Epidemiologic Research Design

流行病学研究设计
  • 文章类型: Journal Article
    临床研究中患者特征的不一致报告妨碍了可重复性并限制了分析机会。本文提出了条件特定的“核心描述符集”(CDS),其中包括人口统计学等关键因素,疾病严重程度,合并症,和预后标准化表1报告。发展需要利益相关者的参与,描述符的系统识别,价值评级,并使用多个Delphi轮建立共识。最终协议在专家会议上达成。好处包括更容易的交叉研究比较,例如通过个体患者荟萃分析,通过比较一致报告的个体数据而不是群体水平的分析来促进。这也可能支持常规数据分析,亚组和风险识别,减少研究浪费。CDS彻底描述了队列,同时最大限度地减少了研究负担。它们旨在改善临床特征,个性化,再现性,数据共享和知识建设。
    BACKGROUND: Inconsistent reporting of patient characteristics in clinical research hampers reproducibility and limits analysis opportunities. This paper proposes condition-specific \'Core Descriptor Sets\' comprising key factors like demographics, disease severity, comorbidities, and prognosis to standardize Table 1 reporting.
    METHODS: Development entails stakeholder involvement, systematic identification of descriptors, value rating, and consensus-building using multiple Delphi rounds. Final agreement comes at an expert meeting.
    CONCLUSIONS: Benefits include easier cross-study comparison, for example, through individual patient meta-analysis, facilitated by comparison of consistently reported individual data rather than group-level analysis. This may also support routine data analyses, subgroup and risk identification, and reduced research waste. Core Descriptor Sets describe cohorts thoroughly while minimizing research burden. They are intended to enable improved clinical characterization, personalization, reproducibility, data sharing, and knowledge building.
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  • 文章类型: Journal Article
    工作中积极的领导行为与员工的幸福感和绩效有关。然而,关于暴露于低水平的积极领导行为是否会增加工人患临床精神障碍的风险的知识却很少。我们调查了低水平的积极领导行为是否与抑郁症和焦虑症的治疗风险有前瞻性关联。在一项队列研究中,我们将来自丹麦工作环境与健康调查的59,743名受访者的调查数据与国家健康登记数据相关联.领导行为是用八项量表衡量的。治疗定义为抗抑郁药或抗焦虑药的兑换处方或抑郁症或焦虑症的医院治疗。使用Cox比例风险回归,调整人口变量,工作类型和部门,不良生活事件和童年逆境,我们估计了基线时的领导行为与随访期间的治疗风险之间的关联.我们在随访期间确定了999例抑郁症和焦虑症治疗。与高水平的领导行为相比,校正协变量后,中低水平和低水平暴露与治疗风险增加相关.结果表明,低水平的积极领导行为与抑郁症或焦虑症的治疗风险增加有关。
    Positive leadership behaviours at work are associated with worker well-being and performance. However there is less knowledge about whether exposure to low levels of positive leadership behaviours increase workers\' risk of clinical mental disorders. We investigated whether low levels of positive leadership behaviours are prospectively associated with risk of treatment for depressive and anxiety disorders. In a cohort study, we linked survey data from 59,743 respondents from the Work Environment and Health in Denmark survey with national health register data. Leadership behaviours were measured with an eight-item scale. Treatment was defined as redeemed prescription for antidepressants or anxiolytics or hospital treatment for depression or anxiety. Using Cox proportional hazard regression, adjusting for demographic variables, job type and sector, adverse life events and childhood adversities, we estimated the association between leadership behaviours at baseline and risk of treatment during follow-up. We identified 999 cases of depression and anxiety treatment during follow-up. Compared to high levels of leadership behaviours, exposure to medium low and low levels were associated with an increased risk of treatment after adjustment for covariates. The results suggest that low levels of positive leadership behaviours are associated with an increased risk of treatment for depressive or anxiety disorders.
