Barriers to conducting prospective multicentre studies in paediatric orthopaedics in Europe: Insights from the EPOS Discoid Meniscus (DiMe) project.

Abstract

Prospective multicentre studies represent a cornerstone of evidence-based advancement. However, within orthopaedics, and particularly in the European context of paediatric orthopaedics, such rigorous investigations are notably scarce. This study aims to explore the organizational, regulatory, and resource-related barriers hindering initiation of these crucial studies, using the setup phase of the '<i>EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol</i>'. A cross-sectional survey was conducted from 19 centres initially recruited for the European Paediatric Orthopaedic Society DiMe Project (NCT05580315) cohort study. Delays and perceived obstacles encountered during initiation phases: contract negotiation, ethics committee approval, and patient enrolment were assessed. A descriptive analysis was performed to characterize the data. Twelve responding centres (63.2%) were still in the contract negotiation phase, while 36.8% (<i>n</i> = 7) had progressed to the patient enrolment stage. Median duration for contract negotiation was 12 months (Q1-Q3: 7-22), matching ethical approval (Q1-Q3: 3-12). Sixty-three point two percent (<i>n</i> = 12) of responding centres were still in the contract negotiation phase, while 36.8% (<i>n</i> = 7) had progressed to patient enrolment, with 41 patients enrolled across these sites. Formal ethics committee submission was required <i>de novo</i> in 84.2% (<i>n</i> = 16) of responding centres. Major challenges identified included bureaucratic delays, lack of institutional support, absence of dedicated research staff, and prolonged administrative processes. The initiation of European multicentre studies in paediatric orthopaedics is hindered by institutional and regulatory barriers. Streamlining administrative and ethical processes and allocation of resources and personnel are needed to improve efficiency and facilitate successful collaborations. V - Expert opinion / Cross-sectional survey.