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.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 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.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    对比剂相关急性肾损伤(CA-AKI)是冠状动脉造影(CAG)后常见的并发症。然而,围绕其精确定义一直存在争议。尽管以前的研究已经证明了适当的定义在管理高风险CA-AKI患者中的成功应用,关于不同定义与慢性肾脏病(CKD)患者预后之间的相关性的研究仍然有限.
    本研究共纳入4197例接受冠状动脉造影(CAG)的CKD患者。使用对比剂相关急性肾损伤(CA-AKI)的两个定义:CA-AKIA,这被定义为在CAG后72小时内血清肌酐(SCr)从基线增加≥0.5mg/dL或>25%,和CA-AKIB,定义为CAG后48小时内SCr从基线增加≥0.3mg/dL或>50%。Cox回归分析用于评估这两种定义与长期死亡率之间的关联。此外,计算人群归因危险度(PAR),以评估CA-AKI定义对长期预后的影响.
    在4.70(2.50-7.78)年的中位随访期内,总的长期死亡率为23.6%,根据CA-AKIA和CA-AKIB标准,CA-AKI患者的长期死亡率分别为33.5%和33.8%,分别。我们发现CA-AKIA(HR:1.45,95%CI:1.23-1.70,p<0.001)和CA-AKIB(HR:1.44,95%CI:1.23-1.69,p<0.001)与长期死亡率相关。CA-AKIA的PAR最高(5.87%),其次是CA-AKIB(5.70%)。
    对比剂相关急性肾损伤(CA-AKI)是CKD患者冠状动脉造影(CAG)中常见的并发症,CA-AKI的两种定义均与不良长期预后显著相关.因此,在CKD患者的临床管理中,至关重要的是优先考虑CA-AKI,无论使用的具体CA-AKI定义如何。
    UNASSIGNED: Contrast-associated acute kidney injury (CA-AKI) is a prevalent complication following coronary angiography (CAG). However, there is ongoing controversy surrounding its precise definition. Although previous studies have demonstrated the successful application of appropriate definitions in managing high-risk CA-AKI patients, there remains limited research on the association between different definitions and prognosis specifically in patients with chronic kidney disease (CKD).
    UNASSIGNED: A total of 4197 CKD patients undergoing coronary angiography (CAG) were included in this study. Two definitions of contrast-associated acute kidney injury (CA-AKI) were used: CA-AKIA, which was defined as an increase of ≥0.5 mg/dL or >25% in serum creatinine (SCr) from baseline within 72 hours after CAG, and CA-AKIB, which was defined as an increase of ≥0.3 mg/dL or >50% in SCr from baseline within 48 hours after CAG. Cox regression analysis was employed to assess the association between these two definitions and long-term mortality. Additionally, population attributable risks (PARs) were calculated to evaluate the impact of CA-AKI definitions on long-term prognosis.
    UNASSIGNED: During the median follow-up period of 4.70 (2.50-7.78) years, the overall long-term mortality was 23.6%, and the long-term mortality in patients with CA-AKI according to both CA-AKIA and CA-AKIB criteria were 33.5% and 33.8%, respectively. We found that CA-AKIA (HR: 1.45, 95% CI: 1.23-1.70, p<0.001) and CA-AKIB (HR: 1.44, 95% CI: 1.23-1.69, p<0.001) were associated with long-term mortality. The PARs were the highest for CA-AKIA (5.87%), followed by CA-AKIB (5.70%).
    UNASSIGNED: Contrast-associated acute kidney injury (CA-AKI) is a frequently observed complication in CKD patients undergoing coronary angiography (CAG), and both definitions of CA-AKI are significantly correlated with a poor long-term prognosis. Consequently, in the clinical management of CKD patients, it is crucial to prioritize CA-AKI, irrespective of the specific CA-AKI definition used.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    具有石墨烯/类石墨烯结构(BGS)的生物质衍生碳质材料在环境修复领域引起了极大的关注。在原料生物炭中引入石墨烯/类石墨烯结构可以有效改善其性能,如导电性,表面官能团,和催化活性。2021年,国际标准化组织将石墨烯定义为“单层碳原子,每个原子与蜂窝状结构中的三个相邻原子结合”。考虑到这个定义,几项研究错误地提到了BGS(例如,生物质衍生的几层石墨烯或多孔石墨烯样纳米片)作为“石墨烯”。迄今为止,尚未对BGS的定义和分类及其在环境修复中的应用进行严格评估。为了准确确定BGS的特定结构,非常需要全面的分析和充分而可靠的证据。从这个角度来看,我们提供了一个系统的框架来定义和分类BGS。仔细检查了当前用于确定BGS结构特性的最新方法。然后,我们讨论了BGS的设计和制造,以及它们的独特特征如何提高生物质衍生碳质材料的适用性,特别是在环境修复方面。强调了这些BGS的环境应用,并确定了未来的研究机会和需求。这一观点的基本见解为BGS在各种环境应用中的进一步开发提供了关键指导。
    Biomass-derived carbonaceous materials with graphene/graphene-like structures (BGS) have attracted tremendous attention in the field of environmental remediation. The introduction of graphene/graphene-like structures into raw biochars can effectively improve their properties, such as electrical conductivity, surface functional groups, and catalytic activity. In 2021, the International Organization for Standardization defined graphene as a \"single layer of carbon atoms with each atom bound to three neighbours in a honeycomb structure\". Considering this definition, several studies have incorrectly referred to BGS (e.g., biomass-derived few-layer graphene or porous graphene-like nanosheets) as \"graphene\". The definitions and classifications of BGS and their applications in environmental remediation have not been assessed critically thus far. Comprehensive analysis and sufficient and robust evidence are highly desired to accurately determine the specific structures of BGS. In this perspective, we provide a systematic framework to define and classify the BGS. The state-of-the-art methods currently used to determine the structural properties of BGS are scrutinized. We then discuss the design and fabrication of BGS and how their distinctive features could improve the applicability of biomass-derived carbonaceous materials, particularly in environmental remediation. The environmental applications of these BGS are highlighted, and future research opportunities and needs are identified. The fundamental insights in this perspective provide critical guidance for the further development of BGS for a wide range of environmental applications.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:对于喂养不耐受(FI)的一个统一的临床定义是为了更好地管理危重患者的肠内营养(EN)。我们旨在根据报告的证据确定最佳的临床FI定义。
    方法:我们搜索了比较FI和非FI的临床研究,通过随机效应荟萃分析总结证据,并通过建议评级评估对证据的确定性进行评级,发展和评价框架。
    结果:确定了五千五百二十五条记录,其中26项符合条件的研究纳入了25,189名成年患者。大多数以患者为中心的结果与整体FI相关。确定的低至极低的FI定义为大的胃残余体积(GRV)≥250±50mL与任何其他胃肠道症状(GIS)与高死亡率,特别是全因住院死亡率(比值比[OR]1.90,95%置信区间[CI]1.40-2.57),肺炎的发生率(OR1.54,95%CI1.13-2.09)和住院时间延长(平均差异4.20,95%CI2.08-6.32),医院患病率中等(41.49%,95%CI31.61-51.38%)。3天肠内喂养(EF)交付百分比<80%具有中度住院患病率(38.23%,95%CI24.88-51.58),但与全因住院死亡率有轻微显著关联(OR1.90,95%CI1.03-3.50)。
