Informing potential participants about research: observational study with an embedded randomized controlled trial

Area of Science:

• Clinical Research
• Health Informatics
• Patient Engagement

Background:

• Traditional paper-based participant information sheets may not be effectively read or understood by potential research participants.
• Assessing the feasibility of electronic information provision is essential for improving research communication.

Purpose of the Study:

• To evaluate the feasibility of providing research information electronically.
• To determine the topics and depth of information accessed by potential participants.
• To assess participant satisfaction and understanding with different information formats.

Main Methods:

• An observational study with an embedded randomized controlled trial was conducted in a primary care setting.
• Participants received either a standard paper information sheet (PDF-PIS) or an interactive electronic information sheet (IIS).
• Key outcomes included email response rates, information access, consent rates, and participant satisfaction.

Main Results:

• Only 24% of eligible participants provided an active email address, and many did not access electronic information.
• Consent rates were 48% for PDF-PIS and 36% for IIS.
• A significant proportion of participants (41%) accessed no electronic information, and only 9% reviewed the full details before booking an appointment.

Conclusions:

• Current written research information may be largely unread, highlighting the importance of the consent interview.
• Novel approaches to presenting complex research information are needed to enhance participant understanding and engagement.
• Electronic information provision shows potential but requires optimization to improve uptake and effectiveness.