Ethical and legal issues regarding artificial intelligence (AI) and management of surgical data.

The advent of AI in surgical practice is representing a major innovation. As its role expands and due to its several implications, strict compliance with ethical, legal and regulatory good practices is mandatory. Observance of ethical principles and legal rules will be a professional imperative for the application of AI in surgical practice, both clinically and scientifically.

Surgical Antibiotic Prophylaxis: A Proposal for a Global Evidence-Based Bundle.

In the multimodal strategy context, to implement healthcare-associated infection prevention, bundles are one of the most commonly used methods to adapt guidelines in the local context and transfer best practices into routine clinical care. One of the most important measures to prevent surgical site infections is surgical antibiotic prophylaxis (SAP). This narrative review aims to present a bundle for the correct SAP administration and evaluate the evidence supporting it. Surgical site infection (SSI) prevention guidelines published by the WHO, CDC, NICE, and SHEA/IDSA/APIC/AHA, and the clinical practice guidelines for SAP by ASHP/IDSA/SIS/SHEA, were reviewed. Subsequently, comprehensive searches were also conducted using the PubMed®/MEDLINE and Google Scholar databases, in order to identify further supporting evidence-based documentation. The bundle includes five different measures that may affect proper SAP administration. The measures included may be easily implemented in all hospitals worldwide and are based on minimal drug pharmacokinetics and pharmacodynamics knowledge, which all surgeons should know. Antibiotics for SAP should be prescribed for surgical procedures at high risk for SSIs, such as clean-contaminated and contaminated surgical procedures or for clean surgical procedures where SSIs, even if unlikely, may have devastating consequences, such as in procedures with prosthetic implants. SAP should generally be administered within 60 min before the surgical incision for most antibiotics (including cefazolin). SAP redosing is indicated for surgical procedures exceeding two antibiotic half-lives or for procedures significantly associated with blood loss. In principle, SAP should be discontinued after the surgical procedure. Hospital-based antimicrobial stewardship programmes can optimise the treatment of infections and reduce adverse events associated with antibiotics. In the context of a collaborative and interdisciplinary approach, it is essential to encourage an institutional safety culture in which surgeons are persuaded, rather than compelled, to respect antibiotic prescribing practices. In that context, the proposed bundle contains a set of evidence-based interventions for SAP administration. It is easy to apply, promotes collaboration, and includes measures that can be adequately followed and evaluated in all hospitals worldwide.

A multi-national, video-based qualitative study to refine training guidelines for assigning an "unsafe" score in laparoscopic cholecystectomy critical view of safety.

BACKGROUND: The critical view of safety (CVS) was incorporated into a novel 6-item objective procedure-specific assessment for laparoscopic cholecystectomy (LC-CVS OPSA) to enhance focus on safe completion of surgical tasks and advance the American Board of Surgery's entrustable professional activities (EPAs) initiative. To enhance instrument development, a feasibility study was performed to elucidate expert surgeon perspectives regarding "safe" vs. "unsafe" practice. METHODS: A multi-national consortium of 11 expert LC surgeons were asked to apply the LC-CVS OPSA to ten LC videos of varying surgical difficulty using a "safe" vs. "unsafe" scale. Raters were asked to provide written rationale for all "unsafe" ratings and invited to provide additional feedback regarding instrument clarity. A qualitative analysis was performed on written responses to extract major themes. RESULTS: Of the 660 ratings, 238 were scored as "unsafe" with substantial variation in distribution across tasks and raters. Analysis of the comments revealed three major categories of "unsafe" ratings: (a) inability to achieve the critical view of safety (intended outcome), (b) safe task completion but less than optimal surgical technique, and (c) safe task completion but risk for potential future complication. Analysis of reviewer comments also identified the potential for safe surgical practice even when CVS was not achieved, either due to unusual anatomy or severe pathology preventing safe visualization. Based upon findings, modifications to the instructions to raters for the LC-CVS OPSA were incorporated to enhance instrument reliability. CONCLUSIONS: A safety-based LC-CVS OPSA has the potential to significantly improve surgical training by incorporating CVS formally into learner assessment. This study documents the perspectives of expert biliary tract surgeons regarding clear identification and documentation of unsafe surgical practice for LC-CVS and enables the development of training materials to improve instrument reliability. Learnings from the study have been incorporated into rater instructions to enhance instrument reliability.

