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Conditional power, predictive power and probability of success in clinical trials with continuous, binary and time-to-event endpoints 在具有连续、二元和事件时间终点的临床试验中,条件能力、预测能力和成功概率
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-02-26 DOI: 10.1007/s10742-023-00302-5
M. G. Kundu, S. Samanta, Shoubhik Mondal
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引用次数: 3
Which patients benefit most from completing health risk assessments: comparing methods to identify heterogeneity of treatment effects 哪些患者从完成健康风险评估中获益最大:比较方法以确定治疗效果的异质性
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-02-24 DOI: 10.1007/s10742-021-00243-x
M. Olsen, K. Stechuchak, E. Oddone, L. Damschroder, M. Maciejewski
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引用次数: 2
Using a spatiotemporal model to estimate the impact of suicide prevention in small areas 利用时空模型估算小区域自杀预防的影响
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-02-07 DOI: 10.1007/s10742-021-00242-y
Lucas Godoy-Garraza, S. Campos, C. Walrath
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引用次数: 0
Using Synthetic Data to Replace Linkage Derived Elements: A Case Study. 使用合成数据替换链接派生元素:一个案例研究。
IF 1.6 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-02-03 DOI: 10.1007/s10742-021-00241-z
Dean M Resnick, Christine S Cox, Lisa B Mirel

While record linkage can expand analyses performable from survey microdata, it also incurs greater risk of privacy-encroaching disclosure. One way to mitigate this risk is to replace some of the information added through linkage with synthetic data elements. This paper describes a case study using the National Hospital Care Survey (NHCS), which collects patient records under a pledge of protecting patient privacy from a sample of U.S. hospitals for statistical analysis purposes. The NHCS data were linked to the National Death Index (NDI) to enhance the survey with mortality information. The added information from NDI linkage enables survival analyses related to hospitalization, but as the death information includes dates of death and detailed causes of death, having it joined with the patient records increases the risk of patient re-identification (albeit only for deceased persons). For this reason, an approach was tested to develop synthetic data that uses models from survival analysis to replace vital status and actual dates-of-death with synthetic values and uses classification tree analysis to replace actual causes of death with synthesized causes of death. The degree to which analyses performed on the synthetic data replicate results from analysis on the actual data is measured by comparing survival analysis parameter estimates from both data files. Because synthetic data only have value to the degree that they can be used to produce statistical estimates that are like those based on the actual data, this evaluation is an essential first step in assessing the potential utility of synthetic mortality data.

虽然记录链接可以扩展从调查微数据中执行的分析,但它也会带来更大的侵犯隐私的披露风险。减轻这种风险的一种方法是用合成数据元素替换通过链接添加的一些信息。本文描述了一个使用国家医院护理调查(NHCS)的案例研究,该调查在保护患者隐私的承诺下收集美国医院样本的患者记录,用于统计分析目的。国家卫生保健中心的数据与国家死亡指数(NDI)相关联,以加强死亡率信息的调查。来自NDI链接的新增信息能够进行与住院有关的生存分析,但由于死亡信息包括死亡日期和详细的死亡原因,将其与患者记录结合起来会增加患者重新识别的风险(尽管仅针对死者)。为此,测试了一种方法来开发综合数据,该数据使用生存分析模型用综合值代替生命状态和实际死亡日期,并使用分类树分析用综合死亡原因代替实际死亡原因。通过比较来自两个数据文件的生存分析参数估计值来衡量对合成数据执行的分析与对实际数据的分析结果的重复程度。由于合成数据只有在能够用于产生与基于实际数据的统计估计相似的统计估计时才有价值,因此这种评价是评估合成死亡率数据潜在效用的重要第一步。
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引用次数: 0
Standard electronic health record (EHR) framework for Indian healthcare system 印度医疗保健系统标准电子健康记录(EHR)框架
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-01-27 DOI: 10.1007/s10742-020-00238-0
M. Pai, R. Ganiga, R. Pai, R. Sinha
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引用次数: 36
Improving risk adjustment with machine learning: accounting for service-level propensity scores to reduce service-level selection 利用机器学习改进风险调整:考虑服务水平倾向得分以减少服务水平选择
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-01-17 DOI: 10.1007/s10742-020-00239-z
Sungchul Park, A. Basu
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引用次数: 2
Guest Editorial: Articles selected from the 2020 International Conference on Health Policy Statistics. 嘉宾评论:选自2020年国际卫生政策统计会议的文章。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-01-01 Epub Date: 2021-02-02 DOI: 10.1007/s10742-021-00240-0
Catherine M Crespi, Ofer Harel
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引用次数: 0
Harnessing real-world evidence to reduce the burden of noncommunicable disease: health information technology and innovation to generate insights. 利用真实世界证据减轻非传染性疾病负担:卫生信息技术和创新以产生见解。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-01-01 Epub Date: 2020-11-06 DOI: 10.1007/s10742-020-00223-7
Kelly H Zou, Jim Z Li, Lobna A Salem, Joseph Imperato, Jon Edwards, Amrit Ray

