File Name: 2017001-XXX_Shigellosis_MichiganDHHS
Instruction: This form should be completed by the primary contact person from the CDC CIO that will be sponsoring the investigation.
Determine if your investigation is appropriate for this Generic mechanism: Instruction: Before completing and submitting this form, determine first if the proposed investigation is appropriate for the EEI Generic ICR mechanism. Complete the checklist below. If you select “yes” to all criteria in Column A, the EEI Generic IR mechanism can be used. If you select “yes” to any criterion in Column B, the EEI Generic ICR mechanism cannot be used.
Column A |
Column B |
CDC epidemiological assistance is requested by one or more external partners (e.g., local, state, tribal, military, port, other federal agency, or international health authority or other partner organization). Yes No |
The Investigation is initiated by CDC, without request from an external partner. Yes No
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The investigation is urgent in nature (i.e., timely data are needed to inform rapid public health action to prevent or reduce injury, disease, or death). Yes No |
The investigation is not urgent in nature. Yes No |
The investigation is characterized by undetermined agent, undetermined source, undetermined mode of transmission, or undetermined risk factors. Yes No |
The investigation is conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research to contribute to generalizable knowledge. Yes No |
One or more CDC staff (including trainees and fellows) will be deployed to the field. Yes No |
CDC staff (including trainees or fellows) are not deployed to the field. Yes No |
Data collection will be completed in 90 days or less. Yes No |
Data collection expected to require greater than 90 days. Yes No |
Did you select “Yes” to all criteria in Column A?
If yes, the EEI Generic ICR may be appropriate for your investigation. → You may proceed with this form.
Did you select “Yes” to any criterion in Column B?
If yes, the EEI Generic ICR is not appropriate for your investigation. → Stop completing this form now.
GenIC # |
2017001 |
- |
XXX |
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Date |
10/11/2016 |
Title of Investigation: Instruction: Provide the title of the investigation in the following format: [Undetermined agent, undetermined source, undetermined mode of transmission, undetermined risk factor] for [disease/problem] among [subpopulation]—[State], [Year]
Undetermined risk factors and modes of transmission for Shigella sonnei infection among residents of Genesee and Saginaw Counties – Michigan, 2016 |
Location of Investigation: Instruction: Indicate location where investigation will occur. If multiple locations, specify each one.
State: |
Michigan |
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City/County (if applicable) |
Genesee and Saginaw Counties |
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Country |
USA |
Requesting Agency: Instruction: Indicate name of agency requesting epidemiological assistance and the name and position title of the requestor
Agency: |
Michigan Department of Health and Human Services |
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Name and Position Title: |
Sarah Lyon-Callo, State Epidemiologist |
Note: Attach the Letter of Invitation requesting support. The letter should include the following information: 1) background on the outbreak or event; 2) steps already taken toward prevention and control, if any; 3) request for CDC assistance, including objectives of the investigation; and 4) how data will be used to inform prevention and control measures. Sensitive information in the Letter of Invitation not appropriate for public dissemination should be redacted.
Description of Investigation
Problem to be Investigated: Instruction: Provide a summary of the outbreak or event. The summary should include all the information you know at this time about the outbreak or event and the investigation that is planned. At a minimum, please provide the following information: 1) background necessary to understand the importance of the outbreak or event, including a justification of the need for an investigation and why this issue requires an urgent response; 2) the objectives of the investigation, including how the information collected will be used to inform prevention and control measures; and 3) a brief overview of the investigation planned, including study design, respondents, mode of data collection. In the description, indicate whether a data collection instrument is attached with the GenIC request (refer to as Appendix 1, etc) and what instruments will be developed in the field. (suggested length: 250-500 words).
Shigella is a bacterial pathogen that causes shigellosis, a generally self-limited illness characterized by fever and enteritis. Of the four Shigella species, S. sonnei is the most common cause of shigellosis in the United States. Due to its low infectious dose, Shigella is readily transmitted person-to-person through the fecal-oral route; additional modes of transmission include contaminated food, drinking water, and recreational water. Outbreaks occur year-round; child care facilities are the most common setting. Attention to hygiene, access to safe water, and adequate sanitation are mainstays of prevention.
In 2016, health departments in Genesee County (GCHD) and Saginaw County (SCHD) reported an increase in shigellosis cases over baseline beginning in March. From January 1, 2016 to October 4, 2016, the Michigan Department of Health and Human Services (MDHHS) received reports of 83 cases from GCHD and 47 cases from SCHD. Epidemiologic and laboratory investigations are needed to identify associated risk factors to inform ongoing prevention efforts.
On October 7, the Michigan Department of Health and Human Services requested CDC assistance to investigate the 2016 outbreak of Shigellosis in Genesee and Saginaw Counties.
The overall objectives of the investigation are to:
Molecular data and municipal water system data will be extracted from existing data sources.
