Seminars in Pediatric Surgery 24 (2015) 141–144
Contents lists available at ScienceDirect
Seminars in Pediatric Surgery journal homepage: www.elsevier.com/locate/sempedsurg
Patients as partners in innovation Sean J. Barnett, MD, MSa,b,n, Aviva Katz, MD, MA, CIPc,d a
Pediatric General and Thoracic Surgery, Department of Surgery, Boonshoft School of Medicine, Dayton Children’s Hospital, Dayton, OH Kaleidoscope, Inc., Cincinnati, OH Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA d Department of Pediatric General and Thoracic Surgery, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA b c
a r t i c l e in fo
Keywords: Innovative therapy Surgical innovation Informed consent Conflict of interest
a b s t r a c t As the culture of medical practice has evolved, so has the relationship between the physician and patient. This is decidedly true with regards to the introduction of innovative therapies, especially in the surgical arena. A critical challenge is identifying and defining innovative therapy. Is the proposed treatment an incremental change, a research proposal, or more commonly someplace in between? This gray area creates a transition zone commonly referred to as innovative therapy. Given the complexities of the current landscape of innovation, innovation therapy committees may provide a mechanism to help to guide both physicians and patients through such difficult topics as the process of informed consent, managing conflicts of interest, and how to evaluate the outcomes of innovative therapies. As surgical innovation remains critical to the advancement of care, it must occur in a transparent partnership with patients, under the eye of guiding entities, aimed at ultimately improving outcomes and care. & 2015 Elsevier Inc. All rights reserved.
Introduction The culture of medical practice has undergone significant change in the past several decades. The relationship between physician and patient has moved from a patriarchal model towards one of equals. This has not occurred in a vacuum, but reflects many other societal changes that have resulted in a flattening of hierarchies and a move towards a more inclusive community. This change in the physician–patient relationship over time, from one of dependency towards a more equal partnership, has illuminated the challenges and obligations both physicians and patients face when they engage in a discussion of innovative therapy.
What is innovative therapy? Advances in medical care, and particularly advances in surgical treatment, have always been dependent upon the incremental improvements in practice brought about by innovative therapy. By the very nature of their practice, surgeons innovate constantly and unexpectedly. This is exemplified by surgery on infants with congenital anomalies where the anatomy and circumstances can vary from patient to patient. In these situations, there may have n Corresponding author at: Kaleidoscope, Inc., 205 W 4th St., Suite 1140, Cincinnati, OH 45202 E-mail address: [email protected] (S.J. Barnett).
http://dx.doi.org/10.1053/j.sempedsurg.2015.02.014 1055-8586/& 2015 Elsevier Inc. All rights reserved.
been no plans to perform an innovative procedure, and the usual standard of care has been altered incrementally, in response to patient need. This situation represents thoughtful, attentive patient care with a slight departure from the accepted standard (i.e., the “practice of medicine”), for which the risks can be reasonably estimated and the likely clinical outcomes are known. On the other end of the spectrum is “research” which is an activity designed to generate knowledge by testing a hypothesis and developing conclusions which may (eventually) be generalizable to other patients. Although there may be a potential for individual patient/subject benefit, that is not the primary intent of the intervention. Generally for the patients’ protection, this kind of innovation is subject to oversight by Institutional review boards (IRBs), which codify the engagement of patients as research subjects. Between incremental innovation and research is a “gray area” or “transition zone” referred to as “Innovative Therapy.” Innovative therapy describes a procedure that represents a degree of novelty that includes the possibility of unforeseen outcomes with the potential for generalizable knowledge to be collected, yet unlike clinical research, the direct intent of the innovation is to benefit the patient. While innovation is critical for the advancement of surgical care as a whole, the risks faced by the individual patient receiving innovative therapy can be substantial, especially early on in the acquisition of procedural experience. A physician’s fiduciary responsibility to his/her patient, and the desire to maintain the trust required to support a true physician–patient partnership, requires that we strive to be transparent in
142
S.J. Barnett, A. Katz / Seminars in Pediatric Surgery 24 (2015) 141–144
differentiating innovative therapy from standard clinical care, and when appropriate, move innovative care to a more rigorous form of evaluation, where the primary intent is understanding treatment outcomes (effectiveness) and risk, rather than treating individual patients. Ultimately, it is the physician who needs to be honest with themselves and the patient in his/her efforts to maintain this transparency.
