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: 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: 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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  • 文章类型: Journal Article
    目的:到目前为止,还没有研究比较“雌马酚生产者”的各种定义。因此,我们旨在探讨5种不同的雌马酚生产者(EQP)定义的准确性及其与健康益处的关联.
    方法:这是一项针对466名年龄在22至88岁之间的健康日本男性和女性的横断面研究。使用五个常用定义,根据其血清和尿液异黄酮浓度计算雌马酚生产者的比例。然后我们检查了它们的准确性,以及与血液参数的关联。
    结果:雌马酚的比例从最严格定义的29%到最敏感定义的47.6%不等。与非雌马酚生产者(NEQP)相比,在所有定义下鉴定的EQP具有显著低的血清PSA1水平。最严格的定义,定义为1.0μM及以上的尿雌马酚水平,对应于最高的中位血清雌马酚水平,并且与更好的健康结局相关.通过该定义确定的男性EQP似乎将LDL2高胆固醇血症的风险降低了50%,通过这个定义确定的女性EQP似乎具有较低的高hs-CRP风险,3与NEQP相比。第一个和第二个严格的定义,定义为1.0ng/mL及以上的血清雌马酚水平,与较低的促甲状腺激素水平有关。
    结论:更严格的定义通常与更好的参数相关。结合饮食询问,雌马酚生产者的可靠定义对于评估雌马酚的健康益处至关重要。
    OBJECTIVE: No studies have compared various definitions of \"equol producers\" until now. Therefore, we aimed to explore the accuracy of five different definitions of equol producers (EQP) and their associations with health benefits.
    METHODS: This is a cross-sectional study of 466 healthy Japanese men and women aged between 22 and 88 years. Equol producer proportions were calculated from their serum and urine isoflavone concentrations using five commonly used definitions. We then examined their accuracy, and associations with the blood parameters.
    RESULTS: Proportions of equol ranged from 29 % in the most stringent definition to 47.6 % in the most sensitive definition. EQP identified under all definitions had significantly low serum PSA1 levels compared to nonequol producers (NEQP). The most stringent definition, which is defined as the urinary equol level of 1.0 μM and above, corresponded to the highest median serum equol level and was associated with better health outcomes. Male EQP identified by this definition seemed to have reduced risk of LDL2-hypercholesterolemia by 50 %, and female EQP identified by this definition seemed to have lower risk of high hs-CRP,3 compared to NEQP. Both the first and second stringent definition, which is defined as the serum equol level of 1.0 ng/mL and above, was associated with lower thyroid stimulating hormone level.
    CONCLUSIONS: More stringent definitions were associated with better parameters in general. Combined with the dietary inquires, a reliable definition for equol producer is crucial to evaluate the health benefits of equol.
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  • 文章类型: Journal Article
    目标:肌肉减少症,与年龄相关的肌肉质量和力量/功能损失,是重要的临床病症。然而,在定义上没有国际共识。
    目的:全球肌肉减少症领导力倡议(GLIS)旨在通过建立肌肉减少症的全球概念定义来解决这一问题。
    方法:GLIS指导委员会于2019-21年成立,来自全球所有相关科学协会的代表。在此期间,指导委员会就该主题发表了一系列声明,并邀请这些协会的成员参加两阶段的国际德尔福研究。在2022年至2023年之间,参与者使用在线调查工具(SurveyMonkey)对他们的协议进行了排名。声明根据预定义的阈值进行分类:强一致性(>80%),中等协议(70-80%)和低协议(<70%)。接受了强烈同意的声明,低协议的声明被拒绝,中等协议的声明被重新提出,直到达成共识。
    结果:107名参与者(平均年龄:54±12岁[1个缺失年龄],来自7大洲/地区的29个国家/地区的64%的男性)完成了Delphi调查。20份声明被发现有一个强有力的协议。这些包括;6个关于“肌肉减少症的一般方面”的陈述(最一致的是:肌肉减少症的患病率随着年龄的增长而增加(98.3%)),关于肌少症的成分的3个陈述(肌肉质量(89.4%),肌肉力量(93.1%)和肌肉特定力量(80.8%)都应成为肌少症概念定义的一部分))和11项关于肌少症结局的陈述(最强的共识:肌少症增加了身体机能受损的风险(97.9%)。德尔菲调查的一个关键发现是肌肉质量,肌肉力量和肌肉比力量都被接受为“肌肉减少症的组成部分”,而受损的身体表现被认为是肌肉减少症的“结果”,而不是“部分”。
    结论:GLIS创建了第一个关于肌少症的全球概念定义,现在将用于为临床和研究环境制定可操作的定义。
    Sarcopenia, the age-related loss of muscle mass and strength/function, is an important clinical condition. However, no international consensus on the definition exists.
