Generating Plain Language Summaries of Scientific Publications with Ethical Foundations: A Practical “How-To” Guide Cocreated with Patients

Abstract

Peer-reviewed scientific publications are written by scientists with peers in mind. However, there is a growing demand of patients and other nonspecialists to understand the potential implications of clinical and medical research. Research summaries of scientific articles in easy-to-read language—called plain language summaries (PLS)—are currently being developed to broaden the reach of scientific articles beyond expert audiences. While PLS can help nonexperts to understand and be informed about scientific articles, there is a risk that PLS contribute to publication bias and hence misinformation of patients and the public and thus achieve the opposite of their intention. Potential issues are an unbalanced selection of the scientific source articles for which a PLS is initiated, lack of alignment of the data presented in the PLS and in the source article, unbalanced reporting of efficacy and safety data, absence of reporting the primary endpoint, or over- or underreporting of secondary endpoint results. To objectively inform patients and to become a trustworthy source of information, the writing of PLS needs to be firmly embedded in a set of ethical principles. To safeguard balanced and fair PLS writing, the cocreated “How To” Guide on PLS writing developed by the Patient Focused Medicines Development initiative comprises a set of 15 ethical considerations. These include the necessity for objective reporting, the need for balanced presentation, the importance of audience focus, the need to apply health literacy principles, and the importance of using inclusive and respectful language. The “How-To” Guide was developed in a stepwise process with several rounds of cocreation, public consultation (two rounds), internal review, and a final external review. The iterative development process ensured input from a wide variety of stakeholders (patient representatives, industry members, publishers, researchers, medical communications agencies, and public officials involved in research bodies). The final “How-To” Guide is a standalone, practical, ready-to-use tool to support multistakeholder cocreation of PLS.