Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices

Abstract

This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium’s instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the process of qualification by the U.S. Food and Drug Administration (FDA) for use in clinical trials where endpoints based on these measures would support product labeling claims. Given the importance of FDA qualification of these measures, the PRO Consortium’s Process Subcommittee determined that a detailed linguistic validation (LV) process was necessary to ensure that all translations of Consortium-developed PRO measures are performed using a standardized approach with the rigor required to meet regulatory and pharmaceutical industry expectations, as well as having a clearly defined instrument translation process that the translation industry can support. The consensus process involved gathering information about current best practices from 13 translation companies with expertise in LV, consolidating the findings to generate a proposed process, and obtaining iterative feedback from the translation companies and PRO Consortium member firms on the proposed process in two rounds of review in order to update existing principles of good practice in LV and to provide sufficient detail for the translation process to ensure consistency across PRO Consortium measures, sponsors, and translation companies. The consensus development resulted in a 12-step process that outlines universal and country-specific new translation approaches, as well as country-specific adaptations of existing translations. The PRO Consortium translation process will play an important role in maintaining the validity of the data generated through these measures by ensuring that they are translated by qualified linguists following a standardized and rigorous process that reflects best practice.

Translation and content validity of the Dutch Impact of Vision Impairment questionnaire assessed by Three-Step Test-Interviewing

“…Since we were interested in the full version for future studies, additional translation was needed for 13 of the items. This translation process was performed using standardized state-of-the-art translation methods recommended by the Patient-Reported Outcome Consortium [22,24,25].…”

Development of a Japanese Version of the Daily Record of Severity of Problems for Diagnosing Premenstrual Syndrome

“…19 In 2018, the PRO Consortium (formed by the Critical Path Institute [C-Path] in cooperation with the U.S. FDA Center for Drug Evaluation and Research and the pharmaceutical industry) updated this guide to enable different translation companies to share standard procedures for TCA. 17 The new guide did not change the principles of TCA, but it details how to perform each step and how to adapt the TCA process to different situations worldwide. 17 The Japanese version of the DRSP was developed based on the 2018 PRO Consortium consensus guide for translating and culturally adapting PRO into other languages, which constitutes a 12-step process (Supplementary Appendix Table SA1).…”

“…17 The new guide did not change the principles of TCA, but it details how to perform each step and how to adapt the TCA process to different situations worldwide. 17 The Japanese version of the DRSP was developed based on the 2018 PRO Consortium consensus guide for translating and culturally adapting PRO into other languages, which constitutes a 12-step process (Supplementary Appendix Table SA1). We followed the 12 steps to develop the Japanese version of the DRSP, including conducting cognitive interviews (step 9) of 8 PMDD outpatients at Kyoto University Hospital.…”

The Reliability and Validity of the Japanese Version of the Daily Record of Severity of Problems (J-DRSP) and Development of a Short-Form Version (J-DRSP(SF)) to Assess Symptoms of Premenstrual Syndrome Among Japanese Women

“…All items are scored daily throughout the menstrual cycle on a scale of 1 (not at all) to 6 (extreme). The J-DRSP was developed according to the formal procedures outlined in the translation guidelines of the latest Patient-Reported Outcomes (PRO) Consortium 6 .…”