Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 May 24;14(5):e079654.
doi: 10.1136/bmjopen-2023-079654.

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

Hollie Sarah Richards  1 , Sian Cousins  2 , Darren L Scroggie  2 , Daisy Elliott  2 , Rhiannon Macefield  2 , Elizabeth Hudson  2 , Ian Rodney Mutanga  2 , Maximilian Shah  2 , Natasha Alford  2 , Natalie S Blencowe  2 , Jane Blazeby  2
Affiliations

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

Hollie Sarah Richards et al. BMJ Open. .

Abstract

Objectives: The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (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, the 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, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.

Results: 48 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 was 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.

Keywords: qualitative research; surgery; systematic review.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Similar articles

See all similar articles

Cited by

References

    1. Kirkham EN, Main BG, Jones KJB, et al. . Systematic review of the introduction and evaluation of magnetic augmentation of the lower Oesophageal sphincter for Gastro-Oesophageal reflux disease. Br J Surg 2020;107:44–55. 10.1002/bjs.11391 - DOI - PMC - PubMed
    1. Pathak S, Main BG, Blencowe NS, et al. . A systematic review of minimally invasive Trans-Thoracic liver resection to examine intervention description, governance, and outcome reporting of an innovative technique. Ann Surg 2021;273:882–9. 10.1097/SLA.0000000000003748 - DOI - PubMed
    1. Sedrakyan A, Campbell B, Merino JG, et al. . IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ 2016;353:i2372. 10.1136/bmj.i2372 - DOI - PubMed
    1. Hirst A, Philippou Y, Blazeby J, et al. . No surgical innovation without evaluation: evolution and further development of the IDEAL framework and recommendations. Ann Surg 2019;269:211–20. 10.1097/SLA.0000000000002794 - DOI - PubMed
    1. Currie A, Brigic A, Blencowe NS, et al. . Systematic review of surgical innovation reporting in Laparoendoscopic Colonic Polyp resection. Br J Surg 2015;102:e108–16. 10.1002/bjs.9675 - DOI - PubMed

Publication types

LinkOut - more resources