The Fight Against COVID-19: A National Patient Registry

Population-level viral testing for COVID-19 hasn’t produced the necessary level of surveillancedata为控制病毒提供信息建立COVID-19患者数字国家患者登记处的最重大挑战包括检测协议的差异、不同且不足的检测设施、治疗策略的差异，以及与多个供应商的数据互操作性问题、缺乏单一数据平台、数据访问和权利，以及地方和州公共卫生战略(包括监测)的差异。世界杯厄瓜多尔vs塞内加尔波胆预测

为了全面了解这种病毒——它如何根据合并症、生活方式因素和更多的研究人员需要以前所未有的速度获得COVID-19的真实世界证据(RWE)。数字国家一级真实数据(RWD)注册是新出现的COVID-19 RWE解决方案，因此有助于更好地了解疫情。

A Standardized, Comprehensive National Patient Registry to Meet the Urgent Need for COVID-19 Understanding

不久，医学研究人员将需要COVID-19 RWE来了解疫苗的安全性和有效性。新批准的疫苗将按照加快的时间表运行，但针对儿童、老年人、青少年和人数不足的少数群体的数据将不足或没有。临床医生、医学研究人员和决策者将需要来自现实环境的持续数据来了解这种影响世界绝大多数地区的疾病。

为了成功地进一步了解COVID-19，患者登记必须在最小可行数据集(MVDS)上运作。这些数据集构成了医院、检测机构和公共机构将为有COVID-19症状但病毒检测未呈阳性的患者和COVID-19检测呈阳性的患者收集的基本数据的元素。临床和科学界以及政策制定者利用MVDS建立登记，利用来自美国各地卫生系统的检测、临床和索赔数据，为确诊和疑似COVID-19患者建立队列。

No singular national authority sets MVDS requirements for COVID-19. As a result, several registries have emerged that lack standardization and cover limited breadth and depth of the data necessary to answer critical questions about COVID-19 for the medical research community and policymakers.

The Case for a National Patient Registry: Top Challenges of a COVID-19

These insufficient existing COVID-19 registries are confronting the global pandemic’s pressure on the worldwide community the think holistically about the healthcare and life sciences ecosystem and the collection and use the data to support various use cases. Hospitals serving COVID-19 patients, as well as medical researchers and pharmaceutical companies, face the following challenges responding to the outbreak:

• 了解疾病的自然历史和进化。
• Meeting testing needs.
• Assessing effectiveness and outcomes associated with various preventative and treatment modalities.
• Administering the vaccine and prioritizing patient populations for vaccination.
• Establishing vaccination rates.
• Monitoring vaccine safety and efficacy.
• Understanding the impact of COVID-19 on other treatment modalities (e.g., immunotherapy) for various comorbidities and diseases.
• Maintaining or expanding their facilities’ capacity to treat patients with COVID-19 and returning to pre-COVID-19 patient volumes and care processes (e.g., elective surgeries and clinical trials).
• 与个人防护设备、检测和人员配置相关的协助。
• 满足供应和耐用设备的需求。
• 会议金融问题。

随着大流行推动上述挑战，迫切需要合作和新的可操作数据，以及了解大流行后的医疗保健和生活将是什么样子，数字注册很好地支持汇总的RWD收集。在医学研究人员公布与COVID-19相关的随机对照试验结果和医疗保健根除COVID-19或有科学证明的治疗方案之前。Withthe FDA’s supportof patient-generated RWD and RWE, healthcare and life sciences organizations must leverage the data available through disparate data sources including EHRs and claims to improve decision making around COVID-19 in clinical, research, and policy settings.

A National COVID-19 Registry Bridges Critical Information Gaps with Real-World Evidence

疫情使莱茵集团有必要扩大使用来支持监管决定。通过开展将适当的科学标准应用于COVID-19注册的莱茵集团研究，并遵循使用案例，生命科学可以通过确保干预措施的安全性和有效性(针对COVID-19和其他疾病)，为公共卫生和政策制定提供支持。

• Designing and improving clinical care pathways and guidelines.
• Informing medical research for diagnostic, therapeutic, and vaccine development.
• 对病人进行分类检查。
• 筛选和测试的有效性。
• Patient and healthcare provider surveillance.
• Understanding the performance of diagnostics in real-world settings.
• Efficacy and safety of therapeutics.
• Addressing health disparities.
• Vaccination.
• Impact on other diseases.
• 轻度COVID-19患者与中度至重度患者的长期结果。
• Vaccination rates, as well as efficacy and safety.

MVDS方法利用来自美国各地卫生系统的临床和索赔数据，填补了信息空白，为COVID-19全国患者注册和COVID-19相关的RWE提供了动力。Touchstone®COVID-19注册和见解(图1)是Hea世界杯葡萄牙vs加纳即时走地lth Catalyst提供的一种此类注册解决方案，旨在为其他更广泛的COVID-19及其他国家注册提供模板。

A national-level registry effectively assembles critical data in a standardized manner, giving healthcare and life sciences organizations a documented, reproducible solution to the pandemic data scarcity and quality challenges. Concepts added in this registry can serve as an MVDS enables the exchange of essential data and improves the quality of data collected, which is vital as disparate sources and organizations collect the data. Also, users can configure their EHRs and other front end data capture systems to manage MVDS, making it an accessible tool for many organizations.

通过利用Health Cat世界杯葡萄牙vs加纳即时走地alyst COVID-19国家专利注册来确定COVID-19患者的关键感兴趣特征，更容易跟踪患者从疑似诊断到确诊诊断的长期趋势。跟踪有几个好处，包括协助患者分诊，以执行ICD-10代码的适当收费，以及预测和分诊有COVID-19体征和症状、检测结果更可能呈阳性的患者。与此同时，COVID-19疑似和确诊病例的记录和编码标准正在演变，进一步的评估和研究将有助于在COVID-19工作中充分利用登记制度。

COVID-19 National Registry Essentials: Patient Cohorts and Lab Test Knowledge Curation

The digital COVID-19 registry allows for two essential capabilities to further understand the virus: defining patient cohorts and lab test knowledge curation (Figure 2).

