Performance-based readability testing of participant information for a Phase 3 IVF trial

Area of Science:

• Clinical Research
• Patient Information Design
• Human Subject Research

Background:

• Clinical trial patient consent processes are often suboptimal.
• Participant information sheets can be overly technical and lengthy.
• Performance-based readability testing assesses patient information effectiveness.

Purpose of the Study:

• To evaluate the application of performance-based User Testing for a Phase 3 clinical trial participant information sheet.
• To assess the readability and comprehensibility of an original and a revised participant information sheet for an In Vitro Fertilisation (IVF) trial.

Main Methods:

• An independent groups design was employed using 20 public members for each version of the information sheet.
• Participants read the sheet and then located and demonstrated understanding of 21 key trial aspects.
• The original sheet was revised and redesigned before re-testing with a new group of 20 participants.

Main Results:

• The original information sheet had 30 instances of information not found or not understood, with only 2 participants understanding all aspects.
• Key areas of difficulty included drug timing, Follicle Stimulating Hormone, and compensation.
• The revised sheet reduced instances of not found/understood information to 17, with 10 participants understanding all aspects; most preferred the revised version.

Conclusions:

• The original participant information sheet may hinder fully informed patient consent.
• A revised information sheet, informed by user testing, significantly improved trial comprehension.
• Performance-based User Testing is a valuable method for identifying and improving clinical trial information design.