The 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 Methods: A 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. Results: The 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. Conclusion: The 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.

Purpose: A patient information leaflet (PIL) on oral and dental care during radiotherapy was tested whether and at which time during therapy it would be helpful to increase the knowledge about the therapy and the resulting side effects and the management of these. Additionally, the participants' subjective perception of being well informed about the topic was examined. Participants and Methods: Surveys were conducted in August 2018-April 2019, at the University Hospitals Halle and Leipzig (Germany). The study population consisted of patients who were treated with radiotherapy in the head and neck region. Half of them received access to the PIL. The survey was conducted with three different versions of a printout questionnaire, which covered the relevant topics at three different times of therapy. The time the participants were surveyed depended on the time of their first therapy appointment. The items of the questionnaires tested their concrete knowledge and assessed the subjective perception of the level of information received. Results: Of the 81 participants who received the PIL, 93.8% read it and 92.1% of them considered it helpful. The sample comprised 181 participants aged 32 to 85 years (M = 62.9), of which 135 were males, 42 were females, and 4 were unspecified. Evaluation showed a difference of 4.7%; 18.5%; and 13.6% in correct answers between subjects with and without access to the PIL before, during, and after the therapy, respectively. The assessment of the participants' personal information level was independent of their access to the PIL (chi-squared test, p = 0.89). Conclusion: Having access to the PIL increased participants' ability to answer the questionnaires correctly. Access to the PIL had no influence on the subjective feeling of being well informed.

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