Adapting the QuinteT recruitment intervention (QRI) to optimize the recruitment of ethnic minority groups in clinical trials: insights from workshops with diverse public contributors.

Background: The global majority, often called ethnic minority (EM) groups in the United Kingdom (UK), are underserved in clinical trials despite a greater disease burden. This means that the trial results are often not applicable to the global majority, perpetuating inequities. Despite extensive evidence on barriers to inclusive research, there is little evidence on strategies to achieve successful EM participation. The QuinteT Recruitment Intervention (QRI) has been successfully employed in over 80 trials to optimize recruitment and informed consent in the general population. We aimed to adapt the QRI to optimize EM recruitment in trials through public contributor workshops in the UK.

Methods: We conducted five workshops with 43 public contributors from diverse ethnic backgrounds. We explored concerns of interest to contributors and sought their views on adapting three QRI components (audio-recordings of trial discussions and patient interviews and feedback provided to health-care professionals, HCPs) and QRI information sheets and consent forms.

Results: Contributors were most interested in discussing barriers to EM research participation (mistrust, inadequate compensation, lack of workforce diversity in research, and inadequate community outreach). Key suggestions for QRI adaptation included: a) offering a copy of the audio-recorded trial consultation, providing patient interview questions in advance and avoiding small print in patient-facing documentation (to foster trust); b) involving EM groups with lived experience of health conditions in training HCPs (to avoid perpetuating harmful stereotypes; ensure training is "with" EM and not "about" EM); c) providing QRI team's expectations of participants in advance (clarity on emotional/mental labor involved); d) discussing participants' expectations of the research team (QRI interviews are not for medical information provision); and e) providing ample reassurance around confidentiality (to avoid identity disclosure to their communities, HCPs, or the government).

Conclusion: It is important to initiate community engagement by focusing on key concerns in the community, though this has been previously well studied (eg, barriers to EM research participation). Providing the space for this prior to discussing our research topic of interest fostered trust. This led to contributors' insightful suggestions to ensure QRI adaptation and acceptability to EM groups, with the aim of ensuring their representation in clinical trials.

Plain Language Summary: People from ethnic minority (EM) groups are more affected by health conditions than the general population. Yet, they are missing from trials, including those on health conditions affecting them the most (eg, diabetes). Researchers have a good understanding of issues that may prevent EM trial participation (barriers), but there is little knowledge of which recruitment methods are effective for such groups. The QuinteT Recruitment Intervention (QRI) is a set of methods successfully used to improve recruitment and informed consent in trials in the general population. We wanted to adapt the QRI so that it can be used to recruit people from EM groups to trials. Over five workshops, we asked 43 public contributors from diverse ethnic backgrounds what changes to make to the following QRI methods: audio-recording of trial discussions, feedback provided to doctors and nurses, interviews with patients, and QRI information sheets and consent forms. We did not intend to discuss barriers to research participation as this has been well explored in multiple studies, but this tended to be what our contributors most wanted to talk about (such as their lack of trust in research, researchers, and health-care professionals). After this discussion, they were open to providing suggestions for QRI adaptations, including ways to foster trust (such as offering a copy of the audio-recorded trial consultation to participants). They felt that training for health-care professionals (HCPs) should be "with" input from people from EM groups rather than "about" such groups. They also provided other suggestions, including clarifying that research interviews are not for medical information provision. Overall, we learnt the importance of providing the space to discuss the community's key concerns before discussing our research topic of interest, even when these concerns have been well explored in the existing research. This helped foster trust among contributors and led to important suggestions on how best to adapt the QRI to help ethnic minority participation in trials. We will now work with a wider group of people, including researchers, doctors, and nurses, to take these suggestions forward in our future QRIs.