Intelligent, Autonomous Machines in Surgery.

Surgeons perform two primary tasks: operating and engaging patients and caregivers in shared decision-making. Human dexterity and decision-making are biologically limited. Intelligent, autonomous machines have the potential to augment or replace surgeons. Rather than regarding this possibility with denial, ire, or indifference, surgeons should understand and steer these technologies. Closer examination of surgical innovations and lessons learned from the automotive industry can inform this process. Innovations in minimally invasive surgery and surgical decision-making follow classic S-shaped curves with three phases: (1) introduction of a new technology, (2) achievement of a performance advantage relative to existing standards, and (3) arrival at a performance plateau, followed by replacement with an innovation featuring greater machine autonomy and less human influence. There is currently no level I evidence demonstrating improved patient outcomes using intelligent, autonomous machines for performing operations or surgical decision-making tasks. History suggests that if such evidence emerges and if the machines are cost effective, then they will augment or replace humans, initially for simple, common, rote tasks under close human supervision and later for complex tasks with minimal human supervision. This process poses ethical challenges in assigning liability for errors, matching decisions to patient values, and displacing human workers, but may allow surgeons to spend less time gathering and analyzing data and more time interacting with patients and tending to urgent, critical-and potentially more valuable-aspects of patient care. Surgeons should steer these technologies toward optimal patient care and net social benefit using the uniquely human traits of creativity, altruism, and moral deliberation.

The Impact of Corporate Payments on Robotic Surgery Research: A Systematic Review.

OBJECTIVE: To quantify the influence of financial conflict of interest (COI) payments on the reporting of clinical results for robotic surgery. DATA SOURCES AND STUDY SELECTION: A systematic search (Ovid MEDLINE databases) was conducted (May 2017) to identify randomized controlled trials (RCTs) and observational studies comparing the efficacy of the da Vinci robot on clinical outcomes. Financial COI data for authors (per study) were determined using open payments database. MAIN OUTCOMES AND MEASURES: Primary outcomes assessed were receipt of financial COI payments and overall conclusion reported between robotic versus comparative approach. Quality/risk of bias was assessed using Newcastle-Ottawa Scale (NOS)/Cochrane risk of bias tool. Disclosure discrepancies were also analyzed. DATA EXTRACTION AND SYNTHESIS: Study characteristics, surgical subspecialty, methodological assessment, reporting of disclosure statements, and study findings dual abstracted. The association of the amount of financial support received as a predictor of reporting positive findings associated robotic surgery was assessed at various cut-offs of dollar amount received by receiver operating curve (ROC). RESULTS: Thirty-three studies were included, 9 RCTs and 24 observational studies. There was a median, 111 patients (range 10 to 6420) across studies. A little more than half (17/33) had a conclusion statement reporting positive results in support of robotic surgery, with 48% (16/33) reporting results not in favor [equivocal: 12/33 (36%), negative: 4/33 (12%)]. Nearly all (91%) studies had authors who received financial COI payments, with a median of $3364.46 per study (range $9 to $1,775,378.03). ROC curve demonstrated that studies receiving greater than $9557.31 (cutpoint) were more likely to report positive robotic surgery results (sensitivity: 0.65, specificity: 0.81, area under the curve: 0.73). Studies with financial COI payment greater than this amount were more likely to report beneficial outcomes with robotic surgery [(78.57% vs 31.58%, P = 0.013) with an odds ratio of 2.07 (confidence interval: 0.47-3.67; P = 0.011)]. Overall, studies were high quality/low risk of bias [median NOS: 8 (range 5 to 9)]; Cochrane risk: "low risk" (9/9, 100%)]. CONCLUSION AND RELEVANCE: Financial COI sponsorship appears to be associated with a higher likelihood of studies reporting a benefit of robotic surgery. Our findings suggest a dollar amount where financial payments influence reported clinical results, a concept that challenges the current guidelines, which do not account for the amount of COI funding received.

Discrepancies in Self-Reported and Actual Conflicts of Interest for Robotic Pediatric Urological Surgery.

