008-60-PR Burden Memo

2014008-XXX Burden Memo.docx

Emergency Epidemic Investigation Data Collections - Expedited Reviews

008-60-PR Burden Memo

OMB: 0920-1011

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

(0920-1011)


GenIC No.:

2014008-060

EPI AID No. (if applicable):

2014-060

Requesting entity (e.g., jurisdiction):

Puerto Rico Department of Health

Title of Investigation:

Undetermined burden of disease and risk factors for chikungunya virus infections—Puerto Rico, 2014

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

The EpiAid Team in collaboration with PRDH completed the following: 1) Conducted cluster investigations around the case-patients' homes. Information obtained included: a) detection of chikungunya cases that would not otherwise have been detected by passive surveillance; b) identification of the health care-seeking behaviors of patients; c) description of the clinical spectrum of disease across age groups; d) estimation of the level of DENV circulation in areas with known CHIKV transmission; e) entomologic surveillance to determine vector density and the frequency with which adult mosquitoes are infected with DENV and/or CHIKV; and f) identification of household and individual risk factors for infection with CHIKV.

2) Established sentinel chikungunya surveillance sites. Because most chikungunya case-patients are likely to only need out-patient care, we established sentinel surveillance sites in outpatient clinics and emergency departments to detect acute febrile illnesses consistent with chikungunya. These sites along with data from the sentinel enhanced dengue surveillance system (SEDSS) enable tracking of the outbreak and estimation of disease incidence.

3) Provided messaging, alerts and educational material for clinicians and the public.

4) Provided recommendations on vector surveillance and control mechanisms to monitor and mitigate the mosquito vectors that transmit CHIKV.

5) Conducted a rapid assessment of hospital needs to ensure availability of necessary medications (IV fluids, pain medication, antipyretics, etc.).

Duration of Data Collection:


Date Began:

6/22/2014

Date Ended:

9/5/2014

Lead Investigator


Name:

Tyler M. Sharp, Ph.D.

CIO/Division/Branch:

NCEZID/DVBD/DB


Complete the following for each instrument used during the investigation.

Data Collection Instrument 1

Name of Data Collection Instrument:

Chikungunya_Household Interview 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):

Performed household investigations to identify demographic, geographic, or behavioral risk factors for infection, health care-seeking behaviors of infected individuals, and clinical awareness and diagnosis of patients with chikungunya to help direct public and clinical mitigation efforts including reducing mosquito exposures and vector control.

Cross-sectional Study (describe):


Cohort Study (describe):


Case-Control Study (describe):


Other (describe):


Environmental Assessment (describe):

Households offered mosquito traps to be placed on the presmise of their household to determine the relative abundance of mosquitoes and the % of infected mosquitoes. No data were collected from households where traps were placed beyond what was collected on the household investigation form.

Laboratory Testing (describe):


Other (describe):




Data Collection Mode (check all that apply)

Survey Mode (indicate which mode(s) below):


Face-to-face Interview (describe):

Interviews completed in households by in-person interview with the head-of-household.

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):

137

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

200

Response Rate (A/B):

69%


Data Collection Instrument 2

Name of Data Collection Instrument:

Chikungunya_Individual Interview 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):

Performed household investigations to identify demographic, geographic, or behavioral risk factors for infection, health care-seeking behaviors of infected individuals, and clinical awareness and diagnosis of patients with chikungunya to help direct public and clinical mitigation efforts including reducing mosquito exposures and vector control.

Cross-sectional Study (describe):


Cohort Study (describe):


Case-Control Study (describe):


Other (describe):


Environmental Assessment (describe):


Laboratory Testing (describe):

All serum specimens collected from individuals participating in the household investigations were tested by RT-PCR and IgM ELISA to detect evidence of current and recent infection with chikungunya virus and dengue virus.

Other (describe):




Data Collection Mode (check all that apply)

Survey Mode (indicate which mode(s) below):


Face-to-face Interview (describe):

Interviews completed in households by in-person interview with the individual.

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):

251

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

416

Response Rate (A/B):

60%


Data Collection Instrument 3

Name of Data Collection Instrument:

Chikunguna_Case Report Form (Spanish)

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):

Established sentinel surveillance for chikungunya.

Cross-sectional Study (describe):


Cohort Study (describe):


Case-Control Study (describe):


Other (describe):


Environmental Assessment (describe):


Laboratory Testing (describe):

Patients with chikungunya-like illness presenting to sentinel surveillance sites had serum specimens collected for clinical diagnostic testing (RT-PCR and IgM ELISA) to confirm evidence of chikungunya or dengue virus infection. All diagnostic testing performed at CDC Dengue Branch, where test results are maintained in a secure database.

Other (describe):




Data Collection Mode (check all that apply)

Survey Mode (indicate which mode(s) below):


Face-to-face Interview (describe):

The chikungunya case investigation form was completed by in-person interview of the patient by their healthcare provider.

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):

531

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

531

Response Rate (A/B):

100%



(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

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*

Chikungunya_Household Interview Form


137

1

15

35

Chikungunya_Individual Interview Form


251

1

15

63

Chikunguna_Case Report Form (Spanish)


531

1

15

133


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 6 of 6 Form Updated: 9/4/2014

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