The Corporate Practice of Medicine: Ethical Implications of Orthopaedic Surgery Practice Ownership by Non-Physicians.

There has been an upsurge in the number of practices owned by non-physicians. With orthopaedic surgery as the next frontier in this market, orthopaedists need to consider the ethical consequences of such acquisitions. The history and trends of practice ownership are reviewed alongside how laws shifted to reflect a changing health-care climate. The 4 tenets of bioethics (beneficence, nonmaleficence, autonomy, and justice) are explored with regard to practice acquisition by non-physician entities. Although non-physician-owned corporations and private equity firms provide liquidity to the health-care sector, there are ethical concerns that may ultimately impact patient care. Orthopaedic surgeons must be cautious when engaging in acquisitions with non-physician-owned entities, as the goals of each party may not align. This may yield situations that infringe on the basic principles of bioethics for both physician and patient.

The Intersection of Hand Surgery Practice and Industry.

This article focuses on the working relationship between practicing hand surgeons and company representatives. The basic job of reps is to influence surgeon behavior to use their products. Surgeons must make certain that nothing of value is received in a quid pro quo for using industry products. Physicians have an ethical obligation to only use industry devices that are in the best interests of their patients. Hand surgeons may become involved in product development and thereby come into contact with industry. Several key steps are required to protect any intellectual property surgeons develop in their interactions with industry.

The Role of Gender, Academic Affiliation, and Subspecialty in Relation to Industry Payments to Orthopaedic Surgeons.

BACKGROUND: The Physician-Payments-Sunshine-Act (PPSA) was introduced in 2010 to provide transparency regarding physician-industry payments by making these payments publicly available. Given potential ethical implications, it is important to understand how these payments are being distributed, particularly as the women orthopaedic workforce increases. The purpose of this study was thus to determine the role of gender and academic affiliation in relation to industry payments within the orthopaedic subspecialties. METHODS: The PPSA website was used to abstract industry payments to Orthopaedic surgeons. The internet was then queried to identify each surgeon's professional listing and gender. Mann-Whitney U, Chi-square tests, and multivariable regression were used to explore the relationships. Significance was set at a value of P < 0.05. RESULTS: In total, 22,352 orthopaedic surgeons were included in the study. Payments were compared between 21,053 men and 1299 women, 2756 academic and 19,596 community surgeons, and across orthopaedic subspecialties. Women surgeons received smaller research and non-research payments than men (both, P < 0.001). There was a larger percentage of women in academics than men (15.9% vs 12.1%, P < 0.001). Subspecialties with a higher percentage of women (Foot & Ankle, Hand, and Pediatrics) were also the subspecialties with the lowest mean industry payments (all P < 0.001). Academic surgeons on average, received larger research and non-research industry payments, than community surgeons (both, P < 0.001). Multivariable linear regression demonstrated that male gender (P = 0.006, P = 0.029), adult reconstruction (both, P < 0.001) and spine (P = 0.008, P < 0.001) subspecialties, and academic rank (both, P < 0.001) were independent predictors of larger industry research and non-research payments. CONCLUSIONS: A large proportion of the US orthopaedic surgeon workforce received industry payments in 2014. Academic surgeons received larger payments than community surgeons. Despite having a larger percentage of surgeons in academia, women surgeons received lower payments than their male counterparts. Women also had a larger representation in the subspecialties with the lowest payments.

Disclosures Undisclosed.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) Open Payments public database, resulting from the Physician Payments Sunshine Act of 2010, was designed to increase transparency of physicians' financial relationships with pharmaceutical manufacturers. We compared physician-reported conflict-of-interest (COI) disclosures in journal articles with this database to determine any discrepancies in physician-reported disclosures. METHODS: COIs reported by authors from 2014 through 2016 were analyzed in 3 journals: Foot & Ankle International (FAI), The Journal of Bone & Joint Surgery (JBJS), and The Journal of Arthroplasty (JOA). Payment information in the CMS Open Payments database was cross-referenced with each author's disclosure statement to determine if a disclosure discrepancy was present. RESULTS: We reviewed 3,465 authorship positions (1,932 unique authors) in 1,770 articles. Within this sample, 7.1% of authorships had a recorded undisclosed COI (disclosure discrepancy), and 13.2% of articles had first and/or last authors with a disclosure discrepancy. Additionally, we saw a great variation in the percentage of authorships with disclosure discrepancies among the journals (JBJS, 2.3%; JOA, 3.6%; and FAI, 23.7%). CONCLUSIONS: Discrepancies exist between payment disclosures made by authors and those published in the CMS Open Payments database. Although the percentage of articles with these discrepancies varies widely among the journals that were analyzed in this study, no trend was found when analyzing the number of discrepancies over the 3-year period. CLINICAL RELEVANCE: COI disclosures are important for the interpretation of study results and need to be accurately reported. However, COI disclosure criteria vary among orthopaedic journals, causing uncertainty regarding which conflicts should be disclosed.

