Definitions

定义
  • 文章类型: Journal Article
    迄今为止,药品的非说明书使用是指未经批准使用已批准的药品,涵盖未经批准的适应症,患者群体,剂量,和/或给药途径,已经存在很多年了。目前,关于抗肿瘤药物的标签外使用的研究频率和普遍性有限,主要是由于定义和分类问题不完整。现在是时候接受抗癌药物标签外使用的新类别了。这篇综述提供了对抗癌药物标签外使用的概念和类别的最新概述,以及举例说明具体的例子,以建立关于抗癌药物在肿瘤学环境中的标签外使用程度的下一步研究。目前的抗癌药物超出以前定义的标签外使用范围不仅包括适应症方面的标签外使用,患者群体,剂量,和/或给药途径,以及药物疗程方面的标签外使用,组合,药物的顺序,临床目的,禁忌症场景,等。此外,抗癌药的标签外用法的定义应在给定时间添加到该病症中,它不同于审批机构。我们提出了一个新的和相对全面的分类,首次提供抗肿瘤药物标签外使用的广泛分析和说明性示例。这种分类有可能促进实际采用并增强抗肿瘤药物的标签外使用的管理策略。
    To date, the definition that the off-label usage of drugs refers to the unapproved use of approved drugs, which covers unapproved indications, patient populations, doses, and/or routes of administration, has been in existence for many years. Currently, there is a limited frequency and prevalence of research on the off-label use of antineoplastic drugs, mainly due to incomplete definition and classification issues. It is time to embrace new categories for the off-label usage of anticancer drugs. This review provided an insight into an updated overview of the concept and categories of the off-label use of anticancer drugs, along with illustrating specific examples to establish the next studies about the extent of the off-label usage of anticancer drugs in the oncology setting. The scope of the off-label use of current anticancer drugs beyond the previous definitions not only includes off-label uses in terms of indications, patient populations, doses, and/or routes of administration but also off-label use in terms of medication course, combination, sequence of medication, clinical purpose, contraindications scenarios, etc. In addition, the definition of the off-label usage of anticancer drugs should be added to the condition at a given time, and it varies from approval authorities. We presented a new and relatively comprehensive classification, providing extensive analysis and illustrative examples of the off-label usage of antineoplastic drugs for the first time. Such a classification has the potential to promote practical adoption and enhance management strategies for the off-label use of antitumor drugs.
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  • 文章类型: Journal Article
    本文介绍了国际度量衡委员会(CIPM)的质量和相关数量协商委员会-硬度工作组(CCM-WGH)用于制定常规罗克韦尔的国际定义的过程,Brinell,维氏硬度和努氏硬度试验方法,供标准化硬度测量的国家计量机构(NMI)使用。
    This paper describes the process used by the Consultative Committee for Mass and Related Quantities - Working Group on Hardness (CCM-WGH) of the International Committee of Weights and Measures (CIPM) to develop international definitions of the conventional Rockwell, Brinell, Vickers and Knoop hardness test methods, for use by the National Metrology Institutes (NMI) that standardize hardness measurement.
