PRESS-Protocols and resources for priority recruitment and retention SWATs
Contact: Prof. Frances Shiely
Why we undertook the PRESS project
Clinical trials are important, but recruiting and retaining participants is challenging. Fewer than half of trials meet their recruitment goals, leading to wasted time, money, and effort for research teams and participants. Additionally, poor retention, when participants drop out before the study ends, comprises trial outcomes. Recruitment and retention problems therefore delay the identification and implementation of effective new treatments.
We conducted systematic reviews and discovered a notable lack of high-quality evidence to effectively guide decisions on recruitment and retention. One way of filling these gaps is to conduct a Study Within A Trial (SWAT). A SWAT is an evaluation done within a ‘host’ trial and can, for example, test whether a new retention strategy is better than an existing strategy. While SWATs are effective for testing recruitment and retention strategies, persuading trial teams to engage in this extra effort alongside their trials is tough. Interviews with Trial Forge SWAT Network institutions highlighted the need for resources like protocols, statistical analysis plans, intervention resources and ethical application templates, to support SWAT research
What was our goal?
The ‘Protocol and resource development for prioritised recruitment and retention strategies’ (PRESS) project aimed to develop these protocols, and resources, to assist and encourage trial teams to evaluate the recruitment and retention strategies in their trials, especially those that we have prioritised for evaluation.
What background work was necessary?
We wanted to create a list of recruitment and retention strategies that should be evaluated first, i.e., prioritised. The Trial Forge SWAT Network (40+ institutions) previously prioritised six recruitment and five retention strategies to be evaluated. Prioritisation was done by combining frequency of strategy use in NIHR HTA trials, evidence from the Cochrane recruitment and retention systematic reviews, a cost-effectiveness review and the findings of PRioRiTY I and II. There are many potentially suitable SWAT research questions that could be us.
What did we do in PRESS?
The two protocols we used for PRESS (reflecting our two funding sources ) can be downloaded here: PRESS 1 protocol and PRESS 2 protocol.
We developed:
- A Master SWAT Protocol Template with a focus on facilitating replication of any SWAT undertaken
- Nine individual protocols for the prioritised recruitment and retention SWATs. We had 11 strategies, but two SWAT research questions are similar with others and the protocols can be adapted. Two of the prioritised SWATs focused on testing patient and public involvement (PPI) strategies for participant recruitment and retention. For these, we worked with three PPI partners to co-produce the two protocols.
- A resource pack for each protocol including:
- A guidance document for researchers applying for funding to conduct high-priority SWATs of recruitment and retention strategies https://osf.io/w6zym/
- Health Economics Guidance for undertaking randomised SWATs of recruitment and retention Strategies https://osf.io/sebnk/
- A randomised recruitment and retention SWAT Statistical Analysis Plan templates https://osf.io/h73ke/
The final protocols were reviewed by SWAT Trial Forge Network members and PPI partners and checked for language suitability.
Guidance, templates and protocol bundles can be downloaded from the Trial Forge site: here.
You can also look at the OSF site: https://osf.io/xfkgp/
