Trial Forge Studies Within A Trial (SWAT) Centre
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.
York Trials Unit is a Trial Forge Studies Within a Trial (SWATs) Centre. 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. Further information about the Trial Forge Initiative can be found here.
What is a SWAT?
A Study Within A Trial (SWAT) is a methodological study which aims to generate new knowledge to improve the design and delivery of future trials. Also known as a ‘nested trial’, ‘embedded trial’, or ‘trial within a trial’ a SWAT is a type of study in which an intervention to improve the conduct of a trial is tested in the context of an ongoing trial. This test of effectiveness using a trial conducted in the context of an ongoing trial forms the most rigorous evaluation of such interventions. SWATs can be randomised trials themselves (i.e. trial within a trial) or non-randomised evaluations, such as comparing electronic data collection methods alongside existing paper based data collection.
SWAT Resources and Collaboration
The Trial Forge SWAT Centre team provide ongoing support to research teams at all stages of embedding a SWAT at no cost to teams. Support includes:
- Protocol development
- Research ethics application advice
- SWAT intervention selection
If you're interested in collaborating with the York Trial Forge SWAT Centre, please fill out our collaboration request form. This will help us better understand your project and determine how we can work together effectively. We look forward to hearing from you
Resources (animations and guidance documents) on the key components of the design and delivery of SWATs are now available.
We have developed a priority list of recruitment and retention strategies to test using randomised SWATs.
Prioritised lists of recruitment and retention strategies (PDF 
, 546kb)
If you have any questions regarding these priorities please email us at trial-forge-swat-centre@york.
Templates and text for protocols, ethics applications and example publications are available. Please contact the team at: trial-forge-swat-centre@york.ac.uk for further information
About YTU's programme of SWATs
Our 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.
Most of our trials have focussed on strategies to enhance participant recruitment and retention of participants in trials.
Successful recruitment of adequate numbers of participants is critical to trials, but many trials fail to meet their recruitment targets. This can waste valuable resources and also lead to underpowered trials that cannot produce meaningful results.
Retention to trials is also important since the more people remain in a trial, the larger the power of the trial, making it possible to draw meaningful conclusions from the results.
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.
Ongoing Programmes
IMPLEMENT SWATs
Funded through an NIHR Advanced Fellowship, IMPLEMENT SWATs is a ten-year programme that aims to use implementation science and SWATs to improve evidence-informed participant recruitment and retention in trials. The overarching ambition is to facilitate better methods, for better research, for better health care and better health.
Trial Forge SWAT Network
The 'Trial Forge SWAT Network’ aims to bring groups together that are conducting SWATs so that the evidence base can be increased more efficiently, results disseminated, and SWAT research priorities identified. In collaboration with Professor Treweek, the PROMETHEUS group at York has agreed to become the York Trial Forge SWAT centre to continue SWAT work.
The Trial Forge SWAT Network members are currently working on improvements to four key
areas:
- SWAT priorities and evidence gaps
- SWAT funding
- SWAT Resources
- SWAT repository
For more information, please see the Trial Forge SWAT Network website.
We are looking for network members so if you are interested please get in touch (trial-forge-swat-centre@york.ac.uk and info@trialforge.org).
Ongoing SWATs which are testing recruitment interventions
- Improving trial recruitment using pens as an incentive: To evaluate the effects of adding a pen printed with the trial logo to the trial invitation.
Completed Programmes
PROMETHEUS
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.
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.
- 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.
- 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.
Completed retention SWATs
- Personalised text message versus standard text message prompts for increasing response to postal questionnaires: 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: 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.
- 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
- 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.
- 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
- Automated text messaging services offer a feasible and acceptable means of monitoring depression within clinical research
- Short message service text messaging was feasible as a tool for data collection in a trial of treatment for irritable bowel syndrome
- Exploration of the feasibility and validity of the EQ5D-5L
- 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.
Registering and reporting SWATs
Below we list some resources which we hope you might find useful:
This is a reporting checklist for embedded recruitment trials, based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010.
This is hosted by the Northern Ireland Methodology Hub and contains outlines for more than 60 SWATs, highlighting trial processes about which there is sufficient uncertainty to justify research to improve future decision making and choice about trial design.
- The ORRCA project (Online Resource for Recruitment research in Clinical triAls)
This project aims to bring together published and ongoing work in the field of recruitment research into a searchable database.
START aims to improve the evidence-base concerning recruitment to trials, enhance recruitment rates and make research more accessible to the public.
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 |