Institutional oversight: The innovative therapy committee Innovative surgical therapy and clinical research involving novel surgical techniques or devices bring forward issues that are not routinely considered in evaluating the safety of medical or pharmaceutical research. These include not only the safety of the procedure, but the inherent variability associated with the skill, insight and experience of the surgeon, and the team that will be performing the procedure. The oversight process must consider not only the procedure or device, but also “human factors” such as foundational expertise, specialized training, demonstrated skill and experience, and should be required whether the proposed innovation is completely novel, or has already been shown to be safe and effective by pioneering surgeon innovators elsewhere, but is new to the institution in question. Institutional review boards may have limited knowledge of these specific variables and cannot readily make informed decisions on their safety and use. Additionally, many IRBs may be overwhelmed with providing oversight for formal clinical research protocols, which are subject to significant regulatory requirements. The surgeon or team requesting privileges to perform an innovative procedure should summarize the existing clinical or experimental evidence, and offer some justification of the anticipated safety and effectiveness of the proposed procedure. Additionally, the review should describe what preparatory work has been done via courses, simulators, and by animal or cadaver labs to try and maximize the safety of the new approach. Innovative therapy committees should be composed of physicians with foundational understanding of the proposed treatment and alternatives (if any), and other stakeholders including social workers, patient advocates, clinical ethicists, and legal representatives when appropriate. The Innovative Therapy committee should also review inclusion and exclusion criteria, the consenting process and should review the consent form for clarity and transparency. All real or perceived conflicts of interest by any member of the surgical team must be declared and discussed. These can be significant when a new device is being utilized. Finally, the committee (or a group designated by the committee) should be prepared to evaluate patient outcomes at appropriate intervals, and help make a determination as to whether the innovative procedure should be trialed in more patients, whether unanticipated outcomes suggest the need to impose a procedural moratorium, or if further evaluation is more appropriate in the context of a clinical trial. They may also be tasked with reaching out to other institutions to confirm their experience in the therapy being proposed. The committee may also comment on how best to disseminate information and education on the innovative procedure regardless of the outcome.
The process of informed consent The participation of patients and their families in shared medical decision-making regarding clinical care is embodied in the informed consent process. At its best, informed consent discussions allow the physician to share information about the disease process and the various therapeutic options while the patient provides information on their understanding of their
illness, and its impact on their life. Productive informed consent discussions depend on physician transparency in sharing the extent of our understanding of the disease and its prognosis, the risks and benefits of various treatment options, and the generally expected outcomes of the recommended options. The process of informed consent provides an opportunity for the physician to consider where along the spectrum from standard clinical care, through to clinical research, the proposed intervention resides. As interventions move towards the research end of the spectrum, there needs to be increasing clarity about what we do not know regarding risk and outcome. This is vitally important to minimize the risk of therapeutic misconception, where physicians, patients and families may be confused regarding the therapeutic intent of a research procedure. Clinical research has very clear guidelines, dictated by federal regulation, regarding the requirements for informed consent, mandating the inclusion of information that the procedure represents research, with a description of the foreseeable risks, any potential benefits, and any alternative procedures or courses of treatment. This guidance may be helpful in considering informed consent discussions surrounding innovative procedures that are not part of a formal clinical trial and should generally be crafted with the assistance of an innovative therapy committee. The preparation for this discussion should provide the physician the opportunity to reflect on his/her intent in proposing the innovative intervention—is he/she proposing this innovative therapy as the best option available to treat or ameliorate the patient’s disease, to have an opportunity to learn or refine new technical skills, or in the hopes of learning more about a new therapeutic option. These are very different indications for introducing an innovative procedure and should be clearly identified in the course of an informed consent discussion as they may influence the patient’s willingness to consent to the procedure. When the balance of surgeon intent “tips” in favor of acquiring new skills or creating an evidence base for the continued utilization of the procedure, it should be considered “research,” and be subject to IRB oversight. More commonly, challenges arise when there is insufficient experience with the procedure to confidently state what benefits the patient will gain, and how those are balanced against potential risks. With less data to share and consider, there is the potential for both the physician and the family to rely instead on their perceptions of the risks and benefits of the proposed intervention. The phenomenon of “Optimism bias” refers to the unwarranted belief in the efficacy of new therapies, and may exist in both the surgeon-innovator and his or her prospective patient. For the surgeon who has invested intellectually (and sometimes financially) in the development of a novel treatment, the desire to demonstrate benefit by the creation of clinical evidence may lead to advocacy, or even excessive, frequently subconscious encouragement for the novel treatment over its conventional alternative. In contrast, a surgeon with equivalent knowledge and expertise, but without personal investment in the procedure is more likely to honestly question the existence of clinical equipoise, and may present the innovative procedure being considered in a more appropriate, but perhaps less favorable light. For this reason, some have suggested that an objective third party, such as a surgeoncolleague not involved in performing the innovative procedure, should be involved in the primary patient discussion rather than the operating surgeon. Alternatively, an innovative therapy committee could meet with the family collectively to discuss the procedure and its alternatives in the presence of the operating surgeon. Patients can also fall victim to optimism bias if they present for surgical consultation having made up their mind that the innovative procedure is better than the traditional alternative. One
S.J. Barnett, A. Katz / Seminars in Pediatric Surgery 24 (2015) 141–144
143
strategy for tempering a patient’s optimism bias is to impose a mandatory “cooling off” period after the initial discussion, which allows the patient time to thoughtfully consider what is being proposed, before authorizing consent, which is formally obtained at a second visit. Additionally, the patient may also believe that the surgeon’s willingness to provide an innovative intervention is something they have little choice in, especially if they believe that to refuse would disappoint or offend their surgeon, and might cause him or her to withhold care. Whatever strategies are undertaken to mitigate bias on the part of the surgeon and the patent, it is the duty of the surgeon to fully disclose exactly what is known or unknown about the innovative procedure, to provide a thorough discussion of alternative procedures and their risks and benefits and to ensure that the patient feels no pressure to choose the innovative therapy: in short, the patient must be a fully-informed equal partner in therapeutic decision making. When the patient is a child without decision-making capacity, our medico-legal systems grant parents the authority to provide permission for treatment on their child’s behalf. Children, who are not deemed able to provide autonomous consent for treatment, can often provide their assent, meaning they agree to treatment in circumstances where they are not legally authorized to give consent. Physicians should be mindful of the opinions and wishes of children who are unable to give consent, and should always strive to obtain their assent, along with their parents’ permission.
