Form 16 Attachment 10 Form 8a Follow Up Assessment

Form Approved
OMB Number 0925-XXXX
Exp. Date: XX/XX/XXX

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Study ID:
CEIRS Human Influenza Surveillance Study
Form 8A: Follow-up Assessment
1. How many attempts were made?
attempts
At most 4 attempts of phone follow-up should be made unless requested otherwise by subject.
Attempt 1:
Date:
Time:

/
/

_/
_/

□ No

Successful Contact:
Attempt 2:
Date:
Time:

/
/

_/
_/

/
/

_/
_/

Successful Contact:
Attempt 4:
Date:
Time:

/
:

□ Yes

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

□ No

Successful Contact:
Attempt 3:
Date:
Time:

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

□ Yes

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

□ No

□ Yes

/
(hh:mm)(24-hour clock)

Successful Contact:

□ No

□ No □ Yes

2. Did the follow-up assessment occur?
If Yes, specify date:

□ Yes

_//

Yes, how did the follow-up occur?

□ In-person

(mm/dd/yyyy) If

□ Telephone

If No, specify reason:
_ Subject unavailable for follow-up
_ Minimum of 4 failed attempts at phone follow-up
_ Contact numbers non-functional
_ Subject requested no further contact
_ Other, specify:
If the Follow-up was performed via the phone, please use the following script:
“Hello Mr. /Ms. (Insert Subject Last Name)
My name is (Insert Research Coordinator Name), I am [calling] from the Emergency Department at (Insert
Name of Medical Center) where you were seen about 3 weeks ago. At that time, you agreed to enroll in
our study on influenza testing in the emergency department. As part of this research study we are
following up with you. The purpose of this call is to get some more information from you regarding your
illness and the outcome.
Are you still willing to answer a few questions?”

□ No □ Yes

If No, stop
If Yes, research coordinator proceeds with the follow-up assessment questions:
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Form 8A: Follow Up

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Study ID:
Follow-up Assessment Questions
1. Have you returned to an Emergency Department since you were enrolled in this study?

□ No

□ Yes

□ Unknown

a. If Yes, how many times?
What was the approximate date and the reason you came to the ED? (Record up to 3 visits):
ED Visit 1

□ JHH
□ BVMC
□ Linkou
□ Keelung □ Other □ Unknown

Which ED was it?

Date:
Reason:

/

/

□ Taipei

(mm/dd/yyyy)

ED Visit 2

□ JHH
□ BVMC
□ Linkou
□ Keelung □ Other □ Unknown

Which ED was it?

Date:
Reason:

/

/

□ Taipei

(mm/dd/yyyy)

ED Visit 3

□ JHH
□ BVMC
□ Linkou
□ Keelung □ Other □ Unknown

Which ED was it?

Date:
Reason:

/

/

□ Taipei

(mm/dd/yyyy)

2. Have you been admitted to the hospital (stayed overnight) since you were enrolled in this study?

□ No

□ Yes

□ Unknown

a. If Yes, how many times?
What was the approximate date and the reason for your hospitalizations? (Record up to 3 visits):
Hospitalization 1
Admit Date:
Reason:
Length of Stay
Hospitalization 2
Admit Date:
Reason:
Length of Stay
Hospitalization 3
Admit Date:
Reason:
Length of Stay

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/

/

(mm/dd/yyyy)

/

/

(mm/dd/yyyy)

/

/

(mm/dd/yyyy)

Form 8A: Follow Up

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Study ID:

3. Following the ED visit during which you were enrolled in this study, did you receive any antiviral medications
to treat influenza? (Note: Do not include any antiviral medications that were prescribed during the initial ED

□ No

visit)

□ Yes

□ Unknown

a. If yes, What influenza antirviral treatment did you take?

□ Zanamavir
□ Oseltamivir
□ Amantadine
□ Rimantadine
□ Other, specify;
□ Unknown
□ None

_

b. If yes, Date antiviral was started:
Duration taken for:
days

/

/

(mm/dd/yyyy)

4. Following the ED visit during which you were enrolled in this study, did you receive any antibiotic
medications? (Note: Do not include any antibiotic medications that were prescribed during the initial ED
visit)

□ No
a. If yes, how many did you take?
Antibiotic 1
Name of antibiotic received:
Date antibiotic was started:
/
Duration taken for:
_ days
Antibiotic 2
Name of antibiotic received:
Date antibiotic was started:
/
Duration taken for:
days
Antibiotic 3
Name of antibiotic received:
Date antibiotic was started:
/
Duration taken for:
days

□ Yes

□ Unknown

_ (Record up to three)

/

/

/

5. Have you been diagnosed with a heart attack since you were enrolled in this study?

□ No

□ Yes

□ Unknown

6. Have you been diagnosed with a stroke since you were enrolled in this study?

□ No
a. If yes, date of stroke diagnosis:

/

□ Yes
/

□ Unknown
(mm/dd/yyyy)

7. Have you been diagnosed with pneumonia since you were enrolled in this study?

□ No
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□ Yes
Form 8A: Follow Up

□ Unknown
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Study ID:
Follow up Blood (Serum) Sample
Blood (Serum) Sample:

□ Collected
□ Patient refused: Reason
□ Phone follow up – unable to obtain successful contact
□ Coordinator Unable to Obtain: Reason
□ Other:
_

_

_

If collected:

Collection:
Date:
/
/
Time:
:
(hh:mm) (24-hour clock)
Coordinator initials:
Placed in refrigerator:
Date:
/
/
Time:
:
(hh:mm) (24-hour clock)
Coordinator initials:
Final sample processing:
Date:
/
/
Time:
:
(hh:mm) (24-hour clock)
Coordinator initials:

Subject notes:

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Form 8A: Follow Up

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