Studies Within A Trial (SWAT) Programme

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.

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.

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

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.

More information

TRIALISt

This project aims to develop and pilot test a short training course for staff recruiting participants into surgical trials.

More information

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. Our programme of work aims to develop and test interventions to enhance participant recruitment into trials.

Ongoing SWATs which are testing recruitment interventions

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.

Objective: To evaluate the effects of adding a pen printed with the trial logo to the trial invitation.

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.

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.

Ongoing SWATs evaluating retention interventions

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.

Objective: To evaluate the effectiveness of a personalised text message versus a standard text message for promoting response to postal follow-up 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.

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.

Improving data collection methods

SWATS we are currently undertaking to improve data collection methods

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.

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

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Medical Research Council Logo SWATs

Wellcome Trust Logo TRIALISt SWATs

Contact details

Dr Adwoa Parker
UK

Tel: 01904 321671