Approaches and experiences when recruiting to infectious disease trials in the primary care setting: survey of GP Practices
Recruiting patients into primary care clinical trials is challenging due to tight schedules and pressures on clinicians’ time. Trials of seasonal, acute infectious diseases raise particular challenges due to the short high incidence periods and patients having to be consented and recruited opportunistically. Despite apparently similar set-ups, recruitment can vary substantially between practices. It is unclear if there are particular strategies in use or if the recruitment process could be better tailored to individual practice set-ups to maximise recruitment. The aim of this study was to explore this by surveying GP practices that participated in two infectious disease trials.
Treatment Options without Antibiotics for Sore Throat (TOAST) and Oral Steroids for Acute Cough (OSAC) were placebo-controlled randomised trials investigating the effects of oral corticosteroids in patients with sore throat and acute cough respectively. In both, participants were recruited opportunistically from GP Practices working with 4 University centres in Bristol, Oxford, Southampton and Nottingham. Both trials recruited successfully to time and target, but both had GP Practices that recruited very few or no participants at all, meaning a waste of money, resource and time in setting up and training these sites. A feedback survey was sent to all 90 participating practices asking them how they dealt with the process of opportunistic recruitment. They were asked about the set-up of their practice, staff involved with the trial and processes put in place to enable recruitment. They were asked what they thought enabled successful recruitment, and what barriers made recruitment into opportunistic trials difficult and how they overcame these (e.g. reserving a recruitment appointment that could be released if not filled). Recruiters that worked on both were asked about any differences between the two trials that resulted in different recruitment rates as a way of looking into the design of opportunistic trials and how researchers can facilitate recruitment.
8 GPs and 14 nurses responded on behalf of 22 (24%) Practices. Vigilance and screening were highlighted as key themes that enabled successful recruitment. 15 responders referred to triage systems being used or implemented, or reception teams flagging patients to recruiters as vital recruitment tools. Identifying potential participants early was very important for ensuring patients and clinicians had time to complete trial procedures, as the length of the recruitment process was the main deterrent. The feedback suggests that after recruiters had recruited one participant they either stopped recruiting because the process was too difficult, or conversely found subsequent recruitment became easier as the process became more familiar.
There were common themes about what enabled or hindered successful opportunistic recruitment into infectious disease trials. Ideas for recruiters and researchers to better support recruitment in primary care will be presented.