9a ED Chart Review

Human Influenza Surveillance of Health Care Centers in the United States and Taiwan

Attachment 15 -Form9a ED Chart Review

Form1a Screening and Enrollment

OMB: 0925-0715

Document [pdf]
Download: pdf | pdf
Study ID: __ __ __ __ __ __ __ __ __ __
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
Date: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
ED Visit 3
Date: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
ED Visit 4
Date: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
ED Visit 5
Date: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
ED Visit 6
Date: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
ED Visit 7
Date: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
ED Visit 8
Date: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
ED Visit 9
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
01/05/2015

Study ID: __ __ __ __ __ __ __ __ __ __
Visit __ of __
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?
No
Yes
Unknown
4a. If yes, how much? ____________L/min
4b. What was the route?
Nasal cannula
Facemask/non-rebreather
BiPAP/CPAP Intubated
5. Pharyngeal Erythema
6. Cervical lymphadenopathy
7. Altered Mental Status or Confusion

No
No
No

Yes
Yes
Yes

Unknown
Unknown
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%)
9. 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)
Page 2 of 5

Form 9A: ED Chart review

Version 2.0
01/05/2015

Study ID: __ __ __ __ __ __ __ __ __ __
Visit __ of __
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: _______________
9ii. Test 2
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: _______________
9iii. Test 3
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
If yes, please specify influenza type: _______________

Unknown

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)
10b. Parainfluenza (1,2, or 3)
10c. Rhinovirus
10d. Metapneumovirus
10e. Adenovirus

□ No
□ No
□ No
□ No
□ No

□ Yes
□ Yes
□ Yes
□ Yes
□ Yes

□ Unknown
□ Unknown
□ Unknown
□ Unknown
□ 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
Page 3 of 5

Form 9A: ED Chart review

Version 2.0
01/05/2015

Study ID: __ __ __ __ __ __ __ __ __ __
Visit __ of __
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)
12. 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: ___________________
13. 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
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: ______________________

(Key:

14. 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: _____________
Page 4 of 5

Form 9A: ED Chart review

Version 2.0
01/05/2015

Study ID: __ __ __ __ __ __ __ __ __ __
Visit __ of __
Discharge Antibiotic 3 Indication: ______________________
15. Did the subject have a Chest X-ray or a Chest CT performed in the ED?
No
Yes
If yes, based on the official read:
15a. Did it show a pulmonary infiltrate?
No
Yes
15b. Did it show consolidation?
No
Yes
15c. Did it show pleural effusions?
No
Yes
15d. Did the radiologist indicate suspicion of pneumonia?
No
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
18a. If yes, how much? ____________L/min
18b. What was the route?
Nasal cannula
Facemask/non-rebreather
BiPAP/CPAP
19. Did the subject die in the ED?
No
Yes
19a. If yes, date of death: __ __/ __ __ / __ __ __ __ (mm/dd/yyyy)
20. Did the subject have a final diagnosis of
20a. Influenza?
20b. Viral Syndrome or Infection?
20c. Pneumonia?
20d. Myocardial Infarction?
20e. Stroke?

No
No
No
No
No

Yes
Yes
Yes
Yes
Yes

Unknown

Unknown

Intubated
Unknown

Unknown
Unknown
Unknown
Unknown
Unknown

1
2
3
more than three
21. How many final ED diagnoses did the subject have?
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: ___________________
22. 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

Page 5 of 5

Form 9A: ED Chart review

Version 2.0
01/05/2015


File Typeapplication/pdf
File TitleData Collection Forms: Johns Hopkins University and Chang Gung University
SubjectCEIRS Protocol: 14-0076
AuthorRebecca Medina
File Modified2015-04-08
File Created2015-04-08

© 2024 OMB.report | Privacy Policy