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.

Mulheres na cirurgia vascular: uma breve análise do perfil brasileiro / Women in vascular surgery: a brief analysis of the Brazilian profile

O aumento da participação feminina no contingente médico brasileiro e mundial tem sido notório; entretanto, o número de mulheres cirurgiãs não acompanha a mesma tendência. Além da análise quantitativa, os fatores determinantes da escolha pela especialidade cirúrgica e as características da atuação profissional necessitam de mais estudos. Objetivos: Delinear o perfil das cirurgiãs vasculares brasileiras no que diz respeito às características demográficas, grau de qualificação, engajamento científico e integração ao mercado de trabalho. Métodos: Um questionário eletrônico foi disponibilizado on-line durante 30 dias e teve seu link amplamente divulgado entre cirurgiãs vasculares. Após coleta, retornaram 101 questionários válidos, cujos dados foram tabulados em planilhas do Microsoft Excel para análise descritiva simples. Resultados: O perfil encontrado foi de mulheres com até 45 anos de idade que atuam na área por no máximo 10 anos. A formação foi predominantemente por meio de residência médica ou estágio reconhecido pela sociedade da especialidade. Cirurgia venosa, flebologia estética e ecografia vascular mostraram-se como principais campos de atuação para cirurgiãs vasculares. Apesar de possuírem titulação e publicações científicas, a sua representatividade nos cargos de liderança permanece baixa. Mais de 64% das participantes referiram sentimento de desvalorização profissional devido ao fato de serem mulheres. Conclusões: Apesar das limitações da população estudada, este estudo preliminar corrobora com a ideia de que as cirurgiãs vasculares demonstram uma contínua dedicação à especialidade e abre um precedente para que novas pesquisas acessem os pormenores dessa atuação profissional, fomentando a discussão sobre as desigualdades entre os gêneros no exercício da medicina

There has been a striking increase in female participation in the Brazilian and worldwide medical contingent, but the number of female surgeons does not follow the same trend. In addition to quantitative analysis, there is a need for further study of the determinants of choice of surgical specialty and the characteristics of professional practice. Objectives: To outline the profile of female vascular surgeons in Brazil in terms of demographic characteristics, qualifications, scientific engagement, and labor market integration. Methods: A survey was made available online for 30 days and its link was widely circulated among female vascular surgeons. At the end of data collection, 101 valid questionnaires had been returned and their data were tabulated in Microsoft Excel spreadsheets for simple descriptive analysis. Results: The profile traced was of women aged up to 45 years who have been working in the area for up to 10 years. They were predominantly trained in medical residencies or internships recognized by the specialty board. Venous surgery, Esthetic Phlebology and Vascular Ultrasound were the major fields of activity for female vascular surgeons. Although they hold degrees and author scientific publications, the proportion of leadership positions held by women remains low. More than 64% of the participants reported feeling undervalued because they were women. Conclusions: Despite the limitations of the study population, this preliminary study confirms the idea that female vascular surgeons demonstrate continuous dedication to practicing their specialty and sets a precedent so that further studies can investigate the professional practice of female vascular surgeons in greater detail, stimulating discussion of gender inequalities in medical practice.

Recruitment in Clinical Trials: The Use of Zelen's Prerandomization in Recent Neurovascular Studies.

OBJECTIVE: Randomized allocation of treatment options is not well accepted within the clinical community. Some methods of implementation may be received more favorably than others. Prerandomization may be an acceptable means to facilitate recruitment in some clinical trials. METHODS: We first compare randomization and prerandomization using illustrative neurovascular trials. We review some problems with conventional trials, Zelen's prerandomization as an alternative method, and the ethical issues that have surrounded prerandomization since its inception in a historic trial. Conventional and Zelen's randomization are then compared with other means to provide and verify care in the context of clinical uncertainty. RESULTS: The major problem with conventional randomization is that consent is requested for 2 management options, one of which the patient will not receive. The problem with prerandomization is that treatment is allocated before the patient has consented to trial participation. Prerandomization may trade recruitment difficulties for excessive crossovers. However, other ways to practice under uncertainty and verify patient outcomes, such as case series and registries, are more ethically and scientifically problematic. CONCLUSIONS: Until the ethical functions of randomized allocation of selected treatment options in the care of patients are recognized by the neurovascular community, Zelen's prerandomization may help recruitment into difficult trials and contribute a means to provide best possible care in the presence of uncertainty.

De entusiasta residente a especialista vascular consumado / From hopeful trainee to accomplished vascular specialist

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La vena lo soporta todo / The vein withstands all

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Carta del presidente de la SEACV a la editorial «MENTOR. Un programa innovador de reclutamiento de residentes» / Letter from the Chairman of the SEACV on the editorial, «MENTOR: a novel program for recruiting residents»

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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.

Transposition of brachiobasilic arteriovenous fistulae: improving the cosmetic effect without compromising patency.