PURPOSE: Transparency of conflicts of interest is essential when assessing publications that address the benefits of robotic surgery over traditional laparoscopic and open operations. We assessed discrepancies between self-reported and actual conflicts of interest as well as whether conflicts of interest are associated with favorable endorsement of robotic surgery. MATERIALS AND METHODS: We searched the Embase® and MEDLINE® databases for articles on robotic surgery within pediatric urology. We included English language articles published since 2013, when data in the Open Payments program (Centers for Medicare and Medicaid Services, Baltimore, Maryland) became available. For all United States based authors Open Payments was used to identify the total amount of financial payment received from Intuitive Surgical®. Chi-square test was used to assess the association between conflicts of interest and favorable endorsement of robotic surgery. RESULTS: A total of 191 articles were initially identified. After exclusion criteria were applied 107 articles remained (267 distinct authors). Of the articles 86 (80.4%) had at least 1 author with a history of payment from Intuitive Surgical, with 79 (91.9%) having at least 1 author who did not declare a conflict of interest despite history of payment. A total of 44 authors (16.5%) had a history of payment from Intuitive Surgical, with an average payment of $3,594.15. Articles with a first and/or last author with a history of payment were more likely to contain a favorable endorsement of robotic surgery compared to articles without a history of payment (85.1% vs 63.6%, p = 0.0124). CONCLUSIONS: Nondisclosure of conflict of interest with Intuitive Surgical is extremely common within pediatric urology. Steps to ensure accurate reporting of conflicts of interest are essential. There appears to be an association between a history of payment and favorable endorsement of robotic surgery.

Assessment of Conflicts of Interest in Robotic Surgical Studies: Validating Author's Declarations With the Open Payments Database.

BACKGROUND: Accurate conflict of interest (COI) statements are important, as a known COI may invalidate study results due to the potential risk of bias. OBJECTIVE: To determine the accuracy of self-declared COI statements in robotic studies and identify risk factors for undeclared payments. METHODS: Robotic surgery studies were identified through EMBASE and MEDLINE and included if published in 2015 and had at least one American author. Undeclared COI were determined by comparing the author's declared COI with industry reported payments found in the "Open Payments" database for 2013 and 2014. Undeclared payments and discrepancies in the COI statement were determined. Risk factors were assessed for an association with undeclared payments at the author and study level. RESULTS: A total of 458 studies (2253 authors) were included. Approximately, 240 (52%) studies had 1 or more author receive undeclared payments and included 183 where "no COI" was explicitly declared, and 57 with no declaration statement present. Moreover, 21% of studies and 18% of authors with a COI declared it so in a COI statement. Studies that had undeclared payments from Intuitive were more likely to recommend robotic surgery compared with those that declared funding (odds ratio 4.29, 95% confidence interval 2.55-7.21). CONCLUSIONS: We found that it was common for payments from Intuitive to be undeclared in robotic surgery articles. Mechanisms for accountability in COI reporting need to be put into place by journals to achieve appropriate transparency to those reading the journal article.

[Rethinking on ethics and principle of surgery].

Surgery is an important part of medicine, it has undergone huge changes in recent decades in China.The concepts of damage control surgery, minimally invasive surgery, and enhanced recovery after surgery are all new with the date, laparoscopic surgery, robotic surgery, natural orifice transluminalendoscopic surgery are not new words to all of us. Surgical operations are becoming more and more specialized, surgical technique is becoming more and more mature, and surgeons are becoming more and more specialized. Medical ethical issues, as the common language of surgeons and basic principle of surgery, should be recognized and understood more stronger than ever, which will enable surgeons to retrieve original intention of surgery. This paper takes this as starting point and explore the common principles of surgery, aims to arouse some mutual encouragement to growing youth surgeons.

Justice and Surgical Innovation: The Case of Robotic Prostatectomy.

Surgical innovation promises improvements in healthcare, but it also raises ethical issues including risks of harm to patients, conflicts of interest and increased injustice in access to health care. In this article, we focus on risks of injustice, and use a case study of robotic prostatectomy to identify features of surgical innovation that risk introducing or exacerbating injustices. Interpreting justice as encompassing matters of both efficiency and equity, we first examine questions relating to government decisions about whether to publicly fund access to innovative treatments. Here the case of robotic prostatectomy exemplifies the difficulty of accommodating healthcare priorities such as improving the health of marginalized groups. It also illustrates challenges with estimating the likely long-term costs and benefits of a new intervention, the difficulty of comparing outcomes of an innovative treatment to those of established treatments, and the further complexity associated with patient and surgeon preferences. Once the decision has been made to fund a new procedure, separate issues of justice arise at the level of providing care to individual patients. Here, the case of robotic prostatectomy exemplifies how features of surgical innovation, such as surgeon learning curves and the need for an adequate volume of cases at a treatment centre, can exacerbate injustices associated with treatment cost and the logistics of travelling for treatment. Drawing on our analysis, we conclude by making a number of recommendations for the just introduction of surgical innovations.

[The digital operating room : Chances and risks of artificial intelligence]. / Der digitale Operationssaal : Chancen und Risiken künstlicher Intelligenz.

At the central workplace of the surgeon the digitalization of the operating room has particular consequences for the surgical work. Starting with intraoperative cross-sectional imaging and sonography, through functional imaging, minimally invasive and robot-assisted surgery up to digital surgical and anesthesiological documentation, the vast majority of operating rooms are now at least partially digitalized. The increasing digitalization of the whole process chain enables not only for the collection but also the analysis of big data. Current research focuses on artificial intelligence for the analysis of intraoperative data as the prerequisite for assistance systems that support surgical decision making or warn of risks; however, these technologies raise new ethical questions for the surgical community that affect the core of surgical work.

Insights from telesurgery expert conference on recent clinical experience and current status of remote surgery.

Remote surgery provides opportunity for enhanced surgical capabilities, wider healthcare reach, and potentially improved patient outcomes. The network reliability is the foundation of successful implementation of telesurgery. It relies on a robust, high-speed communication network, with ultra-low latency. Significant lag has been shown to endanger precision and safety. Furthermore, the full-fledged adoption of telerobotics demands careful consideration of ethical challenges too. A deep insight into these issues has been investigated during the first Telesurgery Consensus Conference that took place in Orlando, Florida, USA, on the 3rd and 4th of February, 2024. During the Conference, the state of the art of remote surgery has been reported from robotic systems displaying telesurgery potential. The Hinotori, a robotic-assisted surgery platform developed by Medicaroid, experienced remote surgery as pre-clinical testing only; the Edge Medical Company, Shenzen, China, reported more than one hundred animal and 30 live human surgeries; the KanGuo reported human telesurgical cases performed with distances more than 3000 km; the Microport, China, collected more than 100 human operations at a distance up to 5000 km. Though, several issues-cybersecurity, data privacy, technical malfunctions - are yet to be addressed before a successful telesurgery implementation. Expanding the discussion to encompass ethical, financial, regulatory, and legal considerations is essential too. The Telesurgery collaborative community is working together to address and establish the best practices in the field.

Legal, regulatory, and ethical frameworks for development of standards in artificial intelligence (AI) and autonomous robotic surgery.

BACKGROUND: This paper aims to move the debate forward regarding the potential for artificial intelligence (AI) and autonomous robotic surgery with a particular focus on ethics, regulation and legal aspects (such as civil law, international law, tort law, liability, medical malpractice, privacy and product/device legislation, among other aspects). METHODS: We conducted an intensive literature search on current or emerging AI and autonomous technologies (eg, vehicles), military and medical technologies (eg, surgical robots), relevant frameworks and standards, cyber security/safety- and legal-systems worldwide. We provide a discussion on unique challenges for robotic surgery faced by proposals made for AI more generally (eg, Explainable AI) and machine learning more specifically (eg, black box), as well as recommendations for developing and improving relevant frameworks or standards. CONCLUSION: We classify responsibility into the following: (1) Accountability; (2) Liability; and (3) Culpability. All three aspects were addressed when discussing responsibility for AI and autonomous surgical robots, be these civil or military patients (however, these aspects may require revision in cases where robots become citizens). The component which produces the least clarity is Culpability, since it is unthinkable in the current state of technology. We envision that in the near future a surgical robot can learn and perform routine operative tasks that can then be supervised by a human surgeon. This represents a surgical parallel to autonomously driven vehicles. Here a human remains in the 'driving seat' as a 'doctor-in-the-loop' thereby safeguarding patients undergoing operations that are supported by surgical machines with autonomous capabilities.

ROBOTIC SURGERY: BIOETHICAL ASPECTS.

Introduction: The use of robots in surgery has been increasingly common today, allowing the emergence of numerous bioethical issues in this area. Objective: To present review of the ethical aspects of robot use in surgery. Method: Search in Pubmed, SciELO and Lilacs crossing the headings "bioethics", "surgery", "ethics", "laparoscopy" and "robotic". Results: Of the citations obtained, were selected 17 articles, which were used for the preparation of the article. It contains brief presentation on robotics, its inclusion in health and bioethical aspects, and the use of robots in surgery. Conclusion: Robotic surgery is a reality today in many hospitals, which makes essential bioethical reflection on the relationship between health professionals, automata and patients.

Introdução: A utilização de robôs em procedimentos cirúrgicos tem sido cada vez mais frequente na atualidade, o que permite a emergência de inúmeras questões bioéticas nesse âmbito. Objetivo: Apresentar revisão sobre os aspectos éticos dos usos de robôs em cirurgia. Método: Realizou-se revisão nas bases de dados Pubmed, SciELO e Lilacs cruzando-se os descritores "bioética", "cirurgia", "ética", "laparoscopia" e "robótica". Resultados: Do total de citações obtidas, selecionou-se 17 artigos, os quais foram utilizados para a elaboração do artigo. Ele contém breve apresentação sobre a robótica, sua inserção na saúde e os aspectos bioéticos da utilização dos robôs em procedimentos cirúrgicos. Conclusão: A cirurgia robótica é uma realidade, hoje, em muitas unidades hospitalares, o que torna essencial a reflexão bioética sobre as relações entre profissionais da saúde, autômatos e pacientes.

Innovation in surgical technology and techniques: Challenges and ethical issues.

The pace of medical innovation continues to increase. The deployment of new technologies in surgery creates many ethical challenges including how to determine safety of the technology, what is the timing and process for deployment of a new technology, how are patients informed before undergoing a new technology or technique, how are the outcomes of a new technology evaluated and how are the responsibilities of individual patients and society at large balanced. Ethical considerations relevant to the implementation of ECMO and robotic surgery are explored to further discussion of how we can optimize the delicate balance between innovation and regulation.

Robotic surgery: bioethical aspects / Cirurgia robótica: aspectos bioéticos

ABSTRACT Introduction: The use of robots in surgery has been increasingly common today, allowing the emergence of numerous bioethical issues in this area. Objective: To present review of the ethical aspects of robot use in surgery. Method: Search in Pubmed, SciELO and Lilacs crossing the headings "bioethics", "surgery", "ethics", "laparoscopy" and "robotic". Results: Of the citations obtained, were selected 17 articles, which were used for the preparation of the article. It contains brief presentation on robotics, its inclusion in health and bioethical aspects, and the use of robots in surgery. Conclusion: Robotic surgery is a reality today in many hospitals, which makes essential bioethical reflection on the relationship between health professionals, automata and patients.

RESUMO Introdução: A utilização de robôs em procedimentos cirúrgicos tem sido cada vez mais frequente na atualidade, o que permite a emergência de inúmeras questões bioéticas nesse âmbito. Objetivo: Apresentar revisão sobre os aspectos éticos dos usos de robôs em cirurgia. Método: Realizou-se revisão nas bases de dados Pubmed, SciELO e Lilacs cruzando-se os descritores "bioética", "cirurgia", "ética", "laparoscopia" e "robótica". Resultados: Do total de citações obtidas, selecionou-se 17 artigos, os quais foram utilizados para a elaboração do artigo. Ele contém breve apresentação sobre a robótica, sua inserção na saúde e os aspectos bioéticos da utilização dos robôs em procedimentos cirúrgicos. Conclusão: A cirurgia robótica é uma realidade, hoje, em muitas unidades hospitalares, o que torna essencial a reflexão bioética sobre as relações entre profissionais da saúde, autômatos e pacientes.