;   Medical Translation Insight: Readability is important (and difficult) when translating informed consent forms - ForeignExchange Translations

Readability is important when translating informed consent forms ICF (medical translation)Informed consent forms (ICFs) are required in all clinical trials which are approved by an independent Ethics Committee before practical use in the trials. However, how much the average patient actually understands of the information contained in an ICF is often uncertain - and that's before it is translated into other languages.

Most ICFs are too complex to understand by an average adult subject. One obvious solution is to reduce the complexity and increasing the ease of readability. This can be achieved by simple measures such as encouraging investigators to participate in the preparation of ICFs, gaining an enhanced understanding of the site specific requirements (culture, language and dialect, literacy rate, and so on), and, of course, improving the deficiencies in translation processes.

The gold standard of back translation is one way to improve translations but fewer and fewer sponsors are able to justify the time and expense required to implement it.

The best way to enhance understanding of translated ICFs is to make sure that they are written and translated to match the reading levels of the target patient population. Many Institutional Review Boards, suggest that the reading level of an ICF should be no higher than an 8th grade level, as JHM IRB does here. That's easier said than done, however.

For one thing, most ICFs can't quite make it "down" to an 8th grade reading level. Pharmalot, reporting on a recent analysis of ICFs, stated that Informed Consent Forms Target 11th Grade Readers.

For another, some experts question the validity of the 8th-grade target. In Six Questions to Ask About Consent Form Readability [PDF link], readability consultant Mark Hochhauser notes that there is little research to support this target and asks: "If a consent form is
24 single-spaced pages, will readability alone make a difference?"

Hochhauser goes on to give a good example of how readability formulas are confusing and maybe even misleading:

" I analyzed a consent form that came to our IRB through Readability Suite (http://www.oleandersolutions.com/) which gives readability statistics for 17 formulas. The scores ranged from grade 11.5 to 16 — a difference of 41/2 grades. If the readability formula doesn't matter, use the lowest scoring formula. If you're using the Flesch-Kincaid formula in Microsoft Word be aware that older versions of Word do not report scores higher than grade 12."
By the time medical translators receive texts, the writing has been completed. That does not mean, however, that reading levels aren't important in translation.

Many medical translators end up making translated texts more difficult. The reason? Keeping translations easy to read yet faithful to the original is hard work - and the extra work is rarely being compensated.

It takes time to understand the intended audience, think of ways to express the target-language text in suitable language, adapt each translation to each culture, and then to measure the resulting translation. And the linguist cannot work in a vacuum either - all of these items have the be coordinated and agreed upon between sponsor, site staff, and translator.

But without this kind of coordination, comprehensibility of translated informed consent documents and patient recruitment will suffer.

While we're on the subject, here are three more helpful articles:
Find out more about ForeignExchange's specialized medical translation services for international clinical trials.


  1. Mary Shillue said...
    Indeed. My mother, who holds a college degree, took part in a clinical trial. She had to read the informed consent form several times and still had questions. I think of this when working with our client's materials - consent forms or other documents. What if a family member's health depended on the outcome of the translation?
    Susana Valdez said...
    Going back to a previous article (Requirements for readability testing of PILs), do you know if the tests are done to the translations? Can you please direct me to some info on this? I'm writing an article about this subject, and this would be really helpful.

    Thanks so much!
    Andres Heuberger said...
    @Susana: Yes and No. One of the language versions must be tested for readability. It is usually English but could be any of the other EU languages.

    Simon Andriesen's presentation Readability Testing for Patient Information in Europe contains tons of information on what's required and how readability testing is done.
    Susana Valdez said...
    Thank you so much Andres. Such a quick answer and so helpful. :) By the way, I love the blog!
    Adriana Beaton said...
    I believe the translation should reflect the minimum education level of the country for which it is translated, i.e. the level of reading for the age when you are legally allowed to leave school (12, 14, 16 years of age). 8th grade level reading and comprehension means nothing in another country and might be ok for US English but not for another language.
    Olga Shrestha said...
    I have the same experience - that ICFs are often too complex. The translators are often templeted to simplify the style to make the text more readable and easy to understand, but their joy at improvement is short-lasting: the deviations from the original source text will "jump out" at back-translation, which is unavoidable 2nd phase of such projects. Too many deviations will require a re-translation and yet another back translation, which may well lead to a "catch 22" situation.

    [Via LinkedIn]
    Beatrice di Venosa said...
    When I translate such kind of text and I find some words a bit high in register I always ask my niece (14 years old) if she understands the word "anamnesi" instead of "storia medica" (medical history) or "effetti collaterali" instead of "effetti indesiderati" (side effects). These are examples for Italian, but this trick helps me to understand what is the best choice.
    Claudio Porcellana said...
    but, indeed, this is why laws say that ICFs are to be fully explained to patients by doctors and both must sign that all queries were answered, so what's the meaning of this post Andres?

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