Ethics of Innovation in Neurosurgery

Ethics of Innovation in Neurosurgery

by Marike L. D. Broekman (Editor)

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This book covers all ethical aspects of introducing novel implants and procedures in neurosurgery in a structured way, addressing the current knowledge gap concerning ethical innovations in neurosurgery. Initially it explores the difficulties involved in defining when a procedure should be considered innovationresearch, or care. To this end, it presents not only an overview of current literature, but also data from a recent surveyamong neurosurgeons in Europe.

The book subsequently discusses the ethical issues related to innovation. These include: informed consent (what should a surgeon tell the patient and how should he/she do so), oversight (can any surgeon simply implant a novel spinal device?), the learning curve (when should a surgeon be allowed to perform a novel procedure?), vulnerable patients (how to innovate in the pediatric population or in an emergency setting), and conflict of interest, as well as the ethics of paying for innovative treatments.

In turn, the closing chapters focus on the evaluation of neurosurgical research and innovation. Are cultural changes necessary and how could innovation benefit from (international) collaborations? Given the range of topics addressed, the book offers neurosurgeons, residents, scientists, companies and hospital administrations a valuable guide to introducing novel implants and techniques in neurosurgery.

Conflicts of interest

Conflicts of interest

Definition

The Institute of Medicine (IOM) defines conflict of interest as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest” 1).


Developmental incentives are fundamental to surgical progress, yet financial and professional incentives inherently create conflicts of interest(COI). Understanding how to manage COI held by neurosurgeons, industryhospitals, and journal editors, without thwarting progress and innovation is critical.

A review of the literature was performed to assess conflicts of interest that affect neurosurgical innovation, and review ways to manage COI of various parties while adhering to ethical standards.

COI are inherent to collaboration and innovation, and are therefore an unavoidable component of neurosurgery. The lack of a clear distinction between clinical practice and innovation, ability to use devices off-label, and unstandardized disclosure requirements create inconsistencies in the way that conflicts of interest are handled. Additionally, lack of requirements to compare innovation to the standard of care and inherent bias that affects study design and interpretation can have profound effects on the medical literature. Conflicts of interest can have both direct and downstream effects on neurosurgical practice, and it is possible to manage them while improving the quality of research and innovation.

Conflicts of interest are inherent to surgical innovation, and can be handled in an ethically sound manner. Neurosurgeons, device companieshospitals, and medical journals can take steps to proactively confront bias and ensure patient autonomy and safety. These steps can preserve public trust and ultimately improve evidence-based neurosurgical practice 2).

Relationships

Financial and nonfinancial relationships between pharmaceutical or medical device industry, physicians, investigators, and academic institutions are common and generally considered essential for development of new technology and advancement in medicine 3) 4).

However, these ties may at the same time create conflicts of interest: a set of circumstances that creates a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest 5).

Industry’s interests

The health care industry-manufacturers of drugs, devices, and medical equipment and its associated political and lobbying power, heavily influence strategic directions in clinical research. They may intervene, through experts with disclosed or silenced financial industry ties, in clinical guideline formation and dissemination, and may ultimately affect daily clinical practice.

The industry’s interests are not necessarily aligned with the interests of patients and society and may lead to study participant injury or harm and also reduce the public’s trust and confidence in clinical research.

It is obvious that the growing number of clinical trials conducted in vulnerable countries requires commitment from all stakeholders to ensure adherence to a core of internationally accepted ethical principles that reflect one of the basic ethical premises of the Declaration of Helsinki; that is, that the interests of science and society are not an excuse to conduct clinical trials in vulnerable countries.

Transnational clinical research should be controlled by internationally accredited ethical review boards, and research protocols rejected in one country should not be given permission to proceed elsewhere.

In addition, international human research monitoring agencies should have “…the power to sanction corporations and research groups that fail to respect universal standards”.

While these mechanisms are implemented, the role of major journals publishing the results of RCTs is crucial. This is because, as Smith emphasizes, when results are published in a major journal, the study receives “…the journal’s stamp of approval”, the published results carry a kind of professional approbation, and the paper becomes more attractive to both the readers and media, who may amplify the real value of the results.


