<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04506528</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0609</org_study_id>
    <secondary_id>OISE-20-66590-1</secondary_id>
    <secondary_id>A534253</secondary_id>
    <secondary_id>SMPH/MEDICINE</secondary_id>
    <secondary_id>CTRI</secondary_id>
    <nct_id>NCT04506528</nct_id>
  </id_info>
  <brief_title>COVID EHR COHORT at the University of Wisconsin</brief_title>
  <acronym>CEC-UW</acronym>
  <official_title>COVID EHR COHORT at the University of Wisconsin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cohort study will obtain electronic health record (EHR) data (limited data set) from 21&#xD;
      health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health&#xD;
      systems with large numbers of COVID-19 patients to explore whether smoking status, cancer&#xD;
      history, and other risk factors among patients diagnosed with COVID-19 are associated with&#xD;
      mortality and/or COVID-19 disease severity/complications. Each site will provide data from&#xD;
      their health system EHR on a regular basis that includes all patients identified as having&#xD;
      COVID-19 at some point in the interval from February 1, 2020, through January 31, 2022.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cohort study will obtain electronic health record (EHR) data (limited data set) from 21&#xD;
      health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health&#xD;
      systems with large numbers of COVID-19 patients to explore whether smoking status, cancer&#xD;
      history, and other risk factors among patients diagnosed with COVID-19 are associated with&#xD;
      mortality and/or COVID-19 disease severity/complications. The Cancer Center Cessation&#xD;
      Initiative (C3I) is a project launched by the US National Cancer Institute (NCI) to improve&#xD;
      the rate at which NCI-designated Cancer Centers provide evidence-based smoking cessation to&#xD;
      patients diagnosed with and treated for cancer. The C3I is coordinated at the University of&#xD;
      Wisconsin-Center for Tobacco Research and Intervention (UW-CTRI) and the University of&#xD;
      Wisconsin Carbone Cancer Center (UWCCC). Twenty-one health systems across the U.S. will&#xD;
      provide EHR data to the UW-CTRI coordinating center on all COVID-19 patients identified&#xD;
      during the period from February 1, 2020, through January 31, 2022.&#xD;
&#xD;
      Current EHR-based data elements collected will include:&#xD;
&#xD;
      Evidence of COVID-19: ICD-10-CM diagnosis of COVID-19, COVID-19 PCR lab test, and/or COVID-19&#xD;
      antigen lab test&#xD;
&#xD;
      Healthcare system encounter type: inpatient, outpatient, emergency department (ED), urgent&#xD;
      care, or other&#xD;
&#xD;
      SES/Demographics variables: insurance status, education, housing status, sex, age,&#xD;
      race/ethnicity, height, weight, body mass index&#xD;
&#xD;
      Comorbid diseases: chronic asthma, chronic COPD, chronic bronchiectasis, diabetes mellitus,&#xD;
      cardiovascular disease, chronic renal disease, on dialysis, immunocompromised [due to SLE&#xD;
      lupus, rheumatoid arthritis, organ transplant, HIV, Crohn's], pregnant, cancer (lymphomas,&#xD;
      leukemias, lung/respiratory, rectal, breast, prostate, pancreas), hypertension, depression,&#xD;
      anxiety, alcohol abuse, pro- clotting disorders, and anti-clotting disorders&#xD;
&#xD;
      Tobacco use variables: smoking status (current, former, never), passive smoke exposure for&#xD;
      never smoker, years since quitting (for former smokers), packs smoked per day, years of&#xD;
      smoking, pack years, smokeless tobacco user, and marijuana use&#xD;
&#xD;
      Signs and symptoms: temperature, pulse, systolic blood pressure, diastolic blood pressure,&#xD;
      oxygen saturation, septic shock, pneumonia, chills, muscle aches/myalgia, rhinorrhea, sore&#xD;
      throat, chronic cough, shortness of breath, nausea or vomiting, headache, abdominal pain,&#xD;
      diarrhea, dizziness, impaired consciousness, acute cerebrovascular event, ataxia, seizure,&#xD;
      taste impairment, smell impairment, vision impairment, nerve pain, and skeletal muscular pain&#xD;
&#xD;
      COVID-19 treatment variables: ICU admission, required supplemental oxygen, intubated for&#xD;
      ventilator use, noninvasive positive pressure, and number of days hospitalized&#xD;
&#xD;
      COVID-19 medications including (but not limited to): chloroquine, hydroxychloroquine,&#xD;
      tocilizumab, remdesivir, dexamethasone, convalescent plasma, and ascorbic acid&#xD;
&#xD;
      Classes of other medications used: nicotine replacement therapies (NRTs), varenicline&#xD;
      medications; blood thinners, steroids, angiotensin converting enzyme (ACE) inhibitors,&#xD;
      angiotensin-receptor blockers (ARBs), short-acting adrenergic bronchodilators, long-acting&#xD;
      adrenergic bronchodilators, anticholinergic bronchodilators, bronchodilators combos, inhaled&#xD;
      corticosteroids (includes combo medications), and inhaled corticosteroid bronchodilators&#xD;
&#xD;
      Lab tests: COVID-19 PCR test, COVID-19 Antigen test, Albumin, ALT, Bicarbonte, BUN, Calcium,&#xD;
      C-Reactive Protein, High Sensitivity, C-Reactive Protein, Creatinine, D-DIMER, ESR, Ferritin,&#xD;
      Hematocrit, HgbA1c., INR, LDH, Leukocytes, Platelet Count, Potassium, Procalcitonin, Sodium,&#xD;
      Troponin-I, Troponin-T&#xD;
&#xD;
      For the initial paper(s) to be prepared based on these data, the main analytic methods will&#xD;
      include GUIDE classification and regression tree models. However, whole sample methods will&#xD;
      also be used as complementary analytic methods, which will vary with regard to outcome type:&#xD;
      i.e., logistic regression for binary outcomes and Cox proportional hazard analyses for&#xD;
      time-to-event outcomes. Initial analyses will focus on hospitalized COVID-19 patients. Later&#xD;
      waves of analyses may use different analytic approaches and address different questions.&#xD;
&#xD;
      Participating healthcare systems:&#xD;
&#xD;
        -  Duke University (Duke Health)&#xD;
&#xD;
        -  Hackensack Meridian Health&#xD;
&#xD;
        -  Mayo Clinic&#xD;
&#xD;
        -  Memorial Sloan Kettering Cancer Center&#xD;
&#xD;
        -  University of Michigan (Michigan Medicine)&#xD;
&#xD;
        -  Mount Sinai Health System&#xD;
&#xD;
        -  Northwestern University&#xD;
&#xD;
        -  New York University (NYU Langone Health)&#xD;
&#xD;
        -  University of California Davis (University of California Davis Comprehensive Cancer&#xD;
           Center / UC Davis Health)&#xD;
&#xD;
        -  University of California San Francisco&#xD;
&#xD;
        -  University of North Carolina at Chapel Hill (UNC Health)&#xD;
&#xD;
        -  University of Chicago&#xD;
&#xD;
        -  University of Illinois at Chicago&#xD;
&#xD;
        -  University of Kansas (University of Kansas Medical Center)&#xD;
&#xD;
        -  University of Maryland&#xD;
&#xD;
        -  University of Utah (University of Utah Health)&#xD;
&#xD;
        -  University of Wisconsin (UW Health)&#xD;
&#xD;
        -  Vanderbilt University (Vanderbilt University Medical Center)&#xD;
&#xD;
        -  Virginia Commonwealth University (VCU Health System/Massey Cancer Center)&#xD;
&#xD;
        -  Washington University St Louis&#xD;
&#xD;
        -  Yale University (Yale New Haven Hospital)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Months</target_duration>
  <primary_outcome>
    <measure>Mortality due to COVID-19</measure>
    <time_frame>February 1, 2020, through January 31, 2022</time_frame>
    <description>In analyses of hospitalized patients, all-cause mortality in patients with COVID-19 illness vs discharge from hospital (binary outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 Severity</measure>
    <time_frame>February 1, 2020, through January 31, 2022</time_frame>
    <description>In analyses of hospitalized patients, COVID-19 severity as measured by intubation for respiratory support (i.e., patient required intubation during hospitalization; binary outcome)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1634381</enrollment>
  <condition>COVID-19</condition>
  <condition>Cancer</condition>
  <condition>Nicotine Dependence</condition>
  <condition>Pulmonary Disease</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Immunosuppression Disorders</condition>
  <arm_group>
    <arm_group_label>Patients with COVID-19</arm_group_label>
