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Innovation in neurosurgery: less than IDEAL? A systematic review.
I S Muskens1,2, S J H Diederen1, J T Senders1,2
1Department of Neurosurgery, University Medical Center Utrecht, HP G03.124, PO Box 85500, 3508 GA, Utrecht, The Netherlands.
Acta Neurochirurgica
|August 7, 2017
Summary
The IDEAL framework for surgical innovation needs adaptation for neurosurgery. Current neurosurgical innovations like endoscopic endonasal approaches and WEB devices were not fully evaluated using this framework, highlighting a need for improved study designs and data collection.
Area of Science:
- Neurosurgery
- Medical Innovation
- Health Technology Assessment
Background:
- Surgical innovation differs significantly from pharmaceutical development.
- The IDEAL Collaboration framework (Idea, Development, Exploration, Assessment, Long-term follow-up) was established in 2009 to guide surgical innovation.
- Evaluating the IDEAL framework's applicability to novel neurosurgical procedures is crucial.
Purpose of the Study:
- To assess the feasibility of the IDEAL framework for introducing novel neurosurgical procedures.
- To examine the introduction of the endoscopic endonasal approach for skull base meningiomas (EEMS) and the WovenEndobridge (WEB device) for intracranial aneurysms using the IDEAL framework.
Main Methods:
- A systematic literature review of EEMS and WEB devices was conducted.
- Identified studies were classified according to the IDEAL framework stages.
- Studies were evaluated for categorization within the IDEAL framework.
Main Results:
- For EEMS, 26 of 576 papers were included; no prospective studies or reports on ethical approval/informed consent were found, preventing IDEAL framework categorization.
- For WEB devices, 21 of 6229 articles were included; two studies were categorized as IDEAL 2a and two as 2b.
- Neither EEMS nor WEB devices were introduced following the IDEAL framework guidelines.
Conclusions:
- The IDEAL framework, emphasizing informed consent, ethical approval, and rigorous outcomes, can enhance neurosurgical research quality.
- Current neurosurgical innovation introduction, exemplified by EEMS and WEB devices, does not consistently align with the IDEAL framework.
- Modifications to the IDEAL framework, including alternative study designs and big data utilization, may be necessary for effective neurosurgical innovation assessment.
