Burden Memo 01OCT2018 - 31DEC2018

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2018001-XXX
Arizona Department of Health Services

Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted
fever—Arizona, 2018
Purpose of Investigation: (Use Rocky Mountain spotted fever (RMSF), a life-threatening and rapidly progressive
as much space as necessary) tickborne disease, is caused by infection with the bacterium Rickettsia rickettsii.
RMSF is an emerging threat to Arizona tribal communities. In 2018, cases have
more than doubled in number compared to what was reported last year at this
time. We conducted an investigation to understand the risk factors associated
with developing neurological dysfunction and long-term disability after
hospitalization with RMSF. In order to provide answer to assist patients and
providers, we conducted:
• Medical Chart abstraction of 126 charts (OMB exempted activity)
• Conducted 22 screening interviews for inclusion in neurologic exams
• Performed 9 neurologic exams
Chart reviews were performed on two tribal reservations, and interviews and
exams conducted on one. The data from the investigation are being entered into
a database for analysis.
Preliminary data suggest that long-term sequela are present in patients,
including, but not limited to decreased mobility, difficulty with concentration and
focus, and sensory impairments. Analysis is ongoing.

Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

7/23/2018
10/19/2018
Naomi Drexler
NCEZID/DVBD/RZB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Patient screening questionnaire
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Cohort Study (describe):

This investigation will evaluated a cohort of persons
hospitalized with RMSF between 2002–2017.

Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
In person interview for patients hospitalized for RMSF between
2002-2017 to screen for neurologic exams
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
22
Total No. Sampled/Eligible to Respond (B): 126
Response Rate (A/B):
17%
Data Collection Instrument 2
Name of Data Collection Instrument: Neurological Examination form
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
This investigation evaluated a cohort of persons
hospitalized with RMSF between 2002–2017.
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Neurologic exam was performed in person by a federal staff
person who is a licensed medical provider. The Exam form
documents the observed neurological signs and responses
relating to the exam.
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
9
Total No. Sampled/Eligible to Respond (B): 16
Response Rate (A/B):
50%
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond (B):
Response Rate (A/B):

(Additional Data Collection Instrument sections may be added if necessary.)

Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)
Screening questionnaire
Patient
22
1
Neurological examination
Patient
9
1
form

Burden per
Response in
Minutes (C)
10
40

Total Burden
in Hours
(A x B x C)/60*
4
6

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2018002-XXX
NYC Department of Health and Mental Hygiene

Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who
traveled to Tijuana area, Mexico
Purpose of Investigation: (Use Valley fever or coccidioidomycosis, is a respiratory fungal disease acquired by inhalation
as much space as necessary) of the microscopic fungal spores which have been aerosolized through soil-disturbing
activities such as digging. Untreated, coccidioidomycosis causes an illness lasting weeks
to months. Antifungal medication reduces the duration and severity of symptoms.
Appropriate medications, however, are often not prescribed because the infection is
misdiagnosed as being of viral or bacterial etiology. People with compromised immune
systems are at risk for life-threatening systemic infection from the fungus.
CDC received notification from New York City (NYC) Department of Health and Mental
Hygiene (DOHMH) on August 8, 2018, that two high school students (Patient 1 and 2)
were hospitalized with pneumonia and persistent fevers following a service trip to Tijuana,
Mexico. Students were in an area endemic for coccidioidomycosis and worked on housing
projects that involved moving large amounts of soil. Both patients had a rash affecting the
back, axilla, and groin. The illnesses were unresponsive to antibacterial medications, and
a respiratory PCR panel (Biofire) was negative for a range of respiratory viruses, as were
Legionella urinary antigen, blood cultures, and influenza testing. Both patients had chest
X-rays showing bilateral patchy infiltrates that did not improve despite antibiotic treatment
(the duration of antibiotic treatment is unknown). These findings are consistent with a
fungal pneumonia.
Patient 1 traveled to the Tijuana area during July 8–15, 2018 as part of a group of 54
people from the same high school in NYC and ~10–15 people from Seattle, Washington.
Patient 2 traveled to the area during July 15–22, 2018, with 22 people from the same high
school as Patients 1 and 2 in NYC and ~30 people from Kansas City, Missouri.
In response to these illnesses, the NYC high school of Patient 1 and 2 notified the
families in early August 2018 that students on the trip became ill with pneumonia and
they should seek appropriate health care if any student or adult on the trip is experiencing
any symptoms not restricted to Valley fever. After that notification, NYC DOHMH heard
of two additional patients (Patients 3 and 4) with respiratory symptoms who both visited
emergency departments but were not hospitalized.
All four illnesses were confirmed as caused by Valley fever by serologic testing,
suggesting that an outbreak occurred, given shared exposure to dust-activities at the same
site. Based on the severity of illness, high inoculum exposure is likely. The Missouri
Health Department recently reported that a student from a Kansas City high school (a
Kansas State resident) who traveled to Tijuana area in July 16–20, 2018 also tested
positive for coccidioidomycosis. All the members of all the known groups who
participated in this service trip during July 16–20, 2018 have been notified that some of
the people have been hospitalized with Valley fever, and additional case finding is
underway. To date, service trip volunteers have been identified in 4 states (NY, MO, KS,
WA). In addition, we completed a binational notification to Mexico and the Mexican
state of Baja California through the CDC US-Mexico Unit.
It is important to ensure that all travelers at risk of coccidioidomycosis from exposure at
this site have been promptly notified to improve chances of timely proper diagnosis and
treatment of infected persons. Better understanding the specific source of this outbreak
could help protect future travelers to this area, as well as local residents, and prevent
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
additional illnesses. The cases of coccidioidomycosis reported to date are of special
concern because they manifested as severe illness in young, otherwise healthy people,
suggesting that travelers were either exposed to massive doses of the pathogen, or
infected by an unusually virulent strain.
CDC assistance with this investigation was requested to determine the scope and extent
of the current cluster of Valley fever infections, identify potential common factors or risk
factors among cases, and develop recommendations to potentially reduce the risk of
additional cases. OMB approved a questionnaire (Appendix 1) to identify risk factors for
and the source of infection. This information will be used to recommend potential
prevention and control measures.
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

10/23/2018
11/27/2018
Mitsuru Toda, MS, PhD
NCEZID/DFWED/MDB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Survey
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
This is a cohort study to systematically collect information about
clinical illness and potential exposures associated with Valley
fever in order to identify cases and risk factors for and the source
of infection.
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil We contacted service trip volunteers who traveled to Tijuana area,
Questionnaire (describe):
Mexico in July 2018 to complete the questionnaire (Appendix 1).
Self-administered Internet
Questionnaire (describe):
Other (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
93
Total No. Sampled/Eligible to Respond (B): 130
Response Rate (A/B):
72%
Data Collection Instrument 2
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond (B):
Response Rate (A/B):

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond (B):
Response Rate (A/B):

(Additional Data Collection Instrument sections may be added if necessary.)

Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)
Questionnaire
General
93
1
public
Page 4 of 5

Burden per
Response in
Minutes (C)
20

Total Burden
in Hours
(A x B x C)/60*
31

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

Page 5 of 5

Form Updated: 9/4/2014