MEDICAL ETHICS

医学伦理学
  • 文章类型: Journal Article
    背景:在阿尔茨海默病和相关痴呆(ADRD)的临床研究中登记的知情决定需要仔细考虑复杂的风险和不确定的收益。关于是否接收关于生物标志物状态的信息的决定是复杂的,因为缺乏关于生物标志物作为阿尔茨海默病的替代终点的科学共识,以及关于个体风险的信息应如何评估和与研究参与者共享。本研究旨在就与ADRD研究参与者分享个人结果的道德最佳方法建立利益相关者共识。
    方法:这项Delphi共识构建研究包括与阿尔茨海默病研究专家进行的多项在线调查,包括神经学家,神经心理学家,伦理学家,研究监督专家和临床试验师。将对小组成员进行问卷调查,该问卷调查是根据已发表文献中确定的研究人员和参与者认可的考虑因素和决策需求以及在阿尔茨海默氏症协会研究补助金的支持下进行的决策需求评估进行的。小组成员还将被问及他们对分享个人研究结果的内容和实施过程的看法。达成共识需要≥75%的协议。响应率,级别的协议,中位数,将分析四分位数范围和小组排名。在每一轮数据收集之后,我们的研究小组将对开放式回应进行定性内容分析。
    背景:将获得克利夫兰诊所机构审查委员会的伦理批准(研究编号22-766)。在同意参与Delphi过程之前,Delphi小组成员将收到描述研究的参与者信息表。我们预期的数据结果将通过这项研究产生,并将提交给同行评审的期刊出版和在国际会议上的介绍。
    BACKGROUND: Informed decisions to enrol in the clinical investigations of Alzheimer\'s disease and related dementias (ADRD) require careful consideration of complex risks and uncertain benefits. Decisions regarding whether to receive information about biomarker status are complicated by lack of scientific consensus regarding biomarkers as surrogate endpoints for Alzheimer\'s disease and how information about individual risk should be evaluated and shared with research participants. This study aims to establish stakeholder consensus regarding ethically optimal approaches to sharing individual results with ADRD research participants.
    METHODS: This Delphi consensus-building study consists of multiple online surveys conducted with Alzheimer\'s disease research experts, including neurologists, neuropsychologists, ethicists, research oversight specialists and clinical trialists. Panellists will be administered questionnaires developed from a synthesis of researcher- and participant-endorsed considerations and decisional needs identified in published literature and a decisional needs assessment conducted with support from an Alzheimer\'s Association Research Grant. Panellists will also be asked their views on the content and implementation of processes for sharing individual research results. ≥75% agreement will be required to achieve consensus. Response rates, level of agreement, medians, interquartile ranges and group rankings will be analysed. Following each round of data collection, our research team will undertake qualitative content analysis of open-ended responses.
    BACKGROUND: Ethical approval will be obtained from the Cleveland Clinic Institutional Review Board (Study Number 22-766). Delphi panellists will receive participant information sheets describing the study before agreeing to participate in the Delphi process. Results from the data we anticipate will be generated through this research and will be submitted for peer-reviewed journal publication and presentation at international conferences.
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  • 文章类型: Journal Article
    1992年,美国麻醉医师学会伦理委员会成立,主要是为了解决现有的“不要复苏”命令提出麻醉的患者的权利。为这些患者的道德管理编写的指南指出,应重新考虑此类命令,而不是撤销,从而尊重患者的自决。委员会还通过扩大其伦理基础以反映不断变化的伦理意见气氛,重写了《麻醉学伦理实践指导原则》。这些准则描述了道德上适当的行为和行为,包括麻醉师对患者的道德责任,自己,同事们,医疗机构,社区和社会。
    In 1992, the American Society of Anesthesiologists Committee on Ethics was formed primarily to address the rights of patients with existing Do-Not-Resuscitate orders presenting for anesthesia. Guidelines written for the ethical management of these patients stated that such orders should be reconsidered-not rescinded-thus respecting patient self-determination. The Committee also rewrote the reigning Guidelines for the Ethical Practice of Anesthesiology by expanding its ethical foundations to reflect the evolving climate of ethical opinions. These Guidelines described ethically appropriate conduct and behavior, including anesthesiologists\' ethical responsibilities to patients, themselves, colleagues, health-care institutions, and community and society.