This EEI GenIC seeks OMB approval for the new information collection associated with accomplishing these objectives. Specifically, approval is requested for a case-control investigation conducted to:
Information will be collected via a case-control investigation to identify risk factors for shigellosis (Appendix 1: Questionnaire). A random sample of cases (n=75) will be selected from Genesee and Saginaw counties; controls (n=225) will be selected at random from the source population (residents of Genesee and Saginaw Counties). Cases and controls will be contacted by phone. A standardized questionnaire will be administered by trained personnel. Data will be stored on secure servers housed at MDHHS and accessed only via password-protected computers by staff with appropriate clearance and security training. |
Characteristics of Outbreak or Event (Check all that Apply):
Undetermined agent
Undetermined source
Undetermined mode of transmission
Undetermined risk factor
Respondents: Instruction: Select all that apply. For each respondent type selected, provide a brief description. Be sure to include a description of control respondents, if applicable. Use as much space as necessary for each description.
General public (describe):
Members of the general public residing in Genesee and Saginaw Counties will be randomly selected as controls (n=225). For controls who are less than 18 years of age, interviews will be conducted with a parent or legal guardian. |
Healthcare staff (describe):
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Laboratory staff (describe):
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Patients (describe):
A random sample of 75 shigellosis case-patients from Genesee and Saginaw counties will be interviewed. For case-patients who are less than 18 years of age, interviews will be conducted with a parent or legal guardian. |
Restaurant staff (describe):
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Other (describe):
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Selection of Respondents: Instruction: Provide a brief description of how respondents will be identified and selected. Use as much space as necessary for the description.
Case-patients (n=75) will be selected at random from the Michigan Disease Surveillance System. Controls (n=225) will be recruited at random from the source population, as described above. We anticipate using a random digit dialing program to identify controls. |
Study Design: Instruction: Select all that apply. For each study design planned, provide a brief description. Use as much space as necessary for the description.
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
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Cross-sectional Study (describe):
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Cohort Study (describe):
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Case-Control Study (describe):
Data will be collected via a case-control investigation to identify risk factors for shigellosis (Appendix 1: Case Questionnaire). |
Other (describe):
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Environmental Assessment (describe):
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Laboratory Testing (describe):
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Other (describe):
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Data Collection Mode: Instruction: Select all that apply. For each data collection mode planned, provide a brief description. Use as much space as necessary for the description.
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
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Telephone Interview (describe):
Cases and controls will be contacted and interviewed by phone. |
Self-administered Paper-and-Pencil Questionnaire (describe):
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Self-administered Internet Questionnaire (describe):
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Other (describe):
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Medical Record Abstraction (describe):
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Biological Specimen Sample
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Environmental Sample:
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Other (describe):
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Type of Information to be Collected: Instruction: Select all that apply. For each type of information to be collected, provide a brief description. Use as much space as necessary for the description.
Behaviors (describe):
e.g., handwashing, bathing, diapering, surface cleaning |
Clinical information/symptoms (describe):
Date of onset, signs, symptoms, treatment, duration of illness, outcome |
Contact information (describe):
Phone number |
Demographic information (describe):
Age, sex, race, ethnicity, address for purposes of assessing exposure to factors related to water quality |
Environmental factors (describe):
Water source, what the person uses water for (consumption, personal hygiene, etc) |
Exposures (describe):
e.g., dietary, drinking and recreational water, social gatherings |
Medical history (describe):
Co-morbidities (e.g., immunocompromised), medications |
Risk factors (describe):
Child care attendee or staff, long term care facility resident or staff, ill contacts, live with children who are in diapers |
Specimen/lab information (describe):
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Travel history (describe):
International travel, domestic travel |
Other (describe):
Food handler, health care worker, missed school or work |
8. Duration of Data Collection (number of weeks):
3 weeks |
Research Determination: Instruction: Indicate the research determination decision. If the decision is research, provide the research determination letter and IRB approval, if required.
Research |
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Not Research |
CDC Investigation Lead: Instruction: Indicate the name, title, and affiliation of the person who will serve as the CDC lead for this investigation.
Name: |
Matt Karwowski, MD, MPH |
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Title: |
Medical Epidemiologist |
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Affiliation: |
CDC/NCEZID/DFWED/WDPB |
CDC Sponsoring Program and Primary Contact Person: Instruction: Indicate the sponsoring CIO/Division/Branch for this investigation. Indicate the name, title, and contact information of the CDC Primary Contact Person for this investigation. Indicate the preferred method of contact during the OMB approval process. Note, contact person or a designee must be available during the OMB approval process in case questions arise.
CIO/Division/Branch: |
NCEZID/DFWED/WDPB |
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Name: |
Matt Karwowski, MD, MPH |
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Title: |
Medical Epidemiologist, ydh4@cdc.gov |
Certification: Please read the certification carefully. Type your name to validate that you are providing certification. Note: If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved. Certification should be signed by the CDC Primary Contact Person for this Investigation.
I, [insert name of CDC sponsoring program contact], certify the following to be true:
The collection is voluntary.
Respondents will not be personally identified in any published reports of the study.
Information gathered will be primarily used to inform effective prevention and control measures.
CDC Sponsoring Program Primary Contact Name: |
Matt Karwowski |
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Date of Certification: |
10/11/2016 |
Requested Approval Date (mm/dd/yyyy): Instruction: Indicate the date by which approval is needed.
10/12/2016 |
E-mail the completed form to the Information Collection Request Liaison (ICRL) or EIS program ICRL designee.
Date
Form Revised: GenIC 6.16.14
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Modified | 0000-00-00 |
| File Created | 2021-01-23 |