Background: New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analysing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage.
Methods: The IDEAL Framework describes five stages of evolution for new surgical therapeutic interventions – Idea, Development, Exploration, Assessment and Long Term Study. This comprehensive update proposes several modifications. First, a “Pre-IDEAL” stage describing pre-clinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added.
Conclusions: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.
- IDEAL framework and recommendations
- medical devices
- randomized controlled trials
- research methodology
- surgical innovation
- RANDOMIZED CONTROLLED-TRIALS
- PELVIC ORGAN PROLAPSE