observational studies

观察性研究
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    研究的目的是寻求答案和新知识。如果正确和系统地进行,研究增加了人类的知识语料库,从而增加了我们的总体进步。然而,只有在报告的研究准确透明的情况下,这才有可能。所有主要类型研究的指南(STROBE,CONSORT,PRISMA,嘘,STARD,和精神)已经发展和完善了多年,和他们的开始,发展,并对其应用进行了简要讨论。的确,目前有超过250种不同类型的医学研究指南,这些都是由EQUATOR网络发布的。本文还将简要回顾接受和采用这些准则的进展。
    The purpose of research is to seek answers and new knowledge. When conducted properly and systematically, research adds to humanity\'s corpus of knowledge and hence to our general advancement. However, this is only possible if reported research is accurate and transparent. Guidelines for all the major types of studies (STROBE, CONSORT, PRISMA, MOOSE, STARD, and SPIRIT) have been developed and refined over the years, and their inception, development, and application are briefly discussed in this paper. Indeed, there are currently over 250 of these guidelines for various types of medical research, and these are published by the EQUATOR network. This paper will also briefly review progress in acceptance and adoption of these guidelines.
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  • 文章类型: Journal Article
    目的:评估现有指南对我们候选项目研究中健康公平性报告的支持,并确定STROBE(加强流行病学观察性研究报告)-公平性扩展的其他项目。
    方法:我们通过搜索Embase进行了范围审查,MEDLINE,CINAHL,Cochrane方法论登记册,LILACS,以及截至2022年1月的加勒比健康科学信息中心。我们还搜索了参考列表和灰色文献以获取更多资源。我们包括指导和评估(以下称为“资源”)与任何类型的健康研究的行为和/或报告有关的人经历健康不平等。
    结果:我们包含了34个资源,在观察性研究中支持一个或多个候选项目或促成了有关健康公平性报告的新项目。每个候选项目由六个(范围:1-15)资源的中位数支持。此外,12个资源建议13个新项目,如“报告调查人员的背景”。
    结论:在观察性研究中报告健康公平性的现有资源与我们的临时候选项目清单一致。我们还确定了在制定基于共识和证据的指南时将考虑的其他项目,以报告观察性研究中的健康公平性。
    To evaluate the support from the available guidance on reporting of health equity in research for our candidate items and to identify additional items for the Strengthening Reporting of Observational studies in Epidemiology-Equity extension.
    We conducted a scoping review by searching Embase, MEDLINE, CINAHL, Cochrane Methodology Register, LILACS, and Caribbean Center on Health Sciences Information up to January 2022. We also searched reference lists and gray literature for additional resources. We included guidance and assessments (hereafter termed \"resources\") related to conduct and/or reporting for any type of health research with or about people experiencing health inequity.
    We included 34 resources, which supported one or more candidate items or contributed to new items about health equity reporting in observational research. Each candidate item was supported by a median of six (range: 1-15) resources. In addition, 12 resources suggested 13 new items, such as \"report the background of investigators\".
    Existing resources for reporting health equity in observational studies aligned with our interim checklist of candidate items. We also identified additional items that will be considered in the development of a consensus-based and evidence-based guideline for reporting health equity in observational studies.
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  • 文章类型: Journal Article
    解决持续和普遍的健康不平等是全球道德要求,COVID-19大流行的社会和健康影响突出了这一点。观察性研究可以帮助我们理解基于性别交叉的健康和结构压迫的影响,种族,种族,年龄和其他因素,因为他们经常收集这些数据。然而,加强流行病学观察研究报告(STROBE)指南,不提供与健康公平报告相关的指导。该项目的目标是开发STROBE-Equity报告指南扩展。
    我们组建了一个跨多个领域的多元化团队,包括性别,年龄,种族,土著背景,学科,地理位置,健康不平等和决策组织的生活经验。使用包容性,综合知识翻译方法,我们将实施一个五阶段计划,其中包括:(1)评估已发表的观察性研究中的健康公平性报告,(2)寻求国际上对项目的广泛反馈,以改善卫生公平的报告,(3)在知识用户和研究人员之间建立共识,(4)与土著贡献者合作评估与全球经历过殖民压迫性遗产的土著人民的相关性,(5)广泛传播并寻求相关知识用户的认可。我们将使用社交媒体寻求外部合作者的意见,邮件列表和其他沟通渠道。
    实现可持续发展目标等全球要务(例如,SDG10减少了不平等,SDG3良好的健康和福祉)要求在研究中促进健康公平。实施STROBE-Equity准则将通过更好的报告来更好地认识和理解健康不平等。我们将广泛传播报告指南,提供工具,使期刊编辑能够采用和使用,作者,和资助机构,使用针对特定受众量身定制的不同策略。
    Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension.