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  • 文章类型: Editorial
    我们有理由重视《统一死亡判定法》(UDDA)。自颁布以来,UDA对美国公民来说是最重要的,昏迷患者的家属,以及照顾他们的医疗保健专业人员。UDA规定了确定死亡的两个标准,并留给医学界详细阐述医生可以确定何时达到这些标准的标准。神经学家和神经重症监护专家一直是这项工作的中心舞台。完美建立,Whychangeit?WhatlightstherecentreviewoftheUDDAwerelawsquestioningmedical(neuronology)authorityleadingtotheworkationandacciracityoftheUDDAbeingrevisioned.几个团体对UDDA语言的主要反对意见导致统一法律委员会任命的一个委员会考虑了该法案的几项重大修改。经过几年的讨论,没有达成共识,委员会主席暂停了这项工作。UpendingUDA将导致各州的法律危机和混乱。我们提出了反对修改本法规的主要论点,并认为委员会未能修改UDA实际上应被视为必要的成功。
    We have a reason to value the Uniform Determination of Death Act (UDDA). Since enactment, the UDDA has been of paramount importance to US citizens, families of comatose patients, and the health care professionals who care for them. The UDDA sets forth two standards for determining death and leaves to the medical community to elaborate criteria by which physicians can determine when those standards have been met. Neurologists and neurocritical care experts always have been center stage in this effort. Perfectly established, why change it? What ignited the recent review of the UDDA were lawsuits questioning medical (neurological) authority leading to the wording and accuracy of the UDDA being revisited. The major objections to the language of the UDDA by several groups led a committee appointed by the Uniform Law Commission to consider several substantial changes in the Act. After several years of discussion without reaching a consensus, the committee\'s chair suspended the effort. Upending the UDDA will lead to a legal crisis and confusion across the states. We present our main arguments against revising this statute and argue that the committee\'s failure to revise the UDDA should actually be seen as a necessary success.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    在目前的临床实践中,定性或半定量测量主要用于在心脏CT上报告冠状动脉疾病。随着心脏CT技术和自动化后处理工具的进步,冠状动脉疾病严重程度的定量测量已变得更加广泛。定量冠状动脉CT血管成像对患者的临床管理具有巨大的潜在价值,也是为了研究。本文件旨在为心脏CT定量测量冠状动脉疾病的性能和报告提供定义和标准。
    In current clinical practice, qualitative or semi-quantitative measures are primarily used to report coronary artery disease on cardiac CT. With advancements in cardiac CT technology and automated post-processing tools, quantitative measures of coronary disease severity have become more broadly available. Quantitative coronary CT angiography has great potential value for clinical management of patients, but also for research. This document aims to provide definitions and standards for the performance and reporting of quantitative measures of coronary artery disease by cardiac CT.
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  • 文章类型: Letter
    多年来,对据称死于婴儿猝死综合症(SIDS)的婴儿的研究质量参差不齐。即使是现在,同行评审的论文也在没有进行尸检的情况下发表,被称为“SIDS”。尽管这是超过五十年来三个主要定义的要求。显然,早期研究中使用的案例不可能符合尚未公布的定义/指南的要求。因此,在引用初步文件时必须小心,因为它们的结果可能因非小岛屿发展中国家案件的存在而有偏差。这可能与荟萃分析特别相关。回顾关于P物质及其与小岛屿发展中国家关系的文献,提供了一个很好的例子,说明在不同时间点如何得出截然相反的结论。对小岛屿发展中国家的早期研究,并研究了在标准NICHD和圣地亚哥定义之前分类的用例,应该,因此,以一定程度的怀疑态度对待,而不是在当代论文或会议上引用,因为它们有可能混淆而不是澄清。
    Research on infants who have allegedly succumbed to sudden infant death syndrome (SIDS) has been of variable quality over the years. Even now peer-reviewed papers are being published on cases termed \'SIDS\' without autopsies having been performed, despite this being a requirement of the three major definitions for over five decades. Clearly cases used in earlier research studies could not have complied with the requirements of as-yet unpublished definitions/guidelines. For this reason care must be taken in citing initial papers as their results may have been skewed by the presence of non-SIDS cases. This may have particular relevance for meta analyses. Reviewing the literature on substance P and its relationship to SIDS provides an excellent example of how diametrically opposed conclusions were reached at different time points. Early studies on SIDS, and studies that use cases that were classified before the standard NICHD and San Diego definitions, should, therefore, be approached with a degree of scepticism and not cited in contemporary papers or at meetings as they have the potential to confuse rather than clarify.
