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dc.contributor.authorDwyer, Christopher P.
dc.contributor.authorJoyce, Robert A.
dc.contributor.authorBane, Eimear M.
dc.contributor.authorMoses, Anusha
dc.contributor.authorAlvarez-Iglesias, Alberto
dc.contributor.authorHynes, Sinéad M.
dc.date.accessioned2020-03-19T10:25:13Z
dc.date.available2020-03-19T10:25:13Z
dc.date.issued2020-01-24
dc.identifier.citationDwyer, Christopher P. , Joyce, Robert A. , Bane, Eimear M., Moses, Anusha, Alvarez-Iglesias, Alberto, & Hynes, Sinéad M. (2020). 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. HRB Open Research, 3(4). doi:10.12688/hrbopenres.12981.1en_IE
dc.identifier.issn2515-4826
dc.identifier.urihttp://hdl.handle.net/10379/15852
dc.description.abstractBackground: 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.en_IE
dc.description.sponsorshipHealth Research Board Ireland [DIFA-FA-2018-027]en_IE
dc.formatapplication/pdfen_IE
dc.language.isoenen_IE
dc.publisherF1000Researchen_IE
dc.relation.ispartofHRB Open Researchen
dc.subjectParticipation informationen_IE
dc.subjectrecruitmenten_IE
dc.subjectretentionen_IE
dc.subjectmultiple sclerosisen_IE
dc.subjectpublic and patient involvementen_IE
dc.subjectPPIen_IE
dc.subjectSWATen_IE
dc.titleAn 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-trialen_IE
dc.typeArticleen_IE
dc.date.updated2020-03-18T18:00:07Z
dc.identifier.doi10.12688/hrbopenres.12981.1
dc.local.publishedsourcehttps://doi.org/10.12688/hrbopenres.12981.1en_IE
dc.description.peer-reviewedpeer-reviewed
dc.contributor.funderHealth Research Boarden_IE
dc.internal.rssid19557499
dc.local.contactSinéad Hynes. Email: sinead.hynes@nuigalway.ie
dc.local.copyrightcheckedYes
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