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Dissemination and Implementation of Evidence Based Best Practice Across the High Value Healthcare Collaborative (HVHC) Using Sepsis as a Prototype - Rapidly Learning from Others. 以败血症为原型,在整个高价值医疗保健合作组织(HVHC)中传播和实施基于证据的最佳实践--快速向他人学习。
Pub Date : 2017-12-15 DOI: 10.5334/egems.192
Andreas Taenzer, Allison Kinslow, Christine Gorman, Shelley Schoepflin Sanders, Shilpa J Patel, Sally Kraft, Lucy Savitz

The dissemination of evidence-based best practice through the entire health care system remains an elusive goal, despite public pressure and regulatory guidance. Many patients do not receive the same quality of care at different hospitals across the same health care system. We describe the role of a data driven learning collaborative, the High Value Healthcare Collaborative (HVHC), in the dissemination of best practice using adherence to the 3-hour-bundle for sepsis care. Compliance with and adoption of sepsis bundle care elements comparing sites with mature vs non-mature care delivery processes were measured during the improvement effort for a cohort of 20,758 patients. Non-mature sites increased their bundle compliance from 71.0 to 86.7 percent (p < 0.005). This compliance increase was primarily based on increased compliance with the fluid element of the bundle that improved for non-mature locations from 76.4 to 94.0 percent (p < 0.005).

尽管有公众压力和监管指导,但在整个医疗系统推广循证最佳实践仍是一个难以实现的目标。许多患者在同一医疗系统的不同医院接受的治疗质量并不相同。我们介绍了一个数据驱动的学习合作组织--高价值医疗保健合作组织(HVHC)--在传播最佳实践方面所发挥的作用,该合作组织坚持使用败血症护理 3 小时捆绑包。在对 20758 名患者进行改进的过程中,对脓毒症捆绑护理要素的依从性和采用情况进行了测量,并对成熟与不成熟的护理提供流程进行了比较。非成熟医疗点的捆绑护理依从性从 71.0% 提高到 86.7%(p < 0.005)。合规率的提高主要是由于非成熟医疗点对捆绑包中液体元素的合规率从 76.4% 提高到 94.0%(p < 0.005)。
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引用次数: 0
Data Cleaning in the Evaluation of a Multi-Site Intervention Project. 多站点干预项目评估中的数据清理。
Pub Date : 2017-12-15 DOI: 10.5334/egems.196
Gavin Welch, Friedrich von Recklinghausen, Andreas Taenzer, Lucy Savitz, Lisa Weiss

Context: The High Value Healthcare Collaborative (HVHC) sepsis project was a two-year multi-site project where Member health care delivery systems worked on improving sepsis care using a dissemination & implementation framework designed by HVHC. As part of the project evaluation, participating Members provided 5 data submissions over the project period. Members created data files using a uniform specification, but the data sources and methods used to create the data sets differed. Extensive data cleaning was necessary to get a data set usable for the evaluation analysis.

Case description: HVHC was the coordinating center for the project and received and cleaned all data submissions. Submissions received 3 sequentially more detailed levels of checking by HVHC. The most detailed level evaluated validity by comparing values within-Member over time and between Member. For a subset of episodes Member-submitted data were compared to matched Medicare claims data.

Findings: Inconsistencies in data submissions, particularly for length-of-stay variables were common in early submissions and decreased with subsequent submissions. Multiple resubmissions were sometimes required to get clean data. Data checking also uncovered a systematic difference in the way Medicare and some members defined intensive care unit stay.

Conclusions: Data checking is a critical for ensuring valid analytic results for projects using electronic health record data. It is important to budget sufficient resources for data checking. Interim data submissions and checks help find anomalies early. Data resubmissions should be checked as fixes can introduce new errors. Communicating with those responsible for creating the data set provides critical information.

背景:高价值医疗保健协作(HVHC)败血症项目是一个为期两年的多站点项目,成员医疗保健提供系统使用HVHC设计的传播和实施框架致力于改善败血症护理。作为项目评估的一部分,参与成员在项目期间提交了5份数据。成员使用统一的规范创建数据文件,但是用于创建数据集的数据源和方法不同。为了获得可用于评估分析的数据集,需要进行大量的数据清理。案例描述:HVHC是该项目的协调中心,负责接收和清理所有提交的数据。HVHC对提交的作品依次进行了3次更详细的检查。最详细的级别通过比较成员内部和成员之间的值来评估有效性。对于一部分患者提交的数据与匹配的医疗保险索赔数据进行比较。发现:数据提交的不一致,特别是在停留时间变量方面,在早期提交中很常见,随着后续提交而减少。有时需要多次重新提交以获得干净的数据。数据检查还发现,医疗保险和一些成员在定义重症监护病房的方式上存在系统性差异。结论:数据检查对于确保使用电子健康记录数据的项目的有效分析结果至关重要。为数据检查预算足够的资源是很重要的。中期数据提交和检查有助于及早发现异常。应该检查重新提交的数据,因为修复可能会引入新的错误。与负责创建数据集的人员进行通信可以提供关键信息。
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引用次数: 10
A Data Driven Approach to Achieving High Value Healthcare. 实现高价值医疗保健的数据驱动方法。
Pub Date : 2017-12-15 DOI: 10.5334/egems.241
Lucy A Savitz, Lisa T Weiss

The purpose of this special issue is to disseminate learning from the High Value Healthcare Collaborative (HVHC). The HVHC is a voluntary, member-led organization based on trusted, working relationships among delivery system leaders. HVHC's mission is to be a provider-based learning health system committed to improving healthcare value through data, evidence, and collaboration. We begin by describing the organization and structure of HVHC in order to lay the context for a series of papers that feature work from this learning health system. HVHC was awarded a grant from the John and Laura Arnold Foundation to develop a generalizable model for dissemination and implementation. Implementation of the 3-hour sepsis bundle was used as a prototypic, complex intervention with an in-depth mixed methods evaluation across 16 member sites. The first four articles in this issue describe, in detail, various data and methodological challenges encountered together with strategies for overcoming these (see Knowlton et al., von Recklinghausen et al., Welch et al., and Taenzer et al.). Next, we illustrate how the Data Trust can support emerging questions relevant to member organizations. The paper by Albritton et al., explores the impact of observation stays on readmission rates. Knighton et al., explore the use of an area-based measure for health literacy to assess risk in disadvantaged populations. Two final papers illustrate the importance of fundamental data sources needed to support advanced data science.

本特刊旨在传播高价值医疗保健合作组织 (HVHC) 的经验。HVHC 是一个由成员自愿组成的组织,其基础是医疗服务系统领导者之间相互信任的工作关系。HVHC 的使命是成为一个以医疗服务提供者为基础的学习型医疗系统,致力于通过数据、证据和协作提高医疗保健价值。我们首先介绍了 HVHC 的组织和结构,以便为一系列介绍该学习型医疗系统工作的论文奠定基础。HVHC 获得了约翰和劳拉-阿诺德基金会(John and Laura Arnold Foundation)的资助,以开发一个可推广和实施的模式。3 小时败血症捆绑疗法的实施被用作一种原型、复杂的干预措施,并在 16 个成员站点进行了深入的混合方法评估。本期的前四篇文章详细描述了所遇到的各种数据和方法挑战,以及克服这些挑战的策略(见 Knowlton 等人、von Recklinghausen 等人、Welch 等人和 Taenzer 等人)。接下来,我们将说明数据信托如何支持与成员组织相关的新问题。Albritton 等人的论文探讨了观察住院对再入院率的影响。Knighton 等人的论文探讨了如何使用基于地区的健康素养测量方法来评估弱势群体的风险。最后两篇论文说明了支持高级数据科学所需的基础数据源的重要性。
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引用次数: 0
Health Information Exchange Use (1990-2015): A Systematic Review. 卫生信息交换使用(1990-2015):系统回顾。
Pub Date : 2017-12-07 DOI: 10.5334/egems.249
Emily Beth Devine, Annette M Totten, Paul Gorman, Karen B Eden, Steven Kassakian, Susan Woods, Monica Daeges, Miranda Pappas, Marian McDonagh, William R Hersh

Background: In June 2014, the Office of the National Coordinator for Health Information Technology published a 10-year roadmap for the United States to achieve interoperability of electronic health records (EHR) by 2024. A key component of this strategy is the promotion of nationwide health information exchange (HIE). The 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act provided significant investments to achieve HIE.

Objective: We conducted a systematic literature review to describe the use of HIE through 2015.

Methods: We searched MEDLINE, PsycINFO, CINAHL, and Cochrane databases (1990 - 2015); reference lists; and tables of contents of journals not indexed in the databases searched. We extracted data describing study design, setting, geographic location, characteristics of HIE implementation, analysis, follow-up, and results. Study quality was dual-rated using pre-specified criteria and discrepancies resolved through consensus.

Results: We identified 58 studies describing either level of use or primary uses of HIE. These were a mix of surveys, retrospective database analyses, descriptions of audit logs, and focus groups. Settings ranged from community-wide to multinational. Results suggest that HIE use has risen substantially over time, with 82% of non-federal hospitals exchanging information (2015), 38% of physician practices (2013), and 17-23% of long-term care facilities (2013). Statewide efforts, originally funded by HITECH, varied widely, with a small number of states providing the bulk of the data. Characteristics of greater use include the presence of an EHR, larger practice size, and larger market share of the health-system.

Conclusions: Use of HIE in the United States is growing but is still limited. Opportunities remain for expansion. Characteristics of successful implementations may provide a path forward.

背景:2014年6月,国家卫生信息技术协调员办公室发布了美国到2024年实现电子健康记录(EHR)互操作性的10年路线图。这一战略的一个关键组成部分是促进全国卫生信息交流。2009年《卫生信息技术促进经济和临床健康法》(HITECH)为实现HIE提供了大量投资。目的:我们进行了一项系统的文献综述,以描述到2015年HIE的使用情况。方法:检索MEDLINE、PsycINFO、CINAHL、Cochrane数据库(1990 - 2015);引用列表;以及未在检索数据库中编入索引的期刊目录。我们提取了描述研究设计、设置、地理位置、HIE实施特征、分析、随访和结果的数据。采用预先指定的标准对研究质量进行双重评价,并通过共识解决差异。结果:我们确定了58项研究描述了HIE的使用水平或主要使用情况。这些是调查、回顾性数据库分析、审计日志描述和焦点小组的混合。设置范围从社区范围到跨国公司。结果表明,随着时间的推移,HIE的使用大幅增加,82%的非联邦医院交换信息(2015年),38%的医生实践(2013年),17% -23%的长期护理机构(2013年)。最初由HITECH资助的全州范围内的努力差异很大,少数几个州提供了大量数据。更多使用的特征包括电子病历的存在、更大的实践规模和更大的卫生系统市场份额。结论:HIE在美国的使用正在增长,但仍然有限。扩张的机会依然存在。成功实现的特征可能提供前进的道路。
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引用次数: 33
Analytical Methods for a Learning Health System: 4. Delivery System Science. 学习型卫生系统的分析方法:输送系统科学。
Pub Date : 2017-12-07 DOI: 10.5334/egems.253
Michael Stoto, Gareth Parry, Lucy Savitz

The last in a series of four papers on how learning health systems can use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning, this review describes how delivery system science provides a systematic means to answer questions that arise in translating complex interventions to other practice settings. When the focus is on translation and spread of innovations, the questions are different than in evaluative research. Causal inference is not the main issue, but rather one must ask: How and why does the intervention work? What works for whom and in what contexts? How can a model be amended to work in new settings? In these settings, organizational factors and design, infrastructure, policies, and payment mechanisms all influence an intervention's success, so a theory-driven formative evaluation approach that considers the full path of the intervention from activities to engage participants and change how they act to the expected changes in clinical processes and outcomes is needed. This requires a scientific approach to quality improvement that is characterized by a basis in theory; iterative testing; clear, measurable process and outcomes goals; appropriate analytic methods; and documented results. To better answer the questions that arise in delivery system science, this paper introduces a number of standard qualitative research approaches that can be applied in a learning health system: Pawson and Tilley's "realist evaluation," theory-based evaluation approaches, mixed-methods and case study research approaches, and the "positive deviance" approach.

作为关于学习型卫生系统如何使用常规收集的电子卫生数据(EHD)来推进知识和支持持续学习的四篇系列论文中的最后一篇,本综述描述了交付系统科学如何提供一种系统手段来回答在将复杂干预措施转化为其他实践环境时出现的问题。当重点放在创新的翻译和传播上时,问题就不同于评价性研究了。因果推理不是主要问题,但人们必须问:干预是如何以及为什么起作用的?什么对谁有效,在什么情况下有效?如何修改模型以适应新的环境?在这些情况下,组织因素和设计、基础设施、政策和支付机制都会影响干预的成功,因此需要一种理论驱动的形成性评估方法,该方法考虑了从活动到参与者参与的干预的完整路径,并改变了他们的行为方式,从而改变了临床过程和结果的预期变化。这需要一种科学的质量改进方法,其特点是有理论基础;迭代测试;明确、可衡量的过程和结果目标;合适的分析方法;并记录了结果。为了更好地回答交付系统科学中出现的问题,本文介绍了一些可以应用于学习型卫生系统的标准定性研究方法:Pawson和Tilley的“现实主义评估”,基于理论的评估方法,混合方法和案例研究方法,以及“积极偏差”方法。
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引用次数: 7
Generalizability of Indicators from the New York City Macroscope Electronic Health Record Surveillance System to Systems Based on Other EHR Platforms. 纽约市宏观电子病历监控系统指标对基于其他电子病历平台系统的推广。
Pub Date : 2017-12-07 DOI: 10.5334/egems.247
Katharine H McVeigh, Elizabeth Lurie-Moroni, Pui Ying Chan, Remle Newton-Dame, Lauren Schreibstein, Kathleen S Tatem, Matthew L Romo, Lorna E Thorpe, Sharon E Perlman

Introduction: The New York City (NYC) Macroscope is an electronic health record (EHR) surveillance system based on a distributed network of primary care records from the Hub Population Health System. In a previous 3-part series published in eGEMS, we reported the validity of health indicators from the NYC Macroscope; however, questions remained regarding their generalizability to other EHR surveillance systems.

Methods: We abstracted primary care chart data from more than 20 EHR software systems for 142 participants of the 2013-14 NYC Health and Nutrition Examination Survey who did not contribute data to the NYC Macroscope. We then computed the sensitivity and specificity for indicators, comparing data abstracted from EHRs with survey data.

Results: Obesity and diabetes indicators had moderate to high sensitivity (0.81-0.96) and high specificity (0.94-0.98). Smoking status and hypertension indicators had moderate sensitivity (0.78-0.90) and moderate to high specificity (0.88-0.98); sensitivity improved when the sample was restricted to records from providers who attested to Stage 1 Meaningful Use. Hyperlipidemia indicators had moderate sensitivity (≥0.72) and low specificity (≤0.59), with minimal changes when restricting to Stage 1 Meaningful Use.

Discussion: Indicators for obesity and diabetes used in the NYC Macroscope can be adapted to other EHR surveillance systems with minimal validation. However, additional validation of smoking status and hypertension indicators is recommended and further development of hyperlipidemia indicators is needed.

Conclusion: Our findings suggest that many of the EHR-based surveillance indicators developed and validated for the NYC Macroscope are generalizable for use in other EHR surveillance systems.

简介:纽约市(NYC) Macroscope是一个电子健康记录(EHR)监测系统,基于枢纽人口健康系统初级保健记录的分布式网络。在eGEMS上发表的前三部分系列文章中,我们报告了NYC Macroscope中健康指标的有效性;然而,关于其推广到其他电子病历监测系统的问题仍然存在。方法:我们从20多个EHR软件系统中提取了2013-14年纽约市健康与营养调查的142名参与者的初级保健图表数据,这些参与者没有向NYC Macroscope提供数据。然后,我们计算了指标的敏感性和特异性,将从电子病历中提取的数据与调查数据进行比较。结果:肥胖和糖尿病指标具有中高敏感性(0.81 ~ 0.96)和高特异性(0.94 ~ 0.98)。吸烟状况和高血压指标敏感性中等(0.78 ~ 0.90),特异性中至高(0.88 ~ 0.98);当样本仅限于证明第一阶段有意义使用的提供者的记录时,灵敏度提高了。高脂血症指标敏感性中等(≥0.72),特异性较低(≤0.59),限制为1期有意义使用时变化最小。讨论:NYC Macroscope中使用的肥胖和糖尿病指标可以在最少验证的情况下适用于其他电子病历监测系统。然而,建议对吸烟状况和高血压指标进行额外的验证,并需要进一步开发高脂血症指标。结论:我们的研究结果表明,为NYC Macroscope开发和验证的许多基于EHR的监测指标可推广用于其他EHR监测系统。
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引用次数: 7
Analytical Methods for a Learning Health System: 1. Framing the Research Question. 学习型卫生系统的分析方法:构建研究问题。
Pub Date : 2017-12-07 DOI: 10.5334/egems.250
Michael Stoto, Michael Oakes, Elizabeth Stuart, Lucy Savitz, Elisa L Priest, Jelena Zurovac

Learning health systems use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning. Even without randomization, observational studies can play a central role as the nation's health care system embraces comparative effectiveness research and patient-centered outcomes research. However, neither the breadth, timeliness, volume of the available information, nor sophisticated analytics, allow analysts to confidently infer causal relationships from observational data. However, depending on the research question, careful study design and appropriate analytical methods can improve the utility of EHD. The introduction to a series of four papers, this review begins with a discussion of the kind of research questions that EHD can help address, noting how different evidence and assumptions are needed for each. We argue that when the question involves describing the current (and likely future) state of affairs, causal inference is not relevant, so randomized clinical trials (RCTs) are not necessary. When the question is whether an intervention improves outcomes of interest, causal inference is critical, but appropriately designed and analyzed observational studies can yield valid results that better balance internal and external validity than typical RCTs. When the question is one of translation and spread of innovations, a different set of questions comes into play: How and why does the intervention work? How can a model be amended or adapted to work in new settings? In these "delivery system science" settings, causal inference is not the main issue, so a range of quantitative, qualitative, and mixed research designs are needed. We then describe why RCTs are regarded as the gold standard for assessing cause and effect, how alternative approaches relying on observational data can be used to the same end, and how observational studies of EHD can be effective complements to RCTs. We also describe how RCTs can be a model for designing rigorous observational studies, building an evidence base through iterative studies that build upon each other (i.e., confirmation across multiple investigations).

学习型卫生系统使用常规收集的电子卫生数据(EHD)来推进知识和支持持续学习。即使没有随机化,观察性研究也可以在国家卫生保健系统接受比较有效性研究和以患者为中心的结果研究时发挥核心作用。然而,无论是广度、及时性、可用信息的数量,还是复杂的分析,都不能让分析师自信地从观测数据中推断出因果关系。然而,根据研究问题,精心的研究设计和适当的分析方法可以提高EHD的效用。作为四篇系列论文的引言,本综述首先讨论了EHD可以帮助解决的研究问题,并指出每个问题需要不同的证据和假设。我们认为,当问题涉及描述当前(以及可能的未来)事件状态时,因果推理是不相关的,因此没有必要进行随机临床试验(rct)。当问题是干预是否改善了感兴趣的结果时,因果推理是至关重要的,但适当设计和分析的观察性研究可以产生比典型的随机对照试验更好地平衡内部和外部效度的有效结果。当问题涉及到创新的转化和传播时,就会出现一系列不同的问题:干预是如何起作用的,为什么起作用?如何修改或调整模型以适应新环境?在这些“输送系统科学”设置中,因果推理不是主要问题,因此需要一系列定量、定性和混合研究设计。然后,我们描述了为什么随机对照试验被视为评估因果关系的黄金标准,依赖于观察数据的替代方法如何用于相同的目的,以及EHD的观察性研究如何成为随机对照试验的有效补充。我们还描述了随机对照试验如何成为设计严格观察性研究的模型,通过相互建立的迭代研究(即跨多个调查的确认)建立证据基础。
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引用次数: 8
The Use of Clinical Registries in the United States: A Landscape Survey. 临床登记在美国的使用:一项景观调查。
Pub Date : 2017-12-07 DOI: 10.5334/egems.248
Seth Blumenthal

Introduction: The use of information from clinical registries for improvement and value-based payment is increasing, yet information about registry use is not widely available. We conducted a landscape survey to understand registry uses, focus areas and challenges. The survey addressed the structure and organization of registry programs, as well as their purpose and scope.

