gms | German Medical Science

Background: For certain medicinal products, so-called Educational Material for healthcare professionals or patients are required as an additional risk minimisation measure (aRMM) as part of the marketing authorization process. To achieve this goal, the content and presentation of this Educational Material must be of high quality and tailored to the needs of the target group Currently, there is no established procedure for assessing the quality of Educational Material. The LEAS project (funded by the Federal Institute for Drugs and Medical Devices, grant number V-2023.1/1516 68605/2023-2025) aims to assess the quality of selected Educational Material using objective criteria. Therefore, appropriate evaluation criteria will be identified and a structured evaluation process will be developed.

Materials and Methods: A narrative literature search in PubMed and an additional search using Google were conducted to identify relevant criteria and assessment tools for evaluating written information materials. In the first step, suitable guidelines, standards, and evaluation instruments were selected from the search results. Sources and tools were deemed suitable if they provided objectively assessable criteria for evaluating written information and were widely recognized and utilized according to the literature. From the selected sources and tools, assessable criteria were extracted. In a second step, these criteria were categorized into thematic domains. This process led to the development of a criteria catalogue that facilitates evaluation within individual sources and tools in the first step and across sources and tools within thematic domains in the second step.

Results: In addition to the regulatory requirements for drafting Educational Material [1], [2], other sources were identified, including DIN 1450 on Lettering – Legibility [3] and DIN 8581-1 on Plain Language [4], [5], the Guideline on Evidence-Based Health Information [6], as well as two evaluation tools for written information: the LIX Readability Formula [7] and the Suitability Assessment of Materials (SAM) [8]. These sources provided suitable evaluation criteria, which were categorized into the following thematic groups: formal requirements, legibility/typography, content, readability, layout, graphics, and learning stimulation/ motivation.

Conclusion: Suitable criteria were derived from the broad range of guidelines and recommendations identified in the literature for evaluating written information materials, and a two-stage, objective evaluation procedure was established. The next step involves a criteria-based evaluation of selected Educational Material. Additionally, this Educational Material will be assessed by the target audience in following projects.