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Article published In: Translation and Interpreting Studies
Vol. 20:2 (2025) ► pp.274–295

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Professional translators in clinical cross‑cultural adaptation protocols

A matter of mistrust?

ORCiD logo with link | The University of Texas Rio Grande Valley
Published online: 6 November 2025
DOI logo with link
https://doi.org/10.1075/tis.21077.fre
Abstract
Transnational clinical research is increasingly commonplace, which has led to a growing need for patient-reported outcome instruments (PROIs) that can be used by patients in different countries. The process to cross-culturally adapt these health questionnaires is described in many guidelines, which coincide in that an appropriate translation and cultural transfer are of outmost importance. This article examines the translation methodology used in 100 recent scholarly articles that report on PROI cross-cultural adaptations to explore who is responsible for the initial translation, its subsequent back translation, and the translation review process. It will be argued that the limited involvement of professional translators in these processes signals a mistrust toward these practitioners that stems from assumptions about translation and bilingualism that are not always accurate.
Article outline
  • Introduction
  • Cross-cultural adaptation of PROIs: Current methods
  • 1.Translation in cross-cultural adaptation methods
  • Bibliographical study of PROI cross-cultural adaptation projects
  • Methods
  • Results
    • Who is translating?
    • Who is reviewing the translations?
  • Discussion
    • Bilinguals as natural translators and ideal reviewers
    • Professional translators cannot deliver adequate FTs
    • FTs are translations and BTs are quality control tools
  • Conclusions
  • Note
  • References
References (75)
References
Aaronson, Neil, Jordi Alonso, Audrey Burnam, Kathleen N. Lohr, Donald L. Patrick, Edward Perrin, and Ruth E. Stein. 2002. “Assessing health status and quality-of-life instruments: Attributes and review criteria.” Quality of Life Research 111: 193–205. Google Scholar logo with link to Google Scholar
Acquadro, Catherine, Katrin Conway, Asha Hareendran, and Neil Aaronson. 2008. “Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials.” Value in Health 11(3): 509–521. Google Scholar logo with link to Google Scholar
Acquadro, Catherine, Louise Lafortune, and Isabelle Mear. 2003. “Quality of life in multiple sclerosis: Translation in French Canadian of the MSQoL-54.” Health and Quality of Life Outcomes 11: 70. Google Scholar logo with link to Google Scholar
Angelelli, Claudia V. 2007. “Assessing medical interpreters. The language and interpreting testing project.” The Translator 13(1): 63–82. Google Scholar logo with link to Google Scholar
2015. “Bilingualism and multilingualism.” In Researching Translation and Interpreting, ed. by Claudia V. Angelelli and Brian James Baer, 32–42. London: Routledge. Google Scholar logo with link to Google Scholar
Arnold, Benjamin J., et al. 2016. “Linguistic validation of the Spanish Version of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).” Supportive Care in Cancer 241: 2843–2851. Google Scholar logo with link to Google Scholar
Banville, Dominique, Pauline Desrosiers, and Yvette Genet-Volet. 2000. “Translating questionnaires and inventories using a cross-cultural translation technique.” Journal of Teaching in Physical Education 191: 374–387. Google Scholar logo with link to Google Scholar
Beaton, Dorcas, Claire Bombardier, Francis Guillemin, and Marcos Bosi Ferraz. 2000. “Guidelines for the process of cross-cultural adaptation of self-report measures.” Spine 25(24): 3186–3191. Google Scholar logo with link to Google Scholar
Behr, Dorothée. 2017. “Assessing the use of back translation: The shortcomings of back translation as a quality testing method.” International Journal of Social Research Methodology 20(6): 573–584. Google Scholar logo with link to Google Scholar
