Form 4 Form 4 Shigella Hypothesis Generating Questionnaire

Form Approved

OMB Control No.: 0XXX-XXXX

Expiration date: XX/XX/XXXX

[Please complete Section 1 prior to conducting interview]

Section 1: INTERVIEW INFORMATION
PulseNet ID: _______________________ and/or WGS ID: _____________ State/Local/Other ID #: _________________	Date of Interview (MM/DD/YYYY): _________________
Interviewer information Name: ________________________________ Agency or organization: ________________________
Respondent was: ☐ Self ☐ Parent ☐ Spouse ☐ Other (specify): _______________
State and county of residence? State _________ County _______
Age at time of illness _________ Days Months Years Unknown
Language interview conducted in: ☐English ☐Spanish ☐Other (specify):______________

Hello, my name is <interviewer name>. I am from <interviewer health department name>. We are contacting you because you (the patient) were recently sick with a Shigella infection, also called shigellosis. Shigella are a group of bacteria that cause diarrheal illness. We are trying to determine how you (the patient) became sick with a Shigella infection. This interview will also help prevent others from getting sick.

You may have already been contacted by the health department. I would like to ask you a few additional questions about your (the patient’s) recent illness and about any exposures you (the patient) may have had before becoming ill. Your help in the investigation is very important. Your participation is voluntary, and you may refuse to answer any question at any time. All information will be kept confidential to the extent permitted by law. No names or other identifying information will be used in any reports. This interview will likely take about 45 minutes. Are you willing to participate?

If yes: Thank you. [Proceed to Section 2]

If no: Thank you for your time. Would you like any additional materials about Shigella or can I answer any questions for you? If you wish at any time to complete the questionnaire, please call <health department phone number>.

For the first few questions, I will ask some basic demographic questions so I can learn more about you (the patient).

Section 2: CASE INFORMATION
State of residence: _______________			County of residence: ____________________
Age at time of illness: __________ ☐ Years ☐ Months ☐ Days ☐ Unknown
Sex: ☐ Male ☐ Female
What is your (the patient’s) race and/or ethnicity? (Select all that apply and enter additional details in the spaces below)
American Indian or Alaska Native Enter, for example, Navajo Nation, Blackfeet Tribe of the Blackfeet Indian Reservation of Montana, Native Village of Barrow Inupiat Traditional Government, Nome Eskimo Community, Aztec, Maya, etc. ___________________________________	Asian Chinese Asian Indian Filipino Vietnamese Korean Japanese Enter, for example, Pakistani, Hmong, Afghan, etc. ___________________________________	Black or African American African American Jamaican Haitian Nigerian Ethiopian Somali Enter, for example, Trinidadian and Tobagonian, Ghanaian, Congalese, etc. ___________________________________
Hispanic or Latino Mexican Puerto Rican Salvadoran Cuban Dominican Guatemalan Enter, for example, Colombian, Honduran, Spaniard, etc. ___________________________________	Middle Eastern or North African Lebanese Iranian Egyptian Syrian Iraqi Israeli Enter, for example, Moroccan, Yemeni, Kurdish, etc. ___________________________________	Native Hawaiian or Pacific Islander Native Hawaiian Samoan Chamorro Tongan Fijian Marshallese Enter, for example, Chuukese, Palauan, Tahitian, etc. ___________________________________
White English German Irish Italian Polish Scottish Enter, for example, French, Swedish, Norwegian, etc. ___________________________________
If case is ≥14 years old, what is your (the patient’s) current occupation? ______________________________

Now I am interested to learn a little about your (the patient’s) household.

Section 3: HOUSEHOLD INFORMATION
What would best describe the type of housing you (the patient) currently live in? For example, a house, apartment, or mobile home. ☐ House/single family home ☐ Apartment ☐ Hotel/motel ☐ Long term care facility ☐ Nursing home/assisted living facility ☐ Mobile home ☐ Shelter ☐ Rehabilitation center ☐ Half-way house ☐ Unknown ☐ Other (specify): _______________
In the past 30 days, did you (the patient) double up or stay overnight with friends, relatives, or someone you didn’t know well because you didn’t have a regular place to stay at night? ☐ Yes ☐ No ☐ Prefer not to answer ☐ Unknown
In the past 30 days, were you (the patient) ever homeless? That is, were you living on the street, in a shelter, in a single room occupancy hotel, or in a car? ☐ Yes ☐ No ☐ Prefer not to answer ☐ Unknown
What is the water source at your (the patient’s) primary place of residence? ☐ Municipal ☐ Well ☐ Unknown ☐ Other (specify): _______________
What is the sewer connection at your (the patient’s) primary place of residence? ☐ Municipal ☐ Septic tank ☐ Unknown ☐ Other (specify): _______________
How many people, including you (the patient), live in your (the patient’s) primary place of residence? _______ ☐ Unknown Do any of these people (either children or adults) wear diapers? ☐ Yes ☐ No ☐ Unknown How many people living in your (the patient’s) household are under the age of 5? _______ ☐ Unknown
What was your (the patient’s) household income last year from all sources before taxes? That is, the total amount of money earned and shared by all people living in your (the patient’s) household. ☐ <$20,000 ☐ $20,000-$39,999 ☐ $40,000-$59,999 ☐ $60,000-$79,999 ☐ $80,000-99,999 ☐ $100,000 or more ☐ Prefer not to answer ☐ Unknown

Next, I have a few questions about your (the patient’s) recent illness. It may be helpful to have a calendar in front of you because I will be asking about the dates your (the patient’s) symptoms started and stopped. Do you need some time to get one?

Section 4: CLINICAL INFORMATION
What date did you (the patient) first feel sick? ______ /_____ /_______ ☐ Approximate date ☐ Unknown Month / Day / Year If unknown, please enter specimen collection date: ______ /_____ /_______ ☐ Unknown Month / Day / Year
How many days total were you (the patient) sick? __________ days ☐ Unknown ☐ Still sick
Yes	No	Maybe	Don’t Know	Did you (the patient) have any of the following symptoms?
☐	☐	☐	☐	Diarrhea (defined as at least 3 loose stools in 24 hours)?
				If yes to question 4a, what day did it start? ______ /_____ /_______ ☐ Unknown Month / Day / Year If yes to question 4a, what day did it end? ______ /_____ /_______ ☐ Unknown Month / Day / Year
☐	☐	☐	☐	Abdominal pain/cramps?
☐	☐	☐	☐	Fever?
☐	☐	☐	☐	Nausea?
☐	☐	☐	☐	Vomiting?
☐	☐	☐	☐	Blood in the stool?
☐	☐	☐	☐	Seizures?
☐	☐	☐	☐	Achy joints/muscles?
☐	☐	☐	☐	Tenesmus (or feeling the need to pass stool [poop] even when bowels are empty)?
☐	☐	☐	☐	Other symptoms I didn’t ask about? (specify): ________________________________________

The next set of questions are about any recent medical care and treatment you (the patient) may have received.

Section 5: MEDICAL CARE AND TREATMENT INFORMATION

Yes

No

Don’t

Know

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1. As a result of your (the patient’s) illness, did you (the patient) seek medical care?

1. If yes to question 1, where did you (the patient) seek medical care? (select all that apply)

☐ Doctor’s office ☐ Urgent care ☐ Pharmacy clinic ☐ STD clinic

☐ Emergency department ☐ Hospital ☐ Unknown ☐ Other (specify): ___________

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2. If yes to question 1, did you (the patient) get admitted overnight to a hospital for this illness?

1. If yes to question 1b, how many nights did you (the patient) spend in the hospital? _________ ☐ Unknown

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ii. If yes to question 1b, the did you (the patient) stay overnight in an intensive care unit (ICU) or critical care unit (CCU)?

1. If yes to question 1bii, for how many nights were you (the patient) in ICU or CCU? ____________

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2. In addition to infection with Shigella, did your (the patient’s) doctor tell you that you (the patient) were sick with any other infection(s)?

1. If yes to question 2, what was the name of the other infection(s): ______________________

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3. Did you (the patient) take any antibiotics for this illness? If yes, I will be asking more questions about the antibiotic, so it may be helpful to get the pill bottles or packages if available.

1. If yes to question 3, please list the name, start date, and duration for every antibiotic.

Antibiotic name	Start date (MM/DD/YYYY; for any part of the date not known, enter ‘99’ or ‘9999’)	Duration (days)
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking

2. If yes to question 3, in the 24 hours after taking the antibiotic(s), did your (the patient’s) symptoms

☐ Get better/Improve ☐ Stay the Same ☐ Get Worse

☐ Other (specify): ______________

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4. In the 30 days before illness, did you (the patient) take an antibiotic by mouth or injection?

