Justification for Change & Crosswalk

Emerging Infections Program

Change Request

February 2014

Amy McMillen, MPH

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Office of the Director

1600 Clifton Rd

Atlanta GA 30333

404-639-1045

[email protected]

Background

The National Center for National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) of the Centers for Disease Control and Prevention (CDC) is requesting approval of changes to four data collection forms that have previously been approved under OMB no. 0920-0978; expiration date 8/31/2016.

These forms are used to conduct surveillance to determine the incidence and epidemiologic characteristics of invasive disease due to Haemophilus influenzae, Neisseria meningitidis, group A Streptococcus, group B Streptococcus, Streptococcus pneumoniae, methicillin-resistant Staphylococcus aureus, Legionella spp., specific foodborne diseases that is captured within FoodNet and Influenza (specifically for the All Age Influenza Hospitalization Surveillance (Flu Hosp) project).

The forms for which approval for changes are being sought include:

1. 2014 ABCs Case Report Form — (Attachment 1)

2. 2014 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form — (Attachment 2 )

3. 2014 ABCs Neonatal Infection Expanded Tracking Form — (Attachment 3 )

4. 2014 ABCs Legionellosis Case Report Form — (Attachment 4)

5. 2014 FoodNet Variable list — (Attachment 5)

6. 2013-14 FluSurv-NET Influenza Surveillance Project Case Report Form — (Attachment 6)

7. 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey — (Attachment 7)

8. 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey (Spanish) — (Attachment 8)

9. 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form — (Attachment 9)

10. 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form (Spanish) — (Attachment 10)

Description of Changes

Minor changes are being requested for the 2014 ABCs Case Report Form, the 2014 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form, the 2014 Neonatal Infection Expanded Tracking Form and the 2014 ABCs Legionellosis Case Report Form in order to streamline and enhance disease surveillance for the pathogens under surveillance.

Minor changes are being requested for the 2014 FoodNet Variable list in order to improve disease surveillance under FoodNet surveillance.

Minor changes are being requested for the 2013-14 FluSurv-NET Influenza Surveillance Project Case Report Form, 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey, 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey (Spanish), 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form, 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form (Spanish) to improve surveillance of hospitalized cases affected by influenza.

The changes from the previously approved forms are minimal and the addition of forms translated to Spanish will not result in a change to previously estimated burden hours, as per communication with surveillance officers (form respondents).

Detailed Description of Changes

1. 2014 ABCs Case Report Form changes include:

1. Question 27: Underlying conditions or prior illnesses

   • Two checkboxes, ‘Chronic Renal Insufficiency’ and ‘Renal Failure/Dialysis’ have been removed.

   • Two checkboxes, ‘Chronic Kidney Disease’ and ‘Current Chronic Dialysis’ were added to distinguish between persons with underlying renal conditions that do or do not require dialysis.

2. Question 30, ‘Is patient currently attending college?’ has been moved to the left to be better grouped with other questions specific to cases of N. meningitidis.

2. 2014 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form changes include:

   1. The order of the questions have been reordered to improve logic flow and shading added to indicate core variables

   2. Question 18: Supplemental Pneumonia Questions, has been removed.

   3. Hospital discharge date was moved to question on patient outcome.

   4. New question added, ‘If yes, (to culture collected > 3 days after hospital admission) was the case selected for full CRF based on sampling frame 1:10?’

   5. Modified question on BMI- added text’ (do not calculate, only if available in the MR).’

   6. Underlying conditions

      • Changed ‘AIDS or CD4 count < 200’ to ‘AIDS’

      • Changed ‘Chronic Renal Insufficiency’ to ‘Chronic Kidney Disease’

      • Added checkbox for ‘Chronic Cognitive Deficit’, to more closely match the Charlson co-morbidity index.

   7. Changed title of question from ‘Classification – Healthcare-associated and community-associated’ to ‘Prior healthcare exposure – Healthcare associated and community-associated’.

3. 2014 ABCs Neonatal Infection Expanded Tracking Form changes include:

   1. Question 9: new question 9c. added; ‘Were any ICD-10 codes reported in the discharge diagnosis of the infant’s chart? This was added to capture ICD-10 codes.

   2. Question 9: new question 9d. added ; ‘If yes, were any of the following ICD-10 codes reported in the discharge diagnosis of the chart?’ This was added to capture ICD-10 codes.

   3. Question 19: will no longer indent ‘If delivery was by C-section…’. This will be left aligned to match the rest of the form’s questions.

   4. Question 26: An unknown checkbox was added for unknown dates of prenatal care visits, to indicate that the question was reviewed and data was missing.

4. 2014 ABCs Legionellosis Case Report Form changes include:

   1. Question 22: Discharge diagnosis; we are adding ICD-10 codes to the appropriate variables capturing ICD-9 codes, where matching ICD-10 codes exist.

   2. Question 23: Underlying conditions or prior illnesses

      • Two checkboxes, ‘Chronic Renal Insufficiency’ and ‘Renal Failure/Dialysis’ have been removed.

      • Two checkboxes, ‘Chronic Kidney Disease’ and ‘Current Chronic Dialysis’ were added to distinguish between persons with underlying renal conditions that do or do not require dialysis.

5. 2014 FoodNet Variable list changes include:

   1. Variable 2: Expanded the list of responses for ‘AgClinicTestType’ to reflect new tests that are now being used in clinical labs.

   2. Variables 80 & 81: Added two new variables (‘DXO157’ and ‘DXO157TestType’) related to culture-independent testing for STEC.

   3. Variables 10-57: Added new variables to capture case exposure information to be used for attribution estimates. These variables were developed by a working group consisting of CDC and state health department sites over a two-year period. Variables were pilot-tested in 4 sites for a three-month period for Salmonella and Campylobacter cases. These variables are already being captured by state health departments on their state forms.

6. 2013-14 FluSurv-NET Influenza Surveillance Project Case Report Form

   1. To better characterize the types of FluSurv-NET cases, a question has been added to differentiate between patients admitted to the hospital versus those who are kept under observation for 24 hours or more.

   2. To better classify patient’s residence before hospitalization, we have replaced the long term care facility information open text fields and replaced them with checkboxes of the most common responses for residence prior to hospitalization.

   3. Question regarding whether or not patient worked in the healthcare industry has been removed.

   4. To better capture information regarding symptoms at the time of admission, question E2 “Reason for current admission” has been rephrased to “Acute conditions at admission”.

   5. To better understand high risk behaviors associated with influenza hospitalizations, questions regarding previous and current smoking status and previous and current alcohol abuse have been added

   6. A question has been added for the patient’s total number of ICU admissions during current hospitalization to better capture the history of the hospitalization since a patient may have more than one admission to state forsmthe ICU.

   7. The antiviral treatment section of the case report form has been reformatted to better capture treatment information, including method of administration and multiple series of medications

   8. The options for terms abstracted from radiographic reports were modified slightly to harmonize with other surveillance tools already in use in similar catchment areas.

   9. The options available for discharge locations have been modified to make the form consistent with the information encountered by the surveillance officers when abstracting data from medical charts.

   10. Vaccination history for mothers of patients < 6 months of age will no longer be collected.

   11. The section on vaccination status was simplified. We will capture vaccination status according to each data source used at the surveillance area and vaccine type will no longer be collected.

   12. Pneumococcal vaccination status will no longer be collected.

7. 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey

   1. To reflect changes made in the 2013-14 FluSurv-NET Influenza Surveillance Project Case Report Form, the 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey was simplified.

      • Vaccination history for mothers of patients < 6 months of age will no longer be collected.

      • The vaccine type will no longer be collected.

      • Pneumococcal vaccination status will no longer be collected.

8. 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey (Spanish)

   1. To better obtain surveillance information of Spanish-speaking individuals, the 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey has been translated into Spanish.

9. 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form

   1. Instructions on where to proceed after the interviewee consents to the continuation of the interview has been changed to better reflect this season’s instructions.

10. 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form (Spanish)

    1. To better obtain surveillance information of Spanish-speaking individuals, the 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form has been translated into Spanish.

