Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience
View / Open Files
Authors
Racine, Emmy
Hurley, Caroline
Cheung, Aoife
Kearney, Patricia
Smithson, Henry
Publication Date
2018-04-12Journal Title
HRB Open Research
ISSN
2515-4826
Publisher
F1000 Research
Volume
1
Number
14
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Sinnott, C., Racine, E., Hurley, C., Cheung, A., Kearney, P., & Smithson, H. (2018). Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience. HRB Open Research, 1 (14)https://doi.org/10.12688/hrbopenres.12817.1
Abstract
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.
Identifiers
External DOI: https://doi.org/10.12688/hrbopenres.12817.1
This record's URL: https://www.repository.cam.ac.uk/handle/1810/280310
Recommended or similar items
The following licence files are associated with this item: