Cyclosporiasis National Hypothesis Generating Questionnaire

Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) during Investigations of Foodborne Disease Clusters and Outbreaks

Attachment 2. Crosswalk of Non-substantive changes to 2018 CNHGQ.DOCX

Cyclosporiasis National Hypothesis Generating Questionnaire

OMB: 0920-1198

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Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ): Crosswalk of non-substantive changes to 2017 CHNGQ to create proposed 2018 CNHGQ

Type of change code: M = Modification, N = New addition, NO = New addition (Optional), D = Deletion, ___ = Highlight of changes

Type of Change

Old Question/Item

New Question / Requested Change

D

1. State/local/other ID: _______________________________


Request deletion of this question as it is repetitive with another data element.


N

N/A


Request addition of the next three questions to capture recent changes in laboratory practices and testing methods that may affect detection, reporting, and classification (e.g., exclusion) of reported cases of cyclosporiasis.

4. Specify type of testing laboratories (Check all that apply including confirmatory lab):

  1. Clinical lab (e.g., at a hospital/clinic)

  2. Commercial lab

  3. State lab

  4. CDC lab

N

N/A

Request addition of this question to capture recent changes in laboratory practices and testing methods.

5. Specify testing method(s) (Check all that apply including confirmatory test):

  1. O&P (e.g., light microscopy, UV fluorescence microscopy, stained smears)

  2. GI PCR Panel (e.g., BioFire FilmArray®)

  3. PCR (Not part of a panel)

  4. Lab-developed test

  5. Other, specify:_________________________

N

N/A


Request addition of this question to capture recent changes in laboratory practices and testing methods.

  1. Specify name(s) of lab-confirmed coinfection:

_________________________________________

D

14. Have you (has your child) submitted a stool specimen for Cyclospora testing?

a. Yes b. Maybe c. No d. Don’t know

Request deletion of this question.


M/D

  1. Before this interview how many times has the case-patient been interviewed about his/her illness?

a. None

b. Once

c. Twice

d. Three times

e. Other

f. Unknown

7a. If other, please specify:__________________

Recommend deletion of the additional question 7a. (If other, please specify)

  1. Before this interview how many times has the case-patient been interviewed about his/her illness?

a. None

b. Once

c. Twice

d. Three or more times

f. Unknown


M

The next two questions ask about the case-patient’s illness.


10. Did you (your child) have any diarrhea (defined as loose or watery stools that you do not normally have)?

a. Yes b. Maybe c. No d. Don’t know


10a. What date did it start? _________


11. Has you (your child’s) diarrhea stopped?

a. Yes b. Maybe c. No d. Don’t know


11a. What date did it stop? _________


Recommend modifying this question set to include additional symptoms to align the CNHGQ with the Cyclosporiasis Case Report Form (CRF). The CNHGQ is used in lieu of the CRF during outbreak investigations.


  1. Have you (your child) had any of the following symptoms?

    1. Diarrhea (loose, watery stools you do not normally have)

a. Yes b. Maybe c. No d. Don’t know

Date diarrhea started: ____________

Date diarrhea stopped: ___________

    1. Weight loss

a. Yes b. Maybe c. No d. Don’t know

c. Fever

a. Yes b. Maybe c. No d. Don’t know

d. Fatigue

a. Yes b. Maybe c. No d. Don’t know

e. Anorexia

a. Yes b. Maybe c. No d. Don’t know

f. Nausea

a. Yes b. Maybe c. No d. Don’t know

g. Vomiting

a. Yes b. Maybe c. No d. Don’t know

h. Abdominal Cramps

a. Yes b. Maybe c. No d. Don’t know

D

13. Were you (your child) hospitalized overnight?

a. Yes b. Maybe c. No d. Don’t know

13a. How many nights were you (you child) hospitalized? _

Hospital name:__________

Admission Date:__________

Discharge Date:__________

Request deletion of the data element (discharge date) from this question.

12. Were you (your child) hospitalized overnight?

a. Yes b. Maybe c. No d. Don’t know

12a. How many nights were you (your child) hospitalized? ________

12b. Admission Date: ________

12c. Hospital Name: _____________________ (Optional)

NO

N/A

Request addition of this (optional) question to capture intrastate travel. While this data is not analyzed at the national level, state public health partners asked to include this question in the CNHGQ to prevent having to create a separate (additional) form.

