Translating for Health: Review and Validation Procedures
Article By Mark Gibbson
Up until recently, reviewing translations was not accorded much, if any, importance. This is the sole reason why we often receive translated manuals for a whole host of consumer goods that are unreadable, nonsensical and useless. An example of how serious a lack of review could be in the pharmaceutical sector is illustrated in the following real (and anonymised) example from an English-to-Spanish translation:
• Source sentence: “XXX has not been proven to cause cancer“
• Forward translation: “Se ha probado que XXX no causa cáncer“ [Back Translation: “XXX has been proven not to cause cancer“]
• Reviewer’s amendment: “No se ha probado que XXX cause cáncer“ [Back Translation: “It has not been proven that XXX causes cancer].
In essence, if a reviewer were not involved in the above translation, the initial effort would have seriously incorrect. Imagine the legal ramifications of this case without the reviewer’s intervention…
The translation review process should be more than simply a proofread. The review procedure must have ‘all the bases’ covered (syntax, punctuation, spelling, general sense, etc.) and ideally be in accordance with the EN 15038 standard. This article focuses on some of the reviewing practices that I’ve encountered in the pharma and medical devices sectors.
Affiliates review
Multinational companies have native speaking affiliates all across the world. The larger companies clearly have hundreds of languages represented by staff in affiliate offices across the globe. Therefore, it is sensible for affiliates to be involved in checking over translations in their respective languages. The advantage of this is clear-cut: affiliates know the products, they are intimate with the subject matter and they understand the technical and scientific aspects of the translated texts.
However, the latter point can also be a disadvantage. For example, I have experienced a number of cases involving patient education materials (such as a PIL or information to support a Risk Management Plan), written for lay audiences, where affiliates have changed lay terms back to the technical terms. Clearly, where these lay terms have been arrived at following patient consultation in a PIL Test, the affiliates’ actions in these cases are completely counterproductive. What is even more counterproductive is the policy of some multinationals to prioritise affiliates’ comments over those put forward by an independent reviewer.
Independent and Expert review
This independent review usually involves a simple review step after the translation, which can be just a read-through by a second person. This is most often conducted by an independent translator who is a native speaker of thesource text. This sounds like an obvious step to take, but it is surprising to learn how many translations do not undergo an independent review.
The expert review is, as its name suggests, a review undertaken by an expert in the subject matter in question. Typically, this would be a clinician or someone from a biomedical background with a published track record in the subject matter. Ideally, the expert review should be conducted in addition to the independent review, but both steps naturally add to the overall cost of the translation.
Parallel translations and independent review
Some companies perform parallel translations of the source text by two independent translators. These translations are then validated and reconciled by a third reviewer. This method is robust to some extent as it displays an influence from the gold standard methodology for linguistic validation of Patient-Reported Outcomes and Quality of Life instruments. However, it has its drawbacks. Primarily, it imposes additional costs to the translation process. Secondly, if this approach is outsourced to two translation agencies for the forward translations and given the point made above about different translation agencies potentially using the same pool of translators, it is possible, albeit remotely, for the two independent translators to be one and the same person. However, this risk is removed entirely by developing your own translation network.
Back translation
Back translation, the practice of translating word-for-word the target text back to the source text, was once the gold standard for translation review methods. While there are advantages to the back-translation approach, the disadvantages are evident: it is time-consuming and the costs of the back-translation equal those of the forward translation. However, there are areas of the pharmaceutical industry where back-translation is a Standard Operating Procedure, such as linguistic validation of measurement instruments, such as Quality of Life or Patient-Reported Outcome tools.
User consultation
This approach involves checking understanding with small numbers of native speakers of the language in question. This could be done by using a number of methods, depending on the client’s appetite for further reviewing, as this implies extra costs to the reviewing process. One method is conducted in the style of a ‘mini’ consumer evaluation test (not dissimilar from a readability test), another is cognitive debriefing, in much the same way as linguistic validation is carried out for multilingual questionnaires for clinical trials follow up studies.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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