    结论:在接受EN的危重成年患者中,在与全因医院死亡率和可接受的医院患病率密切相关方面,以大型GRV为中心的GIS定义FI似乎优于3天EF不全(注册PROSPERO:CRD42022326273).
    背景:本综述和荟萃分析的方案已在PROSPERO:CRD42022326273注册。2022年5月10日注册。
    BACKGROUND: A unified clinical definition of feeding intolerance (FI) is urged for better management of enteral nutrition (EN) in critically ill patients. We aimed to identify optimum clinical FI definitions based on reported evidence.
    METHODS: We searched clinical studies comparing FI with non-FI with a clear definition, summarized the evidence by random-effect meta-analyses, and rated the certainty of evidence by the Grading of Recommendations Assessment, Development and Evaluation frameworks.
    RESULTS: Five thousand five hundred twenty-five records were identified, of which 26 eligible studies enrolled 25,189 adult patients. Most patient-centered outcomes were associated with FI overall. Low to very low certainty evidence established FI defined as large gastric residual volume (GRV) ≥ 250 ± 50 mL combined with any other gastrointestinal symptoms (GIS) had a significant association with high mortalities in particular all-cause hospital mortality (odds ratio [OR] 1.90, 95% confidence interval [CI] 1.40-2.57), the incidence of pneumonia (OR 1.54, 95% CI 1.13-2.09) and prolonged length of hospital stay (mean difference 4.20, 95% CI 2.08-6.32), with a moderate hospital prevalence (41.49%, 95% CI 31.61-51.38%). 3-day enteral feeding (EF) delivered percentage < 80% had a moderate hospital prevalence (38.23%, 95% CI 24.88-51.58) but a marginally significant association with all-cause hospital mortality (OR 1.90, 95% CI 1.03-3.50).
    CONCLUSIONS: In critically ill adult patients receiving EN, the large-GRV-centered GIS to define FI seemed to be superior to 3-day EF-insufficiency in terms of both close associations with all-cause hospital mortality and acceptable hospital prevalence (Registered PROSPERO: CRD42022326273).
    BACKGROUND: The protocol for this review and meta-analysis was registered with PROSPERO: CRD42022326273. Registered 10 May 2022.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    药物短缺是一个全球性问题,影响低,中间,和高收入国家。许多国家制定了各种战略来克服这个问题,当问题加速时,影响整个世界。所有类型的药物,比如基本的救命药物,肿瘤药物,抗菌药物,镇痛药,阿片类药物,心血管药物,放射性药物,和肠胃外产品,容易短缺。在所有药物剂型中,无菌注射产品比其他形式有更高的短缺风险。短缺的原因是多方面的,包括供应问题,需求问题,和监管问题。供应问题包括制造问题,原材料不可用,后勤问题,和商业问题。相比之下,需求问题包括及时库存,对产品的需求更高,季节性需求,不可预测的需求。对于监管问题,一个重要因素是缺乏统一的药物短缺定义。药物短缺影响所有利益相关者从经济,临床,和人文方面。世卫组织从四个层面制定了全球缓解战略,以克服全球药物短缺。它包括解决当前短缺的解决方法,运营改进,降低短缺风险,实现预警,政府政策的变化,以及对所有卫生专业人员进行管理短缺的教育和培训。
    Drug shortage is a global issue affecting low, middle, and high-income countries. Many countries have developed various strategies to overcome the problem, while the problem is accelerating, affecting the whole world. All types of drugs, such as essential life-saving drugs, oncology medicines, antimicrobial drugs, analgesics, opioids, cardiovascular drugs, radiopharmaceutical, and parenteral products, are liable to the shortage. Among all pharmaceutical dosage forms, sterile injectable products have a higher risk of shortage than other forms. The causes of shortage are multifactorial, including supply issues, demand issues, and regulatory issues. Supply issues consist of manufacturing problems, unavailability of raw materials, logistic problems, and business problems. In contrast, demand issues include just-in-time inventory, higher demand for a product, seasonal demand, and unpredictable demand. For regulatory issues, one important factor is the lack of a unified definition of drug shortage. Drug shortage affects all stakeholders from economic, clinical, and humanistic aspects. WHO established global mitigation strategies from four levels to overcome drug shortages globally. It includes a workaround to tackle the current shortage, operational improvements to reduce the shortage risk and achieve early warning, changes in governmental policies, and education and training of all health professionals about managing shortages.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Comparative Study
    The definitions of contrast-associated acute kidney injury (CA-AKI) are diverse and have different predictive effects for prognosis, which are adverse for clinical practice. Few articles have discussed the relationship between these definitions and long-term prognosis in patients with diabetes.
    A total of 1154 diabetic patients who were undergoing coronary angiography (CAG) were included in this study. Two definitions of CA-AKI were used: CA-AKIA was defined as an increase ≥ 0.3 mg/dl or > 50% in serum creatinine (SCr) from baseline within 72 h after CAG, and CA-AKIB was defined as an increase ≥ 0.5 mg/dl or > 25% in SCr from baseline within 72 h after CAG. We used Cox regression to evaluate the association of these two CA-AKI definitions with long-term mortality and calculate the population attributable risks (PARs) of different definitions for long-term prognosis.
    During the median follow-up period of 7.4 (6.2-8.2) years, the overall long-term mortality was 18.84%, and the long-term mortality in patients with CA-AKI according to both CA-AKIA and CA-AKIB criteria were 36.73% and 28.86%, respectively. We found that CA-AKIA (HR: 2.349, 95% CI 1.570-3.517, p = 0.001) and CA-AKIB (HR: 1.608, 95% CI 1.106-2.339, p = 0.013) were associated with long-term mortality. The PARs were the highest for CA-AKIA (31.14%), followed by CA-AKIB (14.93%).
    CA-AKI is a common complication in diabetic patients receiving CAG. The two CA-AKI definitions are significantly associated with a poor long-term prognosis, and CA-AKIA, with the highest PAR, needs more clinical attention.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

