Sense and readability: participant information sheets for research studies

Area of Science:

• Clinical research ethics
• Patient communication

Background:

• Informed consent is crucial for research participation.
• Patient information sheets are intended to facilitate understanding but are often perceived as lengthy and complex.
• Recommended reading level for patient information is grade 6 (11-12 years old).

Purpose of the Study:

• To assess changes in the readability of participant information sheets over time.
• To determine if study characteristics correlate with reduced readability.
• To examine the relationship between readability, study characteristics, and recruitment success.

Main Methods:

• Analysis of 522 information sheets from the UK National Institute for Health Research Clinical Research Network: Mental Health portfolio.
• Readability assessment using the Flesch reading index and Grade level test.
• Correlation analysis between study characteristics, readability, and recruitment success.

Main Results:

• Information sheets have increased in length and complexity over time.
• The average readability level was grade 9.8 (15-16 years old), significantly above the recommended grade 6.
• Patient involvement positively correlated with recruitment success; pharmaceutical/device trials were least successful. Sheet complexity had minimal impact on recruitment.

Conclusions:

• Participant information sheets significantly exceed recommended readability levels.
• Increasing legal content may contribute to complexity.
• Clearer guidance is needed for researchers on writing accessible information sheets, balancing legal requirements with participant comprehension.