Cross walk of 2014 form changes

1. 2014 ABCs Case Report Form

Question on 2013 form	Question on 2014 form
27. Underlying conditions 1 □ Chronic Renal Insufficiency 1 □ Renal Failure/Dialysis	27. Underlying conditions 1 □ Chronic Kidney Disease 1 □ Current Chronic Dialysis

2. 2014 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form

Question on 2013 form	Question on 2014 form
18. Supplemental Pneumonia Questions. Please complete if the patient was determined to have pneumonia per question 15a (Timeframe of interest: within +/- 3 calendar days of initial culture)	Removed
9. Was the patient hospitalized, at the time of, or in the 30 calendar days, after initial culture? 1 □ Yes 2 □ No 9 □ Unknown If yes, date of admission: MM/DD/YYYY Date of discharge: MM/DD/YYYY	18. Patient Outcome 9 □ Unknown 1 □ Survived Date of discharge: MM/DD/YYYY 2 □ Died Date of death: MM/DD/YYYY
17. Classification – Healthcare-associated and community-associated: (Check all that apply) 1 □ Culture collected >3 calendar days after hospital admission.	11. Was culture collected >3 calendar days after hospital admission? 1 □ Yes (HO-MRSA case) 2 □ No (Complete CRF, CA-MRSA or HACO-MRSA case) If yes, was the case selected for full CRF based on sampling frame 1:10? 1 □ Yes (Complete CRF) 2 □ No (STOP data abstraction)
8f. BMI: _____ □ unknown	12e. BMI: _____ (do not calculate, only if available in MR) □ unknown
16. Underlying conditions 1 □ AIDS or CD4 count <200 1 □ Chronic Renal Insufficiency	20. Underlying conditions 1 □ AIDS 1 □ Chronic Renal Disease 1 □ Chronic Cognitive Deficit
17. Classification – Healthcare-associated and community-associated: (Check all that apply)	21. Prior Healthcare Exposure - Healthcare-associated and community-associated: (Check all that apply)

3. 2014 ABCs Neonatal Infection Expanded Tracking Form

Question on 2013 form	Question on 2014 form
N/A	9c. Were any ICD-10 codes reported in the discharge diagnosis of the infant’s chart?
N/A	9d. IF YES, were any of the following ICD-10 codes reported in the discharge diagnosis of the chart? (Check all that apply) 1 □ B36: Bacterial sepsis of newborn 1 □ B36.0: Sepsis of newborn due to streptococcus, group B 1 □ B36.1: Sepsis of newborn to other and unspecified streptococci 1 □ B95.1: Streptococcus, group b as the cause of diseases classified elsewhere 1 □ A40.1: Sepsis due to streptococcus, group B 1 □ A40.9: Streptococcus sepsis, unspecified 1 □ B95.5: Unspecified streptococcus as the cause of diseases classified elsewhere 1 □ G00.2: Streptococcal meningitis
26. Please record the following: the total number of prenatal visits AND the first and last visit dates to the prenatal provider as recorded in the labor and delivery chart. No. of visits: ___ First visit: MM/DD/YYYY Last visit: MM/DD/YYYY	26. Please record the following: the total number of prenatal visits AND the first and last visit dates to the prenatal provider as recorded in the labor and delivery chart. No. of visits: ___ First visit: MM/DD/YYYY Last visit: MM/DD/YYYY 1 □ Unknown