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  • 文章类型: Journal Article
    流行病学家正试图通过开发新的方法来组合来自不同来源的信息来解决日益复杂的研究问题。Coleetal.(美国流行病学杂志。2022;XXX(XX):XXXX-XXXX)提供了两个结合信息以得出人口比例推论的示例。在这篇评论中,我们考虑结合信息来了解目标人群作为流行病学活动,并将其与更传统的荟萃分析区分开来.我们研究了合并信息的可能理由,并讨论了广泛的方法论考虑,强调学习设计的各个方面,包括在候选数据源之间的选择以及从这些数据源中采样观察结果。
    Epidemiologists are attempting to address research questions of increasing complexity by developing novel methods for combining information from diverse sources. Cole et al. (Am J Epidemiol. 2023;192(3)467-474) provide 2 examples of the process of combining information to draw inferences about a population proportion. In this commentary, we consider combining information to learn about a target population as an epidemiologic activity and distinguish it from more conventional meta-analyses. We examine possible rationales for combining information and discuss broad methodological considerations, with an emphasis on study design, assumptions, and sources of uncertainty.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    生物医学研究过程在设计和开发中必须遵循一定的质量标准,以确保结果可信可靠。一旦完成,是时候写一篇文章发表了。文章必须提供足够的细节,以清晰透明的方式,关于已经开展的研究工作的所有信息。这样,读者,在对发布的内容进行批判性阅读之后,将能够判断研究的有效性和相关性,如果他们愿意,利用这些发现。为了改进对出版研究过程的描述,已经制定了一系列指导方针,以简单和结构化的方式,指导作者准备手稿。它们以列表的形式呈现,流程图,或结构化文本,并且在撰写文章时是非常宝贵的帮助。本文介绍了最常见设计的报告指南以及相应的清单。
    The biomedical research process must follow certain quality criteria in its design and development to ensure that the results are credible and reliable. Once completed, the time comes to write an article for publication. The article must present in sufficient detail, and in a clear and transparent manner, all the information on the research work that has been carried out. In this way, readers, after a critical reading of the published content, will be able to judge the validity and relevance of the study and, if they so wish, make use of the findings. In order to improve the description of the research process for publication, a series of guidelines have been developed which, in a simple and structured way, guide authors in the preparation of a manuscript. They are presented in the form of a list, flowchart, or structured text, and are an invaluable aid when writing an article. This article presents the reporting guidelines for the most common designs along with the corresponding checklists.
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  • 文章类型: Journal Article
    背景:传统的活性疫苗安全性监测涉及预先指定健康结果和生物学上合理的结果特定的关注时间窗口,限制可以评估的不良事件。在这项研究中,我们使用基于树的扫描统计量来广泛寻找二价COVID-19疫苗接种后>6万起可能的不良事件.
    方法:在2022年11月之前接受Moderna或Pfizer-BioNTech二价COVID-19疫苗的年龄≥5岁的疫苗安全数据链参与者在疫苗接种后随访56天。在ICD-10-CM的分级诊断代码“树”中以及在疫苗接种后随访中对住院或急诊科的事件诊断进行了聚类分析。使用条件自控树时间扫描统计量,在整个树的扫描风险窗口期间,每个诊断的病例总数和任何诊断发生的病例总数。P=0.01是用于统计显著性的预先指定的截止值。
    结果:分析包括352,509剂Moderna和979,189剂Pfizer-BioNTech二价疫苗。Moderna疫苗接种后,没有发现有统计学意义的聚类.在辉瑞生物技术公司之后,有一组未指定的不良事件(第1-3天,p=0.0001-0.0007),流感(第35-56天,p=0.0001),咳嗽(第44-55天,p=0.0002),和COVID-19(第52-56天,p=0.0004)。
    结论:仅适用于辉瑞生物技术公司,我们检测到:(1)未指明的不良反应,正如在使用这种方法的其他疫苗研究中观察到的那样,(2)随访结束时的呼吸道疾病。呼吸道集群可能是由于随访与呼吸道合胞病毒的传播重叠,流感,和COVID-19,即,季节性混杂。该方法的非目标性质及其对许多诊断和评估的风险区间的固有调整是独特的优势。局限性包括对时变混杂的敏感性,与针对较少结果的传统研究相比,评估特定结果风险的统计能力较低,以及错过不良事件的可能性在时间上或在“树”内没有强烈聚集。\"
    Traditional active vaccine safety monitoring involves pre-specifying health outcomes and biologically plausible outcome-specific time windows of concern, limiting the adverse events that can be evaluated. In this study, we used tree-based scan statistics to look broadly for >60,000 possible adverse events after bivalent COVID-19 vaccination.