    We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels.
    Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.
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  • 文章类型: Journal Article
    观察性研究在评估人群中状况或疾病的患病率和发病率以及确定健康相关干预措施的益处和潜在危害方面发挥着关键作用。目前没有关于牙髓学领域的观察性研究的报告指南。牙髓学(PRIDE)研究设计的首选报告项目团队已经制定并发布了新的基于观察性研究的报告指南,称为“牙髓学(PROBE)2023年观察研究的首选报告项目”指南。通过整合和调整“加强流行病学观察研究报告(STROBE)”清单和“出版物中的临床和实验室图像(CLIP)”原则,专门为牙髓学专业开发了PROBE2023指南。在制定指南的整个过程中,都遵守了《健康研究报告指南开发人员指南》的建议。本文档的目的是通过提供PROBE2023检查表中每个项目的解释以及文献中的相关示例,为作者提供指导。该文件还为作者提供了有关如何在提交给期刊之前解决手稿中的每个项目的建议。PROBE2023检查表可从牙本质学(PRIDE)网站(http://pride-endonticguidelines.org/probe/)的研究设计的首选报告项目免费访问和下载。
    Observational studies play a critical role in evaluating the prevalence and incidence of conditions or diseases in populations as well as in defining the benefits and potential hazards of health-related interventions. There are currently no reporting guidelines for observational studies in the field of Endodontics. The Preferred Reporting Items for study Designs in Endodontology (PRIDE) team has developed and published new reporting guidelines for observational-based studies called the \'Preferred Reporting items for OBservational studies in Endodontics (PROBE) 2023\' guidelines. The PROBE 2023 guidelines were developed exclusively for the speciality of Endodontics by integrating and adapting the \'STrengthening the Reporting of OBservational studies in Epidemiology (STROBE)\' checklist and the \'Clinical and Laboratory Images in Publications (CLIP)\' principles. The recommendations of the Guidance for Developers of Health Research Reporting Guidelines were adhered to throughout the process of developing the guidelines. The purpose of this document is to serve as a guide for authors by providing an explanation for each of the items in the PROBE 2023 checklist along with relevant examples from the literature. The document also offers advice to authors on how they can address each item in their manuscript before submission to a journal. The PROBE 2023 checklist is freely accessible and downloadable from the PRIDE website (http://pride-endodonticguidelines.org/probe/).
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  • 文章类型: Observational Study
    Observational studies are non-interventional studies that establish the prevalence and incidence of conditions or diseases in populations or analyse the relationship between health status and other variables. They also facilitate the development of specific research questions for future randomized trials or to answer important scientific questions when trials are not possible to carry out. This article outlines the previously documented consensus-based approach by which the Preferred Reporting items for Observational studies in Endodontics (PROBE) 2023 guidelines were developed. A steering committee of nine members was formed, including the project leaders (PD, VN). The steering committee developed an initial checklist by combining and adapting items from the STrengthening the Reporting of Observational studies in Epidemiology (STROBE) checklist and the Clinical and Laboratory Images in Publications (CLIP) principles, as well as adding several new items specifically for the specialty of Endodontics. The steering committee then established a PROBE Delphi Group (PDG) and a PROBE Online Meeting Group (POMG) to obtain expert input and feedback on the preliminary draft checklist. The PDG members participated in an online Delphi process to reach consensus on the clarity and suitability of the items present in the PROBE checklist. The POMG then held detailed discussions on the PROBE checklist generated through the online Delphi process. This online meeting was held via the Zoom platform on 7th October 2022. Following this meeting, the steering committee revised the PROBE checklist, which was piloted by several authors when preparing a manuscript describing an observational study for publication. The PROBE 2023 checklist consists of 11 sections and 58 items. Authors are now encouraged to adopt the PROBE 2023 guidelines, which will improve the overall reporting quality of observational studies in Endodontics. The PROBE 2023 checklist is freely available and can be downloaded from the PRIDE website (https://pride-endodonticguidelines.org/probe/).
