PRO Measure Translatability Assessments

At PharmaQuest Ltd., we offer translatability assessments which enable researchers to incorporate an international component into the development of a new PRO measure, while simultaneously reducing possible translation issues caused by items and phrases that are difficult to translate or lack global clarity.

This results in a measure with increased cross cultural equivalence, thus improving the comparability of clinical trial data. We highly recommend this step as part of any ongoing PRO development project.

Translatability assessments of PRO measures include the following steps:

• Resolution of issues relating to clarity of wording through a process of concept elaboration to ensure that ambiguities are not reflected in subsequent translations.
• Discussion with the client and developer to ensure that the meaning and concepts within the measure are not changed but instead that suitable alternatives are obtained for any ambiguous wording.
• Review of the measure by PharmaQuest to highlight any sentences/phrases requiring specific comments from in-country investigators.
• Review of the measure by in-country investigators in 10 countries to elaborate on those sentences which they think would be difficult to translate into their native language or those that do not have equivalent concepts in that particular culture, and whether suitable alternatives are available in that language.
• Collation of comments from all investigators and review of these alongside suggestions for wording changes of problematic sentences/phrases by PharmaQuest based on our experience of translating a large number of PRO measures.
• Recommendations are put forward to the client and developer for sentences/phrases that require modification in the source measure and reasons provided to support these changes.