Background: Peer-reviewed scientific publications and congress abstracts are typically written by scientists for specialist audiences; however, patients and other non-specialists are understandably interested in the potential implications of research and what they may mean for them. Plain language summaries (PLS)-summaries of scientific articles in easy-to-read language-are emerging as a valuable addition to traditional scientific publications. Co-creation of PLS with the intended audience is key to ensuring a successful outcome, but practical guidance on how to achieve this has been lacking.
Methods: Building on the Patient Engagement (PE) Quality Guidance previously developed by Patient Focused Medicines Development (PFMD), a multi-stakeholder working group (WG) of individuals with patient engagement experience and/or expertise in PLS was established to develop further activity-specific guidance. PLS guidance was developed through a stepwise approach that included several rounds of co-creation, public consultation (two rounds), internal review and a final external review. The iterative development process incorporated input from a wide variety of stakeholders (patient representatives, industry members, publishers, researchers, medical communications agencies, and public officials involved in research bodies). Feedback from each step was consolidated by the WG and used for refining the draft guidance. The final draft was then validated through external consultation.
Results: The WG comprised 14 stakeholders with relevant experience in PE and/or PLS. The WG developed a set of 15 ethical principles for PLS development. These include the necessity for objective reporting and the absence of any promotional intent, 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 The first public consultation yielded 29 responses comprising 478 comments or edits in the shared draft guidance. The second public consultation was an online survey of 14 questions which had 32 respondents. The final 'How-To' Guide reflects feedback received and provides a rational, stepwise breakdown of the development of PLS.
Conclusions: The resulting 'How-To' Guide is a standalone, practical, ready-to-use tool to support multi-stakeholder co-creation of PLS.
Keywords: Patient engagement; Plain language summary; Scientific publication.
We wanted to create practical guidance for people who are interested in developing plain language summaries of publications (PLS for short). PLS are summaries of scientific research published in journals or presented at conferences and are written in language that is easy to read and understand. We focused on how to involve patients in developing PLS, as they are often an important audience for these summaries. We brought together a group of people who had experience in PLS and patient involvement. As a working group, we wrote the first version of the ‘How-To’ Guide. Then we asked for feedback from others experienced in patient involvement and also from members of the general public. We got feedback on how we could improve what was in the guidance and also on how useful and user-friendly the guidance was. We used this feedback to create the final version of the ‘How-To’ Guide which is freely available online from https://pemsuite.org/How-to-Guides/WG5.pdf .
© 2022. The Author(s).