Introduction Subjects who undergo haemodialysis are living longer, which necessitates increasingly complex procedures for formation of arteriovenous fistulas. Basilic veins provide valuable additional venous 'real estate' but surgical transposition of vessels is required, which required a cosmetically disfiguring incision. A minimally invasive transposition method provides an excellent aesthetic alternative without compromised outcomes. Methods A retrospective review was made of minimally invasive brachiobasilic fistula transpositions (using two short incisions of <4 cm) between February 2005 and July 2011. Primary endpoints were one-year patency as well as the perioperative and late complications of the procedure. Results Thirty-one patients underwent 32 transposition procedures (eight pre-dialysis cases; 24 haemodialysis patients). All patients were treated with a minimally invasive method. Thirty-one procedures resulted in primary patency, with the single failure refashioned successfully. The only indication for a more invasive approach was intraoperative complications (two haematomas). All other complications presented late and were amenable to intervention (one aneurysm, one peri-anastomotic stricture). Conclusion Formation of arteriovenous fistulae using minimally invasive methods is a novel approach that ensures fistula patency with improved aesthetic outcomes and without significant morbidity.

Obligations and frustrations with high-risk patients: ethics of physicians' evaluations.

A surgeon, Dr A. Droit, has been following a 97-year-old male with a type IV thoracoabdominal aneurysm, which became symptomatic this morning and is leaking. The patient is frail but active with no important comorbidities. The anatomy demands an open procedure. The patient is a former renowned physician who has been a longtime family friend of Dr Droit-like a grandfather. He presented incoherent with sagging blood pressure. A complicating factor is that Dr D. Rag, the chief anesthesiologist, decided that neither he nor any of his staff would provide anesthesia. Dr Droit knows an anesthesiologist who handles high-risk patients at another hospital in the medical center. The patient has worsened over the last hour, is becoming more unstable, and is unable to respond but his wife wishes to consent for surgery. What should Dr Droit do?

A new ethical and medico-legal issue: vascular surgery and the postoperative cognitive dysfunction.

Patients undergoing major surgery are at risk for postoperative cognitive dysfunction (POCD). The consciousness of the POCD arises new ethical and medico-legal issues that should be identified, managed and, if possible, prevented. Elderly patients still represent a real challenge for physicians and medical science. This challenge can be surmounted not only through technical progress but also by safeguarding the correct ethical behavior at the base of each relationship between a patient and his physician. Effective communication with the elderly patient is a prerequisite for clear and complete information, involving family members and caregivers when necessary. In every case, the identification of patients with pre-existing risk factors of POCD, shortening the period of time preceding the surgery and a proper technique of the procedure as well as physical and intellectual exercises, nutrition and medication play an important role in decreasing the incidence of neurocognitive deficits in the elderly.

Discovering overtreatment: second-opinion dilemma.

An experienced vascular surgeon, Dr Al Wright, specializing in venous disease, often sees self-referred patients seeking second opinions primarily for ablation therapy and is deeply disturbed at what he finds. Some patients have no reflux on ultrasound examination and, thus, no treatment is indicated. Others were told they need a ludicrous three to seven ablations in each leg where only one or at most two are needed. Several advertise their services in the media. Dr Wright asked esteemed colleagues from the American Venous Forum what they recommended and they suggested sending a copy of his consultation to the first consultant with the goal of shaming him. He also notified the state medical board 2 years ago about one egregious repeat offender, without action. What should he do? A. Do as suggested, send your consult along with a harsh letter. B. Do nothing. It is none of your business. C. Notify the state medical board, again. D. Notify the insurance companies and regulators. E. There is no good venue to deal with the problem.

Ethics of administrative guidance: how much is too much?

A younger vascular surgeon has been recruited to start a new program at a suburban hospital outside of a large city hosting a world-class medical center. The new program will provide state-of-the-art equipment, including robotics, free office space, and a generous salary guarantee. Dr Ready obtained a license in the state where he is relocating and is preparing to move. He is an excellent technical surgeon but is uncomfortable with complex aneurysm surgery. This morning he went to sign a contract with the hospital and found that a clause that prevents him from referring patients to physicians outside the hospital in strong legalese is included. How should he proceed?

Defining, aligning, or declining do not resuscitate during surgery.

A Professor A. Droit, 93 years of age, formerly your college ethics teacher, developed a painful ischemic foot from distal aortic blockage. A daughter, who is a nurse, brought him to the hospital. He has multiple comorbidities, including leukemia for which he is getting chemotherapy. He agrees to surgery but hands you a completed do not resuscitate (DNR) form and insists it be honored throughout his care. As the operative wound is being closed, he has a slow ventricular tachycardia, which does not respond to intravenous therapy. You should:

Publishing corruption discussion: predatory journalism.

Dr Spock is a brilliant young vascular surgeon who is up for tenure next year. He has been warned by the chair of surgery that he needs to increase his list of publications to assure passage. He has recently had a paper reviewed by one of the top journals in his specialty, Journal X-special, with several suggestions for revision. He received an e-mail request for manuscript submission from a newly minted, open access, Journal of Vascular Disease Therapy, which promises a quick and likely favorable response for a fee. What should be done? A. Send the paper to another peer reviewed journal with the suggested revisions. B. Resubmit the paper to Journal X-special. C. Submit to the online journal as is to save time. D. Submit to the online journal and another regular journal. E. Look for another job.

When money and principles clash: the ethics of a surgical teaching service.

During your preoperative visit, a very wealthy patient, Gill Bates, who donated a wing to the large teaching hospital in which you practice, has an unusual request: He does not want any residents involved with his care. He is scheduled for an open infrarenal aneurysmectomy. He explains that his decision is based on the experience of a relative many years ago who was harmed by a resident's error. You clarify that you will do the procedure but that this is a teaching hospital and residents provide excellent assistance and postoperative care. He is resolute in demanding that only grown-up surgeons provide his care.