patient has heard about the procedure, especially if they appear to be seeking “cutting edge” therapy. Conflicts of interest are often real, but can also be perceived. The history of surgery is replete with stories of innovation by surgeons, who during the time period were innovating, had little to gain, other than to provide better therapeutic options to their patients. Fogarty, for example, developed the balloon catheter when he was a medical student because he had witnessed (as a scrub technician), the dismal outcomes experienced by patients who developed peripheral arterial occlusion. It is likely that most surgeons innovate altruistically, and although personal acclaim and financial gain may ultimately be realized, it is not the primary motivation for their desire to innovate. Regardless of whether the conflict is real or perceived, professionalism demands that the surgeon is transparent in acknowledging all potential conflicts of interest. Conflicts should be carefully explored by whatever institutional processes oversee the granting of privileges for innovative surgical procedures. This process should include objective assessment of all potential sources of conflict by an arm’s length group (often the applicant’s department head, clinical leaders from other departments and possibly a clinical ethicist). Possible conflicts for the surgeon or institution should also be addressed directly and candidly with the patient when discussing a proposed innovative procedure, so that the patient can make their own decision as to whether the presence of conflict on the part of the treating surgeon or institution has influence on their decision making.
Managing conflicts of interest
Evaluating outcomes of innovative surgical therapy
Surgical innovation has the potential to generate conflicts of interest for individual surgeons and the institutions in which they work. Surgeons may pursue surgical innovations for interests that are separate from their concerns for the patient. If the surgeon has spent many years developing a technology, they have a vested interest in seeing it succeed. The development of an innovative procedure also raises the possibility of an enhanced reputation within the surgical community leading to increased referrals to the surgeon (and the hospital at which they work) and the opportunity for academic advancement. The surgeon may have established a relationship with an equipment company that provides the technology or device used in an innovative procedure, and stands to benefit financially if the procedure is shown to be successful, resulting in its widespread adoption. These potential benefits to the surgeon, which are independent of the needs, risks and benefits to the patient create conflicts of interest that may compromise a surgeon’s ability to objectively assess the proposed innovative procedure. These issues highlight the importance of an unbiased committee to help to deal with these pressures objectively. In today’s competitive environment, hospitals frequently use websites to market their services, in what amounts to “direct to consumer” advertising. Sections of a hospital website which appear to be dedicated to patient education may actually directly advocate for an innovative procedure that the hospital offers, and suggest that this treatment offers superior outcomes. Evidence demonstrates that patients are increasingly searching the Internet for reliable information on “state of the art” medical and surgical care, and often consider the information provided on a hospital website to be the “voice” of a physician. Moreover, there are scant regulations governing what hospitals can and cannot report regarding quality of care, and there may be a tendency for websites to overestimate the benefits and underestimate the risks of a procedure or technology their hospital offers, as a means of attracting patients. Surgeons who might offer innovative therapy to patients should anticipate the potential for optimism bias, and address the issue up front by asking what the
Surgical innovation also differs from medical innovation in the very proximate and intimate relationship between surgeon and patient in developing and applying innovative procedures. The intimate relationship between surgeon and patient is a critical aspect of surgical practice, and this feature is often part of the attraction of the field for students and trainees. Surgical culture and training strives to instill a sense of responsibility regarding operative procedures and the care of those patients. Surgical intervention for both routine clinical care and innovative practice is to some degree an extension of the surgeon him/herself, with the outcome in part directly linked to the surgeon’s technical skills and operative decision making. This is vastly different from medical/pharmaceutical clinical trials. Beyond any tangible or intangible rewards from developing an innovative intervention, the surgeon is likely to have a personal investment in the outcome of the intervention. A failure of an innovative procedure to achieve its intended goal may be due to poor execution of the surgical technique rather than a failure of the design or concept. Importantly, due in part to the intimate nature of the surgical process, the surgeon may see a poor outcome as a negative reflection on him/herself. The weight of accepting the potential risks and benefits of an innovative surgical procedure may be perceived very personally by the surgeon, potentially clouding his/her ability to provide an objective (positive or negative) assessment. The same might be said of the patient, who may have made a decision to undergo an innovative procedure because they were convinced in advance of what the outcome would be, and may have difficulty accepting that the outcome experienced is different from what was anticipated. For these reasons, prior to granting approval, it is important to put in place a process of external oversight with objective criteria applied to define success, failure and unintended consequences of the innovative procedure. This plan of rigorous outcomes assessment should be reviewed at regular intervals while experience with the innovative procedure (the learning curve) is progressing.
