Background: Studies suggest that the process of patient consent to clinical trials is sub-optimal. Participant information sheets are important but can be technical and lengthy documents. Performance-based readability testing is an established means of assessing patient information, and this study aimed to test its application to participant information for a Phase 3 trial.
Methods: An independent groups design was used to study the User Testing performance of the participant information sheet from the Phase 3 'Poor Responders' trial of In Vitro Fertilisation (IVF). 20 members of the public were asked to read it, then find and demonstrate understanding of 21 key aspects of the trial. The participant information sheet was then re-written and re-designed, and tested on 20 members of the public, using the same 21 item questionnaire.
Results: The original participant information sheet performed well in some places. Participants could not find some answers and some of the found information was not understood. In total there were 30 instances of information being not found or not understood. Answers to three questions were found but not understood by many of the participants, these related to aspects of the drug timing, Follicle Stimulating Hormone and compensation. Only two of the 20 participants could find and show understanding of all question items when using the original sheet. The revised sheet performed generally better, with 17 instances of information being not found or not understood, although the number of 'not found' items increased. Half of the 20 participants could find and show understanding of all question items when using the revised sheet. When asked to compare the versions of the sheet, almost all participants preferred the revised version.
Conclusion: The original participant information sheet may not have enabled patients fully to give valid consent. Participants seeing the revised sheet were better able to understand the trial. Those who write information for trial participants should take account of good practice in information design. Performance-based User Testing may be a useful method to indicate strengths and weaknesses in trial information.
- INFORMED-CONSENT PROCESS