Live-case demonstrations in pediatric urology: Ethics, patient safety, and clinical outcomes from an 8-year institutional experience.

Purpose: Live case demonstrations have become a common occurrence at surgical meetings around the world. These demonstrations are meant to serve as an educational medium for teaching techniques, promote discussion, improve interventions and outcomes. Despite the valuable educational benefits, many authors still question the ethics of this approach. We present our 8-year experience in live surgery, discuss the ethical issues, and provide recommendations. Materials and Methods: We reviewed records of patients who underwent live robotic surgery during broadcasting events. Procedures performed were robot-assisted laparoscopic pyeloplasty (RAL-P), ureteral reimplantation (RALUR), and hemi-nephrectomy (RAL-HN). Peri- and post-operative outcomes were compared to our previously published case series. Results: From October 2011 to May 2019, the senior author (MSG) performed all live surgery demonstrations on 22 patients: 9 RAL-P, 9 RALUR, and 4 RAL-HN. Live RAL-Ps had a 100% success rate and lower 30-day Clavien-Dindo grade (CDG) III complications when compared to our previous case series (11.1% vs. 21.2%). RALURs performed during live demonstrations had a higher success rate than our previously published cohort (100% vs. 82%). RAL-HN operative time and length of stay were comparable to our non-live control group. Conclusions: Live surgery is a valuable didactic tool, but even experienced surgeons may be adversely affected by inappropriate case selection, technical difficulty, and anxiety associated with particular settings, such as operating at different institutions or working with unfamiliar surgical teams. We suggest consultation of an ethics review board and formulation of standard guidelines for patient selection, surgical equipment, and operative team.

Commercial Interests in Continuing Medical Education: Where Do Electronic Health Record Vendors Fit?

The Accreditation Council for Continuing Medical Education (ACCME) will not accredit an organization that it defines as a commercial interest, that is an entity that produces, markets, resells, or distributes health care goods or services consumed by, or used on, patients. Thus, commercial interests are not eligible to be accredited organizations offering continuing medical education (CME) credit to physicians. This decision is based on the concern that commercial interests may use CME events to market their products or services to physicians, who then might inappropriately prescribe or administer those products or services to patients. Studies have shown that CME events supported by pharmaceutical companies, for example, have influenced physicians' prescribing behaviors.Currently, however, the ACCME does not recognize electronic health record (EHR) vendors, which are part of a multi-billion-dollar business, as commercial interests, and it accredits them to provide or directly influence CME events. Like pharmaceutical company-sponsored CME events, EHR vendor activities, which inherently only focus on use of the sponsoring vendor's EHR system despite its potential intrinsic limitations, can lead to physician reciprocity. Such events also may inappropriately influence EHR system purchases, upgrades, and implementation decisions. These actions can negatively influence patient safety and care. Thus, the authors of this Perspective call on the ACCME to recognize EHR vendors as commercial interests and remove them from the list of accredited CME providers.

Pharmaceutical industry funding of events for healthcare professionals on non-vitamin K oral anticoagulants in Australia: an observational study.

OBJECTIVES: To describe the nature, frequency and content of non-vitamin K oral anticoagulant (NOAC)-related events for healthcare professionals sponsored by the manufacturers of the NOACs in Australia. A secondary objective is to compare these data to the rate of dispensing of the NOACs in Australia. DESIGN AND SETTING: This cross-sectional study examined consolidated data from publicly available Australian pharmaceutical industry transparency reports from October 2011 to September 2015 on NOAC-related educational events. Data from April 2011 to June 2016 on NOAC dispensing, subsidised under Australia's Pharmaceutical Benefits Scheme (PBS), were obtained from the Department of Health and the Department of Human Services. MAIN OUTCOME MEASURES: Characteristics of NOAC-related educational events including costs (in Australian dollars, $A), numbers of events, information on healthcare professional attendees and content of events; and NOAC dispensing rates. RESULTS: During the study period, there were 2797 NOAC-related events, costing manufacturers a total of $A10 578 745. Total expenditure for meals and beverages at all events was $A4 238 962. Events were predominantly attended by general practitioners (42%, 1174/2797), cardiologists (35%, 977/2797) and haematologists (23%, 635/2797). About 48% (1347/2797) of events were held in non-clinical settings, mainly restaurants, bars and cafes. Around 55% (1551/2797) of events consisted of either conferences, meetings or seminars. The analysis of the content presented at two events detected promotion of NOACs for unapproved indications, an emphasis on a favourable benefit/harm profile, and that all speakers had close ties with the manufacturers of the NOACs. Following PBS listings relevant to each NOAC, the numbers of events related to that NOAC and the prescribing of that NOAC increased. CONCLUSIONS: Our findings suggest that the substantial investment in NOAC-related events made by four pharmaceutical companies had a promotional purpose. Healthcare professionals should seek independent information on newly subsidised medicines from, for example, government agencies or drug bulletins.