Patient Cohorts

Based on guidance from national and global agencies, including theCenters for Disease Control and Prevention,World Health Organization, and others, proposedvalue setsmust include two patient cohorts for the registry—confirmed and suspected COVID-19 patients. The guidelines further stratify the cohorts into three levels of confidence (Figure 3):

1. High confidence suspected.
2. Moderate confidence suspected.
3. Low confidence suspected.

The patient cohorts for the registry defined using the value sets above allow the study of patient care outcomes. Examples of outcomes of interest in COVID-19 patients include the following measures:

• ICU admission.
• Ventilator status.
• 体外膜氧合要求。
• Mortality.

Lab Test Knowledge Curation

部分由于实验室检测的诊断重要性，实验室检测结果数据对于了解患者的临床状态和监测患者人群至关重要。然而，对于临床、研究和公共卫生社区来说，从医院和参考实验室获得具有一致LOINC代码和生产信息的实验室数据是非常具有挑战性的。

EHR systems often store lab data with local codes for test types and result values rather than codes from widely standardized terminologies (e.g.,LOINC(Logical Observation Identifiers Names and Codes)). In such cases, researchers need to ascertain the types of lab tests and the meanings of the result values automatically over a large volume of lab result data—without the benefit of a uniform standard lab terminology across the various EHR systems the proved the lab result data.

In the Health Catalyst national-level COVID-19 registry, a lab test knowledge curation workflow provides a knowledge base for recognizing lab test types and understanding lab result values, as expressed in the lab result data records from multiple EHRs (Figure 4).

The lab test knowledgebase, accumulated from many lab result records across multiple EHRs, allows for automated categorization of lab results (e.g., positive, negative, pending, ambiguous, test problem, unmapped) and lab test types (e.g., detection of COVID-19 material or a COVID-19 antibody). This classification system identifies patterns of interest; for example, it classifies the data of patients who are confirmed or suspected COVID-19 cases. The harmonized set of lab result values allows for the following:

• Rapid automated use of readily comprehensible data (e.g., positive and negative result values).
• Identification of results that may be usable with additional data curation (e.g., unmapped).
• The ability to select for patients whose tests may still be in process or unavailable (e.g., “pending”).

制造商信息与实验室检测订单、结果和临床数据集成，可以帮助评估各种COVID-19诊断检测的性能。一个EHR，实验室信息系统和仪器收集几个数据点。由于涉及到不同的提供者和系统，所以没有系统能够捕获全貌。存在互操作性的挑战，并且缺乏推荐的MVDS来实现标准化的数据收集和管理工作，以支持RWE。

To address this industry-wide challenge, Health Catalyst is actively addressing this problem in a collaborative approach with health systems and diagnostic labs to add the data elements of interest from unstructured and structured data in EHRs and Laboratory Information Management Systems. This will enable RWD in the COVID-19 registry to understand the performance and the limitation of testing and understand better how to use data for RWE.

Optimizing the COVID-19 National Patient Registry

While the COVID-19 registry holds promise in better disease understanding and management, optimizing it requires more work with healthcare and life sciences organizations of every size to help their analytics and informatics team develop a registry. The participation of EHR vendors is also crucial to ensure they can leverage their partnerships with hospitals for maximal data collection. Additionally, federal government oversight and leadership by coordinating with local health authorities would coordinate the collection of adequate data to direct current and future decision making to control this pandemic and prevent subsequent outbreaks.

To generate evidence and insights from this registry and other data sets at a national scale, the Health Catalyst Life Sciences division is participating in theCOVID-19 Evidence Acceleratorlaunched by theFriends of Cancer Researchand theReagan-Udall Foundationfor the FDA. Health Catalyst has shared experience with the COVID-19 national patient registry with the Reagan-Udallacceleratorto inform thekey data elementsneeded to support RWE generation for COVID-19.

Understanding the importance of partnerships with several national and local authorities, Health Catalyst collaborated with theMITRE Corporationto convene theCOVID-19 Healthcare Coalition. This group of EHR companies, non-profits, analytics companies, healthcare organizations, and academic community members contributes knowledge to solve public health questions related to COVID-19. The coalition has defined common data elements and study designs to allow its members to replicate these investigations with each of their patient populations independently; no member working alone could produce these insights.

An MVDS-Driven COVID-19 Registry Is a Critical Tool in a Rapidly Changing Landscape

As a dynamic and scalable approach, leveraging EHR data with MVDS can accommodate the rapidly changing COVID-19 landscape and fill in critical gaps of population-level viral testing. Aggregated outbreak information from health systems across the United States will give researchers and providers the comprehensive understanding they need to adapt to pandemic demands, direct resources, and plan for surges in a timely, informed manner.

试金石COVID-19注册和见解工作代表了EHR和分析供应商之间的历史性合作。The completestudyis available on the COVID-19 Healthcare Coalition’s website, courtesy of MITRE.

Additional Reading

Would you like to learn more about this topic? Here are some articles we suggest:

1. Health Catalyst Launches COVID-19 Patient Data Repository to Speed Vaccine Development
2. Using COVID-19 Value Sets for Patient Identification
3. A Sustainable Healthcare Emergency Management Framework: COVID-19 and Beyond
4. Healthcare Trends During COVID-19: Top Five Areas to Watch
5. How Data Transforms the Hospital Command Center to Pandemic Proportions

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