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  • 文章类型: Journal Article
    异种移植的历史始于19世纪。经过几十年的调查,在全球范围内取得了重大突破和临床前里程碑。随着最近将转基因猪的肾脏和心脏移植到人类体内,这些开创性的成就引起了全世界的极大关注,希望异种移植可以缓解甚至解决器官短缺的问题。2022年1月20日,中国器官移植发展基金会召开了“历史,人类异种移植临床试验的现状和未来,“与会专家讨论了促进中国异种移植伦理和可持续发展的方法。作为专题讨论会的产物,达成了正式的共识,概述专家对科学的意见,监管,中国异种移植临床试验的伦理问题。
    The history of xenotransplantation started in the 19th century. After a few decades of investigation, significant breakthroughs and preclinical milestones have been achieved worldwide. With the recent transplantation of genetically modified porcine kidneys and heart into humans, these ground-breaking achievements have attracted great attention worldwide, in the hope that xenotransplantation might alleviate or even solve the problem of organ shortage. On January 20, 2022, the China Organ Transplantation Development Foundation convened a symposium on \"The History, Current Situation and Future of Human Xenotransplantation Clinical Trials,\" where ways to promote the ethical and sustainable development of xenotransplantation in China were discussed among the participating experts. A formal consensus was reached as the product of the symposium, outlining the expert opinions on scientific, regulatory, and ethical issues of clinical trials of xenotransplantation in China.
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  • 文章类型: Journal Article
    目的:临床实践指南(CPGs)对于基于循证医学的标准化患者护理至关重要。然而,CPG作者之间存在财务利益冲突(COI)可能会损害他们的可信度。这项研究旨在检查日本精神病学CPG作者中COI的程度和大小。
    方法:对制药公司披露的付款进行的横断面分析评估了个人演讲付款的普遍性和规模,在2016年至2020年期间,向CPG咨询并撰写有关日本双相情感障碍和重度抑郁症的文章。
    结果:这项研究发现,93.3%的作者在5年内收到了付款,付款总额超过400万美元。每位作者的平均付款额为51403美元(IQR:9982美元-111567美元),由于付款明显集中在少数作者中,包括CPG主席。尽管有这些广泛的财务关系,只有一小部分作者在CPG中披露了他们的COIs。这些大量的个人付款是由制药公司生产CPG中列出的新抗抑郁药和安眠药。
    结论:这项研究发现,在日本,超过93%的针对重度抑郁症和双相情感障碍的CPG作者从制药行业获得了大量的个人付款。调查结果强调了与国际COI管理标准的偏差,并建议日本需要对精神病学CPG采取更严格的COI政策。
    OBJECTIVE: Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan.
    METHODS: This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020.
    RESULTS: This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs.
    CONCLUSIONS: This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.
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  • 文章类型: Journal Article
    背景:临床实践指南(CPGs)基于科学证据提供疾病管理建议。然而,CPG开发商和制药业之间的财务利益冲突可能会偏向这些建议,可能影响患者护理。适当管理这些利益冲突对于保持CPG的完整性尤为重要。该研究旨在评估日本制药业与心血管疾病CPG作者之间的财务关系程度。
    结果:该研究分析了2015年1月至2022年12月日本循环学会发布的从制药业向心血管疾病CPG作者的个人支付。付款数据,包括说话,咨询,以及2016年至2020年的写作费用,均从包含所有主要制药公司披露的个人付款的公开数据库中提取。从37名合格的日本流通协会CPG中总共确定了929名独特作者。值得注意的是,这些作者中有94.4%收到了制药公司的个人付款,总计>7080万美元。在5年内,每位作者的平均±SD付款额为76314±138663美元),每位作者的平均付款额为20792美元(四分位距:4262美元-76998美元)。CPG主席收到的报酬明显高于其他作者。每个CPG中超过80%的作者都收到了个人付款。
    结论:研究表明,日本的制药公司与心脏病学CPG作者之间存在相当大的财务关系。这一发现偏离了国际利益冲突管理政策,建议日本流通协会需要采取更严格的利益冲突管理策略,以确保开发值得信赖和基于证据的CPG。
    BACKGROUND: Clinical practice guidelines (CPGs) offer disease management recommendations based on scientific evidence. However, financial conflicts of interest between CPG developers and the pharmaceutical industry could bias these recommendations, potentially affecting patient care. Proper management of these conflicts of interest is particularly crucial for maintaining the integrity of CPGs. The study aimed to evaluate the extent of financial relationships between the pharmaceutical industry and authors of CPGs for cardiovascular diseases in Japan.