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.

Why do surgeons receive more complaints than their physician peers?

BACKGROUND: Compared with other doctors, surgeons are at an increased risk of medicolegal events, including patient complaints and negligence claims. This retrospective study aimed to describe the frequency and nature of complaints involving surgeons compared with physicians. METHODS: We assembled a national data set of complaints about surgeons and physicians lodged with medical regulators in Australia from 2011 to 2016. We classified the complaints into 19 issues across four domains: treatment and procedures, other performance, professional conduct and health. We assessed differences in complaint risk using incidence rate ratios (IRRs). Finally, we used a multivariate model to identify predictors of complaints among surgeons. RESULTS: The rate of complaints was 2.3 times higher for surgeons than physicians (112 compared with 48 complaints per 1000 practice years, P < 0.001). Two-fifths (41%) of the higher rate of complaints among surgeons was attributable to issues other than treatments and procedures, including fees (IRR = 2.68), substance use (IRR = 2.10), communication (IRR = 1.98) and interpersonal behaviour (IRR = 1.92). Male surgeons were at a higher risk of complaints, as were specialists in orthopaedics, plastic surgery and neurosurgery. DISCUSSION: Surgeons are more than twice as likely to attract complaints as their physician peers. This elevated risk arises partly from involvement in surgical procedures and treatments, but also reflects wider concerns about interpersonal skills, professional ethics and substance use. Improved understanding of these patterns may assist efforts to reduce harm and support safe practise.

Potential Financial Conflict of Interest Among Physician Editorial Board Members of Orthopaedic Surgery Journals.

BACKGROUND: The practice of medicine is based on evidence from peer-reviewed literature. As can occur with author-related funding, the integrity of the process by which manuscripts are reviewed, edited, and approved for publication may be at risk due to financial conflict of interest. The purpose of our study was to assess potential financial conflict of interest among physician editorial board members of orthopaedic surgery journals. METHODS: We identified the physician editorial board members of 15 orthopaedic surgery journals and searched the 2014 payments that were archived in the Centers for Medicare & Medicaid Services Open Payments system (mandated by the Physician Payments Sunshine Act). Total dollar values were calculated and tabulated in a multilevel fashion: nothing reported, >$0 and ≤$10,000, >$10,000, >$250,000, and >$950,000. RESULTS: We identified 908 physician editors of 15 orthopaedic surgery journals. Something of financial value was received by 78% (712 of 908) of these individuals. Rates of editorial board potential financial conflict of interest for individual journals ranged from 4% to 73% in the >$10,000 category. At the >$250,000 mark, rates ranged from 0% (2 journals) to 31%. When applying the >$950,000 criterion, physician potential conflict of interest ranged from 0% (5 journals) to 13%. CONCLUSIONS: Editor-related potential financial conflicts of interest exist in the orthopaedic surgery journals that we analyzed. These potential financial conflicts could possibly impact reviews.

P-Hacking in Orthopaedic Literature: A Twist to the Tail.

BACKGROUND: "P-hacking" occurs when researchers preferentially select data or statistical analyses until nonsignificant results become significant. We wanted to evaluate if the phenomenon of p-hacking was evident in orthopaedic literature. METHODS: We text-mined through all articles published in three top orthopaedic journals in 2015. For anonymity, we cipher-coded the three journals. We included all studies that reported a single p value to answer their main hypothesis. These p values were then charted and frequency graphs were generated to illustrate any evidence of p-hacking. Binomial tests were employed to look for evidence of evidential value and significance of p-hacking. RESULTS: Frequency plots for all three journals revealed evidence of p-hacking. Binomial tests for all three journals were significant for evidence of evidential value (p < 0.0001 for all). However, the binomial test for p-hacking was significant only for one journal (p = 0.0092). CONCLUSIONS: P-hacking is an evolving phenomenon that threatens to jeopardize the evidence-based practice of medicine. Although our results show that there is good evidential value for orthopaedic literature published in our top journals, there is some evidence of p-hacking of which authors and readers should be wary.

[Not Available]. / Il consenso informato in Terapia Occupazionale: proposta di una modulistica.

UNLABELLED: The legislative developments that led to the Three-year Degree of the Health Professions poses any health professional in the position of having to comply with the ethical and legal duty to obtain valid informed consent from the patient prior to treatment. In the present work, attention was focused on the figure of the occupational therapist. MATERIALS AND METHODS: Informed consent forms have been developed according to the specific disease from which the patient undergoing occupational therapy is affected. The following categories of sick were identified: amputation, developmental age, orthopedy, spinal cord injury, neurology, psychiatry, geriatry and oncology. RESULTS AND CONCLUSION: The consent forms are particularly well suited to obtaining valid consent from the patient and, at the same time, allow the occupational therapist to obtain all the information he/she needs to carry out the treatment in safety. This results improved patient compliance to therapy by facilitating a better empathic relationship with the therapist.

