Burden memo - Ebola Guinea

2014010-XXX_Burden Memo.docx

Emergency Epidemic Investigation Data Collections - Expedited Reviews

Burden memo - Ebola Guinea

OMB: 0920-1011

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections

(0920-1011)


GenIC No.:

2014010-063

EPI AID No. (if applicable):

2014-063

Requesting entity (e.g., jurisdiction):

World Heath Organization

Title of Investigation:

Undetermined Sources and Risk Factors for an Ebola Hemorrhagic Fever Outbreak—Guinea, 2014

Purpose of Investigation: (Use as much space as necessary)

The investigation follwed a case series study design, where case report forms (see Appendix 1) were collected for every patient meeting the suspect case definition criteria. Forms were collected through interview of patients or family members if patients have died or are infants, in either French or the local language. Relevant clinical data, including the patient’s date of onset, date of death, hospitalization and funeral information, and contacts that the patient had prior to developing illness all are collected, in an effort to determine the risk factors that led to this patient’s infection. If diagnostic testing confirms that this patient has EVD, a separate contact tracing form (see Appendix 2) is completed to collect information of people who had direct unprotected contact with the patient while they were ill and prior to treatment in a facility with barrier nursing. These contacts were then followed daily for onset of fever and other EVD symptoms, and were investigated as cases and treated under barrier nursing precautions if they develop illness.

Duration of Data Collection:

90 days

Date Began:

6/27/2014

Date Ended:

9/25/2014

Lead Investigator


Name:

Barbara Knust

CIO/Division/Branch:

NCEZID/DHCPP


Complete the following for each instrument used during the investigation.

Data Collection Instrument 1

Name of Data Collection Instrument:

Ebola_Case Investigation Form

Type of Respondent

General public Healthcare staff Laboratory staff Patients Restaurant staff

Other (describe):




Data Collection Methods (check all that apply)

Epidemiologic Study (indicate which type(s) below)


Descriptive Study (describe):

The investigation followed a case series study design, where case report forms were collected for every patient meeting the suspect case definition criteria.

Cross-sectional Study (describe):


Cohort Study (describe):


Case-Control Study (describe):


Other (describe):


Environmental Assessment (describe):


Laboratory Testing (describe):

When possible, diagnostic testing was used to confirm Ebola virus infection or rule out infection. Laboratory testing was not performed by CDC personnel, but laboratory results were recorded.

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):

Hospital records were used to collect relevant clinical information in the case report form

Biological Specimen Sample

Blood or oral swab specimens were collected from patients to confirm or rule out Ebola virus infection. Laboratory testing were not be performed by CDC personnel, but laboratory results were recorded.

Environmental Sample


Other (describe):



Response Rate (if applicable)

Total No. Responded (A):

1200

Total No. Sampled/Eligible to Respond (B):

1200

Response Rate (A/B):

100%


Data Collection Instrument 2

Name of Data Collection Instrument:

Ebola_Contract Tracing Form

Type of Respondent

General public Healthcare staff Laboratory staff Patients Restaurant staff

Other (describe):




Data Collection Methods (check all that apply)

Epidemiologic Study (indicate which type(s) below)


Descriptive Study (describe):

Contacts of confirmed Ebola case-patients were identified and information about their location and type of contact was gathered.

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):

406

Total No. Sampled/Eligible to Respond (B):

406

Response Rate (A/B):

100%




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

Type of Respondent

No. Respondents (A)

No. Responses per Respondent (B)

Burden per Response in Minutes (C)

Total Burden

in Hours

(A x B x C)/60*

Ebola_Case Investigation Form

General Public

1200

1

25

500

Ebola_Contract Tracing Form

General Public

406

1

3

21








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

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