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
dc.contributor.author | Dwyer, Christopher P. | |
dc.contributor.author | Joyce, Robert A. | |
dc.contributor.author | Bane, Eimear M. | |
dc.contributor.author | Moses, Anusha | |
dc.contributor.author | Alvarez-Iglesias, Alberto | |
dc.contributor.author | Hynes, Sinéad M. | |
dc.date.accessioned | 2020-03-19T10:25:13Z | |
dc.date.available | 2020-03-19T10:25:13Z | |
dc.date.issued | 2020-01-24 | |
dc.identifier.citation | Dwyer, 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.12981.1 | en_IE |
dc.identifier.issn | 2515-4826 | |
dc.identifier.uri | http://hdl.handle.net/10379/15852 | |
dc.description.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. | en_IE |
dc.description.sponsorship | Health Research Board Ireland [DIFA-FA-2018-027] | en_IE |
dc.format | application/pdf | en_IE |
dc.language.iso | en | en_IE |
dc.publisher | F1000Research | en_IE |
dc.relation.ispartof | HRB Open Research | en |
dc.subject | Participation information | en_IE |
dc.subject | recruitment | en_IE |
dc.subject | retention | en_IE |
dc.subject | multiple sclerosis | en_IE |
dc.subject | public and patient involvement | en_IE |
dc.subject | PPI | en_IE |
dc.subject | SWAT | en_IE |
dc.title | 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 | en_IE |
dc.type | Article | en_IE |
dc.date.updated | 2020-03-18T18:00:07Z | |
dc.identifier.doi | 10.12688/hrbopenres.12981.1 | |
dc.local.publishedsource | https://doi.org/10.12688/hrbopenres.12981.1 | en_IE |
dc.description.peer-reviewed | peer-reviewed | |
dc.contributor.funder | Health Research Board | en_IE |
dc.internal.rssid | 19557499 | |
dc.local.contact | Sinéad Hynes. Email: sinead.hynes@nuigalway.ie | |
dc.local.copyrightchecked | Yes | |
nui.item.downloads | 125 |
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