OBJECTIVES

Clinical outcome assessments (COAs) are often developed in English using robust qualitative content validation (CV) methodology in line with FDA guidance. However, clinical trials are often conducted on a global scale. Compared with initial English-language CV, translated patient-reported outcome measures may be tested in small samples with a focus on assessing conceptual equivalence rather than conceptual relevance/understanding. Translated clinician-reported outcome measures may not undergo any testing. Our objective was to provide practical guidance to researchers for exploring the content validity of translated COAs.

METHODS

Researcher learnings from combined concept elicitation and cognitive interview studies in Japan and China were compiled. These CV studies were designed and analysed by English-speaking COA specialists. Local interviewers conducted native-language interviews.

RESULTS

Before undertaking CV interviews: a) translated COAs should be reviewed against the validated English version by a dual-language disease specialist to ensure high quality translations are used from the outset; b) COA researchers should provide in-depth, face-to-face methodological and project-specific training to local interviewers. During data collection: a) pilot interviews are recommended so that COA specialists can provide feedback on interview techniques/priorities to ensure consistency across local interviewers; b) ongoing analysis can inform changes to the COA/questioning with input from local interviewers. Following interviews: a) teams transcribing/translating interview recordings should be provided with both the translated and English COAs for consistency across transcripts (terms used in the COA should be transcribed unless the participant uses a different term); b) strengths and limitations of the cross-country research team should be acknowledged.

CONCLUSIONS

Country-specific CV of translated COAs should be undertaken by specialist COA researchers to confirm that translated measures are conceptually relevant and understood. In addition to linguistic validation, this may improve data collection/interpretation in global clinical trials by ensuring COAs are equivalent, fit-for-purpose and/or that limitations of the translations are fully understood.