Table 2 Recommended COA Translation Process Steps

Creation of concept definition document

The concept definition document, also known as a concept elaboration guide or an item definition document, contains information about the conceptual basis for each item or task in the measure. It is provided to all translators (except the back-translator) to ensure a consistent understanding of these concepts throughout the translation process.

Developer review of concept definition document

The original developer or those with the necessary scientific expertise regarding development of the COA should ideally participate in the creation or review of the concept definition document to ensure approval and alignment.

Dual forward translations

The source COA is provided to two separate professional linguists who are native speakers of the target language and have experience in translating COAs or other clinical trial documentation. Each linguist completes an independent translation into the target language, consulting the concept definition document as necessary during the process. Initial cultural adaptation should occur during the forward translation process and is particularly important to consider when translating PRO and PerfO measures. This translation process should be applied to ClinRO measures, which are too often not translated due to the assumption that clinicians and site personnel are sufficiently fluent in English.

Reconciliation of forward translations

Reconciliation of the dual forward translations into one translation. Per ISPOR recommendations, this can be completed either by the two forward translators working together, or alternately by a third qualified translator working independently [10].

Single back-translation

The reconciled translation is provided to a professional linguist to perform a back-translation into the source language. The back-translation is to be completed by a linguist who does not have access to the original source COA or concept definition document. The purpose of the back-translation is to provide a quality control step which is used to ensure that the reconciled translation is conceptually equivalent to the source text.

Project Manager review and evaluation of back-translation

The back-translation is reviewed against the source language by the Project Manager. Any conceptual discrepancies or other problematic items identified are presented to a translator for review and discussion. Updates are made to the reconciled translation as required.

Developer review of back-translation evaluation

The back-translation is reviewed against the source language by the COA developer or those with the necessary scientific expertise in development of the COA. Any conceptual discrepancies or other problematic items identified are presented to the Project Manager and translator for review and discussion. Updates are made to the reconciled translation as required.

Native-speaking clinician review of the translation

The translation is reviewed against the source language by a clinician who is a native speaker of the target language, and who specializes in the condition being studied. Recommended specifically for ClinRO and PerfO measures, although this may be helpful as an optional step when translating ObsRO or PRO measures. For ClinRO and PerfO measures, use of an in-country Key Opinion Leader as the reviewer will serve to further improve acceptability of the version in the country and will also contribute to inter-rater reliability.

Proofreading

The reconciled translation is proofread by a linguist in preparation for cognitive interview/pilot testing activities.