Abstract

Background
Informed consent is fundamental to ethical research, yet participant information leaflets (PILs) are often technical and difficult to understand. Although the importance of accessible study materials is widely recognised, practical guidance on how to develop them remains limited. For RaCeR 2, a randomised controlled trial evaluating different approaches to rehabilitation after shoulder rotator cuff repair, the baseline PIL was developed using Health Research Authority guidance. Early PPI consultation identified major concerns including dense formatting, overly complex language, and an unwelcoming tone, indicating the need for substantial redesign to support informed participation.

Description of Patient and Public Involvement Activity
A diverse PPI group (n = 5) supported the development of an accessible PIL. Contributors varied in age, gender identity, ethnicity, preferred language, employment status, disability, and experience of shoulder surgery. Engagement methods were tailored to participant needs and included online discussions, written feedback, and in-person “think-aloud” sessions. Given the depth of insight provided during initial PPI consultation, we adopted an iterative, user-centred approach drawing on co-design principles to enable contributors to directly influence the content, structure, and presentation of the PIL.

Outcome of the Patient and Public Involvement Activity
Contributors identified challenges with the original materials, including confusing layout, inaccessible formatting, technical terminology, and a tone that did not feel supportive. Through iterative cycles of review and refinement guided by co-design principles, the leaflet was substantially redesigned to include clearer headings, formatting aligned with British Dyslexia Association guidance, bullet-pointed and tiered information, simplified explanations of data protection, and a more conversational tone. Accessibility testing confirmed compatibility with freely available online screen-reading software. During the subsequent regulatory review, inconsistencies between legal requirements and participant preferences highlighted tensions that may limit the accessibility of study materials.

Conclusions
This commentary provides a pragmatic example of integrating co-design principles within PPI to create a more accessible PIL. Early engagement, flexible methods, iterative feedback, and testing with screen reading software were central to the process. Our experience also highlights the need for continued dialogue between researchers and regulators to ensure that participant-facing materials meet ethical and legal requirements while remaining understandable to all potential participants.

Plain English summary
When people take part in health research, it is important they understand what the study involves so they can make an informed choice. Researchers usually provide a written information leaflet, but many are difficult to read, particularly for people with lower literacy, disabilities, neurodivergent conditions, or for whom English is not their first language.RaCeR2 is a study comparing two approaches to helping people recover after shoulder surgery. When preparing to start the study, we drafted an initial leaflet using official guidance, but patients reported that it was hard to read, the images were confusing, it was long, and the tone felt “cold.” In response, we collaborated with a group of patients and public contributors to make the leaflet more accessible. Some joined online meetings, others provided written feedback, and one participated in in-person sessions, sharing thoughts aloud while reading the leaflet. This led to major changes: simplified language, clearer layout, bullet points, improved fonts and colours, and testing with screen readers. However, when submitting the leaflet for Health Research Authority approval, several changes were requested, including additional legal information, making the document longer, more complex, and less aligned with patient preferences. Our experience shows that involving patients and the public makes information leaflets clearer and easier to use. But we also learned that current rules can make it difficult to keep the leaflet simple and accessible. We need better ways for researchers and regulators to work together so that study information meets legal requirements and is easy for everyone to understand when deciding whether to take part.