Ethics on the Learning Curve

Abstract

Advances in surgical techniques and technologies require surgeons to constantly retrain and adopt these into their practices. Until the surgeon gains proficiency in the new technique, he is said to be on the learning curve. During this time, the patient is at higher risk of adverse outcomes. This poses significant ethical challenges. Several factors impact the surgeon's decision-making and ability to obtain a truly informed consent. These factors include personal bias – both the surgeons and the patients, absence of high-quality evidence, and market forces. This paper describes the ethical dilemmas faced by surgeons as they adopt newer technologies into their practice. It suggests measures that can ensure that surgical progress does not happen at the cost of patient safety.

INTRODUCTION

As surgery advances, newer techniques and technologies are regularly introduced. To stay current with best practices, surgeons have to constantly learn and implement these newer operations and technologies in their clinical practice. Not infrequently, surgeons are performing procedures or using tools that they are relatively unfamiliar with. This exposes the patient to additional risks, thereby creating an ethical problem.

Consider the following situation, an experienced surgeon, with competence in performing open choledochal cyst excisions, has recently certified in robot-assisted surgery. He performs his first robotic choledochal cyst excision after adequate thought, preparation, and mentorship. Unfortunately, the patient develops a biliary leak. As a consequence, the patient requires another laparotomy and recovers only after a stormy, long, and expensive hospital course. Hence, has the surgeon, in his drive to adopt a new technology violated a fundamental tenet of medical ethics – Primum non nocere – “first do no harm.” There are several ethics challenges in this scenario, one being, how can the surgeon balance his need to stay current with patient benefit. This paper addresses these challenges, their implications, and strategies to deal with them. It also attempts to reconcile the duality of surgeon benefit and patient benefit.

Although the example above mentions robot-assisted surgery, similar scenarios can occur in any situation, wherein a surgeon is performing an unfamiliar operation. A novice surgeon performing a standard operation on a patient early in his/her career faces the same ethical dilemmas.

Let's start by clarifying some definitions.

1. Ethics: The Oxford English Dictionary defines Ethics as “moral principles that control or influence a person's behavior”[1]

2. Medical ethics: Medical ethics or bioethics is a branch of applied ethics dealing with practice of clinical medicine and related research.[2] It is a set of values that guide a practitioner or scientist in case of conflict. Four basic tenets, which, form the founding principles in patient care are:

   • Autonomy: patient has right to refuse/choose their treatment
   • Beneficence: doctor must act in best interest of patient
   • Nonmaleficence: Primum non nocere (first, do no harm)
   • Justice: equitable and just distribution of scarce health-care resources.

3. The Learning curve (LC): LC has been defined as a graphic representation of experience and outcome for a particular procedure.[3] It represents the process wherein a novice, by repetition, gains proficiency with a particular surgical procedure. As efficiency improves, procedure-related complications reduce. Finally, the surgeon attains a degree of proficiency that is of acceptable standards. However, LC has several characteristics of the LC that need clarification.

   1. LC is a process and NOT some predetermined number. Not only does it vary between surgeons for a particular operative procedure, it also varies between different procedures for a specific surgeon [Figure 1]
   2. One realizes that one has crossed the LC only in retrospect. As one audits one's own outcomes, it becomes clear that at some point, efficiency and complication rates have reached contemporary standards, and it is said that the surgeon has crossed the LC for that particular procedure. Hence, the realization that LC has been crossed occurs only after the event. It is impossible to be prescient
   3. Furthermore, the term steep LC is inaccurate, as a steeper curve suggests a more rapid achievement of proficiency. A better term should be “short” or “long” LC [Figure 2].

Figure 1.

The learning curve is a process. As the number of cases performed by a surgeon increases, proficiency improves, and complications reduce. At a point, both these reach contemporary levels and the surgeon is said to have crossed the learning curve

Figure 2.

Short and long learning curves. When a surgeon learns an operation quickly, the learning curve is short

New drug versus new operation

The risks and ethical dilemmas while on the LC can be understood by comparing the processes involved in introducing a new drug with that involved in the introduction of a new operation. I would argue that even if a standard operation is being performed by a novice surgeon, the risks are similar to a new operation being done.

