The PROMoting the USE of SWATs (PROMETHEUS) programme: Lessons learnt and future developments for SWATs

Clark, Laura; Arundel, Catherine; Coleman, Elizabeth Ann; Doherty, Laura; Parker, Adwoa; Hewitt, Catherine; Beard, David; Bower, Peter; Brocklehurst, Paul; Cooper, Cindy; Culliford, Lucy; Devane, Declan; Emsley, Richard; Eldridge, Sandra; Galvin, Sandra; Gillies, Katie; Montgomery, Alan; Sutton, Chris J; Treweek, Shaun; Torgerson, David

doi:10.1177/26320843221089632

Cited by 11 publications

(13 citation statements)

References 11 publications

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“…Alternatively, there may also be greater time pressure associated with the embedding of a recruitment rather than retention SWAT, due to the additional tasks of site set up. Lessons learned from the PROMETHEUS programme are also discussed by Clark et al 27…”

Section: Discussionmentioning

confidence: 99%

PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely

Doherty

Parker

Arundel

et al. 2022

Research Methods in Medicine & Health Sciences

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Aim PROMoting THE USE of Studies Within A Trial (PROMETHEUS) aimed to improve the evidence base for recruiting and retaining participants in Randomised Controlled Trials (RCTs) by pump-priming and facilitating the start of at least 25 Studies Within A Trial (SWATs) testing recruitment or retention interventions. Methods Ten Clinical Trials Units (CTUs) and one Primary Care Research Centre formed a network to conduct randomised SWATs of recruitment and/or retention strategies. We identified promising recruitment and retention interventions from various sources, which were reviewed by patient and public (PPI) partners to generate an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding of up to £5000 and receive support from the PROMETHEUS team to design, implement, and report SWATs. We additionally tested the feasibility of undertaking coordinated SWATs across multiple host trials simultaneously. Results PROMETHEUS funded 42 SWATs, embedded within 31 host trials, across 12 CTUs. The SWAT cost per SWAT was £3535. Of the 42 SWATs, 12 tested the same SWAT in multiple trials ( simultaneous SWAT design) and eight tested a factorial SWAT design. PROMETHEUS will add 18% and 79% more SWATs to the Cochrane systematic review of recruitment strategies and the Cochrane review of retention strategies respectively. Conclusion The PROMETHEUS programme substantially increased the evidence base for both recruitment and retention strategies within RCTs. Future research should adopt a systematic approach to identifying and targeting gaps in the evidence base and focus on translating SWAT evidence into recruitment and retention practice.

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Section: Discussionmentioning

confidence: 99%

PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely

Doherty

Parker

Arundel

et al. 2022

Research Methods in Medicine & Health Sciences

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“…The costs of including a SWAT can range widely from less than £100 to over £10,000, and so this may also be seen as a barrier to inclusion in a host trial. 30 The tight financial constraints of publicly funded research, and the requirements to monitor these, may mean that trials teams are reluctant to invest in SWATs.…”

Section: Fundingmentioning

confidence: 99%

“…The PROMETHEUS programme was frequently asked to provide support to host trial teams to explain to relevant governance bodies why patient consent and provision of information for the SWAT is unnecessary. 30 For both recruitment and retention SWATs, provision of any information or a requirement for consent may jeopardise and dilute the SWAT evaluation through the Hawthorne effect and/or resentful demoralisation. In addition, where a SWAT is assessing methods of recruitment approach, given their very nature, it may also be impossible to provide information on or to seek consent for SWAT involvement.…”

Section: Approvalsmentioning

confidence: 99%

“…3 Given the limited awareness and education around this methodology, considering peer reviewer nominations is also important to ensure a fair and appropriate review. 30 It may therefore be advisable to review the available literature to identify and propose reviewers with experience of similar SWATs given they are perhaps more likely to be amenable to the intricacies of SWAT design, methods and reporting.…”

Section: Publicationmentioning

confidence: 99%

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Challenges and solutions to the implementation of studies within a trial: The experiences of the PROMETHEUS programme

