Topics and methods for early qualitative and quantitative evaluation will be described, using examples, during the webinar by speakers from both the Translation and Cultural Adaptation and Psychometrics Special Interest Groups of ISOQOL. The presentation will be followed by an interactive Q&A session during which the speakers will address questions from the audience.
Clinical Outcome Assessment (COA) in an international study requires particular caution due to the differences in language, culture, education, and differing standards of care. These differences are likely to be sources of variability in measurement outcomes. If not adequately managed, this variability can potentially jeopardize the accurate capture of the targeted concepts, and make the demonstration of treatment benefit more difficult. Cross-cultural equivalence of COAs used in international studies is, therefore, of particular importance.
A certain amount of cross-cultural variation can be prevented using qualitative methods during the development and translation of a COA. Content can be considered from a cross-cultural perspective using multi-cultural patient interviews and techniques such as Translatability Assessment. Evaluation of cross-cultural equivalence of a measure has traditionally been accomplished using quantitative methods. These methods include investigation of differential item functioning and measurement invariance. Once data have been collected and evaluated quantitatively, further investigation can be conducted qualitatively to focus on specific areas of variability that raise questions about equivalency or comparability. Once the cross-cultural equivalence of a COA used in a multicultural study has been tested and variability addressed using both qualitative and quantitative methods, a more clear demonstration of a treatment benefit can be ascertained with confidence in the results.
After the webinar, the learner will be able to:
- Anticipate potential measurement issues related to cultural differences in the context of a multi-cultural study
- Outline a strategy to investigate cross-cultural equivalence of COAs using appropriate quantitative and qualitative methods
- Stacie Hudgens, MA (AbD) Managing Partner, Strategic Lead for Clinical Outcome Solutions
- Antoine Regnault, PhD Research Director for Mapi
- Lori McLeod, PhD Head, Psychometrics for RTI Health Solutions
- Mona Martin, RN MPA Executive Director for Health Research Associates Inc.
- Sonya Eremenco, MA Director, ePRO New Products for Evidera, Inc.
The Psychometric and Translation & Cultural Adaptation SIGs