DiRisio, BSc afdeling for neurokirurgi, Computational Neurosciences Outcomes Center (CNOC), Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Department of Neurourgery, Computational Neurosciences Outcomes Center (CNOC), Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Innovation in Neurosurgery
Key Ethical Challenges
Department of Neurosurgery, Haaglanden Medical Center, The Hague, Netherlands Department of Neurosurgery, Leiden University Medical Center, Leiden, Netherlands e-mail: [email protected]; [email protected].
Defining Innovation in Neurosurgery
Challenges and Implications
Surgical innovation in both research and the clinical paradigm may contain untested new ideas [7], but innovation in research is aimed at generating generalizable knowledge [26, 27], while innovation in clinical care is aimed at improving the outcome of the individual patient [ 26]. To this end, the Macquarie Surgical Innovation Identification Checklist (MSIIT) has been introduced and is currently being tested in its ability to identify innovations in the clinic [ 42 ].
Informed Consent for Neurosurgical Innovation
Physicians must become proficient in assessing patient capacity and conducting appropriate informed consent [6]. These challenges in the content conveyed in informed consent are only further complicated when we talk about innovation.
Ethical Challenges of Current Oversight and Regulation of Novel Medical Devices
Clinical use of medical devices in the USA and the EEA requires FDA approval or CE marking (Table 3.1). Interpretation of the Customs Union Agreement with Turkey in the field of medical devices 2010 [updated 10 April 2017].
Ethics of Neurosurgical Innovation
Oversight and Regulation
A quality improvement (QI) approach to controlling surgical innovation could ensure surgeon authority and ethical practice. In addition, the framework aims to enable the neurosurgeon to innovate in an efficient and ethical manner and to protect patients.
The Ethics of the Learning Curve in Innovative Neurosurgery
Others define the "learning curve" as the acquired knowledge and experience that is necessary to successfully perform the surgical procedure [7]. Some authors discussed learning curves only in the setting of performing radically new procedures, as in the first phase of the learning curve [9-11]. These logs can ultimately lead to shortening and optimizing the learning curve and result in the prevention of adverse events.
A transparent presentation of the experimental nature of the (un)known risks associated with the intervention is essential.
Innovation in Pediatric Neurosurgery
The Ethical Agenda
Over the past four decades, the concepts of clinical care and clinical research have been strictly separated; while clinical care is intended to benefit “a specific person in need of medical expert attention,” the goal of clinical research is to obtain generalizable knowledge [ 5 , 6 ]. Indeed, "the challenge is to devise a process that eliminates as much as possible the social pressure a candidate subject may feel," for example by leaving subject recruitment to independent health care workers with an interest in child psychology and conducting interviews separately with the child and his or her proxies [2]. This has previously been justified by surgical exceptionalism, "the view that the somewhat exceptional ethical or regulatory status of surgery is justified by the unique nature of surgery" [11].
Neurosurgical innovations occur on a wide spectrum, from minor deviations from standard practice (eg using longer screws for cranioplasty in a patient with mild cranial hyperostosis) to the introduction of radically innovative procedures (eg implantation of a 3D printed skull). in a patient with generalized cortical hyperostosis) [8, 9].
Conflicts of Interest in Neurosurgical Innovation
If the patient is not even aware of the reporting, legal disclosure does little to reduce the impact of COI in practice [1]. In the case of the rhBMP spinal implant, COI may have been one of many factors that led to the underreporting of adverse events. This has resulted in harm to patients, such as in the case of the interspinous process device (IPD) [32].
Maintaining the quality of the published literature and allowing the reader to understand the study in the context of COI will enable improved safety in applying the literature to clinical practice and will improve the integrity of the literature.
The Ethics of Funding Innovation: Who Should Pay?
While financing such innovation is clearly quite costly, it is important to note that this is not always the case. Given their educational missions, it is no surprise that universities contribute substantially to medical innovation in the United States. In the United States, the government is the second largest source of funding for medical research and development [2].
Of course, arguments can be made about whether it is the role of government to fund scientific and medical research.
Payment for and Right to Innovation in Neurosurgery
Public Pressure for Neurosurgical Innovation
While much of the funding for biomedical research in the United States comes from federal agencies, other sources include private donors and industry [10]. In the United States, funding for research and innovation often comes from federal agencies such as the National Institutes of Health (NIH) [ 11 , 12 ]. As the role of the Internet and social media continues to expand access for non-medically trained patients and their ability to "shop around" for different doctors, public pressure for certain treatments has become an increasingly serious problem.
In general, public pressure for innovation needs to be addressed directly so that neurosurgeons can respond directly to public concerns and achieve results that are mutually satisfactory.
