Abstract
BackgroundHundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences.Methods553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference.ResultsOf the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084).ConclusionsTrial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research.Trial registrationThe trial is registered with http://www.isrctn.org/ and ID is ISRCTN76616358.
Highlights
Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed
The structure of this leaflet was presented as: background; aims of the study; how we did it; data collected; what we found; and should General Practitioners (GPs) access to Magnetic Resonance Imaging (MRI) of the knee be introduced into the NHS? Contact details of the trial co-ordinator were included at the end of each leaflet, copies of which are available on request from the corresponding author
Of the 553 participants in the DAMASK trial, 471 (85%) completed the final follow-up questionnaire. For those participants who returned the final follow-up questionnaire, 416 (88%) agreed that they would like to receive the results of the study
Summary
Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. There is a growing demand for the results of randomised trials to be fed back to research participants [1,2]. Despite the recent calls for research to be disseminated to participants and the potential for negative psychological impact there is currently little evidence advocating the most effective approach of communicating results - the preparation of such materials can be costly and time consuming [3,5]
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