Cognitive performance outcomes: considerations for drug development.

ABSTRACT: Ensuring that cognitive assessments are fit for purpose is critical in the evaluation of the clinical benefit of new therapeutic interventions. Although guidelines for Clinical Outcome Assessments (COA) are available, performance outcome (PerfO) assessments, and in particular those assessing cognition (Cog-PerfOs) are more complex and have additional requirements that need to be considered. I outline three areas where further discussion around validation methods for Cog-PerfOs and best practices is warranted: (1) content validity (2) ecological validity, and (3) construct validity in multinational contexts. I conclude with a discussion of several potential avenues for the improvement of validation of Cog-PerfOs used to evaluate the efficacy of medical products that target cognitive symptom

SUBMITTER: Zupan Z 

PROVIDER: S-EPMC10587033 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature