App 2_Data Collections Forms

Appendix 2. Data Collection Forms.pdf

Emergency Epidemic Investigation Data Collections- July 1, 2020 – September 30, 2020

App 2_Data Collections Forms

OMB: 0920-1011

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Form Approved
OMB No. 0920-1011
Exp. Date 02/24/2020
National Case Report Form
October 31, 2019
Page 1

SEVERE PULMONARY DISEASE ASSOCIATED
WITH E-CIGARETTE USE OUTBREAK
NATIONAL CASE REPORT FORM (CDC)
October 31, 2019

Public reporting burden of this collection of information is estimated to average 60 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer;
1600 Clifton Road NE, MS D-74 Atlanta, Georgia 30333; ATTN: PRA (0920-1011)

Lung Injury Associated with E-cigarette Use or Vaping | National Case Report Form
CDC is investigating cases of unexplained lung injury associated with electronic cigarette use or vaping as detailed in CDC’s Health Advisory
(https://emergency.cdc.gov/han/han00421.asp). Local and state health departments should complete this form for any probable or confirmed
case patient (see case definition) and transmit data to CDC using DCIPHER or by contacting CDC State Points of Contact.
Case ID Number _________________________
Case status
☐ Probable ☐ Confirmed
Was patient hospitalized?
☐ Yes ☐ No
Date reported to public health department
Person completing form

Medical Record Number ___________________________________
Died? ☐ Yes ☐ No If yes, date of death _____________ (see clinical section)
If yes, hospitalization date __________ Discharge date ________
Name of Public Health Department
________________
Contact phone number

PART I: PATIENT DEMOGRAPHICS AND EXPOSURES
Patient Demographics
County __________________
State _____________________
Gender ☐Male ☐ Female ☐ Other Age _________years
Race
☐White ☐Black ☐American Indian/Alaska Native ☐Asian ☐Native Hawaiian or Other Pacific Islander ☐Other
Ethnicity ☐Hispanic ☐ Non-Hispanic
Patient Substance Use in the Past 3 Months (90 days)
Any e-Cigarette use or vaping (e.g., vaping, dabbing)?
☐ Yes ☐ No ☐ Refused to answer
If yes, substance(s) vaped or dabbed in past 3 months?
☐ Nicotine ☐ Marijuana, THC oil, THC concentrates, hash oil, wax ☐ Cannabidiol (CBD) ☐ Synthetic Cannabinoids ☐ Flavors alone
☐ Other substances, specify _____ ☐ Unknown
Any combustible tobacco smoking (e.g., cigarettes, cigars)? ☐Yes ☐No Any other tobacco products (e.g., smokeless tobacco)? ☐Yes ☐No
Any combustible marijuana smoking (i.e., any non-vape marijuana)? ☐Yes ☐No Any other marijuana products (e.g., edibles)? ☐Yes ☐No
Any nicotine e-cigarette use or vaping reported? ☐ Yes ☐ No ☐ Unknown
Date last used
If yes, what is the frequency of use? ☐ Daily ☐ A few times per week, specify: _________ ☐ A few times per month, specify ______
☐ Monthly or less [Skip logic: On average, how many times per day? __________ ]
Did patient report vaping flavoured nicotine in e-Cigarette and/or vape product(s)? ☐ Yes
☐ No
How many brands of nicotine containing products vaped or dabbed in the past 3 months? _____ [enter whole number]
Where was the nicotine e-Cigarette(s) or vaping product(s) purchased or obtained? Check all that apply
☐ Recreational dispensary ☐ Vape or smoke shop ☐ Pop-up shop ☐ Grocery store/drugstore/Convenience store ☐ Family or friend
☐ Dealer ☐ Online ☐ Other, describe _____________
What kind of device(s) were used with this substance? Select all that apply
☐ Disposable e-cigarette or vaping device ☐ E-cigarettes with pre-filled or refillable cartridges (e.g., using battery pens, Ego, EVO, Ooze
pen, Caliplug, 510 battery) ☐ E-cigarette with tank that you refill with liquids (including sub-ohm, mod or modifiable systems)
☐ E-cigarettes with pre-filled or refillable “pods” or pod cartridges (e.g. JUUL, Suorin) ☐ Other, describe ___________
Was this a mod device (a device that allows user to choose higher and/or variable temperatures)?
☐ Yes ☐ No ☐ Unknown
Did patient modify, or add a substance to, the device(s) that was not intended by the manufacturer? ☐ Yes ☐ No ☐ Unknown
If yes, explain __________________________________________________________________________________
Does patient know anyone else who became ill from vaping nicotine? ☐Yes ☐No
If yes, were nicotine products or devices shared with that person? ☐Yes ☐No
Product sample sent for testing? ☐ Yes ☐ No If yes, where was sample tested
_ Product sample ID number(s) __________
Any THC e-cigarette use or vaping reported? ☐ Yes ☐ No ☐ Unknown Date last used
If yes, what is the frequency of use? ☐ Daily ☐ A few times per week, specify: _________ ☐ A few times per month, specify________
☐ Monthly or less [Skip logic: On average, how many times per day? __________ ]
Did patient report vaping flavoured THC in e-Cigarette and/or vape product(s)? ☐ Yes
☐ No
How many brands of THC containing products vaped or dabbed in the past 3 months? _____ [enter whole number]
What was the purpose of THC product(s) use? ☐ medical purposes ☐ nonmedical (recreational) purposes ☐ other, specify ____
Which THC substance(s) were used in an e-cigarette, vaping device, vaporizer, or dab rig? Select all that apply
☐ Marijuana herb ☐THC oils ☐Butane hash oil ☐THC concentrate (e.g., wax, batter/budder, crumble, shatter, pull and snap)
☐THC powder (e.g., dry sift) ☐ Other, describe ___________
Where was the THC e-Cigarette(s) or vaping product(s) purchased or obtained? Check all that apply
☐ Medical dispensary ☐ Recreational dispensary (retail cannabis/marijuana shop) ☐ Vape or smoke shop ☐ Pop-up shop
☐ Grocery store/Drugstore/Convenience store ☐ Family or friend ☐ Illicit dealer ☐ Online ☐ Other, describe __________
What kind of device(s) were used with this substance? Select all that apply
☐ Disposable device ☐ Device with pre-filled cartridges ☐ Device with tank that you refill with liquids (e.g., mods)
☐ Device with pre-filled or refillable “pods” or pod cartridges (e.g. JUUL, Suorin) ☐ Dab rig ☐ Vaporizer (for dry herbs, etc.) ☐ Other ____
What brand of THC cartridge(s) were used with device(s): ☐ Rove ☐ Dank Vapes ☐ Golden Gorilla ☐ Smart Cart ☐ Other ____________
Was this a mod device (a device that allows user to choose higher and/or variable temperatures)?
☐ Yes ☐ No ☐ Unknown
Did patient modify, or add a substance to, the device(s) that was not intended by the manufacturer? ☐ Yes ☐ No ☐ Unknown
If yes, explain __________________________________________________________________________________
Does patient know anyone else who became ill from vaping THC? ☐Yes ☐No
If yes, were THC products or devices shared with that person? ☐Yes ☐No
Product sample sent for testing? ☐ Yes ☐ No If yes, where was sample tested
_ Product sample ID number(s) ______

