Health literacy is the degree to which individuals have the ability to find, understand, and use information and services to inform health-related actions for themselves and others¹. A 2015 report, commissioned by Public Health England, identified that up to 61% of the English working-age population do not routinely understand health and wellbeing information that they are given². Further, 7.1 million adults in the UK have been found to read at or below the level of an average 9-year-old³.

In the context of real-world patient- and caregiver-reported studies, a participant’s ability to understand study materials is essential for their meaningful and ethical involvement. The fact that participants may join and take part in the study remotely (and therefore may not have the opportunity to ask questions in person) further emphasizes the importance of content being clear, accurate, and concise.

Set of messy clew symbols connected between them line of symbols with scribbled round element, consept of transition from complicated to simple, isolated on white background Vector illustration.

What types of participant-facing content are included in real-world studies?

Real-world patient- and caregiver-reported studies can include a wide range of participant-facing content, including:

    • Materials advertising the study
    • Legal materials (i.e., informed consent documents, privacy policies, terms and conditions)
    • Survey content
    • Materials to update participants on study progress (e.g., webinars and newsletters)
    • Email updates and reminders.

What are the best practices for creating health-literate content?

Use simple language and short sentences
Use the active voice
Use large sans serif fonts
Break information down into sections, using bullet points and icons where appropriate
Highlight important text using call-out boxes or bold font
Use jargon, idioms, or too many acronyms
Use long sentences
Use long sections of text
Use unrelated images – these can be misleading or distracting
Require the reader to do calculations to understand the point

It is vital to tailor study content to the participant cohort, taking into account requirements and preferences that are common to the target population. Participants in real-world studies will vary in terms of their age, their level of education, the category and severity of their condition, as well as its potential impact on their attention span, vision, and motor skills. Further, certain terminology in relation to the condition of interest may be more familiar to the target population. Careful consideration needs to be given to the design and development of data collection tools and materials to ensure that participants are able and willing to engage. At Vitaccess, user-testing and focus groups with patient advocates and representatives help to ensure that participant preferences are accounted for in study design.

Crossing language and cultural barriers

Localization of study materials is key in ensuring that content is received consistently by participants in international studies. Adapting health-related content in the context of multi-country studies is no mean feat – the potential complexity and volume of study content necessitates involvement of localization experts specialized in life-sciences translation. These individuals will guide the localization process to meet national standards, while ensuring that health literacy of the content is maintained.

At Vitaccess, our in-house Patient-Centered Outcomes, Localization, and Marketing and Communications teams are experts in creating health-literate content to achieve a range of real-world study objectives. To find out more, get in touch at





By Fatemeh Amini and Emma Bagshaw

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