Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Surgical Residents' Perspective on Informed Consent-How Does It Compare With Attending Surgeons?

BACKGROUND: The informed consent discussion (ICD) is a compulsory element of clinical practice. Surgical residents are often tasked with obtaining informed consent, but formal instruction is not included in standard curricula. This study aims to examine attitudes of surgeons and residents concerning ICD. MATERIALS AND METHODS: A survey regarding ICD was administered to residents and attending surgeons at an academic medical center with an Accreditation Council for Graduate Medical Education-accredited general surgery residency. RESULTS: In total, 44 of 64 (68.75%) residents and 37 of 50 (72%) attending surgeons participated. Most residents felt comfortable consenting for elective (93%) and emergent (82%) cases, but attending surgeons were less comfortable with resident-led ICD (51% elective, 73% emergent). Resident comfort increased with postgraduate year (PGY) (PGY1 = 39%, PGY5 = 85%). A majority of participants (80% attending surgeons, 73% residents) believed resident ICD skills should be formally evaluated, and most residents in PGY1 (61%) requested formal instruction. High percentages of residents (86%) and attendings (100%) believed that ICD skills were best learned from direct observation of attending surgeons. CONCLUSIONS: Resident comfort with ICD increases as residents advance through training. Residents acknowledge the importance of their participation in this process, and in particular, junior residents believe formal instruction is important. Attending surgeons are not universally comfortable with resident-led ICDs, particularly for elective surgeries. Efforts for improving ICD education including direct observation between attending surgeons and residents and formal evaluation may benefit the residency curriculum.

Neuroenhancement in surgeons: benefits, risks and ethical dilemmas.

BACKGROUND: Surgeons traditionally aim to reduce mistakes in healthcare through repeated training and advancement of surgical technology. Recently, performance-enhancing interventions such as neurostimulation are emerging which may offset errors in surgical practice. METHODS: Use of transcranial direct-current stimulation (tDCS), a novel neuroenhancement technique that has been applied to surgeons to improve surgical technical performance, was reviewed. Evidence supporting tDCS improvements in motor and cognitive performance outside of the field of surgery was assessed and correlated with emerging research investigating tDCS in the surgical setting and potential applications to wider aspects of healthcare. Ethical considerations and future implications of using tDCS in surgical training and perioperatively are also discussed. RESULTS: Outside of surgery, tDCS studies demonstrate improved motor performance with regards to reaction time, task completion, strength and fatigue, while also suggesting enhanced cognitive function through multitasking, vigilance and attention assessments. In surgery, current research has demonstrated improved performance in open knot-tying, laparoscopic and robotic skills while also offsetting subjective temporal demands. However, a number of ethical issues arise from the potential application of tDCS in surgery in the form of safety, coercion, distributive justice and fairness, all of which must be considered prior to implementation. CONCLUSION: Neuroenhancement may improve motor and cognitive skills in healthcare professions with impact on patient safety. Implementation will require accurate protocols and regulations to balance benefits with the associated ethical dilemmas, and to direct safe use for clinicians and patients.

ANTECEDENTES: Los cirujanos tratan de reducir sus errores durante la atención médica mediante el entrenamiento reiterado y los avances tecnológicos. Recientemente, han surgido otras opciones para mejorar el rendimiento, como la neuroestimulación que puede subsanar los errores en la práctica quirúrgica. MÉTODOS: Se revisó la utilización de la estimulación transcraneal de corriente directa (transcranial direct-current stimulation, tDCS), una técnica de estimulación neurológica que se ha aplicado a cirujanos para mejorar su rendimiento técnico. Se revisaron las evidencias que dan soporte a la mejoría en el rendimiento motor y cognitivo tras tDCS en otros ámbitos más allá de la cirugía y se correlacionó con datos recientes obtenidos en el entorno quirúrgico y sus posibles aplicaciones a otras áreas de la atención médica. También se discuten aspectos éticos y las implicaciones que la utilización de la tDCS pudiera tener en el entrenamiento quirúrgico y perioperatorio. RESULTADOS: Al margen de la cirugía, los estudios de tDCS demuestran una mejoría en el rendimiento motor medido por el tiempo de reacción, de finalización de tareas, de fuerza y la fatiga, así como también sugieren un incremento de la función cognitiva a través de evaluaciones multitarea, de vigilancia y de atención. En cirugía, la investigación actual ha demostrado una mejoría en el rendimiento para la realización de nudos abiertos, habilidades laparoscópicas y robóticas, mientras también contrarresta las exigencias subjetivas materiales. Sin embargo, surgen aspectos éticos ante la posible aplicación de la tDCS en cirugía, como son la seguridad, la coerción, la justicia distributiva y la equidad, situaciones que deben considerarse antes de su implementación. CONCLUSIÓN: La estimulación neurológica puede mejorar las habilidades motoras y cognitivas de los profesionales sanitarios con repercusión en la seguridad del paciente. Su implementación requerirá de protocolos y regulaciones específicas para equilibrar los beneficios con los dilemas éticos asociados y garantizar su seguridad para médicos y pacientes.

