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Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report

Abstract

Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report Abstract. Objectives: With the internationalization of clinical trial programs, there is an increased need to translate and culturally adapt patient-reported outcome (PRO) measures. Although guidelines for good practices in translation and linguistic validation are available, the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Task Force identified a number of areas where they felt that further discussion around methods and best practices would be beneficial. The areas identified by the team were as follows: 1) the selection of the languages required for multinational trials; 2) the approaches suggested when the same language is required across two or more countries; and 3) the assessment of measurement equivalence to support the aggregation of data from different countries. Methods: The task force addressed these three areas, reviewed the available literature, and had multiple discussions to develop this report. Results: Decision aid tools have also been developed and presented for the selection of languages and the approaches suggested for the use of the same language in different countries. Conclusion: It is hoped that this report and the decision tools proposed will assist those involved with multinational trials to 1) decide on the translations required for each country; 2) choose the approach to use when the same language is spoken in more than one country; and 3) choose methods to gather evidence to support the pooling of data collected using different language versions of the same tool.

About the Authors

Diane Wild
Oxford Outcomes Ltd
United Kingdom


Sonya Eremenco
United BioSource Corporation
United States


Isabelle Mear
Mapi Research Institute
France


Mona Martin
Health Research Associates, Inc
United States


Caroline Houchin
Oxford Outcomes Ltd
United Kingdom


Mary Gawlicki
Corporate Translations, Inc
United States


Asha Hareendran
Global Outcomes Research
United Kingdom


Ingela Wiklund
Global Health Outcomes
United Kingdom


Lee Yee Chong
Formerly at AHP Research Ltd
United Kingdom


Robyn Von Maltzahn
Oxford Outcomes Ltd
United Kingdom


Lawrence Cohen
Washington State University
United States


Elizabeth Molsen
International Society for Pharmacoeconomics & Outcomes Research
United States


A. V. Pavlysh
First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia
Russian Federation

к.м.н., докторант,

г. Санкт-Петербург



E. V. Verbitskaya
First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia
Russian Federation

к.ф.-м.н., ассистент, 

г. Санкт-Петербург



References

1. Wild D., Grove A., Martin M.L., et al. ISPOR principles of good practice: the cross-cultural adaptation process for patient reported. Value Health 2005;8:94-104.

2. Acquadro C., Conway K., Hareendran A., Aaronson, N., for the ERIQA Group. Literature review of methods to translate health related quality of life questionnaires for use in multinational clinical trials. Value Health 2008;11:509-21.

3. Eremenco S., Cella D., Arnold B.J. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval Health Prof 2005;28:212-32.

4. Bonomi A.E., Cella D.F., Hahn E.A., et al. Multilingual translation of the functional assessment of cancer therapy (FACT) quality of life measurement system. Qual Life Res 1996;5:309-20.

5. Cella D., Hernandez L., Bonomi A.E., et al. Spanish language translation and initial validation of the functional assessment of cancer therapy quality-of-life instrument. Med Care 1998;36:1407-18.

6. Koller M., Aaronson N.K., Blazeby J., et al. Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach. Eur J Cancer 2007;43:1810-20.

7. Hunt S.M., Alonso J., Bucquet D., et al. Cross-cultural adaptation of health measures. European Group for Health Management and Quality of Life Assessment. Health Policy 1991;19:33-44.

8. Thumboo J., Fong K.Y., Chan S.P., et al. The equivalence of English and Chinese SF-36 versions in bilingual Singapore Chinese. Qual Life Res 2002;11:495-503.

9. Rungtusanatham M.J., Ng C.H., Zhao X., Lee T.S. Pooling data across transparently different groups of key informants: measurement equivalence and survey research. Decis Sci 2008;39:115-45.

10. Mark B.A., Wan T.T.H. Testing measurement equivalence in a patient satisfaction instrument. West J Nurs Res 2005;27:772-87.

11. Luo N., Chew L.H., Fong K.Y., et al. Do English and Chinese EQ-5D versions demonstrate measurement equivalence? An exploratory study. Health Qual Life Outcomes 2003;1:7.

12. Maneesriwongul W., Dixon J.K. Instrument translation process: a methods review. J Adv Nurs 2004;48:175-86.

13. Horn J., McA.rdle J. A practical and theoretical guide to measurement invariance in aging research. Exp Aging Res 1992;1:117- 44.

14. Mullen MR. Diagnosing measurement equivalence in cross national research. J Int Bus Stud 1995;26:573-96.

15. Davies S., Little I.S., Ross R. Ensuring the measurement equivalence and appropriate use of personality assessments across cultures. Paper presented at the Annual Meeting of the Society for Industrial-Organizational Psychology, May 2006, Dallas.

16. Scott Lennox J.A., Wu A., Boyer G., Ware J.E. Reliability and validity of French, German, Italian, Dutch, and UK English translations of the Medical Outcomes Study HIV Health Survey. Med Care 1995.

17. Stahl E., Postma D.S., Juniper E.F., et al. Health-related quality of life in asthma studies. Can we combine data from different countries? Pulm Pharmaco Ther 2003;16:53-9.

18. Smith C.S., Tisak J., Bauman T., Green E. Psychometric equivalence of a translated circadian rhythm questionnaire: implications for ISPOR Task Force Translation Guidelines 439 between- and within- population assessments. J Applied Psycho 1991;76:628-36.

19. Wee H.L., Ravens-Sieberer U., Erhart M., Li S. Factor Structure of the Singapore English version of the KINDL Children Quality of Life Questionnaire. Health Qual Life Outcomes 2007.

20. Timmerman E.M., Hoogstraten J., Nauta M., Meijer K. Structural comparison of a translated dental attitude questionnaire: a factor analytic study. Community Dent Oral Epidemiol 1996;24:236-9.

21. Poirier S., Bureau V., Lehoux C., et al. A factor analysis of the Strauss and Carpenter revised outcome criteria scale: a validation of the French translation. J Nerv Ment Dis 2004;192:864-7.

22. Vandenberg R.J., Lance C.E. A review and synthesis of the measurement invariance literature: suggestions, practices, and recommendations for organizational research. Organ Res Methods 2000;4-69.3

23. Scott N.W., Fayers P.M., Bottomley A., et al. Comparing translations of the EORTC QLQ-C30 using differential item functioning. Qual Life Res 2006;1103-15.

24. Pagano I.S., Gotay C.C. Ethnic differential item functioning in the assessment of quality of life in cancer patients. Health Qual Life Outcomes 2005;3:60.

25. Harvey P.D., Fortuny L.A., Vester-Blackland E., De Smedt G. Cross national cognitive assessment in schizophrenia clinical trials: a feasibility study. Schizophr Res 2002;59:243-51.

26. Patrick D.L., Burke L.B., Powers J.H., et al. Patient-reported outcomes to support medical product labelling claims: FDA perspective. Value Health 2007;10(Suppl.):S125-37.

27. Lenderking W.R. Comments on the ISPOR Task Force Report on Translation and Adaptation of Outcomes Measures: guidelines and the need for more research. Value Health 2005;8:92-3.


Review

For citations:


Wild D., Eremenco S., Mear I., Martin M., Houchin C., Gawlicki M., Hareendran A., Wiklund I., Chong L.Ye., Von Maltzahn R., Cohen L., Molsen E., Pavlysh A.V., Verbitskaya E.V. Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2015;(2):29-43. (In Russ.)

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