4. 2014 ABCs Legionellosis Case Report Form

Question on 2013 form	Question on 2014 form
22. Discharge diagnosis 1 □ 482.84 (Legionnaire’s disease) 1 □ 482 (Other bacterial pneumonia) 1 □ 482.3 (Pneumonia due to other specified bacteria) 1 □ 482.83 (Other gram-negative bacteria) 1 □ 482.89 (Pneumonia due to other specified bacteria) 1 □ 482.9 (Bacterial pneumonia unspecified) 1 □ 483 (Pneumonia due to other specified organism) 1 □ 483.8 (Pneumonia due to other specified organism) 1 □ 484 (Pneumonia in infectious diseases classified elsewhere) 1 □ 484.8 (Pneumonia in infectious diseases classified elsewhere) 1 □ 485 (Bronchopneumonia, organism unspecified) 1 □ 486 (Pneumonia, organism unspecified) 1 □ None of these listed 1 □ No ICD-9 codes in chart	22. Discharge diagnosis 1 □ 482.84/A48.1 (Legionnaire’s disease) 1 □ 482 (Other bacterial pneumonia) 1 □ 482.3 (Pneumonia due to other specified bacteria) 1 □ 482.83/J15.6 (Other gram-negative bacteria) 1 □ 482.89/J15.8 (Pneumonia due to other specified bacteria) 1 □ 482.9/J15.9 (Bacterial pneumonia unspecified) 1 □ 483 (Pneumonia due to other specified organism) 1 □ 483.8/J16.8 (Pneumonia due to other specified organism) 1 □ 484 (Pneumonia in infectious diseases classified elsewhere) 1 □ 484.8/J17 (Pneumonia in infectious diseases classified elsewhere) 1 □ 485/J18.0 (Bronchopneumonia, organism unspecified) 1 □ 486/J18.9 (Pneumonia, organism unspecified) 1 □ None of these listed 1 □ No ICD codes in chart
23. Underlying conditions 1 □ Chronic Renal Insufficiency 1 □ Renal Failure/Dialysis	23. Underlying conditions 1 □ Chronic Kidney Disease 1 □ Current Chronic Dialysis

5. 2014 FoodNet Variable list

Variable list 2012	Variable list 2014
2. AgClinicTestType 1 □ Immunocard STAT! EHEC (Meridian); 1 □ Duopath Verotoxins (Merck); 1 □ Premier EHEC (Meridian); 1 □ ProSpecT STEC (Remel); 1 □ VTEC Screen (Denka Seiken); 1 □ ImmunoCard STAT! Crypto/Giardia (Meridian); 1 □ XPect Cryptosporidium (Remel); 1 □ XPect Crypto/Giardia (Remel); 1 □ ColorPAC Crypto/Giardia (Becton Dickinson); 1 □ ProSpecT Cryptosporidium (Remel); 1 □ ProSpecT Crypto/Giardia (Remel); 1 □ Wampole EIA Cryptosporidium; 1 □ TechLab EIA Cryptosporidium; 1 □ Crypto CELISA (Cellabs); 1 □ Para-TECT Crypto Antigen 96 (Medical Chemical Corporation); 1 □ Triage parasite panel (BioSite) ProSpecT Campylobacter assay (Remel); 1 □ PREMIER™ CAMPY assay (Meridian); 1 □ ImmunoCard STAT! CAMPY (Meridian); 1 □ Xpect Campylobacter assay (Remel); 1 □ Other; 1 □ Unknown	2. AgClinicTestType 1 □ Alere Shiga Toxin Quik Chek 1 □ Immunocard STAT! EHEC (Meridian); 1 □ Duopath Verotoxins (Merck); 1 □ Premier EHEC (Meridian); 1 □ ProSpecT STEC (Remel); 1 □ VTEC Screen (Denka Seiken); 1 □ Alere Giardia/Crypto Quik Chek 1 □ ImmunoCard STAT! Crypto/Giardia (Meridian); 1 □ XPect Cryptosporidium (Remel); 1 □ XPect Crypto/Giardia (Remel); 1 □ ColorPAC Crypto/Giardia (Becton Dickinson); 1 □ ProSpecT Cryptosporidium (Remel); 1 □ ProSpecT Crypto/Giardia (Remel); 1 □ Wampole EIA Cryptosporidium; 1 □ TechLab EIA Cryptosporidium; 1 □ Crypto CELISA (Cellabs); 1 □ Para-TECT Crypto Antigen 96 (Medical Chemical Corporation); 1 □ Triage parasite panel (BioSite) ProSpecT Campylobacter assay (Remel); 1 □ PREMIER™ CAMPY assay (Meridian); 1 □ ImmunoCard STAT! CAMPY (Meridian); 1 □ Xpect Campylobacter assay (Remel); 1 □ Other; 1 □ Unknown
N/A	10. CEA_Beef 11. CEA_Beef_grnd 12. CEA_Beef_out 13. CEA_Beef_unckgrnd 14. CEA_Berries 15. CEA_Bird 16. CEA_Cantaloupe 17. CEA_Cat 18. CEA_Chicken 19. CEA_Chx_grnd 20. CEA_Chx_out 21. CEA_Dairy 22. CEA_Dog 23. CEA_Eggs 24. CEA_Eggs_out 25. CEA_Eggs_unck 26. CEA_Farm_ranch 27. CEA_Fish 28. CEA_Fish_unck 29. CEA_Herbs 30. CEA_Lettuce 31. CEA_Live_poultry 32. CEA_Milk_raw 33. CEA_Odairy_raw 34. CEA_Ountreat_water 35. CEA_Pig 36. CEA_Pocketpet 37. CEA_Pork 38. CEA_Raw_cider 39. CEA_Reptile_amphib 40. CEA_Ruminants 41. CEA_Seafd 42. CEA_Seafd_unck 43. CEA_Sewer_water 44. CEA_Sick_contact 45. CEA_Sick_pet 46. CEA_Softcheese 47. CEA_Softcheese_raw 48. CEA_Spinach 49. CEA_Sprouts 50. CEA_Swim_treat 51. CEA_Swim_untreat 52. CEA_Tomatoes 53. CEA_Turkey 54. CEA_Turkey_grnd 55. CEA_Turkey_out 56. CEA_Watermelon 57. CEA_Well_water Responses for all variables listed above (□Yes; □No; □Unknown)
N/A	80. DXO157 1 □ Positive; 1 □ Negative; 1 □ Not tested
N/A	81. DXO157TestType 1 □ ImmunoCard STAT! O157 (Meridian) 1 □ Diatherix; 1 □ Luminex; 1 □ Metametrix; 1 □ Other