Surgical Innovation for Terminal Illnesses: Do Patients Have a Right
While medical innovation has traditionally been limited to well-regulated clinical trials, surgical innovation is part of the daily life of surgery [15]. Doctors who are part of the care team are often blind to the patient's arm during the examination. For patients with terminal illnesses, informed consent becomes significantly more important due to the increased vulnerability of the patient population.
Surgical innovation nevertheless falls under the protection of the IRB if certain conditions are met [15].
Ethics Committees, Innovative Surgery, and Organizational Ethics
Although this EC was not typically consulted on organizational ethics issues, committee members approached this consultation in a similar manner to clinical ethics consultations. As a result, the final recommendations came out in the following form: “The hospital appears to have a moderately strong ethical obligation to financially support the uterus transplant program. Another notable aspect of this case is that the administration initiated the ethics consultation.
As the uterus transplant case shows, taking a similar approach to clinical and organizational ethics consultations can be effective.
Evaluating Awake Craniotomies in Glioma Patients: Meeting
These practice variations, if properly registered and shared, could be exploited to evaluate the awake craniotomy procedure. Indeed, it is possible that patients with recently diagnosed glioma may not be in the "right psychological state" to properly weigh the risks and benefits associated with a particular one. Greater awareness of the evidence-based nature of medicine could reduce this “therapeutic misconception”.
Furthermore, we believe that promoting an improved public and professional understanding of the nature of evidence-based medicine would facilitate the process of informed consent and reduce
Evaluation of Innovations in Neurosurgery
Ethical Considerations of Neuro- oncology Trial Design in the Era
Clinical trials of precision medicine therapy are currently being tested in patients whose cancers contain mutations targeted by these therapies. An example of this is 'drug repositioning', the concept of applying therapies initially developed for one pathology to another. Patients from low SES backgrounds require representation in clinical trials to ensure their equitable inclusion in precision medicine [ 18 , 19 ].
Awareness, understanding, and adoption of precision medicine to provide personalized treatment for patients with cancer: a multinational survey comparison of physicians and patients.
The Ethics of Passive Data and Digital Phenotyping in Neurosurgery
Invasion of privacy is one of the major concerns regarding the collection of PD [22–37]. For example, in the treatment of elderly patients, human touch and direct communication can have a significant impact on the patient's well-being. The required level of investigation depends on the source of the material, the purpose of the investigation and the extent to which additional information is needed.
Parkinson's ethical concerns are also similar to those outside the medical community, such as those associated with the tracking of online behavior by major companies like Google, Facebook and Verizon.
Research Ethics: When Innovation Is Clearly Research
Spinal cord fusion after transection remains one of the technical challenges of human head transplantation [5]. In the case of head transplant surgery, the patient in whom the operation is planned should come to the surgeon who is interested in the procedure himself [3]. Due to the radical nature of the unprecedented head transplant surgery, the procedure gained international media attention.
If head transplants are to be performed on other patients in the future, more care must be taken to protect the privacy of patients undergoing surgery.
Required Culture and Team Collaboration
Innovation and Team Collaboration in Neurosurgery
Some of the benefits of MDM are sharing the latest knowledge about new treatment options. Examples include negotiation, cooperation with given information, openness of communication, quality of communication and specific communication practices; it is important to know that deficiencies in the quality of communication can jeopardize patient safety. Teams can only be effective if the individual members have a common understanding of the goals and are also committed to them.
If the outcome of different treatments and quality of life are shared goals, issues related to patient treatment, including feedback as a team, must be achieved collectively.
Culture and Attitudes Supporting Ethical Innovation in Neurosurgery
This requires each of the members of the team to become more transparent than before. In addition to trusting yourself, it is essential to trust the other members of the team. In neurosurgery, an adapted version of the orthopedic surgeons' survey showed that high levels of "dangerous attitudes" are not so common among neurosurgeons [12].
However, the same attitudes can result in a situation in which team members do not dare to speak up or admit mistakes and are not eager to learn from them.
![Table 17.1 Six advices for team leaders to foster an environment of innovation and initiative (Adapted from [4])](https://thumb-ap.123doks.com/thumbv2/azdoknet/10590751.0/164.659.338.579.792.897/table-advices-leaders-foster-environment-innovation-initiative-adapted.webp)
Perspective: Future of Innovation in Neurosurgery
The ethical introduction of new surgical techniques could be helped by a structured approach, such as the IDEAL framework (Idea, Development, Exploration, Assessment, Long-term Follow-up) [1]. We have previously shown that two recent innovations in neurosurgery (namely the WEB device and endonasal endoscopic meningioma surgery) were not introduced according to this framework [2]. This might suggest that the IDEAL design may not always be the perfect answer for the ethically sound introduction of new devices and procedures in neurosurgery, but the framework has great potential for the introduction and evaluation of at least some innovations in neurosurgery.
Some have suggested that the introduction of new procedures and devices (for a predetermined roadmap) should depend on the level of potential risk to patients.
