Guidelines for the process of cross-cultural adaptation of self-report measures.

With the increase in the number of multinational and multicultural research projects, the need to adapt health status measures for use in other than the source language has also grown rapidly. Most questionnaires were developed in English-speaking countries, but even within these countries, researchers must consider immigrant populations in studies of health, especially when their exclusion could lead to a systematic bias in studies of health care utilization or quality of life. The cross-cultural adaptation of a health status selfadministered questionnaire for use in a new country, culture, and/or language necessitates use of a unique method, to reach equivalence between the original source and target versions of the questionnaire. It is now recognized that if measures are to be used across cultures, the items must not only be translated well linguistically, but also must be adapted culturally to maintain the content validity of the instrument at a conceptual level across different cultures. Attention to this level of detail allows increased confidence that the impact of a disease or its treatment is described in a similar manner in multinational trials or outcome evaluations. The term “cross-cultural adaptation” is used to encompass a process that looks at both language (translation) and cultural adaptation issues in the process of preparing a questionnaire for use in another setting. Cross-cultural adaptations should be considered for several different scenarios. In some cases, this is more obvious than in others. Guillemin et al suggest five different examples of when attention should be paid to this adaptation by comparing the target (where it is going to be used) and source (where it was developed) language and culture. The first scenario is that it is to be used in the same language and culture in which it was developed. No adaptation is necessary. The last scenario is the opposite extreme, the application of a questionnaire in a different culture, language and country—moving the Short Form 36-item questionnaire from the United States (source) to Japan (target) which would necessitate translation and cultural adaptation. The other scenarios are summarized in Table 1 and reflect situations when some translation and/or adaptation is needed. The guidelines described in this document are based on a review of cross-cultural adaptation in the medical, sociological, and psychological literature. This review led to the description of a thorough adaptation process designed to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires.. Further experience in cross-cultural adaptation of generic and diseasespecific instruments and alternative strategies driven by different research groups have led to some refinements in methodology since the 1993 publication.. These guidelines serve as a template for the translation and cultural adaptation process. The process involves the adaptation of individual items, the instructions for the questionnaire, and the response options. The text in the next section outlines the methodology suggested (Stages I–V). The subsequent section (Stage VI) presents a suggested appraisal process whereby an advisory committee or the developers review the process and determine whether this is an acceptable translation. Although such a committee or the developers may not be engaged in tracking translated versions of the instrument, this stage has been included in case there is a tracking system. Records of translated versions not only can save considerable time and effort (by using already available questionnaires) but also avoid erroneous comparisons of results across different translated versions. The process of cross-cultural adaptation tries to produce equivalency between source and target based on content. The assumption that is sometimes made is that this process will ensure retention of psychometric properties such as validity and reliability at an item and/or a scale level. However, this is not necessarily the case: For instance, if the new culture has a different way of approaching a task that makes it inherently more or less difficult compared with other items, it would change the validity, certainly in terms of item-level analyses (such as item response theory, similar to Rasch). Further tests should be conducted on the psychometric properties of the adapted questionnaire after the translation is complete. This will be discussed briefly at the end of the guidelines. In fact, the translation process outlined in this article is the first step in the three-step process adopted by the International Society for Quality of Life Assessment (IQOLA) project. The other two steps From the *Institute for Work and Health; †St. Michael’s Hospital; Departments of ‡Occupational Therapy and 4Medicine and the §Clinical Epidemiology and Health Care Research Program, University of Toronto ¶The University Health Network, Toronto General Hospital; and #Mt. Sinai Hospital, Toronto, Ontario, Canada; **Ecole de Sant, Publique, Facult, de M,decine,Vandoeuvre-les-Nancy, France; and the ††Division of Rheumatology, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de Sõo Paulo, Sõo Paulo, Brazil. Supported in part by the American Academy of Orthopaedic Surgeons and the Institute for Work & Health who co-sponsored the development of these guidelines. DB was supported by a Medical Research Council of Canada PhD Fellowship during the preparation of this work.