5. 2013-14 FluSurv-NET Influenza Surveillance Project Case Report Form

Question on 2011-12 Form	Question on 2013-14 Form
N/A	C2. Admission Type:  Hospitalization  Observation Only
C12. Was patient a resident of an institutional setting or other chronic care facility prior to hospitalization (e.g., nursing home, prison, long-term care facility)?  Yes  No  Unknown	C13. Where did patient reside at the time of hospitalization? Indicate TYPE of residence.  Private residence  Rehabilitation facility  Group home/Retirement home  Assisted living/Residential care  Homeless/Shelter  Nursing home  Unknown  Other, specify: _____________________
C12a. If yes, indicate TYPE of facility: ____________________	Removed
C13. Does patient work in the healthcare industry?  Yes  No  Unknown	Removed
E2.Reason for current admission (Check all that apply):  Acute respiratory illness  Asthma and/or COPD exacerbation  Pneumonia  Other respiratory or cardiac conditions  Other, neither respiratory nor cardiac conditions  Unknown	E2. Acute conditions at admission (Check all that apply):  Acute respiratory illness  Asthma and/or COPD exacerbation  Fever  Pneumonia  Other respiratory or cardiac conditions  Other, neither respiratory nor cardiac conditions  Unknown
N/A	E7.  Smoker:  Current  Former  No/Unknown
N/A	E8.  Alcohol abuse:  Current  Former  No/Unknown
N/A	F1a. Number of ICU Admissions   _________  Unknown
I1a. If yes, indicate which antiviral medication(s) were used, or check unknown:  Antiviral Medication(s) Unknown	Removed

