York Trials Unit, University of York, UK
York Trials Unit is a Trial Forge Studies Within a Trial (SWATs) Centre (https://www.york.ac.uk/healthsciences/research/trials/research/swats/). Randomised controlled trials are the fairest tests for healthcare treatments, and aim to improve the health and wellbeing of people worldwide. However, there is very little evidence about how to design, deliver and report these trials.
Our Trial Forge SWAT Centre is part of the Trial Forge initiative, which aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency and reduce waste in research. Our centre focuses on improving trial efficiency using a SWAT approach. More information about our SWATs programme is outlined below.
WHAT IS A SWAT?
ABOUT YORK TRIALS UNIT’S PROGRAMME OF SWATS
Dr Adwoa Parker leads the York Trial Forge Centre’s work, along with Prof David Torgerson, the Director of York Trials Unit. York’s programme of SWATs aims to add to the evidence base for trial methodology, particularly the conduct and delivery of trials through the successful recruitment and retention of trial participants. Our overall ambition is to generate evidence to ensure the timely delivery of trials in order to improve the health of patients.
If you are starting a trial, please consider embedding your own SWAT to test the effectiveness of any ideas you have about improving recruitment, retention or the conduct of the trial. We are also keen to collaborate with others to test our ideas, so please consider testing one of our interventions below.
If you would like to contact the York Trial Forge SWAT Centre, you can send an email to trial-forge-swat-centre@york.ac.uk.
Ongoing Funded Programmes
PROMETHEUS
This is a collaboration with the York Trial Forge Centre. The aim of this programme is to pump prime existing trial teams up to £5,000 to test commonly used strategies for improving trial recruitment and retention by embedding RCTs within already funded trials. The ultimate goal is to make the inclusion of Studies Within A Trial (SWATs) routine when conducting a trial.
TRIALISt
This project aims to develop and pilot test a short training course for staff recruiting participants into surgical trials.
Recruitment interventions
Ongoing SWATs which are testing recruitment interventions
- Effects of a re-designed Participant Information Sheet
- Objective: To establish if the number of patients recruited and retained in a clinical trial is improved by the use of participant information sheets (PIS) with different input to their design.
- Improving trial recruitment using pens as an incentive
- Objective: To evaluate the effects of adding a pen printed with the trial logo to the trial invitation.
- Remote versus on site initiation visits
- Objective: To investigate the costs and effects of providing on-site initiation visits at trial sites (prior to application for research governance approval) on subsequent set up times, recruitment measures, data collection and costs.
Completed SWATs testing different recruitment interventions
- An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study
- Advertising patient and public involvement to potential trial participants using a leaflet does not increase recruitment or response rates
- A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial
- An randomized controlled trial of Post-it® notes did not increase postal response rates in older depressed participants
- Envelope colour does not affect response to participate in a trial or questionnaire returns. There is weak evidence to suggest envelope colour may affect consent into a trial.
Retention interventions
Ongoing SWATs evaluating retention interventions
- Effects of a newsletter and Post-it® note on postal questionnaire response rates
- Objective: To evaluate the effects of a patient newsletter and a Post-it® note as a means of increasing response rates to a postal follow-up questionnaire.
- Personalised text message versus standard text message prompts for increasing response to postal questionnaires
- Objective: To evaluate the effectiveness of a personalised text message versus a standard text message for promoting response to postal follow-up questionnaires.
- Timing of text message prompts to increase trial participant response to postal questionnaires
- Objective: To evaluate whether SMS text messages sent as pre- or post-notification reminders improve questionnaire response rates during the follow-up for a randomised trial.
- Remote versus on site initiation visits
- Objective: To investigate the costs and effects of providing on-site initiation visits at trial sites (prior to application for research governance approval) on subsequent set up times, recruitment measures, data collection and costs.
Completed retention SWATs
- Electronic prompts significantly increase response rates to postal questionnaires
- Enclosing a pen reduces time to response to questionnaire mailings
- Prior notification of trial participants by newsletter increased response rates
- Offering study results to women living in the community aged over 70 does not increase response rates to postal questionnaires
Improving data collection methods
SWATS we are currently undertaking to improve data collection methods
- Remote versus on site initiation visits
- Objective: To investigate the costs and effects of providing on-site initiation visits at trial sites (prior to application for research governance approval) on subsequent set up times, recruitment measures, data collection and costs.
Completed SWATs to improve data collection methods
Registering and reporting SWATs
Funders
PROMETHEUS – This project is funded by the Medical Research Council (MRC). – Grant number MR/R013748/1
TRIALISt – This project is funded by The Wellcome Trust through the Centre for Future Health (CFH) at the University of York. Ref: 204829
