Leading through expertise: a qualitative study of clinicians' experience of a paediatric clinical trial for displaced medial epicondyle fracture.

Aims: We sought to explore staff experience of a paediatric randomized controlled trial (RCT), comparing operative fixation and nonoperative treatment for displaced medial epicondyle fractures. Methods: A total of 20 staff (eight surgeons and 12 research delivery staff) recruiting to the RCT in 18 NHS Trusts across the UK took part in a telephone/online qualitative interview. Interviews were informed by Heideggerian Phenomenology and thematic analysis. Results: We identified the concept of 'leading through expertise' demonstrated through two themes: 1) choosing ways of making it work; and 2) enabling parental/child decision making. Staff drew on their clinical and organizational expertise to take a position of equipoise and invested time to make the trial work within their local context. Building trust and confidence and using creative ways to engage with children enabled parent/child decision making in the context of uncertainty. Recruitment was sustained by the energy, enthusiasm, and expertise of staff, by the local investigator and research delivery staff, the digital resources, and the support of the trial team. Recruitment was hindered by clinical pressures, a variable research culture, and lack of consistent digital access. Conclusion: For this relatively rare injury in children, 'leadership through expertise' was critical for successful trial recruitment. National and local networks of surgeons were imperative to support the trial activity. The development of similar networks among research delivery staff could improve knowledge exchange and enhance trial activities. Parental/child trust and confidence to decide about trial participation could be enabled by work to deepen child engagement in research. Educational tools engaging children may help to support family decision making in an emergency context.