Laparoscopic cholecystectomy critical view of safety (LC-CVS): a multi-national validation study of an objective, procedure-specific assessment using video-based assessment (VBA).

BACKGROUND: A novel 6-item objective, procedure-specific assessment for laparoscopic cholecystectomy incorporating the critical view of safety (LC-CVS OPSA) was developed to support trainee formative and summative assessments. The LC-CVS OPSA included two retraction items (fundus and infundibulum retraction) and four CVS items (hepatocystic triangle visualization, gallbladder-liver separation, cystic artery identification, and cystic duct identification). The scoring rubric for retraction consisted of poor (frequently outside of defined range), adequate (minimally outside of defined range) and excellent (consistently inside defined range) and for CVS items were "poor-unsafe", "adequate-safe", or "excellent-safe". METHODS: A multi-national consortium of 12 expert LC surgeons applied the OPSA-LC CVS to 35 unique LC videos and one duplicate video. Primary outcome measure was inter-rater reliability as measured by Gwet's AC2, a weighted measure that adjusts for scales with high probability of random agreement. Analysis of the inter-rater reliability was conducted on a collapsed dichotomous scoring rubric of "poor-unsafe" vs. "adequate/excellent-safe". RESULTS: Inter-rater reliability was high for all six items ranging from 0.76 (hepatocystic triangle visualization) to 0.86 (cystic duct identification). Intra-rater reliability for the single duplicate video was substantially higher across the six items ranging from 0.91 to 1.00. CONCLUSIONS: The novel 6-item OPSA LC CVS demonstrated high inter-rater reliability when tested with a multi-national consortium of LC expert surgeons. This brief instrument focused on safe surgical practice was designed to support the implementation of entrustable professional activities into busy surgical training programs. Instrument use coupled with video-based assessments creates novel datasets with the potential for artificial intelligence development including computer vision to drive assessment automation.

A Crucial Moment for Reflection on the Importance of Ethical Leadership in Academic Medicine.

The extreme disturbances caused by the COVID -19 pandemic on our academic medical centers compounded by a recurrent surge of violence against people of color have reopened our wounds exposing fragility, inequality, and continued racial disparities in society and health. At the center of this severe institutional disruption, leaders will be compelled to take action to keep their constituents and patients safe and their hospitals and departments afloat during and after a pandemic, all while simultaneously addressing and implementing the cultural changes required to eliminate systemic racism and discrimination. Organizational disruptions of this magnitude will naturally test one's principles, loyalties and responsibilities while challenging the practical burdens of leadership. If the goal of responding to these upheavals is to bring them to resolution and ultimately to bring about organizational change for the better, ethical leadership is critical. Applying ethical principles allows leaders to chart clear paths to solutions both in the short and long term. We review the principles of ethical leadership exemplified by a case illustration and provide a novel resource to help ensure ethical leadership in academic medicine and beyond.

Ethical Issues in the Introduction of New Technologies: From Mis to POEM.

The ethical debate regarding the introduction of new technologies in the surgical health care environment is discussed in this manuscript, with a special emphasis on minimally invasive and NOTES procedures for the treatment of esophageal achalasia. It offers an overview of the ethical principles and considerations about the implementation of new techniques and technologies.

Surgical Considerations of the Cystic Duct and Heister Valves.

Objectives Heister valves are mucosal folds located on the endoluminal surface of the cystic duct (CD) and were first described by Lorenz Heister in 1732. Their presence could represent an obstacle that impedes transcystic exploration. It has been suggested that the distribution of Heister valves follows a steady rhythmic pattern in a spiral disposition; however, there is no conclusive data to support this claim. The aim of this study was to describe the main characteristics of the CD and Heister valves in adult human cadavers. Methods A descriptive cross-sectional study was performed on 46 extrahepatic biliary tracts. Results The CD has an average length of 25.37 mm and diameter of 4.53 mm. The most frequent level of junction was the middle union. Heister valves were present on 32 CDs; in most cases, they were distributed uniformly on the duct and presented an oblique disposition. A nonreticular pattern was the most frequent reticular pattern. The most frequent type of the nonreticular type was the B1 subtype. The most frequent type of distribution was the nonreticular type, particularly the B1 type. Conclusions The cystic fold could hinder transcystic exploration. The cysticotomy incision should not be determined by the distribution of the fold on the CD. The morphology of the Heister valves does not show evidence of a steady systematic pattern.

