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Table 3 Summary of Translatability Assessment (TA) Good Practices for patient-reported outcome (PRO) measures

From: Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures

Category

Description

Terminology

Translatability Assessment (TA)

Definition

Translatability assessment of a patient-reported outcome (PRO) measure is the review of its source text preferably during the development stage, prior to its use, in order to determine its suitability for future translations in multilingual studies. In this context, the translation process aims to create conceptual equivalence to the original in a way that allows data from multiple languages to be compared. The goal of TA is to facilitate future translations and use of the measure in global studies by 1) identifying and categorizing potential translation issues in the source text, and 2) providing alternative wordings on which translations can be based and/or recommendations of how to modify the source text so that future translations are conceptually, culturally appropriate for the target populations.

Steps

Four major steps should be considered: preparation, review, recommendations, writing of a report.

People Involved

- The developer(s) of the PRO measure under review;

- Reviewer(s) who will perform the TA;

- A project manager.

Timing of Assessment

TA should be performed during the development of the PRO measure, as early as possible, when adjusting the conceptual framework and drafting the instrument. It should happen during the qualitative phase of development, before finalization of the wording, while changes can still be made to the wording, and before use in quantitative research. It is less useful to conduct TA after the psychometric evaluation has been performed, and if performed during this later stage, options to address issues detected are limited to providing alternative wording for future translations which may still be beneficial.

- TA should be iterative when new wording is generated. If cognitive interviews with patients lead to changes in the wording during the qualitative phase of development, a TA should be performed again. The number of iterations should follow the number of changes made to the wording. It is of foremost importance that the translatability of all new wordings be assessed before the final round of cognitive interviews.

Review Criteria

The review criteria should be divided in three categories: culture, language, and item construction.

Recommendations

- No change to the original wording.

- No change to the original wording, but suggestions for alternative wording suitable for translation to address known issues.

- Change to the original wording.

- Consider removing wording because of extreme degree of difficulty to translate in the future.