A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing

A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing

Trials, March 2015

25873096

Sangeetha Paramasivan, Sean Strong, Caroline Wilson, Bruce Campbell, Jane M Blazeby, Jenny L Donovan

Recruitment to pragmatic randomised controlled trials (RCTs) is acknowledged to be difficult, and few interventions have proved to be effective. Previous qualitative research has consistently revealed that recruiters provide imbalanced information about RCT treatments. However, qualitative research can be time-consuming to apply. Within a programme of research to optimise recruitment and informed consent in challenging RCTs, we developed a simple technique, Q-QAT (Quanti-Qualitative Appointment Timing), to systematically investigate and quantify the imbalance to help identify and address recruitment difficulties. The Q-QAT technique comprised: 1) quantification of time spent discussing the RCT and its treatments using transcripts of audio-recorded recruitment appointments, 2) targeted qualitative research to understand the obstacles to recruitment and 3) feedback to recruiters on opportunities for improvement. This was applied to two RCTs with different clinical contexts and recruitment processes. Comparisons were made across clinical centres, recruiters and specialties. In both RCTs, the Q-QAT technique first identified considerable variations in the time spent by recruiters discussing the RCT and its treatments. The patterns emerging from this initial quantification of recruitment appointments then enabled targeted qualitative research to understand the issues and make suggestions to improve recruitment. In RCT1, presentation of the treatments was balanced, but little time was devoted to describing the RCT. Qualitative research revealed patients would have considered participation, but lacked awareness of the RCT. In RCT2, the balance of treatment presentation varied by specialists and centres. Qualitative research revealed difficulties with equipoise and confidence among recruiters presenting the RCT. The quantitative and qualitative findings were well-received by recruiters and opportunities to improve information provision were discussed. A blind coding exercise across three researchers led to the development of guidelines that can be used to apply the Q-QAT technique to other difficult RCTs. The Q-QAT technique was easy to apply and rapidly identified obstacles to recruitment that could be understood through targeted qualitative research and addressed through feedback. The technique's combination of quantitative and qualitative findings enabled the presentation of a holistic picture of recruitment challenges and added credibility to the feedback process. Note: both RCTs in this manuscript asked to be anonymised, so no trial registration details are provided.