Identifying research priorities in clubfoot management through a Delphi process : a study protocol.

Aims: Clubfoot is the most common congenital foot deformity. Clubfoot management is lacking high-quality research to support clinical decision-making. It has been chosen as one of the elective priorities in research by the James Lind Alliance priority setting. We present the protocol of a consensus-based approach to identify research priorities for clinical trials in clubfoot management. Methods: A modified Delphi technique will be used, which will involve an initial scoping survey, a two-round Delphi process, and a consensus meeting. The survey will be conducted among key stakeholders in the management of clubfoot, as well as patients and carers in the UK. The priorities identified during this process will each be assigned to core areas of consideration. The final list of research priorities will then be discussed and agreed in a consensus meeting of representative key stakeholders. Conclusion: While treatment of clubfoot has become more consistent with the use of the Ponseti method, most research is retrospective from single centres, and outcomes are variable. Identifying research priorities in this group of patients through this study will shape and drive the development of multicentre prospective clinical trials deemed most important for improving clinical practice and health outcomes.