A study aimed to determine the prevalence and financial magnitude of potential conflict of interest among editorial board members of five leading spine journals. The editorial boards of: The Spine Journal; Spine; European Spine Journal; Journal of Neurosurgery: Spine; and Journal of Spinal Disorders & Techniques were extracted on January 2013 from the journals’ websites. Disclosure statements were retrieved from the 2013 disclosure index of the North American Spine Society; the program of the 20th International Meeting on Advanced Spine Techniques; the program of the 48th Annual Meeting of the Scoliosis Research Society; the program of the AOSpine global spine congress; the presentations of the 2013 Annual Eurospine meeting; and the disclosure index of the American Academy of Orthopaedic Surgeons. Names of the editorial board members were compared with the individuals who completed a disclosure for one of these indexes. Disclosures were extracted when full names matched. Two hundred and ten (29%) of the 716 identified editorial board members reported a potential conflict of interest and 154 (22%) reported nothing to disclose. The remaining 352 (49%) editorial board members had no disclosure statement listed for one of the indexes. Eighty-nine (42%) of the 210 editorial board members with a potential conflict of interest reported a financial relationship of more than $10,000 during the prior year. This finding confirms that potential conflicts of interest exist in editorial boards which might influence the peer review process and can result in bias. Academia and medical journals in particular should be aware of this and strive to improve transparency of the review process. Janssen et al. emphasize recommendations that contribute to achieving this goal 6).


Traditional peer-review processes used by journal editors to aid in deciding which papers are worth publishing is not capable of filtering some of the more sophisticated techniques of covered marketing and conflicts of interest. The incorporation of ethicists in the peer review process would likely help to raise red flags and to properly consider the routine statement that the study was accepted by the “human review board” of some prestigious university. By rejecting suspicious ethical studies, editors may not be able to help make the world a fairer place, but they will help in building a healthier scientific community and sending a clear message, to both scientists and the industry, that it is unacceptable to exploit and potentially harm a few people for the sake of many 7).

Surgeon-industry

Surgeon-industry conflict of interest (COI) has become a source of considerable interest. Professional medical societiesindustry, and policy makers have attempted to regulate potential COI without consideration for public opinion.

The objective of a study was to report on the opinions of individuals representing the general public regarding surgeon-industry consulting relationships.

Survey was administered using a “spine Web site,” and opinions are collected on surgeon-industry consulting and regulation. Associations among responses to similar questions were assessed to ensure validity and subgroup analysis performed for respondent age, sex, education, insurance, employment, and patient status.

Six hundred ten of 642 surveys had complete data. The sample population comprised more females and was older and more educated than the American population. About 80% of respondents felt it was ethical and either beneficial or of no influence to the quality of health care if surgeons were consultants for surgical device companies. Most felt disclosure of an industry relationship was important and paying surgeons royalties for devices, other than those they directly implant, would not affect quality of care. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies to head this effort.

Despite the known potential negative impact of surgeon-industry COI on patient care, this study revealed that this does not seem to be reflected in the opinion of the general public. The respondents felt that disclosure is deemed one of the most important means of self-regulation and COI management, which is in agreement with current trends of most spine societies and journals that are increasing the stringency of disclosure policies 8).

Editorial board members of medical journals

Conflicts of interest arising from ties between pharmaceutical industry and physicians are common and may bias research. The extent to which these ties exist among editorial board members of medical journals is not known.

A study aims to determine the prevalence and financial magnitude of potential conflicts of interest among editorial board members of five leading spine journals. The editorial boards of: The Spine Journal; Spine; European Spine Journal; Journal of Neurosurgery: Spine; and Journal of Spinal Disorders & Techniques were extracted on January 2013 from the journals’ websites. Disclosure statements were retrieved from the 2013 disclosure index of the North American Spine Society; the program of the 20th International Meeting on Advanced Spine Techniques; the program of the 48th Annual Meeting of the Scoliosis Research Society; the program of the AOSpine global spine congress; the presentations of the 2013 Annual Eurospine meeting; and the disclosure index of the American Academy of Orthopaedic Surgeons. Names of the editorial board members were compared with the individuals who completed a disclosure for one of these indexes. Disclosures were extracted when full names matched. Two hundred and ten (29%) of the 716 identified editorial board members reported a potential conflict of interest and 154 (22%) reported nothing to disclose. The remaining 352 (49%) editorial board members had no disclosure statement listed for one of the indexes. Eighty-nine (42%) of the 210 editorial board members with a potential conflict of interest reported a financial relationship of more than $10,000 during the prior year. This finding confirms that potential conflicts of interest exist in editorial boards which might influence the peer review process and can result in bias. Academia and medical journals in particular should be aware of this and strive to improve transparency of the review process. Janssen et al. emphasize recommendations that contribute to achieving this goal 9).

Physician fully employed by industry

We would not allow a physician fully employed by industry to make a scientific presentation or publish an article for a peer-reviewed journal related to his or her company’s device or drug, yet we know from previously released orthopedic surgeon related data that many physician lecturers and writers are receiving yearly “consulting fees” and “royalty arrangements” that greatly exceed what is paid to physicians employed by device manufacturers—many above $1 million/year 10) 11) 12).

