Abstract
Background: 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. Methods: 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. Discussion: 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. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store ( SWAT105). COB-MS trial: ISRCTN11462710.
Highlights
It is obvious that the authors know their field
Early pilot studies have shown that cognitive occupation-based programme for people with MS (COB-MS) training may lead to improvements in daily living and cognitive functioning in people with MS (Reilly & Hynes, 2018)
If a patient-informed participant information sheet (PIS) is found to be an effective way of increasing recruitment, the current SWAT protocol could provide a beneficial template for future clinical research in MS
Summary
It is obvious that the authors know their field. Well written. I suggest you re-phrase the Introduction so that each paragraph outlines the key points that the reader needs to know (e.g. PIS, Why PIS are important, PPI, What we know about PPI (e.g. Cockayne et al. , Crocker et al.2), what we don’t know about PPI- knowledge gap, study objective). Other suggestions for the Introduction: ○ Paragraph 1: ‘primary source of written information’- I suggest inserting the word ‘written’ here as potential participants often receive verbal information from the study team before they consent to participate. This protocol describes a double-blind, randomised noninferiority 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. I suggest rephrasing this paragraph to reflect the key points that you put forward in the discussion
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