[Recomendaciones a los cuerpos directivos de las agrupaciones médicas en su relación con la industria].

Continuing medical education activities are often financially supported by pharmaceutical and device companies. With the purpose to ensure ethics and accountability in the management of this assistance, the Committee of Ethics and Transparency in the Physician-Industry Relationship of the National Academy of Medicine of Mexico formulates recommendations to medical associations' leaders in this text.

Las actividades de educación médica continua con frecuencia son apoyadas financieramente por la industria farmacéutica y de implementos médicos. Con el propósito de velar por la ética y rendición de cuentas en el manejo de estos apoyos, en el presente texto el Comité de Ética y Transparencia en la Relación Médico-Industria (Cetremi) de la Academia Nacional de Medicina de México formula recomendaciones a los directivos de agrupaciones médicas.

Survey of practices around pharmaceutical company funding for continuing professional development among medical oncologists and trainees in Australia.

BACKGROUND: The completion of continuing professional development (CPD) is mandatory for medical oncologists and trainees (MO&T). Pharmaceutical companies may fund some CPD activities, but there is increasing debate about the potential for conflicts of interest (COI). AIM: To assess current practices around funding to attend CPD activities. METHODS: An electronic survey was distributed to Australian MO&T. The survey asked questions about current practices, institutional policies and perceptions about attending CPD funded by pharmaceutical companies. The design looked at comparing responses between MO&T as well as their understanding of and training around institutional and ethical process. RESULTS: A total of 157 of 653 (24%) responses was received, the majority from MO (76%). Most CPD activities attended by MO&T were self-funded (53%), followed by funding from institutions (19%), pharmaceutical companies (16%) and salary award (16%). Most institutions allowed MO&T to receive CPD funding from professional organisations (104/157, 66%) or pharmaceutical companies (90/157, 57%). A minority of respondents (13/157, 8%) reported that the process to use pharmaceutical funds had been considered by an ethics committee. Although 103/157 (66%) had received pharmaceutical funding for CPD, most (109/157, 69%) reported never receiving training about potential COI. The lack of education was more noticeable among trainees (odds ratio (OR) 8.61, P = 0.02). MO&T acknowledged the potential bias towards a pharmaceutical product (P = 0.05) but believed there was adequate separation between themselves and pharmaceutical companies (P < 0.01). CONCLUSION: Majority of CPD attended by MO&T is self-funded. There is lack of clarity in institutional policies regarding external funding support for CPD activities. Formal education about potential COI is lacking.

The Impact of Financial Disclosure on Attendee Assessment of Objectivity in Continuing Medical Education Programs in Psychiatry: A Randomized, Controlled Trial.

OBJECTIVE: The purpose of financial conflict of interest disclosures by speakers at continuing medical education (CME) programs is to assist attendees in their assessment of the objectivity of the information presented. This empirical study was undertaken to determine what level of disclosure is optimal to achieve this goal. METHODS: Attendees at five CME programs were randomly assigned to receive either a standard financial disclosure, an intermediate level that included whether speakers received more or less than 5% of their income from each company they disclosed, or a high level of disclosure that included the percent of their income derived from each company. A total of 169 attendees (85.4% response rate) completed a questionnaire regarding the objectivity of the CME presentation they attended. RESULTS: Attendees receiving the highest level of disclosure came significantly closer to the ratings of speaker bias made by peer reviewers than did attendees receiving medium or low levels of disclosure (p = 0.03; effect size 0.31). Among the minority of attendees who received the highest level of disclosure but whose assessment of bias differed from that of peer reviewers, however, there was a tendency to underestimate bias (5.9 vs 31.4%; p < 0.0001). CONCLUSIONS: The major limitation of this study was an overall low level of bias in the presentations, making it difficult to generalize these findings to less objective programs. The study did not address whether the process of disclosure had an impact on speakers' behavior. This study provides mixed support for higher levels of financial disclosure than are currently required for CME programs.

[METHODOLOGICAL APPROACHES TO DEFINING CRITERIA FOR ACCREDITATION OF SPECIALISTS (IN CASE OF MEDICAL PARASITOLOGISTS)].

In 2016, provision is made for the transition for an accreditation system for all health workers to have individual permits for specific kinds of medical activities. Regular accreditation of health workers is one of the constituents of medical education, which is being intensively elaborated by the Ministry of Health of Russia jointly with a professional community by the module principle of using an accumulation system of valid credits. Despite the fact that higher educational establishments belong to different agencies, educational programs for physicians, criteria and procedures for their accreditation must be uniform. In this connection, there is today's challenge of methodological and methodical approaches to defining criteria for the accreditation of specialists of healthcare facilities of the Ministry of Health of Russia, bodies and institutions of the Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare. In the context of systemic and functional methodological approaches, the paper shows a procedure for defining criteria for the accreditation of specialists (in case of medical parasitologists).