Ethical issues of expert witness testimony.

Being a surgical expert witness (EW) in professional liability claims implies ethical responsibilities, which are usually unknown to the parties who try to obtain such testimony as well as to the surgeons involved in providing the expert opinion required by the courts. Giving medical testimony can be included in the field of surgery since (1) being an expert medical witness and judge the performance of another surgeon means that the witness must have a medical license and preferably be board-certified as a surgeon, and (2) the EW opinion sets the standard of care to be applied in each particular case. Thus, the role of the surgeon EW in the legal arena must have the same degree of integrity as the surgeon in his practice with direct patient care and it should be reviewed and subject to regulation.

Technical aspects of cholecystectomy.

The gold standard for the surgical treatment of symptomatic cholelithiasis is conventional laparoscopic cholecystectomy (LC). Although it has been associated with a slightly higher incidence of bile duct injury (BDI) in comparison with open cholecystectomy (OC), LC is considered a very safe operation. Prevention of BDI should be routinely performed in every LC. Recent trends include the performance of cholecystectomy through a single incision and NOTES (Natural Orifice Transluminal Endoscopic Surgery). However, lack of evidence of clinical advantages prevents their widespread adoption, and more data are needed to assess whether their use is warranted.

The extent of surgical patients' understanding.

The notion that consent to surgery must be informed implies not only that information should be provided by the surgeon but also that the information should be understood by the patient in order to give a foundation to his or her decision to accept or refuse treatment and thus, achieve autonomy for the patient. Nonetheless, this seems to be an idyllic situation, since most patients do not fully understand the facts offered and thus the process of surgical informed consent, as well as the patient's autonomy, may be jeopardized. Informed consent does not always mean rational consent.

Ethical debate: the ethics of not performing extended lymphadenectomy in patients with gastrointestinal cancer.

The ethical debate about performing-or not-extended lymphadenectomy in patients with a gastrointestinal malignancy is approached in this work. It offers a thorough overview of the ethical principles. Problem-solving tools are provided to assist in framing the issues and resolving the conflicts.

Investigación prospectiva de 200 protocolos quirúrgicos / Prospective evaluation of 200 operative records

Antecedentes: El protocolo quirúrgico es un elemento fundamental en la historia clínica de los pacientes quirúrgicos y cumple varias funciones (informativa, docente, administrativa, fuente de datos en litigios). De ahí la importancia de los datos documentados en el mismo. Objetivo: Comparar la documentación registrada en los protocolos quirúrgicos por médicos residentes y de planta. Diseño: Observacional, prospectivo y comparativo. Método: Se analizaron aspectos formales y sustanciales de 200 protocolos quirúrgicos, correspondientes a 100 operaciones, efectuados uno por el médico residente cirujano y otro por el médico de planta participante. Resultados: El análisis de los aspectos formales reveló diferencias entre la documentación efectuada por médicos residentes y de planta; la divergencia en la información registrada referida a los aspectos sustanciales fue de hasta un 43 por ciento. Conclusiones: Las divergencias y omisiones detectadas en los 2 grupos comparados responden a diferencias de educación y formación. Se debe insistir en la enseñanza de la adecuada confección del protocolo quirúrgico y concientizar a los cirujanos en formación sobre las implicancias médico-legales

Análisis de los reclamos originados en la cirugía de las hernias inguinales / Analysis of professional liability claims in the ordinary justice in groin hernia surgery