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  • 文章类型: Journal Article
    新冠肺炎大流行戏剧性地显示了人类人口的相互联系程度,人类健康与生态系统之间的直接关系,以及全球应对所需的巨大道德挑战。相关地,社会直接面临着全球健康问题,“无论是在世界各地的健康状况和卫生系统弹性的认识,以及全球对策的治理及其在国家和地方各级的影响。虽然全球健康经常被用作新殖民主义方法的化妆品标签,这实际上是一种跨学科的方法,包括全球化和健康决定因素之间的相互作用。因此,它涉及生态系统及其转型,并在其战略的定义中暗示了一种系统的“一个健康”非殖民化方法。Covid-19大流行凸显了当前霸权的全球卫生系统治理的不平等和局限性;呼吁伦理提供新的,全面,包容性,以及全球健康的非殖民化概念化。
    The Covid-19 pandemic has dramatically shown the level of interconnectedness of the human population, the direct relation between human health and the ecosystem, as well as the enormous ethical challenges required for a global response. Relatedly, society has been directly confronted by issues of \'Global health,\' both in terms of awareness of health conditions and health systems resiliency all around the world, as well as in terms of governance of the worldwide response and its implications at national and local levels. While Global health is often used as a cosmetic label for neocolonial approaches, it is really an interdisciplinary approach consisting of the interaction between globalization and the determinants of health. Thus, it involves the ecosystem and its transformation and implies a systemic \'One Health\' decolonized approach in the definition of its strategies. The Covid-19 pandemic has highlighted the inequities and the limits of the current hegemonic Global health system governance; calling for ethics to provide a renewed, comprehensive, inclusive, and decolonized conceptualization of Global health.
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  • 文章类型: Journal Article
    吻合口漏(AL)是一种严重且令人恐惧的术后并发症,尽管外科技术取得了进步,但发病率高达30%。随着额外干预等影响,住院时间延长,再入院,AL对个体患者和医疗保健提供者的水平具有重要影响,以及整个医疗系统。事实证明,在开发统一的泄漏定义和分级系统方面的挑战是有问题的,尽管承认结直肠AL是肠道手术中的关键问题,但后果严重。本研究的目的是对围绕AL的定义和分级系统的文献进行叙述性回顾,以及这种术后并发症的后果。
    通过检查包括PubMed,WebofScience,OVIDEmbase,谷歌学者,和Cochrane图书馆数据库。使用以下关键词进行搜索:吻合,吻合口漏,结直肠,手术,分级系统,并发症,危险因素,和后果。对检索到的出版物进行进一步评估,以确保确定并包括其他相关出版物。
    仍然缺乏普遍接受的AL定义和评分系统,导致文献中报告的发病率变化。其他因素增加了估计的可变性,包括吻合部位的差异和手术技术的机构/个体差异。各种小组都在努力发布定义和分级AL的指南,国际直肠癌研究小组(ISGRC/ISREC)的定义是目前最推荐的结直肠AL通用定义。AL对患者的负担,医疗保健提供者,医院有很好的证据证明泄漏的后果,如发病率和死亡率增加,更高的再手术率,再入院率提高,在其他人中。
    结直肠AL仍然是肠道外科的重大挑战,尽管医学进步。了解在定义和分级泄漏方面取得的进展,以及AL产生的一系列负面结果,对改善病人护理至关重要,降低手术死亡率,并推动AL早期检测和治疗的进一步发展。
    UNASSIGNED: Anastomotic leaks (ALs) are a significant and feared postoperative complication, with incidence of up to 30% despite advances in surgical techniques. With implications such as additional interventions, prolonged hospital stays, and hospital readmission, ALs have important impacts at the level of individual patients and healthcare providers, as well as healthcare systems as a whole. Challenges in developing unified definitions and grading systems for leaks have proved problematic, despite acknowledgement that colorectal AL is a critical issue in intestinal surgery with serious consequences. The aim of this study was to construct a narrative review of literature surrounding definitions and grading systems for ALs, and consequences of this postoperative complication.
    UNASSIGNED: A literature review was conducted by examining databases including PubMed, Web of Science, OVID Embase, Google Scholar, and Cochrane library databases. Searches were performed with the following keywords: anastomosis, anastomotic leak, colorectal, surgery, grading system, complications, risk factors, and consequences. Publications that were retrieved underwent further assessment to ensure other relevant publications were identified and included.
