NIRG: Evaluation of interventions with rare events: methods for parallel cluster randomised trials and stepped-wedge cluster randomised trials

NIRG:罕见事件干预措施的评估:平行整群随机试验和阶梯楔形整群随机试验的方法

基本信息

项目摘要

This project will improve the statistical methods of trials when the outcome of the trial is rare. It will focus on trials that randomise groups of people rather than individual people. Trials are the gold standard for assessing whether an intervention has a positive impact across all areas of health research and beyond. However, it is sometimes difficult to randomise individual people. This could be because the intervention being tested affects a whole village or hospital ward, or the trial is testing the impact of large-scale rollout of an individual intervention. When this is the case, we can randomise groups of individuals such as whole villages or hospital wards that we call clusters. This randomisation of groups has implications for how we analyse data from the trial because individuals in the same cluster are likely to be more like one another than individuals from different clusters. This analysis is further complicated if the outcome we are trying to affect in the trial is a rare event, such as reducing levels of a disease from an already low starting point. For example, in infectious diseases, even a small increase in the number of disease cases can have a large impact on the disease trajectory. When we are interested in a rare event, there might be some clusters (the groups of people) where no one experience the event of interest (e.g. contracted the disease). In this project, I will explore how we deal with these rare events in the analysis of these trials, so that even when we have a rare outcome, we can trust the results. The project will focus on two types of trials. In the first type, the clusters are randomised to receive either the new intervention or a control condition for the duration of the trial. Current methods of analysing these trials are known to inaccurately estimate the effect of the intervention or underestimate our confidence in that estimate. I will develop a new method of analysis to over come this issue. New software will be created to help researchers implement our new analysis method.The second type of trial is called a stepped-wedge cluster randomised trial. Here, we randomise clusters to switch to the intervention at different times during the trial so that by the end of the trial all or most clusters have received the intervention. When events are rare, it is expected that standard methods of analysis will struggle to provide results or will give inaccurate estimates of our uncertainty in results. This project will determine how to conduct an existing analysis method for stepped-wedge cluster randomised trials; the method has not been used for these trials before. Like the first type of trial, I will also create software to help researchers implement the analysis methods I find work well.It is vital that we have validated and trustworthy analysis methods to use with these trials to be able to improve human health. By the end of this project, both types of trials will have improved, validated methods of analysis that can be used when the outcome of the trial is a rare event.
本项目将改进罕见试验结果的统计方法。它将把重点放在随机分组而不是个人的试验上。试验是评估一项干预措施是否在所有卫生研究领域及其他领域产生积极影响的黄金标准。然而,有时很难随机选取个体。这可能是因为正在测试的干预措施影响了整个村庄或医院病房,或者该试验正在测试大规模推出个人干预措施的影响。在这种情况下,我们可以随机分组,比如整个村庄或医院病房,我们称之为集群。组的随机化对我们如何分析试验数据有影响,因为同一组中的个体可能比来自不同组的个体更像彼此。如果我们在试验中试图影响的结果是一个罕见的事件,例如从一个已经很低的起点降低疾病的水平,那么这种分析就会进一步复杂。例如,在传染病方面,即使疾病病例数量的小幅增加也可能对疾病轨迹产生重大影响。当我们对罕见事件感兴趣时,可能会有一些群集(人群),其中没有人经历感兴趣的事件(例如感染了疾病)。在这个项目中,我将探讨我们在分析这些试验时如何处理这些罕见事件,这样即使我们有一个罕见的结果,我们也可以相信结果。该项目将侧重于两种类型的试验。在第一种类型中,这些集群在试验期间随机接受新的干预措施或控制条件。目前分析这些试验的方法被认为不能准确地估计干预的效果,或者低估了我们对这种估计的信心。我将开发一种新的分析方法来克服这个问题。我们将开发新的软件来帮助研究人员实施我们的新分析方法。第二种类型的试验被称为阶梯楔形聚类随机试验。在这里,我们随机分组,在试验期间的不同时间切换到干预措施,以便在试验结束时所有或大多数分组都接受了干预措施。当事件罕见时,标准的分析方法将难以提供结果,或者对结果的不确定性给出不准确的估计。该项目将确定如何对楔形聚类随机试验进行现有的分析方法;这种方法以前从未用于这些试验。与第一种试验一样,我也会创建软件来帮助研究人员很好地实施我发现的分析方法。至关重要的是,我们有经过验证和值得信赖的分析方法用于这些试验,以便能够改善人类健康。到本项目结束时,两种类型的试验都将改进和验证分析方法,这些方法可以在试验结果罕见的情况下使用。

