Readability of patient information can be improved

Area of Science:

• Medical Research Ethics
• Clinical Trial Recruitment

Background:

• Declining participation in medical experiments is linked to participant information sheets (PIS) that impede informed consent.
• The PIS, central to informed consent, often retains technical language, creating a barrier between expert environments and lay recipients.
• Research ethics committee (REC) members' awareness of these PIS comprehension issues was investigated.

Purpose of the Study:

• To assess the extent to which research ethics committee (REC) members recognize comprehension barriers in participant information sheets (PIS).
• To identify specific terminology and content presentation issues within PIS that hinder understanding for lay recipients.

Main Methods:

• A mixed-methods approach involving retrospective analysis of REC applications and prospective surveys of REC members.
• Naïve reading and structural analysis of PIS to identify themes and subthemes.
• Focus group interviews with REC members to explore comprehension barriers, followed by a survey to quantify problematic terms and phrases.

Main Results:

• Key comprehension barriers identified include specialized terminology and content presentation issues.
• Problematic terms were concentrated in areas such as epidemiology, study design, anatomy, physiology, diagnostic procedures, and medications.
• Content-related problems involved irrelevant information and suboptimal organization and presentation.

Conclusions:

• Participant information sheets (PIS) require significant improvements in language, structure, and format.
• Strategies for enhancement include avoiding technical jargon, explaining complex terms, using simpler vocabulary, and adopting a clearer structure.
• These improvements are essential for strengthening informed consent and potentially increasing participation in medical research.