Home  Publications Research Papers Work in Progress Classification of Translations |
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Classification of Translations |
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Page 8 of 8 Conclusion
There is a need to develop a standardized classification system for the translations of PRO measures. This system should be based on the review of existing classifications and include input from the key stakeholders- developers, users and regulatory agencies as well as documentation specialists. It should ideally be based on the recognition that a standardized translation methodology is key to ensuring conceptual equivalence and cultural relevance across languages to ultimately support international comparison and pooling of data. This classification system should include a multi-step process where each step can be used as a building block to which an additional step can be added. This could provide an increasing level of confidence about the validity of a translation for the context in which the PRO measure and its translation will be used. For example, different levels of confidence may be expected if the PRO measure is being used as an exploratory, primary or secondary endpoint in a research programme. The new, standardized classification system might then be extended to all translations in the PRO field. References | 1 | Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N, for the European Regulatory Issues on Quality of Life Assessment (ERIQA) group. Patient-Reported Outcomes: The Example of Health-Related Quality of Life – A European guidance document for the improved integration of Health-Related Quality of Life assessment in the drug approval process. DIA Journal 2001;36:209-38. | | 2 | Draft Guidance for Industry – Patient-reported Outcomes Measures: Use in Medical Product Development to support Labeling Claims. Docket 2006D-0044, FDA Federal Register, 2006. | | 3 | Acquadro C, Konway K, Hareendran A, Aaronson N. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value in Health, 2007. Accepted. | | 4 | Maneesriwongul W, Dixon JK. Instrument translation process: a methods review. J Adv Nurs. 2004;48(2):175-86. | | 5 | Nadjar A, Berne C, Mear I, Jones P. A classification of the St George’s Respiratory Questionnaire Translations. ERS Congress Munich, 2006. | | 6 | Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31. | | 7 | Swaine-Verdier A, Doward LC, Hagell P, Thorsen H, McKenna SP. Adapting quality of life instruments. Value in Health 2004;7(Suppl 1):27-30. | | 8 | Newmark, P. About Translation. Clevedon: Philadelphia; Multilingual Matters, 1991. |
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