Setting: The survey was conducted by the National Quality Registry Network (NQRN), a community of organizations interested in registries. NQRN is a program of the PCPI, a national convener of medical specialty and professional societies and associations, which constitute a majority of registry stewards in the United States.

Methods: We surveyed 152 societies and associations, asking about registry programs, governance, number of registries, purpose and data uses, data collection, expenses, funding and interoperability.

Results: The response rate was 52 percent. Many registries were self-funded, with 39 percent spending less than $1 million per year, and 32 percent spending $1-9.9 million. The typical registry had three full-time equivalent staff. Registries were frequently used for quality improvement, benchmarking and clinical decision support. 85 percent captured outpatient data. Most registries collected demographics, treatments, practitioner information and comorbidities; 53 percent captured patient-reported outcomes. 88 percent used manual data entry and 18 percent linked to external secondary data sources. Cost, interoperability and vendor management were barriers to continued registry development.

Conclusions: Registries captured data across a broad scope, audited data quality using multiple techniques, and used a mix of automated and manual data capture methods. Registry interoperability was still a challenge, even among registries using nationally accepted data standards.

导论:临床注册信息用于改善和基于价值的支付的使用正在增加,但有关注册使用的信息并不广泛可用。我们进行了一项景观调查,以了解登记处的用途、重点领域和挑战。该调查讨论了注册表程序的结构和组织,以及它们的目的和范围。背景:这项调查是由国家质量注册网络(NQRN)进行的,这是一个对注册感兴趣的组织社区。NQRN是PCPI的一个项目,PCPI是医学专业和专业学会和协会的全国召集人,这些协会和协会构成了美国注册管理人员的大多数。方法:我们调查了152个学会和协会,询问注册项目、治理、注册数量、目的和数据使用、数据收集、费用、资金和互操作性。结果:有效率为52%。许多注册中心都是自筹资金的,39%的注册中心每年的支出少于100万美元,32%的注册中心每年的支出为100万至990万美元。典型的登记处有三个全职工作人员。登记经常用于质量改进、基准制定和临床决策支持。85%的门诊数据。大多数登记收集人口统计、治疗、从业人员信息和合并症;53%捕获了患者报告的结果。88%的人使用手动数据输入,18%的人链接到外部辅助数据源。成本、互操作性和供应商管理是继续注册中心开发的障碍。结论:注册中心在广泛的范围内捕获数据,使用多种技术审计数据质量,并混合使用自动和手动数据捕获方法。注册中心互操作性仍然是一个挑战,即使在使用国家认可的数据标准的注册中心之间也是如此。
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引用次数: 21
Analytical Methods for a Learning Health System: 2. Design of Observational Studies. 学习型卫生系统的分析方法:2。观察性研究设计。
Pub Date : 2017-12-07 DOI: 10.5334/egems.251
Michael Stoto, Michael Oakes, Elizabeth Stuart, Elisa L Priest, Lucy Savitz

The second paper in a series on how learning health systems can use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning, this review summarizes study design approaches, including choosing appropriate data sources, and methods for design and analysis of natural and quasi-experiments. The primary strength of study design approaches described in this section is that they study the impact of a deliberate intervention in real-world settings, which is critical for external validity. These evaluation designs address estimating the counterfactual - what would have happened if the intervention had not been implemented. At the individual level, epidemiologic designs focus on identifying situations in which bias is minimized. Natural and quasi-experiments focus on situations where the change in assignment breaks the usual links that could lead to confounding, reverse causation, and so forth. And because these observational studies typically use data gathered for patient management or administrative purposes, the possibility of observation bias is minimized. The disadvantages are that one cannot necessarily attribute the effect to the intervention (as opposed to other things that might have changed), and the results do not indicate what about the intervention made a difference. Because they cannot rely on randomization to establish causality, program evaluation methods demand a more careful consideration of the "theory" of the intervention and how it is expected to play out. A logic model describing this theory can help to design appropriate comparisons, account for all influential variables in a model, and help to ensure that evaluation studies focus on the critical intermediate and long-term outcomes as well as possible confounders.