    Vaccine Safety Datalink enrollees aged ≥5 years receiving Moderna or Pfizer-BioNTech bivalent COVID-19 vaccine through November 2022 were followed for 56 days post-vaccination. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within the hierarchical ICD-10-CM diagnosis code \"tree\" and temporally within post-vaccination follow-up. The conditional self-controlled tree-temporal scan statistic was used, conditioning on total number of cases of each diagnosis and total number of cases of any diagnosis occurring during the scanning risk window across the entire tree. P = 0.01 was the pre-specified cut-off for statistical significance.
    Analysis included 352,509 doses of Moderna and 979,189 doses of Pfizer-BioNTech bivalent vaccines. After Moderna vaccination, no statistically significant clusters were found. After Pfizer-BioNTech, there were clusters of unspecified adverse events (Days 1-3, p = 0.0001-0.0007), influenza (Days 35-56, p = 0.0001), cough (Days 44-55, p = 0.0002), and COVID-19 (Days 52-56, p = 0.0004).
    For Pfizer-BioNTech only, we detected clusters of: (1) unspecified adverse effects, as have been observed in other vaccine studies using this method, and (2) respiratory disease toward the end of follow-up. The respiratory clusters were likely due to overlap of follow-up with the spread of respiratory syncytial virus, influenza, and COVID-19, i.e., confounding by seasonality. The untargeted nature of the method and its inherent adjustment for the many diagnoses and risk intervals evaluated are unique advantages. Limitations include susceptibility to time-varying confounding, lower statistical power for assessing risks of specific outcomes than in traditional studies targeting fewer outcomes, and the possibility of missing adverse events not strongly clustered in time or within the \"tree.\"
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  • 文章类型: Journal Article
    这篇综述调查了基于地点的方法在多大程度上被用来概念化上下文,以及在明确援引联合组织框架的研究中探索的与地点相关的背景因素。文献检索集中于29项同行评审的实证研究。只有11项研究使用基于地点的方法来定义和测量上下文因素,并且使用诸如人口普查区之类的行政边界来表示空间上下文,郡,和国家。探索了一系列与地点有关的环境因素,其中大多数与用于定义地点的社会和经济因素有关。确定了方法上的差距,例如缺乏多层次研究和使用基于地点的方法来衡量上下文的研究。未来的流行病研究应利用多维地理空间方法来破译与地点相关的上下文因素在流行病动力学中的作用。
    This review investigates the extent to which a place-based approach has been used to conceptualize context, as well as the place-related contextual factors explored in studies that explicitly invoked a syndemic framework. The literature search focused on 29 peer-reviewed empirical syndemic studies. Only 11 studies used a place-based approach to define and measure contextual factors and the spatial context was denoted using administrative boundaries such as census tracts, counties, and countries. A narrow range of place-related contextual factors were explored and most of them were related to social and economic factors that were used to define a place. Methodological gaps like a paucity of multilevel studies and studies using a place-based approach to measure context were identified. Future syndemics research should leverage multidimensional geospatial approaches to decipher the role of place-related contextual factors in syndemic dynamics.