1. If yes to question 4, please list the name, start date (at least the month) and duration for every antibiotic.

Antibiotic name	Start date (MM/DD/YYYY; for any part of the date not known, enter ‘99’ or ‘9999’)	Duration (days)
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking
__________________________	__ __ / __ __ / __ __ __ __	________ ☐ Still taking

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5. Are you pregnant?

Have you (the patient) ever been told by a physician that you (the patient) have or had any of the following conditions:

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5. Immune deficiency or a condition that could lead to immune deficiency (e.g., complement deficiency, antibody or immunoglobulin deficiency, asplenia, HIV/AIDS)?

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5. Sickle cell disease?

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5. Cancer (including leukemia/lymphoma)?

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5. Diabetes?

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5. Irritable bowel syndrome?

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5. Peptic ulcer disease

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5. Gastroesophageal reflux disease?

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5. Liver cirrhosis or liver failure?

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5. Other chronic health condition?

1. If yes to question 13, specify:

_______________________________________________________________

Have you (the patient) ever had any of the following procedures or treatments:

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5. Immunosuppressive medicine, such as medicines you would take for autoimmune disease, cancer or organ transplant?

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5. Radiation therapy?

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5. Bariatric surgery (e.g., gastric bypass, gastric banding)?

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5. Other abdominal surgery (e.g., removal of appendix, removal of gall bladder, any surgery of the stomach, small intestine, or large intestine)?

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5. Organ transplant (e.g. kidney)?

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5. Bone marrow transplant?

I would now like to know about your (the patient’s) recent activities, including travel, events, and contact with others.

Section 6: EXPOSURE INFORMATION

Yes

No

Don’t

Know

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1. In the 7 days before illness, did you (the patient) travel to another state in the U.S.?

1. If yes to question 1, list all cities and states inside the United States where you (the patient) traveled.

City and State	Date of Arrival	Date of Departure	Accommodation Type & Name (e.g., hotel, cruise ship)	Reason(s) for Travel
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other

2. If yes to question 1, what activities did you (the patient) engage in while traveling domestically? (select all that apply)

☐ Purchase or eat food ☐ Go swimming ☐ Attend gathering of people

☐ Drink untreated water ☐ Other (specify):________________________

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2. In the 6 months before illness, did you (the patient) travel to a country outside of the U.S.?

1. If yes to question 2, list all countries outside of the U.S. where you (the patient traveled:

City and Country	Date of Arrival	Date of Departure	Accommodation Type & Name (e.g., hotel, cruise ship)	Reason(s) for Travel
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other
				Tourism Business or work Visiting friends or relatives Other

2. If yes to question 2, what activities did you (the patient) engage in while traveling internationally? (select all that apply)

☐ Purchase or eat food ☐ Go swimming ☐ Attend gathering of people

☐ Drink untreated water ☐ Other (specify):__________________________

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3. Did any household member or close contact return from visiting another country during the 30 days before you (the patient) got sick?

1. If yes to question 3, which country/countries? __________________________________

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2. If yes to question 3, were they ill with symptoms similar to your (the patient’s) symptoms?

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3. If yes to question 3, did you (the patient) eat any food or drink any beverages they brought back? ______________________________________________________

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4. If no to question 3, did you (the patient) eat any food or drink any beverages anyone brought back or mailed to you from another country?

1. If yes to question 3c or 3d, what did you (the patient) eat or drink? (specify): _________________________________________________________________

4. In the 7 days before illness, did you (the patient) attend, visit, work in, or volunteer at any of the following:

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1. A religious gathering (such as church, mosque, or synagogue)? (specify): _______________

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2. Camp? (specify): _______________

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3. Conference or other large meeting? (specify): _______________

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4. Festival, fair, play, or concert? (specify): _______________

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5. Party, picnic, or barbeque? (specify): _______________

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6. Sports practice, sports game, or exercise class? (specify): _______________

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7. Other gathering of people I did not ask about? (specify): _______________

5. In the 7 days before illness, did you (the patient):

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1. Drink water from an untreated source, such as lake, pond, or river? (specify): _______________

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2. Eat any foods prepared by a friend, neighbor, or coworker in their home? (specify): ____________

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3. Eat any foods prepared by a catering company? (such as food served at a wedding or conference?) (specify): _____________________

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4. Eat at a restaurant? (specify): _____________________

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5. Swim in treated water, such as a swimming pool? (specify): ________________________

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6. Swim in untreated water, such as a lake, river, or ocean? (specify): __________________

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7. Play in an interactive water fountain, water table, children’s pool, kiddie pool, or baby pool? (specify): _______________

6. In the 7 days before illness, did you (the patient) visit, work in, or volunteer at:

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1. A place that serves food, such as a restaurant or cafeteria? (specify): __________________

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2. A homeless shelter? (specify): _______________

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3. A health care facility? (specify): _______________

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4. A nursing home, long term care, or assisted living facility? (specify): _______________

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7. In the 7 days before illness, did you (the patient) have any close contact with anyone with diarrhea (at least 3 loose stools in 24 hours) or symptoms similar to your (the patient’s) symptoms?

