Consensus agreement on the Delphi Method for Digital Surgery

This study is the first in the published literature to define the term “digital surgery”. Despite the fact that digital technologies are widespread in healthcare, the exact meaning of the term “digital surgery” is unclear. We present a practical, consistent definition that can be used by clinicians and scientists, as well as other stakeholders in the field of digital surgery, including patients and policy makers. This is based on well-established definitions of terms such as surgical data science, which “aims to improve the quality of interventional medicine and its value through data collection, organization, analysis and modeling” (4,5). Although the Delphi method demonstrates the potential benefits that digital surgery can bring, we highlight the ethical and data management challenges that developers and users of digital surgical technologies will have to face. In order for digital solutions to be successful in the operating room, the identified ethical and data management issues should not be secondary. They should be a priority for those who develop and use digital surgery applications at all stages.

Despite the fact that many of the problems of digital surgery identified by the Delphi method have parallels with digital healthcare, it is necessary to highlight those that are unique to digital surgery. First, the term “digital surgery” is widely used within the specialty, although 71% of the participants in this analysis agreed that the definition of digital surgery is unclear. In order for these technologies to be safely transferred into clinical practice and applied in research, standardization of this terminology is necessary.

Secondly, surgery is a high-risk clinical environment where the consequences of disruptions in digital technologies can cause significant and immediate harm on a time scale that is not comparable to other areas of clinical practice. Thirdly, the high quality of surgical results depends on the effectiveness and behavior of a multidisciplinary team, and therefore the scaling of digital technologies will require broad cultural progress. Fourth, even routine recording and analysis of operating room video data creates unprecedented ethical obstacles unique to procedural specialties. These problems must be resolved urgently before scaling up these techniques in the operating room. This goes beyond patient privacy alone (usually the primary privacy consideration in digital healthcare applications) and touches on the privacy of surgeons and their teams, who may be subject to scrutiny for their every action. In this regard, the threat of litigation may be a more serious obstacle to the development and implementation of digital surgical instruments than in other areas of healthcare. For example, surgeons may be reluctant to allow their data to be used to develop algorithms, fearing that the same video could be used against them for judicial purposes. Finally, there is a unique set of barriers to access to potentially large and diverse sets of surgical data that lack standardization, ontology, or quality assurance. Many operating rooms remain analog, and many surgical departments lack the technical infrastructure to collect the digital information available to them, or they may simply not do so. Therefore, we identify 3 key areas of digital surgery in the future.

Firstly, digital surgery is already here, but hospitals and healthcare systems are not ready for it. Significant investments in infrastructure are needed for the success of digital surgery. The pioneers who introduced digital surgery had to face a double challenge: bureaucracy and cost. In order for digital surgery to become widespread, efforts must be made to optimize this process. Template data exchange agreements and commercial models designed specifically for digital surgery applications can serve as a starting point for hospitals involved in complex and lengthy negotiations. However, appropriate commercial and legal expertise must be provided in order to receive individual advice. The United Kingdom has established a National Centre of Expertise to oversee and provide guidance to hospitals involved in these partnerships. Success can also be achieved in establishing a national health research data center in surgery, similar to existing national health research data centers in areas such as pain, mental health, and cancer treatment (24).

The panelists noted that interoperability is a key issue in the implementation of digital surgery in healthcare. Surgical data standards should be defined. Steps in this direction have already been taken with the recent publication of data annotation standards (25). Interoperability issues go beyond digital surgery and pose challenges to the wider application of digital technologies in healthcare. Current problems with data exchange between devices or hospitals will be further complicated by future applications requiring global data aggregation. International data exchange processes will have to deal with interoperability issues amid changing privacy requirements, and future efforts should focus on standardizing and streamlining this process.

Modern operating rooms have the potential to generate vast and heterogeneous datasets, but most hospitals currently cannot benefit from this. They lack the technical means to store data, as well as the networks and cybersecurity tools, including funding, needed to keep up with the development of technology. Digital surgery also has to contend with broader digital health challenges, such as varying levels of digitalization in public and private hospitals or national healthcare providers, combined with the challenges of heterogeneous hospital IT systems and electronic medical records, which pose significant obstacles to the large-scale adoption of secure digital surgery technologies.

Finally, although they are not specific to digital surgery, cybersecurity issues should not be overlooked. Digital surgical systems operate in high-risk clinical environments, and cybersecurity breaches affecting them can cause significantly greater harm to patients compared to other medical specialties. Despite the fact that no harm to patients was reported as a result of the WannaCry malware attack in 2017, she highlighted the vulnerability of hospitals to cybersecurity threats (26,27). Cybersecurity measures should not only be robust enough to protect these systems, but also take into account the “worst-case but possible” scenarios.

