A Prediction Model for High Risk of Positive RT-PCR Tests in Discharged Patients with COVID-19 Based on Random Forest Model
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Several recent studies have reported that a few patients had positive SARS-CoV-2 RNA tests after hospital discharge. The high-risk factors associated with these patients remain to be identified. A total of 463 patients with COVID-19 discharged from Leishenshan Hospital in Wuhan, China, between February 8 and March 8, 2020 were initially enrolled, and 351 patients with at least two weeks of follow-up were finally included. Seventeen of the 351 discharged patients had positive tests for SARS-CoV-2 RNA. Based on clinical characteristics and mathematical modeling, patients with shorter hospital stays and less oxygen desaturation were at higher risk of SARS-CoV-2 RNA reoccurrence after discharge. Notably, traditional Chinese medicine treatment offered extensive benefits to reduce risk. Particular attention should be paid to those patients with high risk, and traditional Chinese medicine should be advocated.Funding Statement: The study was supported by National Key Research and Development Plan of China (2020YFC0845500).Declaration of Interests: All authors have no conflicts of interest or financial ties to disclose.Ethics Approval Statement: The study was approved by the ethics committee of Zhongnan Hospital of Wuhan University (No. 2020074). The informed consent of the patients was waived for this infectious disease by the ethics committee.Keywords:
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In the article by Wong A, Sanchez-Gonzalez MA, Son W-M, Kwak Y-S, Park S-Y. The effects of a 12-week combined exercise training program on arterial stiffness, vasoactive substances, inflammatory markers, metabolic profile, and body composition in obese adolescent girls. Ped Exerc Sci. 2018;30:480–486. https://doi.org/10.1123/pes.2017-0198, it was incorrectly reported that institutional review board (IRB) approval was obtained. The study was performed in 2011, which predated South Korea’s IRB, initiated in 2013. The authors confirm that data collection and all procedures were appropriately performed in accordance with the Declaration of Helsinki, and informed consent from each participant was obtained despite the absence of IRB approval. The authors apologize for this error.
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Objectives: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure. Design: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers. Results: During the period, the proportion of journals requiring IRB approval increased from 42% (95% CI 32.2% to 51.2%, p<0.001) to 76% (95% CI 66.4% to 83.1%, p<0.001). In 2005, an additional 9% referred to the Declaration of Helsinki or the International Committee of Medical Journal Editors’ Uniform requirements for ethical guidelines ; 15% (95% CI 8.5% to 22.5%, p<0.01) provided ambiguous or no requirements. The proportion of journals requiring COI disclosure increased from 75% (95% CI 66.6% to 83.3%, p<0.05) to 94% (95% CI 89.4% to 98.6%, p<0.05); 41% had comprehensive requirements, while some addressed only funding source (6%), were vague (10%) or both (14%). Criteria for authorship rose from 40% (95% CI 30.5% to 49.5%, p<0.05) to 72% (95% CI 63.3% to 80.7%, p<0.05). Journals with higher impact factors were more likely to require IRB approval (p<0.01). Journals in anaesthesia and radiology all required IRB approval; requirements in other disciplines varied. Conclusions: Instructions to authors regarding ethical standards have improved. Some remain incomplete, especially regarding the scope of disclosure of COI. The ethical guidelines presented to authors need further clarification and standardisation.
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Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?
Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.
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The World Medical Association's Declaration of Helsinki was first adopted in 1964. In its 40‐year lifetime the Declaration has been revised five times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research. The most recent revision, however, has resulted in considerable controversy, particularly in the area of the ethical requirements surrounding placebo‐controlled trials and the question of responsibilities to research participants at the end of a study. This review considers the past versions of the Declaration of Helsinki and asks the question: How exactly has the text of the Declaration changed throughout its lifetime? Regarding the present form of the Declaration of Helsinki we ask: What are the major changes in the most recent revision and what are the controversies surrounding them? Finally, building on the detailed review of the past and present versions of the Declaration of Helsinki, we give consideration to some of the possible future trajectories for the Declaration in the light of its history and standing in the world of the ethics of medical research.
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“The Declaration of Helsinki” and “The Helsinki Declaration” are short titles frequently used for the World Medical Association's “Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.” The Declaration which was first issued in 1964 is one of the foundational documents in medical research ethics. This entry outlines the history of the Declaration and its main principles. It then provides an analysis of three major areas of controversy in relation to the Declaration its scope and reach, its provisions for research in groups of vulnerable participants, and its provisions for placebo‐controlled clinical trials in circumstances where there already is a standard treatment for the condition in question.
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Abstract The “Declaration of Helsinki” or the “Helsinki Declaration” are the short titles usually used for the World Medical Association's “Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.”
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The World Medical Association's ‘Declaration of Helsinki’ on Medical Research on Human Subjects is undergoing its sixth revision in its 44 years. The aim of this paper is to put the Declaration into an historical context, define and identify the core ethical principles, and illustrate how these are applied within the Declaration.
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