这是关于学习型卫生系统如何使用常规收集的电子卫生数据(EHD)来推进知识和支持持续学习的系列文章的第二篇,本文综述了研究设计方法,包括选择适当的数据源,以及设计和分析自然实验和准实验的方法。本节中描述的研究设计方法的主要优势在于,它们研究了现实环境中故意干预的影响,这对外部效度至关重要。这些评估设计旨在估计反事实——如果没有实施干预会发生什么。在个体水平上,流行病学设计侧重于确定将偏见最小化的情况。自然实验和准实验关注的是分配的变化打破了通常可能导致混淆、反向因果关系等的联系的情况。由于这些观察性研究通常使用为患者管理或行政目的收集的数据,因此观察偏倚的可能性被最小化。缺点是,人们不一定把效果归因于干预(与其他可能发生变化的事情相反),而且结果并没有表明干预是如何产生影响的。因为它们不能依靠随机化来建立因果关系,所以项目评估方法需要更仔细地考虑干预的“理论”以及预期如何发挥作用。描述这一理论的逻辑模型有助于设计适当的比较,考虑模型中所有有影响的变量,并有助于确保评估研究侧重于关键的中期和长期结果以及可能的混杂因素。
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引用次数: 8
Analytical Methods for a Learning Health System: 3. Analysis of Observational Studies. 学习型卫生系统的分析方法:3。观察性研究分析。
Pub Date : 2017-12-07 DOI: 10.5334/egems.252
Michael Stoto, Michael Oakes, Elizabeth Stuart, Randall Brown, Jelena Zurovac, Elisa L Priest

The third paper in a series on how learning health systems can use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning, this review describes how analytical methods for individual-level electronic health data EHD, including regression approaches, interrupted time series (ITS) analyses, instrumental variables, and propensity score methods, can also be used to address the question of whether the intervention "works." The two major potential sources of bias in non-experimental studies of health care interventions are that the treatment groups compared do not have the same probability of treatment or exposure and the potential for confounding by unmeasured covariates. Although very different, the approaches presented in this chapter are all based on assumptions about data, causal relationships, and biases. For instance, regression approaches assume that the relationship between the treatment, outcome, and other variables is properly specified, all of the variables are available for analysis (i.e., no unobserved confounders) and measured without error, and that the error term is independent and identically distributed. The instrumental variables approach requires identifying an instrument that is related to the assignment of treatment but otherwise has no direct on the outcome. Propensity score methods approaches, on the other hand, assume that there are no unobserved confounders. The epidemiological designs discussed also make assumptions, for instance that individuals can serve as their own control. To properly address these assumptions, analysts should conduct sensitivity analyses within the assumptions of each method to assess the potential impact of what cannot be observed. Researchers also should analyze the same data with different analytical approaches that make alternative assumptions, and to apply the same methods to different data sets. Finally, different analytical methods, each subject to different biases, should be used in combination and together with different designs, to limit the potential for bias in the final results.

这是关于学习型健康系统如何使用常规收集的电子健康数据(EHD)来推进知识和支持持续学习的系列文章中的第三篇,本文描述了个人层面电子健康数据EHD的分析方法,包括回归方法、中断时间序列(ITS)分析、工具变量和倾向评分方法,也可以用来解决干预是否“有效”的问题。在卫生保健干预措施的非实验研究中,两个主要的潜在偏倚来源是,比较的治疗组不具有相同的治疗或暴露概率,以及被未测量的协变量混淆的可能性。尽管非常不同,本章中提出的方法都是基于对数据、因果关系和偏差的假设。例如,回归方法假设治疗、结果和其他变量之间的关系是适当指定的,所有变量都可用于分析(即没有未观察到的混杂因素),并且测量没有误差,并且误差项是独立的和均匀分布的。工具变量方法需要确定一种与治疗分配相关但对结果没有直接影响的工具。另一方面,倾向评分方法假设没有未观察到的混杂因素。所讨论的流行病学设计也做了假设,例如,个人可以作为他们自己的对照。为了正确处理这些假设,分析人员应该在每种方法的假设范围内进行敏感性分析,以评估无法观察到的潜在影响。研究人员还应该用不同的分析方法来分析相同的数据,这些方法可以做出不同的假设,并将相同的方法应用于不同的数据集。最后,不同的分析方法,每一种都有不同的偏差,应该与不同的设计结合使用,以限制最终结果中的偏差。
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引用次数: 7
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