Question on 2011-12 Form	Question on 2013-14 Form
I1a. If yes, indicate which antiviral medication(s) were used, or check unknown:  Amantadine (Symmetrel)                 Series 1:  [Start Date]   [End Date]     Series 2:  [Start Date]   [End Date]  Rimantadine (Flumadine)                 Series 1:  [Start Date]   [End Date]     Series 2:  [Start Date]   [End Date]  Zanamivir (Relenza)                 Series 1:  [Start Date]   [End Date]     ­[Frequency and Dose] Series 2:  [Start Date]   [End Date]    [Frequency and Dose]  Oseltamivir (Tamiflu)                 Series 1:  [Start Date]   [End Date]     ­[Frequency and Dose] Series 2:  [Start Date]   [End Date]    [Frequency and Dose]  Other, specify: ______________                 Series 1:  [Start Date]   [End Date]     ­[Frequency and Dose] Series 2:  [Start Date]   [End Date]    [Frequency and Dose]	I2a-I5a. Treatment 1-4:  Oseltamivir (Tamiflu)  Zanamivir (Relenza)  Amantadine  (Symmetrel)  Rimantadine (Flumadine)  Other, specify: _______________________________  Unknown
N/A	I2b-I5b.  Method of Administration:   Oral  Intravenous (IV)  Inhaled  Unknown
N/A	I2c-I5c. Start Date: ___/____/____  Start Date Unknown
N/A	I2d-I5d. End Date: ____/____/____  End Date Unknown
N/A	I2e-I5e. Dose _________________  Dose Unknown
N/A	I2f-I5f. Frequency: _________________  Frequency Unknown
J2b. For first abnormal chest x-ray, please check all that apply:  Report not available  Bronchopneumonia/pneumonia  Cannot rule out pneumonia  Air space density/opacity  Consolidation  Interstitial infiltrate  Pleural effusion  Single lobar infiltrate  Multiple lobar infiltrate (unilateral or bilateral)  Other, specify: ______________	J2b. For first abnormal chest x-ray, please check all that apply:  Report not available  Consolidation  Interstitial infiltrate  Air space density/opacity  Atelectasis  Pleural effusion/empyema  Bronchopneumonia/pneumonia  Cavitation  Lobar (NOT interstitial) infiltrate  Cannot rule out pneumonia  ARDS (acute respiratory distress syndrome)  Other

Question on 2011-12 Form	Question on 2013-14 Form
N/A	J2c. Please specify location for bronchopneumonia/pneumonia/consolidation/lobar infiltrate/air space density/opacity:  Single lobar  Multiple lobar (unilateral)  Multiple lobar (bilateral)  Unknown
K3a. If discharged alive, please indicate to where:  Home  Other hospital  Hospice  Long-term care facility  Other, specify: _______________________  Unknown	K2a. If discharged alive, please indicate to where:  Home  Other hospital  Hospice/Home hospice  Homeless/Shelter  Rehabilitation Facility  Group home/Retirement home  Assisted living/Residential Care  Home with Services  Nursing home  Other, specify: _____________________  Unknown
M1. Did patient’s mother receive the influenza vaccine during fall or winter of the current influenza season?  Yes  No  Unknown	Removed
M1a. If yes, specify mother’s vaccine type:  Injected Vaccine – Trivalent inactivated influenza vaccine (TIV)  Nasal Spray – Live attenuated influenza vaccine (LAIV)  Vaccine type unknown	Removed
M2b. If yes, specify patient’s vaccine type:  Injected Vaccine – Trivalent inactivated influenza vaccine (TIV)  Nasal Spray – Live attenuated influenza vaccine (LAIV)  Vaccine type unknown	Removed
M2c. If patient ≥ 18 years and received injected vaccine (TIV), please specify type:  Regular IM  High dose IM  Intradermal  TIV type unknown	Removed
M4. Did patient receive any type of pneumococcal vaccine at any age?  Yes  No  Unknown	Removed

Question on 2011-12 Form	Question on 2013-14 Form
M4a. If yes, please provide dosage date information: Dose 1 ___/ ___/ ___                                Dose 2 ___/ ___/ ___ Dose 3 (Pediatrics Only) ___/ ___/ ___     Dose 4 (Pediatrics Only) ___/ ___/ ___	Removed
M4b. If patient ≥ 65 years, was vaccine received within last five years?  Yes  No  Unknown	Removed