. 2018. “Translating questionnaires for cross-national surveys: A description of a genre and its particularities based on the ISO 17100 categorization of translator competences.” Translation & Interpreting 10(2): 5–20. Google Scholar logo with link to Google Scholar
Behr, Dorothée, and Kuniaki Shishido. 2016. “The translation of measurement instruments for cross-cultural surveys.” In The SAGE Handbook of Survey Methodology, ed. by Christof Wolf et al., 269–287. London: SAGE. Google Scholar logo with link to Google Scholar
Bolaños-Medina, Alicia, and Víctor González-Ruiz. 2013. “Deconstructing the translation of psychological tests.” Meta 57(3): 715–739. Google Scholar logo with link to Google Scholar
Bonomi, Amy E., et al. 1996. “Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system.” Quality of Life Research 51: 309–320. Google Scholar logo with link to Google Scholar
Brislin, Richard W. 1970. “Back-translation for cross-cultural research.” Journal of Cross-Cultural Psychology 1(3): 185–216. Google Scholar logo with link to Google Scholar
Bullinger, Monika, et al. 1998. “Translating health status questionnaires and evaluating their quality: The IQOLA Project approach.” Journal of Clinical Epidemiology 51(11): 913–23. Google Scholar logo with link to Google Scholar
Bundgaard, Kristine, and Matilde Nisbeth Brøgger. 2018. “‘Don’t fix bad translations’: A netnographic study of translators’ understandings of back translation in the medical domain.” MonTI 10(1): 205–224. Google Scholar logo with link to Google Scholar
. 2019. “Who is the back translator? An integrative literature review of back translator descriptions in cross-cultural adaptation of research instruments.” Perspectives: Studies in Translation Theory and Practice 27(6): 833–845. Google Scholar logo with link to Google Scholar
Calvo, Elisa, and Catherine Way. 2024. “Translating psychometric tests: When skopos gets lost in literality.” In A Qualitative Approach to Translation Studies: Spotlighting Translation Problems, 228–245. New York: Routledge.Google Scholar logo with link to Google Scholar
Carl, Michael, and Matthias Buch-Kromann. 2010. “Correlating translation product and translation process data of professional and student translators.” In The 14th Annual Conference of the European Association for Machine Translation. EAMT 2010, 71:343–54. Saint-Raphaël, France: European Association for Machine Translation.Google Scholar logo with link to Google Scholar
Jenn, Ng Chirk. 2006. “Designing a questionnaire.” Malaysian Family Physician 1(1): 32–35.Google Scholar logo with link to Google Scholar
Coco, Laura, Sonia Colina, Samuel R. Atcherson, and Nicole Marrone. 2017. “Readability level of Spanish-language patient-reported outcome measures in audiology and otolaryngology.” American Journal of Audiology 26(3): 309–317. Google Scholar logo with link to Google Scholar
Colina, Sonia, Nicole Marrone, Maia Ingram, and Daisey Sánchez. 2017. “Translation quality assessment in health research: A functionalist alternative to back-translation.” Evaluation and the Health Professions 40(3): 267–293. Google Scholar logo with link to Google Scholar
Congost-Maestre, Nereida. 2016. “Aspectos lingüísticos en la traducción de cuestionarios de salud (británicos y estadounidenses).” JoSTrans: The Journal of Specialised Translation 261: 116–135. Google Scholar logo with link to Google Scholar
. 2018. “La traducción de la escala de calidad de vida de la OMS: El cuestionario WHOQOL-BREF — Translation of the WHO Quality of Life Scale: The WHOQOL-BREF questionnaire.” JoSTrans: The Journal of Specialised Translation 301: 312–334. Google Scholar logo with link to Google Scholar
Congost-Maestre, Nereida, and Maichou Lor. 2020. “Sociocultural issues in adapting Spanish health survey translation: The case of the Quality of Well-Being Scale (QWB-SA).” In The Essential Role of Language in Survey Research, ed. by Mandy Sha and Tim Gabel, 203–220. Research Triangle Park: RTI Press. Google Scholar logo with link to Google Scholar
