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

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.

COVID-19: Public and patient involvement, now more than ever

“…In Ireland, the Health Research Board (HRB) has been at the fore of promoting PPI in research and with the Irish Research Council, in 2017 launched a joint call entitled PPI Ignite, to support higher education institutions to embed PPI into their organisational structures. The use of different PPI approaches is increasingly evident in research in Ireland ( Dwyer et al , 2020 ; Ní Shé et al , 2019 ; O’Hara et al , 2017 ; O’Shea et al , 2019 ; Tierney et al , 2018 ; Walsh et al , 2018 ).…”

Enhancing involvement of people with multiple sclerosis in clinical trial design

“…Involvement in the design enables the development of interventions that are acceptable to patients and feasible, as well as the selection of outcomes that are important to patients, enhancing future uptake in clinical practice. Patient feedback regarding information provided to potential participants; 19 the consent process and study burden may facilitate recruitment and retention. PPI may be particularly important when devising materials and strategies, such as transportation support, to engage underrepresented groups as discussed further in a companion paper.…”