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.author Racine, Emmy
dc.contributor.author Hurley, Caroline
dc.contributor.author Cheung, Aoife
dc.contributor.author Sinnott, Carol
dc.contributor.author Matvienko-Sikar, Karen
dc.contributor.author Smithson, W. Henry
dc.contributor.author Kearney, Patricia M.
dc.date.accessioned 2017-07-27T11:01:59Z
dc.date.available 2017-07-27T11:01:59Z
dc.date.issued 2017-07-04
dc.identifier.citation Racine, 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.2017.07.001 en
dc.identifier.volume 7 en
dc.identifier.startpage 163 en
dc.identifier.endpage 165 en
dc.identifier.issn 2451-8654
dc.identifier.uri http://hdl.handle.net/10468/4275
dc.identifier.doi 10.1016/j.conctc.2017.07.001
dc.description.abstract Introduction: 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.sponsorship Health Research Board (Trials Methodology Research Network (HRB-TMRN)); en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Elsevier en
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.uri http://creativecommons.org/licenses/BY/4.0/ en
dc.subject Public and patient involvement en
dc.subject PPI en
dc.subject Study within a trial en
dc.subject SWAT en
dc.subject Clinical trial result dissemination en
dc.subject End of trial results en
dc.subject Trial results en
dc.title Study within a trial (SWAT) protocol. Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Patricia Kearney, Epidemiology & Public Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: patricia.kearney@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2017-07-27T10:55:51Z
dc.description.version Published Version en
dc.internal.rssid 401869047
dc.contributor.funder Health Research Board en
dc.contributor.funder Seventh Framework Programme en
dc.description.status Peer reviewed en
dc.identifier.journaltitle Contemporary Clinical Trials en
dc.internal.copyrightchecked No !!CORA!! en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress patricia.kearney@ucc.ie en
dc.internal.IRISemailaddress karen.msikar@ucc.ie en
dc.relation.project info: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/TRUST en


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© 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/). Except where otherwise noted, this item's license is described as © 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/).
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