Responsible innovation in surgery: a proposal for an anonymous registry of surgical innovation

Abstract

Surgical innovation exists in an ethical and regulatory no-man's-land; its inherent risks necessitate careful ethical consideration, but its ad hoc nature makes it less amenable to forms of regulation typically associated with formal research. One solution, which has been proposed in the surgical literature, is to keep a registry of surgical innovation. For numerous reasons, however, such a registry does not currently exist in the USA or elsewhere. Here, we propose an innovation registry with the following characteristics: online, anonymous, secure, organized by specialty and diagnosis, keyword searchable, and containing an interactive forum for posting comments on individual innovations. We argue that such a registry would be a valuable tool for promoting responsible innovation in surgery. Furthermore, we report the results of a pilot study, which suggest that such a registry could be successfully implemented in the USA.

Keywords:

• surgical innovation
• registry
• surgery
• anonymous

Surgery, by its very nature, is a field crucially dependent on the innovation of its practitioners. Innovation allows surgeons to develop new techniques, which incorporate the latest technologies and address the unique challenges of each surgical case. Likewise, the development of innovative techniques ensures the importance of surgical care in a constantly evolving clinical landscape, which increasingly stresses the value of minimally invasive procedures (Cosgrove 2000). Clearly, the ingenuity of innovative surgeons is essential to the advancement of surgery and the objective of providing patients with the most effective treatment options.

At the same time, surgeons are bound by the norms of medical ethics, such that they ought to respect patient autonomy and adhere to the principles of beneficence, nonmaleficence, and justice.¹ The relevance of these principles to surgical innovation is intuitive. Patient autonomy must be respected by obtaining informed consent whenever possible, ensuring that patients understand the innovative nature and associated risk of proposed techniques. Beneficence is served by offering innovative techniques that give patients the best chance of a positive outcome, while nonmaleficence is served by ensuring that such techniques have been carefully planned in light of all available information. Justice demands that innovative techniques are carried out in a manner that makes efficient use of scarce healthcare resources. Thus, responsible surgical innovation requires that surgeons weigh competing ethical and professional obligations in the development and execution of innovative techniques.

The Society of University Surgeons Taskforce on Surgical Innovation defined surgical innovation as ‘a new or modified surgical procedure that differs from currently accepted local practice, the outcomes of which have not been described, and which may entail risk to the patient’ (Biffl et al. 2008). In doing so, this group distinguished ‘surgical innovation’, which must be disclosed to patients, from ‘minor variations’ in technique, which do not entail additional risk to patients nor require additional disclosure in the informed consent process. Likewise, innovation is distinct from systematic surgical research, which typically requires prior review and approval by an institutional review board. Surgical research is highly regulated (as is all research on human subjects) and also must be carefully planned. In this regard, a key distinction from surgical research is that, whereas surgical research must follow a defined research protocol, surgical innovation often arises in an ad hoc fashion as surgeons seek new solutions to meet the demands of unique or especially difficult clinical scenarios. Surgical innovation, therefore, exists in a sort of ethical and regulatory no-man's-land; its inherent risks necessitate careful ethical consideration, but its ad hoc nature makes it less amenable to forms of regulation typically associated with formal research.

The implementation of innovative surgical techniques is fraught with risk and often results in unintended morbidity and mortality (Strasberg and Ludbrook 2003). For instance, the implementation of laparoscopic cholecystectomy led initially to a dramatic rise in the rate of common bile duct injury (Carroll, Birth, and Phillips 1998; Gigot et al. 1997). Although improved techniques and increased training eventually resolved this issue, the widespread adoption of an innovative procedure led to a number of unexpected, yet preventable, surgical complications (Strasberg, Eagon, and Drebin 2000). Certainly, such complications do not outweigh the value of surgical innovation, a truth attested to by the eventual establishment of laparoscopic surgery as the procedure of choice for routine cholecystectomy (Litwin and Cahan 2008). However, the potential for surgical innovation to cause serious harm demands that steps be taken to ensure that innovative procedures are as safe as possible.

Unlike positive results of surgical innovation, which are frequently published in the surgical literature or presented at meetings, the results of unsuccessful innovative approaches often go unreported (Epstein 2008). The reasons for this are likely numerous: surgeons’ fear of litigation, the importance of professional reputations, and journals’ unwillingness to publish negative results, to name a few. Whatever the reasons, underreporting of unsuccessful attempts at innovation creates the potential for multiple surgeons to unwittingly attempt the same ill-advised innovation, thereby subjecting patients to unnecessary harm.

