Unattainable equipoise in randomized controlled trials: STAFF VIEWS OF A FEASIBILITY STUDY OF SURGICAL TREATMENTS FOR SEGMENTAL TIBIAL FRACTURES

Abstract

Aims To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. Methods A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants' experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis. Results The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes: The ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident; an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills; and treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment. Conclusion Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity, and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice.