An evidence-based methodology for systematic evaluation of clinical outcome assessment measures for traumatic brain injury.

ABSTRACT:

Introduction

The high failure rate of clinical trials in traumatic brain injury (TBI) may be attributable, in part, to the use of untested or insensitive measurement instruments. Of more than 1,000 clinical outcome assessment measures (COAs) for TBI, few have been systematically vetted to determine their performance within specific "contexts of use (COU)." As described in guidance issued by the U.S. Food and Drug Administration (FDA), the COU specifies the population of interest and the purpose for which the COA will be employed. COAs are commonly used for screening, diagnostic categorization, outcome prediction, and establishing treatment effectiveness. COA selection typically relies on expert consensus; there is no established methodology to match the appropriateness of a particu

SUBMITTER: Christoforou AN 

PROVIDER: S-EPMC7735614 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature