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Acta bioethica

versión On-line ISSN 1726-569X

Acta bioeth. vol.24 no.2 Santiago dic. 2018

http://dx.doi.org/10.4067/S1726-569X2018000200167 

Originales

Ethical aspects involving the use of information technology in new surgical aplications: telesurgery and surgical telementoring

Aspectos éticos relacionados con el uso de información tecnológica en nuevas aplicaciones quirúrgicas: tele-cirugía y tele-tutoría

Aspectos éticos envolvendo o uso de tecnologia da informação em novas aplicações cirúrgicas: telescirurgia e telemonitoria cirúrgica

Fernando Fuertes-Guiró1 

Eduardo Viteri Velasco2 

1Spain. Universitat Internacional de Catalunya, Faculty of Medicine and Health Sciences, Barcelona Correo electrónico: fernandofuer@gmail.com

2Spain. Quirón Salud University Hospitals, Department of Surgery, Barcelona Correo electrónico: fernandofuer@gmail.com

Abstract:

Background: The surgical telementoring is a technology that involves surgical procedures guided by an expert or mentor, performed by other surgeons from a distance, using information and knowledge technologies. This therapeutic innovation has generated new opportunities to improve the surgical attention and the training of the surgeons. However, their ethical implications should be analyzed to clarify their use, to check the patient's safety and eliminate uncertainties. The characteristics of surgical telementoring generate specific challenges and ethical dilemmas that must be identified, analyzed and solved. Results: In this paper the ethical challenges and dilemmas of surgical telementoring identified and analyzed cover multiple aspects such as patient safety, privacy and vulnerability, the surgeon-mentor-patient relationship and informed consent, professional responsibility, cost-effectiveness analysis and Solidarity and social justice regarding the use of healthcare resources, the systematic approach to validation of the proposed new technology and conflicts of interest. For many of these issues solutions are provided, but they are still to be solved. Conclusions: surgical telementoring potentially improves patient healing and surgeon education. It will have a rapid evolution in the next years. This rapid growth should not be anticipated to the solid implantation of ethical guarantees for its use due to the particular characteristics that this technology has in the field of telemedicine.

Key words: surgical telementoring; telesurgery; ethical analysis

Resumen:

Antecedentes: El uso de tele-tutoría en cirugía es una tecnología que incluye procedimientos quirúrgicos guiados por un experto o tutor, realizado por otros cirujanos a distancia usando tecnologías de información y conocimiento. Esta innovación terapéutica ha generado nuevas oportunidades para mejorar la práctica de cirugía y la formación de los cirujanos. Sin embargo, deberían de analizarse sus implicaciones éticas para clarificar su uso, comprobar la seguridad del paciente y eliminar incertidumbres. Las características de la tele-tutoría en cirugía generan desafíos específicos y dilemas éticos que deben identificarse, analizarse y resolverse. Resultados: En este artículo se identificaron y analizaron múltiples aspectos en cuanto a desafíos éticos y dilemas de tele-tutoría en cirugía tales como: seguridad del paciente, privacidad y vulnerabilidad, la relación cirujano-tutor-paciente y el consentimiento informado, la responsabilidad profesional, análisis de costo-efectividad, solidaridad y justicia social respecto al uso de recursos en el cuidado de la salud, la aproximación sistemática para la validación de la nueva tecnología propuesta y los conflictos de interés. Para muchos de estos temas se han proporcionado soluciones, pero todavía no han sido resueltas. Conclusiones: La tele-tutoría en cirugía mejora potencialmente la sanación del paciente y la educación del cirujano. Va a tener una rápida evolución en los próximos años. Este rápido crecimiento no debería anticiparse a la implantación sólida de garantías éticas para su uso debido a las características particulares que tiene esta tecnología en el campo de la tele-medicina.

Palabras clave tele-tutoría en cirugía; tele-cirugía; análisis ético

Resumo:

Fundo: A cirurgia teleguiada é uma tecnologia que envolve procedimentos cirúrgicos, guiados por um especialista ou mentor, executados por outros cirurgiões à distância, usando tecnologias da informação e do conhecimento. Esta inovação terapêutica tem gerado novas oportunidades para melhorar a atenção cirúrgica e a formação dos cirurgiões. No entanto, suas implicações éticas devem ser analisadas para esclarecer seu uso, para verificar a segurança do paciente e eliminar as incertezas. As características da cirurgia teleguiada geram desafios específicos e dilemas éticos que devem ser identificados, analisados e resolvidos. Resultados: Neste artigo os desafios éticos e dilemas da cirurgia teleguiada identificados e analisados vislumbram vários aspectos como a segurança do paciente, sua privacidade e vulnerabilidade, o relacionamento paciente-cirurgião-mentor e consentimento informado, responsabilidade profissional, análise custo-eficácia e solidariedade e justiça social em relação ao uso dos recursos de saúde, a abordagem sistemática para validação da tecnologia nova proposta e conflitos de interesse. Para muitas destas questões são fornecidas soluções, mas muitas ainda estão para serem resolvidas. Conclusões: a cirurgia teleguiada potencialmente melhora o atendimento do paciente e o ensino do cirurgião. Vai ter uma rápida evolução nos próximos anos. Este rápido crescimento não deve ser antecipado para a implantação contínua de garantias éticas para seu uso devido as características particulares que esta tecnologia tem no campo da telemedicina.

Palavras-chave: cirurgia teleguiada; análise ética

Introduction

The definition of surgical ethics has been constantly evolving since its inception in the eighteenth century by Gregory and Percival(1). While it was initially a response to the need to protect patients, provide more safety in medical procedures and maintain confidence in surgeons, in the following centuries it was developed based on advances in the field of anesthesia, antisepsis and the development of new methodologies, techniques and surgical procedures. The era of transplantation and the consolidation of mini-invasive surgery in the twentieth century and surgical robotics and information and knowledge technologies (ICTs) applied to surgery in the twenty-first century are creating new previously unknown areas of surgical ethics.

The doctor-patient relationship is the central feature of clinical ethics, and thus also of surgery. This relationship must be the starting point and the cornerstone of surgical ethics. However, there is some distance between surgical ethics regarding the doctor-patient relationship and medical ethics according to the differences defined by Miles Little(2): the surgeon's power to rescue patients, the special surgeon-patient proximity in the operating theatre, tests that patients undergo in the pre-, peri- and post-surgery periods, and the physical-emotional consequences of surgical treatment, as well as the patient's desire to be treated by an experienced surgeon.

The general criterion for surgical progress has always been reduced morbidity and mortality in terms of complications or death. When evaluating surgical innovations, other variables that are taken into account are the disease-free period, the recurrence rate, and shorter hospitalization times. However, in recent years, the values for the patient in terms of subjective benefits, such as the aesthetic result, have been added to these variables. When new surgical procedures are proposed, it is therefore necessary to assess the true progress that their implementation entails(3).

Telemedicine, Telementoring and Telesurgery

We consider telemedicine to be procedures that use medical information that is exchanged from one physical location to another using ICTs in order to improve the patient's state of health(4). For part of the scientific community, this term is too specific and they prefer to call it telehealth or telecare(5). As this major field of applied medicine has developed, various ways of exchanging this medical information have emerged, and have been called by various names, such as teleconferencing, telemonitoring, telepresence, interoperabilityteleconsultation and telementoring(6). We will consider the last two.

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) defines telementoring(7) as an relationship facilitated by ICTs, in which an expert (mentor) provides advice to another less experienced professional (mentoring) from a remote location. It is different from teleconsultation, in which the professional expert uses store and forward or videoconferencing to provide information to a professional user.

Telementoring is based on four premises: 1. The establishment of a strong professional relationship between mentor and mentee, in which the former is aware of the mentee's abilities, limitations and way of working; 2. The mentee must be able to manage the patient's illness, as if the mentor were not present, despite using a different surgical technique; 3. It is an educational process in which mentor and mentee have had to prepare previously for the experience; 4. The advice must be comprehensive and sufficient, so that the mentee can work safely and the technological support therefore must be extensive (including telestration).

Telementoring is the result of a twofold need (educating and providing care) at a time in the history of medicine when technological progress is so rapid that outside the hospital environment they have a well developed infrastructure which other professionals are unable to assimilate. Since its inception, telementoring has been an almost exclusively surgical application, and specifically for mini-invasive surgery, with its main applications being correction of the deficit in the learning curve of new surgical techniques for surgeons in rural hospitals(8) and counseling in special situations, such as hospitals in war zones(9). Hospitals providing this service(10) with surgical robots and joint development projects have appeared in recent years(11). Several review studies on the application of telementoring in mini-invasive surgery have been published, and concluded that it is a safe and effective procedure that is comparable to face-to-face mentoring(12-17).

However, surgical telementoring is not without its disadvantages. It is a procedure that relies on an adequate telecommunications infrastructure, and any failure would leave the mentee without expert assistance with consequences for the patient. In addition, the legal requirements and the authorization to practice vary from one country to another. Furthermore, the doctor-patient relationship is altered by including a third person whose role in this new interpersonal relationship is to be defined. Logistical changes, the development of a new business, the sharing of responsibilities and the inherent legal aspects (regulations, licenses, competence and suitability of surgeons, among others) must also be considered. Finally, other issues that arise with the use of surgical telementoring are new responsibilities for professionals, the patient's increased vulnerability, the need for a new informed consent, new intellectual rights, jurisdictional problems depending on the type of health system in which the telementoring takes place (public health, i.e. copayment, or private health, i.e. reimbursement), protection and safety, the right of the patient to access this new technology, and the need to establish new protocols and clinical guidelines.

The latest new step in this process of surgical mentoring using ICT is telementoring telesurgery. In this new technology, the mentor is the surgeon who performs the surgical operation at a distance, and only requires one or two surgeons to supervise the operation. The development of this new technique has been dazzling, with the arrival of robotic surgery (robotic tele-surgical system), which was first proposed and documented in 2005(18) with the da Vinci® system. With this system, the mentor surgeon personally directs the movements of the robot in the operating room, performing the operation, or part of the operation, when the surgeons present in the operating theatre have difficulties.

Telementoring is an increasingly consolidated procedure in surgical practice, and needs a legal and ethical architecture for its correct development and application.

Telemedicine, ethics and ethical guidelines

Telemedicine has been used by the international medical community for more than 60 years, but the ethical debates around it emerged later. There have been three generations of telemedicine. The first generation (which began in the United States and Canada in the 1950s and 1960s, aimed to demonstrate its technological viability by extending scarce medical resources over long distances using audio and video media and the telephone. The second generation began to emerge in the late 1980s, with the miniaturization and portability of information technology, the emergence of the Internet, multimedia browsers and e-mail. Finally the third generation began in the late 1990s, and includes today’s telemedicine. However, unlike previous generations, the third generation is being controlled by government legislation with the establishment of the first ethical guidelines for telemedicine.

With this passage of time, the feasibility, safety and clinical advantages of telemedicine have been confirmed and today it is recognized as one of many tools for improving patients’ healthcare. Indeed, many patients have benefited from telemedicine when they had no other means of accessing health systems. In addition, the patients themselves are satisfied with ICTs because they provide them with uninterrupted care. For professionals, telemedicine has had many advantages: the development of protocols for the immediate treatment of emerging pathologies, the creation of systems to obtain information quickly, a means to receive specialized and expert advice, support for the follow-up of chronic pathologies, treatment adherence systems, and monitoring patients.

However, from the economic point of view, there is no unanimity regarding the cost-effectiveness of this new technology, partly due to the few studies that analyze the necessary variables(19).

The application of telemedicine should be guided by the same ethical principles upon which medicine was based before the use of this new technology. However, the particular technical characteristics of this medical innovation create a series of ethical issues that have begun to arise only after years of application. These issues include the impact on the patient-physician relationship, including the loss of direct professional-patient physical contact with potential depersonalization; the new burden of information that must be placed on the patients regarding the technology used, in addition to the information that is normally provided to them about their pathology; new challenges related to privacy and confidentiality; possible inequality in the distribution of the benefits of telemedicine services; technology as an additional burden for patients with chronic and terminal illnesses; the impact of replacing real visits with virtual visits, and the risk of exploitation when using new and expensive technology.

Telemedicine has developed as such a rapid rate that numerous variants in its application have appeared in only a few years. Many of them have not been subjected to rigorous ethical studies and are applied based on general principles based mostly on common sense. In some cases, ethics committees or governments act as filters for the approval of these new types of telemedicine(20). On other occasions, the scientific community follows all the established steps to prove its effectiveness and security before announcing a new technology based on ICT(21).

However, there are potential ethical dilemmas posed by applications of telemedicine in which the value of individuals able to pursue their own interests in their own way contradicts the value of society's efforts to reduce harm and to use public resources more fairly and efficiently. Scientific societies and professional associations have begun to adopt ethical guidelines for the application of telemedicine for this reason.

The Standing Committee of European Doctors (CPME) approved the first ethical guidelines on telemedicine in 1997 and confirmed them in 2002. This guide defined the basic principles for authorization and professional competence for their application, the doctor-patient relationship, the responsibility of the physician, and established quality and safety criteria and stipulated the rules for preserving the confidentiality of patients’ data(22).

Later, in 2007, the General Assembly of the World Medical Association (WMA) established its basic ethical principles for the use of telemedicine, which consisted of three aspects: the physician-patient relationship and confidentiality, establishment of professional responsibilities and quality of medical care(23). Recently, in 2016, the American Medical Association (AMA) established its ethical guidelines for the use of telemedicine(24). These guidelines are based on an awareness that the multiple and novel applications of telemedicine have their limitations. These ethical principles oblige physicians who use them to make a series of commitments: to inform patients of the limitations of telemedicine, to warn patients how to plan the monitoring of their diseases; to advise patients to go to their primary healthcare doctors to let them know that they are involved in a telemedicine process; and to promote initiatives to universalize the use of telemedicine to those who can benefit from it. All these guidelines and minimum ethical guidelines approved by these medical associations are an important framework for action in telemedicine. However if we consider all technologies, both new and old, encompassing telemedicine, there are particular dilemmas and challenges for each one. These particular issues must be identified and resolved to be able to work under optimum conditions. Surgical telementoring is a technology that uses ICTs requiring an in-depth analysis of their ethical challenges and dilemmas, to which a solution must be provided. The rapid evolution and implementation of surgical telementoring also justifies this analysis.

Dicussion

The Belmont Report of 1979(25) defined the four basic ethical principles to take into account in medical practice: beneficence, non-maleficence, respect for the patient’s autonomy and justice. The principles of truthfulness, integrity, honesty and respect for the rights of patients were subsequently added to the previous ones. The first principle means that any medical act is intended to benefit the patient. The second principle states that no medical act must cause harm to the patient. The third assumes that the patient is able to make decisions about medical acts that affect his or her health and the surgical team must respect them. For this, two conditions are required of the patient: they must make these decisions without external interference (with total freedom) and the patient must be psychophysically fit to take them (intentionality). The fourth ethical principle refers to the fairness, adequacy and fair treatment that must be applied to the patient by the professionals.

When we want to implement a telementoring program, these principles must be respected in order to make medical practice an act of morality and respect towards patients. However, there are 10 issues, including dilemmas and challenges, that we find when we want to apply this surgical telementoring programme (which are also applicable to robotic telesurgery) and which could violate these ethical principles(26).

Safety of telementoring in terms of ICT for the live exchange of information; the interrelation and degree of training of the surgeons (mentor and surgeons operating): parameters of surgical suitability.

When applying a surgical innovation, concern for patient safety should be the first need to be addressed. This involves complying with the ethical principles of charity and not malfeasance. When a surgical novelty is applied, there is very often an increase in morbidity and mortality - in comparison with the applied standard - because it is related to the learning curve. However in telementoring, the aim is to reduce morbidity and mortality related to certain operations because of the lack of training and experience of the surgeons involved. Consequently, the safety of telementoring refers to the safety of ICT in terms of the live exchange of information, safety in the personal interrelations and the degree of training of the surgeons (the mentor and surgeons operating) to carry out telementoring and the safety security of the experience of the surgeons in the pathology to be operated on.

Regarding the first point, numerous studies(27,28) have demonstrated the safety and feasibility of surgical telementoring, which has complication rates lower than 5%, similar to the same surgery without telementoring(29). However, there are still some issues to be resolved regarding the ideal method for videoconferencing, resolution and latency requirements, and the ability to adapt telementoring to emerging technology. We will act according to ethical principles if we ensure a correct exchange of information between the mentor and the operating surgeon. To achieve this, the following minimum requirements must be met: the use of cameras that combine high resolution and high resolution; the mentor surgeon's ability to zoom directly; the existence of an additional interactive communication system as well as voice and image, such as telestration or laser pointing. The connection delay should also be less than 250 ms, although numbers of up to 700 can be used in telementoring without any problems. A delay exceeding 500 ms has been documented as being potentially harmful(30).

