Readability Testing: Practical recommendations for a standard methodology in assessing medical device or PIL Labelling

Readability Testing an important consideration in the development of patient information leaflets (PILs), labelling for medical devices, and clinical outcome assessments (COAs). It enables researchers and clinicians to assess the appropriateness of a given text for target patient populations and make any needed updates , thus promoting inclusivity, maximizing engagement, and enhancing COA measurement properties.

Existing regulatory guidelines for readability testing are scant, and no standardized methodological approach exists, leading to varied implementations and incomparability of results. Our poster (Readability Testing: Practical recommendations for a standard methodology in assessing medical device or PIL Labelling) reviews existing readability methodologies and proposes a rigorous, multi-step approach to address the gap in guidance and provide a new tool for ensuring patient comprehension of medical text.

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