Abstract
Background
Participants want to receive the results of trials that they have participated in. Dissemination practices are disparate, and there is limited guidance available on what information to provide to participants and how to deliver it.
Objectives
This study aimed to establish what trial participants believe should be included in a results summary and how this information should be delivered.
Methods
A mixed-methods design was used with focus groups and interviews involving women convenience-sampled from two host randomized-controlled trials. Participants ranked information items in order of their importance for inclusion in a trial results summary and potential modes of delivery by preference. All participants provided written informed consent.
Results
Sixteen women (mean age [SD] = 71.6 [9.7] years) participated. Participants ranked ‘individual results from the study’ and ‘summary of overall trial results’ as most important. Themes such as reassurance and setting results in context were identified as contributing to participants' decisions around ranking. ‘A thank you for your contribution to the study’ was ranked the least important. Delivery by post was the preferred mode of receiving results, with receiving a hard copy of results cited as helpful to refer back to.
Conclusion
Our findings provide insight into what information trial participants deem as important when receiving trial results and how they would like results delivered. Involving patients during development of trial results to be communicated to participants could help to ensure that the right information is delivered in the right way.
Patient or Public Contribution
Public partners were involved in focussed aspects of study conduct.
Participants want to receive the results of trials that they have participated in. Dissemination practices are disparate, and there is limited guidance available on what information to provide to participants and how to deliver it.
Objectives
This study aimed to establish what trial participants believe should be included in a results summary and how this information should be delivered.
Methods
A mixed-methods design was used with focus groups and interviews involving women convenience-sampled from two host randomized-controlled trials. Participants ranked information items in order of their importance for inclusion in a trial results summary and potential modes of delivery by preference. All participants provided written informed consent.
Results
Sixteen women (mean age [SD] = 71.6 [9.7] years) participated. Participants ranked ‘individual results from the study’ and ‘summary of overall trial results’ as most important. Themes such as reassurance and setting results in context were identified as contributing to participants' decisions around ranking. ‘A thank you for your contribution to the study’ was ranked the least important. Delivery by post was the preferred mode of receiving results, with receiving a hard copy of results cited as helpful to refer back to.
Conclusion
Our findings provide insight into what information trial participants deem as important when receiving trial results and how they would like results delivered. Involving patients during development of trial results to be communicated to participants could help to ensure that the right information is delivered in the right way.
Patient or Public Contribution
Public partners were involved in focussed aspects of study conduct.
| Original language | English |
|---|---|
| Pages (from-to) | 419-429 |
| Number of pages | 11 |
| Journal | Health Expectations |
| Volume | 25 |
| Issue number | 1 |
| Early online date | 8 Dec 2021 |
| DOIs | |
| Publication status | Published - 16 Feb 2022 |
Bibliographical note
ACKNOWLEDGEMENTSThe authors would like to thank Suzanne Breeman, Lynda Constable and David Emele, who identified eligible participants from the VUE and PROSPECT trials; Andrea Fraser and Janice Cruden for their help preparing the mail-merge documents for the invitation packs; and Rosemary Humphreys and Sandra Jayacodi for their valuable feedback on the first drafts of the patient information leaflets and ranking exercises. This study was conducted as a Masters of Public Health research project (Jessica Wood) at the University of Aberdeen with funding provided through the School of Medicine, Medical Sciences and Nutrition. Katie Gillies was supported by an Academy of Medical Sciences (SBF002\1014) award and a Medical Research Council Fellowship (MR/L01193X/1). The Health Services Research Unit is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates (CZU/3/3). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the funders. Open access funding enabled and organized by Projekt DEAL.
Open Access via UoA Wiley Agreement
Article Funding
Open access funding enabled and organized by Projekt DEAL.
Data Availability Statement
Consent was not received to share original data sets and, therefore, research data are not shared.Keywords
- clinical trials
- dissemination
- focus groups
- interviews
- mixed methods
- participants
- results