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© Springer Nature Switzerland AG 2019
M. L. D. Broekman (ed.), Ethics of Innovation in Neurosurgery, https://doi.org/10.1007/978-3-030-05502-8_5
L. W. M. van Kalmthout · A. L. Bredenoord (*)
Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
e-mail: [email protected] I. S. Muskens · M. L. D. Broekman
Department of Neurosurgery, Computational Neurosciences Outcomes Center (CNOC), Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands e-mail: [email protected]; [email protected]
J. P. Castlen · N. Lamba
Department of Neurosurgery, Computational Neurosciences Outcomes Center (CNOC), Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
5
The Ethics of the Learning Curve
by patients with the overarching goal to innovate in order to improve outcomes for future patients is a major challenge that needs careful consideration. Here, we will examine the unique ethical challenges posed by the learning curve associated with an innovative procedure.
Definition of Learning Curve
In the literature, there seems to be no uniform definition of “learning curve,” as it applies to innovative procedures. Some have described it as the gradual increase of knowledge and skill that comes with the repeated performance of the innovative procedure and perioperative patient care [4–6]. Others define “learning curve” as the gained knowledge and experience that is necessary for successful performance of the surgical procedure [7].
The influence of learning curves is recognized in several different settings of innovative surgery. Berstein et al. recognize three stages of innovation in which learning curves are relevant [8]. Starting with performing the procedure for the first time in stage one, followed by studies to prove safety and efficacy of an innovation that has shown to be beneficial to the individual patient in stage two, implementa- tion of a procedure that has been proven to be beneficial and safe outside of the initial performing centers occurs in stage three.
Some authors discussed learning curves only in the setting of performing radi- cally new procedures, such as in the first phase of the learning curve [9–11].
Interestingly, only two papers have described how evaluation of learning curves should be incorporated in a research setting, which would apply to the second phase of learning curves [7, 12]. Perhaps unsurprisingly, most authors describe the influ- ence of learning curves only in the third phase, which consists of the implementa- tion of the innovative procedure in general practice [13–16].
Authors’ views of learning curves in the literature vary greatly, ranging from the opinion that they are an unavoidable part of surgical innovation [5, 17] to the view that they are a serious problem that needs to be addressed [5, 9, 13–16, 18–21].
Some have even described learning curves as a menace to patient safety [22].
Ethical Management of Learning Curves
Since innovative surgery by definition is initially performed by surgeons with little to no experience with the procedure in question, the associated learning curve could have unforeseen consequences. For instance, this inexperience could confound and complicate evaluation and interpretation of patient out- comes [12, 17, 19, 23]. Furthermore, adverse outcomes in the context of inex- perience could result in reduced patient trust in the surgeon [5]. Since the scope of the risks of innovative procedures cannot always be fully defined, it is dif- ficult, and in some cases impossible, for the surgeon to completely explain the
risks involved in the procedure to the patient [13]. From an educational stand- point, since the attending surgeon in these cases has him or herself not com- pletely mastered the procedure, surgical training of residents who are participating may not be completely effective either [4, 9]. How to deal with these and other aspects of learning curves in surgical innovation has been described by various authors, describing both technical and professional requirements (Table 5.1) [8, 4–29].
Technical Requirements
Surgeons have a moral obligation to train, and various training methods have been proposed to ensure technical competency of those performing an innovative proce- dure [5, 7–11, 14, 16, 19–21, 23, 26]. There are three different time periods when training is appropriate: (1) the preclinical phase, which involves preparation prior to the performance of the procedure on an actual patient; (2) the clinical phase, in which the procedure actually takes place; and (3) the post-clinical phase, in which proficiency of the surgeon is maintained [7].
Preclinical Phase
The purpose of the preclinical phase of training is to maximally reduce the risk to patient safety that is inherent from surgeon inexperience with a new procedure. In this phase, both cognitive and technical training are essential. In order to achieve adequate preparation, the use of in vivo, in vitro, computer, and cadaver models has been suggested in order to simulate human anatomy during training [5, 7, 9, 10, 16, 26]. Furthermore, the available literature and videos of similar cases (if available)
Table 5.1 Professional and technical requirements for each phase of innovation Phase of
innovation Goal Technical requirements
Professional requirements Preclinical
phase
Maximum preparedness for first procedure
• Train through simulation (e.g., cadaveric or computer models, etc.)