13. *(Optional – for local analysis) List cities, date departed, date returned, and foods eaten in home state where you (your child) might have purchased or eaten foods during the 14 days before onset of illness.

a. Did not travel outside the U.S.

b. Unknown

D

15. Did you (your child) spend all, or some, of the 14 days before becoming ill outside your home state?

a. Yes b. Maybe c. No d. Don’t know


15c. If you (your child) traveled with others, did any of the travel partners also become ill?

a. Yes b. Maybe c. No d. Don’t know


15d. If yes, please provide information on other ill person(s), including number of ill persons and relations to you (e.g. son, mother, neighbor, friend, etc.).

Request deletion of this question set.

M

15a. List all US states where you (your child) might have purchased or eaten foods. This includes airports, bus or train stations.

a. Did not travel outside the U.S.

b. Unknown

Recommend modifying this question to capture dates traveled and foods eaten during travel within the U.S. Many states have been reporting this information in the comments section of the CNHGQ.

14. List all US states, date departed, date returned, and foods eaten where you (your child) might have purchased or eaten foods during the 14 days before onset of illness. This includes airports, bus or train stations.

a. Did not travel outside the U.S.

b. Unknown

M

15b. List all countries outside of the U.S. where you (your child) might have purchased or eaten foods.

a. Did not travel outside the U.S.

b. Unknown

Recommend modifying this question to capture dates traveled and location of stay for persons who traveled internationally. Many states have been reporting this information in the comments section of the CNHGQ.

15. List all countries outside of the U.S., date departed, date returned, and hotel/resort stayed in (if applicable) where you (your child) might have purchased of eaten foods during the 14 days before onset of illness

a. Did not travel outside the U.S.

b. Unknown

D

16b. Do you know of any other ill person(s) who attended the event(s)?

a. Yes b. Maybe c. No d. Don’t know


16c. If yes, please provide information on other ill person(s), including number of ill persons and relationship to you (e.g. son, mother, neighbor, friend, etc.).


Additional comments: _______________________

Request deletion of this question set.


N

N/A

Request addition of this new question to obtain concise, detailed information about other ill person(s) associated with case-patient (previously captured with multiple data elemets, now captured with one question).

17a. If yes/maybe, specify if you (your child) and the other ill person(s):

a. Live in same household

b. Attended same event

c. Traveled together

d. Other, specify: ___________________________

D

The next two questions refer to shopper cards or membership cards for grocery stores and wholesale clubs.

17a. Do you have a shopper card or membership card for any of the grocery stores or wholesale clubs mentioned above?

a. Yes b. Maybe c. No d. Don’t know

Request deletion of this question.


M

17b. If “Yes”, may we have your shopper card number(s)?


Recommend modifying the question to provide further explanation of potential usage of the shopping card number and creating refusal option.

18. *Shopper card #: _________________


*By giving your shopper card number, you are permitting retrieval of information regarding your purchases. This information may be shared with other public health officials to help with outbreak investigations. (refused to give shopper card #)

M

The next two questions list fresh berries eaten at home and/or outside the home 14 days before case-patient illness began.


19. Did you (your child) eat any fresh red raspberries?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

19a. Brand(s):_________________________________

19b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

19c. List name(s) of establishment(s): ______________________

19d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)

Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

30. Did you (your child) eat fresh red raspberries?

a. Yes b. Maybe c. No d. Don’t know

30a. If eaten at home, what was the:

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

30b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)


M

20. Did you (your child) eat any fresh blackberries?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

20a. Brand(s):_________________________________

20b. Place(s) and date(s) of purchase______________

not applicable (did not eat at home)

If eaten outside the home, what was the:

20c. List name(s) of establishment(s): ______________________

20d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)

Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

31. Did you (your child) eat fresh blackberries?

a. Yes b. Maybe c. No d. Don’t know

31a. If eaten at home, what was the:

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

31b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

The next seven questions list leafy greens eaten at home and/or outside the home 14 days before case-patient illness began.


47. Did you (your child) eat any prepackaged salad mix?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

47a. Brand(s), store(s), and date(s) purchased:__________

47b. What were the ingredients (lettuce, cabbage, carrots, etc): _______________________________________


Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

65. Did you (your child) eat other prepackaged salad mix (not previously identified above)??

a. Yes b. Maybe c. No d. Don’t know

65a. What were the:

Ingredients (lettuce, cabbage, carrots, etc):____________

Brand(s):________________________________________

Place(s) purchased (names, locations):________________

M

48. Did you (your child) eat any iceberg lettuce?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

a. Prepackaged b. Loose c. Topping/Garnish d. Unknown

48a. Brand(s):_________________________________

48b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

48c. List name(s) of establishment(s): ______________________

48d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

59. Did you (your child) eat iceberg lettuce?

a. Yes b. Maybe c. No d. Don’t know

59a. If eaten at home, what was the:

Type(s): a. Prepackaged b. Loose c. Topping/Garnish

d. Unknown

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

59b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

49. Did you (your child) eat any romaine lettuce?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

a. Prepackaged b. Loose c. Topping/Garnish d. Unknown

49a. Brand(s):_________________________________

49b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

49c. List name(s) of establishment(s): ______________________

49d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

60. Did you (your child) eat romaine lettuce?

a. Yes b. Maybe c. No d. Don’t know

60a. If eaten at home, what was the:

Type(s): a. Prepackaged b. Loose c. Topping/Garnish

d. Unknown

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

60b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M/N

50. Did you (your child) eat any mesclun lettuce (aka, spring mix, field greens, baby greens, gourmet salad)?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

50a. Brand(s):_________________________________

50b. Place(s) and date(s) of purchase______________

not applicable (did not eat at home)

If eaten outside the home, what was the:

50c. List name(s) of establishment(s): ______________________

50d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase, reduce the number of additional questions, and add types(s) of mesclun lettuce to provide additional exposure information on fresh produce.

61. Did you (your child) eat mesclun lettuce (aka, spring mix, field greens, baby greens, gourmet salad)?

a. Yes b. Maybe c. No d. Don’t know

61a. If eaten at home, what was the:

Type(s): a. Prepackaged b. Loose c. Topping/Garnish

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

61b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

51. Did you (your child) eat any fresh cabbage?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

a. Red b. Green c. Savoy (aka, curly) d. Napa e. Bok choy

f. Brussels sprouts e. Other/Unknown

51a. Brand(s):_________________________________

51b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

51c. List name(s) of establishment(s): ______________________

51d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

62. Did you (your child) eat fresh cabbage?

a. Yes b. Maybe c. No d. Don’t know

62a. If eaten at home, what was the:

a. Red b. Green c. Savoy (aka, curly) d. Napa e. Bok choy

f. Brussels sprouts e. Other, specify___________________

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

62b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

52. Did you (your child) eat any fresh spinach?

a. Yes b. Maybe c. No d. Don’t know


Request addition of supplemental questions to this question to capture the brand of spinach and the location spinach was purchased/consumed in.

63. Did you (your child) eat fresh spinach?

a. Yes b. Maybe c. No d. Don’t know

63a. If eaten at home, what was the:

Type(s): a. Prepackaged b. Head/ Loose c. Topping/ Garnish d. Unknown

Brand(s): ________________________________________

Place(s) purchased (names, locations):_________________

63b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

N

N/A

Request addition of this new question to capture additional exposure to fresh produce. This produce type was reported in section 4 and in the comments section during previous outbreak season.

65. Did you (your child) eat pre-made, single serving salad (e.g., ready to eat salads with toppings, meats, dressing)?

a. Yes b. Maybe c. No d. Don’t know

65a. What were the:

Ingredients (lettuce, cabbage, carrots, etc.):________________

Brand(s):____________________________________

Place(s) purchased (names, locations):____________________

M

The next three questions list fresh herbs eaten at home and/or outside the home 14 days before case-patient illness began.


54. Did you (your child) eat any fresh basil?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

a. Sweet basil b. Purple basil (i.e., purple leaves and stems) c. Thai basil (i.e., green leaves and purple stems) d. Other/Unknown

54a. Brand(s):_________________________________

54b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

54c. List name(s) of establishment(s): ______________________

54d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)

Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

20. Did you (your child) eat fresh basil?

a. Yes b. Maybe c. No d. Don’t know

20a. If eaten at home, what was the:

Type(s): a. Sweet basil

b. Purple basil (i.e., purple leaves and stems)

c. Thai basil (i.e., green leaves and purple stems)

d. Other, specify:_______________________

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

20b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

55. Did you (your child) eat any fresh cilantro?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

a. Prepackaged b. Loose c. Topping/Garnish d. Unknown

55a. Brand(s):_________________________________

55b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

55c. List name(s) of establishment(s): ______________________

55d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is already collected in Section 4 of the questionnaire.

21. Did you (your child) eat fresh cilantro?

a. Yes b. Maybe c. No d. Don’t know

21a. If eaten at home, what was the:

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

21b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

57. Did you (your child) eat any other fresh herbs (sage, thyme, dill, rosemary, etc)?

a. Yes b. Maybe c. No d. Don’t know


57a. Type(s), variety(-ies), brands(s)?_______________________


Recommend modifying this question set to be formatted into separate exposure questions instead of a free text question; this will better capture specific herb exposures and align with the CRF.

