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临床试验/NCT04544176
NCT04544176已完成不适用

Determining the Risk of Developing Symptomatic SARS-COV2-19 Infection After Attending Hospital for Radiological Examinations: a Controlled Cohort Study

Nottingham University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 48,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48,000
试验地点
1
主要终点
A microbiological diagnosis of COVID infection.

研究概览

简要总结

By using recent data on hospital attendance and COVID-19 laboratory tests, available within two NHS trusts in Nottingham and Cardiff we will enable the calculation of the risk of developing COVID-19 infection after attending an outpatient hospital appointment. This will assist in the restart planning when resuming face to face outpatient radiology appointment.

详细描述

Since March 2020, the novel coronavirus (COVID-19) pandemic has caused considerable disruption to the provision of routine healthcare in the UK. A key priority for healthcare providers when gaining control of COVID-19, is to restart the provision of urgent non-COVID care. There are several barriers including a reluctance for people to attend hospital appointments for fears of contracting COVID-19. Although SARS-COV2 infections have been reported to occur during hospital inpatient stay, the risk of acquiring SARS-COV2 during outpatient consultations or radiological investigations has not been reported.

In a pilot study at our hospitals during the pandemic, we have found radiology to reliably record in person attendance contrary to outpatient clinic appointments records that were contaminated by remote consultations. The investigators will calculate the incidence of infection in approximately 30,000 patients at Nottingham and 17,000 patients at Cardiff and calculate the risk of infection within 28 days of attending outpatient radiology appointments. Controls will use data on patients who attended the hospitals in 2019.

The study team will utilize the data held in the electronic systems of NUH and University Hospital of Wales to perform a cohort study which will comprise both an exposed cohort and unexposed cohort.

The exposed cohort will comprise patients who attended outpatient radiology appointments during (between 29/1/20 - 24/5/20) and whether they subsequently developed a positive or negative PCR test for Sars-CoV2 result within 28-days of their attendance. The unexposed cohort will work as a control group, comprising individuals who attended outpatient radiology appointments during the equivalent period in 2019.

All of this data will be retrospective, so will not require any additional data collection, nor will it interfere with routine clinical care. Pseudo-anonymised data will be transferred from University Hospital of Wales in Cardiff to Nottingham University Hospitals (NUH) Trust via a password-protected, encrypted spreadsheet, with original patient identifiers removed, and a unique code assigned, that only the researcher in Cardiff can use to trace back to the individual, this is so all the analysis can be performed at NUH by a Nottingham based statistician.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Exposed Cohort: outpatient radiology attendance at NUH between 29/1/20 - 24/5/20 or at University Hospital of Wales, Cardiff between 7/3/20 - 11/5/
  • Unexposed Cohort: outpatient attendance outpatient attendance at NUH between 29/1/19 - 24/5/19 or at University Hospital of Wales, Cardiff between 7/3/19 - 11/5/19.

排除标准

  • Patients who had an inpatient stay in the previous 28-days but excluding the 2 days prior to the SARS-COV2 test Radiological examinations that were part of an inpatient stay were not considered

结局指标

主要结局

A microbiological diagnosis of COVID infection.

时间窗: 6 months

Information will be collected on patients who receive a positive or negative COVID-19 test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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