If publicly reporting these numbers places some in an uncomfortable position, so be it. This information is critical in the analysis of the clarity, sanctity, and scientific integrity of information and data presented. Collaboration has been valuable, but full transparency is critical to open, unbiased scientific dialogue and exchange.

References

1)

IOM (Institute of Medicine) Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press; 2009.
2)

DiRisio AC, Muskens IS, Cote DJ, Babu M, Gormley WB, Smith TR, Moojen WA, Broekman ML. Oversight and Ethical Regulation of Conflicts of Interest in Neurosurgery in the United States. Neurosurgery. 2019 Feb 1;84(2):305-312. doi: 10.1093/neuros/nyy227. PubMed PMID: 29850841.
3)

Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003; 289: 454–465.
4)

Garfin SR. Spine surgeons: spine industry. Eur Spine J. 2008; 17: 785–790.
5)

Steering Committee on Science and Creationism: National Academy of Sciences (1999) Science and Creationism: A View from the National Academy of Sciences, Second Edition The National Academies Press;
6) , 9)

Janssen SJ, Bredenoord AL, Dhert W, de Kleuver M, Oner FC, Verlaan JJ. Potential Conflicts of Interest of Editorial Board Members from Five Leading Spine Journals. PLoS One. 2015 Jun 4;10(6):e0127362. doi: 10.1371/journal.pone.0127362. eCollection 2015. PubMed PMID: 26042410.
7)

Sahuquillo J, Biestro A. Is intracranial pressure monitoring still required in the management of severe traumatic brain injury? Ethical and methodological considerations on conducting clinical research in poor and low-income countries. Surg Neurol Int. 2014 Jun 5;5:86. doi: 10.4103/2152-7806.133993. eCollection 2014. PubMed PMID: 25024886; PubMed Central PMCID: PMC4093744.
8)

DiPaola CP, Dea N, Noonan VK, Bailey CS, Dvorak MF, Fisher CG. Surgeon-industry conflict of interest: survey of North Americans’ opinions regarding surgeons consulting with industry. Spine J. 2014 Apr;14(4):584-91. doi: 10.1016/j.spinee.2013.06.028. Epub 2013 Aug 22. PubMed PMID: 23973098.
10)

Feder BJ. New focus of inquiry into bribes: doctors. New York Times. 2008 Mar 22; Available at: http://www.nytimes.com/2008/03/22/business/22device.html. Accessed December 30, 2010.
11)

Burns G. Partnerships between surgeons, implant makers raise ethical concerns. Chicago Tribune. 2008 Oct 26;
12)

Carryerou J, McGinty T. Top spine surgeons reap royalties, Medicare bounty. Wall Street Journal. 2010 Dec 20;:A1. Available at: http://online.wsj.com/article/SB10001424-052748703395204576024023361023138.html. Accessed December 30, 2010.

4K resolution

4K resolution, also called 4K, refers to a horizontal screen display resolution in the order of 4,000 pixels

There are several different 4K resolutions in the fields of digital television and digital cinematography. In television and consumer media, 3840 × 2160 (4K UHD) is the dominant 4K standard. In the movie projection industry, 4096 × 2160 (DCI 4K) is the dominant 4K standard.

The 4K television market share increased as prices fell dramatically during 2014 and 2015. By 2020, more than half of U.S. households are expected to have 4K-capable TVs, which would be a much faster adoption rate than that of Full HD (1080p).


A 4K 3D video microscope is compact, and provides high-resolution images, contributing larger surgical space and facilitating a multi-team surgery1).


Advances in video and fiber optics since the 1990s have led to the development of several commercially available high-definition neuroendoscopes. This technological improvement, however, has been surpassed by the smartphone revolution. With the increasing integration of smartphone technology into medical care, the introduction of these high-quality computerized communication devices with built-in digital cameras offers new possibilities in neuroendoscopy. The aim of a study of Mandel et al., was to investigate the usefulness of smartphone-endoscope integration in performing different types of minimally invasive neurosurgery.

They presented a new surgical tool that integrates a smartphone with an endoscope by use of a specially designed adapter, thus eliminating the need for the video system customarily used for endoscopy. They used this novel combined system to perform minimally invasive surgery on patients with various neuropathological disorders, including cavernomas, cerebral aneurysms, hydrocephalussubdural hematomas, contusional hematomas, and spontaneous intracerebral hematomas.

The new endoscopic system featuring smartphone-endoscope integration was used by the authors in the minimally invasive surgical treatment of 42 patients. All procedures were successfully performed, and no complications related to the use of the new method were observed. The quality of the images obtained with the smartphone was high enough to provide adequate information to the neurosurgeons, as smartphone cameras can record images in high definition or 4K resolution. Moreover, because the smartphone screen moves along with the endoscope, surgical mobility was enhanced with the use of this method, facilitating more intuitive use. In fact, this increased mobility was identified as the greatest benefit of the use of the smartphone-endoscope system compared with the use of the neuroendoscope with the standard video set.