144
S.J. Barnett, A. Katz / Seminars in Pediatric Surgery 24 (2015) 141–144
Most discussions of the ethical introduction of innovative surgery focus on protecting patients from undergoing procedures without adequate informed consent and a full understanding of the potential risks of untested procedures. There is also increasing concern regarding the rights of patients to demand access to innovative procedures. This right may be framed as a right to decisional privacy, the right to make important, intensely personal life decisions, or the right to life with the opportunity to decide what risks they are willing to accept without externally imposed barriers. While patients clearly do not have a right to interventions that are dangerous or ineffective, it is less clear how much evidence of benefit is required to support a right to access. It is universally accepted that patients with decision-making capacity have an absolute right to refuse even life-saving interventions; this is a negative right, to be free from unwanted interference. There has been less written supporting the positive right to demand care, either routine care or novel therapies. This is a more difficult situation, as rather than limiting others actions, a positive right to care would compel others to act, possibly against their professional judgment. It is hard to envision this right as an absolute right, especially as it would mandate action from others, and therefore the right to innovative care may be restricted to meet patient safety or other societal concerns such as cost or resource allocation. Surgical innovation is crucial to the continued advancement of surgical care, and the ability to provide further improvements in care for future patients. These innovations must be undertaken in partnership with our current patients, recognizing the need for thorough ongoing informed consent coupled with appropriate oversight that is transparent regarding the limited data available on an innovative procedure and careful personal reflection, aiming to actively pursue innovations that are in the patients’ interests.
Further reading 1. National Commission for the Protection of Human Subjects. The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Research. DHEW Publications. (Publication No: OS78-0012). 2. Innovation versus research: guidelines, concepts and procedures for differentiation. The Clinical Investigation Policy and Procedure Manual. Boston: Boston Children’s Hospital; 2012, CIPP 081.015. 3. Kennedy D. Report on the Lasker Forum on Ethical Challenges in Biomedical Research and Practice. Washington: 2003. 4. Kastenberg Z, Dutta S. Guidelines for innovation in pediatric surgery. J Laparoendosc Adv Surg Tech A. 2011;21:371–374. 5. Schwartz J. Innovation in pediatric surgery: the surgical innovation continuum and the ETHICAL model. J Pediatr Surg. 2014;49:639–645. 6. Miller ME, Siegler M, Angelos P. Ethical issues in surgical innovation. World J Surg. 2014;38:1638–1643. 7. Riskin DJ, Longaker MT, Gertner M, Krummel TK. Innovation in surgery. a historical perspective. Ann Surg. 2006;244:686–693. 8. Lenihan JP. Navigating credentialing, privileging, and learning curves in robotics with an evidence and experienced-based approach. Clin Obstet Gynecol. 2011;54:382–390. 9. Jin LX, Ibrahim AM, Newman NA. Robotic surgery claims on United States hospital websites. J Healthc Qual. 2011;33:48–52. 10. Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet. 2009;374(9695):1097–1104. 11. Angelos P. Surgical ethics and the challenge of surgical innovation. Am J Surg. 2014;208(6):881–885. 12. Angelos P. Ethics and surgical innovation: challenges to the professionalism of surgeons. Int J Surg. 2013;11(suppl. 1):S2–S5. 13. Sagar SP, Law PW, Shaul RZ, et al. Hey, I just did a new operation! Introducing innovative procedures and devices within an academic health center. Ann Surg. 2015;261(1):30–31. 14. McKneally, MF, Daar AS, Introducing new technologies: protecting subjects of surgical innovation and research. World J Surg 2003;27:930–935. 15. Johnson J, Rogers W. Innovative surgery: the ethical challenges J Med Ethics. 2012;38:9–12. 16. Morreim H, Mack MJ, Sade RM. Surgical innovation: too risky to remain unregulated? Ann Thorac Surg. 2006;82:1957–1965. 17. Fins JJ. Surgical innovation and ethical dilemmas: precautions and proximity. Cleve Clin J Med. 2008;75:S7–S12. 18. Meyerson D. Is there a right to access innovative surgery? Bioethics. 2014, http://dx. doi.org/10.1111/bioe.12111.
