CONSIDERATIONS FOR UPDATING EXISTING LINGUISTICALLY VALIDATED CLINICAL OUTCOME ASSESSMENTS (COAS)

Author(s)

Simpson-Finch H1, Yohe Moore ES2, Brandt B3, Poepsel T2, McKown S3
1RWS Life Sciences, Bloxham, UK, 2RWS Life Sciences, Chicago, IL, USA, 3RWS Life Sciences, East Hartford, CT, USA

Objective: Existing linguistically validated translations of COAs should be maintained wherever possible between studies, but cases exist where updates are needed to ensure that the COA remains fit for its intended purpose. These revisions include updating spelling to a new orthographic system, updating cultural adaptations, and improving alignment with source concepts. Updating existing translations as necessary ensures that COAs remain fit for purpose over time and improves the quality of COA data. Background: For the purposes of clinical trials or labeling claims, a number of factors should be considered when updating an existing COA translation. The ability to update a study-specific COA translation depends on the stage of ethical board submissions for that study. If translations have already been submitted to an ethical board, revision to that project’s translations may not be logistically possible. However, in cases where updates significantly improve validity or reliability, the study team may choose to update the translations and submit an amended application. Outside of individual submissions logistics, it is more difficult to determine when an update is needed versus being simply stylistic in nature. The copyright for the source instruments is often held by the COA developer or publishing house. The ability to update a translation will be contingent upon their permission, and evidence of the need for a change should be compiled. Some updates are straightforward and simple, like changes in orthography. More complex updates typically include changes to increase the semantic validity of key question words or response option sets. Conclusions: When and how to update a linguistically validated translation depends on both study logistics, and the magnitude of need. Need for an update depends on the severity of issues and perceived impacts, including the potential to bias data and potential influence on treatment decisions.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PCP71

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Multiple Diseases

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