Development of an online resource for recruitment research in clinical trials to organise and map current literature

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Background: Implant-based breast reconstruction (IBBR) is the most commonly performed breast reconstruction technique worldwide but the technique is evolving rapidly. High-quality evidence is needed to support practice. Randomised controlled trials (RCTs) provide the best evidence but can be challenging to conduct. iBRA is a four-phased study which aimed to inform the feasibility, design and conduct of an RCT in IBBR. In phase 3, the randomisation acceptability study, an electronic survey and qualitative interviews were conducted to explore professionals' perceptions of future trials in IBBR. Findings from the interviews are presented here.Methods: Semi-structured qualitative interviews were undertaken with a purposive sample of 31 health professionals (HPs) who completed the survey to explore their attitudes to the feasibility of potential RCTs in more detail. All interviews were transcribed verbatim and data were analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved.Results: Almost all HPs acknowledged the need for better evidence to support the practice of IBBR and most identified RCTs as generating the highest-quality evidence. Despite highlighting potential challenges, most participants supported the need for an RCT in IBBR. A minority, however, were strongly opposed to a future trial. The opposition and challenges identified centred around three key themes; (i) limited understanding of pragmatic study design and the value of randomisation in minimising bias; (ii) clinician and patient equipoise and (iii) aspects of surgical culture and training that were not supportive of RCTs.(Continued on next page)

Section: Discussionmentioning

confidence: 99%

Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study

Davies

Mills

Holcombe

et al. 2020

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“…As the literature on the use of incentives in trials is limited, we drew upon evidence from two other healthcare settings in which incentives are commonly used: pay for performance, and health behaviour change. The ORCCA database was launched in September 2016, bringing together published studies and ‘work in progress’ on recruitment [12]. We updated our search in September 2018 by assessing studies relating to ‘incentives’ in the ORCCA database.…”

Section: Methodsmentioning

confidence: 99%

Designing and using incentives to support recruitment and retention in clinical trials: a scoping review and a checklist for design

Parkinson

Meacock

Sutton

et al. 2019

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BackgroundRecruitment and retention of participants are both critical for the success of trials, yet both remain significant problems. The use of incentives to target participants and trial staff has been proposed as one solution. The effects of incentives are complex and depend upon how they are designed, but these complexities are often overlooked. In this paper, we used a scoping review to ‘map’ the literature, with two aims: to develop a checklist on the design and use of incentives to support recruitment and retention in trials; and to identify key research topics for the future.MethodsThe scoping review drew on the existing economic theory of incentives and a structured review of the literature on the use of incentives in three healthcare settings: trials, pay for performance, and health behaviour change. We identified the design issues that need to be considered when introducing an incentive scheme to improve recruitment and retention in trials. We then reviewed both the theoretical and empirical evidence relating to each of these design issues. We synthesised the findings into a checklist to guide the design of interventions using incentives.ResultsThe issues to consider when designing an incentive system were summarised into an eight-question checklist. The checklist covers: the current incentives and barriers operating in the system; who the incentive should be directed towards; what the incentive should be linked to; the form of incentive; the incentive size; the structure of the incentive system; the timing and frequency of incentive payouts; and the potential unintended consequences. We concluded the section on each design aspect by highlighting the gaps in the current evidence base.ConclusionsOur findings highlight how complex the design of incentive systems can be, and how crucial each design choice is to overall effectiveness. The most appropriate design choice will differ according to context, and we have aimed to provide context-specific advice. Whilst all design issues warrant further research, evidence is most needed on incentives directed at recruiters, optimal incentive size, and testing of different incentive structures, particularly exploring repeat arrangements with recruiters.

“…The value of SWATs is increasingly being recognised, with several developments moving to raise their profile and encourage their routine use in RCTs [ 11 ]. These include online research platforms specifically designed to address recruitment and retention challenges within RCTs, such as Trials Forge [ 12 ] and Clinical triAls [ 13 ]. These online resources primarily aim to share knowledge from existing studies and build a platform to collate the findings and inform new hypotheses.…”

Section: Introductionmentioning

confidence: 99%

Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial

Mattock

Ryan

O’Farrelly

et al. 2020

Background Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial. Methods One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase. All participants went on to receive the information sheet as part of the existing consent procedure. Results The video condition did not increase the odds of recruitment into the trial, such that those in the video condition were significantly less likely to participate in the main trial (OR = 0.253, CI = 0.104–0.618, p = 0.003). Conclusion The introduction of a video clip into the recruitment stages of a parenting trial did not lead to an improvement in recruitment; however, the small sample size precludes definitive inferences. We offer reflections on challenges encountered in implementing the SWAT and suggestions for other researchers seeking to embed recruitment SWATs into similar trials. Trial registration Current controlled trials ISRCTN 58327365. Registered on 19 March 2015. SWAT registration SWAT 106; Effects of a video clip on recruitment into a randomised trial. Registered on 20 December 2016.