Preop COVID Testing Patterns

Preoperative COVID Testing as a Predictor of Community Disease Burden

This study is an investigation of preoperative asymptomatic COVID screening nationwide. The hypothesis is that because these tests are performed without reference to pretest probability of COVID-19 disease, unlike tests based on symptoms or close contact with infected individuals, these studies may represent a more unbiased sample of the local population prevalence of asymptomatic COVID disease burden.

Study Overview

• Status: Completed
• Conditions: COVID-19

Detailed Description

Study will gather publicly reported, aggregated statistics on positive COVID tests over time and across geographically diverse parts of the United States, summarized weekly, from the onset of the pandemic in Spring 2020 to the present time. Study will also gather contemporaneous data on weekly community COVID cases diagnosed, local positive test percentage, hospital admissions and ICU admissions for COVID-19, and deaths from COVID 19. Similar data will be obtained from a coalition of approximately 20 academic medical centers from around the United States, with Wake Forest School of Medicine, Department of Anesthesiology serving as the coordinating center. No individual patient information will be collected. Aggregated testing data, hospital disease burden, and local disease prevalence are all publicly reported.

Data will analyzed as interrupted time series.

• Study Type: Observational
• Enrollment (Actual): 375692

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Publicly reported aggregate data on asymptomatic preoperative COVID tests (no individual patient information)

Description

Inclusion Criteria:

• having preoperative asymptomatic COVID testing
• > or = 18 years of age

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with a preoperative asymptomatic COVID screening test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of asymptomatic preoperative COVID-19 positive testing	March 2020-February 2021

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of hospitalization per geographic area	March 2020-February 2021
Percentage of death per geographic area	March 2020-February 2021
ICU census per geographic area	March 2020-February 2021
Percentage of asymptomatic preoperative COVID-19 positive testing per geographic area	March 2020-February 2021

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: B S Segal, MD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Testing, preoperative
• Other Study ID Numbers: IRB00071985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No