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?
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. Trial Forge has published some general SWAT guidance if you’d like to know more about SWATs.
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.
Ongoing Funded Programmes
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.
This project aims to develop and pilot test a short training course for staff recruiting participants into surgical trials.
Recruitment interventions
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 under-powered trials that cannot produce meaningful results. The York Trials Unit’s programme of work aims to develop and test interventions to enhance participant recruitment into trials.
- 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.
- 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
One of the common problems that researchers face is losing participants in trials, either from loss to follow up or from participants withdrawing. Retention to trials is 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.
- 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.
- 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
- 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:
Guidelines for reporting embedded recruitment trials
This is a reporting checklist for embedded recruitment trials, based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010.
Guidelines for reporting embedded recruitment trials
This is a reporting checklist for embedded recruitment trials, based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010.
The ORRCA project
This project aims to bring together published and ongoing work in the field of recruitment research into a searchable database.
MRC START
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