项目成果

期刊论文数量(0)
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专利数量(0)

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Jennifer Thompson其他文献

The Death of the Scholarly Monograph in the Humanities? Citation Patterns in Literary Scholarship
  • DOI:
    10.1515/libr.2002.121
  • 发表时间:
    2002
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Jennifer Thompson
  • 通讯作者:
    Jennifer Thompson
Adherens junction breakdown in the periderm following cadmium administration in the chick embryo: distribution of cadherins and associated molecules.
鸡胚施用镉后周皮中的粘附连接破坏:钙粘蛋白和相关分子的分布。
  • DOI:
  • 发表时间:
    2008
  • 期刊:
  • 影响因子:
    3.3
  • 作者:
    Jennifer Thompson;L. Wong;Puong Sing Lau;J. Bannigan
  • 通讯作者:
    J. Bannigan
Disturbance of SHH signalling pathway during early embryogenesis in the cadmium-induced omphalocele chick model
镉诱导脐膨出雏鸡模型早期胚胎发生过程中SHH信号通路的干扰
  • DOI:
    10.1007/s00383-012-3193-4
  • 发表时间:
    2013
  • 期刊:
  • 影响因子:
    1.8
  • 作者:
    N. Fujiwara;Johannes W Duess;P. Puri;Jennifer Thompson
  • 通讯作者:
    Jennifer Thompson
012 – The Building Blocks of Professional Pediatric Nursing Practice
  • DOI:
    10.1016/j.pedn.2008.11.014
  • 发表时间:
    2009-04-01
  • 期刊:
  • 影响因子:
  • 作者:
    Lezlie Brown-Zoller;Toni Christopherson;Erin Erb;Annie Evans;Donna Greenhalgh;Jessica Holtorf;Patty Schriver;Jennifer Thompson;Erik Zurko
  • 通讯作者:
    Erik Zurko
Impact of Lifestyle Modifications on the Prevention and Treatment of Pelvic Organ Prolapse
  • DOI:
    10.1007/s00192-024-05992-0
  • 发表时间:
    2024-11-19
  • 期刊:
  • 影响因子:
    1.800
  • 作者:
    Peter C. Jeppson;Sunil Balgobin;Tom Wheeler;Lori Forner;Delena Caagbay;Jennifer Thompson;Tyler M. Muffly;Isuzu Meyer;Molly Beestrum;Sarah Collins;Vivian Sung
  • 通讯作者:
    Vivian Sung

Jennifer Thompson的其他文献

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{{ truncateString('Jennifer Thompson', 18)}}的其他基金

RUI: Collaborative: unPAK: undergraduates Phenotyping Arabidopsis Knockouts: A distributed genomic approach to examine evolutionarily important traits
RUI:协作:unPAK:本科生拟南芥表型敲除:检查进化重要性状的分布式基因组方法
  • 批准号:
    1354771
  • 财政年份:
    2014
  • 资助金额:
    $ 52.79万
  • 项目类别:
    Continuing Grant

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基于重要农地保护LESA(Land Evaluation and Site Assessment)体系思想的高标准基本农田建设研究
  • 批准号:
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    2013
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HSI Implementation and Evaluation Project: Leveraging Social Psychology Interventions to Promote First Year STEM Persistence
HSI 实施和评估项目:利用社会心理学干预措施促进第一年 STEM 的坚持
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HSI 实施和评估项目:通过预测建模和早期个性化学术干预提高计算机科学本科生的保留率
  • 批准号:
    2345378
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    2024
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Health economic evaluation of public health interventions for the primary prevention of cardiovascular disease
心血管疾病一级预防公共卫生干预措施的卫生经济学评价
  • 批准号:
    23K09710
  • 财政年份:
    2023
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    $ 52.79万
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Development of a comprehensive evaluation method for muscle properties useful for verifying the effects of nutrition and exercise interventions
开发肌肉特性综合评估方法,有助于验证营养和运动干预的效果
  • 批准号:
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Evaluation of the Caring Letters Suicide Prevention Intervention after Removal of an Electronic Health Record Flag for Suicide Risk: An Effectiveness-Implementation Hybrid Type 2 Trial
移除电子健康记录自杀风险标记后关怀信自杀预防干预的评估:有效性-实施混合 2 型试验
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Innovation and evaluation of interventions to reduce marine plastic pollution
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Development and Evaluation of "Peer-HELP": Peers Harnessing E-health interventions for older individuals with Lower limb loss to support social Participation
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A circuit-driven evaluation of the use of physical activity interventions to improve binge-like ethanol drinking
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Evaluation of food waste reduction interventions - Social experiment research with sorting analysis of household food waste
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