Table 1.

Definitions of Key Terms

Key Term	Definition
Back-translation	Process of translating a document that has already been translated into another language back to the original language - preferably by an independent translator.
Country-specific translation	Translation approach focused on respecting the diversity of languages and sense of cultural identity of the target populations through their languages. Involves preparing separate translations for countries sharing the same language (e.g., separate Spanish translations for Spain, Mexico, Chile, and U.S.).
Forward translation	Translation from the source language to the target language.
International Harmonization	Harmonization of all translations with each other and the source version. Objective is to detect and deal with any discrepancies between different language versions that threaten conceptual equivalence and comparability across languages. Provides an additional quality control step and further ensures that data from global trials can be safely aggregated.
Linguistic validation	The process of assessing and confirming the conceptual equivalence [4, 5] and content validity of translations of patient-reported outcome (PRO) measures. Usually, linguistic validation refers to a process whereby translated text is actively tested with patients in the target population and target language group through cognitive interviews.
Preparation	Initial planning and actions carried out before the translation process begins, such as identifying translation consultants and in-country affiliates and creating translation files if needed.
Forward translation reconciliation	Process of comparing and merging more than one forward translation into a single forward translation resulting in a reconciled forward translation.
Universal translation	Translation approach focused on commonalities rather than differences to develop one version to be used in regions or countries speaking the same language (e.g., preparing a single Spanish translation that will be used by all Spanish-speaking countries).