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The Official News & Technical Journal Of The International Society For Pharmacoeconomics And Outcomes Research


Caroline Houchin MA, Translation Coordinator, and Diane Wild MSc, BSc, Director, Oxford Outcomes Ltd., Oxford, UK, and Sheryl Pease MBA, Pfizer, Inc., Ann Arbor, MI, USA

Same Language, Different Country: Do All Roads Lead to Rome?

Due to increasing interest in assessing Patient Reported Outcomes in multi-national clinical trials, it is necessary to have cross-culturally valid instruments in order to pool data across countries. With the changing of boundaries and the fluidity of populations, choosing a language to correspond to a study site is an increasingly pertinent issue, and can be complicated. While one country can host several languages, certain languages are spoken in multiple countries, for example English, French, Spanish, Russian, and Arabic.

Determining Appropriate Methodology
Those involved in conducting multinational studies have sought to determine the methodology that should be employed for translating a questionnaire for particular groups of countries that share a language. However, there is no consensus on this issue, and certainly an absence of systematic evidence to support any single methodology over another. Thus, decisions are currently based on the ad hoc accumulation of experience and discussion by those involved in the planning of multinational trials and those involved in the translation and linguistic validation of PROs.

Despite the absence of guidance on the best strategy for same language/ different country translations, we have chosen to outline the relevant issues and to describe and critique current translation methodologies. It is hoped that this paper will be helpful in assisting with the decision making process in this area.

Potential Methodology
Four key methodologies exist for the development of a measure in one language for use in different countries. The first and simplest of these is to develop a single translation in a single country, to be used worldwide, on the assumption that because of its “simplicity”, the translated measure will be understood in other countries where the same language is spoken. The second methodology is to create a single version in one country which is reviewed early in the translation process in order to assess its comprehension in another target country. A third, alternative approach is to determine from the outset that a separate translation will be produced for each country, with translators working independently. Finally, it is also possible to establish from the outset that representatives from all countries involved will work together to a produce a single, universal language version to be used in multiple countries.

The methodologies are described below in the form of responses to frequently asked questions in this area.

Is It Possible To Create A Single Version In One Country And Use It Worldwide? There are advantages as well as disadvantages to this methodology, many of which are highlighted from the opposite perspective in subsequent sections. The key benefits are time and money: with only one translation needed, the translation can be used throughout the world as soon as it is completed. However, there are significant risks when using one language version that has not been checked for its suitability in other countries, including using language that is unfamiliar to respondents, brand names with which respondents cannot identify, and inappropriate idioms. One way of overcoming some of these may be to pilot test the translation in the appropriate patient groups in each of the countries where it is needed. Though more costly and time-consuming, should any changes be required as a result of the testing, the end result would be country-specific versions.

Would A Better Alternative Be To Develop A Single Translation In One Country And Review It To Assess Its Comprehension In Another Target Country? Preferably performed early in the translation process, one or two in-country consultants (native speakers of the target language, residing in the country in question and preferably with expertise in health outcomes and related medical research as well as in translation and/or translation management) can review the translation, and pilot testing in the appropriate patient group would usually be conducted. If a language version already exists this method will be quicker, but this may not be possible (see point b below). Based on the review the following actions can be taken:

a. Where no issues arise, there is no need for a separate version to be developed.
b. If issues do arise, they can be fed into the translation process with the aim of producing a single harmonised version of the measure. This may not be possible if the original version has already been used in trials or as the basis for other translations. In these cases it is necessary to create separate language versions, as in point c below.
c. Where significant irreconcilable differences arise, separate language versions can be developed for each country.

The in-country review of an existing language version will therefore result in language versions that are appropriate for use in different countries, whether this means separate language versions or one single version for use in multiple countries.

Again, several advantages and disadvantages are associated with this method. For example, checking that the vocabulary used is appropriate for each country ensures that the translation is more understandable and familiar to respondents, which may make them more comfortable completing the measure. This may especially be the case with older patients who are used to a more traditional language with fewer foreign loan words.

The inclusion of some items may have been due to their particular importance in the culture within which the measure was developed. These items may be less relevant in other cultures, where there may be certain related questions of greater importance that have not been included. Where this is the case, and if the developer can be consulted, decentering can occur. With the insertion of additional phrases or words into the translation for the new country, the original measure may consequently also be altered, if deemed acceptable and necessary by the developer. This can only happen if the measure has not already been translated in its original form On a non-linguistic level, there are other aspects which should be considered in terms of cultural relevance. For example, with the use of the metric system in some countries and the imperial system in others, cultural adaptation is required. When culturally adapting an item which includes a unit of measurement, the employment of a sensible degree of accuracy is recommended, for example 100 yards is better adapted to 100 metres than the more precise 91 metres. Similarly, product brand names may not be known in all countries. Substituting a cultural equivalent in these cases is a necessity. Another non-linguistic issue is the choice of response scales; an additional explanatory sentence or an example may be necessary in some countries to aid comprehension. Finally, the content of the measure might be deemed unsuitable for particular countries. For example, a questionnaire with items about sexual behaviour or alcohol consumption may cause offence in some cultures.