Patient Attitudes Toward Orthopedic Surgeon Ownership of Related Ancillary Businesses.

BACKGROUND: Physician ownership of businesses related to orthopedic surgery, such as surgery centers, has been criticized as potentially leading to misuse of health care resources. The purpose of this study was to determine patients' attitudes toward surgeon ownership of orthopedic-related businesses. METHODS: We surveyed 280 consecutive patients at 2 centers regarding their attitudes toward surgeon ownership of orthopedic-related businesses using an anonymous questionnaire. Three surgeon ownership scenarios were presented: (1) owning a surgery center, (2) physical therapy (PT), and (3) imaging facilities (eg, Magnetic Resonance Imaging scanner). RESULTS: Two hundred fourteen patients (76%) completed the questionnaire. The majority agreed that it is ethical for a surgeon to own a surgery center (73%), PT practice (77%), or imaging facility (77%). Most (>67%) indicated that their surgeon owning such a business would have no effect on the trust they have in their surgeon. Although >70% agreed that a surgeon in all 3 scenarios would make the same treatment decisions, many agreed that such surgeons might perform more surgery (47%), refer more patients to PT (61%), or order more imaging (58%). Patients favored surgeon autonomy, however, believing that surgeons should be allowed to own such businesses (78%). Eighty-five percent agreed that patients should be informed if their surgeon owns an orthopedic-related business. CONCLUSION: Although patients express concern over and desire disclosure of surgeon ownership of orthopedic-related businesses, the majority believes that it is an ethical practice and feel comfortable receiving care at such a facility.

Moral Dilemmas in Pediatric Orthopedics.

All orthopedic surgeons face moral dilemmas on a regular basis; however, little has been written about the moral dilemmas that are encountered when providing orthopedic care to pediatric patients and their families. This article aims to provide surgeons with a better understanding of how bioethics and professionalism apply to the care of their pediatric patients. First, several foundational concepts of both bioethics and professionalism are summarized, and definitions are offered for 16 important terms within the disciplines. Next, some of the unique aspects of pediatric orthopedics as a subspecialty are reviewed before engaging in a discussion of 5 common moral dilemmas within the field. Those dilemmas include the following: (1) obtaining informed consent and assent for either surgery or research from pediatric patients and their families; (2) performing cosmetic surgery on pediatric patients; (3) caring for pediatric patients with cognitive or physical impairments; (4) caring for injured pediatric athletes; and (5) meeting the demand for pediatric orthopedic care in the United States. Pertinent considerations are reviewed for each of these 5 moral dilemmas, thereby better preparing surgeons for principled moral decision making in their own practices. Each of these dilemmas is inherently complex with few straightforward answers; however, orthopedic surgeons have an obligation to take the lead and better define these kinds of difficult issues within their field. The lives of pediatric patients and their families will be immeasurably improved as a result.

Oral information in orthopaedics: how should the patient's understanding be assessed?

INTRODUCTION: Patient information is governed by recommendations of best practices required from any healthcare professional. The aim of this study was to design a tool to measure patient comprehension of the information provided during a surgical consultation before a scheduled surgery. MATERIAL AND METHODS: This was a single-center prospective study of 21 patients using a rating scale-type visual analog scale. Each patient was interviewed and asked to score his or her understanding of the information provided. The investigator checked the external validity of the tool using questions to assess patient's understanding level. RESULTS: The results show that there is a tendency to overvalue some information (reasons for the intervention and alternatives to surgery) and that certain information is not understood (risks and complications) or not provided (postoperative follow-up). CONCLUSION: This study confirms that a rating scale can measure the understanding of information and there is a variation between perceived and actual understanding.

How do you know it is true? Integrity in research and publications: AOA critical issues.

High-quality medical care is the result of clinical decisions based upon scientific principles garnered from basic, translational, and clinical research. Information regarding the natural history of diseases and their responses to various treatments is introduced into the medical literature through the approximately one million PubMed journal articles published each year. Pharmaceutical and device companies, universities, departments, and researchers all stand to gain from research publication. Basic and translational research is highly competitive. Success in obtaining research funding and career advancement requires scientific publication in the medical literature. Clinical research findings can lead to changes in the pattern of orthopaedic practice and have implications for the utilization of pharmaceuticals and orthopaedic devices. Research findings can be biased by ownership of patents and materials, funding sources, and consulting arrangements. The current high-stakes research environment has been characterized by an increase in plagiarism, falsification or manipulation of data, selected presentation of results, research bias, and inappropriate statistical analyses. It is the responsibility of the orthopaedic community to work collaboratively with industry, universities, departments, and medical researchers and educators to ensure the integrity of the content of the orthopaedic literature and to enable the incorporation of best practices in the care of orthopaedic patients.