Medical Writing Patient-reported outcomes Patient-reported outcome measure translation: An overview

Volume 27, Issue 4 - Patient-reported outcomes

Patient-reported outcome measure translation: An overview


The unique nature of patient-reported outcome (PRO) measures presents unique challenges for translation. Regulators emphasise the importance of maintaining conceptual equivalence across all languages in multilingual
and multinational trials, while making necessary cultural adaptations. This article will provide an overview of the central issues affecting PRO measure translation, best practices for PRO measure translation, and ways
to improve the translatability of PRO measures at the development stage.

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  1. Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of healthrelated quality of life (HRQL) measures in the evaluation of medicinal products. London, European Medicines Agency. 2005 Jul 27. Available from: http://
  2. US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patientreported outcome measures: use in medical product development to support labelling claims: draft guidance. Health Qual Life Outcomes. 2006 Dec;4:1–20. Available from: http://
  3. Wild D, Grove A, Martin M, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar;8(2):94–104. Available from: http://
  4. Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013 Oct 1;22(8):1889–905. Available from: http://
  5. Gawlicki MC, Angun Ç, Brandt BA, McKown S, Schulz C, Talbert M. Localization of activities and equivalence of movements in clinical outcomes Patient-reported outcome measure translation: An overview – Talley and McKown Volume 27 Number 4 | Medical Writing December 2018 | 29 assessments. Value Health. 2013 Nov 1;16(7):A597. Available from: http://
  6. Gawlicki MC, Brandt BA, McKown S, Talbert M. The translatability of fatigue across languages. Presented at the International Society for Quality of Life Research, 21st Annual Conference, Berlin, October 15–18, 2014 (poster). Available from: http://
  7. Gawlicki MC, McKown SM, Talbert MJ, Brandt BA. Application of Bother in patient reported outcomes instruments across cultures. Health Qual Life Outcomes. 2014 Dec;12(1):18. Available from: http://
  8. McKown S, Angun C, Talbert M, Brandt BA, Gawlicki MC. Assessing the translatability of the term “frustrated”. Value Health. 2014 Nov 1;17(7):A516–7. Available from: http://
  9. Talbert M, Brandt B, McKown S, Gawlicki M. Assessing the translatability of the term “distressed”. Value Health. 2015 Nov 1;18(7):A710. Available from: http://
  10. Gawlicki MC, Brandt B, McKown S, Talbert M. Translatability of response sets used in patient reported outcomes and best practices for development. Value Health. 2012;7(15):A484. Available from: http://
  11. Gawlicki MC, Brandt BA, McKown S, Talbert M. Face Validation and Trans - latability Assessment of Clinical Outcomes Assessments. Presented at the 20th Annual Conference of the International Society for Quality of Life Research, Miami, October 9 - 12, 2013 (poster). Available from: http://
  12. Gawlicki MC, Handa M, McKown S. Preempting difficulties in linguistic validation: the use of face validation to create more sound translations. Value Health. 2010;13(7):A336. Available from: http://
  13. Acquadro C, Patrick DL, Eremenco S, et al. Emerging good practices for translatability assessment (TA) of patientreported outcome (PRO) measures. J Patient Rep Outcomes. 2017 Dec 1;2(1):8. Available from: http://



Patient reported outcomes
President's Message
Measuring health outcomes: The foundation of contemporary healthcare decision-making
Measuring quality of life – theoretical background
Quality of life measures – an overview
Publication planning and patient-reported outcomes: Demonstrating value in a multi-stakeholder era
Patient-reported outcome measure translation: An overview
Systematic hospital collection of patient-reported outcome data via patient apps
The PROMIS of electronic patient-reported outcomes
Interview with Professor Matthias Rose on developing patient-reported outcomes and the PROMIS initiative
The UK pharmaceutical industry braces for Brexit, be it mild, severe, or doomsday
Awareness of medical writing as a profession and its career prospects
Estimands – closing the gap between study design and analysis
Protecting the rights of clinical trial patients through disclosure: The significance of plain language
News from the EMA
Regulatory Matters & Regulatory Public Disclosure
Medical Communications
Medical Devices
Journal Watch
In the Bookstores
Good Writing Practice
Getting Your Foot In The Door
My First Medical Writing
Out on Our Own


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Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

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