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设施，以收集各种类型和各种来源的数据，以便使用一组综合的相关数据进行关键分析，这些数据代表SARS CoV-2核酸扩增测试（NAAT）和抗体测试在患者水平上的商业纵向实验室测试结果，以评估已知SARS-CoV-2血清阳性对后续再感染率的影响。使用真实的世界数据（RWD）设计的队列研究感染。这些数据将被分析，以确定SARS-CoV-2抗体是否对再次感染具有保护作用，如果是，这种保护作用会持续多久。虽然疫苗相关的临床试验正在进行中，但结果可能比使用RWD的潜在分析慢。该队列定义为所有接受SARS-CoV-2抗体检测的患者，可以纵向随访（至少一年）。纵向分析将使用与数据相关的商业实验室测试结果数据进行（从2020年1月至今的数据开始，在四个月的执行期内每月下载给政府），来自住院、门诊和药房数据的索赔，代表住院期间收到的详细服务的医院收费数据，和EMR数据从门诊设施都集成了医疗保健系统以及社区的做法。