Showing RESPECT for trial participants
18 Oct 2021
Sharing trial results with participants using a printed summary, sent by post, in addition to webpages, improves participants’ satisfaction with how the results are shared. This finding comes from the Show RESPECT study, which tested several approaches to sharing trial results with participants in the ICON8 ovarian cancer trial. These results were published today in the PLOS Medicine journal.
Previous research has shown that most people who take part in clinical trials want to be told the results of those trials. However, many participants never get to find them out. Researchers have been unsure how best to share results with participants, with little evidence to guide practice.
The Show RESPECT study was carried out to test different ways of sharing trial results with people taking part in the ICON8 ovarian cancer trial. The 43 hospitals that took part were randomly allocated to share results with participants using a combination of approaches:
- A link to an enhanced webpage or a basic webpage
- A printed summary sent by post on an opt-out basis, or no printed summary
- An invitation to join an email list to find out the results, or no email list invitation
180 ICON8 participants completed feedback questionnaires about their views on how the results were shared. More than 9 in 10 of them had wanted to receive the results.
People at hospitals that were randomised to the printed summary were more satisfied with how the results were shared than those at hospitals which did not send out the printed summary. Sending printed summaries by post also helped more people who wanted to know the results to find them out.
Women who received the results said that the information was easy to understand and find, were glad and did not regret finding out the results.
These findings suggest that trials with similar participants to the ICON8 ovarian cancer trial (mainly women aged 50 or older), should share results through opt-out mailed printed summaries, rather than rely on participants visiting webpages or signing up to email lists.
Annabelle South, who led the study, said “Trials depend on people volunteering to take part, often with increased risk or inconvenience. We have an ethical obligation to offer results to these people, in a way that is appropriate to them. Show RESPECT provides evidence to guide us on how to share the results of future trials with similar patient populations.