COVID EHR COHORT at the University of Wisconsin

This cohort study will obtain electronic health record (EHR) data (limited data set) from 21
health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health
systems with large numbers of COVID-19 patients to explore whether smoking status, cancer
history, and other risk factors among patients diagnosed with COVID-19 are associated with
mortality and/or COVID-19 disease severity/complications. The Cancer Center Cessation
Initiative (C3I) is a project launched by the US National Cancer Institute (NCI) to improve
the rate at which NCI-designated Cancer Centers provide evidence-based smoking cessation to
patients diagnosed with and treated for cancer. The C3I is coordinated at the University of
Wisconsin-Center for Tobacco Research and Intervention (UW-CTRI) and the University of
Wisconsin Carbone Cancer Center (UWCCC). Twenty-one health systems across the U.S. will
provide EHR data to the UW-CTRI coordinating center on all COVID-19 patients identified
during the period from February 1, 2020, through January 31, 2022.

Current EHR-based data elements collected will include:

Evidence of COVID-19: ICD-10-CM diagnosis of COVID-19, COVID-19 PCR lab test, and/or COVID-19
antigen lab test

Healthcare system encounter type: inpatient, outpatient, emergency department (ED), urgent
care, or other

SES/Demographics variables: insurance status, education, housing status, sex, age,
race/ethnicity, height, weight, body mass index

Comorbid diseases: chronic asthma, chronic COPD, chronic bronchiectasis, diabetes mellitus,
cardiovascular disease, chronic renal disease, on dialysis, immunocompromised [due to SLE
lupus, rheumatoid arthritis, organ transplant, HIV, Crohn's], pregnant, cancer (lymphomas,
leukemias, lung/respiratory, rectal, breast, prostate, pancreas), hypertension, depression,
anxiety, alcohol abuse, pro- clotting disorders, and anti-clotting disorders

Tobacco use variables: smoking status (current, former, never), passive smoke exposure for
never smoker, years since quitting (for former smokers), packs smoked per day, years of
smoking, pack years, smokeless tobacco user, and marijuana use

Signs and symptoms: temperature, pulse, systolic blood pressure, diastolic blood pressure,
oxygen saturation, septic shock, pneumonia, chills, muscle aches/myalgia, rhinorrhea, sore
throat, chronic cough, shortness of breath, nausea or vomiting, headache, abdominal pain,
diarrhea, dizziness, impaired consciousness, acute cerebrovascular event, ataxia, seizure,
taste impairment, smell impairment, vision impairment, nerve pain, and skeletal muscular pain

COVID-19 treatment variables: ICU admission, required supplemental oxygen, intubated for
ventilator use, noninvasive positive pressure, and number of days hospitalized

COVID-19 medications including (but not limited to): chloroquine, hydroxychloroquine,
tocilizumab, remdesivir, dexamethasone, convalescent plasma, and ascorbic acid

Classes of other medications used: nicotine replacement therapies (NRTs), varenicline
medications; blood thinners, steroids, angiotensin converting enzyme (ACE) inhibitors,
angiotensin-receptor blockers (ARBs), short-acting adrenergic bronchodilators, long-acting
adrenergic bronchodilators, anticholinergic bronchodilators, bronchodilators combos, inhaled
corticosteroids (includes combo medications), and inhaled corticosteroid bronchodilators

Lab tests: COVID-19 PCR test, COVID-19 Antigen test, Albumin, ALT, Bicarbonte, BUN, Calcium,
C-Reactive Protein, High Sensitivity, C-Reactive Protein, Creatinine, D-DIMER, ESR, Ferritin,
Hematocrit, HgbA1c., INR, LDH, Leukocytes, Platelet Count, Potassium, Procalcitonin, Sodium,
Troponin-I, Troponin-T

For the initial paper(s) to be prepared based on these data, the main analytic methods will
include GUIDE classification and regression tree models. However, whole sample methods will
also be used as complementary analytic methods, which will vary with regard to outcome type:
i.e., logistic regression for binary outcomes and Cox proportional hazard analyses for
time-to-event outcomes. Initial analyses will focus on hospitalized COVID-19 patients. Later
waves of analyses may use different analytic approaches and address different questions.

Participating healthcare systems:

- Duke University (Duke Health)

- Hackensack Meridian Health

- Mayo Clinic

- Memorial Sloan Kettering Cancer Center

- University of Michigan (Michigan Medicine)

- Mount Sinai Health System

- Northwestern University

- New York University (NYU Langone Health)

- University of California Davis (University of California Davis Comprehensive Cancer
Center / UC Davis Health)

- University of California San Francisco

- University of North Carolina at Chapel Hill (UNC Health)

- University of Chicago

- University of Illinois at Chicago

- University of Kansas (University of Kansas Medical Center)

- University of Maryland

- University of Utah (University of Utah Health)

- University of Wisconsin (UW Health)

- Vanderbilt University (Vanderbilt University Medical Center)

- Virginia Commonwealth University (VCU Health System/Massey Cancer Center)

- Washington University St Louis

- Yale University (Yale New Haven Hospital)