There are several disadvantages associated with developing a translation in one country and reviewing it for use in another country. It can be difficult to determine whether the changes suggested during a review of an existing translation are essential or rather the preferences of those doing the reviewing. It may also be a challenge for alternative, culturally sensitive wording to be found. In addition, logistically, using just one language version rather than numerous versions is more straightforward.

To demonstrate the variety in the types of changes necessary when reviewing an existing version, some examples are as follows. The Catalan for Spain translation of “education” (“Educació“) in the Polytrauma-Outcome Chart had to be changed to estudis for use with Catalan speakers in France. This is a simple vocabulary change.

A grammatical change was necessary when reviewing the Brazilian Portuguese translation of the same measure, for use in Portugal. In Brazil, the pronoun “you” (você) needs to be inserted in the phrase “have you become...” but pronouns are rarely used in this way in Portuguese for Portugal; instead the verb ending is relied upon to indicate the subject of the verb.

Cultural changes can also be necessary: in the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) one question asks the respondent whether they “lacked support in the ways you need from your spouse or partner?”. There was no problem translating this into Russian for use in Russia, but when the translation was reviewed for Ukraine it was necessary to remove “or partner” as Russian-speaking Ukrainians still mean “business partner” by this term. Another cultural change, this time in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, was to change “10lbs” to “5kg” in South African English. Lastly, in the Mini Mental State Examination (MMSE) respondents are asked “What is the county [we are in now]?” This was translated as Bundesland in German for use in Germany but when revised for Switzerland the term had to be replaced by kanton, as Switzerland is divided into cantons.

Should Separate Versions Be Produced For Each Country? The advantages and disadvantages of this approach are similar to those of the previous approach. However, one clear disadvantage with this process over the previous method is that creating separate language versions from the outset leads to a high risk of different translations, simply due to translator styles. It cannot be determined if one version would have been appropriate for use in both or all countries in question, or if all the differences between versions were absolutely necessary.

One advantage of this approach, however, is that the translators are not restricted by vocabulary and terms that may not be optimal for their country. For countries that share the same language but are different culturally, geographically or linguistically, this is also a benefit.

Is It Feasible To Create A Universal Language Version For Use In All Countries? This approach involves discussion at every stage between representatives of all countries involved, and also pilot testing with a relevant patient group in each of the target populations.

The production of a single harmonised version to be used in more than one country can be time consuming. Agreement is required at all points between consultants and reaching consensus might be difficult. This differs according to the countries and languages involved. One example of a problem encountered when trying to create a unified Spanish translation for use in both Spain and Mexico was in an Interactive Voice Response System (IVRS) bowel study script. When respondents were asked to “enter your PIN,” each in-country consultant used a different term for “enter” and could not accept the other country's word, as this had a different meaning in their own country. In the same measure, translations for AM and PM had to differ because while people living in Mexico use these terms, they are not frequently used or understood in Spain. This latter country used “morning” and “afternoon/evening” instead. In the Satisfaction with Oral Anti-Diabetic Agents Scale (SOADAS) a compromise was reached between France and Canada as numbers under ten are spelt out as words in Canada, whereas in France these are left as numerals. The final unified translation included the word followed by the figure in brackets. As we can see, when creating a unified translation, the final version may end up being a compromise: “acceptable” and not “ideal” for any of the countries concerned. It may also lack the richness of idioms that is often present in a language version for use in just one country. The principal advantage of this method, though, is that if only one version exists this will be simpler for those involved in running multinational trials.

Decision-making Criteria
Having explored the key methods for producing translations of a measure into one language for use in multiple countries, it is necessary to consider the following issues:

A. How much time and financial resources are available and what is the attitude to risk and error margin?

B. Developer requirements must be adhered to. Many developers do not advocate a specific strategy with regard to same language/different country translations; however there are some notable exceptions, including the EuroQol and the EORTC group. Thus it is necessary to take account of:
• The developer's translation requirements.
• Previously employed translation strategies of the measure in question.

C. The measure itself should be examined in order to determine the presence of characteristics that are likely to result in country-specific language differences. Such characteristics include:
• References to country-specific health care or education systems; • References to product names;
• Complicated vocabulary that will present challenges to the respondent;
• Response scales that can present cognitive challenges to the respondent;
• Areas of enquiry that may offend the respondent; and
• Technical details; for example ePRO scripts may include terminology that is unfamiliar in certain countries.

D. Thinking about the languages and countries in question is also important. The strategy to be employed will differ according to which language and which countries are being considered as certain countries and languages share more linguistically and culturally than others. Languages that are commonly translated for multiple countries include: English, Spanish, French, Portuguese, Chinese, Russian, Arabic, and Malay.

E. Finally there is a need to determine whether a language version is already in existence.

There are no hard and fast rules relating to the method that should be employed when translating a measure into one language for use in multiple countries. Guidelines can be followed which take into account the above criteria, but with the high number of factors involved in deciding on the best translation methodology to use, a number of options may still be available. The complexity and characteristics of the questionnaire might well be as important to the decision-making process as the language and countries involved. It may be beneficial to conduct more research into the methods described above, including comparing psychometric results of translations for use in the same countries but obtained by different methods. However, should conclusions be reached as a result of this research, it is still important to consider future projects on a case-by-case basis, due to differing characteristics of individual measures? Considering the highlighted pros and cons of each method should nonetheless facilitate the decision-making process.


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