App 1_Burden Memos

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:

2016024-XXX
2016-051
Colombian Ministry of Health and Instituto Nacional de Salud

Undetermined risk factors and modes of transmission for Candida auris infection —
Colombia, 2016
Purpose of Investigation: (Use Candida auris is an emerging fungus that has caused hospital-associated outbreaks of
as much space as necessary) invasive infections with high mortality. Since May 2016, over 50 cases of C. auris
infection have been identified in 7 hospitals in 5 cities in Colombia. New cases continue
to occur, including seven cases recently reported from a Bogotá hospital in August 2016.
Little is known about risk factors for C. auris infection or the organism’s environmental
reservoirs, modes or transmission, and reason for its recent emergence. The Colombian
Ministry of Health and Instituto Nacional de Salud (INS) requested CDC assistance with
the following objectives:
1. Characterize the burden of C. auris infection in Colombia
2. Determine risk factors for infection
3. Identify epidemiologic links between cases
4. Elucidate transmission mechanisms to control ongoing outbreak
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

3 weeks
9/20/216
10/7/2016
Paige Armstrong MD MHS
NCEZID/DFWED/MDB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Case Report Form
Type of Respondent
General public
Healthcare staff
Laboratory staff
Patients
Restaurant staff
X Other (describe): Used for chart abstraction, performed by federal and local MoH and National Institute of
Health staff
Data Collection Methods (check all that apply)
X

Epidemiologic Study (indicate which type(s) below)
X Descriptive Study (describe):
Collected data to help describe cases characteristics
Cross-sectional Study (describe):
Cohort Study (describe):
X Case-Control Study (describe):
Data from cases of C. auris candidemia will be analyzed with
data from candidemia with other species identify risk factors for
this form of cadidemia.
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):

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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):
X Medical Record Abstraction
Abstracted data from medical records for cases of C. auris Candidemia
(describe):
and other candidemias at four hospitals
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
NA (chart review)
Total No. Sampled/Eligible to Respond (B): NA (chart review)
Response Rate (A/B):
NA (chart review)

Data Collection Instrument 2
Name of Data Collection Instrument: Healthcare Provider Interview Questions
Type of Respondent
General public
Other (describe):

X

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
X

Epidemiologic Study (indicate which type(s) below)
X Descriptive Study (describe):
Helped inform information regarding patient colonization,
potential modes of transmission, and overall thoughts from
healthcare providers about possible epidemiologic links
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
X Environmental Assessment
Helped inform information collected from environmental sampling
(describe):
and possible epidemiologic links.
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
X

Survey Mode (indicate which mode(s) below):
X Face-to-face Interview (describe): 30 minute interviews, face-to-face, voluntary, written consent
obtained
Telephone Interview (describe):
Self-administered Paper-and-Pencil
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):
10
Total No. Sampled/Eligible to Respond (B): 10
Response Rate (A/B):
1
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent

Patient Open-Ended Interview Questions

General public
Healthcare staff
Laboratory staff
Patients
X Other (describe): Patients and family members/close contacts of 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):
X Environmental Assessment
Better informed level of contact and exposure in patients and family
(describe):
members as swabs were obtain from both to look for C. auris
colonization.
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
X

Survey Mode (indicate which mode(s) below):
X Face-to-face Interview (describe): Face-to-face interview, voluntary, written consent obtained
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):
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Response Rate (if applicable)
Total No. Responded (A):
5
Total No. Sampled/Eligible to Respond (B): 5
Response Rate (A/B):
1

(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)

Data Collection
Instrument Name
Case Report Form
Healthcare Provider
Interview Questions
Patient Open-Ended
Interview Questions

Type of Respondent
Instituto Nacional de
Salud Staff
Healthcare Staff
General Public

No.
Respondents
(A)
1

No. Responses
per Respondent
(B)
50

Burden per
Response in
Minutes (C)
30

Total Burden
in Hours
(A x B x
C)/60*
25

10

1

30

5

5

1

30

3

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:

2017001-XXX
2017-003
Michigan Department of Health & Human Services

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

9 days
10/25/2016
11/2/2016

Undetermined risk factors and modes of transmission for Shigella sonnei infection
among residents of Genesee and Saginaw Counties – Michigan, 2016
Purpose of Investigation: (Use
1. Determine the magnitude of the outbreak and characterize patient morbidity and
as much space as necessary)
mortality (if applicable) in the context of individual-level risk factors (e.g., comorbidities, access to health care, etc.).
2. Combine epidemiologic data from interviews and molecular data (PFGE and
WGS) to 1) identify chains of transmission, 2) determine genetic relatedness of
Shigella isolates from case-patients, and 3) outline the evolution of the outbreak
over time and space.
3. Conduct a case-control investigation to identify risk factors for shigellosis in
Genesee and Saginaw Counties; among other factors, water type and water use
will be examined.
4. Map existing data related to quality of water from municipal systems (e.g.,
disinfectant residuals, sewage and water main breaks, triggered positives for total
coliforms, and other aspects of water quality) and assess spatial and temporal
correlations with incident shigellosis.
5. Assess the need for household water testing among cases and controls based on
the results of epidemiologic investigation as outlined in objectives 3 and 4.

R. Paul McClung, EIS Officer
NCEZID/DFWED/WDPB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Interview 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):
Interview of all households containing a reported case of
shigellosis during the outbreak period. The first person to become
ill in each house was identified; illness information was collected
for all household members. Risk factor questions were pertained
to household practices or to the first person ill in the house.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):
Telephone interviews were conducted from three call centers:
Genesee County, Saginaw County, and MDHHS offices in Lansing,
MI. Members of the field team conducted all interviews along with
employees and students associated with MDHHS.
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):
90 households
Total No. Sampled/Eligible to Respond (B): 126 households
Response Rate (A/B):
0.71
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
Type of
Respondents
per Respondent
Data Collection Instrument
Name
Respondent
(A)
(B)
90
1
Case Interview Form, Epi- Patients

Burden per
Response in
Minutes (C)
20

Total Burden
in Hours
(A x B x C)/60*
30

Aid 2017-003: Shigellosis
in Genesee and Saginaw
Counties, MI, 2016
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