User testing

User testing is a set of package leaflet (PL) analysis methods aimed at studying the readability, comprehensibility and ease of perception of PL by target groups of patients. The purpose of including user testing as an addition to the PL is to improve the developed and submitted as part of the drug registration dossier and to create a PL that allows the majority of drug users to make safe and correct decisions about its use.

The key point in the development of a PL is how easily the user perceives information in the process of reading. The perception of the text and its readability are influenced by both polygraphic factors (proportions, letter sizes, their color, contrast and boldness of the font, the distance between letters), and linguistic features of the presentation of the material (the length of words and sentences, the complexity of syntactic constructions, the repetition of the same words, an abundance of terms).

There are also a number of font requirements including minimum font size, typeface, styles. If the medicinal product is intended for the treatment of an eye disease, a larger type should be used. Thoughtful document navigation (headings and subheadings), line spacing, print color, etc. are of great importance.

For each test, a questionnaire is developed (12-13 questions) which reflects all the important and complex aspects of the use of the drug. When preparing for the study, it is necessary to make sure that the questions reflect all the features of the safe and effective use of drugs. Questions in the questionnaire should follow in a random order, different from the submission of information in the leaflet.

Initially, a pilot test is conducted, in which 3-6 participants participate to check the correctness of the questions. The main testing is carried out on 10 participants. All necessary changes are made to the PL based on the first stage of the study. Further testing is repeated on the next 10 participants until satisfactory results are obtained.