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No pain, no gain

No pain, no gain Ethics, Risk, Treatment outcome, Diffusion of innovation Nothing can come from nothing. Lucretius An 81-year-old man who is the primary caretaker of his wheelchair-bound wife presented at our clinic with early oesophageal cancer. In his particular case, endoscopic resection was not feasible due to technical reasons, and because of his comorbidities and social situation, oesophagectomy also appeared unsuitable. What were his options? The status quo (i.e. endoscopic resection or oesophaghectomy) had no other curative-intent alternative for him. Over the course of several years, we have developed a technique for oesophageal mucosectomy via a laparoscopic transgastric approach (laparoscopic transgastric oesophageal mucosectomy; LTEM). Our goal was to design a therapeutic option for patients who are not candidates for endoscopic therapy or oesophagectomy and to validate it with experimental data.† †Please note that we often refer to patients as ‘not a candidate for’ a treatment. This burdens the patient as if the patient was not appropriate for the treatment. In reality, the available treatment options are failing the patient. Once we had developed a reproducible technique in a porcine model, we shared our findings with our institutional multidisciplinary oesophageal group and presented our results at 2 meetings [1]. In reality, LTEM is just a combination of 2 established procedures: oesophageal mucosal resection and laparoscopic transgastric resection. A very small number of published clinical reports with comparable techniques suggested clinical safety and effectiveness. On the basis of our experimental results, available published clinical data and feedback from our peers, we perceived the need to fill the therapeutic gap between endoscopic resection and oesophagectomy. After 10 years, we were ready to propose LTEM for a suitable patient and that patient was now at our clinic. We first asked for consensus within our multidisciplinary oesophageal team on the appropriateness of LTEM for this patient, and only then did we offer him this option. Because LTEM is not the status quo, we documented our team’s rationale in the patient’s medical record. We also decided to forego formal Institutional Review Board (IRB) approval, because LTEM is a combination of already existing procedures. At the time of offering this potentially curative procedure to our patient, we were very transparent about our lack of clinical experience as well as the potential for unknown risks [2]. Our patient weighed the potential risks of the innovation versus the known risks of the status quo (no curative-intent therapy in his case) and decided to proceed with LTEM. Two surgeons and 1 gastroenterologist from our multidisciplinary oesophageal team performed the procedure without intraoperative problems. The postoperative course was complicated by atrial fibrillation and upper gastrointestinal bleeding that did not require transfusion. Our patient gradually recovered and was discharged on the 10th postoperative day. The final specimen revealed a T1b lesion (extension into submucosa) with negative margins, he has no evidence of disease at 10-month follow-up, and he is able to lead his life and care for his wife as he did before surgery. Did we follow a reasonable path to innovation? We received diametrically opposed opinions about our path to innovation from 2 highly regarded thoracic surgeons: one condemned the lack of formal Internal Review Board approval, and the other applauded our deliberate approach. Before 1904, pneumothorax was generally fatal and thoracic surgery was inconceivable [3]. Now, we can perform complex lung resections through tiny incisions on spontaneously breathing patients. We only reached this point through surgical innovation and by challenging the status quo. Everything we do in surgical practice started at some point with an innovation that aimed to improve patient care. At the time of an innovation, we may not have sufficient evidence to support an outcome, and we will have to create new data; lack of data leads to uncertainty, and uncertainty equals risk [4, 5]. Poor outcomes are therefore an inevitable component of surgical innovation. Patients and surgeons must accept this part of the equation in order to make progress. In healthcare, errors and poor outcomes are associated with pain: pain for the patient and pain for the surgeon. On the other hand, it is important to look at the alternative to innovation: the status quo. An entirely risk-averse approach to patient care seems safe at first glance, because ‘the status quo appears to be the only way things can be’ [5]. However, lack of innovation also carries a risk. Some patient needs will not be met by the status quo, and those patients will be left with no proper therapeutic alternative. The uncertainty about an outcome applies not only to the risk but also to success. Successful innovation begets more innovation and positive ramifications we could not have possibly foreseen. If we had guided our decisions based entirely on the unchallenged status quo, pneumothorax would still be a fatal disease and the publication you are reading now would not exist. The unchallenged status quo is detrimental to patients and surgeons—no pain, no gain. So, how should we innovate to minimize pain and maximize gain? We believe that the path to innovation should have 3 major components: first, find or create data to support a hypothesis [5]; second, validate the innovative concept and data through a peer review; and third, transparent and ethical clinical application. In an ideal world, we would create new data in a non-clinical experimental setting, we would validate our data with publications and obtain formal IRB approval for clinical application, and then we offer the innovation to patients. Although an ideal path potentially minimizes the risk of poor outcomes during innovation, it is also time- and resource-intensive and is not applicable to all innovations [4, 6]. For instance, clinical trials often do not come to fruition because of challenges with accrual. If all innovations were to follow such a formalized path, progress would be excruciatingly slow or even impossible and the risk inherent to the unchallenged status quo would prevail. As a result, the majority of surgical innovations do not follow such a path prior to implementation [7]. Nonetheless, it is the responsibility of the innovating surgeons to exercise self-awareness and check their judgement with their peers [8–10]. With these challenges in mind, how then can we practically explore the risks and benefits of surgical innovation? The perspective of the risks associated with innovation in comparison to the risks associated with the unchallenged status quo is different for patients and surgeons. Patients look for a solution to their health problem and are generally willing to accept risk as long as the risk-to-benefit ratio seems favourable. Many innovations are born out of necessity when the status quo fails to meet the patients’ needs; under these circumstances, patients can be accepting of an uncertain outcome [2]. A patient’s risk acceptance is critical for the implementation of an innovation, but it can also render a patient vulnerable to unreasonable propositions. A thoughtful approach to innovation can offer some protection to patients. For surgeons, innovation poses different types of risk. Surgeons are responsible for a poor outcome, and the potential for a poor outcome puts an enormous emotional and ethical strain on a surgeon. Additionally, innovation requires surgeons to take a disconcerting step outside their comfort zones and become novices at something new [11]. Finally, a surgeon who unsuccessfully implements an innovation potentially faces professional risk, which can range from an informal reprimand to legal consequences and loses the right to practise. The gains of innovation also vary based on the perspective. The patient has the most to gain from successful innovation, as health is priceless. The gains of innovation for a surgeon are the satisfaction of helping a patient, professional recognition and sometimes a legacy of changing the status quo. Our 81-year-old patient with oesophageal cancer accepted the unknown risks of an innovation, because for him the anticipated risk of LTEM appeared lower than the known risk of the status quo. Together, we navigated uncharted territory. Though it went smoothly, we were very apprehensive during the procedure. Our patient suffered complications and endured a long hospital stay, while we were extremely concerned about these unforeseen complications. However, he made a full recovery and has been able to continue living his life independently. Most importantly, he is able to care for his wife as he did before surgery. Thankfully, we were all rewarded in the end, patient and surgeon alike. No pain, no gain. Conflict of interest: none declared. REFERENCES 1 Alsaied O , Rueth N , Andrade R. P-124 laparoscopic transgastric oesophageal mucosectomy in a porcine animal model . Interact CardioVasc Thorac Surg 2017 ; 25(Suppl_1) : ivx280.124 . 2 Lee Char SJ , Hills NK , Lo B , Kirkwood KS. Informed consent for innovative surgery: a survey of patients and surgeons . Surgery 2013 ; 153 : 473 – 80 . Google Scholar Crossref Search ADS PubMed 3 Cherian SM , Nicks R , Lord RS. Ernst Ferdinand Sauerbruch: rise and fall of the pioneer of thoracic surgery . World J Surg 2001 ; 25 : 1012 – 20 . Google Scholar Crossref Search ADS PubMed 4 Angelos P. The ethical challenges of surgical innovation for patient care . Lancet 2010 ; 376 : 1046 – 7 . Google Scholar Crossref Search ADS PubMed 5 Golsby-Smith RLM. Management is much more than a science . Harvard Business Review 2017 ; 95 : 129 – 35 . 6 Broekman ML , Carriere ME , Bredenoord AL. Surgical innovation: the ethical agenda: a systematic review . Medicine (Baltimore) 2016 ; 95 : e3790. Google Scholar Crossref Search ADS PubMed 7 Reitsma AM , Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg 2002 ; 194 : 792 – 801 . Google Scholar Crossref Search ADS PubMed 8 Biffl WL , Spain DA , Reitsma AM , Minter RM , Upperman J , Wilson M et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons . J Am Coll Surg 2008 ; 206 : 1204 – 9 . Google Scholar Crossref Search ADS PubMed 9 Angelos P. Surgical ethics and the challenge of surgical innovation . Am J Surg 2014 ; 208 : 881 – 5 . Google Scholar Crossref Search ADS PubMed 10 Healey P , Samanta J. When does the ‘learning curve’ of innovative interventions become questionable practice? Eur J Vasc Endovasc Surg 2008 ; 36 : 253 – 7 . Google Scholar Crossref Search ADS PubMed 11 Andersen E. Learning to learn . Harvard Business Review 2016 ; 94 : 98 – 101 . © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cardio-Thoracic Surgery Oxford University Press

