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.

Are the Lives of Animals Well-spent in Laboratory Science Research? A Study of Orthopaedic Animal Studies in Turkey.

BACKGROUND: As in all fields of medicine, animal studies are widely performed in orthopaedics and have increased in number over time. However, it is not clear to what extent these studies provide a basis for future research or advancements in clinical science. Concerns about the reliability and translational ability of animal studies have been reported, and major orthopaedic journals and organizations are encouraging the reduction of unnecessary experiments on animals. QUESTION/PURPOSES: (1) What proportion of animal studies conducted for orthopaedic research in Turkey were never published? And of those that were published, how long did it take to publish? (2) What proportion of those studies were published in journals with an Impact Factor of 2 or more? (3) What proportion of those published papers were never cited or cited only once? (4) What was the contribution to science of an animal euthanized for orthopaedic research in Turkey? METHODS: We reviewed all oral and poster presentations at the Turkish National Congress of Orthopaedics and Traumatology from 2009 to 2017 (retrieved from the archives of Acta Orthopaedica et Traumatologica Turcica), as well as all postgraduate theses in orthopaedics from 1991 to 2017 (retrieved from the archives of the National Thesis Center of the Council of Higher Education) to identify all orthopaedic studies that involved animals. We searched the keywords "animal studies," "experimental studies," and "orthopaedics" in these archives. We defined animal research as orthopaedic studies based on animal models. From this search and using that definition, 252 studies were identified. Of those, 4% (9) were excluded as they were thesis studies with no abstract in the archives. Thus, a total of 243 animal studies performed in Turkey were included for analysis in this retrospective study. The abstracts of these studies were examined to determine the study model (such as bone fracture models, tendon healing models, cartilage models) and number of euthanized animals. Between 1991 and 2017, 9412 vertebrate animals were euthanized for these studies. We searched PubMed, Google Scholar, ResearchGate, and ORCID to determine whether these papers were subsequently published, in which journal, and how long after the initial presentation publication occurred. The Web of Science 2019 database was used to determine the Impact Factor of the journals, the total citation count of each study, and the mean annual citation for each study (citations per year). For purposes of this analysis, we divided journals into those with an Impact Factor of 2 or more, 4 or more, and those with an Impact Factor below 2. The mean annual citation per euthanized animal (citations per animal per year) was calculated to determine the contribution of a euthanized animal to science. RESULTS: A total of 42% (101 of 243) of the animal studies in Turkey were never published. For all published studies, the mean time to publication was 2.2 ± 2.6 years (95% CI 1.7 to 2.6). The proportion of studies published in orthopaedic journals with an Impact Factor of 2 or more was 14% (34 of 243). Among the 142 published papers, 38% (54) were either never cited or were cited only once, and the mean citations per year was 1.1 ± 1.7 (95% CI 0.7 to 1.3). The mean citations per animal/year among the 142 published studies was 0.03 ± 0.04 (95% CI 0.02 to 0.04). CONCLUSION: In the 243 theses and national congress presentations, 9412 animals were euthanized. Based on the low percentage of papers using animals that were euthanized and the very low proportion of studies published in higher-Impact Factor journals or garnering more than a single citation, in aggregate, little seems to have been gained from the loss of animal life. Future studies should try to replicate or refute our results in other countries. CLINICAL RELEVANCE: Orthopaedic researchers should try to reduce their use of unnecessary animal studies, for example, by reporting on the use of the "3Rs" (replacement, reduction, and refinement) in the development of an animal study design, as well as through following universal guidelines so that a study might have a clinical impact. Researchers should not conduct an animal study until they are convinced that the expected results are quite likely to deliver substantial benefit to people or to advance science in a meaningful way; although this seems intuitive, our results suggest that this may not be taking place. Ethics committees in Turkey should consider more detailed questioning before approving animal studies. If our results are replicated elsewhere, then a broader look at how these approvals are conducted should be performed.

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.

