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Overview

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.

 

Who should attend?

Professionals involved in the writing of documents for study participants to either increase recruitment or retention and people active in the writing of lay summaries of clinical study results or similar documents. This includes people in clinical operations, medicine, and medical writing.

 

Learning objectives

At the conclusion of this short course, attendees will be able to:
• Assess the usefulness (and also the limits) of the different instruments used to assess the readability as well as the ease of understanding (Hamburg Index) of texts.
• Explain the importance of sentence length, word choice, layout and tonality and other factors related to the understanding of texts.
• Recognise factors to be taken into account for effective communication with a lay audiences
• Develop an approach for implementing company standards for the writing of lay-friendly texts