Good Practices for the Translation, Cultural Adaptation, and Linguistic Validation of Clinician-Reported Outcome, Observer-Reported Outcome, and Performance Outcome Measures
Organized By: Translation and Cultural Adaptation SIG
Organized By: Translation and Cultural Adaptation SIG
Description
Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measure subcategories. However, despite this conceptual expansion, recommendations associated with translation, cultural adaptation, and linguistic validation of COAs remain focused on PRO measures, which has created a gap in specific process recommendations for the remaining types. This lack of recommendations has led to inconsistent approaches being implemented, leading to uncertainty in the scientific community regarding suitable methods. To address this gap, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) has developed recommendations specific to each of the three COA types currently lacking such documentation to support a standardized approach to their translation, cultural adaptation, and linguistic validation. This webinar will provide a review of the TCA-SIG’s recommendations.
Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measure subcategories. However, despite this conceptual expansion, recommendations associated with translation, cultural adaptation, and linguistic validation of COAs remain focused on PRO measures, which has created a gap in specific process recommendations for the remaining types. This lack of recommendations has led to inconsistent approaches being implemented, leading to uncertainty in the scientific community regarding suitable methods. To address this gap, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) has developed recommendations specific to each of the three COA types currently lacking such documentation to support a standardized approach to their translation, cultural adaptation, and linguistic validation. This webinar will provide a review of the TCA-SIG’s recommendations.
Audience Benefits
This webinar will enable participants to have a:
- Greater understanding of the industry change from focusing on the concept of PRO measures to focusing on the concept of COA measures
- Greater understanding of COA categories and the differences between them, particularly ClinRO, ObsRO and PerfO measures
- Greater ability to select appropriate methodologies for translation and linguistic validation of COAs for use in clinical trials
Learning Outcomes/Objectives
- Review of the regulatory and industry focus on COA measures rather than PRO measures
- Detailed understanding of specific methodology recommendations for linguistic validation of ClinRO measures
- Detailed understanding of specific methodology recommendations for linguistic validation of ObsRO measures
- Detailed understanding of specific methodology recommendations for linguistic validation of PerfO measures
- Review and understanding of recommended approaches to cognitive debriefing and pilot testing, and how they compare across COA types
- Shawn McKown, VP, Clinical Outcome Assessments, RWS Life Sciences
- Ben Arnold, Executive Director, FACITtrans
- Caroline Anfray, Director, Author Collaborations, Mapi Research Trust
- Dana Weiss, Account Manager, Author Collaboration Unit, Mapi Research Trust
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