No pain, no gain

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Publisher
Oxford University Press
Copyright
© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
ISSN
1010-7940
eISSN
1873-734X
DOI
10.1093/ejcts/ezy347
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Abstract

Ethics, Risk, Treatment outcome, Diffusion of innovation Nothing can come from nothing. Lucretius An 81-year-old man who is the primary caretaker of his wheelchair-bound wife presented at our clinic with early oesophageal cancer. In his particular case, endoscopic resection was not feasible due to technical reasons, and because of his comorbidities and social situation, oesophagectomy also appeared unsuitable. What were his options? The status quo (i.e. endoscopic resection or oesophaghectomy) had no other curative-intent alternative for him. Over the course of several years, we have developed a technique for oesophageal mucosectomy via a laparoscopic transgastric approach (laparoscopic transgastric oesophageal mucosectomy; LTEM). Our goal was to design a therapeutic option for patients who are not candidates for endoscopic therapy or oesophagectomy and to validate it with experimental data.† †Please note that we often refer to patients as ‘not a candidate for’ a treatment. This burdens the patient as if the patient was not appropriate for the treatment. In reality, the available treatment options are failing the patient. Once we had developed a reproducible technique in a porcine model, we shared our findings with our institutional multidisciplinary oesophageal group and presented our results at 2 meetings [1]. In reality, LTEM is just a combination of 2 established procedures: oesophageal mucosal resection and laparoscopic transgastric resection. A very small number of published clinical reports with comparable techniques suggested clinical safety and effectiveness. On the basis of our experimental results, available published clinical data and feedback from our peers, we perceived the need to fill the therapeutic gap between endoscopic resection and oesophagectomy. After 10 years, we were ready to propose LTEM for a suitable patient and that patient was now at our clinic. We first asked for consensus within our multidisciplinary oesophageal team on the appropriateness of LTEM for this patient, and only then did we offer him this option. Because LTEM is not the status quo, we documented our team’s rationale in the patient’s medical record. We also decided to forego formal Institutional Review Board (IRB) approval, because LTEM is a combination of already existing procedures. At the time of offering this potentially curative procedure to our patient, we were very transparent about our lack of clinical experience as well as the potential for unknown risks [2]. Our patient weighed the potential risks of the innovation versus the known risks of the status quo (no curative-intent therapy in his case) and decided to proceed with LTEM. Two surgeons and 1 gastroenterologist from our multidisciplinary oesophageal team performed the procedure without intraoperative problems. The postoperative course was complicated by atrial fibrillation and upper gastrointestinal bleeding that did not require transfusion. Our patient gradually recovered and was discharged on the 10th postoperative day. The final specimen revealed a T1b lesion (extension into submucosa) with negative margins, he has no evidence of disease at 10-month follow-up, and he is able to lead his life and care for his wife as he did before surgery. Did we follow a reasonable path to innovation? We received diametrically opposed opinions about our path to innovation from 2 highly regarded thoracic surgeons: one condemned the lack of formal Internal Review Board approval, and the other applauded our deliberate approach. Before 1904, pneumothorax was generally fatal and thoracic surgery was inconceivable [3]. Now, we can perform complex lung resections through tiny incisions on spontaneously breathing patients. We only reached this point through surgical innovation and by challenging the status quo. Everything we do in surgical practice started at some point with an innovation that aimed to improve patient care. At the time of an innovation, we may not have sufficient evidence to support an outcome, and we will have to create new data; lack of data leads to uncertainty, and uncertainty equals risk [4, 5]. Poor outcomes are therefore an inevitable component of surgical innovation. Patients and surgeons must accept this part of the equation in order to make progress. In healthcare, errors and poor outcomes are associated with pain: pain for the patient and pain for the surgeon. On the other hand, it is important to look at the alternative to innovation: the status quo. An entirely risk-averse approach to patient care seems safe at first glance, because ‘the status quo appears to be the only way things can be’ [5]. However, lack of innovation also carries a risk. Some patient needs will not be met by the status quo, and those patients will be left with no proper therapeutic alternative. The uncertainty about an outcome applies not only to the risk but also to success. Successful innovation begets more innovation and positive ramifications we could not have possibly foreseen. If we had guided our decisions based entirely on the unchallenged status quo, pneumothorax would still be a fatal disease and the publication you are reading now would not exist. The unchallenged status quo is detrimental to patients and surgeons—no pain, no gain. So, how should we innovate to minimize pain and maximize gain? We believe