    <description>Analyses of the cohort data will include (1) all patients, or (2) hospitalized patients meeting specific inclusion criteria.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with COVID-19 in the 21 participating healthcare systems&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 ICD-10-CM diagnosis (U07.1 or J12.82) during a healthcare visit and/or&#xD;
&#xD;
          -  COVID-19 positive PCR test and/or&#xD;
&#xD;
          -  COVID-19 positive antigen test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Betsy Rolland, PhD, MLIS, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael C Fiore, MD, MPH, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin Center for Tobacco Research and Intervention</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karen L Conner, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of Wisconsin Center for Tobacco Research and Intervention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Loh, W.-Y. (2002). Regression trees with unbiased variable selection and interaction detection. Stat. Sinica, 12:361-386.</citation>
  </reference>
  <reference>
    <citation>Loh, W.-Y. (2011). Classification and regression trees. WIRES Data Min. Knowl., 1:14-23.</citation>
  </reference>
  <reference>
    <citation>Loh WY, Man M, Wang S. Subgroups from regression trees with adjustment for prognostic effects and postselection inference. Stat Med. 2019 Feb 20;38(4):545-557. doi: 10.1002/sim.7677. Epub 2018 Apr 19.</citation>
    <PMID>29671896</PMID>
  </reference>
  <reference>
    <citation>Loh, W.-Y. and Zhou, P. (2020). The GUIDE approach to subgroup identification. In Ting, N., Cappelleri, J. C., Ho, S., and Chen, D.-G., editors, Design and analysis of Subgroups with Biopharmaceutical Applications, pages 147-165. Springer.</citation>
  </reference>
  <reference>
    <citation>Nolan MB, Piasecki TM, Smith SS, Baker TB, Fiore MC, Adsit RT, Bolt DM, Conner KL, Bernstein SL, Eng OD, Lazuk D, Gonzalez A, Hayes-Birchler T, Jorenby DE, D'Angelo H, Kirsch JA, Williams BS, Kent S, Kim H, Lubanski SA, Yu M, Suk Y, Cai Y, Kashyap N, Mathew J, McMahan G, Rolland B, Tindle HA, Warren GW, Abu-El-Rub N, An LC, Boyd AD, Brunzell DH, Carrillo VA, Chen LS, Davis JM, Deshmukh VG, Dilip D, Goldstein AO, Ha PK, Iturrate E, Jose T, Khanna N, King A, Klass E, Lui M, Mermelstein RJ, Poon C, Tong E, Wilson KM, Theobald WE, Slutske WS. Relations of Current and Past Cancer with Severe Outcomes among 104,590 Hospitalized COVID-19 Patients: The COVID EHR Cohort at the University of Wisconsin. Cancer Epidemiol Biomarkers Prev. 2023 Jan 9;32(1):12-21. doi: 10.1158/1055-9965.EPI-22-0500.</citation>
    <PMID>35965473</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Cohort</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Limited data set will be secured, cleaned, harmonized, and undergo initial analyses in mid to late 2022.The existing Data Transfer and Use Agreements (DTUA) negotiated with each 21 participating health systems precludes the University of Wisconsin (UW) from sharing these data with any entity at this time. This was a requirement of the UW IRB prior to transferring the de-identified site data sets to UW. Starting in 2023, investigators desiring access to CEC-UW data will need to apply for access via an NCI contractor organization, Information Management Services (IMS; https://www.imsweb.com/).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be available starting in 2023; no decision yet on how long data will be available but likely multiple years.</ipd_time_frame>
    <ipd_access_criteria>Scientists at the 21 participating healthcare systems will be given priority in terms of access to study data; data sharing with other scientists not affiliated with the 21 participating healthcare systems will be determined in consultation with the study funder (National Cancer Institute).</ipd_access_criteria>
    <ipd_url>https://ctri.wisc.edu/cec-uw/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04506528
org study id: 2020-0609
secondary id: OISE-20-66590-1
secondary id: A534253
secondary id: SMPH/MEDICINE
secondary id: CTRI
nct id: NCT04506528
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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. Each site will provide data from
      their health system EHR on a regular basis that includes all patients identified as having
      COVID-19 at some point in the interval from February 1, 2020, through January 31, 2022.
