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dc.contributor.authorSinnott, Carolen
dc.contributor.authorRacine, Emmyen
dc.contributor.authorHurley, Carolineen
dc.contributor.authorCheung, Aoifeen
dc.contributor.authorKearney, Patriciaen
dc.contributor.authorSmithson, Henryen
dc.description.abstractBackground: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients’ final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.
dc.publisherF1000 Research
dc.rightsAttribution 4.0 International*
dc.titleParticipants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experienceen
prism.publicationNameHRB Open Researchen
dc.contributor.orcidSinnott, Carol [0000-0002-8620-7461]
rioxxterms.typeJournal Article/Reviewen

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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International