Cognitive performance outcomes: considerations for drug development
Apstrakt
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 concept...s, supplementing qualitative with quantitative evidence when establishing content validity, demonstrating ecological validity, and ensuring normative data are available in multinational contexts.
Ključne reči:
cognition / performance outcomes / drug developmentIzvor:
Journal of Patient Reported Outcomes, 2023, 7, 102-Izdavač:
- Springer
Institucija/grupa
Psihologija / PsychologyTY - JOUR AU - Zupan, Zorana PY - 2023 UR - http://reff.f.bg.ac.rs/handle/123456789/5349 AB - 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. PB - Springer T2 - Journal of Patient Reported Outcomes T1 - Cognitive performance outcomes: considerations for drug development SP - 102 VL - 7 DO - https://doi.org/10.1186/s41687-023-00644-1 ER -
@article{ author = "Zupan, Zorana", year = "2023", 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 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.", publisher = "Springer", journal = "Journal of Patient Reported Outcomes", title = "Cognitive performance outcomes: considerations for drug development", pages = "102", volume = "7", doi = "https://doi.org/10.1186/s41687-023-00644-1" }
Zupan, Z.. (2023). Cognitive performance outcomes: considerations for drug development. in Journal of Patient Reported Outcomes Springer., 7, 102. https://doi.org/https://doi.org/10.1186/s41687-023-00644-1
Zupan Z. Cognitive performance outcomes: considerations for drug development. in Journal of Patient Reported Outcomes. 2023;7:102. doi:https://doi.org/10.1186/s41687-023-00644-1 .
Zupan, Zorana, "Cognitive performance outcomes: considerations for drug development" in Journal of Patient Reported Outcomes, 7 (2023):102, https://doi.org/https://doi.org/10.1186/s41687-023-00644-1 . .