The aim of a linguistic validation is to produce a target language version that is conceptually equivalent to the source instrument and allows data pooling and/or comparison across countries.

The standard linguistic validation process comprises seven steps (see also diagram):

Conceptual definition

Forward translation

Backward translation

Pilot Testing

1. Cognitive interviews
2. Review by clinician

International Harmonization

Proofreading

Report



Conceptual Definition

Aim : To clarify the concepts investigated by each item of the original instrument to ensure they are reflected appropriately in the target languages.


Process:

Analysis of the original instrument. Definition of the concepts underlying each item of the questionnaire.

Discussion with the Developer. Based on this review, the Project Manager submits his/her findings to the Developer for confirmation or clarification. All information given by the Developer is recorded in a report.



Forward Translation

Aim : To obtain a consensus target language version.

Process:

Production of two independent translations by two professional translators in the target language conducted in the target country.

Reconciliation meeting between the two "forward" translators and the local project manager to obtain a consensus version.
Quality control by the MAPI Institute and discussion.

Based on this discussion, the consensus language version may be further modified.

Backward Translation

Aims : To obtain a translation into English of the target language version, to assess and control its quality.

Process:

Translation of the forward consensus version into the source language by one independent translator.

Comparison of the source questionnaire with the "backward" translation by the local team to check the conceptual content of forward consensus versions.

Discussion with MAPI Institute. Based on this discussion, a second target language version will be created.



Pilot Testing

The aim of Pilot Testing is to get input from people representing future users of the questionnaire, i.e., experts in the therapeutic areas in question, as well as the eventual respondents/patients. There are two procedures occurring in parallel: the Cognitive Interviews with a sample of respondents and the Clinician’s Review.

Cognitive Interviews

Aim : To assess the clarity, intelligibility, appropriateness, and cultural relevance of the target language version to the target population.

Process:

Interviews with patients/healthy subjects to test the interpretation of the translation.

Quality control by the MAPI Institute.

Clinician’s Review

Aim: To get input from medical experts on the translation as to the domain-specific terminology of the instrument and to incorporate feedback from potential clinical users of the instrument.

Process:

Review. The target version is sent via the Institute to the appointed Reviewer (clinician, etc). The Reviewer makes comments and suggestions for changes in the translation and returns it to the Institute.

Discussion with the Consultant and MAPI Institute. Suggestions retained are incorporated into the second target language version with the results of the cognitive interview (see above), giving rise to a third target language version.



International Harmonization

This is only necessary when more than one language version is linguistically validated at the same time.

Aim : To ensure consistency of translation decisions and use of colloquial language across countries and to enhance cross-cultural comparability.

Process:

Meeting:the original instrument and the target language versions are compared, item by item, in order to harmonize solutions proposed for different languages.

Discussion with the Consultant: each target language version with revisions suggested during international harmonization is submitted to the appropriate Consultant who will review the suggestions and inform the Institute whether they can be retained or explain why they shouldn’t be. If necessary, the Institute will contact the Developer for information.

Suggestions retained and incorporated into the target language version give rise to a fourth target language version.



Proofreading

Aim : To ensure that no typing, spelling, or grammatical mistakes remain in the fourth target language version.

Process: Prior to delivery of the target language version to the future users, it undergoes at least two rounds of proofreading. Integration of relevant corrections leads to the final target language version.




Report

Aim : To keep track of the work done, methodology followed, translation issues raised, and decisions made during the linguistic validation process.

Process: The Institute writes a report (in English) addressed to the Sponsor and to the Developer. The report describes the translation methodology followed, based on the structure of the present manual, as well as a synthesis of the translation problems encountered and solutions retained in the course of the linguistic validation process. The report covers all languages included in the project.


All these steps are fully detailed in the “Linguistic Validation Manual of PRO Instruments”.

Standard linguistic validation process diagram ©