An International Collaboration to Improve the Precision of the Glasgow Outcome Scale Extended (GOSE)
Abstract
Service Members are at high risk of experiencing traumatic brain injuries (TBI), which can cause long- term disabilities. There are currently no medications known to help the brain recover from TBI, and the brain has limited ability to heal from injuries on its own. Unfortunately, previous clinical trials that tested promising drug treatments for TBI did not show clear improvements due to treatment in TBI-related disability. A key problem with previous clinical trials was that disability was measured coarsely using the Glasgow Outcome Scale (GOS) or GOS-Extended (GOSE), which groups people into only 2–8 outcome levels depending on how it is scored. The limited score range of the GOS/GOSE makes it unable to adequately reflect the diverse outcomes experienced by persons with TBI. Moreover, the limited granularity of the GOSE limits its ability to detect differences in outcome between treatment and control groups in clinical trials and/or necessitates unfeasibly large numbers of participants to show benefit. The limited score range of the GOS/GOSE also hinder ongoing efforts to understand the factors that predict long-term morbidity associated with TBI. The objective of the current study is to create more precise measures of TBI-related disability and demonstrate their utility to detect the impact of treatment and other factors on disability. The project is expected to produce a more refined way to measure disability and provide new evidenced-based recommendations for conducting future TBI clinical trials. Our international team has led parallel, complementary lines of research that show great promise for improving methods for sensitively indexing disability after TBI using the GOSE. GOSE scores are normally determined through a detailed interview developed by our group that asks about how an injury has impacted patients’ daily functioning. Because of its original purpose, however, most of the information gathered from this interview is not reflected in the resulting GOSE score. Importantly, our preliminary data show that modern test development tools can be used to produce a more precise index of functional disability from the questions in the GOSE structured interview. Leveraging the rich information normally obtained in the widely used GOSE assessment to achieve a more precise index of disability may transform how clinical trials are conducted and facilitate our ability to establish the relationship between treatments and other factors on TBI-related disability. This project will analyze existing data from the two largest multicenter studies of civilian TBI conducted to date – the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study and the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) study. Aims 1 and 2 will significantly expand upon our preliminary work to broaden our new GOSE scoring approach to different timepoints after injury and to both study samples, testing the hypothesis that new approaches to scoring the GOSE yield an index of disability with greater precision and validity than the traditional GOSE score. Aim 3 will compare historical and new approaches to scoring the GOSE to test the hypothesis that using new approaches to score the GOSE would allow a certain treatment effect to be found in a smaller sample of participants than historical approaches. The project directly addresses the FY22 TBIPHRP IIRA Focus Area 2 aimed at developing and validating measures to better monitor the sequelae of TBI. The supporting analyses associating GOSE-based measures of functional outcome with diverse biomarker and clinical variables will indirectly inform Focus Area 1A, which aims to understand risk, protective, and biological factors contributing to long-term TBI outcomes. Observing improvements in functional limitations is both important to patients and necessary to demonstrate the value of experimental treatments. Thus, improving the measurement of TBI
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252311035
Entities
People
- Lindsay D Nelson
Organizations
- Medical College of Wisconsin
- United States Army