Usability Testing: Ensuring User–friendly Data Collection in Clinical Trials
Usability testing is recommended to verify that Patient-Reported Outcome (PRO) questionnaires migrated from their original paper version, into another format like an app, have the same properties of reliability and validity in both formats. However, our research shows usability testing is more effective when cognitive debriefing is de-emphasized during this process.…
The Impact of the New European Union Medical Devices Regulations (EU MDR) 2017/745 and MDR 2017/746
This paper provides an overview of the European Union Medical Device Regulations (EU MDR) 2017/745 and MDR 2017/746 and their impact on device manufacturers.
Translation and Comprehension of Disease Activity
With the growing use of patient-reported outcomes (PRO), it is becoming increasingly important to iron out any language barriers and translation issues to achieve the most reliable results possible. The objective of this Linguistic Validation study was to identify terminology found in PROs that causes difficulty in translation and comprehension.…
An Investigation of Issues in the Translation and Comprehension of the Terms “Self-conscious” and “Embarrassed” in Patient Reported Outcome (PRO) Measures
Identifying problematic terminology and proposing solutions for improved translation is critical to increasing PRO content validity and the quality of respondent data. This research, selected for presentation at ISPOR Europe in Barcelona, November 2018, examines patients’ comprehension of the terms “self-conscious” and “embarrassed”, which have considerable semantic overlap and frequently…
The Importance of Concept Elaboration Guides in Linguistic Validation and Recommendations for Development
The objective of this study was to review and analyze Concept Elaboration Guides (CEGs) created for Clinical Outcomes Assessments (COAs), and then identify the most beneficial approaches for building CEGs from a localization and cognitive interview perspective. This study was selected for presentation at the International Society for Quality of…
Linguistic And Cultural Considerations When Implementing A Global ‘Bring Your Own Device’ (BYOD) Study
As discussions regarding the Bring Your Own Device (BYOD) clinical trial model intensify, it is imperative that the global and multi-lingual ramifications of the model are examined closely. This research, selected for presentation at ISPOR Asia Pacific in Tokyo, discusses the potential benefits of the BYOD approach and examines linguistic…
A Case Study of Successful Collaboration on a Global Immunology and Dermatology Phase II Study
A review of the Clinical Outcome Assessment (COA) Licensing, Translation and Linguistic Validation and eCOA Migration study between Kayentis and RWS Life Sciences.
Aligning Strategies and Deliverables for Global eCOA Translation Submissions to Ethics Committees in Clinical Trials
Have you ever wondered how to best align your strategies and deliverables in clinical trials when delivering eCOA translation submissions to ethics committees? This research, selected for presentation at DIA Global in Boston, June 2018, addresses this question and proposes specific solutions.
Getting The Words Right: Device Documentation And Translation In Asia
The medical device sector has seen increasing harmonization of regulations on both a global and regional basis. Nonetheless, market-entry requirements retain a significant degree of localization, particularly in relation to product labeling and documentation. Asia is no exception. For device companies prepared to negotiate the obstacles, though, the potential rewards…
An Investigation of Issues in the Translation and Comprehension of Disease Activity in Patient Reported Outcome (PRO) Measures
The RWS Life Sciences Linguistic Validation and Survey Analyst Teams carried out a study investigating the issues in the translation and comprehension of diseases activity in Patient Reported Outcome (PRO) measures. Learn about what the research entailed, the results of the study and concluding thoughts by viewing RWS’s research poster.
Variation in Interpretation of Fatigue Across Neuro-QoL – Fatigue – Version 1.0 Translations
The Research team explores the interpretation of fatigue across translations of the Neuro-QoL – Fatigue – V1.0 , adapted from PROMIS(R) item bank questions. Because fatigue assessment can measure impact on physical, mental, and social domains, one should consider the variation of interpretations across languages and disease sufferers.