Contents lists available at ScienceDirect
Seminars in Pediatric Surgery journal homepage: www.elsevier.com/locate/sempedsurg
Patients as partners in innovation Sean J. Barnett, MD, MSa,b,n, Aviva Katz, MD, MA, CIPc,d a
Pediatric General and Thoracic Surgery, Department of Surgery, Boonshoft School of Medicine, Dayton Children’s Hospital, Dayton, OH Kaleidoscope, Inc., Cincinnati, OH Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA d Department of Pediatric General and Thoracic Surgery, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA b c
a r t i c l e in fo
Keywords: Innovative therapy Surgical innovation Informed consent Conflict of interest
a b s t r a c t As the culture of medical practice has evolved, so has the relationship between the physician and patient. This is decidedly true with regards to the introduction of innovative therapies, especially in the surgical arena. A critical challenge is identifying and defining innovative therapy. Is the proposed treatment an incremental change, a research proposal, or more commonly someplace in between? This gray area creates a transition zone commonly referred to as innovative therapy. Given the complexities of the current landscape of innovation, innovation therapy committees may provide a mechanism to help to guide both physicians and patients through such difficult topics as the process of informed consent, managing conflicts of interest, and how to evaluate the outcomes of innovative therapies. As surgical innovation remains critical to the advancement of care, it must occur in a transparent partnership with patients, under the eye of guiding entities, aimed at ultimately improving outcomes and care. & 2015 Elsevier Inc. All rights reserved.
Introduction The culture of medical practice has undergone significant change in the past several decades. The relationship between physician and patient has moved from a patriarchal model towards one of equals. This has not occurred in a vacuum, but reflects many other societal changes that have resulted in a flattening of hierarchies and a move towards a more inclusive community. This change in the physician–patient relationship over time, from one of dependency towards a more equal partnership, has illuminated the challenges and obligations both physicians and patients face when they engage in a discussion of innovative therapy.
What is innovative therapy? Advances in medical care, and particularly advances in surgical treatment, have always been dependent upon the incremental improvements in practice brought about by innovative therapy. By the very nature of their practice, surgeons innovate constantly and unexpectedly. This is exemplified by surgery on infants with congenital anomalies where the anatomy and circumstances can vary from patient to patient. In these situations, there may have n Corresponding author at: Kaleidoscope, Inc., 205 W 4th St., Suite 1140, Cincinnati, OH 45202 E-mail address: [email protected] (S.J. Barnett).
http://dx.doi.org/10.1053/j.sempedsurg.2015.02.014 1055-8586/& 2015 Elsevier Inc. All rights reserved.
been no plans to perform an innovative procedure, and the usual standard of care has been altered incrementally, in response to patient need. This situation represents thoughtful, attentive patient care with a slight departure from the accepted standard (i.e., the “practice of medicine”), for which the risks can be reasonably estimated and the likely clinical outcomes are known. On the other end of the spectrum is “research” which is an activity designed to generate knowledge by testing a hypothesis and developing conclusions which may (eventually) be generalizable to other patients. Although there may be a potential for individual patient/subject benefit, that is not the primary intent of the intervention. Generally for the patients’ protection, this kind of innovation is subject to oversight by Institutional review boards (IRBs), which codify the engagement of patients as research subjects. Between incremental innovation and research is a “gray area” or “transition zone” referred to as “Innovative Therapy.” Innovative therapy describes a procedure that represents a degree of novelty that includes the possibility of unforeseen outcomes with the potential for generalizable knowledge to be collected, yet unlike clinical research, the direct intent of the innovation is to benefit the patient. While innovation is critical for the advancement of surgical care as a whole, the risks faced by the individual patient receiving innovative therapy can be substantial, especially early on in the acquisition of procedural experience. A physician’s fiduciary responsibility to his/her patient, and the desire to maintain the trust required to support a true physician–patient partnership, requires that we strive to be transparent in
142
S.J. Barnett, A. Katz / Seminars in Pediatric Surgery 24 (2015) 141–144
differentiating innovative therapy from standard clinical care, and when appropriate, move innovative care to a more rigorous form of evaluation, where the primary intent is understanding treatment outcomes (effectiveness) and risk, rather than treating individual patients. Ultimately, it is the physician who needs to be honest with themselves and the patient in his/her efforts to maintain this transparency.
