A 2021 survey conducted by the Centre for Information and Study on Clinical Research Participation (CISCRP) found that a quarter of respondents do not feel confident about their knowledge and understanding of clinical research, which is consistent with the findings from previous years. Fear and mistrust of research are linked to a lack of knowledge and understanding of clinical research and are barriers to public involvement in research.
In recent years, there has been a move towards involving patients more in healthcare decisions. While information about the latest treatments and research is now available online, this is often presented in technical and complex language that non-expert readers struggle to understand and could be misinterpreted. This is starting to be addressed through plain language summaries of publications (PLSPs). A PLSP is a summary of a publication written in clear, easy-to-understand, non-technical language for a non-scientifically trained audience. The Good Publication Practice (GPP) 2022 update now recognises PLSP as a type of publication that should be written according to the plain language writing principles.
Patients are a key audience for PLSPs, but these are also valuable for caregivers or family members, healthcare professionals, scientists, journalists, regulatory reviewers, and the general public. A well-written PLSP facilitates discussions, especially between patients and their healthcare providers to support shared healthcare decision-making.
To produce good PLSPs, sponsors need to carefully consider the following aspects:
- Develop a PLSP strategy
While PLSPs are not mandatory for most journals, these can help sponsors achieve their patient-centricity goals. Sponsors should develop a PLSP strategy, for example, decide whether they will develop PLSPs for all publications or only for select publications based on defined criteria. While defining the criteria for PLSPs, they should consider factors such as the phase of the clinical study, type of clinical study, and drug product status.
- Determine the sourcing model and budget
Writing PLSPs requires a particular set of skills that enables the understanding of complex scientific concepts and translating these into easy-to-understand language. Scientific writers who support manuscript writing and editing activities may not possess the appropriate skills. Decisions need to be made on the best sourcing approach: to retrain existing writers, recruit plain language writers, or outsource PLSP writing to an experienced vendor. The budget supporting the sourcing model and strategy should be determined.
- Define the process and criteria for creating PLSPs
Many factors impact the PLSP writing process and journal requirements are rapidly changing. Not all journals accept a PLSP. There is no standard format for PLSPs across journals and the format mandated often differs. Some journals however, such as Future Medicine, have less restrictive requirements and accept standalone PLSPs for articles published in any journal. Sponsors need to consider these factors while defining the PLSP process.
- Disseminate PLSPs effectively
It is best practice to publish PLSPs as open-access publications. Once PLSPs are published, it is important to raise awareness about them. Sponsors should establish approaches for disseminating PLSPs (e.g., via patient advocacy groups, sharing information via social media) so that their reach and value to the intended audience are maximised.
- Measure impact
Many journals allow sponsors to track metrics of the number of clicks, downloads and citations for PLSPs. These measures can help quantify the impact of PLSPs. In addition, feedback could be sought from readers through patient advocacy groups. This can help further refine the PLSP process.
The experts at Krystelis have helped several sponsors establish their plain language communication strategy and processes. To learn more about our services, contact us at [email protected].