Life Sciences (Pharmaceuticals)
Linguistic validation of patient reported outcomes
Linguistic validation, cultural & linguistic consulting, editing, translation, adaptation (transcreation), back-translation, localization, desktop publishing, QA testing, international harmonization, cognitive debriefing study
Arabic, Armenian, Bosnian, Cambodian, Chinese (Simplified), Chinese (Traditional), Croatian, Farsi, French, Haitian Creole, Hindi, Hmong, Hungarian, Japanese, Korean, Laotian, Polish, Portuguese, Punjabi, Russian, Somali, Spanish, Tagalog, Thai, Ukrainian, Vietnamese
assessment tool in 26 languages, harmonization with existing copy in 19 languages, forward- and back-translations, cognitive debriefing interviews (development of interview materials and data analysis), report compilation
6 months
A global pharmaceutical company (the Client) uses Paragon’s experience and expertise to validate the linguistic and cultural understanding of a tool used by patients to assess their own health status. Paragon performed this linguistic validation in 26 languages, specifically for the US market, using our team of experienced linguists, and expert project management skills to ensure excellence in every step of the process, from initial translations to in-language cognitive debriefing interviews of 3 lay subjects. Although this was Paragon’s first linguistic validation of a patient reported outcomes study that included a cognitive debriefing phase, we were able to deliver our client confidence in the tool’s 26 versions in different languages. We were able to refine our workflow and leverage the knowledge we gained to solve future problems.
The Client, who already had a longstanding relationship with Paragon, developed a test for a common respiratory condition, COPD. This tool helps English-speaking people self-assess the current state of their condition, and the Client’s goal is to establish conceptual equivalence in 26 languages. A version of the test is currently available online in 19 languages, but the Client developed and linguistically validated the translations in the United Kingdom for European consumption. Paragon was brought in to develop the 26 language translations of the test for non-English speakers residing in the US. Although Paragon had never conducted a linguistic validation study at this scale, the Client trusted our expertise in foreign language and excellent project management skills to deliver them the results they were looking for.
Before beginning formal work on the language of the assessment tool, Paragon’s first step was to establish a deep understanding of the methodology of linguistic validation of patient reported outcomes as it is practiced by other organizations in both academia and the private sector. In this research phase, recommendations detailed by organizations like the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Mapi Research Trust were invaluable and we closely aligned our workflow with their standards and best practices. Because of our agency’s size, our research team was quickly able to disseminate its findings of best practice workflows and areas of difficulty intrinsic in cognitive debriefing and specifically foreign language validation to the rest of the team.
Paragon has experience and expertise in international harmonization of text, and harmonization of multiple versions for a single translation. This meant that our vast network of linguists with healthcare/life science expertise was well established and consisted of our most trusted linguists in each of the 26 languages. Throughout the entire project, no less than 5 linguists for each language had contact with the short assessment tool: two forward translations were created by translators familiar with previous Client and other pharmaceutical projects. A third qualified linguist analyzed both forward translations and merged and created a translation that reflected the best quality of the two forward translations. A fourth linguist, native English speakers with expertise in the target languages, produced a back translation in English; the project manager compared this back translation with the English source to ensure equivalence. Any issues that arose in this process were worked through in consultation with all of the translators to reach the best solution. Finally, a fifth (or sometimes sixth or more) language expert was used to analyze the results of the cognitive debriefing phase—including listening to recorded interviews—which involved 3 lay subjects who were native speakers of the target language as well as a bilingual interviewer.
Although the process was complicated and involved new areas of work for Paragon, by the end of the project, Paragon could certify understanding in 26 languages based on at least 9 people’s input per language (5 or more professional linguists, 3 lay subjects, and 1 bilingual interviewer) and the resolution of issues they raised. This favorable outcome was delivered to the Client, for whom the results exceeded expectations.