Institutional oversight: The innovative therapy committee Innovative surgical therapy and clinical research involving novel surgical techniques or devices bring forward issues that are not routinely considered in evaluating the safety of medical or pharmaceutical research. These include not only the safety of the procedure, but the inherent variability associated with the skill, insight and experience of the surgeon, and the team that will be performing the procedure. The oversight process must consider not only the procedure or device, but also “human factors” such as foundational expertise, specialized training, demonstrated skill and experience, and should be required whether the proposed innovation is completely novel, or has already been shown to be safe and effective by pioneering surgeon innovators elsewhere, but is new to the institution in question. Institutional review boards may have limited knowledge of these specific variables and cannot readily make informed decisions on their safety and use. Additionally, many IRBs may be overwhelmed with providing oversight for formal clinical research protocols, which are subject to significant regulatory requirements. The surgeon or team requesting privileges to perform an innovative procedure should summarize the existing clinical or experimental evidence, and offer some justification of the anticipated safety and effectiveness of the proposed procedure. Additionally, the review should describe what preparatory work has been done via courses, simulators, and by animal or cadaver labs to try and maximize the safety of the new approach. Innovative therapy committees should be composed of physicians with foundational understanding of the proposed treatment and alternatives (if any), and other stakeholders including social workers, patient advocates, clinical ethicists, and legal representatives when appropriate. The Innovative Therapy committee should also review inclusion and exclusion criteria, the consenting process and should review the consent form for clarity and transparency. All real or perceived conflicts of interest by any member of the surgical team must be declared and discussed. These can be significant when a new device is being utilized. Finally, the committee (or a group designated by the committee) should be prepared to evaluate patient outcomes at appropriate intervals, and help make a determination as to whether the innovative procedure should be trialed in more patients, whether unanticipated outcomes suggest the need to impose a procedural moratorium, or if further evaluation is more appropriate in the context of a clinical trial. They may also be tasked with reaching out to other institutions to confirm their experience in the therapy being proposed. The committee may also comment on how best to disseminate information and education on the innovative procedure regardless of the outcome.
The process of informed consent The participation of patients and their families in shared medical decision-making regarding clinical care is embodied in the informed consent process. At its best, informed consent discussions allow the physician to share information about the disease process and the various therapeutic options while the patient provides information on their understanding of their
illness, and its impact on their life. Productive informed consent discussions depend on physician transparency in sharing the extent of our understanding of the disease and its prognosis, the risks and benefits of various treatment options, and the generally expected outcomes of the recommended options. The process of informed consent provides an opportunity for the physician to consider where along the spectrum from standard clinical care, through to clinical research, the proposed intervention resides. As interventions move towards the research end of the spectrum, there needs to be increasing clarity about what we do not know regarding risk and outcome. This is vitally important to minimize the risk of therapeutic misconception, where physicians, patients and families may be confused regarding the therapeutic intent of a research procedure. Clinical research has very clear guidelines, dictated by federal regulation, regarding the requirements for informed consent, mandating the inclusion of information that the procedure represents research, with a description of the foreseeable risks, any potential benefits, and any alternative procedures or courses of treatment. This guidance may be helpful in considering informed consent discussions surrounding innovative procedures that are not part of a formal clinical trial and should generally be crafted with the assistance of an innovative therapy committee. The preparation for this discussion should provide the physician the opportunity to reflect on his/her intent in proposing the innovative intervention—is he/she proposing this innovative therapy as the best option available to treat or ameliorate the patient’s disease, to have an opportunity to learn or refine new technical skills, or in the hopes of learning more about a new therapeutic option. These are very different indications for introducing an innovative procedure and should be clearly identified in the course of an informed consent discussion as they may influence the patient’s willingness to consent to the procedure. When the balance of surgeon intent “tips” in favor of acquiring new skills or creating an evidence base for the continued utilization of the procedure, it should be considered “research,” and be subject to IRB oversight. More commonly, challenges arise when there is insufficient experience with the procedure to confidently state what benefits the patient will gain, and how those are balanced against potential risks. With less data to share and consider, there is the potential for both the physician and the family to rely instead on their perceptions of the risks and benefits of the proposed intervention. The phenomenon of “Optimism bias” refers to the unwarranted belief in the efficacy of new therapies, and may exist in both the surgeon-innovator and his or her prospective patient. For the surgeon who has invested intellectually (and sometimes financially) in the development of a novel treatment, the desire to demonstrate benefit by the creation of clinical evidence may lead to advocacy, or even excessive, frequently subconscious encouragement for the novel treatment over its conventional alternative. In contrast, a surgeon with equivalent knowledge and expertise, but without personal investment in the procedure is more likely to honestly question the existence of clinical equipoise, and may present the innovative procedure being considered in a more appropriate, but perhaps less favorable light. For this reason, some have suggested that an objective third party, such as a surgeoncolleague not involved in performing the innovative procedure, should be involved in the primary patient discussion rather than the operating surgeon. Alternatively, an innovative therapy committee could meet with the family collectively to discuss the procedure and its alternatives in the presence of the operating surgeon. Patients can also fall victim to optimism bias if they present for surgical consultation having made up their mind that the innovative procedure is better than the traditional alternative. One
S.J. Barnett, A. Katz / Seminars in Pediatric Surgery 24 (2015) 141–144
143
strategy for tempering a patient’s optimism bias is to impose a mandatory “cooling off” period after the initial discussion, which allows the patient time to thoughtfully consider what is being proposed, before authorizing consent, which is formally obtained at a second visit. Additionally, the patient may also believe that the surgeon’s willingness to provide an innovative intervention is something they have little choice in, especially if they believe that to refuse would disappoint or offend their surgeon, and might cause him or her to withhold care. Whatever strategies are undertaken to mitigate bias on the part of the surgeon and the patent, it is the duty of the surgeon to fully disclose exactly what is known or unknown about the innovative procedure, to provide a thorough discussion of alternative procedures and their risks and benefits and to ensure that the patient feels no pressure to choose the innovative therapy: in short, the patient must be a fully-informed equal partner in therapeutic decision making. When the patient is a child without decision-making capacity, our medico-legal systems grant parents the authority to provide permission for treatment on their child’s behalf. Children, who are not deemed able to provide autonomous consent for treatment, can often provide their assent, meaning they agree to treatment in circumstances where they are not legally authorized to give consent. Physicians should be mindful of the opinions and wishes of children who are unable to give consent, and should always strive to obtain their assent, along with their parents’ permission.