One solution, which has been proposed in the surgical literature, is the establishment of a registry of surgical innovation (Biffl et al. 2008; McCulloch et al. 2009). Such a registry would provide a forum for reporting negative results, potentially limiting the number of unnecessary iterations of unsuccessful innovations. Furthermore, a registry of surgical innovation would facilitate collaboration between surgeons in developing new techniques. In all, a well-developed registry has the potential to protect patient safety, while promoting the advancement of surgery. However, for numerous reasons, such a registry does not currently exist in the USA or elsewhere.

The reasons why a surgical innovation registry does not exist are likely numerous and varied. Among these is the reality that publication of negative results could potentially damage a surgeon's reputation or increase the likelihood of litigation. Additionally, there may be opposition to perceived interference by regulatory bodies in the field of surgery, which has remained largely self-governing. With this in mind, we propose the establishment of a secure, anonymous innovation registry, which would achieve the aforementioned benefits without requiring surgeons to risk their reputations or submit to mandatory oversight.

Such a registry should be maintained online by a trusted party, such as a major professional society. To gain access, surgeons would be required to register with a valid medical license number, ensuring that access is limited to practicing surgeons. In this regard, the registry would function similarly to morbidity and mortality conferences, in which surgeons discuss unfavorable results with their peers in a spirit of academic advancement and professional growth. A key difference is that an online registry would be available to surgeons across the country, whereas morbidity and mortality conferences are confined to individual institutions.² One might argue that opening the registry to other medical professionals, or even patients, might enrich discussion and make surgeons more accountable for failed innovations. On the contrary, we believed that if the registry is open to individuals outside of the surgical community, surgeons will be unwilling to contribute for fear that their entries could be used in litigation or by outside regulators. From this perspective, a widely used registry, which is accessible only to surgeons, is far better than a publicly available registry, which surgeons are unwilling to use.

Although surgeons would be required to provide their license number to access the registry, we propose that no personally identifiable information should be recorded with individual submissions. In this way, the registry could be made secure without compromising the identity of its contributors. An anonymous registry would allow surgeons to feel confident posting positive and negative results, without worrying about the impact such results may have on their professional reputations. Meanwhile, the secure format would reassure contributors that data housed within the registry would not be abused by unintended parties. The purpose of an innovation registry of the form described here is to promote surgical advancement, while providing a resource to aid in the responsible implementation of innovative techniques. We believe that this purpose is best served if surgeons are comfortable contributing openly and without fear of unintended repercussions.

In addition to a secure, anonymous format, an ideal registry should provide convenient access to information. Along these lines, posts should be organized by surgical specialty and patient diagnosis, as identified by the contributing surgeon. Additionally, all posts should be keyword searchable. Such features would allow surgeons to easily identify posts that are relevant to their field or a particular diagnosis. In this way, surgeons could query the registry before attempting innovative procedures, using previously attempted innovations to guide the development and implementation of their own innovative techniques.

Finally, the registry should include an interactive forum for discussing individual innovations. Each post should be associated with a message board, where other surgeons could post comments. Comments may include ideas for future innovation or suggestions as to how a particular innovation went awry. This feature would allow the registry to better promote the advancement of surgery by facilitating discussion of unsuccessful innovations across institutional boundaries. Moreover, by incorporating critiques from the broader surgical community, individual surgeons will be more able to refine their techniques and improve patient outcomes. Like the rest of the registry, this forum would be available only to practicing surgeons. We believe that this feature will allow surgeons to engage in candid discussion, which best serves the goal of improving innovative techniques.

While a secure, anonymous registry would provide maximum protection for contributors, this format would necessitate voluntary contribution as it would be impossible to track the participation of individual surgeons. In one sense, a system of voluntary contribution may be ideal for those surgeons who are wary of mandatory oversight. Nevertheless, a registry that relies on voluntary contribution presents several challenges, which will need to be overcome for its implementation.

The usefulness of an innovation registry would be limited by the number of surgeons who contribute on a regular basis. In the absence of mandatory reporting, it would be important that surgeons are willing to make regular, voluntary contributions. Widespread participation likely depends on several factors. First, it is essential that surgeons view the registry as an important tool for improving patient safety and advancing surgical practice. Second, surgeons must feel comfortable submitting positive and negative results of innovation without fear of unintended consequences. Finally, surgeons need to be confident that their colleagues are making regular contributions to the registry. After all, there is little incentive for surgeons to utilize an innovation registry unless they believe the contents of the registry accurately represent the state of innovation within the field.

