Testing a questionnaire to assess the experience of trial participants
Research type
Research Study
Full title
Preliminary psychometric assessment of a questionnaire to measure the experience of people taking part in randomised trials - the Patient-Centred Trials (PACT) Study
IRAS ID
248007
Contact name
Peter Bower
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
We are seeking ethical approval to conduct preliminary testing of a questionnaire developed to measure patient experience in randomised trials.
Involving members of the public in designing trials helps to make them better and easier for those taking part, but we also need a way of finding out from trial participants themselves how they found taking part.
In our previous work, we identified the topic areas and questions that we think are of importance to patient experience in trials from existing questionnaires, but none were fit for purpose. We asked 12 people who had taken part in trials about their experiences, and their views on the pre-identified topics of importance. We also asked 12 professionals involved in the funding, management and delivery of trials their views on measuring participant experience.
Good patient experience of being in a trial involved feelings of contributing to something worthwhile, having reassurance throughout the trial to avoid feeling disappointed, communication with the team, flexible logistics (e.g. parking), and smooth assessment processes (e.g. information and consent).
We devised questions to capture the core experiences and incorporated these in a questionnaire. We are now undertaking testing of the questions with a sample of 30 people with various degrees of trial experience.
We would now like 500 patients who are taking part in ongoing trials that are near to the end to complete our questionnaire. We will invite 3 ongoing trials to include our questionnaire in their trial to check it is assessing what is has been developed to measure.
We will also develop guidance and resources to enhance collection, analysis and presentation of the questionnaire data to help trial units to improve trial delivery, such as the comparison of experience data over time.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
19/YH/0034
Date of REC Opinion
8 Feb 2019
REC opinion
Further Information Unfavourable Opinion