    The Global Leadership Initiative in Sarcopenia (GLIS) aimed to address this by establishing the global conceptual definition of sarcopenia.
    The GLIS steering committee was formed in 2019-21 with representatives from all relevant scientific societies worldwide. During this time, the steering committee developed a set of statements on the topic and invited members from these societies to participate in a two-phase International Delphi Study. Between 2022 and 2023, participants ranked their agreement with a set of statements using an online survey tool (SurveyMonkey). Statements were categorised based on predefined thresholds: strong agreement (>80%), moderate agreement (70-80%) and low agreement (<70%). Statements with strong agreement were accepted, statements with low agreement were rejected and those with moderate agreement were reintroduced until consensus was reached.
    107 participants (mean age: 54 ± 12 years [1 missing age], 64% men) from 29 countries across 7 continents/regions completed the Delphi survey. Twenty statements were found to have a strong agreement. These included; 6 statements on \'general aspects of sarcopenia\' (strongest agreement: the prevalence of sarcopenia increases with age (98.3%)), 3 statements on \'components of sarcopenia\' (muscle mass (89.4%), muscle strength (93.1%) and muscle-specific strength (80.8%) should all be a part of the conceptual definition of sarcopenia)) and 11 statements on \'outcomes of sarcopenia\' (strongest agreement: sarcopenia increases the risk of impaired physical performance (97.9%)). A key finding of the Delphi survey was that muscle mass, muscle strength and muscle-specific strength were all accepted as \'components of sarcopenia\', whereas impaired physical performance was accepted as an \'outcome\' rather than a \'component\' of sarcopenia.
    The GLIS has created the first global conceptual definition of sarcopenia, which will now serve to develop an operational definition for clinical and research settings.
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  • 文章类型: Journal Article
    目的:本文件的目的是制定非中性粒细胞减少的侵袭性真菌病(IFD)的标准化研究定义,没有IFD经典宿主因子的成年患者,入住重症监护病房(ICU)。
    方法:在对已有定义和实验室检查的目标人群中IFD的诊断性能进行系统评估之后,共识定义由专家小组使用RAND/UCLA适当性方法制定.
    结果:为已证实的侵袭性念珠菌病制定了标准化的研究定义,可能是深层念珠菌病,已经证实的侵袭性曲霉病,可能的侵袭性肺曲霉病,和可能的气管支气管曲霉病。除了念珠菌病和曲霉病以外,关于诊断IFD的现有定义和实验室测试的证据有限,因此无法制定专门的定义。至少等待进一步的数据。本文件提供的标准化定义旨在加快设计速度,并增加可行性,未来的比较研究。
    OBJECTIVE: The aim of this document was to develop standardized research definitions of invasive fungal diseases (IFD) in non-neutropenic, adult patients without classical host factors for IFD, admitted to intensive care units (ICUs).
    METHODS: After a systematic assessment of the diagnostic performance for IFD in the target population of already existing definitions and laboratory tests, consensus definitions were developed by a panel of experts using the RAND/UCLA appropriateness method.
    RESULTS: Standardized research definitions were developed for proven invasive candidiasis, probable deep-seated candidiasis, proven invasive aspergillosis, probable invasive pulmonary aspergillosis, and probable tracheobronchial aspergillosis. The limited evidence on the performance of existing definitions and laboratory tests for the diagnosis of IFD other than candidiasis and aspergillosis precluded the development of dedicated definitions, at least pending further data. The standardized definitions provided in the present document are aimed to speed-up the design, and increase the feasibility, of future comparative research studies.
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