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  • 文章类型: Journal Article
    背景:2020年初,2019年冠状病毒病(COVID-19)大流行在全球范围内蔓延,医院的重症患者不堪重负,迫切需要临床证据来指导患者护理。第一个可用的治疗选择是重新利用药物来对抗炎症,凝血病,和病毒复制。在全球范围内开展了大量临床研究,以测试其有效性和安全性。我们的分析描述了关于再利用药物的全球证据的发展,特别是皮质类固醇,抗凝剂,根据不同的研究类型,住院COVID-19患者的(羟基)氯喹。我们跟踪国际和国家治疗指南中临床数据的纳入情况,并确定对治疗建议影响最大的研究和分析的特征因素。
    方法:在MEDLINE中进行了文献检索,以评估皮质类固醇治疗的临床证据,抗凝剂,大流行第一年住院COVID-19患者的(羟基)氯喹。在世界卫生组织(WHO)的治疗指南中采用这些临床数据中的证据,德国,随着时间的推移,对美国(US)进行了评估。
    结果:我们确定了106项关于皮质类固醇的研究,141项抗凝剂研究,和115项关于(羟基)氯喹的研究。大多数研究是回顾性队列研究;一些是随机临床试验(RCTs),还有一些是平台试验。这些研究与世卫组织直接和间接提及的研究(7个版本)进行了比较,德语(5个版本)和美国(21个版本)指南。我们发现最初很大,调整得很好,主要是回顾性队列研究和最终的大型平台试验或随机对照试验的协调荟萃分析提供了支持治疗建议的最佳可用临床证据.
    结论:特别是在大流行的早期,再利用药物的有效性和安全性的证据质量低,因为时间和科学的严谨性似乎是竞争因素。大流行的准备,协调努力,和组合分析对于产生及时而有力的临床证据以了解国家和国际皮质类固醇治疗指南至关重要,抗凝剂,和(羟基)氯喹。具有主协议和协调荟萃分析的多臂平台试验被证明特别成功,研究人员联手尽快回答最紧迫的问题。
    BACKGROUND: In early 2020, the coronavirus disease 2019 (COVID-19) pandemic spread worldwide, overwhelming hospitals with severely ill patients and posing the urgent need for clinical evidence to guide patient care. First treatment options available were repurposed drugs to fight inflammation, coagulopathy, and viral replication. A vast number of clinical studies were launched globally to test their efficacy and safety. Our analysis describes the development of global evidence on repurposed drugs, in particular corticosteroids, anticoagulants, and (hydroxy)chloroquine in hospitalized COVID-19 patients based on different study types. We track the incorporation of clinical data in international and national treatment guidelines and identify factors that characterize studies and analyses with the greatest impact on treatment recommendations.
    METHODS: A literature search in MEDLINE was conducted to assess the clinical evidence on treatment with corticosteroids, anticoagulants, and (hydroxy)chloroquine in hospitalized COVID-19 patients during the first year of the pandemic. Adoption of the evidence from this clinical data in treatment guidelines of the World Health Organization (WHO), Germany, and United States (US) was evaluated over time.
    RESULTS: We identified 106 studies on corticosteroids, 141 studies on anticoagulants, and 115 studies on (hydroxy)chloroquine. Most studies were retrospective cohort studies; some were randomized clinical trials (RCTs), and a few were platform trials. These studies were compared to studies directly and indirectly referred to in WHO (7 versions), German (5 versions), and US (21 versions) guidelines. We found that initially large, well-adjusted, mainly retrospective cohort studies and ultimately large platform trials or coordinated meta-analyses of RCTs provided best available clinical evidence supporting treatment recommendations.
    CONCLUSIONS: Particularly early in the pandemic, evidence for the efficacy and safety of repurposed drugs was of low quality, since time and scientific rigor seemed to be competing factors. Pandemic preparedness, coordinated efforts, and combined analyses were crucial to generating timely and robust clinical evidence that informed national and international treatment guidelines on corticosteroids, anticoagulants, and (hydroxy)chloroquine. Multi-arm platform trials with master protocols and coordinated meta-analyses proved particularly successful, with researchers joining forces to answer the most pressing questions as quickly as possible.