Arundel

Clark

Coleman

et al. 2022

Research Methods in Medicine & Health Sciences

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Background Effective and efficient conduct of randomised controlled trials (RCTs) ensures accurate, timely results and prevents research waste. There is however limited evidence available to inform the design, conduct and reporting of RCTs. A self-contained, randomised Study Within A Trial (SWAT), embedded within a host RCT or cohort study, offers an opportunity to fill this evidence gap. While SWATs are generally easy to implement, a range of challenges to undertaking SWATs have also been identified, however there is limited detail regarding practical solutions to tackle these. Methods Information and observations collected from PROMETHEUS members and participating trials, focusing on SWATs across a wide range of questions and settings, was reviewed to identify the challenges and solutions of delivery of a programme of SWATs. Results A range of challenges to undertaking SWATs (e.g., obtaining governance approvals) were identified along with potential solutions to these, which were implemented accordingly during programme delivery. Central to the solutions to resolve SWAT challenges is education to develop knowledge and understanding in the wider research community on the importance, purpose, and key methodological principles in relation to SWATs. In addition, the sharing of experience, best practice or resources to prevent or help negotiate the barriers to undertaking SWAT evaluation is also recommended. Conclusions Potential solutions to the barriers experienced in the design, conduct and implementation of a programme of SWATs have been identified. As more SWATs are completed, this will further develop evidence to support the mitigation or removal of barriers and in doing so this should increase the efficiency of randomised controlled trials.

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“…More recently, programmes such as PROMETHEUS (Promoting the use of Studies within a Trial) have facilitated the generation of higher quality evidence regarding recruitment processes [24]. These have made clear that adaptations to patient information leaflets or inclusion of multi-media information resources, for example, appear to have little effect upon recruitment [25].…”

Section: Existing Literature On Trial Recruitment Strategiesmentioning

confidence: 99%

Optimising recruitment in clinical trials for progressive multiple sclerosis: observational analysis from the MS-SMART and MS-STAT2 randomised controlled trials

Williams

Alexander

Blackstone

et al. 2022

Trials

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Background Slower than planned recruitment is a major factor contributing to the delay or failure of randomised controlled trials to report on time. There is a limited evidence base regarding the optimisation of recruitment strategies. Here we performed an observational review of our experience in recruitment for two large randomised controlled trials for people with secondary progressive multiple sclerosis. We aimed to explicitly determine those factors which can facilitate trial recruitment in progressive neurodegenerative disease. Methods Recruitment data from the sequential MS-SMART [NCT01910259] and MS-STAT2 [NCT03387670] UK randomised controlled trials was reviewed from the largest recruiting site, University College London (UCL). The trial population was similar which allowed comparison over the two recruitment periods of 2015–2016 and 2018–2021. This included sources of referral, progress through stages of recruitment, reasons for participant ineligibility and the impact of publicity events upon recruitment. Results In MS-SMART, 18% of patients contacted were enrolled, compared to 27% for MS-STAT2. Online registration of interest portals provided the greatest number of referrals (76% in MS-SMART, and 51% in MS-STAT2), with publicity in national media outlets producing a demonstrable increase in the number of potential participants. The introduction of an online self-screening questionnaire for MS-STAT2 resulted in 67% of potential participants (3080 of 4605) automatically determining their own ineligibility. In both studies, however, around 60% of those directly telephoned to discuss the study were not eligible, with difficulties related to travel to trial visits, or excluded medication, being the most common issues. Eighty-four percent of those deemed potentially eligible following telephone calls were enrolled in the MS-STAT2 study, compared to only 55% for MS-SMART. Conclusions Through a detailed review of recruiting participants at the largest centre into two large randomised controlled trials with similar entry criteria, we have identified a number of approaches that may improve recruitment efficiency. We highlight here the importance of mandatory online self-screening questionnaires, a coordinated publicity campaign, and simple interventions such as eligibility checklists and appointment reminders. Recruitment approaches should be further assessed through a studies within a trial (SWAT) design. Trial registration MS-SMART: NCT01910259; registered July 2013 and MS-STAT2: NCT03387670; registered Jan 2018

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The PROMoting the USE of SWATs (PROMETHEUS) programme: Lessons learnt and future developments for SWATs

Cited by 11 publications

References 11 publications

PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely

PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely

Challenges and solutions to the implementation of studies within a trial: The experiences of the PROMETHEUS programme

Optimising recruitment in clinical trials for progressive multiple sclerosis: observational analysis from the MS-SMART and MS-STAT2 randomised controlled trials

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