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Simpler language makes for better clinical research - medical translation
We've said it before: Readability is important when it comes to clinical studies.

While informed consent forms (ICFs) are required in all clinical trials which are approved by an independent Ethics Committee, most ICFs are too complex to understand by an average adult patient. One obvious solution is to reduce the complexity and increase readability.

While this has been advocated for quite a while, clinical researchers have largely resisted efforts to encourage investigators to participate in the preparation of ICFs, gain an enhanced understanding of the site specific requirements (culture, language and dialect, literacy rate, and so on), and, of course, improve deficiencies in the translation process.

Despite this foot-dragging, pressure has been growing on researchers to improve communications to trial participants. Adding even more pressure is a recently published report which states that preparing lay studies is not just feasible but generally easy to do.

For the report, technical clinical results for two drugs were rewritten in layman's language. Extra touches were added, like sending thank-you cards to volunteers and updating them on the progress of reporting the results.

In discussing the report, The Wall Street Journal notes that:
"Volunteers appreciated the thanks and the updates. And a majority felt they understood the results of their trial very well or somewhat well after reviewing the lay summaries."
Efforts like these will have a positive impact on the entire clinical research chain, from patient recruitment, reporting, and translation.

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  1. cgtradmed said...
    About ICFs, there's a real problem in France, and maybe in Western Europe too, I think.
    To speak quite frankly, when I read an ICF which was initially prepared in English for an US audience - most of those I have to translate are of this type - I find myself torn by two contradictory feelings :
    My first reaction is to laugh out loudly at the reading of some paragraphs, while at the same time, if I imagine myself in the position of a patient, I feel insulted, wondering if the authors believed that they were addressing fools or, maybe, 5-years old children.

    One typical example, among many others : the description of blood taking. Everybody knows how blood tests are done, nowadays ! I'm always amazed when I read the description of the procedure, explaining in extensive detail the quantities taken, expressed as spoons, or even worse, as cups !!
    Almost better than Polanski’s Fearless Vampire Killers, or pardon me, but your teeth are in my neck (full original title).

    The problem is « the average patient ». This individual is different from one country to another one, and from a social class to another one inside the same country. While the educated patient will be shocked to be addressed like a foolish in a far too childish language, the less educated patients still may have difficulties to understand that childish language.

    When I was holding the fort once a week at the Secours Catholique (French Caritas), I was astounded to see the number of persons who could not read, or, when they could read, who were unable to just understand the content of a very simple administrative mail and, in a panic, were asking me to explain. For those persons, even the simplest ICF, written in the layest language possible, will remain incomprehensible to them.

    Last point : If you simplify the language used in ICFs in a too great extent, there will be a true gap between the lay terms that the patient will read in the document and the words that the physicians and the whole health staff will use and that the patient will hear in the « real life », during the study; this can be very destabilising to him/her as s/he would be unable to recognize what s/he read in the doctors speech.
    At least, it is the way .it works in France.

    Not so easy, isn’t it ?
    Suji said...
    When I was in college, we also conducted a research study about drug compliance. Our participants were residents in a community. At first, we used nursing/medical terms but the residents weren't able to comprehend everything. We modified our study and eventually we achieved better result.
    Cassy said...
    I would agree- simpler language makes it more understandable.

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