    RESULTS: The study analyzed personal payments from the pharmaceutical industry to authors of cardiovascular disease CPGs published by the Japanese Circulation Society from January 2015 to December 2022. Payment data, including speaking, consultancy, and writing fees from 2016 to 2020, were extracted from a publicly available database containing personal payments disclosed by all major pharmaceutical companies. A total of 929 unique authors from 37 eligible Japanese Circulation Society CPGs were identified. Notably, 94.4% of these authors received personal payments from pharmaceutical companies, totaling >US $70.8 million. The mean±SD payment per author was US $76 314±138 663) and the median payment per author was US $20 792 (interquartile range: US $4262-US $76 998) over the 5-year period. Chairs of CPGs received significantly higher payments than other authors. More than 80% of authors in each CPG received personal payments.
    CONCLUSIONS: The study elucidated that there were considerable financial relationships between pharmaceutical companies and cardiology CPG authors in Japan. This finding deviates from international conflict of interest management policies, suggesting the need for more stringent conflict of interest management strategies by the Japanese Circulation Society to ensure the development of trustworthy and evidence-based CPGs.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    目的评估制药公司与2020年日本风湿病学学会类风湿性关节炎管理临床实践指南(CPG)作者之间的财务关系,并评估支持指南建议的证据质量。方法这项回顾性研究评估了CPG的所有27位作者与日本制药公司之间的财务关系。2016年至2020年间,制药公司向这些作者支付的个人款项是从每家制药公司公开披露的数据库中提取的。还评估了支持CPG建议的证据的质量。结果所有27位作者都收到了制药公司的个人付款,在五年内总计3,683,048美元。每位作者的平均付款额分别为101,624美元和136,409美元。演讲补偿占所有个人付款的80%以上。77.8%以上(21位作者),66.7%(18位作者),51.9%(14位作者)在五年内获得了超过1万美元、5万美元和10万美元的总付款,分别。然而,未披露CPG作者与制药公司之间的财务关系.超过81.8%的CPG建议得到低质量或极低质量证据的支持。在强有力的建议中,66.7%得到低质量或极低质量证据的支持。结论即使所有CPG作者都从制药公司收到了大量的个人付款,这些利益冲突(COI)没有在CPG中披露。这些发现强调了迫切需要采取政策干预措施来提高透明度,完整性,以及日本CPG发展的可靠性。
    Objective To assess the financial relationships between pharmaceutical companies and authors of the 2020 Japan College of Rheumatology Clinical Practice Guidelines (CPG) for the Management of Rheumatoid Arthritis and to evaluate the quality of evidence supporting the guideline recommendations. Methods This retrospective study evaluated financial relationships between all 27 authors of the CPG and pharmaceutical companies in Japan. Personal payments from pharmaceutical companies to these authors between 2016 and 2020 were extracted from publicly disclosed databases for each pharmaceutical company. The quality of the evidence supporting the CPG recommendations was also assessed. Results All 27 authors received personal payments from pharmaceutical companies, totaling $3,683,048 over five years. The median and mean payments per author were $101,624 and $136,409, respectively. Speaking compensations accounted for more than 80% of all personal payments. More than 77.8% (21 authors), 66.7% (18 authors), and 51.9% (14 authors) received more than $10,000, $50,000, and $100,000 in total payments over the five years, respectively. Nevertheless, these financial relationships between the CPG authors and pharmaceutical companies were not disclosed. More than 81.8% of the CPG recommendations were supported by low- or very-low-quality evidence. Of the strong recommendations, 66.7% were supported by low- or very-low-quality evidence. Conclusion Even though all CPG authors received substantial amounts of personal payments from pharmaceutical companies, these conflicts of interest (COIs) were not disclosed in the CPG. These findings underscore the urgent need for policy interventions to enhance transparency, integrity, and reliability in the development of CPGs in Japan.
