Linguistic validation of patient reported outcomes (PROs) consists of a pilot test to evaluate patients' understanding of the target language in the instructions and body of the instrument. Each patient is interviewed to confirm that his or her answers correspond to a linguistically equivalent understanding of the questions as intended by the developers of the instrument.

The goal of the linguistic validation process is that patients in the target population reading a translation of the instrument have an understanding that is functionally equivalent to that of similar patients reading the questions in the source language. This ensures that all completed patient reported outcomes from a study are balanced and equivalent across all languages and can be pooled for statistical analysis.

This rigorous process comes only after conducting a thorough translation of the instrument using the standard, accepted, full translation procedure as outlined by Guillemin et al in a manuscript published in the Journal of Clinical Epidemiology, 1993.

Health Outcomes Group has conducted hundreds of linguistic validations in more than 60 countries worldwide working in over 80 major languages and dialects. This virtually ensures that we have worked with whatever language you may need.

Once an instrument has been translated and linguistically validated, a certificate of quality assurance is issued by Health Outcomes Group. Certification of a translation by Health Outcomes Group is security that a standard of quality has been maintained throughout the entire process of translation and linguistic validation that will meet the standards of the FDA, EC and other regulatory agencies.