Study within a trial (SWAT) protocol. Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience

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dc.contributor.authorRacine, Emmy
dc.contributor.authorHurley, Caroline
dc.contributor.authorCheung, Aoife
dc.contributor.authorSinnott, Carol
dc.contributor.authorMatvienko-Sikar, Karen
dc.contributor.authorSmithson, W. Henry
dc.contributor.authorKearney, Patricia M.
dc.contributor.funderHealth Research Boarden
dc.contributor.funderSeventh Framework Programmeen
dc.date.accessioned2017-07-27T11:01:59Z
dc.date.available2017-07-27T11:01:59Z
dc.date.issued2017-07-04
dc.date.updated2017-07-27T10:55:51Z
dc.description.abstractIntroduction: Dissemination of results of randomised controlled trials is traditionally limited to academic and professional groups rather than clinical trial participants. While there is increasing consensus that results should be communicated to trial participants, there is a lack of evidence on the most appropriate methods of dissemination. This study within a trial (SWAT) aims to address this gap by using a public and patient involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving trial results of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial (TRUST). Methods: An experimental (intervention) study will be conducted using mixed methods to inform the development of and evaluation of a patient-preferred method of communication of trial results. The study will involve three consecutive phases. In the first phase, focus groups of trial participants will be conducted to identify a patient-preferred method of receiving trial results. The method will be developed and then assessed and refined by a patient and public expert group. In the second phase participants will be randomly assigned to the intervention (patient-preferred method) and comparison groups (standard dissemination method as developed by the lead study site in Glasgow, Scotland). In the third phase, a quantitative questionnaire will be used to measure and compare patient understanding of trial results between the two groups. Discussion: This protocol provides a template for other trialists who wish to enhance patient and public involvement and additionally, will provide empirical evidence on how trialists should best disseminate study results to their participants.en
dc.description.sponsorshipHealth Research Board (Trials Methodology Research Network (HRB-TMRN));en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationRacine, E., Hurley, C., Cheung, A., Sinnott, C., Matvienko-Sikar, K., Smithson, W. H. and Kearney, P. M. (2017) 'Study within a trial (SWAT) protocol. Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience', Contemporary Clinical Trials Communications, 7, pp. 163-165. doi: 10.1016/j.conctc.2017.07.001en
dc.identifier.doi10.1016/j.conctc.2017.07.001
dc.identifier.endpage165en
dc.identifier.issn2451-8654
dc.identifier.journaltitleContemporary Clinical Trialsen
dc.identifier.startpage163en
dc.identifier.urihttps://hdl.handle.net/10468/4275
dc.identifier.volume7en
dc.language.isoenen
dc.publisherElsevieren
dc.relation.projectinfo:eu-repo/grantAgreement/EC/FP7::SP1::HEALTH/278148/EU/Multi-modal effects of thyroid hormone replacement for untreated older adults with subclinical hypothyroidism; a randomised placebo-controlled trial/TRUSTen
dc.rights© 2017 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/BY/4.0/).en
dc.rights.urihttp://creativecommons.org/licenses/BY/4.0/en
dc.subjectPublic and patient involvementen
dc.subjectPPIen
dc.subjectStudy within a trialen
dc.subjectSWATen
dc.subjectClinical trial result disseminationen
dc.subjectEnd of trial resultsen
dc.subjectTrial resultsen
dc.titleStudy within a trial (SWAT) protocol. Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experienceen
dc.typeArticle (peer-reviewed)en
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