Minimally invasive approaches are the new frontier in neurosurgery, and technological innovation and integration are crucial to ongoing progress in the application of these techniques. The use of smartphones with endoscopes is a safe and efficient new method of performing endoscope-assisted neurosurgery that may increase surgeon mobility and reduce equipment cost2).


Three commercially available cameras were tested: GoPro Hero 4 Silver, Google Glass, and Panasonic HX-A100 action camera. Typical spine surgery was selected for video recording; posterior lumbar laminectomy and fusion. Three cameras were used by one surgeon and video was recorded throughout the operation. The comparison was made on the perspective of human factor, specification, and video quality.

The most convenient and lightweight device for wearing and holding throughout the long operation time was Google Glass. The image quality; all devices except Google Glass supported HD format and GoPro has unique 2.7K or 4K resolution. Quality of video resolution was best in GoPro. Field of view, GoPro can adjust point of interest, field of view according to the surgery. Narrow FOV option was the best for recording in GoPro to share the video clip. Google Glass has potentials by using application programs. Connectivity such as Wi-Fi and Bluetooth enables video streaming for audience, but only Google Glass has two-way communication feature in device.

Action cameras have the potential to improve patient safety, operator comfort, and procedure efficiency in the field of spinal surgery and broadcasting a surgery with development of the device and applied program in the future 3).


Patients were operated on through transnasal transsphenoidal endoscopic approaches performed using Olympus NBI 4K UHD endoscope with a 4 mm 0° Ultra Telescope, 300 W xenon lamp (CLV-S400) predisposed for narrow band imaging (NBI) technology connected through a camera head to a high-quality control unit (OTV-S400 – VISERA 4K UHD) (Olympus Corporation, Tokyo, Japan). Two screens are used, one 31“ Monitor – (LMD-X310S) and one main ultra-HD 55” screen optimised for UHD image reproduction (LMD-X550S). In selected cases, we used a navigation system (Stealthstation S7, Medtronic, Minneapolis, MN, US).

Rigante et al., evaluated 22 pituitary adenomas (86.3% macroadenomas; 13.7% microadenomas). 50% were not functional (NF), 22.8% GH, 18.2% ACTH, 9% PRL-secreting. Three of 22 were recurrences. In 91% of cases we achieved total removal, while in 9% near total resection. A mean follow-up of 187 days and average length of hospitalisation was 3.09 ± 0.61 days. Surgical duration was 128.18± 30.74 minutes. We experienced only 1 case of intraoperative low flow fistula with no further complications. None of the cases required any post- or intraoperative blood transfusion. The visualisation and high resolution of the operative field provided a very detailed view of all anatomical structures and pathologies allowing an improvement in safety and efficacy of the surgical procedure. The operative time was similar to the standard 2D HD and 3D procedures and the physical strain was also comparable to others in terms of ergonomics and weight 4).

References

1)

Yoshida K, Toda M, Akiyama T, Takahashi S, Nishimoto M, Ozawa H, Ikari Y, Yoshida K. Combined Endoscopic Endonasal and Video-microscopic Transcranial Approach with Preoperative Embolization for a Posterior Pituitary Tumor. World Neurosurg. 2018 Nov;119:201-208. doi: 10.1016/j.wneu.2018.07.245. Epub 2018 Aug 6. PubMed PMID: 30092469.
2)

Mandel M, Petito CE, Tutihashi R, Paiva W, Abramovicz Mandel S, Gomes Pinto FC, Ferreira de Andrade A, Teixeira MJ, Figueiredo EG. Smartphone-assisted minimally invasive neurosurgery. J Neurosurg. 2018 Mar 1:1-9. doi: 10.3171/2017.6.JNS1712. [Epub ahead of print] PubMed PMID: 29529913.
3)

Lee CK, Kim Y, Lee N, Kim B, Kim D, Yi S. Feasibility Study of Utilization of Action Camera, GoPro Hero 4, Google Glass, and Panasonic HX-A100 in Spine Surgery. Spine (Phila Pa 1976). 2017 Feb 15;42(4):275-280. doi: 10.1097/BRS.0000000000001719. PubMed PMID: 28207670.
4)

Rigante M, La Rocca G, Lauretti L, D’Alessandris GQ, Mangiola A, Anile C, Olivi A, Paludetti G. Preliminary experience with 4K ultra-high definition endoscope: analysis of pros and cons in skull base surgery. Acta Otorhinolaryngol Ital. 2017 Jun;37(3):237-241. doi: 10.14639/0392-100X-1684. PubMed PMID: 28516968; PubMed Central PMCID: PMC5463515.
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