patient has heard about the procedure, especially if they appear to be seeking “cutting edge” therapy. Conflicts of interest are often real, but can also be perceived. The history of surgery is replete with stories of innovation by surgeons, who during the time period were innovating, had little to gain, other than to provide better therapeutic options to their patients. Fogarty, for example, developed the balloon catheter when he was a medical student because he had witnessed (as a scrub technician), the dismal outcomes experienced by patients who developed peripheral arterial occlusion. It is likely that most surgeons innovate altruistically, and although personal acclaim and financial gain may ultimately be realized, it is not the primary motivation for their desire to innovate. Regardless of whether the conflict is real or perceived, professionalism demands that the surgeon is transparent in acknowledging all potential conflicts of interest. Conflicts should be carefully explored by whatever institutional processes oversee the granting of privileges for innovative surgical procedures. This process should include objective assessment of all potential sources of conflict by an arm’s length group (often the applicant’s department head, clinical leaders from other departments and possibly a clinical ethicist). Possible conflicts for the surgeon or institution should also be addressed directly and candidly with the patient when discussing a proposed innovative procedure, so that the patient can make their own decision as to whether the presence of conflict on the part of the treating surgeon or institution has influence on their decision making.
Managing conflicts of interest
Evaluating outcomes of innovative surgical therapy
Surgical innovation has the potential to generate conflicts of interest for individual surgeons and the institutions in which they work. Surgeons may pursue surgical innovations for interests that are separate from their concerns for the patient. If the surgeon has spent many years developing a technology, they have a vested interest in seeing it succeed. The development of an innovative procedure also raises the possibility of an enhanced reputation within the surgical community leading to increased referrals to the surgeon (and the hospital at which they work) and the opportunity for academic advancement. The surgeon may have established a relationship with an equipment company that provides the technology or device used in an innovative procedure, and stands to benefit financially if the procedure is shown to be successful, resulting in its widespread adoption. These potential benefits to the surgeon, which are independent of the needs, risks and benefits to the patient create conflicts of interest that may compromise a surgeon’s ability to objectively assess the proposed innovative procedure. These issues highlight the importance of an unbiased committee to help to deal with these pressures objectively. In today’s competitive environment, hospitals frequently use websites to market their services, in what amounts to “direct to consumer” advertising. Sections of a hospital website which appear to be dedicated to patient education may actually directly advocate for an innovative procedure that the hospital offers, and suggest that this treatment offers superior outcomes. Evidence demonstrates that patients are increasingly searching the Internet for reliable information on “state of the art” medical and surgical care, and often consider the information provided on a hospital website to be the “voice” of a physician. Moreover, there are scant regulations governing what hospitals can and cannot report regarding quality of care, and there may be a tendency for websites to overestimate the benefits and underestimate the risks of a procedure or technology their hospital offers, as a means of attracting patients. Surgeons who might offer innovative therapy to patients should anticipate the potential for optimism bias, and address the issue up front by asking what the
Surgical innovation also differs from medical innovation in the very proximate and intimate relationship between surgeon and patient in developing and applying innovative procedures. The intimate relationship between surgeon and patient is a critical aspect of surgical practice, and this feature is often part of the attraction of the field for students and trainees. Surgical culture and training strives to instill a sense of responsibility regarding operative procedures and the care of those patients. Surgical intervention for both routine clinical care and innovative practice is to some degree an extension of the surgeon him/herself, with the outcome in part directly linked to the surgeon’s technical skills and operative decision making. This is vastly different from medical/pharmaceutical clinical trials. Beyond any tangible or intangible rewards from developing an innovative intervention, the surgeon is likely to have a personal investment in the outcome of the intervention. A failure of an innovative procedure to achieve its intended goal may be due to poor execution of the surgical technique rather than a failure of the design or concept. Importantly, due in part to the intimate nature of the surgical process, the surgeon may see a poor outcome as a negative reflection on him/herself. The weight of accepting the potential risks and benefits of an innovative surgical procedure may be perceived very personally by the surgeon, potentially clouding his/her ability to provide an objective (positive or negative) assessment. The same might be said of the patient, who may have made a decision to undergo an innovative procedure because they were convinced in advance of what the outcome would be, and may have difficulty accepting that the outcome experienced is different from what was anticipated. For these reasons, prior to granting approval, it is important to put in place a process of external oversight with objective criteria applied to define success, failure and unintended consequences of the innovative procedure. This plan of rigorous outcomes assessment should be reviewed at regular intervals while experience with the innovative procedure (the learning curve) is progressing.
