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

Journal of Patient-reported Outcomes
Sonya EremencoPRO Consortium’s Process Subcommittee

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 principl...Continue Reading

References

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Citations

Jun 25, 2019·The Journal of Craniofacial Surgery·Rafael DenadaiJonathan R Skirko
Mar 12, 2021·European Journal of Cardiovascular Nursing : Journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology·Petra Schäfer-KellerAnna Strömberg
Mar 25, 2021·Journal of Medical Economics·Stephen P McKenna, Alice Heaney
Jun 20, 2021·Social Psychiatry and Psychiatric Epidemiology·Yohannes Gebreegziabhere HaileAtalay Alem
Jul 2, 2021·Alzheimer's & Dementia : Translational Research & Clinical Interventions·Dorene M RentzChristopher J Weber
Aug 10, 2021·Psychiatric Services : a Journal of the American Psychiatric Association·Emily McKenzieUNKNOWN Psychotic Disorders Working Group of the International Consortium for Health Outcomes Measurement

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