that the path to innovation should have 3 major components: first, find or create data to support a hypothesis [5]; second, validate the innovative concept and data through a peer review; and third, transparent and ethical clinical application. In an ideal world, we would create new data in a non-clinical experimental setting, we would validate our data with publications and obtain formal IRB approval for clinical application, and then we offer the innovation to patients. Although an ideal path potentially minimizes the risk of poor outcomes during innovation, it is also time- and resource-intensive and is not applicable to all innovations [4, 6]. For instance, clinical trials often do not come to fruition because of challenges with accrual. If all innovations were to follow such a formalized path, progress would be excruciatingly slow or even impossible and the risk inherent to the unchallenged status quo would prevail. As a result, the majority of surgical innovations do not follow such a path prior to implementation [7]. Nonetheless, it is the responsibility of the innovating surgeons to exercise self-awareness and check their judgement with their peers [8–10]. With these challenges in mind, how then can we practically explore the risks and benefits of surgical innovation? The perspective of the risks associated with innovation in comparison to the risks associated with the unchallenged status quo is different for patients and surgeons. Patients look for a solution to their health problem and are generally willing to accept risk as long as the risk-to-benefit ratio seems favourable. Many innovations are born out of necessity when the status quo fails to meet the patients’ needs; under these circumstances, patients can be accepting of an uncertain outcome [2]. A patient’s risk acceptance is critical for the implementation of an innovation, but it can also render a patient vulnerable to unreasonable propositions. A thoughtful approach to innovation can offer some protection to patients. For surgeons, innovation poses different types of risk. Surgeons are responsible for a poor outcome, and the potential for a poor outcome puts an enormous emotional and ethical strain on a surgeon. Additionally, innovation requires surgeons to take a disconcerting step outside their comfort zones and become novices at something new [11]. Finally, a surgeon who unsuccessfully implements an innovation potentially faces professional risk, which can range from an informal reprimand to legal consequences and loses the right to practise. The gains of innovation also vary based on the perspective. The patient has the most to gain from successful innovation, as health is priceless. The gains of innovation for a surgeon are the satisfaction of helping a patient, professional recognition and sometimes a legacy of changing the status quo. Our 81-year-old patient with oesophageal cancer accepted the unknown risks of an innovation, because for him the anticipated risk of LTEM appeared lower than the known risk of the status quo. Together, we navigated uncharted territory. Though it went smoothly, we were very apprehensive during the procedure. Our patient suffered complications and endured a long hospital stay, while we were extremely concerned about these unforeseen complications. However, he made a full recovery and has been able to continue living his life independently. Most importantly, he is able to care for his wife as he did before surgery. Thankfully, we were all rewarded in the end, patient and surgeon alike. No pain, no gain. Conflict of interest: none declared. REFERENCES 1 Alsaied O , Rueth N , Andrade R. P-124 laparoscopic transgastric oesophageal mucosectomy in a porcine animal model . Interact CardioVasc Thorac Surg 2017 ; 25(Suppl_1) : ivx280.124 . 2 Lee Char SJ , Hills NK , Lo B , Kirkwood KS. Informed consent for innovative surgery: a survey of patients and surgeons . Surgery 2013 ; 153 : 473 – 80 . Google Scholar Crossref Search ADS PubMed 3 Cherian SM , Nicks R , Lord RS. Ernst Ferdinand Sauerbruch: rise and fall of the pioneer of thoracic surgery . World J Surg 2001 ; 25 : 1012 – 20 . Google Scholar Crossref Search ADS PubMed 4 Angelos P. The ethical challenges of surgical innovation for patient care . Lancet 2010 ; 376 : 1046 – 7 . Google Scholar Crossref Search ADS PubMed 5 Golsby-Smith RLM. Management is much more than a science . Harvard Business Review 2017 ; 95 : 129 – 35 . 6 Broekman ML , Carriere ME , Bredenoord AL. Surgical innovation: the ethical agenda: a systematic review . Medicine (Baltimore) 2016 ; 95 : e3790. Google Scholar Crossref Search ADS PubMed 7 Reitsma AM , Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg 2002 ; 194 : 792 – 801 . Google Scholar Crossref Search ADS PubMed 8 Biffl WL , Spain DA , Reitsma AM , Minter RM , Upperman J , Wilson M et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons . J Am Coll Surg 2008 ; 206 : 1204 – 9 . Google Scholar Crossref Search ADS PubMed 9 Angelos P. Surgical ethics and the challenge of surgical innovation . Am J Surg 2014 ; 208 : 881 – 5 . Google Scholar Crossref Search ADS PubMed 10 Healey P , Samanta J. When does the ‘learning curve’ of innovative interventions become questionable practice? Eur J Vasc Endovasc Surg 2008 ; 36 : 253 – 7 . Google Scholar Crossref Search ADS PubMed 11 Andersen E. Learning to learn . Harvard Business Review 2016 ; 94 : 98 – 101 . © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Journal

European Journal of Cardio-Thoracic Surgery – Oxford University Press

Published: Nov 5, 2018

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