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1. If yes to question 7, was this person diagnosed with a Shigella infection?

For interviewer only:

If yes and this person is part of the outbreak, what is their PulseNet or WGS ID? ____________________

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2. If yes to question 7, was this person a member of your (the patient’s) household?

(specify): _______________

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3. If yes to question 7, does this person wear diapers?

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1. If yes to question 7c, did you (the patient) change this person’s diapers?

8. While you (the patient) were sick with the Shigella infection, did you (the patient) do any of the following:

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1. Prepare or handle food for other people? (specify): _______________

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2. Go swimming or play in a swimming pool, baby pool, interactive fountain, or water table? (specify): _______________

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3. Visit, work in, or volunteer at a healthcare facility? (specify): _______________

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4. Visit, work in, or volunteer at a nursing home, long term care, or assisted living facility? (specify): _______________

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5. Visit, work in, volunteer, or attend a school or childcare facility? (specify): _______________

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6. Visit, work in, volunteer, or attend any gathering of people? For example, a picnic, party, concert, conference, or religious gathering. (specify): _________________________________

We are nearly finished. I have a few questions about your (the patient’s) recent child care or school attendance.

Section 7: CHILD CARE AND SCHOOL INFORMATION
Yes	No	Don’t Know
☐	☐	☐	In the 7 days before illness, did you (the patient) visit, work in, volunteer, or attend a child care center, daycare, or preschool?
			If yes to question 1, what is the name of the facility? ______________________________
☐	☐	☐	If yes to question 1, at this facility were there any other children or adults ill with diarrhea (at least 3 loose stools in 24 hours) or symptoms similar to yours (the patient’s) before you (the patient) became ill?
☐	☐	☐	If yes to question 1, did you (the patient) use a school bus or other school transport to get to and from the child care center, daycare, or preschool?
☐	☐	☐	If yes to question 1, were you (the patient) excluded from this facility while ill?
			If yes to question 1d, how many days were you (the patient) excluded? _______________
			If yes to question 1d and case is ≤ 18 years, while excluded from daycare, what alternative care did your child receive? (select all that apply) ☐ Babysitter ☐ Care at home ☐ Other child care center ☐ Unknown ☐ Other (specify): _______________
☐	☐	☐	In the 7 days before illness, did you (the patient) attend, visit, work in, or volunteer in a school (such as an elementary, middle, after school center, or other type of school)?
			If yes to question 2, what is the name of the school? ______________________________
☐	☐	☐	If yes to question 2, at this school were there any other children or adults ill with diarrhea (at least 3 loose stools in 24 hours) or symptoms similar to yours (the patient’s) before you became ill?
☐	☐	☐	If yes to question 2, did you (the patient) use a school bus or other school transport to get to and from the school?
☐	☐	☐	If yes to question 2, were you (the patient) excluded from school while ill?
			If yes to question 2d, how many days were you (the patient) excluded? _______________
			If yes to question 2d and case is ≤ 18 years, while excluded from school, what alternative care did your child receive? (select all that apply) ☐ Babysitter ☐ Care at home ☐ Self-care ☐ Unknown ☐ Other (specify): _______________

[Proceed if participant is ≥ 18 years of age and answering survey on behalf of themself. Otherwise skip section 8 and conclude interview]

Finally, I would like to ask about your recent sexual activity because Shigella can be spread through sexual contact. Shigella germs are very contagious; it takes just a small number of Shigella germs to make someone sick. People can get shigellosis when they put something in their mouths or swallow something that has come into contact with the stool of someone else who is sick with shigellosis. This can happen during sex.

As I stated previously, your responses are voluntary, and you may refuse to answer any question at any time. We ask all adults who were diagnosed with a Shigella infection these questions. Your answers to these questions will be kept private and may help us to identify how you became sick with a Shigella infection. This may also help us to prevent others from getting sick.

Do you wish to proceed with the next section?