Depression and Non-modifiable Patient Factors Associated with Patient Satisfaction in an Academic Orthopaedic Outpatient Clinic: Is it More Than a Provider Issue?

BACKGROUND: Patient satisfaction surveys play an increasingly important role in United States healthcare policy and serve as a marker of provided physician services. In attempts to improve the patient's clinical experience, focus is often placed on components of the healthcare system such as provider interaction and other experiential factors. Patient factors are often written off as "non-modifiable"; however, by identifying and understanding these risk factors for dissatisfaction, another area for improvement and intervention becomes available. QUESTIONS/PURPOSES: (1) Do patients in the orthopaedic clinic with a preexisting diagnosis of depression report lower satisfaction scores than those without a preexisting diagnosis of depression? (2) What other non-modifiable patient factors influence patient-reported satisfaction? METHODS: We reviewed Press Ganey Survey scores, which assess patient experiential satisfaction with a single clinical encounter, from 3044 clinic visits (2527 patients) in adult reconstructive, sports, and general orthopaedic clinics at a single academic medical center between November 2010 and May 2017, during which time approximately 19,000 encounters occurred. Multiple patient factors including patient age, gender, race, health insurance status, number of previous clinic visits with their physician, BMI, and a diagnosis of depression were recorded. Patient satisfaction was operationalized as a binary outcome as satisfied or less satisfied, and a multiple logistic regression analysis was used to estimate the odds of being satisfied. RESULTS: After adjusting for all other covariates in the model, we found that patients with a diagnosis of depression were less likely to be satisfied than patients without this diagnosis (odds ratio 0.749 [95% confidence interval, 0.600-0.940]; p = 0.01). Medicare-insured patients were more likely to be satisfied than non-Medicare patients (OR 1.257 [95% CI, 1.020-1.549]; p = 0.03), patients in the sports medicine clinic were more likely to be satisfied than those seen in the general orthopaedic clinic (OR 1.397 [95% CI, 1.096-1.775]; p = 0.007), and established patients were more likely to be satisfied than new patients (OR 0.763 [95% CI, 0.646-0.902]; p = 0.002). CONCLUSIONS: Given the association of depression with lower satisfaction with a single visit at the orthopaedic clinic, providers should screen for depression and address the issue during the outpatient encounter. The impact of such comprehensive care or subsequent treatment of depression on improving patient-reported satisfaction offers areas of future study. LEVEL OF EVIDENCE: Level III, therapeutic study.

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.

Informed consent in orthopaedics: do patients in the United Kingdom understand the written information we provide?

Aims: Informed patient consent is a legal prerequisite endorsed by multiple regulatory institutions including the Royal College of Surgeons and the General Medical Council. It is also recommended that the provision of written information is available and may take the form of a Patient Information Leaflet (PIL) with multiple PILs available from leading orthopaedic institutions. PILs may empower the patient, improve compliance, and improve the patient experience. The national reading age in the United Kingdom is less than 12 years and therefore PILs should be written at a readability level not exceeding 12 years old. We aim to assess the readability of PILs currently provided by United Kingdom orthopaedic institutions. Patients and Methods: The readability of PILs on 58 common conditions provided by seven leading orthopaedic associations in January 2017, including the British Orthopaedic Association, British Hip Society, and the British Association of Spinal Surgeons, was assessed. All text in each PIL was analyzed using readability scores including the Flesch-Kincaid Grade Level (FKGL) and the Simple Measure of Gobbledygook (SMOG) test. Results: The mean FKGL was 10.4 (6.7 to 17.0), indicating a mean reading age of 15 years. The mean SMOG score was 12.8 (9.7 to 17.9) indicating a mean reading age of 17 years. Conclusion: Orthopaedic-related PILs do not comply with the recommended reading age, with some requiring graduate-level reading ability. Patients do not have access to appropriate orthopaedic-related PILs. Current publicly available PILs require further review to promote patient education and informed consent. Cite this article: Bone Joint J 2018;100-B:1253-9.

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.