreement between CST-assigned and user-perceived complexity categories was 60% for study initiation and 58% for maintenance. The Kendall rank correlation coefficient between the raters and ROC categories was strong, with a value of 0.48 for study initiation and 0.47 for maintenance. Conclusion Development of the CST allows IDS pharmacies to objectively measure the complexity of clinical trials, which is a significant step towards assessing workload and guiding resource allocation. [ABSTRACT FROM AUTHOR]

Objectives: The association between traumatic brain injury (TBI) and alcohol use disorder (AUD) is known, but the extent of TBI's role in developing AUD remains unclear. This study examines the association between TBI severity with subsequent AUD diagnosis, and hazard for death due to alcohol, drug overdose, or suicide., Methods: Data from a national US military/veteran cohort (October 1999-September 2016, followed until September 2020) were analyzed using Fine-Gray competing risk models to investigate the relationships between TBI exposure, subsequent AUD, and hazards of death due to specific causes (alcohol, drug overdose, or suicide)., Results: TBI severity correlated with an increased likelihood of an incident AUD diagnosis: mild TBI (hazard ratio [HR]: 1.25, 95% confidence interval [CI] 1.22-1.27), moderate-severe TBI (HR: 1.34, 95% CI 1.32-1.37), and penetrating TBI (HR: 1.90, 95% CI 1.86-1.94). For those who developed AUD, TBI was associated with a higher hazard of death from specific causes such as alcohol, drug overdose, or suicide (HR: 2.47 (95% CI 2.03-3.02) for mild TBI, 4.25 (95% CI 3.49-5.17) for moderate-severe TBI, and 3.39 (95% CI 2.80-4.13) for penetrating TBI., Conclusions: Veterans with TBI were more likely to develop AUD and experience increased mortality, even after adjusting for demographic and clinical factors. Care strategies that are sensitive to the cognitive and/or emotional impairments associated with varying levels of TBI may lead to better outcomes, reducing both AUD and mortality rates. Further research is needed to develop evidence-based methods for integrating TBI and AUD care., Competing Interests: The authors report no conflicts of interest., (Copyright © 2025 American Society of Addiction Medicine.)