• Evaluate relevant literature and operative videos
• Shadow experts Clinical
phase
Independent performance of the procedure
• Involve mentor for guidance
• Review video postoperatively
Disclosure of relative inexperience during the informed consent procedure Post-clinical
phase
Maintain and enhance skills
• Participate in mentoring programs
• Share experiences and learn from mistakes (e.g., on a conference)
• Evaluate outcomes among peers
Evaluate personal experience and outcomes
should be studied extensively [6, 7, 11]. Finally, gaining first-hand experience from experts, when such experts are available, by visiting an specialized center or by doing a fellowship, may be valuable tools to understand the new procedure [6, 8, 9, 11, 16, 26]. It is crucial that surgeons are as prepared as possible for new procedures since the initial part of the learning curve is when they have the least experience and there is the greatest risk of adverse events for patients.
Clinical Phase
The clinical phase of training is comprised of the actual repeated performance of the new procedure, and it begins as soon as a surgeon performs the procedure on a real- life patient. Ideally, the first procedure is performed under the supervision of a surgeon with greater experience [9, 11, 26]. Although not always possible in the case of very new procedures, mentors could help to aid navigation, answer questions that may arise, and offer guidance via back-and-forth communication [16, 20]. Moreover, when experts in the technique are not available, any senior surgeon with more experience overall can offer technical guidance and advice in times of crises. Alternatively, some have suggested that reviewing operative vid- eos may be sufficient in certain cases, such as when a new procedure is a slight variation on a familiar one [9]. Utilization of videos would also broaden the geo- graphic reach of new procedures, allowing areas without a resident expert to receive training via technology. Finally, whenever possible, an expert should review the new surgeon’s competency before he or she undertakes full indepen- dent performance of the procedure [8].
Overall, the ultimate goal is for the surgeon to be able to perform the procedure independently with the highest proficiency possible. To reach this point, multiple factors must facilitate the learning process for the surgeon, including strong mentor- ship, use of technology for training, as well as expert evaluation.
Post-Clinical Phase
After having gained enough experience with the new procedure so as to successfully perform the procedure independently, it is vital for the surgeon to maintain and enhance these acquired skills. Some have suggested that this should be carried out through a mentoring program [9]. A mentor could oversee and evaluate his mentee at various time points to optimize proficiency.
It is essential for the surgical community to share their experiences openly, exchange tips and advice, and problem-solve with one another based on the suc- cesses and failures they have faced when implementing a new procedure. This could be achieved through audits and conferences with the aim of discussing new procedures [20]. By learning from mistakes, identifying problems, and describing risks and limitations of the procedure based on experiences of a broad group of surgeons, outcomes could be improved more efficiently [20].
This continued improvement and expansion of accumulated knowledge com- prises the post-clinical phase of training, with the hope being that this knowl- edge could be used to develop more accurate training modules to assist in the earlier phases of training [20].
Assessment of Learning Curve
These is no standardized method to assess the learning curve associated with innova- tive procedures. However, several ways to monitor the learning curve have been described [4, 8, 25]. These include the formation of specific oversight bodies. Some have suggested that these bodies could consist of one expert surgeon, whereas other have argued that multidisciplinary committees that could even oversee learning curves at multiple regional institutions would be superior [4, 6, 8, 25]. The goals of these committees could be to define standardized requirements for appropriate train- ing, review fledgling innovative procedures, and provide accreditation [6, 8, 29].
Professional Requirements
Professional requirements of surgeons learning an innovative procedure include (1) obtaining adequate informed consent from patients and (2) honest communication of technical competency with peers [7–13, 16–24, 26–29]. During the acquisition of informed consent, transparent communication is essential in order to provide patients with accurate information about the relative inexperience of the surgeon performing the procedure [5, 11, 13, 16–19, 21, 22, 24, 27, 28]. This information could include a description of the success rate of the surgeon or other quantitative or qualitative forms of describing outcomes, both positive and negative [9, 24]. An honest disclosure becomes even more important when the surgeon performs the procedure for the first time [16]. Some view it as an obligation of the surgeon to evaluate their personal outcomes and reflect on their own skill and performance when deciding whether to get involved with an innovative procedure [4, 5, 9, 11, 24]. This can be achieved through accurate registration of outcomes with adequate follow-up, which then can be used to improve the training of other surgeons [5, 7, 9, 11, 12, 16, 18, 20, 24, 29].
Discussion
Even though there seems to be a lack of a clear definition of learning curves, they are inherent to surgical innovation and pose unique challenges. Ethical management of learning curves during the separate phases of innovation requires both technical and professional competencies.
Some have defined the learning curve only as a problem that arises when sur- geons other than the original innovator start performing the procedure [13]. Whether or not this is the case, the experience of the primary investigator certainly could guide the learning process of other surgeons attempting to master the innovative procedure [7]. One could argue that the learning curve that attending surgeons face when performing an innovative procedure is similar to residents gaining experience with established procedures, which requires practice, mentorship, and supervision.