PART II: CLINICAL INFORMATION
Symptoms at Initial Presentation to Medical Care
Chief complaint
GI symptoms?
☐ Yes ☐ No
Respiratory symptoms?
☐ Yes ☐ No
Constitutional symptoms?
☐ Yes ☐ No

☐ Unknown
☐ Unknown
☐ Unknown

Date symptom(s) started
If yes, describe
If yes, describe
If yes, describe

☐ Unknown

If yes, amount (lb)

_________
_________
__________

(e.g., fever, chills, malaise)

Weight loss during current illness?

☐ Yes

☐ No

Medical History
Chronic respiratory disease (including asthma, COPD, etc.)? ☐ Yes ☐ No If yes, specify type of disease
Heart disease?
☐ Yes ☐ No
If yes, specify type of disease
Anxiety?
☐ Yes ☐ No
Depression?
☐ Yes ☐ No
Other chronic illness?
☐ Yes ☐ No
If yes, specify type of chronic illness
Pregnant?
☐ Yes ☐ No
☐ Unknown If yes, trimester ☐ First ☐ Second ☐ Third ☐ Unknown
Imaging
CT performed
☐ Yes ☐ No If yes, location of abnormal findings ☐ Bilateral ☐ Right ☐ Left ☐ Normal (no findings)
If yes, infiltrates/opacities present ☐ Yes ☐ No
Subpleural sparing ☐ Yes ☐ No ☐ Unknown
Chest X-ray performed
☐ Yes ☐ No If yes, location of abnormal findings ☐ Bilateral ☐ Right ☐ Left ☐ Normal (no findings)
If yes, infiltrates/opacities present ☐ Yes ☐ No
Specify other abnormal chest imaging findings (e.g., pneumothorax)_________________
Infectious Disease Testing
Respiratory viral panel
Influenza
Blood cultures
Legionella urinary antigen
Strep pneumoniae urinary antigen
Mycoplasma pneumoniae
Other

☐ Positive (specify _________ )
☐ Positive (specify _________ )
☐ Positive (specify organisms_____)
☐ Positive
☐ Positive
☐ Positive (specify _________ )
☐ Positive (specify _________ )