The mechanism of introducing a new drug into the market is a stringently regulated process. A well laid out process of several phases of clinical trials confirms the efficacy and safety of the new drug. Even after introduction and widespread use of the drug, monitoring for adverse drug reactions continues. Furthermore, the efficacy and risks of the drug are independent of the physician administering the medication. It is similar, for most part, in the hands of the novice physician as well as the more experienced one – there is no LC.

In sharp contrast, introduction of new surgical procedures is a more chaotic, trial and error process.[4] Often a new surgical procedure is developed and pushed by a charismatic surgeon, often with industry backing when medical devices are involved. A few early adopters then start to do this novel procedure.[5] The supposed benefits of the new procedure are then presented and demonstrated in conferences and workshops – often pushed by clever marketing by industry. Hands-on training (over a week end or a couple of days) is organized, and more surgeons are encouraged to learn and try out this new procedure. The novel procedure gradually comes into clinical practice. Most literature until this time is single surgeon/single-center case series. These are “proof of concept” papers that usually provide a “positive” report of the novel procedure. This results in wider application of this procedure into routine clinical practice – despite being backed by scratchy evidence. It is at this time, when most surgeons performing this novel procedure are on their LC, that most harm could potentially be caused. Unfortunately, complications remain underreported. Robust literature, usually multicenter and sobering, appears much later and refines the role of the procedure. This sequence is best demonstrated in the evolution of laparoscopic cholecystectomy.[6] Hartman reported that the incidence of serious injury after laparoscopic cholecystectomy was around 15 times that of open surgery and recommended steps to reduce this risk.[7]

Therefore, unlike with a new drug, the outcome of a surgical procedure is influenced strongly by experience of the surgeon to put it differently, the position on the LC of that individual surgeon for that specific operation.

However, as surgeons, we are obliged to remain current in our practice and learn new techniques and new procedures as they evolve. Therefore, LC is an inevitable reality for all of us. Despite extensive laboratory training and simulation, there will come a time when we have to perform an operation for the first time on a real patient! As we have seen, it is impossible to predict how long this LC will last. During this time, we have to appreciate that we are at risk of causing serious harm to our patients. The issue is further complicated by the fact that not all risks are immediately apparent.

The issue becomes even more acute when major paradigm shifts occur in surgical technologies. These shifts and their implications are described in Figure 3. The evolution of safe open surgery was a true milestone in the history of surgery. Outcomes were measured in clear parameters such as lives and limbs saved. The advent of MIS was the next milestone. Outcomes were still assessed by measurable parameters such as length of hospital stay and requirement of analgesic medications. The benefits were commensurate with the additional costs for MIS. The most recent paradigm shift has been the advent of robot-assisted Surgery, wherein, success is usually measured in more subjective parameters – scar position, esthetics, etc. Such subjective benefits are highly variable, difficult to quantify, and impossible to generalize.[8] Robot-assisted surgery is significantly costlier, making it accessible to only a few, often at the cost of others.

Figure 3.

Changing paradigms in surgery and their salient features

The changing paradigms require the surgeon to constantly upgrade his skills and learn new procedures. This results in a large number of surgeons being on their LC whenever major new technologies are introduced into practice. The ethical conundrums for the surgeon at this time are illustrated in Figure 4.

Figure 4.

Ethical challenges to patient–surgeon relationship while the surgeon in on the learning curve. Summarized from Johnson and Rogers[9]

1. Potential for harm

   It should be appreciated that even if the risks are low in the hands of the innovator, the actual risks to patients when surgeons are learning the new technique are unknown.[8] Potential harm to patients can arise from a variety of sources. The most obvious is from direct injury during the procedure (e.g., common bile duct injury during cholecystectomy). However, harm can also be caused indirectly from prolonged operative time, increased intensive care unit needs, reoperations, etc. This leads to significant financial and emotional hardship to the patient and their families, often culminating in an environment of distrust between the community and the medical fraternity.[9]

2. Inadequately informed consent

   In this scenario of a new operation or a novice surgeon, educating the patient for a truly informed consent can be a major challenge. Often the patients are not explicitly told that they are being exposed to a new technology or procedure.

