Readability-Testing of-PILsAs part of our specialist Bulgarian language services, we offer Bulgarian readability testing of patient information leaflets (PILs) to meet the standards and expectations of the regulators and your life science business.  We ensure that your patient information leaflets are clear and easy to read and use.

How the testing works

The aim of the readability test is to assess whether certain information can be found and properly understood.

The readability test starts with a preparation phase where the text of the leaflet is carefully edited.  We correct any spelling or grammatical errors and rephrase sentences if necessary.  We also check that the leaflet complies with the European Medicines Agency’s (EMA) Quality Review of Documents (QRD) template.

The next phase is the test preparation phase. This includes creating a list of about 15 questions that cover the most important aspects of the leaflet, specifically the safety and side effects. We also consider appropriate answers for the questions.

Next, we conduct a pilot test with five patients. The results from the pilot test are used to revise the leaflet (text and/or design) and the test questions if necessary.

The leaflet is then tested with two rounds of 10 participants (20 in total). The interviewer assesses each participant’s responses to the questions and provides feedback on the efficacy of the leaflet.