Form 27 Attachment 11 Form9a ED Chart Review

               

Form Approved

OMB Number 0925-XXXX

Exp. Date: XX/XX/XXX

Public reporting burden for this form is estimated to average 10 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX). Do not return the completed form to this address.

CEIRS Human Influenza Surveillance Study Form 9A: ED Chart Review - ED Visit

Review the subject’s medical record for the day of enrollment and the subsequent 21 days for visits to the Emergency Department (ED). Each subject will have at least one ED Visit (ED Visit 1), which will be the ED visit during which the subject was enrolled.

Include the date of the ED visit during which the subject was enrolled, how many ED visits did the subject have in the past 21 days? ED visits

Indicate the date of the ED Visit(s):

ED Visit 1 (date of enrollment)

Date: / / (mm/dd/yyyy)

ED Visit 2

ED Visit 3

ED Visit 4

ED Visit 5

ED Visit 6

ED Visit 7

ED Visit 8

ED Visit 9

Date: / / (mm/dd/yyyy) Date: / / (mm/dd/yyyy) Date: / / (mm/dd/yyyy) Date: / / (mm/dd/yyyy) Date: / / (mm/dd/yyyy) Date: / / (mm/dd/yyyy) Date: / / (mm/dd/yyyy) Date: / / (mm/dd/yyyy)

For each ED visit, complete a separate ED Chart Review Form.

Page 1 of 5 Form 9A: ED chart review Version 2.0

ED Chart Review Form

Instructions: For each ED visit, complete an ED Chart Review Form. Each subject will have at least one ED Visit (ED Visit 1), which will be the ED visit during which the subject was enrolled. Add subsequent forms for additional ED visits within 21 days of enrollment, as necessary, numbering sequentially.

ED Visit # _ (Begin with visit 1 for the enrollment visit)

1. ED arrival

Arrival Date: / / (mm/dd/yyyy) Arrival Time (24-hour clock): : (hh:mm)

2. ED departure

Departure Date: __/ / (mm/dd/yyyy) Departure Time (24-hour clock): : (hh:mm)

ED Physical Exam (Initial Exam of ED visit)

3. Initial Vital Signs upon presentation to the ED: (if unknown or not obtained, use “999”)

3a. Temperature: ##.#C (range: 35.0 – 42.0; if unknown use “999.9”) 3b. Pulse: Beats Per Minute (range: 40 - 200)

3c. Respiratory Rate: _ Breaths Per Minute (range: 10 - 30) 3d. Systolic Blood Pressure: mm Hg (range: 60 - 200)

3e. Oxygen Saturation: % (range: 70 - 100)

4. Was oxygen supplementation given at this time?

4a. If yes, how much? _L/min 4b. What was the route?

• No Yes Unknown

Nasal cannula Facemask/non-rebreather BiPAP/CPAP Intubated

5.	Pharyngeal Erythema	No	Yes	Unknown
6.	Cervical lymphadenopathy	No	Yes	Unknown
7.	Altered Mental Status or Confusion	No	Yes	Unknown

ED Laboratory:

8. Please insert the following laboratory values (if obtained while in the ED). Use the first set of laboratory values obtained in the ED: (if unknown or not obtained, use “999”)

8a. pH: (range: 4– 10)

8b. BUN: mg/dL (range: 6 to 20 mg/dL) 8c. Sodium: mEq/L (range: 135 - 145 mEq/L) 8d. Glucose: mg/dL (range: 70 - 180 mg/dL) 8e. Hematocrit: _ % (range: 20 – 70%)

8. Did the subject receive influenza testing in the ED? No Yes Unknown

(Note: This does not including testing done as part of this study protocol)

9a. If yes, how many? influenza tests

For each influenza test, specify the test name, type, result, and the time the test was collected and resulted:

9i. Test 1

Test 1 Name:

Test 1 Type: PCR DFA Culture Antigen Other: Test 1 Result: Negative Positive Other

Test 1 Collection Date: / __/ (mm/dd/yyyy)

9ii. Test 2

9iii. Test 3

Test 1 Collection Time (24-hour clock): __: (hh:mm) Test 1 Result Date: / __/ (mm/dd/yyyy) Test 1 Result Time (24-hour clock): __: (hh:mm)

Was influenza typing performed? No Yes  Unknown If yes, please specify influenza type:

Test 2 Name:

Test 2 Type: PCR DFA Culture Antigen Other: Test 2 Result: Negative Positive Other

Test 2 Collection Date: / __/ (mm/dd/yyyy) Test 2 Collection Time (24-hour clock): __: (hh:mm) Test 2 Result Date: / __/ (mm/dd/yyyy) Test 2 Result Time (24-hour clock): : (hh:mm)

Was influenza typing was performed? No Yes  Unknown If yes, please specify influenza type:

Test 3 Name:

Test 3 Type: PCR DFA Culture Antigen Other: Test 3 Result: Negative Positive Other

Test 3 Collection Date: / __/ (mm/dd/yyyy)

Test 3 Collection time (24-hour clock): : (hh:mm) Test 3 Result Date: / __/ (mm/dd/yyyy) Test 3 Result Time (24-hour clock): __: (hh:mm)

Was influenza typing was performed? No Yes  Unknown If yes, please specify influenza type:

9iv. Test 4

Test 4 Name:

Test 4 Type: PCR DFA Culture Antigen Other: Test 4 Result: Negative Positive Other

Test 4 Collection Date: / __/ (mm/dd/yyyy) Test 4 Collection time (24-hour clock): : (hh:mm) Test 4 Result Date: / __/ (mm/dd/yyyy) Test 4 Result Time (24-hour clock): __: (hh:mm)

Was influenza typing was performed? No Yes  Unknown If yes, please specify influenza type:

10. Was the subject diagnosed with any other viruses? 10a. Respiratory Syncytial Virus (RSV)	No	Yes	Unknown
10b. Parainfluenza (1,2, or 3)	No	Yes	Unknown
10c. Rhinovirus	No	Yes	Unknown
10d. Metapneumovirus	No	Yes	Unknown
10e. Adenovirus	No	Yes	Unknown

ED Course

11. Did subject receive an influenza antiviral in the ED? No Yes  Unknown 11a. If yes, how many antivirals were received? influenza antivirals

11b. For each influenza antivirals received, specify the antiviral name, route of administration, and time influenza antiviral was given.

(Key: PO = by mouth; IN = intranasal; IV = intravenous)

Influenza antiviral 1

Influenza Antiviral 1 Name: _ Influenza Antiviral 1 Route: PO IN  IV

Influenza Antiviral 1 Date administered: __/ __/ (mm/dd/yyyy) Influenza Antiviral 1 Time administered (24-hour clock): : (hh:mm)

Influenza antiviral 2

Influenza Antiviral 2 Name: _ Influenza Antiviral 2 Route: PO IN  IV

Influenza Antiviral 2 Date administered: __/ __/ (mm/dd/yyyy) Influenza Antiviral 2 Time administered (24-hour clock): : (hh:mm)

11. Did the subject receive a prescription for an influenza antiviral upon discharge?

• No Yes Unknown N/A, Subject not discharged

12a. If yes, how many? _ influenza antiviral prescriptions 12b. Please list all influenza antivirals prescribed at discharge (up to two)

Antiviral 1:

Antiviral 2:

11. Did subject receive an antibiotic in the ED? No Yes  Unknown 13a. If yes, how many antibiotics were received? antibiotics

For each antibiotic received, specify the antibiotic name, route of administration, and indication (Key: PO = by mouth; IM = intramuscular; IV = intravenous)

Antibiotic 1

Antibiotic 1 Name: Antibiotic 1 Route: PO IM IV Antibiotic 1 Indication: _

Antibiotic 2

Antibiotic 2 Name: Antibiotic 2 Route: PO IM IV Antibiotic 2 Indication: _

Antibiotic 3

Antibiotic 3 Name: Antibiotic 3 Route: PO IM IV Antibiotic 3 Indication: _

11. Did the subject receive a prescription for an antibiotic upon discharge?

No Yes Unknown N/A, Subject not discharged

14a. If yes, how many? _ antibiotics upon discharge 14b. Please list all antibiotics prescribed at discharge and indication.

Discharge Antibiotic 1

Discharge Antibiotic 1 Name: Discharge Antibiotic 1 Indication: Discharge Antibiotic 2

Discharge Antibiotic 2 Name: Discharge Antibiotic 2 Indication: Discharge Antibiotic 3

Discharge Antibiotic 3 Name:

Discharge Antibiotic 3 Indication:

11. Did the subject have a Chest X-ray or a Chest CT performed in the ED?

If yes, based on the official read:	No	Yes	Unknown
15a. Did it show a pulmonary infiltrate? 15b. Did it show consolidation? 15c. Did it show pleural effusions? 15d. Did the radiologist indicate suspicion of pneumonia?	No No No No	Yes Yes Yes Yes	Unknown Unknown Unknown Unknown
16. Was the subject intubated in the ED?	No	Yes	Unknown
17. Did the patient receive BiPAP or CPAP in the ED?	No	Yes	Unknown

18. When the subject left the ED did they require supplemental oxygen?

No Yes Unknown

18a. If yes, how much? L/min 18b. What was the route?

Nasal cannula Facemask/non-rebreather BiPAP/CPAP Intubated

18. Did the subject die in the ED? No Yes  Unknown 19a. If yes, date of death: / / (mm/dd/yyyy)

18. Did the subject have a final diagnosis of

20a. Influenza?	No	Yes	Unknown
20b. Viral Syndrome or Infection?	No	Yes	Unknown
20c. Pneumonia?	No	Yes	Unknown
20d. Myocardial Infarction?	No	Yes	Unknown
20e. Stroke?	No	Yes	Unknown

18. How many final ED diagnoses did the subject have? 1 2 3 more than three List the ICD-9 codes for up to the first few final ED Diagnoses, up to the first three:

(Do not list E or V codes)

21a. Final ED Diagnosis Code 1: 21b. Final ED Diagnosis Code 2: 21c. Final ED Diagnosis Code 3:

18. What was the final subject disposition for this ED visit?

ADMIT DISCHARGE ELOPE^ OTHER

^Elope includes elopement and left without being seen or against medical advice

22a. If other, please specify: _

24. If this subject had a final disposition of discharge, at any time during this ED visit were they placed in Observation?

No Yes Unknown

For each additional ED Visit, as applicable, complete another ED Visit Chart Review form