The overall aim of this planned work is to establish the ‘OptiMeth-CRPS’ Networking Group in order to produce an expert-derived methodological framework with which to guide, inform, optimise and harmonise the design and conduct of future clinical trials involving people living with chronic CRPS, based on the best available approaches for investigating the effectiveness of interventions for rare disorders. A methodological framework ‘provides structured practical guidance or a tool to guide the user through a process, using stages or a step-by-step approach’. In the absence of formal guidance on how to develop a methodological framework, we will utilise an ‘Experience and expertise’ approach (McMeekin et al. 2020). The workplan consists of 2 in-person and 4 online meetings to be conducted over a 12-month period. These meetings will enable the development and dissemination of the methodological framework. The networking group will be comprised of experts in rare disease trial methodologies, clinical trial design and implementation, CRPS-related evidence synthesis and CRPS clinical guidelines. The unique contribution of our group will be the provision of a clear, expert-derived methodological framework with which to inform future clinical trials and studies in CRPS. Such a framework will inform and optimise future trial designs, produce better quality research, better clinical guidelines and the best possible clinical management for patients living with chronic CRPS.