   “Optimism bias,” both on the part of the doctor and the patient, effects balanced decision-making. The concept, pushed by clever advertising, that anything new is automatically better is the basis of this bias. However, in truth, the gains are often small and incremental than imagined.

   Aggressive direct marketing of newer technologies to patients by industry, the impact of social media promotions, and the biased nature of search results on internet search engines such as Google result in a substantial increase in patients demanding specific procedures or treatments.

   In addition, good unbiased evidence of risks and benefits in simply not available.[9] High quality evidence of surgical interventions is lacking, and things have not improved much over time. As is apparent in Figure 5, the quality of pediatric surgical literature remains unchanged over the past two decades.

   The evidence-based medicine (EBM) movement, despite all its benefits, has several limitations.[10] Biased reporting and selective publication of results further skews the evidence. Ridker and Torres reported on a review of 324 superiority trials.[11] They found that, in case of drug trials, 67% of industry sponsored studies favored the new drug, while only 49% of those sponsored by nonprofits found the new therapy better. In case of medical devices, the difference was even more stark – 82.4% of industry sponsored studies finding the new device superior, while only 50% of nonprofit sponsored studies favored the new device. Even when such studies found newer therapies and devices to be useful, most used surrogate markers to report positive findings rather than clinical endpoints. The gold standard randomized controlled trial that forms the basis of EBM in medical specialties, is often impractical to evaluate actual surgical procedures.[12]

   Continuing with the example of robot-assisted surgery, a report by Criss and Gadepalli evaluated publications by top twenty surgeons, ranked by their payments from the makers of the surgical robot.[13] They highlighted the low quality and exaggerated positivity of the conclusions, often resulting from a confirmational bias and conflict of interest. They called for a larger and systematic review of the potential influence of sponsored surgeons on medical literature.

   Nondisclosure of conflict of interest was common and medical industry does influence results of publications.[14] Studies by first/last authors who had received payments were more likely to endorse the technology they were reporting on (85% vs. 63%, P = 0.0124). Hence, it is important to carefully scrutinize studies for their source of funding and conflicts on interest of the authors.

3. Unfortunately, most surgical innovation and new technology are very expensive. The procurement of these technologies diverts resources from more established options, for example, investing in a surgical robot could potentially divert resources from procuring regular surgical and laparoscopic equipment. Optimism bias encourages a tendency to overestimate the positive benefit of a new innovation

4. Conflict of interest can seriously compromise patients’ best interest. The conflict may be personal, such as financial incentives, professional advancement, publications, and academic achievement. The hospital, looking for return on investment, corporate one-upmanship and ranking, pushes newer technologies.[9] However, it is unambiguous that patient benefit must always override surgeon benefit.

Figure 5.

Evidence base from pediatric surgical literature remains low, despite two decades of enthusiasm for evidence-based medicine

CONCLUSIONS

The LC, with its attendant risk of harm to the patient, is unavoidable in a surgeon's professional life. However, it is imperative that the surgeon takes every possible measure educate the patient/family to ensure that they fully understand the implications of the procedure that is being recommended. Ensuring the safety of the patient is the surgeon's primary duty.

The various measures that could help a surgeon avoid pitfalls while of the LC could be:

1. Remember to place patient's interest above your own at all times

2. Recognize problems early and discuss these with peers – so both you and they might learn

3. Audit and honestly report complications – so people get a balanced view

4. Audit and present your own data while counseling patients and not that from “literature”

5. Be wary of “conflict of interest” – your own and of that in literature. Be especially wary of evidence that is industry sponsored

6. Explain that some risks could be remote and unknown at this time

7. Be honest while counseling and strive to obtain a truly informed consent

8. Anything less will be unethical and may amount to negligence!

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.