Intelligent, Autonomous Machines in Surgery.

Surgeons perform two primary tasks: operating and engaging patients and caregivers in shared decision-making. Human dexterity and decision-making are biologically limited. Intelligent, autonomous machines have the potential to augment or replace surgeons. Rather than regarding this possibility with denial, ire, or indifference, surgeons should understand and steer these technologies. Closer examination of surgical innovations and lessons learned from the automotive industry can inform this process. Innovations in minimally invasive surgery and surgical decision-making follow classic S-shaped curves with three phases: (1) introduction of a new technology, (2) achievement of a performance advantage relative to existing standards, and (3) arrival at a performance plateau, followed by replacement with an innovation featuring greater machine autonomy and less human influence. There is currently no level I evidence demonstrating improved patient outcomes using intelligent, autonomous machines for performing operations or surgical decision-making tasks. History suggests that if such evidence emerges and if the machines are cost effective, then they will augment or replace humans, initially for simple, common, rote tasks under close human supervision and later for complex tasks with minimal human supervision. This process poses ethical challenges in assigning liability for errors, matching decisions to patient values, and displacing human workers, but may allow surgeons to spend less time gathering and analyzing data and more time interacting with patients and tending to urgent, critical-and potentially more valuable-aspects of patient care. Surgeons should steer these technologies toward optimal patient care and net social benefit using the uniquely human traits of creativity, altruism, and moral deliberation.

Informed consent: a shared decision-making process that creates a new professional obligation for care.

This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This statement is provided to offer guidance about the purpose and process of obtaining informed consent, and it is intended for practicing surgeons as well as patients seeking surgical intervention. It is an expression of well-established principles and extensive literature. Excluded from this document are discussions of informed consent for research and informed consent for introduction of new technology, as that has been addressed in previous publications (Strong in Surg Endosc 28:2272, 2014; Stefanidis in Surg Endosc 28:2257, 2014; as reported by Sillin (in: Stain (ed) The SAGES Manual Ethics of Surgical Innovation, Springer, Switzerland, 2016)).

Multisource Evaluation of Surgeon Behavior Is Associated With Malpractice Claims.

OBJECTIVE: We merged direct, multisource, and systematic assessments of surgeon behavior with malpractice claims, to analyze the relationship between surgeon 360-degree reviews and malpractice history. BACKGROUND: Previous work suggests that malpractice claims are associated with a poor physician-patient relationship, which is likely related to behaviors captured by 360-degree review. We hypothesize that 360-degree review results are associated with malpractice claims. METHODS: Surgeons from 4 academic medical centers covered by a common malpractice carrier underwent 360-degree review in 2012 to 2013 (n = 385). Matched, de-identified reviews and malpractice claims data were available for 264 surgeons from 2000 to 2015. We analyzed 23 questions, highlighting positive and negative behaviors within the domains of education, excellence, humility, openness, respect, service, and teamwork. Regression analysis with robust standard error was used to assess the potential association between 360-degree review results and malpractice claims. RESULTS: The range of claims among the 264 surgeons was 0 to 8, with 48.1% of surgeons having at least 1 claim. Multiple positive and negative behaviors were significantly associated with the risk of having malpractice claims (P < 0.05). Surgeons in the bottom decile for several items had an increased likelihood of having at least 1 claim. CONCLUSION: Surgeon behavior, as assessed by 360-degree review, is associated with malpractice claims. These findings highlight the importance of teamwork and communication in exposure to malpractice. Although the nature of malpractice claims is complex and multifactorial, the identification and modification of negative physician behaviors may mitigate malpractice risk and ultimately result in the improved quality of patient care.

Analysis of Open Payments Receipts Among Surgical Faculty at a Large Academic Institution.

