Predominantly designed to evaluate COAs for people with traumatic brain injury (TBI) but may be adapted for other populations.
Among the more than 1,000 COAs currently used for TBI, few have been systematically evaluated to determine their performance within specific COU. As described by the U.S. Food and Drug Administration, 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. Despite the pivotal role that outcome assessment plays in research, COA selection typically relies on expert consensus. There is currently no methodology designed to determine the appropriateness of a particular COA within a specific COU. To address this gap, we developed and pilot tested the Evidence-Based Clinical Outcome Assessment Platform (EB-COP) to efficiently and transparently evaluate the suitability of TBI COAs for specific purposes of use (PoUs). Development of the EB-COP was informed by the FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials, the American Academy of Neurology’s (AAN’s) well-established Clinical Practice Guideline Process Manual, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and other literature describing standards for measurement development.
The framework of the EB-COP is built around the six distinct PoUs shown below:
Christoforou AN, Armstrong MJ, Bergin MJG, Robbins A, Merillat SA, Erwin P, Getchius TSD, McCrea M, Markowitz AJ, Manley GT, Giacino JT. An evidence-based methodology for systematic evaluation of clinical outcome assessment measures for traumatic brain injury. PLoS One. 2020 Dec 14;15(12):e0242811. doi: 10.1371/journal.pone.0242811. PMID: 33315925; PMCID: PMC7735614.