144
S.J. Barnett, A. Katz / Seminars in Pediatric Surgery 24 (2015) 141–144
Most discussions of the ethical introduction of innovative surgery focus on protecting patients from undergoing procedures without adequate informed consent and a full understanding of the potential risks of untested procedures. There is also increasing concern regarding the rights of patients to demand access to innovative procedures. This right may be framed as a right to decisional privacy, the right to make important, intensely personal life decisions, or the right to life with the opportunity to decide what risks they are willing to accept without externally imposed barriers. While patients clearly do not have a right to interventions that are dangerous or ineffective, it is less clear how much evidence of benefit is required to support a right to access. It is universally accepted that patients with decision-making capacity have an absolute right to refuse even life-saving interventions; this is a negative right, to be free from unwanted interference. There has been less written supporting the positive right to demand care, either routine care or novel therapies. This is a more difficult situation, as rather than limiting others actions, a positive right to care would compel others to act, possibly against their professional judgment. It is hard to envision this right as an absolute right, especially as it would mandate action from others, and therefore the right to innovative care may be restricted to meet patient safety or other societal concerns such as cost or resource allocation. Surgical innovation is crucial to the continued advancement of surgical care, and the ability to provide further improvements in care for future patients. These innovations must be undertaken in partnership with our current patients, recognizing the need for thorough ongoing informed consent coupled with appropriate oversight that is transparent regarding the limited data available on an innovative procedure and careful personal reflection, aiming to actively pursue innovations that are in the patients’ interests.
Further reading 1. National Commission for the Protection of Human Subjects. The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Research. DHEW Publications. (Publication No: OS78-0012). 2. Innovation versus research: guidelines, concepts and procedures for differentiation. The Clinical Investigation Policy and Procedure Manual. Boston: Boston Children’s Hospital; 2012, CIPP 081.015. 3. Kennedy D. Report on the Lasker Forum on Ethical Challenges in Biomedical Research and Practice. Washington: 2003. 4. Kastenberg Z, Dutta S. Guidelines for innovation in pediatric surgery. J Laparoendosc Adv Surg Tech A. 2011;21:371–374. 5. Schwartz J. Innovation in pediatric surgery: the surgical innovation continuum and the ETHICAL model. J Pediatr Surg. 2014;49:639–645. 6. Miller ME, Siegler M, Angelos P. Ethical issues in surgical innovation. World J Surg. 2014;38:1638–1643. 7. Riskin DJ, Longaker MT, Gertner M, Krummel TK. Innovation in surgery. a historical perspective. Ann Surg. 2006;244:686–693. 8. Lenihan JP. Navigating credentialing, privileging, and learning curves in robotics with an evidence and experienced-based approach. Clin Obstet Gynecol. 2011;54:382–390. 9. Jin LX, Ibrahim AM, Newman NA. Robotic surgery claims on United States hospital websites. J Healthc Qual. 2011;33:48–52. 10. Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet. 2009;374(9695):1097–1104. 11. Angelos P. Surgical ethics and the challenge of surgical innovation. Am J Surg. 2014;208(6):881–885. 12. Angelos P. Ethics and surgical innovation: challenges to the professionalism of surgeons. Int J Surg. 2013;11(suppl. 1):S2–S5. 13. Sagar SP, Law PW, Shaul RZ, et al. Hey, I just did a new operation! Introducing innovative procedures and devices within an academic health center. Ann Surg. 2015;261(1):30–31. 14. McKneally, MF, Daar AS, Introducing new technologies: protecting subjects of surgical innovation and research. World J Surg 2003;27:930–935. 15. Johnson J, Rogers W. Innovative surgery: the ethical challenges J Med Ethics. 2012;38:9–12. 16. Morreim H, Mack MJ, Sade RM. Surgical innovation: too risky to remain unregulated? Ann Thorac Surg. 2006;82:1957–1965. 17. Fins JJ. Surgical innovation and ethical dilemmas: precautions and proximity. Cleve Clin J Med. 2008;75:S7–S12. 18. Meyerson D. Is there a right to access innovative surgery? Bioethics. 2014, http://dx. doi.org/10.1111/bioe.12111.
