Cognitive performance outcomes: considerations for drug development.
Journal
Journal of patient-reported outcomes
ISSN: 2509-8020
Titre abrégé: J Patient Rep Outcomes
Pays: Germany
ID NLM: 101722688
Informations de publication
Date de publication:
19 Oct 2023
19 Oct 2023
Historique:
received:
21
06
2023
accepted:
08
10
2023
medline:
2
11
2023
pubmed:
19
10
2023
entrez:
19
10
2023
Statut:
epublish
Résumé
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 symptomatology. These include the involvement of cognitive psychologists in establishing content validity of Cog-PerfOs, evaluating the congruence of laypeople's and expert understanding of cognitive concepts, supplementing qualitative with quantitative evidence when establishing content validity, demonstrating ecological validity, and ensuring normative data are available in multinational contexts.
Identifiants
pubmed: 37855938
doi: 10.1186/s41687-023-00644-1
pii: 10.1186/s41687-023-00644-1
pmc: PMC10587033
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
102Informations de copyright
© 2023. International Society for Quality of Life Research (ISOQOL).
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