An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial.

This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. : During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial's participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets.  : SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store ( SWAT105). COB-MS trial: ISRCTN11462710.