       PDF(Pubmed)

  • 文章类型: Comparative Study
    Delayed graft function (DGF) is an important complication of kidney transplantation and can be diagnosed according to different definitions. DGF has been suggested to be associated with the long-term outcome of kidney transplantation surgery. However, the best DGF definition for predicting renal transplant outcomes in Chinese donations after cardiac death (DCDs) remains to be determined.
    A total of 372 DCD kidney transplant recipients from June 2013 to July 2017 in the First Affiliated Hospital of Xi\'an Jiaotong University were included in this retrospective study to compare 6 different DGF definitions. The relationships of the DGF definitions with transplant outcome were analyzed, including graft loss (GL) and death-censored graft loss (death-censored GL). Renal function indicators, including one-year estimated glomerular filtration rate (eGFR) and three-year eGFR, and were compared between different DGF groups.
    The incidence of DGF varied from 4.19 to 35.22% according to the different DGF diagnoses. All DGF definitions were significantly associated with three-year GL as well as death-censored GL. DGF based on requirement of hemodialysis within the first week had the best predictive value for GL (AUC 0.77), and DGF based on sCr variation during the first 3 days post-transplant had the best predictive value for three-year death-censored GL (AUC 0.79). Combination of the 48-h sCr reduction ratio and classical DGF can improve the AUC for GL (AUC 0.85) as well as the predictive accuracy for death-censored GL (83.3%).
    DGF was an independent risk factor for poor transplant outcome. The combination of need for hemodialysis within the first week and the 48-h serum creatinine reduction rate has a better predictive value for patient and poor graft outcome.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

