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
Recruitment is a critical process within research interventions, given its impact on statistical power, the validity of findings and investment of resources (Britton et al, 1998; Wade et al, 2009)
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
Background and rationale Recruitment is a critical process within research interventions, given its impact on statistical power, the validity of findings and investment of resources (Britton et al, 1998; Wade et al, 2009). 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. 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. I suggest rephrasing this paragraph to reflect the key points that you put forward in the discussion
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