Secondly, the participation of the public and patients is vital for the development and implementation of digital surgery. Our community group has shown that patients support digital surgery and are willing to donate data. Concerns arose mainly due to a lack of awareness about what digital surgery entails and how patient data will be used. This lack of awareness about digital surgery can lead to a poor understanding of the benefits available to digital surgery compared to current surgical practice.

Transparency of the digital approach to patient care and public trust have consistently been highlighted as key issues for both the public and experts, as well as in the guidelines for the implementation of AI in other areas. The public is a key stakeholder in digital surgery. Her participation at all stages of development and implementation is vital for building trust. We must not forget that patients are in the center of digital surgery. The public acceptance of digital surgery applications, as well as the collection and sharing of data that they may require, should not be overlooked.

However, our community group has shown that the levels of understanding of digital surgery and artificial intelligence vary significantly. Patients may not fully understand the scope of data collection, how it might affect them, or what digital surgery entails. Digital surgery patient education can build on existing initiatives such as the Wellcome Trust’s Understanding Patient Data Program (28). They allow patients to be informed about what data is being collected and how it is being used in digital surgery applications. It is only through education and interaction with the public that they can provide properly informed consent as to whether they want to share their data.

Thirdly, training is necessary not only for patients, but also for all stakeholders. Although an important research goal identified by our group was the need to identify the most appropriate applications for surgical AI, this will only be achieved if there is sufficient interdisciplinary education. Developers should have an understanding of the surgical problems that can be solved with the help of digital technologies. Similarly, clinicians need to understand the fundamentals of the technologies they use if they want to protect the interests of their patients.

In addition, the Delphi method has revealed broader ethical, managerial, and legal issues related to digital surgery. The panelists noted that there is a poor understanding of legal issues, as well as a lack of legal knowledge in hospitals. Efforts should be made to educate stakeholders and seek expertise on these issues, as well as to ensure that they are aware of the changing legal and regulatory environment, which may go beyond data privacy legislation. And also include issues of competition law and intellectual property rights, including commercial issues such as liability, damages and data ownership. The future digital surgeon will not only be a surgeon. They should have an understanding of artificial intelligence and technology, as well as awareness of legal, ethical and data management issues related to their use.

While the Delphi method is successfully used in the literature to provide a consensus opinion (29,30), it has limitations. Firstly, the conclusions drawn from the Delphi method are the subjective opinion of one group. To mitigate this effect, efforts have been made to reduce systematic error and ensure the representativeness of the findings by involving a large number of experts with a national or international profile from a number of key areas of digital surgery. Moreover, in areas such as digital surgery, where existing knowledge is limited and there is a need for knowledge from several different fields, the Delphi method has proven to be a highly effective methodology (31).

Secondly, the reliability of Delphi’s methodology has been criticized due to the lack of methodological standardization (20). We have sought to increase the reliability of this study based on the existing methodology used in the literature. We also addressed this limitation through extensive discussion at the final meeting to ensure that the conclusions reached are sound and appropriate.

Finally, it can be argued that our final definition of “digital surgery” may lack specifics, for example, due to the fact that we do not expand terms such as “technology”. This issue was widely discussed by the Delphic Commission, and the final definition was agreed upon for several reasons. First, it is unclear how to prioritize technologies that should or should not be included in the definition, and erroneous conclusions may be drawn from technologies that have been omitted. Secondly, listing all the technologies that should be included would significantly expand the definition, which would limit its practical use. Finally, there will be no perspective in the definition. Due to the strict definition of technologies included in digital surgery, technologies that are not currently being developed are excluded. Thus, we believe that this first agreed definition of “digital surgery” fulfills the purpose of creating a usable definition and can serve as a platform for future iterations.

In conclusion, this Delphi method defines digital surgery as the use of technology to improve preoperative planning, surgical performance, therapeutic support, or training in order to improve outcomes and reduce harm. Data generation technologies carry both opportunities and risks. This Delphi method has identified key ethical issues, barriers, and research goals that will serve as the basis for future research in this area. Issues related to data, privacy, confidentiality and public trust, consent, law, litigation and liability, and commercial partnerships should be addressed at all stages by those who develop and use digital surgery. Future research on the issues identified above should involve all stakeholders in digital surgery and, therefore, work in partnership with patients.