As a result, the learning curves of residents could provide valuable insights that are also applicable to innovative surgery. There are several essential differences,
however, between a resident’s learning curve and the learning curve of a fully trained innovative surgeon. First of all, potential complications and outcomes of the procedures performed by the residents are well-defined, and the responsible attend- ing has a wealth of experience with the procedures and can therefore step in and take charge should something go wrong. Beyond just the attending, during the train- ing of residents, the whole team (including nurses and technicians) is experienced with the procedure, knows the typical outcomes, and has previously been involved in the training of residents. Conversely, during an innovative procedure, like the performing surgeon, the team is also inexperienced and unaware of the possible consequences, confounding and impeding the learning process which is more sys- tematic for residents.
Therefore, in the case of performing a radically new procedure, the entire team has a moral obligation to prepare as much as possible to ethically manage the surgi- cal learning curve. This is especially important since no earlier experience is avail- able to guide decision-making intra- and perioperatively, which may be considered routine for established procedures. In this scenario, the IDEAL (idea, development, exploration, assessment, long-term follow-up) framework may prove helpful, as it describes clear steps that should be taken during development and implementation of innovative procedures [12]. This could be further aided by pre- and post-clinical training, which we deem as imperative to ensure patient safety by minimizing risks.
Since each innovative procedure is unique, it requires a carefully tailored training program in order to achieve maximum preparedness. This could be attained through various forms of simulations and/or direct mentoring by an expert surgeon.
Currently, there is no standard way to assess learning curves of innovative proce- dures. Even though we think that specific oversight bodies as described above could play a role, another approach could be a critical review of a surgeon’s performance (and that of the team) by the surgeon him or herself. This could take place before, during, and after preforming an innovative procedure and could be performed in collaboration with an expert or mentor. It is essential for a surgeon to have a proper understanding of his or her own limitations, and a framework that encourages self- review at every step of the process can optimize both the learning curve and ulti- mately patient outcomes, as well. Through self-reflection, a surgeon’s errors and past complications are acknowledged, evaluated, and form a basis for future improvement. This may sometimes mean that a surgeon chooses to forego perform- ing a certain procedure that he does not yet feel proficient in. This should be lauded rather than looked at as a sign of weakness so as to encourage open communication and continuous self-improvement in an environment where innovation is occurring so rapidly. One efficient way of achieving this may be through patient registries that promote adequate follow-up of all outcomes in order to evaluate not only safety but also progression of the surgeon along the learning curve. These registries may ulti- mately lead to shortening and optimization of the learning curve and result in pre- vention of adverse events.
Ethical management of learning curves requires also nontechnical skills as obtain- ing adequate informed consent. Transparent presentation of the experimental nature of the (un)known risks associated with the procedure is essential. A description of the
surgeon’s relative (in)experience is a necessity in order to meet the requirements of adequate informed consent: disclosure, decisional capacity, patient understanding of the information, voluntariness, and consent [21]. In reality, however, perhaps out of fear that the disclosure might confuse or distress the patient, present informed con- sent procedures probably do not meet these criteria [18]. Because fully disclosing the level of experience of a surgeon who is performing a new procedure may not cast that surgeon in the best light, some surgeons may avoid attaining informed consent in the proper manner and choose to leave out important information [18]. According to a survey among patients and surgeons, however, honest, descriptive disclosure of the risks and benefits and disclosure of whether the surgeon is performing the procedure for the first time appears to be the best approach [30].
Both adequate (self) assessment of learning curves and informed consent require specific (“soft”) skills and an environment in which adverse events can be openly discussed with patients and peers. Self-reflection, verifiability, and honesty among surgeons form the foundations of such an environment.
Conclusion
Learning curves are associated with several challenges, including the increased risk of (unknown) complications, while surgeons master an innovative procedure.
Ethical management of learning curves associated with innovative procedures in neurosurgery requires optimal preparation to balance these risks with potential ben- efits of a novel procedure. Surgeons have a moral obligation to train and need to meet several technical and professional requirements during the different phases of innovation.
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© Springer Nature Switzerland AG 2019
M. L. D. Broekman (ed.), Ethics of Innovation in Neurosurgery, https://doi.org/10.1007/978-3-030-05502-8_6
B. Lutters
Department of Neurosurgery, Erasmus University Medical Center, Rotterdam, The Netherlands
Department of Pediatric Neurosurgery, Brain Center Rudolf Magnus,
University Medical Center Utrecht—Princess Máxima Center, Utrecht, The Netherlands E. Hoving
Department of Pediatric Neurosurgery, Brain Center Rudolf Magnus,
University Medical Center Utrecht—Princess Máxima Center, Utrecht, The Netherlands M. L. D. Broekman (*)
Department of Neurosurgery, Computational Neurosciences Outcomes Center (CNOC), Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands e-mail: [email protected]; [email protected]