When a hospital decides to undertake a surgical telementoring procedure, the suitability of the mentor surgeon's relationship with the acting surgeons must be assured. The professionals must also have acquired sufficient telementoring skills and knowledge. Like all professionals, the participants in the telementoring should make sure of the benefit rather than malfeasance of their actions towards the patient. Pellegrini(31) defined three phases for the incorporation of a new technology in surgical practice: familiarization with the cognitive aspects of the new technology, acquisition of the necessary psychomotor skills and evaluation of the training acquired (based on the minimum required). Surgeons who participate in a telementoring operation must have met all three requirements. This training must be accredited by obtaining a training certificate for both the mentor and the acting surgeons. Some professional societies already demand it(32). Furthermore, the professionals involved in this procedure to have a mutual understanding of the way each other works in the operating room, their degree of consolidation of skills, and their surgical experience. Pre-telementoring and on-site verification (in the operating room) of all these conditions is therefore required: the mentor must play a coordinating and supervising role in this prior phase, and must pay particular attention to ascertaining the acting surgeon's learning curve for the operations to be mentored. Some authors(33) even consider it necessary for the mentor to also participate in the patient’s pre and postoperative periods of care. This involvement by the mentor should consist of discussion of the clinical cases to be operated on to assess the surgical indication, the suitability of telementoring, surgical planning, the suitability of the instruments and technology and the management of possible complications. In the postoperative period, the mentor must issue a report specifying the how the operation took place in terms of the telementoring aspects, which should be part of the record of the operation and therefore of the patient's medical history. The existence of this document will preserve the ethical principle of patient autonomy, as it will provide information for future decisions related to their health.

Finally, the hospital and professional societies must ascertain the general professional experience of the surgeons who will be involved in the operations with telementoring. A precondition for participation is that the acting surgeons must be at an intermediate stage in their learning curve of the pathologies that they want to operate on, and for the mentor to have completed their learning curve and to have already mentored –-these pathologies in the operating theatre and online. Official training certificates for mentoring ICT operations must be issued(34).

Conclusions

Surgical telementoring allows real information to be shared online between an experienced mentor surgeon and operating surgeons in the operating room, who are in different geographic locations, using ICT. The goal of this new technology is to provide education for surgeons and to improve patient care. The most important beneficiaries of this technology are health centers in rural and remote areas and hospitals on the battlefield, where it is almost impossible to obtain expert care for some operations and pathologies.

The world’s increasing globalization and the development of ICT have enabled this technology to develop rapidly in recent years. Many studies have corroborated its reliability, efficiency and cost-effectiveness and suggest that telementoring is safe and achievable. It is possible that in the future it will be adopted as a service at more health centers, due to the demand among professionals. For all these reasons, and because it offers certain advantages for both patients and the surgeons, it is necessary to consider the ethical aspects to validate its use in medical practice.

The ethical challenges and dilemmas of surgical telementoring identified and analyzed in this paper cover multiple aspects, such as patient safety, privacy and vulnerability, the surgeon-mentor-patient relationship and informed consent, professional responsibility, a cost-effectiveness analysis and solidarity and social justice regarding the use of healthcare resources, a systematic approach to the validation of the proposed new technology and conflicts of interest.

When implementing a surgical innovation, concern for patient safety should be the first need to be addressed, and safety in telementoring includes the safety of ICT for the exchange of live information, safery in personal interrelationships and the degree of training of the surgeons (the mentor and operating surgeons) for undertaking telementoring, and the safety of the experience of surgeons in the pathology to be operated on.

Surgical telementoring establishes a new mentor-patient relationship that should be part of a new three-way relationship with the operating surgeons. Meanwhile, there is a dimension involved in the determination of professional responsibility towards the mentor within the surgical team; this responsibility can only be required of the mentor due to the competences that have been assigned to him as part of the role defined for him in the pre, intra and postoperative periods.

This new technology needs a new informed consent in which the mentor figure appears. In addition, the principle of therapeutic privilege should be avoided, and the patient should have the opportunity to be informed of the risks with their complications, benefits and alternatives of surgical telementoring. When it is a surgical innovation, offering the patient biased information should be avoided, to ensure that the patient does not take the decision without adequately assessing the new technique offered. The principle of autonomy must be maintained, while always taking into account vulnerability and fragility.

There is no scientific evidence to conclude that surgical telementoring is more cost-effective than traditional surgery, but due to its shorter surgery time and shorter hospital stays, the use of mentoring is anticipated to be more economical. It is important that this telemedicine system can be used to bring surgical experience closer to areas with the most disadvantaged population groups.

Once these issues have been identified and resolved, it is necessary to subsequently establish a regulation - also in the legal field - governing the use of surgical telementoring, which should be the responsibility of public health institutions and professional societies. This will enable surgical telementoring to be reliably adapted to each specific case.

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Received: February 19, 2018; Accepted: March 14, 2018

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