Synthesis of the 19th ArgoSpine Symposium.

After a short introduction of the meeting by the President 2015, Wilco Peul, the opening lecture was delivered by Bart Koes, who dealt with Health Technology Assessment and Guidelines. Then, it was the turn of Carmen Vleggert to show whether there was any Evidence for the Use of Implants in Spinal Stenosis. The final presentation of this session was delivered by Björn Strömqvist who dealt with Surgery for Lumbar Disc Herniation, patients' selection and outcomes. Developing the subject of "Do Not's", Jeremy Fairbank described the UK experience for Low Back Pain. Yves Coppens then took over and further elaborated on "Lucy's legacy". Prof. Coppens recalled that Lucy is a partial skeleton of a pre-human found in Ethiopia among other remains. Prof. Alan Crockard offered what he called "a whimsical view" of his practice of Craniocervical Surgery. Wafa Skalli was asked to speak about Finite Element Analysis of the Spine and Arts et Métiers Paris Tech where there is a long tradition of close collaboration between engineers and clinicians. Rune Hedlund, who will serve as 2016 Symposium President, further elaborated on Scoliosis with a focus on Unsolved Issues in Adolescent Idiopathic Scoliosis Treatment.

A survey of healthcare industry representatives' participation in surgery: some new ethical concerns.

OBJECTIVE: To provide preliminary evidence of the types and amount of involvement by healthcare industry representatives (HCIRs) in surgery, as well as the ethical concerns of those representatives. METHODS: A link to an anonymous, web-based survey was posted on several medical device boards of the website http://www. cafepharma.com. Additionally, members of two different medical device groups on LinkedIn were asked to participate. Respondents were self-identified HCIRs in the fields of orthopedics, cardiology, endoscopic devices, lasers, general surgery, ophthalmic surgery, oral surgery, anesthesia products, and urologic surgery. RESULTS: A total of 43 HCIRs replied to the survey over a period of one year: 35 men and eight women. Respondents reported attending an average of 184 surgeries in the prior year and had an average of 17 years as an HCIR and six years with their current employer. Of the respondents, 21 percent (nine of 43) had direct physical contact with a surgical team or patient during a surgery, and 88 percent (38 of 43) provided verbal instruction to a surgical team during a surgery. Additionally, 37 percent (16 of 43) had participated in a surgery in which they felt that their involvement was excessive, and 40 percent (17 of 43) had attended a surgery in which they questioned the competence of the surgeon. CONCLUSIONS: HCIRs play a significant role in surgery. Involvement that exceeds their defined role, however, can raise serious ethical and legal questions for surgeons and surgical teams. Surgical teams may at times be substituting the knowledge of the HCIR for their own competence with a medical device or instrument. In some cases, contact with the surgical team or patient may violate the guidelines not only of hospitals and medical device companies, but the law as well. Further study is required to determine if the patients involved have any knowledge or understanding of the role that an HCIR played in their surgery.

Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland.

There should be protocol-driven, fast-track admission of patients with hip fractures through the emergency department. Patients with hip fractures require multidisciplinary care, led by orthogeriatricians. Surgery is the best analgesic for hip fractures. Surgical repair of hip fractures should occur within 48 hours of hospital admission. Surgery and anaesthesia must be undertaken by appropriately experienced surgeons and anaesthetists. There must be high-quality communication between clinicians and allied health professionals. Early mobilisation is a key part of the management of patients with hip fractures. Pre-operative management should include consideration of planning for discharge from hospital. Measures should be taken to prevent secondary falls. 10. Continuous audit and targeted research is required in order to inform and improve the management of patients with hip fracture.

Conflicts of interest with the hand surgeon's relationship with industry.

Many advances in hand surgery have been supported and enabled by the integral relationship that exists between the profession of hand surgery and industry. This relationship takes many forms, including medical education, development of new technology and methodology, research, and opportunities for patient education. As with all of these endeavors, the primary focus of both the physician and industry must be the care of the patient. When a collaborative relationship exists between physicians and industry, a conflict of interest is present and must be recognized as such and managed to avoid any detriment to patient care. Although the hand surgeon, the patient, and industry share the common interest of advancement of patient care, there does exist real and potential conflicts of interest, which are unavoidable, but not necessarily undesirable. Multiple guidelines exist to govern relationships between industry and physicians. The cooperative relationship between the physician and industry is not only helpful, but it can be critical to the advancement of and innovations in patient care. When properly managed, collaboration between the physician and industry can effectively achieve the common goal of serving the best interest of the patient.

How do medical device manufacturers' websites frame the value of health innovation? An empirical ethics analysis of five Canadian innovations.

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology's promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate "value proposition" of their innovation and seek to respond to what they consider the key expectations of their customers. Our analysis shows that the manufacturers' framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians' and patients' expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others.

Restarting Orthopaedic Care in a Pandemic: Ethical Framework and Case Examples.

The question about how to resume typical orthopaedic care during a pandemic, such as coronavirus disease 2019, should be framed not only as a logistic or safety question but also as an ethical question. The current published guidelines from surgical societies do not explicitly address ethical dilemmas, such as why public health ethics requires a cessation of nonemergency surgery or how to fairly allocate limited resources for delayed surgical care. We propose ethical guidance for the resumption of care on the basis of public health ethics with a focus on clinical equipoise, triage tiers, and flexibility. We then provide orthopaedic surgery examples to guide physicians in the ethical resumption of care.

A Bioethical Perspective for Navigating Moral Dilemmas Amidst the COVID-19 Pandemic.

The Coronavirus disease 2019 pandemic has been an unprecedented challenge to healthcare systems and clinicians around the globe. As the virus has spread, critical questions arose about how to best deliver health care in emergency situations where material and personnel resources become scarce. Clinicians who excel at caring for the individual patient at the bedside are now being reoriented into a system where they are being asked to see the collective public as their responsibility. As such, the clinical ethics that clinicians are accustomed to practicing are being modified by a framework of public health ethics defined by the presence of a global pandemic. There are many unknowns about Coronavirus disease 2019, which makes it difficult to provide consistent recommendations and guidelines that uniformly apply to all situations. This lack of consensus leads to the clinicians' confusion and distress. Real-life dilemmas about how to allocate resources and provide care in hotspot cities make explicit the need for careful ethical analysis, but the need runs far deeper than that; even when not trading some lives against others, the responsibilities of both individual clinicians and the broader healthcare system are changing in the face of this crisis.

Ethical Implications of Resuming Elective Orthopedic Surgery During the COVID-19 Pandemic.

The COVID-19 pandemic has had unprecedented impact on the United States health care system. One of the consider-ations was the decision to halt elective orthopedic surgery to preserve consumption of scarce resources. However, as the number of COVID-19 cases decrease, there will be discus-sions regarding the modality of resuming elective orthopedic surgery. Ethical considerations will come to the forefront in terms of determining the best course of action, patient selection, resource rationing, and financial implications. These factors will be examined through the lens of the four tenets of bioethics, beneficence, maleficence, autonomy, and justice, to elucidate the best approach in ethically manag-ing elective orthopedic surgery during a global pandemic.

Scoliosis repair in a teenager with Duchenne's muscular dystrophy: who calls the shots?

In this exchange, a clinician (the first author) presents a case scenario for comment by an ethicist (the second author). The case concerns a 15-year-old boy with Duchenne's muscular dystrophy requested palliative surgical correction of a 60 degree thoraco-lumbar scoliosis. The surgical team were initially reluctant to offer surgery given their assessment of the perioperative and postoperative risks (anesthetic review suggested an 80% chance of surviving the surgery and 50% likelihood of returning home), but the operation proceeded. The case raises issues of the rights of patients to insist on nonfutile but high risk surgery, risk perception, resource allocation, autonomy, and the integrity of clinicians.

Informed consent in spinal surgery.