       PDF(Pubmed)

  • 文章类型: Clinical Trial Protocol
    The objective of present paper is to outline the methodology of the International Study of Definitions of English-Language Terms for Suicidal Behaviours (ISDELTSB). The aim of the study is to survey existing English language terms and definitions used around the world for suicidal behaviour.
    The ISDELTSB is a worldwide survey based on one \'designated expert\' per each WHO-registered country. \'Experts\' were contacted through the International Association for Suicide Prevention (IASP), the World Psychiatric Association and the World Organization of Family Doctors. Each individual was sent an invitation to participate and a link to an online questionnaire. A comparison sample was created by inviting all IASP members to respond to the questionnaire. The questionnaire was designed to assess respondents\' preferences about a particular set of terms and definitions by using the four major criteria of the definition of suicide identified in the literature (outcome, intent, knowledge and agency). The questionnaire used a multiple-choice question format. Participants were asked to choose one term in the list for each of the proposed definitions. Statements and definitions in the questionnaire were elaborated using the four main features of the definition of suicide, starting by the definitions and terms for which there is already a certain degree of consensus and then progressing to definitions and terms less agreed on.
    The study protocol obtained approval of Griffith University\'s Ethics Committee (ethics reference number 2017/601) and in accordance with the Australian National Statement on Ethical Conduct in Human Research. Respondents are asked if they accept to be personally acknowledged in any output originating from this study, and if so to provide their full name, title and affiliations. If respondents do not accept, they are informed that the conduct of this research respects Griffith University\'s Privacy Plan and that identified personal information is confidential and that anonymity will at all times be safeguarded. As detailed in the questionnaire cover letter, by answering the online or paper version of the questionnaire, respondents express their consent to participate. Dissemination of results will be done through a peer-reviewed journal article publication. This study aims to map the international use of definitions and terms for suicidal behaviour and ideation and favour the future use of an internationally shared set of terms and definitions. This will hopefully avoid undue duplication of efforts and reliably permit meta-analysis of data produced in different countries.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

       PDF(Pubmed)

  • 文章类型: Journal Article
    Traditionally, research in the ultra-high risk (UHR) for psychosis population has focused on the treatment of existing symptomatology and prevention of transition to psychosis. Recently, there has been an increase in focus on outcomes in individuals who do not transition to psychosis. However, there is a lack of standardised definitions of remission, recovery, recurrence and relapse in UHR, resulting in the inability to generalise and replicate outcomes.
    The aims of the current study were to develop definitions for remission, recovery, recurrence and relapse, and apply them to a UHR cohort allowing the identification of longitudinal clinical trajectories. Further stratification in broader categories of favourable and unfavourable outcomes was applied. The predictive value of various baseline factors on specific clinical trajectories was also assessed.
    17 different trajectories were identified in a cohort of 202 individuals within a 12-month period and classified according to the suggested definitions for recovery (35.7%), remission (7.5%), any recurrence (20%), no remission (17.3%), relapse (4.0%) and transition to psychosis (15.8%). Favourable and unfavourable trajectories represented 43.2% and 57.1% respectively. Long duration of untreated symptoms and high depression scores were associated with unfavourable outcomes.
    It is possible to apply clear definitions of remission, recovery, recurrence, relapse and transition to psychosis to a UHR cohort to evaluate longitudinal clinical trajectories. Acceptance and use of these definitions will help to facilitate comparisons between trials and to improve clinical clarity across the range of available therapeutic options in UHR individuals.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

公众号