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International Clinical Trials

PRO Translation

The use of patient-reported outcomes (PROs) has grown considerably in the last several decades, spreading into new technologies and supporting the evaluation of endpoints in clinical trials and regulatory decision-making. With this growth in their use and impact comes an increased obligation to ensure PROs collect high-quality data, both in terms of properly defining the constructs that PROs intend to measure and ensuring that patients are able to comprehend their content despite typically low familiarity with PROs and the language they use compared to healthcare professionals. An analysis was conducted on the term ‘disease activity’ as used in four separate PROs. Through investigation of patients’ comprehension of this term and their reactions to its translation in a variety of languages and countries, suggestions can be drawn to improve the quality of data collected by PROs that assess disease activity.

Study Objective

The objective of the study was to identify terminology found in PROs that causes difficulty in translation and comprehension. Identifying such terminology and solutions that improve translation and patient comprehension is critical to increasing the validity of PROs and their treatment insights. As such, the use of the term ‘disease activity’ was investigated in PROs across 29 languages. Disease activity can be defined as “manifestations of a disease” and typically appears in instruments assessing the state of a patient’s disease signs and symptoms (1-2).

Previous translation projects have suggested that disease activity is frequently identified by patients as a problematic term. However, to date, a systematic analysis of instruments that use this term has not been conducted. Here, data is presented from several translation projects involving the term ‘disease activity’, illustrating the difficulties that patients face in interpreting the term, and ways to mitigate these difficulties through revised or expanded translations are proposed.

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Dr Tim Poepsel is a Survey Research Analyst with RWS Life Sciences. He has a BA in linguistics from Northwestern University, US, and a PhD in psychology and language science from Penn State University, US. Tim specialises in the area of linguistic validation, and his research focusses on the patient perspective in the development and administration of clinical outcome assessment (COA) instruments.

Barbaa Brandrt is Survey Research Analyst Team Lead at RWS Life Sciences. Barbara has 17 years of experience in COAs, linguistic validation, translatability assessment, and electronic COAs and usability testing. She has a BA in linguistics and psychology and an MA in Survey Research from the University of Connecticut, US.

Elizabeth Yohe Moore is the COA process development lead at RWS Life Sciences with eight years of healthcare industry experience. She received a BA in neuroscience and economics from Oberlin College, US, and an MPH from Northwestern University, US.

Elizabeth McCullough is the Manager of Linguistic Validation Services at RWS Life Sciences. Elizabeth has worked in the areas of medical translation and linguistic validation for 10 years. She holds an MA in translation from the Institute for Applied Linguistics at Kent State University, US.

Shawn McKown is the Senior Director and Practice Lead of Linguistic Validation at RWS Life Sciences. Shawn has worked with COAs, patient-reported outcomes, and linguistic validation within the clinical trial space for over 15 years and holds an MA from the University of Chicago, US.
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Dr Tim Poepsel
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Barbara Brandt
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Elizabeth Yohe Moore
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Elizabeth McCullough
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Shawn McKown
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