Informed consent is a very important part of surgical treatment. In this paper, we report a number of legal judgements in spinal surgery where there was no criticism of the surgical procedure itself. The fault that was identified was a failure to inform the patient of alternatives to, and material risks of, surgery, or overemphasizing the benefits of surgery. In one case, there was a promise that a specific surgeon was to perform the operation, which did not ensue. All of the faults in these cases were faults purely of the consenting process. In many cases, the surgeon claimed to have explained certain risks to the patient but was unable to provide proof of doing so. We propose a checklist that, if followed, would ensure that the surgeon would take their patients through the relevant matters but also, crucially, would act as strong evidence in any future court proceedings that the appropriate discussions had taken place. Although this article focuses on spinal surgery, the principles and messages are applicable to the whole of orthopaedic surgery. Cite this article: Bone Joint J 2019;101-B:355-360.

Regenerative Medicine in Orthopaedics and Trauma: Challenges, Regulation and Ethical Issues.

The ability of stem cells to self-renew and differentiate into cell types of different lineages forms the basis of regenerative medicine, which focuses on repairing or regenerating damaged or diseased tissues. This has a huge potential to revolutionize medicine. It is anticipated that in future, stem cell therapy will be able to restore function in all major organs. Intensive research has been on-going to bring stem cell therapy from bench to bedside as it holds promise of widespread applications in different areas of medicine. This is also applicable to orthopaedics, where stem cell transplantation could benefit complications like spinal cord injury, critical bone defects, cartilage repair or degenerative disc disorders. Stem cell therapy has a potential to change the field of orthopaedics from surgical replacements and reconstructions to a field of regeneration and prevention. This article summarizes advances in stem cell applications in orthopaedics as well as discussing regulation and ethical issues related to the use of stem cells.

Overlapping and Concurrent Surgery: A Professional and Ethical Analysis.

Overlapping and concurrent surgeries form a continuum of simultaneous surgical practice in which a single surgeon has 2 or more patients in operating rooms at the same time. Undeniably, in an acute life-or-limb-threatening presentation, it may be essential for a surgeon to care for 2 individual patients simultaneously. These situations are different from scheduled elective surgery. Concurrent surgery is defined as the attending surgeon not being present for "critical and key" portions of a procedure. Billing for concurrent surgical procedures is a violation of the U.S. Centers for Medicare & Medicaid Services guidelines. The American College of Surgeons Statement of Principles (April 2016), adopted by the American Academy of Orthopaedic Surgeons, judges the practice of concurrent surgery to be "inappropriate." Overlapping surgery, although permissible under regulatory guidelines in the United States, presents substantial professional, bioethical, and legal concerns, and threatens our obligation as orthopaedic surgeons to respect the primacy of patient welfare and an individual's autonomy.

Randomized surgical trials and "sham" surgery: relevance to modern orthopaedics and minimally invasive surgery.

Surgical techniques are constantly changing and evolving, though research trials supporting the value of a specific surgical intervention are often limited by the lack of a legitimate control group. In surgical trials, the use of a placebo, or a "sham" surgery, is controversial. This article explores the debate regarding the use of sham surgeries and summarizes the few surgical studies that have used them. Arguments for and against their use in research are presented.

Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives.

BACKGROUND: Industry payments to surgeons have received public attention, but little is known about the relationships between surgeons and medical device representatives. Medical device representatives ("device reps") have become an integral part of operating room personnel. The effect of their presence on patient care deserves discussion. STUDY DESIGN: We conducted a qualitative, ethnographic study to explore relationships between surgeons and medical device representatives, and characterize industry involvement in the training of surgeons. We used group and individual open-ended interviews to gain insight into the beliefs, values, and perspectives of surgeons and device reps. We conducted two focus groups, one with ear, nose, and throat surgeons, and one with hospital-based attending orthopedic surgeons. We also conducted individual interviews with three former or current medical device representatives, a director of a surgical residency program at an academic medical center, and a medical assistant for a multi-physician orthopedic practice. RESULTS: While surgeons view themselves as indisputably in charge, device reps work hard to make themselves unobtrusively indispensable in order to establish and maintain influence, and to imbue the products they provide with personalized services that foster a surgeon's loyalty to the reps and their companies. Surgeons view industry-funded training opportunities as a necessary service. Device reps and some surgeons believe that reps benefit patient care, by increasing efficiency and mitigating deficiencies among operating room personnel (including the surgeons themselves). CONCLUSIONS: Our study raises ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel.