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:
- Back translations - useful or waste of time?
- Requirements for readability testing of PILs
- Talk about "usability", not "quality"
Find out more about ForeignExchange's specialized medical translation services for international clinical trials.
Categories: clinical research