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  • 文章类型: Journal Article
    COVID-19大流行凸显了解决健康不平等的全球必要性。观察性研究是实施COVID-19政策对不平等再分配的现实影响和影响的宝贵证据来源。我们组建了一个多元化的全球多学科团队,以制定临时指南,以提高COVID-19观察性研究报告健康公平性的透明度。我们在STROBE(加强流行病学观察研究报告)清单中确定了14个领域,这些领域需要更多细节,以鼓励透明地报告卫生公平。我们搜索了COVID-19观察性研究的例子,这些研究分析并报告了一个或多个健康社会决定因素的健康公平性分析。我们与土著利益相关者和其他遇到健康不平等的团体合作,共同制作本指南,并带来交叉镜头。考虑到健康公平和健康的社会决定因素有助于对该疾病的临床和流行病学理解,确定具体需求并支持决策过程。鼓励利益相关者考虑使用本观察性研究指南,以帮助提供证据来缩小健康结果中的不公平差距。
    The COVID-19 pandemic has highlighted the global imperative to address health inequities. Observational studies are a valuable source of evidence for real-world effects and impacts of implementing COVID-19 policies on the redistribution of inequities. We assembled a diverse global multi-disciplinary team to develop interim guidance for improving transparency in reporting health equity in COVID-19 observational studies. We identified 14 areas in the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist that need additional detail to encourage transparent reporting of health equity. We searched for examples of COVID-19 observational studies that analysed and reported health equity analysis across one or more social determinants of health. We engaged with Indigenous stakeholders and others groups experiencing health inequities to co-produce this guidance and to bring an intersectional lens. Taking health equity and social determinants of health into account contributes to the clinical and epidemiological understanding of the disease, identifying specific needs and supporting decision-making processes. Stakeholders are encouraged to consider using this guidance on observational research to help provide evidence to close the inequitable gaps in health outcomes.
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  • 文章类型: Journal Article
    背景:高质量的数据对整个科学企业至关重要,然而,数据管理所涉及的复杂性和工作量却被大大低估了。对于大型观测来说尤其如此,临床研究,因为捕获的多模态数据的数量和通过分析解决众多研究问题的机会,单独或与其他数据集结合使用。然而,缺乏有关数据管理方法的细节可能会导致有关数据稳健性的悬而未决的问题,它用于解决特定的研究问题或假设以及如何解释结果。我们旨在开发一个设计框架,为了提高科学的严谨性,对数据整理方法进行记录和报告,数据的可重复性和分析。
    方法:46名专家参与了一个改进的德尔菲过程,以就可用于设计和报告研究的数据管理指标达成共识。
    结果:我们确定了适用于设计的46个指标,培训/测试,研究的运行时间和收集后阶段。
    结论:数据采集,观察性研究设计的质量和固化(DAQCORD)指南是大型观察性研究的第一套全面的数据质量指标。它们是围绕神经科学项目的需要而开发的,但是我们相信它们是相关的和普遍的,全部或部分,其他健康研究领域,以及较小的观察性研究和临床前研究。DAQCORD指南提供了实现高质量数据的框架;健康研究的基石。
    BACKGROUND: High-quality data are critical to the entire scientific enterprise, yet the complexity and effort involved in data curation are vastly under-appreciated. This is especially true for large observational, clinical studies because of the amount of multimodal data that is captured and the opportunity for addressing numerous research questions through analysis, either alone or in combination with other data sets. However, a lack of details concerning data curation methods can result in unresolved questions about the robustness of the data, its utility for addressing specific research questions or hypotheses and how to interpret the results. We aimed to develop a framework for the design, documentation and reporting of data curation methods in order to advance the scientific rigour, reproducibility and analysis of the data.
    METHODS: Forty-six experts participated in a modified Delphi process to reach consensus on indicators of data curation that could be used in the design and reporting of studies.
    RESULTS: We identified 46 indicators that are applicable to the design, training/testing, run time and post-collection phases of studies.
    CONCLUSIONS: The Data Acquisition, Quality and Curation for Observational Research Designs (DAQCORD) Guidelines are the first comprehensive set of data quality indicators for large observational studies. They were developed around the needs of neuroscience projects, but we believe they are relevant and generalisable, in whole or in part, to other fields of health research, and also to smaller observational studies and preclinical research. The DAQCORD Guidelines provide a framework for achieving high-quality data; a cornerstone of health research.
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