In order to evaluate the willingness of surgeons to utilize the proposed innovation registry, we conducted an anonymous survey of 271 surgical faculty, fellows, and residents at a single university hospital (Hodges and Angelos 2012). Of the 61 respondents, 27.9% were in favor of mandatory submission to an innovation registry, while 86.9% stated that surgeons should voluntarily submit results of attempted innovations. These responses reaffirm our belief that surgeons are resistant to mandatory oversight, while indicating that most are likely to view an innovation registry as a valuable tool for the responsible implementation of innovative techniques. When taken together, these data suggest that an innovation registry, which relied on voluntary submission rather than mandatory reporting, would be the easiest to implement.

When asked about their willingness to utilize a secure, anonymous registry of surgical innovation, 72.2% of respondents stated that they would be somewhat or very likely to access a registry before attempting innovative surgical techniques. Likewise, 77.0% of respondents indicated that they would be somewhat or very likely to submit positive results of surgical innovation, and 67.2% said they would be somewhat or very likely to submit negative results. These data suggest that a majority of surgeons would be likely to utilize a secure, anonymous registry of surgical innovation, by querying the registry and by contributing the results of their own innovations. Such strong willingness to participate suggests that an anonymous registry could be implemented successfully. Furthermore, with effective education regarding the value of a registry for promoting responsible innovation, an even larger proportion might be willing to contribute.

In contrast, surgeons demonstrated mixed feelings about the willingness of their colleagues to utilize such a secure, anonymous registry of surgical innovation. Of the respondents, 65.6% believed that other surgeons would be somewhat or very likely to access a secure, anonymous registry before attempting innovative techniques, and 76.7% believed that other surgeons would be somewhat or very likely to submit positive results of surgical innovation. However, only 46.6% of respondents believed that other surgeons would be somewhat or very likely to submit negative results of surgical innovation. Such pessimism about the willingness of surgeons, in general, to submit negative results represents a major hurdle to the effective implementation of an anonymous registry. Since a major objective of the registry would be to provide a forum for reporting negative results, the perception that surgeons are unwilling to do so could be devastating to the success of the registry.

If surgeons are pessimistic about the willingness of their colleagues to submit negative results, the development of a registry must be accompanied by steps to promote active participation. First, large-scale studies should be conducted to more convincingly demonstrate the willingness of surgeons to participate. Such data, which would likely mirror the results of our survey, would be powerful in demonstrating the perceived value of a registry. Additionally, there should be coordinated educational programs to foster a culture of responsible innovation. Such programs should emphasize the value of an innovation registry for promoting patient safety as well as the role of a registry in advancing surgical practice. This could be accomplished through the surgical literature, by professional organizations or by institutional surgical innovation committees.

Another potential disadvantage of the proposed registry is that an anonymous format would make it difficult to verify the accuracy of the data entered. For this reason, surgeons would need to approach the registry critically, understand the limitations of the data, and think carefully before applying reports from the registry to actual practice. This limitation is true of all anecdotal data, whether reported at a meeting or an institutional morbidity and mortality conference, and surgeons should be accustomed to critically examining these sources before making changes to their practice. In this context, the requirement that surgeons approach the registry with a certain degree of skepticism seems a small one. In all, the disadvantages of an anonymous registry seem to be overshadowed by the protection of surgeon privacy afforded by an anonymous format.

Despite these challenges we believe that a secure, anonymous registry of surgical innovation may be a viable response to a recognized need within the surgical community and should be further explored. By providing a venue for reporting negative results, a registry could minimize the inadvertent duplication of ill-advised innovations. Furthermore, an interactive forum for discussing individual innovations would serve to promote the advancement of surgical practice by troubleshooting and fine-tuning innovative techniques. Meanwhile, a secure, anonymous format would protect the identities of surgeons and mitigate fears about the effects negative results may have on professional reputations. In all, a secure, anonymous registry of surgical innovation could be a powerful tool for promoting responsible surgical innovation at a time of increasing financial constraints.

Funding

No outside funding was obtained for the completion of this manuscript.

Notes on contributors

Kevin Hodges earned his Bachelor of Science in Biological Sciences and Philosophy from the University of Notre Dame. He is currently a medical student at the University of Chicago Pritzker School of Medicine.

Peter Angelos, MD, PhD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, Chief of Endocrine Surgery, and Associate Director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. He is a graduate of Boston University for all of his degrees. He practices endocrine surgery at the University of Chicago Medicine.

Notes

1. For the most prominent elaboration of these principles, see Principles of Biomedical Ethics, by Beauchamp and Childress (2012).

2. The need for an innovation registry has been expressed in the surgical literature in USA and abroad (Biffl et al. 2008; McCulloch et al. 2009). However, regulatory bodies and major professional societies for surgery have been established on the national level, such that a national registry would be most practical from the standpoint of implementation.