Translation and Linguistic Validation

A patient reported outcome (PRO) measure is a broad term describing any measurement of the patient’s health that has come directly from the patient. It can include multidimensional measures assessing health related quality of life (HRQOL), functional status measures, patient satisfaction measures and symptom assessments, but it can also refer to single items assessing single symptoms.

PharmaQuest has worked on the translation and linguistic validation of numerous disease-specific measures including the widely used EORTC oncology modules, as well as generic quality of life measures such as the EQ-5D (both self-complete and telephone interview versions).

In order to enable the pooling, comparison and evaluation of data from multinational clinical trials, multiple language translations of measures are often required. For the translation of a PRO measure, it is necessary to follow a strict methodology with quality control steps to ensure that both conceptual and semantic equivalence are achieved, and to enable the accurate assessment of data from multinational trials. PharmaQuest’s methodology ensures that:

• translated versions of a measure contain items that are interpreted the same way
• translated versions contain conceptually equivalent constructs to the original source version of the measure
• the entire content is culturally relevant and meaningful for use in the target countries.

Regulatory agencies support the use of PRO measures in clinical trials as a basis for submissions, with up to a third of all submissions including PRO evidence. It is therefore critical that the translation and linguistic validation of such measures follows a rigorous methodology to ensure that they are accurately translated and culturally acceptable for the target population for which they are designed. Our methodology conforms to generally accepted industry standards.

We particularly recognise the importance of maintaining a close working relationship throughout the translation and linguistic validation process between ourselves, our in-country investigators, certified translators, the developer(s) of the measure and the client. This ensures that all relevant translation-related issues are dealt with at an early stage of the process with the relevant parties, thus guaranteeing that the client’s needs in terms of costs, deadlines and other requirements are met satisfactorily.