Readability testing is an important component in the process of designing product literature (product information leaflets) as well as clinical documents (Informed Consent Forms, Patient Reported Outcomes questionnaires).
Such documents addressed to the lay public (patients or their carers) rather than life sciences professionals should be phrased in a manner that allows easy reading and comprehension by the general public.
Some people may have poor reading skills, and some may have poor health literacy. Therefore, FDA recommends that product literature and clinical documents meant for the lay public should match the reading level of a 8th grade student. For the same purpose, EMA has designed syntactic and stylistic guidelines and QRD templates that should be followed by those involved in the creation and multilingual translation of such documents.
Patient leaflet readability testing is a legal requirement for medicines in Europe. The testing should be performed by the medical writing/ regulatory team of the sponsor or CRO, but also by the translation agency undertaking the multilingual translation of these documents.
The goals of the PIL readability testing is to verify that the users can easily locate and understand the PIL information, and can explain it in their own words.
The translatability assurance process results in a report which highlights problematic words, items or response options, makes recommendations for re-wordings that will increase translatability, while pinpointing words or phrases that could benefit from further explanation or definition through a concept elaboration report.
A simple mechanism of reducing the reading difficulty level is by replacing, wherever possible, technical terms with common terms. Using tools like outlining, bullet points, a large typeface and diagrams can help the reader to follow complex concepts. Using active verbs rather than the passive voice, short sentences and frequent paragraphing can make text simpler.
Last but not least, readability should be checked by interviewing patients and/ or their carers on the understanding and ability to identify certain key elements in the scrutinized texts. Such interviews are prepared and administered by cognitive debriefing interview specialists based on specially designed questionnaires. The results are quantified and reported to the client, with recommendations to re-phrase certain items if needed.
Only when the readability testing has been successfully completed can the translation process continue, for results to be satisfactory and compliant with regulatory requirements of EMA, FDA etc.