Examining the application of the IDEAL Framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review.

Objectives
The development of new surgical procedures is fundamental to advancing patient care. The IDEAL framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.
Design
Secondary qualitative analysis of a systematic review.
Data Sources
Citation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.
Eligibility Criteria
Studies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.
Data extraction and synthesis
All relevant text was extracted. Three frameworks were developed: i) type of innovation under evaluation; ii) terminology used to describe stage of innovation; and iii) reported rationale for IDEAL stage.

Results
Forty-eight articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous, and were not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.
Conclusion
Identifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors’ rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision making.