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.

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.

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.

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.

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.

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.

Recognizing conflict of interest in orthopaedic surgery: a survey across medical education levels.

The relationship between pharmaceutical and biomedical technology companies (industry) and medical practitioners has been a topic of discussion and concern for several decades. The large monetary payments and extravagant gifts to physicians from these companies have been regulated and largely stopped; however, there still exists an active rapport between physicians and industry. Little formal instruction is given to medical students and residents on what constitutes a conflict of interest when entering these business partnerships. In this study, we presented a set of scenarios depicting industry-physician interactions to medical students, orthopaedic surgery residents, and attending physicians and asked them to decide whether a conflict of interest is depicted. Our goal was to determine whether a disparity exists in the ability to identify conflicts of interest across the levels of training. Of 200 potential participants, 70 provided responses to the survey (35%). Thirty-five (50%) were attending physicians, 18 (25.7%) residents, 12 (17.1%) medical students, and 8 (11.4%) declined to provide level of training. There was no significant difference in the ability to identify a conflict of interest across seniority level for the 13 questions. Our results suggest that both medical students and resident physicians are able to identify which interactions with industry pose a possible conflict of interest as accurately as attending physicians can.

Evaluating the extent of clinical uncertainty among treatment options for patients with early-onset scoliosis.

BACKGROUND: Literature guiding the management of early-onset scoliosis consists primarily of studies with a low level of evidence. Evaluation of clinical equipoise (i.e., when there is no known superiority among treatment modalities) allows for prioritization of research efforts. The objective of this study was to evaluate areas of clinical uncertainty among pediatric spine surgeons regarding the treatment of early-onset scoliosis. METHODS: Fourteen experienced pediatric spine surgeons participated in semistructured interviews to identify clinical variables that influence decision making in the treatment of early-onset scoliosis. A series of case scenarios of 315 patients with idiopathic and neuromuscular early-onset scoliosis was then developed to be representative of those encountered in clinical practice. Using an online survey, eleven surgeons selected their choice of eight treatment options for each case scenario. Associations between case characteristics and treatment choices were assessed with chi-square and logistic regression analysis. Participants then reviewed the areas of treatment uncertainty identified in the survey, nominated additional research questions of interest, and ranked their interest to further explore the identified research questions. RESULTS: Collective equipoise was identified in numerous scenarios in the survey spanning a range of ages and magnitudes of scoliosis, and additional questions were identified during the nominal group technique. Areas that had the greatest clinical uncertainty included the management of patients who have finished treatment with a growing-rod, timing of rod-lengthening intervals, and indications for spine-based and rib-based proximal instrumentation anchors. The use of rib anchors compared with spine-based anchors was ranked highly for consideration in future clinical trials. CONCLUSIONS: Variability in decision making with regard to the optimum treatment of certain subsets of patients with early-onset scoliosis reflects gaps in the available evidence. Structured consensus methods identified priorities for higher levels of research in this area of scoliosis. Higher-level studies, including randomized trials, should focus on answering the questions highlighted in this report.