If yes: Thank you [Begin section 8]

If no: That is OK. We appreciate the information you have given us. ☐ Refused/Prefer Not to Complete

[Skip to Section 9 to close out interview]

Section 8: RECENT SEXUAL ACTIVITY [Only ask if ≥ 18 years of age]
Which of the following best represents how you think of yourself?    ​​☐​ Lesbian or gay    ​☐​ Straight, that is not lesbian, gay, or bisexual    ​☐​ Bisexual     ​☐​ Something else (specify): _______________      ​​☐​ I don’t know       ​☐​ Prefer not to answer
Yes		No	Prefer not to answer
☐	☐			☐	Are you currently sexually active? (if no skip to question 3)
☐	☐			☐	If yes to question 2, since your illness started, have you had sexual contact with another person? Sexual contact would include genital sex, anal sex, oral sex, or any other sexual contact.
☐	☐			☐	If yes to question 2 in the 7 days before illness, did you have sexual contact with another person? Sexual contact would include genital sex, anal sex, oral sex, or any other sexual contact.
☐	☐			☐	If yes to question 2b, in the 7 days before illness, did any of your sex partners have diarrhea or symptoms similar to your own?
					If yes to question 2b, read prompt. For the next questions I’m going to be more explicit about the kind of sex you had in the week before your illness started. This will help me to better understand how you could have become sick.
					In the 7 days before illness, what kind of sexual contact did you have?
☐	☐			☐	Genital sex (for example, penis in the vagina)?
☐	☐			☐	Anal sex (for example, penis in the anus)?
☐	☐			☐	Oral sex (for example, mouth on penis or vagina)?
☐	☐			☐	Anilingus or rimming (meaning mouth on anus)?
☐	☐			☐	Other sexual contact (for example touching your partner’s anus with your hands, your partner touching your anus with their hands, or sharing of sex toys)?
☐	☐			☐	If yes to question 2b, in the 7 days before illness, did you use drugs or alcohol during or immediately before sex?
					If yes to question 2biv, what did you use? ☐ Alcohol ☐ Viagra or similar ☐ Cannabis (☐ Ecstasy ☐ Cocaine ☐ GHB/GBL (liquid ecstasy) ☐ Methamphetamine (crystal meth, Tina) ☐ Poppers ☐ Mephedrone (4-MMC, meow, methylone) ☐ Ketamine (K/Special K) ☐ LSD (acid) ☐ Other (specify): ___________________________________ ☐ Prefer Not to Answer
					If yes to question 2biv, how did you use? ☐ Oral (by mouth) ☐ Inhalation ☐ Smoked ☐ Patch ☐ IV injection ☐ Skin popping/nonvenous injection ☐ Other (specify): ____________________________
					If yes to question 2biv, in what setting did you use? ______________________________________________________________________________________________________________________________________
					In the 7 days before illness, how many sex partners did you have? (specify): _________
☐	☐			☐	If yes to question 2b, were any of these partners new?
					If yes to question 2bv1, in the 7 days before illness, did you meet your new sex partner(s) at any of the following places?
☐	☐			☐	Bar, restaurant, or club? (specify): _______________________
☐	☐			☐	Bathhouse? (specify): _______________________
☐	☐			☐	Bookstore? (specify): _______________________
☐	☐			☐	Gym? (specify): _______________________
☐	☐			☐	Park? (specify): _______________________
☐	☐			☐	Social media sites? (specify): _______________________
☐	☐			☐	Dating or hookup sites? (specify): ______________________
☐	☐			☐	Party, conference, or other type of event? (specify): ______________
☐	☐			☐	Cruise ship? (specify name of ship and dates): ________________________
☐	☐			☐	Sex club or sex party? (specify): _______________________
☐	☐			☐	Other location I didn’t ask about? (specify): _______________
☐	☐			☐	In the past 12 months, have you been told by a doctor that you have a sexually transmitted infection?
					If yes to question 3, which infection? (select all that apply) ☐Chlamydia ☐ Gonorrhea ☐ Syphilis ☐ Genital warts ☐ Herpes ☐ Other (specify):_____________

Section 9: CLOSING
Yes	No	Don’t Know
☐	☐	☐	This is the end of the questionnaire. Thank you very much for your time. Would you like any additional materials on Shigella or can I answer any questions for you?

Thank you for your time. Have a nice day.

[Conclude interview]

Page 23 of 23

Public reporting burden of this collection of information is estimated to average 45 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30333; ATTN: PRA 0XXX-XXXX