7. 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey

Question on 2011-12 Form	Question on 2013-14 Form
Patients <6 months old: 1) Did [you (if speaking to patient’s mother)/patient’s mother] receive the influenza vaccine during fall or winter of the current influenza season?                  Yes (go to Q1a)                  No (go to Q2)                  Unknown (go to Q2)	Removed
Patients <6 months old: 1a) If yes, what vaccine type did [you/the patient’s mother] receive?                  Shot [Injected vaccine --Trivalent inactivated influenza vaccine (TIV)]                  Spray [Nasal spray -- Live-attenuated influenza vaccine (LAIV)]                  Unknown	Removed
Patients <6 months old: 1b) What type of injected vaccine did [you/patient’s mother] receive?                  Regular IM                  High dose IM                  Intradermal                  TIV type unknown	Removed
Patients <6 months old: 2) At any time, did [your child/patient’s name] receive the pneumonia vaccine [may need to read: pneumococcal, PCV(7), PCV(13), or Prevnar®]?                  Yes                  No                   Unknown	Removed
Patients <6 months old: 2a) Can you tell me the dates [your child's/patient’s name] received the pneumonia vaccine?                 1)   _____-_____-________ [MM-DD-YYYY]                 2)   _____-_____-________ [MM-DD-YYYY]                 3)   _____-_____-________ [MM-DD-YYYY]                 4)   _____-_____-________ [MM-DD-YYYY]	Removed
Patients <6 months old: 3) Can you tell me what is [your child’s/patient’s name] race (check all that apply)?  White  Black or African American  Asian/Pacific Islander  American Indian or Alaska Native  Multiracial, unspecified  Not specified (refused) Are you / they….?  Hispanic or Latino  Non-Hispanic or Latino	Removed
Children>6 months old and Adults: 1b) Did [you/child’s name] receive a shot or was it sprayed into their nose?                  Shot [Injected vaccine --Trivalent inactivated influenza vaccine (TIV)]                  Spray [Nasal spray -- Live-attenuated influenza vaccine (LAIV)]                  Unknown	Removed
Children  >6 months old: 3). At any time, did [you/child’s name] receive the pneumonia vaccine [may need to read: pneumococcal, PCV(7), PCV(13), or Prevnar®]?                  Yes                  No                  Unknown	Removed
Adult Patient: 1b) Did [you/child’s name] receive a shot or was it sprayed into their nose?                  Shot [Injected vaccine --Trivalent inactivated influenza vaccine (TIV)]                  Spray [Nasal spray -- Live-attenuated influenza vaccine (LAIV)]                  Unknown	Removed
Adult Patient: 1c) What type of injected vaccine did [you/patient’s name] receive?                  Regular IM                  High dose IM                  Intradermal                  TIV type unknown	Removed
Adult Patients: 2) At any time, did [you/patient’s name) receive the pneumonia vaccine [may need to read: pneumococcal,  Pneumovax®]?                  Yes                  No                  Unknown	Removed

7. 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey (Spanish)

   1. To better obtain surveillance information of Spanish-speaking individuals, the 2013-14 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey has been translated into Spanish.

