Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study

Abstract

Background Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addressing the challenge of comparing surgery, antibiotics and placebo. The embedded MACRO conversation study (MCS) used qualitative research techniques pioneered by the University of Bristol QuinteT team to explore recruitment issues during the pilot phase, to maximise recruitment in the main trial. Methods Setting: Five outpatient Ear Nose and Throat (ENT) departments recruiting for the pilot phase of the MACRO trial (ISRCTN Number: 36962030, prospectively registered 17 October 2018). We conducted a thematic analysis of telephone interviews with 18 recruiters and 19 patients and 61 audio-recordings of recruitment conversations. We reviewed screening and recruitment data and mapped patient pathways at participating sites. We presented preliminary findings to individual site teams. Group discussions enabled further exploration of issues, evolving strategies and potential solutions. Findings were reported back to the funder and used together with recruitment data to justify progression to the main trial. Results Recruitment in the MACRO pilot trial began slowly but accelerated in time to progress successfully to the main trial. Research nurse involvement was pivotal to successful recruitment. Engaging the wider network of clinical colleagues emerged as an important factor, ensuring the patient pathway through primary and secondary care did not inadvertently affect trial eligibility. The most common reason for patients declining participation was treatment preference. Good patient-clinician relationships engendered trust and supported patient decision-making. Overall, trial involvement appeared clearly presented by recruiters, possibly influenced by pre-trial training. The weakest area of understanding for patients appeared to be trial medications. A clear presentation of medical and surgical treatment options, together with checking patient understanding, had the potential to allay patient concerns. Conclusion The MACRO conversation study contributed to the learning process of optimising recruitment by helping to identify and address recruitment issues. Although some issues were trial-specific, others have applicability to many clinical trial situations. Using qualitative research techniques to identify/explore barriers and facilitators to recruitment may be valuable during the pilot phase of many RCTs including those with complex designs.

Autopsy of a failed trial part 1: A qualitative investigation of clinician's views on and experiences of the implementation of the DAISIES trial in UK‐based intensive eating disorder services

“…Patient‐related barriers primarily surrounded the acceptability of the treatment arms, which was further complicated by aspects of ED symptomatology, such as high ambivalence. This is consistent with previous literature suggesting patient treatment preference as a key recruitment barrier in randomised controlled trials (RCT; Donovan et al., 2014 ; Elliott et al., 2017 ; McDermott et al., 2021 ). Additionally, AN populations are noted to be challenging to recruit and retain in RCTs due in part to high ambivalence and low treatment acceptability (Halmi, 2008 ; Halmi et al., 2005 ; Vinchenzo et al., 2022 ; Watson & Bulik, 2013 ).…”

Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT

“…The involvement of the QRI in the NAIROS was also cited by staff as having a positive influence on recruitment rates. As in previous studies, 148,149 research nurses in particular were highlighted by surgeons as being essential to the implementation of the trial at their sites. However, participants also described several challenges in relation to implementation.…”

A qualitative study exploring clinicians’ views on clinical trials in thumb carpometacarpal joint osteoarthritis

“…It has been widely shown that a pre-existing patient treatment preference is a common reason for not taking part in a clinical trial, while the perception of not getting treatment in a placebo arm is something that has been shown to harm recruitment. 31 The presence of a placebo or no-treatment control has been shown to be a frequent barrier to recruitment in cancer trials. 32 Work using the QuinteT recruitment intervention has demonstrated that failing to explore patient preference and difficulties explaining the trial intervention arms were frequent problems in surgical clinical trials.…”