• Helene Bacher, Ramona Schweyen, Dirk Vordermark, Bernd Leplow, and Jeremias Hey.
• Department of Dental Prosthetics, University Hospital Halle/Saale, Halle (Saale), Germany.
• Patient Prefer Adher. 2020 Jan 1; 14: 1791-1799.

PurposeThe aim of the study was to develop an optimally designed and comprehensibly formulated patient information leaflet (PIL) to improve patients' memory of information provided by physicians during a radiotherapy (head and neck area) consultation. This PIL was tested on unaffected probands for its usefulness in clinical practice.Patients And MethodsA panel of experts compiled the main topics using Lawshe's content validity ratio. Flesch's Reading Ease Score (FRE) and the Baker Able Leaflet Design (BALD) index were adapted to appropriate values to determine text comprehensibility and graphic design. The evaluation involving unaffected participants (231 men, 380 women, 21 not specified; mean age = 32 ± 13.63 years, range = 18-79 years) was conducted based on three questionnaires for four groups of respondents with varying prior knowledge of the subject. When answering the questionnaires, only half the participants had access to the PIL.ResultsThe expert panel included 59 out of 75 proposed topics. After reformulations, the FRE was adjusted from 38.5 to 51.4. The BALD index ranged from 24 to 26, depending on the printout edition. The evaluation of 632 unaffected participants indicated a difference in the correctly answered items that ranged from 2.86% to 30.76% between participants with and without access to the PIL.ConclusionThe general guidelines for the design of written patient information material were met. The evaluation of unaffected volunteers resulted in an advantage by answering the questionnaires after receiving the PIL. This study supports health practitioners in the development, design, and evaluation of written information material using scientific methods. An evaluation should be performed on affected patients.© 2020 Bacher et al.

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