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  • 文章类型: Journal Article
    背景:在重大健康危机的背景下,卫生专业人员必须首先比较患者的康复前景,从而优先实现拯救最多生命的目标。
    目的:严格评估稀缺重症监护病房(ICU)的分配方案,作者在COVID-19大流行开始时提出了这一建议,最初发表在巴西的两家报纸上;并将该方案与类似的建议进行了比较,特别是巴西重症监护协会连续发布的2个方案。主要目的是强调作者\'方法的优势,并讨论在2020年原始发布后对拟议协议提出的一些批评。
    方法:3种不同方案(作者提出的方案和巴西重症监护协会发布的2种连续方案)在伦理原则方面的比较分析。
    结果:医疗保健系统的主要目标是在不可能为所有需要治疗的患者提供入院时,确保公平的患者分诊过程。关于ICU入院的公正优先次序的决策必须主要基于临床标准。序贯器官衰竭评估(SOFA)是,出于道德和技术原因,对患者进行临床评估的有用工具。根据SOFA分数的三个范围,患者可以分为“高”,a\"medium\",和一个“低优先级”组。在关系的情况下,生命周期原则必须是决胜局。如果领带坚持住,必须使用抽奖。
    结论:作者提出的方案比其他两个方案具有优势,因为它具有更大的实用性和同时解释平等主义和结果主义原则的能力。它旨在在公平的约束下拯救尽可能多的生命。此外,拟议的议定书避免了对残疾人的歧视,同时,促进对老年人的歧视。
    BACKGROUND: In the context of a major health crisis, health professionals must first compare patients\' recovery prospects, thus giving priority to the goal of saving the greatest number of lives.
    OBJECTIVE: Critically evaluate a protocol for allocation of scarce intensive care units (ICU), which the authors proposed at the onset of the COVID-19 pandemic and originally published in two Brazilian newspapers; and compare that protocol with similar proposals, particularly with 2 successive protocols issued by the Brazilian Critical Care Association. The main objective is to highlight the advantages of the authors\' approach and discuss some criticisms that has been levelled against the proposed protocol after its original publication in 2020.
    METHODS: Comparative analysis of 3 different protocols (the authors\' proposed protocol and 2 successive protocols issued by the Brazilian Critical Care Association) with regard to ethical principles.
    RESULTS: The main objective of a healthcare system is to ensure a fair patient triage process when it is impossible to grant admission to all patients in need of treatment. Decision-making regarding the impartial prioritization of ICU admissions must be based primarily on clinical criteria. The Sequential Organ Failure Assessment (SOFA) is, for ethical and technical reasons, a useful tool for clinical assessments of patients. Based on three ranges of SOFA scores, patients can be classified into a \"high\", a \"medium\", and a \"low\" priority group. In the case of ties, the life cycle principle must be the tiebreaker. If the tie persists, a draw must be used.
    CONCLUSIONS: The authors\' proposed protocol has advantages over the other two protocols due to its greater practicality and capacity to account for egalitarian and consequentialist principles simultaneously. It aims at saving as many lives as possible within the constraints of fairness. Furthermore, the proposed protocol avoids discrimination against people with disabilities without, at the same time, promoting discrimination against the elderly.