Did you (your child) eat:

23. Fresh oregano?

a. Yes b. Maybe c. No d. Don’t know

24. Fresh thyme?

a. Yes b. Maybe c. No d. Don’t know

25. Fresh mint?

a. Yes b. Maybe c. No d. Don’t know

26. Fresh dill?

a. Yes b. Maybe c. No d. Don’t know

27. Fresh sage?

a. Yes b. Maybe c. No d. Don’t know

28. Fresh rosemary?

a. Yes b. Maybe c. No d. Don’t know

29. Other fresh herbs?

a. Yes b. Maybe c. No d. Don’t know

a. Type(s):___________________________________


M

The next seven questions list fresh vegetables eaten 14 days before case-patient illness began.


65. Did you (your child) eat any fresh, raw peas? (May be shelled or in the pod)

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

a. Garden peas b. Snow peas (i.e., flat, shiny pods containing peas) c. Sugar snap peas (i.e., plump, crisp, edible pods) d. Unknown

e. Other, specify:__________________________

65a. Brand(s):_________________________________

65b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

65c. List name(s) of establishment(s): ______________________

65d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase to prevent redundancy in the CNHGQ and reduce the number of additional questions. Information regarding dates is alerady collected in Section 4 of the questionnaire.

75. Did you (your child) eat fresh, raw peas? (May be shelled or in the pod)

a. Yes b. Maybe c. No d. Don’t know

75a. If eaten at home, what was the:

Type(s): a. Garden peas

b. Snow peas (i.e., flat, shiny pods containing peas)

c. Sugar snap peas (i.e., plump, crisp, edible pods)

d. Unknown

e. Other, specify:__________________________

Brand(s):_________________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

75b. If eaten outside the home, what was the:

List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

58. Did you (your child) eat any cucumbers, zucchini, squash?

a. Yes b. Maybe c. No d. Don’t know


Recommend modification of this question to be divided into 3 separate exposure questions to facilitate data collection and analysis.

Did you (your child) eat:

66. Cucumbers? a. Yes b. Maybe c. No d. Don’t know

67. Zucchini? a. Yes b. Maybe c. No d. Don’t know

68. Squash? a. Yes b. Maybe c. No d. Don’t know


M

59. Did you (your child) eat any bell peppers (green, red, orange, or yellow)?

  1. Yes b. Maybe c. No d. Don’t know


Request addition of this additional question (69a) to obtain details about type(s) of bell peppers to provide additional exposure information.

69. Did you (your child) eat bell peppers?

a. Yes b. Maybe c. No d. Don’t know

69a. Type(s): a. Red b. Green c. Orange d. Yellow e. Unknown

M

69. Did you (your child) eat any raw onions (white, yellow, or red/purple)?

a. Yes b. Maybe c. No d. Don’t know


Request addition of this additional question (79a) to obtain details about type(s) of raw onion to provide additional exposure information.

79. Did you (your child) eat raw onions? (Of note: green onions/scallions are addressed in the next question)

a. Yes b. Maybe c. No d. Don’t know

79a. Type(s): a. White b. Yellow c. Red/Purple d. Unknown

e. Other, specify:_______________

M

71. Did you (your child) eat any fresh tomatoes?

a. Yes b. Maybe c. No d. Don’t know

Request addition of this additional question (81a) to obtain details about type(s) of fresh tomatoes to provide additional exposure information.

81. Did you (your child) eat fresh tomatoes?

a. Yes b. Maybe c. No d. Don’t know

81a. Type(s): a. Red round b. Roma (oval-shaped)

c. Grape/Cherry (bite-sized) d. Unknown

e. Other, specify:_______________

M

72. Did you (your child) eat any fresh salsa?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

72a. Brand(s):_________________________________

72b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

72c. List name(s) of establishment(s): ______________________

72d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase and reduce the number of additional questions.

82. Did you (your child) eat fresh salsa?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

82a. Brands:________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

82b. List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)

M

73. Did you (your child) eat any fresh guacamole?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

73a. Brand(s):_________________________________

73b. Place(s) and date(s) of purchase_______________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

73c. List name(s) of establishment(s): ______________________

73d. List location(s) and date(s) of purchase__________________

not applicable (did not eat outside the home)


Recommend modifying this question set to exclude the date(s) of purchase and reduce the number of additional questions.

83. Did you (your child) eat fresh guacamole?

a. Yes b. Maybe c. No d. Don’t know

If eaten at home, what was the:

83a. Brand(s):________________________

Place(s) purchased (names, locations):_________________

not applicable (did not eat at home)

If eaten outside the home, what was the:

83b. List name of establishment(s) and locations(s):___________

not applicable (did not eat outside the home)



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