Noncommunicable diseases (NCDs) are the leading causes of mortality and morbidity across the world and factors influencing global poverty and slowing economic development. We summarize how the potential power of real-world data (RWD) and real-world evidence (RWE) can be harnessed to help address the disease burden of NCDs at global, national, regional and local levels. RWE is essential to understand the epidemiology of NCDs, quantify NCD burdens, assist with the early detection of vulnerable populations at high risk of NCDs by identifying the most influential risk factors, and evaluate the effectiveness and cost-benefits of treatments, programs, and public policies for NCDs. To realize the potential power of RWD and RWE, challenges related to data integration, access, interoperability, standardization of analytical methods, quality control, security, privacy protection, and ethical standards for data use must be addressed. Finally, partnerships between academic centers, governments, pharmaceutical companies, and other stakeholders aimed at improving the utilization of RWE can have a substantial beneficial impact in preventing and managing NCDs.

非传染性疾病(NCDs)是世界各地死亡和发病的主要原因,也是影响全球贫困和减缓经济发展的因素。我们总结了如何利用真实世界数据(RWD)和真实世界证据(RWE)的潜在力量,帮助解决全球、国家、区域和地方各级的非传染性疾病负担。RWE对于了解非传染性疾病的流行病学、量化非传染性疾病负担、通过确定最具影响力的风险因素协助早期发现非传染性疾病高危人群,以及评估非传染性疾病治疗、规划和公共政策的有效性和成本效益至关重要。为了实现RWD和RWE的潜在力量,必须解决与数据集成、访问、互操作性、分析方法标准化、质量控制、安全、隐私保护和数据使用道德标准相关的挑战。最后,学术中心、政府、制药公司和其他利益攸关方之间旨在改善RWE利用的伙伴关系可以在预防和管理非传染性疾病方面产生实质性的有益影响。
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引用次数: 5
The use of segmented regression for evaluation of an interrupted time series study involving complex intervention: the CaPSAI project experience. 使用分段回归评估涉及复杂干预的中断时间序列研究:CaPSAI项目经验。
IF 1.6 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-01-01 Epub Date: 2020-11-24 DOI: 10.1007/s10742-020-00221-9
Ndema Habib, Petrus S Steyn, Victoria Boydell, Joanna Paula Cordero, My Huong Nguyen, Soe Soe Thwin, Dela Nai, Donat Shamba, James Kiarie

An interrupted time series with a parallel control group (ITS-CG) design is a powerful quasi-experimental design commonly used to evaluate the effectiveness of an intervention, on accelerating uptake of useful public health products, and can be used in the presence of regularly collected data. This paper illustrates how a segmented Poisson model that utilizes general estimating equations (GEE) can be used for the ITS-CG study design to evaluate the effectiveness of a complex social accountability intervention on the level and rate of uptake of modern contraception. The intervention was gradually rolled-out over time to targeted intervention communities in Ghana and Tanzania, with control communities receiving standard of care, as per national guidelines. Two ITS GEE segmented regression models are proposed for evaluating of the uptake. The first, a two-segmented model, fits the data collected during pre-intervention and post-intervention excluding that collected during intervention roll-out. The second, a three-segmented model, fits all data including that collected during the roll-out. A much simpler difference-in-difference (DID) GEE Poisson regression model is also illustrated. Mathematical formulation of both ITS-segmented Poisson models and that of the DID Poisson model, interpretation and significance of resulting regression parameters, and accounting for different sources of variation and lags in intervention effect are respectively discussed. Strengths and limitations of these models are highlighted. Segmented ITS modelling remains valuable for studying the effect of intervention interruptions whether gradual changes, over time, in the level or trend in uptake of public health practices are attributed by the introduced intervention. Trial Registration: The Australian New Zealand Clinical Trials registry. Trial registration number: ACTRN12619000378123. Trial Registration date: 11-March-2019.

