Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital

Abstract

ObjectivesTo examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature.DesignStudies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study.ResultsOf 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more ‘real’ RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent.ConclusionThere is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment.

Randomised controlled trials as part of clinical care: A seven‐step routinisation framework proposal

“…Routinising pre‐screening of eligible patients in order to increase enrolment in RCTs was one of the suggestions to increase the recruitment rate and routinise RCTs in clinical care . The research and clinical nurses in our study said that they would routinely perform pre‐screening of patients' logs prior to the clinic.…”

“…Some large centres use semi‐automated pre‐selection, which was found to be effective . There is evidence that the regular use of screening logs would optimise the recruitment …”

“…However, the evidence that clinicians' generic and trial‐specific training increases recruitment rates is limited as there is only a systematic review of training programmes for recruiters of RCTs . Latest studies suggest that appropriate training and support have the potential to facilitate recruitment even to more complex RCTs . Pre‐trial training may, in part, address the urgent need for improvements in the education and training of clinicians to increase the uptake of evidence‐based practice in wound care in Australia…”

“…Routinising pre-screening of eligible patients in order to increase enrolment in RCTs was one of the suggestions to increase the recruitment rate and routinise RCTs in clinical care. 50,51 The research and clinical nurses in our study said that they would routinely perform pre-screening of patients' logs prior to the clinic. Routinised pre-screening of patients' logs also allows better planning of the next appointment, for example, booking a longer appointment for patients who were pre-selected for the RCT.…”

“…55 Latest studies suggest that appropriate training and support have the potential to facilitate recruitment even to more complex RCTs. 51 Pre-trial training may, in part, address the urgent need for improvements in the education and training of clinicians to increase the uptake of evidence-based practice in wound care in Australia. 6…”