THE CONTRACTOR SHALL DEVELOP AN INFRASTRUCTURE TO INTEGRATE VARIOUS TYPES OF REAL WORLD DATA FROM A VARIETY OF CLINICAL AND NONCLINICAL SOURCES IN ORD

承包商应开发基础设施来集成来自各种临床和非临床来源的各种类型的真实世界数据。

• 批准号: 10462049
• 负责人: SANDY LEONARD
• 金额: $ 349.22万
• 依托单位: HEALTHVERITY, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-11 至 2021-12-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10462049
• 关键词: 2019-nCoV; Asthma; Cardiovascular Diseases; Chronic Obstructive Airway Disease; Clinical; Clinical Trials; Cohort Studies; Community Practice; Contractor; Contracts; Data; Demographic Factors; Diabetes Mellitus; Diagnostic tests; Geographic Locations; Government; Healthcare Systems; Hospitalization; Hospitals; Hypertension; Immune System Diseases; Impairment; Infection; Infrastructure; Inpatients; Kidney; Laboratories; Link; Malignant Neoplasms; Nucleic Acid Amplification Tests; Nursing Homes; Obesity; Occupations; Outpatients; Patients; Pattern; Performance; Pharmacy facility; Pilot Projects; Relative Risks; Research Design; Risk; SARS-CoV-2 antibody; SARS-CoV-2 infection; SARS-CoV-2 positive; Serology test; Services; Source; Test Result; Testing; Time; Vaccines; antibody test; base; cohort; comorbidity; infection rate; longitudinal analysis; outpatient facility; primary outcome; residence; respiratory; seropositive; slow potential

The objective of this contract is to develop infrastructure to collect data of various types and from various sources in order to perform critical analyses using an integrated set of linked data representing commercial longitudinal laboratory test results at the patient level for SARS CoV-2 Nucleic Acid Amplification Test (NAAT) and antibody testing to assess the impact of known SARS-CoV-2 seropositivity on the rate of subsequent re-infection with a cohort study design using Real World Data (RWD). The data will be analyzed to determine whether antibodies to SARS-CoV-2 are protective against re-infection, and if so, how long that protection last. While vaccine-related clinical trials are underway, results are likely to be slower than potential analyses using RWD. The cohort is defined as all patients tested for SARS-CoV-2 antibodies that can be followed longitudinally (for a minimum of one year). The longitudinal analysis will be conducted using data from commercial lab test results linked to data (beginning with data pulled from January 2020 through present with monthly downloads to the Government for the Period of Performance over four months) from claims for inpatient, outpatient and pharmacy data, hospital chargemaster data representing detailed services received during an inpatient hospital admission, and EMR data from outpatient facilities both integrated with a health care system as well as for community practices.

该合同的目的是开发基础架构，以收集各种类型的数据和各种来源的数据，以便使用一组集成的链接数据进行关键分析，这些链接数据代表患者在患者级别的商业纵向实验室测试结果，用于SARS COV-2核酸核酸扩增测试（NAAT），并使用已知的SARS-COV-COV-COV-2 SEROPITITY在COHS-COV-2的影响效果的影响，以评估已知的SARS-COV-COV-COV-COV-2 SEROPITITY在COH中的影响。 （RWD）。将对数据进行分析，以确定SARS-COV-2抗体是否可以防止再感染，如果是这样，则该保护持续了多长时间。尽管正在进行与疫苗相关的临床试验，但结果可能比使用RWD进行的分析要慢。该队列的定义是所有对可以纵向遵循的SARS-COV-2抗体测试的患者（至少一年）。 The longitudinal analysis will be conducted using data from commercial lab test results linked to data (beginning with data pulled from January 2020 through present with monthly downloads to the Government for the Period of Performance over four months) from claims for inpatient, outpatient and pharmacy data, hospital chargemaster data representing detailed services received during an inpatient hospital admission, and EMR data from outpatient facilities both integrated with a health care system as well as for community practices.