Innovation in neurosurgery: less than IDEAL? A systematic review

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.Electronic supplementary materialThe online version of this article (doi:10.1007/s00701-017-3280-3) contains supplementary material, which is available to authorized users.

The IDEAL framework in neurosurgery: a bibliometric analysis

“…Of them, 13 (35%) were narrative reviews [ 9 , 11 , 15 , 27 , 29 – 31 , 43 – 45 , 52 , 53 , 64 ]. Eleven (30%) were systematic reviews [ 1 , 5 , 10 , 14 , 16 , 38 , 40 , 46 , 48 , 49 , 66 ].…”

“…While utilization has increased overall, this has predominantly happened in other surgical fields [ 28 ]. A recent review of the IDEAL framework applied within minimally invasive neurosurgical research assessed historical studies involved in the development of the endoscopic endonasal approach for skull base meningiomas and the Woven EndoBridge (WEB) device for endovascular treatment of intracranial aneurysms [ 48 ]. The authors assessed the quality of the research that contributed to these developments by measuring the adherence of various studies to IDEAL guidelines.…”

Innovation in neurosurgery response to: “Ideal”, the operating microscope, and the parachute

“…We would be satisfied with a simple informed consent when a planned new procedure is offered to a patient. It is a fact that none of the reports on Endoscopic Endonasal Approaches for Skull Base Meningiomas (EEMS) quoted in Muskens' paper had an informed consent, let alone ethical approval or outside evaluation of results [3]. On the other hand, the Wowen Endobridge (WEB device) reports quoted in the same paper had ethical approval and informed consent in four studies and outside independent result evaluation in two of the four studies [3].…”

“…It is a fact that none of the reports on Endoscopic Endonasal Approaches for Skull Base Meningiomas (EEMS) quoted in Muskens' paper had an informed consent, let alone ethical approval or outside evaluation of results [3]. On the other hand, the Wowen Endobridge (WEB device) reports quoted in the same paper had ethical approval and informed consent in four studies and outside independent result evaluation in two of the four studies [3]. This is clear evidence that minimal common sense requirements for the introduction of new procedures are not hampering innovation, rather making it more robust while at the same time attempting to protect patients.…”

Innovation in neurosurgery

“…The paper by Muskens et al [1] endeavors to evaluate two innovative neurosurgical procedures, the endonasal approach to skull base meningiomas (EEMS) and the WovenEndobridge (WEB device) for endovascular treatment of intracranial aneurysms, according to the IDEAL recommendations.The IDEAL recommendations are an evolving set of guidelines on how to introduce innovations in surgery and, if widely accepted, may represent a quantum leap improvement in the way surgical innovations are introduced. This is sorely needed to improve patient safety and resource allocations.…”