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Creating concise and readable patient information sheets for interventional studies in Australia: are we there yet?
Tanya Symons1, Joshua S Davis2,3
1Department of Medicine and Health, Northern Clinical School, The University of Sydney, Sydney, Australia.
Trials
|September 21, 2022
Summary
Participant information sheets and consent forms (PICFs) in Australian interventional studies are too complex. Most PICFs exceed the recommended readability level, hindering participant understanding and informed consent.
Area of Science:
- Clinical Research
- Health Literacy
- Informed Consent
Background:
- Participant Information and Consent Forms (PICFs) in interventional studies frequently face criticism for poor readability and comprehension.
- Assessing the readability and associated factors of a diverse set of Australian PICFs is crucial for improving participant engagement.
Purpose of the Study:
- To evaluate the readability of Australian Participant Information and Consent Forms (PICFs) used in interventional studies.
- To identify factors correlating with PICF length and readability, including sponsor type and consent type.
- To assess compliance with established readability improvement measures.
Main Methods:
- Analysis of the participant information sheet component of 248 PICFs.
- Readability assessment using Flesch Reading Ease, Flesch-Kincaid Grade Level, and Simple Measure of Gobbledygook (SMOG) formulae.
- Correlation analysis of features like sponsor type and PICF type with length and readability; examination of readability best practices.
Main Results:
- Mean Flesch Reading Ease score was 49.3, Flesch-Kincaid Grade Level was 11.4, and SMOG score was 13.2.
- Median PICF length was 3848 words (8 pages).
- Commercial PICFs were longer but more readable (SMOG, p=0.03); self-consenter PICFs were more readable than proxy-consenter PICFs. Tables improved readability, illustrations did not.
Conclusions:
- Australian PICFs analyzed are lengthy and complex, with only 3 out of 248 meeting the Grade 8 or below readability benchmark.
- Adoption of best practices in consumer health information writing and development of adaptable templates can enhance PICF utility.
- Improving PICF readability is essential for ensuring genuine informed consent in clinical research.
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