☐ Negative
☐ Negative
☐ Negative
☐ Negative
☐ Negative
☐ Negative
☐ Negative

☐ Pending
☐ Pending
☐ Pending
☐ Pending
☐ Pending
☐ Pending
☐ Pending

☐ Not done
☐ Not done
☐ Not done
☐ Not done
☐ Not done
☐ Not done
☐ Not done

Clinical Course of Lung Injury
Is this the first time patient is presenting for clinical care for these symptoms? ☐ Yes ☐ No If yes, is a follow-up visit scheduled? ☐ Yes ☐ No
Was patient hypoxemic (<95) at any outpatient visit or hospitalization? ☐ Yes ☐ No If yes, date(s)________ Lowest value:_________
Outpatient visit #1 ☐ Yes ☐ No If yes, date of visit _______ Outpatient visit #2 ☐ Yes ☐ No If yes, date of visit ______
Were there additional outpatient/clinic visits? ☐ Yes ☐ No If yes, specify number of additional visits _______
Urgent care visit #1 ☐ Yes ☐ No If yes, date of visit ____ Urgent care visit #2 ☐ Yes ☐ No If yes, date of visit _______
Were there additional urgent care visits? ☐ Yes ☐ No
If yes, specify number of additional visits _______
Emergency Department (ED) visit #1
☐ Yes ☐ No If yes, date of visit _______
ED visit #2 ☐ Yes ☐ No If yes, date of visit____
Were there additional ED visits? ☐ Yes ☐ No If yes, specify number of additional visits _______
If hospitalized, was patient re-hospitalized at a later date? ☐ Yes ☐ No If yes, hospitalization date __________
Discharge date ________
Were there additional hospitalizations? ☐ Yes ☐ No If yes, specify number of additional hospitalizations _______
ICU Admission
☐ Yes ☐ No If yes, ICU admission date _________ ICU duration (in days) __________
Treated with steroids?
☐ Yes
☐ No If yes, medication(s): ________ dose: ____ start date:______ duration: __ ☐ Taper
Treated with antibiotics?
☐ Yes
☐ No If yes, medication(s): ________ dose: ____ start date:______ duration:________
Treated with antivirals?
☐ Yes
☐ No If yes, medication(s): ________ dose: ___ _ start date:______ duration:________
Required respiratory support? ☐ Yes
☐ No ☐ Intubated (duration_________)
☐ BiPAP/CPAP/High flow ☐ Supplemental oxygen
Required ECMO (Extracorporeal membrane oxygenation)?
☐ Yes (duration_________) ☐ No
Clinical specimens
Bronchoalveolar lavage performed? ☐ Yes, date of sample_____ ☐ No If yes, where tested _________________
If yes, lipid staining
☐ Yes
☐ No
If yes, lipid-laden macrophages seen ☐ Yes
☐ No
Blood sample testing performed?
☐ Yes, date of sample ____ ☐ No If yes, where tested _________________
Urine sample testing performed?
☐ Yes, date of sample ____ ☐ No If yes, where tested _________________
Lung biopsy performed?
☐ Yes, date of sample ____ ☐ No If yes, where tested _________________
If yes, lipid staining?
☐ Yes
☐ No
If yes, lipid-laden macrophages seen? ☐ Yes
☐ No
If yes, findings consistent with acute lung injury? ☐ Yes
☐ No If no, specify findings __________________
If yes, other significant findings __________________

Specimen ID _______

Specimen ID _______
Specimen ID _______
Specimen ID _______

Death Information
Died
☐ Yes ☐ No
If yes, specify location_______________ Date of death _______________
Immediate cause of death ____________________________
Contributing causes of death ____________________________
Autopsy performed? ☐ Yes ☐ No
If yes, autopsy sample collected ☐ Yes ☐ No If yes, where tested______ Specimen ID ________
If yes, lipid staining performed on autopsy lung tissue? ☐ Yes
☐ No If yes, lipid-laden macrophages seen? ☐ Yes
☐ No
If yes, findings consistent with acute lung injury?
☐ Yes
☐ No If no, specify findings _________________
If yes, other significant autopsy findings ___________________
National Case Report Form v.02

Last updated October 31, 2019

Form Approved
OMB # 0920-1011
Exp. 02/24/2020
Specimen Manifest Form
CDC Case ID
(note: this is
used by state
epidemiologists
when
submitting case
data to CDC)

State Case
ID

Sample
ID

Matrix
(urine,
whole
blood,
serum,
plasma,
BAL, etc)

Box # or
ID

Position in
Box

Volume
(mL)

Collection
Date

Any pertinent comments
(hemolyzed sample, clotted
sample, etc)

CDC estimates the average public reporting burden for this collection of information as 10 minutes per response, including the time for reviewing instructions, searching existing data/information
sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1011).


File Typeapplication/pdf
AuthorO'Laughlin, Kevin (CDC/DDID/NCEZID/DFWED)
File Modified2020-04-02
File Created2020-04-02

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