012-66-Refugee Burden Memo

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

(0920-1011)

GenIC No.:	2014012-066
EPI AID No. (if applicable):	2014-066
Requesting entity (e.g., jurisdiction):	Office of Refugee Resettlement
Title of Investigation:	Undetermined agent and risk factors in a cluster of respiratory illnesses among unaccompanied alien children housed at a temporary shelter—California, 2014
Purpose of Investigation: (Use as much space as necessary)	An urgent investigation is needed to determine the scope of the outbreak, identify predisposing factors and other risk factors for these respiratory illnesses, to determine the primary agent of the outbreak, and to implement appropriate measures to control and limit respiratory illnesses in this vulnerable population.
Duration of Data Collection:	14 days
Date Began:	July 13, 2014
Date Ended:	July 26, 2014
Lead Investigator
Name:	Steve Waterman
CIO/Division/Branch:	DGMQ/NCEZID

Complete the following for each instrument used during the investigation.

Data Collection Instrument 1

Name of Data Collection Instrument:

Respiratory Illness_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):		A descriptive study was conducted to identify the primary agent and source of the outbreak. Traceback of contacts and travel history were completed to identify risk factors for exposure.
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):		Face-to-face interviews were conducted with ill case patients to identify contacts and interactions with ill persons in cluster and to ascertain travel history prior to arriving at shelter. These interviews were used to complete questions 1-20.
Telephone Interview (describe):
Self-administered Paper-and-Pencil Questionnaire (describe):
Self-administered Internet Questionnaire (describe):
Other (describe):		Questions 21 to the end of the form were completed by using the shelter clinic’s records.
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):

Response Rate (if applicable)

Total No. Responded (A):	32
Total No. Sampled/Eligible to Respond (B):	72
Response Rate (A/B):	44.4%

Data Collection Instrument 2

Name of Data Collection Instrument:

Respiratory Illness_Hospitaized 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):		We reviewed medical records of hospitalized UC.
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):	For hospitalized UC, inpatient medical charts were reviewed, and data was abstracted to complete the form.
Biological Specimen Sample
Environmental Sample
Other (describe):

Response Rate (if applicable)

Total No. Responded (A):	8
Total No. Sampled/Eligible to Respond (B):	8
Response Rate (A/B):	100%

Data Collection Instrument 3

Name of Data Collection Instrument:

Respiratory Illness_Interview Assent 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):		This form was used to document verbal consent/assent for interviews of the ill case patients and for obtaining nasopharyngeal and/or throat swabs. This same form was also used to document verbal consent/assent for asymptomatic UC that were available for pneumococcal carriage swab.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):	This was conducted to evaluate potential etiologies in children with acute lower respiratory infection and/or influenza-like illness as well as to estimate the prevalence of Streptococcus pneumoniae carriage in UC at the shelter.
Other (describe):

Data Collection Mode (check all that apply)

Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):		A personal interview was conducted to receive consent/assent.
Telephone Interview (describe):
Self-administered Paper-and-Pencil Questionnaire (describe):
Self-administered Internet Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample	For each assenting child with influenza-like illness, a nasopharyngeal and an oropharyngeal swab were obtained for processing on the Taqman Array Card, a multi-pathogen detection tool that uses real-time PCR for the rapid, simultaneous detection of over 21 respiratory pathogens. For asymptomatic UC residing at the shelter on July 18, 2014, these children were invited to participate in the pneumococcal carriage study. A trained clinic staff member inserted a flexible wire Rayon-tipped swab to the posterior pharynx and collected the nasopharyngeal specimen to evaluate for Streptococcus pneumoniae carriage. The swabs were processed and transported to CDC for pneumococcal isolation and serotyping.
Environmental Sample
Other (describe):

Response Rate (if applicable)

Total No. Responded (A):	For ILI: 27; For pneumococcal carriage: 380
Total No. Sampled/Eligible to Respond (B):	For ILI: 72; For pneumococcal carriage: 357
Response Rate (A/B):	For ILI: 37.5%; For pneumococcal carriage: 94%

(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*
Respiratory Illness_Case Investigation Form	Patients	32	1	30	16
Respiratory Illness_Hospitaized Case Investigation Form	Patients	8	1	30	4
Respiratory Illness_Interview Assent Form	Patients	384	1	10	64

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