BACKGROUND: Section 6002 of the Affordable Care Act, commonly referred to as "The Sunshine Act," is legislation designed to provide transparency to the relationship between physicians and industry. Since 2013, medical product and pharmaceutical manufacturers were required to report any payments made to physicians to the Centers for Medicare and Medicaid Services (CMS). We predicted that most clinical faculty at our institution would be found on the Open Payments website. We elected to investigate payments in relationship to divisions within the department of surgery and the level of professorship. METHODS: All clinical faculty (n = 86) within the department of surgery at our institution were searched within the database: https://openpaymentsdata.cms.gov/. The total amount of payments, number of payments, and the nature of payments (food and beverage, travel and lodging, consulting, education, speaking, entertainment, gifts and honoraria) were recorded for 2017. Comparison by unpaired t-test (or ANOVA) where applicable, significance defined as P < 0.05. RESULTS: Of the 86 faculty studied, 75% were found within the CMS Open Payments database in 2017. The mean amount of payment was $4024 (range $13-152,215). Median amount of payment was $434.90 (range $12.75-152,214.70). Faculty receiving outside compensation varied significantly by division and academic rank (P < 0.05). Plastic surgery had the highest percentage of people receiving any form of payment ($143-$1912) and GI surgery had the largest payments associated with device management ($0-$152,215). The variation seen by rank was driven by a small number of faculty with receipt of large payments at the associate professor level. The median amount of payment was $428.53 (range $13.97-2306.05) for assistant professors, $5328.03 (range $28.30-152,214.70) for Associate Professors, and $753.82 (range $12.75-17,708.65) for full professors. CONCLUSIONS: Reporting of open payments to CMS provides transparency between physicians and industry. The significant relationship of division and rank with open payments database is driven by relatively few faculty. The majority (94%) received either no payments or less than $10,000.

Surgeon Volume in Benign Gynecologic Surgery: Review of Outcomes, Impact on Training, and Ethical Contexts.

It is becoming increasingly clear that surgeon volume affects surgical outcomes. High-volume surgeons demonstrate reduced perioperative complications, shorter operative times, and reduced blood loss during multiple modalities of benign gynecologic surgery. Furthermore, high-volume surgeons consistently demonstrate higher rates of minimally invasive approaches, low rates of conversion to laparotomy, and lower per-procedure case costs. It is suggested that surgeons who have completed postresidency training have improved surgical outcomes, although these data are limited. Surgical exposure in obstetrics and gynecology residency is varied and does not consistently meet demonstrated surgical learning curves. Deficiencies in residency surgical training may be related to the volume-outcome relationship. We suggest reforming residency surgical training and tracking postresidency practice to provide optimal surgical care. Additionally, surgeons may have an ethical obligation to inform patients of their surgical volume and outcomes, with options for referrals if needed.

You Are the Perfect Age: An Inquiry into Surgical Ethics during the Arc of a Career.

There is an old saying that history only makes sense in retrospect. I am sure that I am as susceptible to this adage as any other person. However, I will tell the story of my long history as an amateur medical ethicist, which is, to this day, how I would describe myself. My interest in the ethics of medicine, particularly as these ethical principles apply to interventions or procedures, started at a young age, fairly frequently going to the hospital with my father, a General and Thoracic Surgeon. I think that I found myself agreeing to accompany him, when invited, presuming that doing so would be a chance to spend some time with my dad, who was, throughout my childhood, either a surgical resident or a busy practicing surgeon. I will admit that I probably also figured that, at least late at night on the way home, we would stop by some establishment where we could get burgers and fries. However, I will start my reminiscences and reflections on these issues with a more recent story, as it prompted me to think back on my perceptions of those experiences of my youth.

How Do Thresholds of Principle and Preference Influence Surgeon Assessments of Learner Performance?

OBJECTIVE: The present study asks whether intraoperative principles are shared among faculty in a single residency program and explores how surgeons' individual thresholds between principles and preferences might influence assessment. BACKGROUND: Surgical education continues to face significant challenges in the implementation of intraoperative assessment. Competency-based medical education assumes the possibility of a shared standard of competence, but intersurgeon variation is prevalent and, at times, valued in surgical education. Such procedural variation may pose problems for assessment. METHODS: An entire surgical division (n = 11) was recruited to participate in video-guided interviews. Each surgeon assessed intraoperative performance in 8 video clips from a single laparoscopic radical left nephrectomy performed by a senior learner (>PGY5). Interviews were audio recorded, transcribed, and analyzed using the constant comparative method of grounded theory. RESULTS: Surgeons' responses revealed 5 shared generic principles: choosing the right plane, knowing what comes next, recognizing normal and abnormal, making safe progress, and handling tools and tissues appropriately. The surgeons, however, disagreed both on whether a particular performance upheld a principle and on how the performance could improve. This variation subsequently shaped their reported assessment of the learner's performance. CONCLUSIONS: The findings of the present study provide the first empirical evidence to suggest that surgeons' attitudes toward their own procedural variations may be an important influence on the subjectivity of intraoperative assessment in surgical education. Assessment based on intraoperative entrustment may harness such subjectivity for the purpose of implementing competency-based surgical education.