Cortabarria, Beatriz. 2016. “Non-standard Spanish in the United States and translation norm behavior: A study of hospital and court interpreters.” Universitat Rovira i Virgili.Google Scholar logo with link to Google Scholar
Coulthard, Robert James. 2013. “Rethinking back-translation for the cross-cultural adaptation of health-related questionnaires: Expert translators make back-translation unnecessary.” Universidade Federal de Santa Catarina.Google Scholar logo with link to Google Scholar
Dorer, Brita. 2022. “Advance translation — The remedy to improve translatability of source questionnaires? Results of a think-aloud study.” Field Methods 35(1): 33–47. Google Scholar logo with link to Google Scholar
Epstein, Jonathan, Richard H. Osborne, Gerald R. Elsworth, Dorcas E. Beaton, and Francis Guillemin. 2015. “Cross-cultural adaptation of the Health Education Impact Questionnaire: Experimental study showed expert committee, not back-translation, added value.” Journal of Clinical Epidemiology 68(4): 360–369. Google Scholar logo with link to Google Scholar
Epstein, Jonathan, Ruth Miyuki Santo, and Francis Guillemin. 2015. “A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus.” Journal of Clinical Epidemiology 68(4): 435–441. Google Scholar logo with link to Google Scholar
Eremenco, Sonya L., David Cella, and Benjamin J. Arnold. 2005. “A comprehensive method for the translation and cross-cultural validation of health status questionnaires.” Evaluation and the Health Professions 28(2): 212–232. Google Scholar logo with link to Google Scholar
Ferreira, Aline, and John W. Schwieter, eds. 2023. The Routledge Handbook of Translation, Interpreting and Bilingualism. London: Routledge. Google Scholar logo with link to Google Scholar
Fourie, Jean, and Ilse Feinauer. 2005. “The quality of translated medical research questionnaires.” Southern African Linguistics and Applied Language Studies 23(4): 349–367. Google Scholar logo with link to Google Scholar
Fukuhara, Shunichi, Seiji Bito, Joseph Green, Amy Hsiao, and Kiyoshi Kurokawa. 1998. “Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan.” Journal of Clinical Epidemiology 51(11): 1037–1044. Google Scholar logo with link to Google Scholar
Glickman, Seth W., John G. McHutchison, Eric D. Peterson, Charles B. Cairns, Robert A. Harrington, Robert M. Califf, and Kevin A. Schulman. 2009. “Ethical and scientific implications of the globalization of clinical research.” New England Journal of Medicine 360(8): 816–823. Google Scholar logo with link to Google Scholar
Göpferich, Susanne. 2010. “The translation of instructive texts from a cognitive perspective: Novices and professionals compared.” In New Approaches in Translation Process Research, ed. by Susanne Göpferich, Fabio Alves, and Inger M. Mees, 5–52. Copenhagen: Samfundslitteratur.Google Scholar logo with link to Google Scholar
Grosjean, Françlois. 1992. “Another view of bilingualism.” Advances in Psychology 831 (January): 51–62. Google Scholar logo with link to Google Scholar
Guillemin, Francis, Claire Bombardier, and Dorcas Beaton. 1993. “Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines.” Journal of Clinical Epidemiology 46(12): 1417–1432. Google Scholar logo with link to Google Scholar
Harkness, Janet. 2002. “Questionnaire translation.” In Cross-Cultural Survey Methods, ed. by Janet A. Harkness, Fons J. R. Van de Vijver, and Peter Ph. Mohler, 35–56. Hoboken: Wiley.Google Scholar logo with link to Google Scholar
Harkness, Janet, and Alicia Schoua-Glusberg. 1998. “Questionnaires in translation.” In Cross-Cultural Survey Equivalence, ed. by Janet Harkness, 87–126. Mannheim: Zentrum für Umfragen, Methoden und Analysen -ZUMA.Google Scholar logo with link to Google Scholar
Harris, Brian. 1976. “The importance of natural translation.” Working Papers in Bilingualism 12 (January): 96–114.Google Scholar logo with link to Google Scholar
Hunt, Sonja M., Jordi Alonso, Denis Bucquet, Mauro Niero, Ingela Wiklund, and Stephen P. McKenna. 1991. “Cross-cultural adaptation of health measures.” Health Policy 19(1): 33–44. Google Scholar logo with link to Google Scholar
Hurtado Albir, Amparo. 2017. “Translation and translation competence.” In Researching Translation Competence by PACTE Group, ed. by Amparo Hurtado Albir, 3–34. Amsterdam: John Benjamins. Google Scholar logo with link to Google Scholar
International Test Commission. 2017. “The ITC Guidelines for Translating and Adapting Tests (Second Edition).” [URL]
Koller, Michael, et al. 2007. “Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) Approach.” European Journal of Cancer 43(12): 1810–20. Google Scholar logo with link to Google Scholar
Kuliś, Dagmara, Andrew Bottomley, Galina Velikova, Eva Greimel, and Michael Koller. 2017. “EORTC Quality of Life Group translation procedure.”Google Scholar logo with link to Google Scholar
Leplège, Alain, and A. Verdier. 1995. “The adaptation of health status measures: Methodological aspects of the translation procedure.” In The International Assessment of Health-Related Quality of Life: Theory, Translation, Measurement, and Analysis, ed. by Sally Shumaker and Richard Berzon, 93–101. Oxford: Rapid Communications.Google Scholar logo with link to Google Scholar
Lörscher, Wolfgang. 2009. “Form- and sense-oriented approaches to translation revisited.” Translation Quarterly 51–521: 1–28.Google Scholar logo with link to Google Scholar
. 2014. “Bilingualism and translation competence: A research project and its projected results.” InTRAlinea, ed. by Maria Piotrowska and Sergiy Tyupa. [URL]
Mackensen, Syvlia von, Irène Gil-Campos, Catherine Acquadro, and Martin Strandberg-Larsen. 2013. “Cross-cultural adaptation and linguistic validation of age-group-specific haemophilia patient-reported outcome (PRO) instruments for patients and parents.” Haemophilia 19(2): e73–83. Google Scholar logo with link to Google Scholar
Maneesriwongul, Wantana, and Jane K. Dixon. 2004. “Instrument translation process: A methods review.” Journal of Advanced Nursing 48(2): 175–186. Google Scholar logo with link to Google Scholar
Marquis, Patrick, Dorothy Keining, Catherine Acquadro, and Christine de la Loge. 2005. “Translating and evaluating questionnaires: Cultural issues for international research.” In Assessing Quality of Life in Clinical Trials: Methods and Practice, ed. by Peter Fayers and Ron Hays, 77–93. Oxford: Oxford University Press. Google Scholar logo with link to Google Scholar
McKenna, Stephen P., Lynda C. Doward, Jordi Alonso, Thomas Kohlmann, Mauro Niero, Luis Prieto, and Lena Wiren. 1999. “The QoL-AGHDA: An instrument for the assessment of quality of life in adults with growth hormone deficiency.” Quality of Life Research 81: 373–383. Google Scholar logo with link to Google Scholar
Mellinger, Christopher D., and Thomas A. Hanson. 2017. Quantitative Research Methods in Translation and Interpreting Studies. London: Routledge.Google Scholar logo with link to Google Scholar
. 2022. “Latent variables in translation and interpreting studies: Ontology, epistemology, and methodology.” In Contesting Epistemologies in Cognitive Translation and Interpreting Studies, ed. by Sandra L. Halverson and Álvaro Marín García, 104–128. New York: Routledge. Google Scholar logo with link to Google Scholar
. 2024. “Psychometric properties of survey translations: A simulation study.” Translation, Cognition & Behavior 7(1): 159–185. Google Scholar logo with link to Google Scholar
Mota Falcão, Rozana Mesquita Ciconelli, and Marcos Bosi Ferraz. 2003. “Translation and cultural adaptation of health questionnaires: An evaluation of methodology.” The Journal of Rheumatology 30(2): 379–385.Google Scholar logo with link to Google Scholar
Newmark, Peter. 1991. Paragraphs on Translation. Clevedon: Multilingual Matters.Google Scholar logo with link to Google Scholar
Ozolins, Uldis. 2009. “Back translation as a means of giving translators a voice.” Translation & Interpreting 1(2): 1–13.Google Scholar logo with link to Google Scholar
