Better Conversations for Better Informed Consent: Talking with Surgical Patients.

For more than sixty years, surgeons have used bioethical strategies to promote patient self-determination, many of these now collectively described as "informed consent." Yet the core framework-understanding, risks, benefits, and alternatives-fails to support patients in deliberation about treatment. We find that surgeons translate this framework into an overly complicated technical explanation of disease and treatment and an overly simplified narrative that surgery will "fix" the problem. They omit critical information about the goals and downsides of surgery and present untenable options as a matter of patient choice. We propose a novel framework called "better conversations." Herein, surgeons provide context about clinical norms, establish the goals of surgery, and comprehensively delineate the downsides of surgery to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm shift meets the standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of treatment.

Trust-building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent.

The coronavirus disease 2019 pandemic forced a wide range of medical practices to virtual formats, including the preoperative informed consent practice. However, virtual informed consent persists despite the pandemic being largely considered resolved. The continued use of virtual formats relies on a problematic "information transfer" model of informed consent. We suggest a "trust-building" model of consent as a better conceptualization of what is occurring during the consent process. Highlighting how virtual formats might fail to fulfill this fuller understanding of consent on both interpersonal and systemic levels, we offer an ethical structure for physicians to navigate this novel virtual space.

Capacity Assessment in Emergency Surgery.

AbstractInformed consent is a necessary component of the ethical practice of surgery. Ideally, consent is performed in a setting conducive to a robust patient-provider conversation, with careful consideration of risks, benefits, and outcomes. For patients with medical or surgical emergencies, navigating the consent process can be complicated and requires both careful and expedited assessment of decision-making capacity. We present a recent case in which a patient in need of emergency care refused intervention, requiring urgent capacity assessment and a modification to usual care.

[Surgery in the balance between humanity, ethics and economics]. / Chirurgie im Spannungsfeld "Humanität-Ethik-Ökonomie".

BACKGROUND: The economic pressure in the healthcare system has noticeably increased in the past few years. The manifestation of an "economization in medicine" development raises questions about the compatibility of physicians' duties and economic incentives in the healthcare system. OBJECTIVE: Against this background the article analyzes areas of conflict in the German healthcare system and surgery in particular. The main questions focus on: what lines of conflict can arise between ethical duties and economic requirements and what possibilities for conflict resolution can provide orientation on the macrolevel and microlevel? MATERIAL AND METHODS: The article is based on the analysis of normative regulations, guidelines and statements from the self-administrative institutions and multidisciplinary literature from medicine, medical ethics and health economics. Core issues in the conflict area between "humanity-ethics-economics" are structured and recommendations for action are derived. RESULTS AND DISCUSSION: Superordinate regulatory framework conditions and their subsequent incentives must not conflict with the ethical principles of medical care, especially the primary orientation to patient welfare. Institutional and individual healthcare providers have a responsibility towards patients first and only secondarily for an economically appropriate spending of public resources. The provision of medical care for people must enable an adequate livelihood. Institutional maximization of profits is to be avoided, especially concerning financial investors. In the corona pandemic, economic disincentives are becoming apparent and necessitate readjustments. Possible recommendations for action are the empowerment of the medical profession and management to engage in a qualified exchange.

Global Overview of Response Rates in Patient and Health Care Professional Surveys in Surgery: A Systematic Review.

OBJECTIVE: Identify key demographic factors and modes of follow-up in surgical survey response. SUMMARY BACKGROUND DATA: Surveys are widely used in surgery to assess patient and procedural outcomes, but response rates vary widely which compromises study quality. Currently there is no consensus as to what the average response rate is and which factors are associated with higher response rates. METHODS: The National Library of Medicine (MEDLINE/PubMed) was systematically searched from Januray 1, 2007 until February 1, 2020 using the following strategy: (((questionnaire) OR survey) AND "response rate") AND (surgery OR surgical). Original survey studies from surgical(-related) fields reporting on response rate were included. Through one-way analysis of variance we present mean response rate per survey mode over time, number of additional contacts, country of origin, and type of interviewee. RESULTS: The average response is 70% over 811 studies in patients and 53% over 1746 doctor surveys. In-person surveys yield an average 76% response rate, followed by postal (65%) and online (46% web-based vs 51% email) surveys. Patients respond significantly more often than doctors to surveys by mail (P < 0.001), email (P = 0.003), web-based surveys (P < 0.001) and mixed mode surveys (P = 0.006). Additional contacts significantly improve response rate in email (P = 0.26) and web-based (P = 0.041) surveys in doctors. A wide variation in response rates was identified between countries. CONCLUSIONS: Every survey is unique, but the main commonality between studies is response rate. Response rates appear to be highly dependent on type of survey, follow-up, geography, and interviewee type.

Editorial: Artificial Intelligence (AI) in Clinical Medicine and the 2020 CONSORT-AI Study Guidelines.

Artificial intelligence (AI) in clinical medicine includes physical robotics and devices and virtual AI and machine learning. Concerns have been raised regarding ethical issues for the use of AI in surgery, including guidance for surgical decisions, patient confidentiality, and the need for support from controlled clinical trials to use these methods so that clinical guidelines can be developed. The most common applications for virtual AI include disease diagnosis, health monitoring and digital patient consultations, clinical training, patient data management, drug development, and personalized medicine. In September 2020, the CONSORT-A1 extension was developed with 14 additional items that should be reported for AI studies that include clear descriptions of the AI intervention, skills required, study setting, inputs and outputs of the AI intervention, analysis of errors, and the human and AI interactions. This Editorial aims to present current applications and challenges of AI in clinical medicine and the importance of the new 2020 CONSORT-AI study guidelines.

Obstinación terapéutica y su límite con la ética: ¿cuándo detenerse? / Therapeutic effort limit, when do we stop?

Obstinacy or therapeutic cruelty is a medical practice based on the application of extraordinary and disproportionate methods of life support in terminally ill or irrecoverable patients. It is not without risks and can cause physical, psychological and social damage, which is why this practice is not ethically acceptable. It violates the four principles of bioethics: non-maleficence, beneficence, justice and autonomy. The reasons that lead to therapeutic obstinacy are: 1) lack of a definitive diagnosis; 2) false expectation of improvement of the patient; 3) disagreement (between doctors and family or between doctors themselves) with respect the patient's situation; 4) difficulty in communicating with the patient and his/her family; 5) compliance with unrealistic or futile treatments; 6) cultural or spiritual barriers and 7) medical-legal aspects. Limitation of therapeutic effort (LTE) is a deliberate or thoughtful decision about the non-implementation or withdrawal of therapeutic measures that will not provide significant benefit to the patient. But, refusing a treatment, must not imply the artificial acceleration of the death process. Chile does not contemplate euthanasia or assisted suicide in its legislation. Criteria used to justify the limitation of the therapeutic effort are: 1) futility of the treatment (futility); 2) declared wishes of the patient; 3) quality of life and 4) economic cost. The Healthcare Ethics Committee of the Hospital de Urgencia Asistencia Pública has prepared a LET Clinical Guide, proposing a decision-making flow chart that takes in account the autonomy of the patient, the opinion of the medical team, patient and family. In case of disagreement, the Healthcare Ethics Committee's may be requested to issue a pronouncement.

La obstinación o ensañamiento terapéutico es una práctica médica basada en la aplicación de métodos extraordinarios y desproporcionados de soporte vital en enfermos terminales o irrecuperables. No está exenta de riesgos y puede producir daño físico, psicológico y social, motivo por el cual no es aceptable desde el punto de vista ético. Viola los cuatro principios de la bioética: no maleficencia, beneficencia, justicia y autonomía. Las razones que conducen a la obstinación terapéutica son: 1) la falta de un diagnóstico definitivo; 2) la falsa expectativa en el mejoramiento del paciente; 3) el desacuerdo (entre médicos y familia o entre los médicos mismos) con la situación del paciente; 4) la dificultad para comunicarse con el paciente y con la familia; 5) la conformidad con tratamientos poco realistas o fútiles; 6) barreras culturales o espirituales y 7) aspectos médico legales. La limitación del esfuerzo terapéutico (LET) es una decisión deliberada o meditada sobre la no implementación o la retirada de medidas terapéuticas que no aportarán un beneficio significativo al paciente. Pero, rechazar un tratamiento no puede implicar la aceleración artificial del proceso de la muerte. Chile no contempla en su legislación la eutanasia ni el suicidio asistido. Criterios utilizados para justificar o no, la limitación del esfuerzo terapéutico: 1) la inutilidad del tratamiento (futilidad); 2) los deseos expresos del paciente; 3) la calidad de vida y 4) el costo económico. El Comité de Ética Asistencial del Hospital de Urgencia Asistencia Pública, ha elaborado una Guía Clínica de LET. Propone un flujograma de toma de decisiones que considera la autonomía del paciente, la postura tanto del equipo médico, del paciente y su familia y en caso de no acuerdo, del comité de Ética Asistencial.

