Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, Sapienza University of Rome, Rome, Italy.
Department of Excellence of Biomedical Sciences and Public Health, University Politecnica delle Marche, Ancona, Italy.
BMC Med Ethics. 2020 Nov 19;21(1):117. doi: 10.1186/s12910-020-00562-7.
The Authors have laid out an analysis of Italian COVID-19 confirmed data and fatality rates, pointing out how a dearth of health care resources in northern regions has resulted in hard, ethically challenging decisions in terms of granting patient access to intensive care units (ICU).
Having to make such decisions certainly entails substantial difficulties, and that has led many health care professional to seek ethical guidance. The Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) has attempted to meet that growing need by a set of recommendations, applying "clinical soundness" as a beacon standard; that approach tends to prioritize patients with higher life expectancy, which could be characterized as a "moderately utilitarian" approach. Yet, such a selection has engendered daunting ethical quandaries. The authors believe it can only be warranted and acceptable if rooted in a transparent decision-making process and verifiable, reviewed criteria. Moreover, the authors have stressed how clinical experimentation in a pandemic setting is a subtext of great interest from an ethical perspective. In Italy, no drug therapy and trials were undertaken for COVID-19 patients for a rather long period of time. When the epidemic was already circulating, an intervention proved necessary on the system of administrative procedures, aimed at expediting the authorization and validation of protocols, then bogged down by bureaucracy. A new system has since been instituted by a government decree that was signed about one month after the first Covid-19 case was officially recorded in the country. Such a swift implementation, which took just a few weeks, is noteworthy and proves that clinical trials can be initiated in a timely fashion, even with a pandemic unfolding. The concerted, action of supportive care and RCTs is the only way to attain effective forms of treatments for COVID-19 and any other future outbreak.
The authors have arrived at the conclusion that the most effective and ethically sound response on the part of any national health care system would be to adequately reconfigure its organizational mechanisms, by making clinical trials and all related administrative procedures consistent with the current state of emergency.
作者对意大利 COVID-19 确诊数据和死亡率进行了分析，指出北部地区医疗资源匮乏，导致在重症监护病房（ICU）患者准入方面做出艰难、具有伦理挑战性的决策。
做出这样的决策肯定存在很大的困难，这导致许多医疗保健专业人员寻求伦理指导。意大利麻醉、镇痛、复苏和重症监护学会（SIAARTI）试图通过一系列建议来满足这一日益增长的需求，以“临床合理性”作为标准；这种方法倾向于优先考虑预期寿命较高的患者，可以说是一种“适度功利主义”的方法。然而，这种选择引发了令人畏惧的伦理困境。作者认为，只有在透明的决策过程和可验证、可审查的标准的基础上，这种选择才是合理和可以接受的。此外，作者强调了在大流行背景下进行临床实验从伦理角度来看是一个非常重要的问题。在意大利，由于官僚主义的阻碍，相当长一段时间内，没有对 COVID-19 患者进行药物治疗和试验。当疫情已经在传播时，需要对行政程序系统进行干预，旨在加快协议的授权和验证，然后被官僚主义所阻碍。此后，政府通过一项法令建立了一个新系统，该法令是在该国正式记录首例新冠病毒病例一个月后签署的。这种快速实施引人注目，证明了即使在大流行期间，临床试验也可以及时启动。支持性护理和 RCT 的协同行动是为 COVID-19 及任何未来爆发获得有效治疗方法的唯一途径。
作者得出的结论是，任何国家医疗保健系统最有效的、符合伦理的应对方式是充分调整其组织机制，使临床试验和所有相关行政程序与当前的紧急状态相一致。
