Defining key design elements of registry-based randomised controlled trials: A scoping review

Abstract

Background: Traditional randomised controlled trials remain the gold standard for improving clinical care but they do have their limitations, including their associated high costs, high failure rate and limited external validity. An alternative methodology is the newly defined, prospective, registry-based randomised controlled trial (RRCT), where treatment and outcome data is collected in an existing registry. This scoping review explores the current literature regarding RRCTs to help identify the key design elements of RRCTs and the characteristics of clinical registries on which they are reliant on. Methods: A scoping review methodology conducted in accordance with the Joanna Briggs Instit..