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  • 文章类型: Journal Article
    目的:这项研究的目的是确定和比较澳大利亚执业脊医和学者在所列研究领域的研究重点,并寻求他们对现有脊医研究策略的看法。同时的目标是深入了解研究特征的观点,并征求两个小组对未来研究的想法和建议。
    方法:本研究使用混合方法研究设计,使用在线调查门户收集数据。澳大利亚脊椎按摩师(n=220)和执业脊椎按摩师,他们也是全国代表的成员,基于实践的研究网络数据库(n=1680)被邀请参加。收集数据(2019年2月19日至2019年5月24日)。在类别与文本数据完全匹配的情况下,主要通过语义编码和逐字参照单元分析自由文本数据。定性数据的内容分析以表格和叙述方式呈现为已识别的领域。逐字提供了一些代表性例子。
    结果:全职同等学者的调查回复率为44%,8%为临时工和兼职脊椎按摩学者,澳大利亚脊骨疗法研究网络数据库脊骨疗法从业者占21.5%。开放文本数据包括对肌肉骨骼(MSK)状况的关注,以及学者和一些从业者对支持传统概念和术语的研究议程的反对或保留。两组的评论都说明了脊骨治疗行业分歧派别的强烈观点。一些从业者对澳大利亚大学研究的狭隘焦点和认识论范式持高度批评态度,而其他人则强烈支持澳大利亚脊柱研究基金会的传统重点。澳大利亚学者在4所大学的项目中认为MSK和脊柱疼痛,一些证据已经存在,应该是未来研究的重点,建立在已知的基础上。从业者认为,未来的研究应该针对基础科学等扩展领域,年轻人口,和非MSK条件。受访者对传统脊骨疗法术语的态度存在严重分歧,概念,哲学和未来研究这些主题的实用性。
    结论:我们的定性研究结果表明,澳大利亚脊椎按摩师行业在研究方向和优先事项方面存在分歧。这种鸿沟存在于学者和研究人员之间以及现场从业人员内部。这项研究强调了人们的态度,意见,以及对重要利益相关者群体的看法,决策者在制定研究政策时应该考虑这一点,战略,以及资金的优先次序。
    The purpose of this study was to identify and compare the research priorities of Australian practicing chiropractors and academics across listed research domains and to seek their views on existing chiropractic research strategies. Concurrent objectives were to gain insight into the perspectives on characteristics of research and solicit ideas and suggestions for future research from both groups.
    This study used a mixed-method research design to collect data using an online survey portal. Australian chiropractic academics (n = 220) and practicing chiropractors who were also members of a nationally representative, practice-based research network database (n = 1680) were invited to participate. Data were collected (February 19, 2019, to May 24, 2019). The free-text data were analyzed primarily via semantic coding and verbatim referential units in cases where the category was an exact match for the textual data. Content analyses of the qualitative data were presented in a tabulated and narrative manner as identified domains. Selected representative examples were provided verbatim.
    The response rate for the survey was 44% for full-time equivalent academics, 8% for casuals and part-time chiropractic academics, and 21.5% for Australian Chiropractic Research Network database chiropractic practitioners. Open-text data comprised a narrower focus on musculoskeletal (MSK) conditions and opposition or reservations by academics and some practitioners toward the research agenda of those espousing traditional concepts and terminology. Comments from both groups illustrate the strongly held views that characterize divergent factions of the chiropractic profession. Some practitioners were highly critical of the narrow focus and epistemological paradigm of Australian university-based research, while others were strongly supportive of the traditional focus of the Australian Spinal Research Foundation. Australian academics at the 4 university-based programs held the view that MSK and spinal pain, for which some evidence already exists, should be the priority of future research, building on what is known. Practitioners believed that future research should be directed toward expanded areas such as basic science, younger populations, and non-MSK conditions. Respondents were sharply divided on attitudes toward traditional chiropractic terminology, concepts, and philosophy and the utility of future research on these topics.
    Our qualitative findings suggest there is a division in the Australian chiropractic profession regarding research direction and priorities. This divide exists between academics and researchers and within field practitioners. This study highlights the attitudes, opinions, and perceptions of important stakeholder groups, which should be considered by decision-makers when formulating research policy, strategy, and prioritization of funding.
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  • 文章类型: Editorial
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