具有平行对照组的中断时间序列(ITS-CG)设计是一种强大的准实验设计,通常用于评估干预措施在加速吸收有用公共卫生产品方面的有效性,并且可以在定期收集数据的情况下使用。本文说明了如何将利用一般估计方程(GEE)的分段泊松模型用于ITS-CG研究设计,以评估复杂的社会责任干预对现代避孕的水平和吸收率的有效性。随着时间的推移,干预措施逐步推广到加纳和坦桑尼亚的有针对性的干预社区,对照社区根据国家指导方针接受标准护理。提出了两种ITS - GEE分段回归模型,用于评价吸收。第一种是两段模型,拟合干预前和干预后收集的数据,但不包括干预实施期间收集的数据。第二个是一个三段模型,适合所有数据,包括在推出期间收集的数据。一个更简单的差中差(DID) GEE泊松回归模型也被说明。分别讨论了its分割泊松模型和DID泊松模型的数学公式、得到的回归参数的解释和意义,以及对干预效果不同变异源和滞后的解释。强调了这些模型的优点和局限性。分段智能交通系统模型对于研究干预中断的影响仍然有价值,无论引入的干预措施是否会随着时间的推移导致采用公共卫生做法的水平或趋势的逐渐变化。试验注册:澳大利亚新西兰临床试验注册。试验注册号:ACTRN12619000378123。试验注册日期:2019年3月11日。
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引用次数: 0
Minimally important difference in cost savings: Is it possible to identify an MID for cost savings? 成本节约的最小差异:是否有可能确定成本节约的MID ?
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2021-01-01 Epub Date: 2021-01-07 DOI: 10.1007/s10742-020-00233-5
Mary Dooley, Annie N Simpson, Paul J Nietert, Dunc Williams, Kit N Simpson

As healthcare costs continue to increase, studies assessing costs are becoming increasingly common, but researchers planning for studies that measure costs differences (savings) encounter a lack of literature or consensus among researchers on what constitutes "small" or "large" cost savings for common measures of resource use.  Other fields of research have developed approaches to solve this type of problem. Researchers measuring improvement in quality of life or clinical assessments have defined minimally important differences (MID) which are then used to define magnitudes when planning studies. Also, studies that measure cost effectiveness use benchmarks, such as cost/QALY, but do not provide benchmarks for cost differences. In a review of the literature, we found no publications identifying indicators of magnitude for costs. However, the literature describes three approaches used to identify minimally important outcome differences: (1) anchor-based, (2) distribution-based, and (3) a consensus-based Delphi methods. In this exploratory study, we used these three approaches to derive MID for two types of resource measures common in costing studies for: (1) hospital admissions (high cost); and (2) clinic visits (low cost). We used data from two (unpublished) studies to implement the MID estimation. Because the distributional characteristics of cost measures may require substantial samples, we performed power analyses on all our estimates to illustrate the effect that the definitions of "small" and "large" costs may be expected to have on power and sample size requirements for studies. The anchor-based method, while logical and simple to implement, may be of limited value in cases where it is difficult to identify appropriate anchors. We observed some commonalities and differences for the distribution and consensus-based approaches, which require further examination. We recommend that in cases where acceptable anchors are not available, both the Delphi and the distribution-method of MID for costs be explored for convergence.

随着医疗保健成本的持续增加,评估成本的研究变得越来越普遍,但研究人员计划进行测量成本差异(节约)的研究时,缺乏文献或研究人员之间就资源使用的常见措施的“小”或“大”成本节约构成的共识。其他研究领域已经开发出解决这类问题的方法。研究人员测量生活质量的改善或临床评估已经定义了最小重要差异(MID),然后在计划研究时用于确定大小。此外,测量成本有效性的研究使用基准,例如成本/质量aly,但不提供成本差异的基准。在文献回顾中,我们发现没有出版物确定成本的大小指标。然而,文献描述了用于识别最小重要结果差异的三种方法:(1)基于锚定的,(2)基于分布的,(3)基于共识的德尔菲方法。在这项探索性研究中,我们使用这三种方法来推导成本研究中常见的两种类型的资源度量的MID:(1)住院(高成本);(2)门诊就诊(费用低)。我们使用了两项(未发表的)研究的数据来实现MID估计。由于成本测量的分布特征可能需要大量的样本,我们对所有的估计进行了功率分析,以说明“小”和“大”成本的定义可能对研究的功率和样本量要求产生的影响。基于锚点的方法虽然符合逻辑且易于实现,但在难以确定适当锚点的情况下可能价值有限。我们观察到分布和基于共识的方法的一些共性和差异,这需要进一步研究。我们建议,在没有可接受的锚点的情况下,对成本的德尔菲法和MID的分布法都进行收敛探索。
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引用次数: 5
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Health Services and Outcomes Research Methodology
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