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)
observational model: Cohort
time perspective: Other
measure: Mortality due to COVID-19
time frame: February 1, 2020, through January 31, 2022
description: In analyses of hospitalized patients, all-cause mortality in patients with COVID-19 illness vs discharge from hospital (binary outcome)
measure: COVID-19 Severity
time frame: February 1, 2020, through January 31, 2022
description: In analyses of hospitalized patients, COVID-19 severity as measured by intubation for respiratory support (i.e., patient required intubation during hospitalization; binary outcome)
arm group label: Patients with COVID-19
description: Analyses of the cohort data will include (1) all patients, or (2) hospitalized patients meeting specific inclusion criteria.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: No
last name: Betsy Rolland, PhD, MLIS, MPH
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Michael C Fiore, MD, MPH, MBA
role: Principal Investigator
affiliation: University of Wisconsin Center for Tobacco Research and Intervention
last name: Karen L Conner, MPH
role: Study Director
affiliation: University of Wisconsin Center for Tobacco Research and Intervention
facility: 
country: United States
citation: Loh, W.-Y. (2002). Regression trees with unbiased variable selection and interaction detection. Stat. Sinica, 12:361-386.
citation: Loh, W.-Y. (2011). Classification and regression trees. WIRES Data Min. Knowl., 1:14-23.
citation: Loh WY, Man M, Wang S. Subgroups from regression trees with adjustment for prognostic effects and postselection inference. Stat Med. 2019 Feb 20;38(4):545-557. doi: 10.1002/sim.7677. Epub 2018 Apr 19.
PMID: 29671896
citation: Loh, W.-Y. and Zhou, P. (2020). The GUIDE approach to subgroup identification. In Ting, N., Cappelleri, J. C., Ho, S., and Chen, D.-G., editors, Design and analysis of Subgroups with Biopharmaceutical Applications, pages 147-165. Springer.
citation: Nolan MB, Piasecki TM, Smith SS, Baker TB, Fiore MC, Adsit RT, Bolt DM, Conner KL, Bernstein SL, Eng OD, Lazuk D, Gonzalez A, Hayes-Birchler T, Jorenby DE, D'Angelo H, Kirsch JA, Williams BS, Kent S, Kim H, Lubanski SA, Yu M, Suk Y, Cai Y, Kashyap N, Mathew J, McMahan G, Rolland B, Tindle HA, Warren GW, Abu-El-Rub N, An LC, Boyd AD, Brunzell DH, Carrillo VA, Chen LS, Davis JM, Deshmukh VG, Dilip D, Goldstein AO, Ha PK, Iturrate E, Jose T, Khanna N, King A, Klass E, Lui M, Mermelstein RJ, Poon C, Tong E, Wilson KM, Theobald WE, Slutske WS. Relations of Current and Past Cancer with Severe Outcomes among 104,590 Hospitalized COVID-19 Patients: The COVID EHR Cohort at the University of Wisconsin. Cancer Epidemiol Biomarkers Prev. 2023 Jan 9;32(1):12-21. doi: 10.1158/1055-9965.EPI-22-0500.
PMID: 35965473
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Cardiovascular Diseases
mesh term: Tobacco Use Disorder
sharing ipd: Yes
ipd description: The Limited data set will be secured, cleaned, harmonized, and undergo initial analyses in mid to late 2022.The existing Data Transfer and Use Agreements (DTUA) negotiated with each 21 participating health systems precludes the University of Wisconsin (UW) from sharing these data with any entity at this time. This was a requirement of the UW IRB prior to transferring the de-identified site data sets to UW. Starting in 2023, investigators desiring access to CEC-UW data will need to apply for access via an NCI contractor organization, Information Management Services (IMS; https://www.imsweb.com/).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be available starting in 2023; no decision yet on how long data will be available but likely multiple years.
ipd access criteria: Scientists at the 21 participating healthcare systems will be given priority in terms of access to study data; data sharing with other scientists not affiliated with the 21 participating healthcare systems will be determined in consultation with the study funder (National Cancer Institute).
ipd url: https://ctri.wisc.edu/cec-uw/