Innovation in neurosurgery: less than IDEAL? A systematic review

W R Van Furth,M L D Broekman,J T Senders,A L Bredenoord,S J H Diederen,I S Muskens,A H Zamanipoor Najafabadi,A M May,T R Smith

doi:10.1007/s00701-017-3280-3

Abstract

BackgroundSurgical innovation is different from the introduction of novel pharmaceuticals. To help address this, in 2009 the IDEAL Collaboration (Idea, Development, Exploration, Assessment, Long-term follow-up) introduced the five-stage framework for surgical innovation. To evaluate the framework feasibility for novel neurosurgical procedure introduction, two innovative surgical procedures were examined: the endoscopic endonasal approach for skull base meningiomas (EEMS) and the WovenEndobridge (WEB device) for endovascular treatment of intracranial aneurysms.MethodsThe published literature on EEMS and WEB devices was systematically reviewed. Identified studies were classified according to the IDEAL framework stage. Next, studies were evaluated for possible categorization according to the IDEAL framework.ResultsFive hundred seventy-six papers describing EEMS were identified of which 26 papers were included. No prospective studies were identified, and no studies reported on ethical approval or patient informed consent for the innovative procedure. Therefore, no clinical studies could be categorized according to the IDEAL Framework. For WEB devices, 6229 articles were screened of which 21 were included. In contrast to EEMS, two studies were categorized as 2a and two as 2b.ConclusionThe results of this systematic review demonstrate that both EEMS and WEB devices were not introduced according to the (later developed in the case of EEMS) IDEAL framework. Elements of the framework such as informed consent, ethical approval, and rigorous outcomes reporting are important and could serve to improve the quality of neurosurgical research. Alternative study designs and the use of big data could be useful modifications of the IDEAL framework for innovation in neurosurgery.

Highlights

Today, it is unusual to perform neurosurgical procedures in most countries without access to an operative microscope, state-of-the-art neuro-navigational systems, or even hemostatic agents such as a bipolar electrocautery devices
As an randomized controlled trial (RCT) may not have been feasible for ethical or pragmatic reasons, we evaluated studies with different designs [16, 23]
This review suggests that neurosurgical innovation has not historically followed the IDEAL framework

Summary

Introduction

It is unusual to perform neurosurgical procedures in most countries without access to an operative microscope, state-of-the-art neuro-navigational systems, or even hemostatic agents such as a bipolar electrocautery devices. Technological innovation has been the hallmark of neurosurgery, and the vast majority of procedures that are currently considered routine would not be possible at all without innovation. Low incidence and high burden may further hinder systematic evaluation of any new technique. Regardless of these difficulties, it is vital that new technologies and procedures undergo a strategic and ethical clinical introduction [9]. Surgical innovation is different from the introduction of novel pharmaceuticals. To evaluate the framework feasibility for novel neurosurgical procedure introduction, two innovative surgical procedures were examined: the endoscopic endonasal approach for skull base meningiomas (EEMS) and the WovenEndobridge (WEB device) for endovascular treatment of intracranial aneurysms

Methods

Results

Discussion

Conclusion