Tailoring study design to each stage of surgical innovation: the ideal recommendations

Abstract

The pathway of surgical innovation is complex. Inherent ethical and practical characteristics make scientific evaluation of new techniques or devices by a definitive randomized controlled trial (RCT) challenging. The IDEAL Collaboration (http://www.ideal-collaboration.net) Framework for evaluating surgical innovation describes a five stage process - Idea, Development, Exploration, Assessment and Long-term study.(1) Early stage studies should be designed to facilitate and prepare the way for a rigorous evaluation by RCT. IDEAL Recommendations in the early stages (Idea/Development) emphasise prospective designs, transparency and full reporting in open registries, to provide reliable data early in the innovation development process. At the Exploration stage, prospective observational studies need to address factors such as case-mix, learning and outcomes, building cooperatively and explicitly towards a definitive evaluation study, preferably an RCT, optimising the contribution of data from non-randomised prospective evaluations (Assessment stage). The Long-term stages should be characterised by registry-based surveillance for both new procedures and devices. IDEAL proposals for high quality RCTs of surgical procedures focus on three key areas: definition of the intervention; who delivers the intervention and preferences of surgeons and patients. IDEAL Recommendations identify modifications to study design which may help address these difficult areas. We will describe examples of good practice using these suggested methods. Everyone involved in evaluating surgical innovations is invited to join the IDEAL Collaboration community and help further evolve methodology and reporting standards for robust trials in surgery.