The development of the recruitment intervention followed an iterative and accumulative process, and while this largely mirrored guidelines now published [15 (link)–17 (link)], it did not strictly follow all the recommendations, as they were not then available. The first version of the recruitment intervention was developed in the feasibility study of an RCT that was considered difficult for recruitment: the NIHR ProtecT (Prostate cancer testing and Treatment) trial with randomisation between radical surgery, radical radiotherapy, and active monitoring for clinically localised prostate cancer. This trial started in 1999, and the recruitment was completed in 2009. The theoretical framework, the context for the intervention, and the evolution and key components of the framework have been published elsewhere [18 (link)–20 (link)]. Additional file 1 contains RCT registration details.
The initial version of the recruitment intervention was then applied through the MRC Quartet (Qualitative Research in Trials) programme in four RCTs expected to have recruitment challenges in different contexts: mental health, paediatrics, treatment for laryngeal cancer, and follow-up strategies following treatment for cancer [8 (link)]. Three RCTs completed recruitment successfully (see, for example, [21 (link)]) and the other closed with clear explication [22 ]. After further refinement, the near-final intervention was applied to another cancer trial, which also closed with clear reasons [23 (link)]. These six RCTs were phase III, pragmatic, unblinded trials in feasibility stages or full-scale recruitment, and all were considered challenging for recruitment because of very contrasting arms, no-treatment comparators, or controversial clinical contexts. The accumulated experience and data from these RCTs were synthesised and used to finalise the intervention, which was then applied in seven further RCTs by the QuinteT (Qualitative Research Integrated in Trials) team (http://www.bristol.ac.uk/social-community-medicine/research/groups/social-sciences-health/quintet/qri-rcts/ ). The intervention was named after the team: the QuinteT Recruitment Intervention (QRI).
The initial version of the recruitment intervention was then applied through the MRC Quartet (Qualitative Research in Trials) programme in four RCTs expected to have recruitment challenges in different contexts: mental health, paediatrics, treatment for laryngeal cancer, and follow-up strategies following treatment for cancer [8 (link)]. Three RCTs completed recruitment successfully (see, for example, [21 (link)]) and the other closed with clear explication [22 ]. After further refinement, the near-final intervention was applied to another cancer trial, which also closed with clear reasons [23 (link)]. These six RCTs were phase III, pragmatic, unblinded trials in feasibility stages or full-scale recruitment, and all were considered challenging for recruitment because of very contrasting arms, no-treatment comparators, or controversial clinical contexts. The accumulated experience and data from these RCTs were synthesised and used to finalise the intervention, which was then applied in seven further RCTs by the QuinteT (Qualitative Research Integrated in Trials) team (
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