7. 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form

Question on 2011-12 Form	Question on 2013-14 Form
Hello.  My name is __________ from the _____[state] Department of Public Health.  May I speak to ______ [patient’s name /parent of [child’s name] ] . We are working with the Centers for Disease Control and Prevention and other health departments to learn more about influenza disease or the flu.  To do this, we are talking to people who have been in the hospital with the flu.  We want to look at things that may affect their illness and whether they were vaccinated against the flu.   Because you/your child [or NAME if speaking with proxy] were in the hospital for the flu beginning on _______[day admitted], I would like to ask you a few questions about whether you/your child [or NAME if speaking with proxy] received the flu vaccine this season.  This will take about five minutes. Your participation is voluntary and if you choose to refuse it will not affect any medical care or benefits you receive.  All of your responses will be kept confidential as much as the law allows.  You may refuse to answer any questions and may stop at any time.  This information will help [State/Local Health Department] and CDC better describe influenza-associated hospitalizations.  Additionally, this information may help us improve vaccination recommendations for flu and better protect the public’s health.  There is no other benefit to you for answering these questions.  There is also no risk to you.  If you have any questions about the study, you may call _____[state contact] at the Department of Public Health at XXX-XXX-XXXX.  Do you have any questions before I begin? May I continue with this interview?                                 □ Yes                          □ No If YES, go to Appendix D. If NO: Thank you for your time.  Have a good day.	Hello.  My name is __________ from the _____[state] Department of Public Health.  May I speak to ______ [patient’s name /parent of [child’s name] ] . We are working with the Centers for Disease Control and Prevention and other health departments to learn more about influenza disease or the flu.  To do this, we are talking to people who have been in the hospital with the flu.  We want to look at things that may affect their illness and whether they were vaccinated against the flu.   Because you/your child [or NAME if speaking with proxy] were in the hospital for the flu beginning on _______[day admitted], I would like to ask you a few questions about whether you/your child [or NAME if speaking with proxy] received the flu vaccine this season.  This will take about five minutes. Your participation is voluntary and if you choose to refuse it will not affect any medical care or benefits you receive.  All of your responses will be kept confidential as much as the law allows.  You may refuse to answer any questions and may stop at any time.  This information will help [State/Local Health Department] and CDC better describe influenza-associated hospitalizations.  Additionally, this information may help us improve vaccination recommendations for flu and better protect the public’s health.  There is no other benefit to you for answering these questions.  There is also no risk to you.  If you have any questions about the study, you may call _____[state contact] at the Department of Public Health at XXX-XXX-XXXX.  Do you have any questions before I begin? May I continue with this interview?                                 □ Yes                          □ No If YES, go to Appendix F. If NO: Thank you for your time.  Have a good day.
Question on 2011-12 Form	Question on 2013-14 Form
Hello.  My name is __________ from the _____[state] Department of Public Health.  May I speak to ______ [patient’s name /parent of [child’s name] ] . We are working with the Centers for Disease Control and Prevention and other health departments to learn more about influenza disease or the flu.  To do this, we are talking to people who have been in the hospital with the flu.  We want to look at things that may affect their illness and whether they were vaccinated against the flu.   Because you/your child [or NAME if speaking with proxy] were in the hospital for the flu beginning on _______[day admitted], I would like to ask you a few questions about whether you/your child [or NAME if speaking with proxy] received the flu vaccine this season.  This will take about five minutes. Your participation is voluntary and if you choose to refuse it will not affect any medical care or benefits you receive.  All of your responses will be kept confidential as much as the law allows.  You may refuse to answer any questions and may stop at any time.  This information will help [State/Local Health Department] and CDC better describe influenza-associated hospitalizations.  Additionally, this information may help us improve vaccination recommendations for flu and better protect the public’s health.  There is no other benefit to you for answering these questions.  There is also no risk to you.  If you have any questions about the study, you may call _____[state contact] at the Department of Public Health at XXX-XXX-XXXX.  Do you have any questions before I begin? May I continue with this interview?                                 □ Yes                          □ No If YES, go to Appendix D. If NO: Thank you for your time.  Have a good day.	Hello.  My name is __________ from the _____[state] Department of Public Health.  May I speak to ______ [patient’s name /parent of [child’s name] ] . We are working with the Centers for Disease Control and Prevention and other health departments to learn more about influenza disease or the flu.  To do this, we are talking to people who have been in the hospital with the flu.  We want to look at things that may affect their illness and whether they were vaccinated against the flu.   Because you/your child [or NAME if speaking with proxy] were in the hospital for the flu beginning on _______[day admitted], I would like to ask you a few questions about whether you/your child [or NAME if speaking with proxy] received the flu vaccine this season.  This will take about five minutes. Your participation is voluntary and if you choose to refuse it will not affect any medical care or benefits you receive.  All of your responses will be kept confidential as much as the law allows.  You may refuse to answer any questions and may stop at any time.  This information will help [State/Local Health Department] and CDC better describe influenza-associated hospitalizations.  Additionally, this information may help us improve vaccination recommendations for flu and better protect the public’s health.  There is no other benefit to you for answering these questions.  There is also no risk to you.  If you have any questions about the study, you may call _____[state contact] at the Department of Public Health at XXX-XXX-XXXX.  Do you have any questions before I begin? May I continue with this interview?                                 □ Yes                          □ No If YES, go to Appendix F. If NO: Thank you for your time.  Have a good day.

7. 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form (Spanish)

1. To better obtain surveillance information of Spanish-speaking individuals, the 2013-14 FluSurv-NET Influenza Surveillance Project Consent Form has been translated into Spanish.

12