Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience [version 2; peer review: 2 approved]

Racine, Emmy; Hurley, Caroline; Cheung, Aoife; Sinnott, Carol; Matvienko-Sikar, Karen; Baumgartner, Christine; Rodondi, Nicolas; Smithson, William H.; Kearney, Patricia M. (2019). Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience [version 2; peer review: 2 approved]. HRB Open Research, 1, p. 14. F1000Research 10.12688/hrbopenres.12817.2 (Version 1: 10.12688/hrbopenres.12817.1)

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Background: 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine

UniBE Contributor:

Baumgartner, Christine and Rodondi, Nicolas

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2515-4826

Publisher:

F1000Research

Language:

English

Submitter:

Christine Baumgartner

Date Deposited:

23 Jan 2019 12:30

Last Modified:

25 Oct 2019 02:29

Publisher DOI:

10.12688/hrbopenres.12817.2 (Version 1: 10.12688/hrbopenres.12817.1)

BORIS DOI:

10.7892/boris.125017

URI:

https://boris.unibe.ch/id/eprint/125017

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