Ozolins, Uldis, Sandra Hale, Xiang Cheng, Amelia Hyatt, and Penelope Schofield. 2020. “Translation and back-translation methodology in health research–A critique.” Expert Review of Pharmacoeconomics and Outcomes Research 20(1): 69–77. Google Scholar logo with link to Google Scholar
Pan, Yuling, and Manuel de La Puente. 2005. “Census bureau guideline for the translation of data collection instruments and supporting materials: Documentation on how the guideline was developed.” Research Report Series, Survey Methodology. Statistical Research Division. Washington, DC: U.S. Bureau of the Census.Google Scholar logo with link to Google Scholar
Perneger, Thomas V., Alain Leplège, and Jean François Etter. 1999. “Cross-cultural adaptation of a psychometric instrument: Two methods compared.” Journal of Clinical Epidemiology 52(11): 1037–1046. Google Scholar logo with link to Google Scholar
Przepiórkowska, Danuta. 2016. “Translation of questionnaires in cross-national social surveys: A niche with its own theoretical framework and methodology.” Między Oryginałem a Przekładem 22(1/31): 119–133. Google Scholar logo with link to Google Scholar
Regnault, Antoine, Jean-François Hamel, and Donald L. Patrick. 2015. “Pooling of cross-cultural PRO data in multinational clinical trials: How much can poor measurement affect statistical power?” Quality of Life Research 241: 273–277. Google Scholar logo with link to Google Scholar
Regnault, Antoine, and Michael Herdman. 2015. “Using quantitative methods within the universalist model framework to explore the cross-cultural equivalence of patient-reported outcome instruments.” Quality of Life Research 241: 115–124. Google Scholar logo with link to Google Scholar
Shishido, Kuniaki, Noriko Iwai, and Tokio Yasuda. 2009. “Designing response categories of agreement scales for cross-national surveys in east Asia: The approach of the Japanese general social surveys.” International Journal of Japanese Sociology 18(1): 97–111. Google Scholar logo with link to Google Scholar
Swaine-Verdier, Angelo, Lynda C. Doward, Peter Hagell, Hanne Thorsen, and Stephen P. McKenna. 2004. “Adapting quality of life instruments.” Value in Health 7(1): S27–30. Google Scholar logo with link to Google Scholar
Thiery, Christopher. 1978. “True bilingualism and second-language learning.” In Language Interpretation and Communication. NATO Conference Series, ed. by David Gerver and H. Wallace Sinaiko, 145–153. Boston: Springer. Google Scholar logo with link to Google Scholar
Thorsen, Hanne, Troels M. Hansen, Stephen P. McKenna, Søren F. Sørensen, and Diane Whalley. 2001. “Adaptation into Danish of the Stanford Health Assessment Questionnaire (HAQ) and the Rheumatoid Arthritis Quality of Life Scale (RAQoL).” Scandinavian Journal of Rheumatology 30(2): 103–109. Google Scholar logo with link to Google Scholar
Tirkkonen-Condit, Sonja. 2005. “The monitor model revisited: Evidence from process research.” Meta 50(2): 405–412. Google Scholar logo with link to Google Scholar
Tyupa, Sergiy. 2011. “A theoretical framework for back-translation as a quality assessment tool.” New Voices in Translation Studies 71: 35–46.Google Scholar logo with link to Google Scholar
Villar, Ana. 2009. “Agreement answer scale design for multilingual surveys: Effects of translation-related changes in verbal labels on response styles and response distributions.” Unpublished Ph.D. dissertation. Lincoln, NE: University of Nebraska. [URL]
Ware, John E., Susan D. Keller, Barbara Gandek, John E. Brazier, and Marianne Sullivan. 1995. “Evaluating translations of health status questionnaires. Methods from the IQOLA Project.” International Journal of Technology Assessment in Health Care 11(3): 525–551. Google Scholar logo with link to Google Scholar
Wild, Diane, Alyson Grove, Mona Martin, Sonya Eremenco, Sandra McElroy, Aneesa Verjee-Lorenz, and Pennifer Erikson. 2005. “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 in Health 8(2): 94–104. Google Scholar logo with link to Google Scholar
World Health Organization. n.d. “Process of translation and adaptation of instruments.” [URL]
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