This course will present the scientific background and the application of readability concepts for documents in the pharmaceutical industry. An overview of the history of readability research and introduce the different methods for the assessment of readability will be provided. Besides different readability formulas (Flesh-Kincaid Reading Ease, LIX, SMOG & Co.), qualitative models for the ease of understanding (e.g. Hamburg model) will be introduced. The strength and weaknesses of the various instruments will be discussed. To set the context the results of recent international literacy surveys will be summarised and the impact of their findings on the writing of documents for lay audiences assessed.

The second part will summarise the typical barriers for comprehension of written material and will show real-world solutions. Using examples from lay summaries and informed consent the impact of terminology, sentence length, word choice, and tonality on the ease of understanding will be demonstrated. The importance of the adequate structuring and layout of text, especially for readers with limited reading skills will be highlighted. Participants will learn different ways of establishing quality gates and benchmarks for lay-friendly text, from implementing writing rules to the management of terminology and the maintenance of a lay language glossary. A short in-class exercise will help participants to apply the information to the writing and improving of a pharmaceutical text.