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  • 文章类型: Journal Article
    在定义用于预防输血相关移植物抗宿主病(TA-GVHD)的血液成分照射适应症时,已发布的指南和临床实践有所不同。这项研究评估了由多个人工智能(AI)程序生成的辐照指示列表,或者聊天机器人,并将其与2020年英国血液学会(BSH)实践指南进行了比较。四个聊天机器人(ChatGPT-3.5、ChatGPT-4、Bard、和BingChat)被提示列出照射以防止TA-GVHD的适应症。根据BSH指南对反应进行分级。Chatbot响应长度,差异,并注意到遗漏。Chatbot的反应不同,但都是相关的,长度短,通常与BSH指南相比更一致,大致完整。他们缺乏BSH指南中列出的几种适应症,并且在胎儿和新生儿的辐照合格标准方面显着不同。聊天机器人可变地列出了预防TA-GVHD的错误指示,例如接受来自不同种族或民族的献血者的血液的患者。这项研究证明了生成AI在输血医学和血液学主题中的潜在用途,但强调了聊天机器人医学错误信息的风险。进一步研究TA-GVHD的危险因素,以及聊天机器人在输血医学和血液学中的应用,是有保证的。
    Published guidelines and clinical practices vary when defining indications for irradiation of blood components for the prevention of transfusion-associated graft-versus-host disease (TA-GVHD). This study assessed irradiation indication lists generated by multiple artificial intelligence (AI) programs, or chatbots, and compared them to 2020 British Society for Haematology (BSH) practice guidelines. Four chatbots (ChatGPT-3.5, ChatGPT-4, Bard, and Bing Chat) were prompted to list the indications for irradiation to prevent TA-GVHD. Responses were graded for concordance with BSH guidelines. Chatbot response length, discrepancies, and omissions were noted. Chatbot responses differed, but all were relevant, short in length, generally more concordant than discordant with BSH guidelines, and roughly complete. They lacked several indications listed in BSH guidelines and notably differed in their irradiation eligibility criteria for fetuses and neonates. The chatbots variably listed erroneous indications for TA-GVHD prevention, such as patients receiving blood from a donor who is of a different race or ethnicity. This study demonstrates the potential use of generative AI for transfusion medicine and hematology topics but underscores the risk of chatbot medical misinformation. Further study of risk factors for TA-GVHD, as well as the applications of chatbots in transfusion medicine and hematology, is warranted.
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    文章类型: Journal Article
    本研究旨在为伊朗的医疗保健提供者编写和制定有关网络空间使用的专业指南。这是一项混合方法研究,分三个阶段进行。在第一阶段,网络空间的道德原则是通过对文献和现有文件的审查来收集的,然后进行内容分析。在第二阶段,专家对医学伦理的看法,虚拟教育,信息技术和医学教育,以及临床科学专家以及医学生和毕业生的代表使用焦点小组方法进行了评估。在第三阶段,各利益攸关方对草案进行了评估。最后,收到评论后,对指南进行了必要的修改.卫生保健专业人员使用网络空间的专业指南包括5个领域的30个代码,包括一般法规领域,护理和治疗,研究,教育,和个人发展。本指南介绍了在网络空间互动中保持专业性的各种方式。为了保护和维护公众对医疗保健专业人员的信任,必须遵守网络空间的专业原则。
    The present study aimed to compile and develop a professional guideline for health-care providers in Iran regarding cyberspace usage. This was a mixed-methods study, conducted in three phases. In the first phase, the principles of ethics in cyberspace were collected through a review of the literature and available documents, and were then subjected to content analysis. In the second phase, the views of experts on medical ethics, virtual education, information technology and medical education, as well as clinical sciences experts and representatives of medical students and graduates were evaluated using the focus group method. In the third phase, the draft was evaluated by various stakeholders. Finally, after receiving the comments, the necessary modifications were applied to the guideline. The professional guideline for the use of cyberspace by health-care professionals comprised 30 codes in 5 domains, including the general regulations domain, care and treatment, research, education, and personal development. This guideline presents the various ways professionalism can be maintained in cyberspace interactions. Adherence to the principles of professionalism in cyberspace is required to protect and preserve the public trust in health-care professionals.
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