Surgical informed consent in children: a systematic review.

BACKGROUND: The purpose of the article was to analyze current literature on surgeon and parents' understanding and role in the informed consent process for children undergoing surgery. METHODS: A systematic database search (MEDLINE, EMBASE, PsycINFO, and EBM Reviews) was performed to identify articles concerning any aspect of the surgical informed consent for children undergoing an invasive procedure. Articles analyzing informed consent in research studies, non-English-language articles, review articles, case reports and/or series, letters-commentaries, and dentistry and/or nursing-related articles were excluded. Articles meeting inclusion criteria were analyzed to identify common themes related to the process of informed consent. RESULTS: One hundred seventy-eight articles were identified on primary search, after removing duplicates and screening titles for relevance, 83 abstracts were reviewed. Thirty-two additional abstracts were identified by secondary search. Twelve of 115 articles met inclusion criteria. Analysis identified five different study themes. Information delivered during consent (Content) was studied in five articles (42%), three (25%) studied the mechanics or delivery of the information (Delivery), three (25%) studied parent participation and discussion (Interchange), six articles (50%) discussed surgeons' perceptions or the parents' ability to understand or recall the information (Comprehension), and five articles (42%) evaluated surgeon or parent satisfaction or anxiety (Satisfaction). None of the articles studied all five categories. CONCLUSIONS: Studies of the surgical informed consent process in children are scarce. Prospective studies evaluating surgeon and parent perception regarding the Content, Delivery, and Interchange of information as well as Comprehension and Satisfaction are needed to understand barriers to the surgeon-patient relationship and to optimize the informed consent process in children undergoing surgery.

Association for Academic Surgery presidential address: sticky floors and glass ceilings.

This 2017 Presidential Address for the Association for Academic Surgery was delivered on February 8, 2017. It addresses the difficult topic of gender disparities in surgery. Mixing empirical data with personal anecdotes, Dr. Caprice Greenberg provides an insightful overview of this difficult challenge facing the surgical discipline and practical advice on how we can begin to address it.

When You Operate on Friends and Relatives: Results of a Survey among Surgeons.

OBJECTIVE: We designed a questionnaire to collect data on surgeons' views and experiences of operating on friends or relatives. SUBJECTS AND METHODS: A link to a 38-item online survey was sent to all 16,849 members of the Professional Board of German Surgeons (Bund Deutscher Chirurgen, BDC) several times. Standard interview software was used. The questionnaire collected a wide variety of information concerning how surgeons have experienced, think about, and deal with the situation when they operate on friends or relatives. RESULTS: Of the 16,849 BDC members notified of the survey, 1,643 completed the questionnaires (9.8%). Of these, 1,275 (77.6%) had previously performed surgery on friends or relatives. Overall, the surgeons willingly accepted doing so without experiencing any difficulties. However, the surgeons frequently used different techniques when operating on friends and relatives (123 [10%] when self-assessed compared to 527 [35%] when observed by others). Out of the whole sample, 506 (30.8%) would appreciate having a guideline or ethical code and 370 (41.2%) of those who have not yet operated on friends and relatives would like to have such an ethical code. CONCLUSION: Most of the surgeons who responded accepted the task of operating on friends or relatives. Performing surgery on friends or relatives was a complex matter because objectivity was not guaranteed. Negative implications on personal relationships were rare. We recommend that this matter should be well considered and discussed with the patient and an ethical guideline or code should be created.

Fiduciary disparity clarity: Ethics of divided allegiances.

An experienced senior vascular surgeon, Dr H. O. Nest, at a university medical center is asked to evaluate a patient with a rare complex vascular problem. The patient is a high-ranking university official, Mr N. Otable, well known to all in the university setting. Dr Nest has had very limited experience with the condition. He has viewed presentations about it but is aware of a world expert at another institution. He discusses transfer with the patient, who agrees on that approach. Later that day, when Dr Nest receives a visit from the Chief-of-Staff and the hospital CEO asking about Mr Otable, they are very concerned that transfer will reflect badly on the medical center's reputation. Dr Nest is strongly requested to reconsider his recommendation--almost at gunpoint. What should he do? A. If he believes that the outcome will be satisfactory, he should schedule the operation. B. He should explain the situation to the patient and let him choose where he wishes to have his surgery. C. He should continue with the plan to refer the patient to another center. D. He must understand his limits and base his decision accordingly. E. He should arrange a conference with the surgeons in the vascular division and the administrators.