Antecedentes: La hernioplastía inguinal, tanto por vía convencional como laparoscópica, está expuesta a accidentes, riesgos y complicaciones, siendo la atrofia testicular, secuela de la orquitis isquémica una de las más proclives para iniciar un juicio por responsabilidad médica. Objetivo: Analizar los reclamos por presunta malapraxis vinculados a hernioplastías, en trámite ante la justicia ordinaria. Diseño: Descriptivo, observacional y retrospectivo. Método: Se evaluaron 10 reclamos por responsabilidad profesional médica, motivados en cirugía de hernias inguinales, cuyas pericias fueron solicitadas al Cuerpo Médico Forense en el período 1993-98 en los fueros Penal y Civil. Resultados: En los 7 procedimientos por vía anterior, el motivo fue una atrofia de testículo que se atribuyó a sección de la arteria espermática (2 casos), falla de la hemostasia (3 casos) y estrechamiento marcado del orificio inguinal (2 casos). Tres de las hernioplastías convencionales habían recidivado al momento del examen. En ningún caso se pudo comprobar alteración estética o daño psicológico y el espermograma fue normal en los 5 casos en que se efectuó. Los 2 enfermos con hernioplastía laparoscópica fallecieron como consecuencia de perforación del intestino delgado, por lesión de trocar de ingreso y por electrocauterio. Se analizan la formación, edad y remuneración de los cirujanos involucrados así como ámbito y financiador del procedimiento. Conclusiones: La AT es una de las causas más proclives para iniciar un juicio de responsabilidad profesional luego de cirugía convencional herniaria mientras que la lesión de víscera hueca es la causa más frecuente luego del abordaje laparoscópico. Debe mejorarse la calidad de la documentación de los actos médicos, de fundamental importancia frente a la prueba pericial

Cirugía del lado equivocado: error quirúrgico e implicancias médico-legales / Analysis of professional liability claims due to wrong side surgery

Antecedentes: La cirugía del lado equivocado es un ejemplo de error médico y del quirúrgico, debiendo distinguirla de la cirugía del sitio equivocado y del enfermo erróneo. La aparición reciente de varios estudios sobre el error médico impone un cabal conocimiento de su incidencia para tender a su prevención. Objetivo: Analizar los reclamos judiciales por responsabilidad profesional médica, vinculados a cirugías en el lado equivocado. Diseño: Descriptivo, observacional y retrospectivo. Método: Se analizan 8 reclamos por responsabilidad profesional médica, motivados en cirugía del lado equivocado, cuyas pericias fueron solicitadas al Cuerpo Médico Forense en el período 1980-1997 en los fueros Penal y Civil. Resultados: En todos los casos se operó sobre el lado sano, o sea el lado contrario al que presentaba la patología, siendo todos los pacientes, a excepción de uno, reoperados por otro equipo. Los reclamos se iniciaron dentro de los 6 meses. El ámbito fue privado en 5 casos y público en 3. Todos los cirujanos eran mayores de 35 años. La calidad de la documentación médica fue regular. En todos los casos los cirujanos fueron hallados responsables de error grosero e inexcusable, originado en negligencia. Conclusiones: La buena práctica quirúrgica debe basarse en la prevención del error, tanto individual como el de sistema. El informe de errores e incidentes debería constituirse en un adecuado instrumento de manejo de riesgo médico-legal

El protocolo quirúrgico: su análisis médico-legal / Operative note: medico-legal analysis

Antecedentes: El protocolo quirúrgico es un elemento fundamental en la historia clínica de los pacientes quirúrgicos y de comunicación entre los integrantes del equipo de salud. La actual epidemia de juicios por responsabilidad profesional médica impone una cuidadosa elaboración para el conocimiento adecuado del desarrollo del acto quirúrgico. Objetivo: Analizar desde un punto de vista médico-legal los protocolos operatorios de historias clínicas vinculadas a juicios por responsabilidad profesional médica. Diseño: Evaluación retrospectiva de historias clínicas. Método: Se analizaron aspectos formales y materiales de 120 protocolos quirúrgicos correspondientes a 100 historias clínicas vinculadas con juicios por responsabilidad profesional médica, cuyas pericias fueron solicitadas al Cuerpo Médico Forense de la Justicia Nacional. Resultados: 6 historias clínicas no tenían el/los protocolo/s. Los aspectos formales presentaron una omisión de datos superior en algunos casos al 50 por ciento mientras que la omisión de algunos aspectos materiales superó el 75 por ciento de incidencia. Conclusiones: El porcentaje de omisiones y errores detectada impone que la calidad de los protocolos debe ser mejorada