    UNASSIGNED: A universally accepted definition and grading system for ALs continues to be lacking, leading to variability in reported incidence in the literature. Additional factors add to variability in estimates, including differences in the anastomotic site and institutional/individual differences in operative technique. Various groups have worked to publish guidelines for defining and grading AL, with the International Study Group of Rectal Cancer (ISGRC/ISREC) definition the current most recommended universal definition for colorectal AL. The burden of AL on patients, healthcare providers, and hospitals is well documented in evidence from leak consequences, such as increased morbidity and mortality, higher reoperation rates, and increased readmission rates, among others.
    UNASSIGNED: Colorectal AL remains a significant challenge in intestinal surgery, despite medical advancements. Understanding the progress made in defining and grading leaks, as well as the range of negative outcomes that arise from AL, is crucial in improving patient care, reduce surgical mortality, and drive further advancements in earlier detection and treatment of AL.
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  • 文章类型: Journal Article
    在接受机械循环支持(MCS)的患者中,感染仍然是一个重要的问题。包括耐用和急性装置。这份共识手稿提供了与耐用MCS设备相关的感染的最新定义,以及急性MCS感染的新定义。整合现有文献的全面审查和多学科专家之间的合作讨论。通过建立共识定义,我们寻求加强临床护理,促进研究中一致的报告,并最终改善接受MCS的患者的预后。
    Infections remain a significant concern in patients receiving mechanical circulatory support (MCS), encompassing both durable and acute devices. This consensus manuscript provides updated definitions for infections associated with durable MCS devices and new definitions for infections in acute MCS, integrating a comprehensive review of existing literature and collaborative discussions among multidisciplinary specialists. By establishing consensus definitions, we seek to enhance clinical care, facilitate consistent reporting in research studies, and ultimately improve outcomes for patients receiving MCS.
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  • 文章类型: Journal Article
    背景:早产儿慢性肺病(CLD)是早产最常见的并发症,表明长期肺部并发症的可能性增加。这种情况的准确诊断对于长期健康管理至关重要。许多定义定义了具有不同临床参数和放射学结果的CLD,使疾病的诊断含糊不清和潜在的不准确。
    方法:本研究确定了95例患者,根据放射科医师胸片报告中CLD的诊断或确认确定。在每个患者生命的最初几个月内,在多个基准时间范围内记录肺功能和并发症,并用于确定每个定义下的资格。
    结果:CLD的每个临床定义对于放射科医师确定患有CLD的患者都有很高的敏感性,正确拟合超过90%的患者。大多数患者在月经后36周时需要有创机械通气或正压通气,表明放射学证实的CLD患者倾向于患有更严重的疾病。放射科医生倾向于在月经后36周之前诊断CLD,多个标准临床定义使用的时间点,与较早调用的情况相比,在更大的定义百分比下拟合。
    结论:放射科医师倾向于在患有严重呼吸损害的年轻患者中诊断CLD,并且可以在满足临床定义的发展里程碑之前准确诊断病情。
    BACKGROUND: Chronic lung disease of prematurity (CLD) is the most prevalent complication of preterm birth and indicates an increased likelihood of long-term pulmonary complications. The accurate diagnosis of this condition is critical for long-term health management. Numerous definitions define CLD with different clinical parameters and radiology findings, making diagnosis of the disease ambiguous and potentially inaccurate.
    METHODS: 95 patients were identified for this study, as determined by the diagnosis or confirmation of CLD in the impression of the radiologist\'s report on chest x-ray. Pulmonary function and complications were recorded at multiple benchmark timeframes within each patient\'s first few months of life and used for determining eligibility under each definition.
    RESULTS: Each clinical definition of CLD had a high sensitivity for patients identified to have CLD by radiologists, correctly fitting over 90% of patients. Most patients included required invasive mechanical ventilation or positive pressure ventilation at 36 weeks postmenstrual age, indicating patients with radiographically confirmed CLD tended to have more severe disease. Radiologists tended to diagnose CLD before 36 weeks postmenstrual age, a timepoint used by multiple standard clinical definitions, with cases called earlier fitting under a larger percentage of definitions than those called later.
    CONCLUSIONS: Radiologists tend to diagnose CLD in young patients with severe respiratory compromise, and can accurately diagnose the condition before developmental milestones for clinical definitions are met.
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