The Meaning of "Doing Everything".

Evaluating a high-risk patient for a high-risk operation is complicated. Discussing the benefits and burdens with your patient is only a part of the process. Should the decision be not to operate, explaining and planning the nonoperative path forward with all of its inherent challenges is crucial. Because the inevitable is likely to happen, the patient as well as their family must be prepared. If they are not, then the result may be exactly what the patient was hoping to avoid in the first place by declining the operation. Critical to this conversation is understanding the nuances of "doing everything" when dealing with a patient facing a life-limiting condition.

Ethics in Surgical Innovations from the Patient Perspective.

OBJECTIVE: Surgical innovation (SI) can place patients at risk. We sought to explore what clinical information is readily available to patients who have been offered innovative surgical procedures, using two examples drawn from our recent experience: one a surgical technique, and the other a prosthetic material. We wanted to determine from our review the extent to which information available on the Internet might augment the medical literature and help satisfy the ethical requirements for patients to be adequately informed before they proceed with innovative surgery. METHODS: A scoping review of the medical literature was performed to look for studies addressing the review aims; targeted searches on Google, YouTube, and patient websites were carried out to find readily available patient information on two chosen innovative surgical procedures. We conducted a content analysis of the selected references to determine the availability, relevance, and the utility of the published information to a layperson. RESULTS: Medical database searches identified 614 records, 91 were screened and only six were relevant. The Internet searches returned thousands of results; however, we limited our screening to the first five pages of results for those sources. From both types of searches, 348 references were excluded because they did not meet the inclusion criteria and 51 were included in the analysis. The findings are presented in four themes: safety and feasibility of the technique, availability and accessibility to a layperson, relevance and utility to a layperson, and commercial information. CONCLUSION: The review has shown that lay people seeking to find out more about the two innovations would get very little useful information from Google, YouTube, or patient websites. Practitioners offering SI should provide sufficient information to allow their patients to make an autonomous decision about whether to proceed. For major SI, we encourage innovators to develop a plain language statement that would be made available on the Internet to the mutual advantage of both innovators and patients.

Human rights-based approach to global surgery: A scoping review.

BACKGROUND: Health is a basic human right, yet surgery remains a neglected stepchild of global health. Worldwide, five billion people lack access to safe, timely, and affordable surgical and anesthesia care when needed. This disparity results in over 18 million preventable deaths each year and is responsible for one-third of the global burden of disease. Here, we evaluate the role of surgical care in protecting human rights and attempt to make a human rights argument for universal access to safe surgical care. MATERIAL AND METHODS: A scoping review was done using the PubMed/MEDLINE, Embase, and Scopus databases to identify articles evaluating human rights and disparities in accessing surgical care globally. A conceptual framework is proposed to implement global surgical interventions with a human rights-based approach. RESULTS: Disparities in accessing surgical care remain prevalent around the world, including but not limited to gender inequality, socioeconomic differentiation, sexual stigmatization, racial and religious disparities, and cultural beliefs. Lack of access to surgery impedes lives in full health and economic prosperity, and thus violates human rights. Our normative framework proposes human rights principles to make surgical policy interventions more inclusive and effective. CONCLUSION: Acknowledging human rights in the provision of surgical care around the world is critical to attain and sustain the Sustainable Development Goals and universal health coverage. National Surgical, Obstetric, and Anesthesia Planning and wider health systems strengthening require the integration of human rights principles in developing and implementing policy interventions to ensure equal and universal access to comprehensive health care services.