Randomized trials and similarly robust research methods generate evidence in carefully controlled settings, often with strict inclusion criteria. But patients in the ‘real world’ often have multiple comorbidities, and treatments are delivered within diverse environments. Trials are also difficult to fund, and rarely collect longitudinal data. Because of these, and other limitations, researchers are increasingly recognizing the inherent value of real world evidence (RWE). This is not only true for pharmaceutical products, and may have even more relevance in the evaluation of complex interventional procedures and non-medicines healthcare technologies. The Idea, Development, Exploration, Assessment, Learning (IDEAL) Framework guides the developmental ‘pipeline’ of surgical (and other) procedures, as well as medical device research (IDEAL-D). IDEAL informs the production of high-quality evidence of safety and effectiveness, but there is potential to further expand its applications.

Our aim is to investigate the feasibility of using of RWE alongside the IDEAL Framework in the assessment of procedures and devices. Methodological experts from the IDEAL Collaboration, HTA agencies and other healthcare research organisations are contributing their unique perspectives and experiences to explore these methods. As part of this work, Cedar Healthcare Technology Research Centre (Cedar) has attempted to retrospectively apply the IDEAL criteria to a series of RWE projects conducted on behalf of the National Institute for Health and Care Excellence (NICE) Interventional Procedures and Medical Technologies Evaluation Programmes.

Cedar's experience indicates that there may be options for using retrospective routinely-collected linked data and other existing sources to address some of the requirements of IDEAL. Likewise, the IDEAL Framework is expected to be a helpful reference when designing new databases and clinical registries for prospective collection of relevant and informative evidence. Examples from several projects will be shared at the Health Technology Assessment International (HTAi) conference.

Initial signs are that there are likely to be a number of ways in which IDEAL and RWE could complement one another.