Electronic Supplementary Material 1: Case (and control ...10.1007/s40264-017-0583... · episode Age...
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Electronic Supplementary Material 1: Case (and control) Report Form Article title: Antidepressant-induced acute liver injury: a case-control study among Italian inpatient population Journal name: Drug Safety Author names: Carmen Ferrajolo, Cristina Scavone, Monia Donati, Oscar Bortolami, Giovanna Stoppa, Domenico Motola, Alfredo Vannacci, Alessandro Mugelli, Roberto Leone, Annalisa Capuano, on behalf of DILI-IT Study Group Corresponding author: Carmen Ferrajolo Department of Experimental Medicine, Unit of Clinical Pharmacology, Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, University of Campania “Luigi Vanvitelli”, via de Crecchio 7, 80138, Naples, Italy;article title, [email protected] QUESTIONNAIRE FOR CASES To fill in by monitor Sender Hospital Code: ___________ Monitor code*: ______________ Identificative case number (progressive numeration): * If for some reason the interview was not performed by the monitor, indicate the name of the interviewer:________________________________________________________________________ Index date: ________ / ________ / _________ For items with asterisk data must derive from the patient’s clinical record Patient initials* (name first): Nosographic n.*: City of residence: _____________________________ Residence time: Phone n. (only if necessary): _________________ Gender: M F Year of birth*: 1 Age: Years of study: Years Months
Transcript of Electronic Supplementary Material 1: Case (and control ...10.1007/s40264-017-0583... · episode Age...
Electronic Supplementary Material 1: Case (and control) Report Form
Article title: Antidepressant-induced acute liver injury: a case-control study among Italian inpatient
population
Journal name: Drug Safety
Author names: Carmen Ferrajolo, Cristina Scavone, Monia Donati, Oscar Bortolami, Giovanna
Stoppa, Domenico Motola, Alfredo Vannacci, Alessandro Mugelli, Roberto Leone, Annalisa Capuano,
on behalf of DILI-IT Study Group
Corresponding author: Carmen Ferrajolo
Department of Experimental Medicine, Unit of Clinical Pharmacology, Campania Regional Center of
Pharmacovigilance and Pharmacoepidemiology, University of Campania “Luigi Vanvitelli”, via de
Crecchio 7, 80138, Naples, Italy;article title,
QUESTIONNAIRE FOR CASES
To fill in by monitor
Sender Hospital Code: ___________ Monitor code*: ______________
Identificative case number (progressive numeration):
* If for some reason the interview was not performed by the monitor, indicate the name of the
interviewer:________________________________________________________________________
Index date: ________ / ________ / _________
For items with asterisk data must derive from the patient’s clinical record
Patient initials* (name first): Nosographic n.*:
City of residence: _____________________________ Residence time:
Phone n. (only if necessary): _________________ Gender: M F
Year of birth*: 1 Age: Years of study:
Years
Months
Weight*(Kg): High* (cm): BMI (automatically computed):
day month year day month year
Date of inpatient admission*: Date of Interview:
Admission diagnoses*:
1. _________________________________________________________________________
2. _________________________________________________________________________
Presence of symptoms*: NO YES
If YES, please specify signs and symptoms*:____________________________________________
________________________________________________________________________________
day/ month/ year
Liver function tests* (as alternative, enclosing a copy): Date of blood sampling*:
ALT: __________ (U/L) AST: __________ (U/L) gammaGT: ______ (U/L)
ALP: _______ (U/L) Total bilirubin: _______ (mg/dl) Conjugated bilirubin: ___(mg/dl)
Transfer from another hospital* NO YES NA
if YES, please indicate: day/ month/ year
Hospital*: ______________________________ Date of inpatient admission
When was the last date of admission in an Hospital, Emergency Department or a Day Hospital?
day/ month/ year day/ month/ year
Date of admission: Date of discharge:
Previous reason of hospital admission: ________________________________________________
Description of the current disease, according to the patient:_________________________________
________________________________________________________________________________
Did you have any of the following symptoms before the hospital admission?
asthenia NO YES NA Starting date: _____/____/_____
Easy fatigue NO YES NA Starting date: _____/____/_____
Joint/muscle pain NO YES NA Starting date: _____/____/_____
Fever NO YES NA Starting date: _____/____/_____
Headache NO YES NA Starting date: _____/____/_____
nausea NO YES NA Starting date: _____/____/_____
vomiting NO YES NA Starting date: _____/____/_____
Lack of appetite NO YES NA Starting date: _____/____/_____
dyspnea/respiratory failure NO YES NA Starting date: _____/____/_____
cutaneous eruption NO YES NA Starting date: _____/____/_____
Jaundice NO YES NA Starting date: _____/____/_____
Itch NO YES NA Starting date: _____/____/_____
Abdominal pain NO YES NA Starting date: _____/____/_____
Abdominal bloating NO YES NA Starting date: _____/____/_____
Pale stools NO YES NA Starting date: _____/____/_____
Dark urine NO YES NA Starting date: _____/____/_____
During your life you had:
Age at first
episode
Age at last
episode
N. episodes
1. Hepatic disorders NO YES NA
Do you rember the type of problem?
2. Hepatitis NO YES NA
3. Cholelithiasis NO YES NA
4. Hepatic cirrhosis NO YES NA
5. Nodule in liver NO YES NA
6. Other hepatic diseases NO YES NA
If YES, please specify the other hepatic diseases:
___________________________________________________________
Did you have a hospital admission? NO YES (if YES specifiy the date)
day / month/ year day/ month/ year
Date of last hospitalization: Date of discharge:
7. Do you know if your hepatic disease was drug-related?
NO YES NA
Date of onset: ________/________/________
8. If YES, which drug/drugs: _______________________________________________ NA
9. Have you ever suffered from cardiac diseases?
NO YES NA
Age at first
episode
Age at last
episode
N. episodes
10. Myocardial infarction NO YES NA
11. Angina pectoris NO YES NA
12. Heart failure NO YES NA
13. Cardiac arrhythmias NO YES NA
14.Have you ever had a cardiac
surgery?
NO YES NA
15. Stent NO YES NA
16. Angioplasty NO YES NA
17. By-pass NO YES NA
18. Other cardiac diseases or
cardiac surgeries
NO YES NA Specify:
Confirm the surgery by checking the clinical records; if it does not coincide, specify below the
information in the folder:
day / month/ year
Date of surgery:
19. Indication for surgery: ____________________________________________
Have you ever suffered of:
Age at first
episode
Age at last
episode
N. episodes
20. Cerebrovascular damage
(cerebral embolism)
NO YES NA
21. Transient ischemic damage NO YES NA
22. Gout NO YES NA
23. Anemia NO YES NA
24. Claudicatio intermittens NO YES NA
25. Cerebrovascular failure NO YES NA
26. Hypertension NO YES NA
27. Dyslipidemie NO YES NA
28. Diabetes mellitus NO YES NA
29. Other endocrine diseases NO YES NA Specify::
30. Kidney disease NO YES NA Specify:
31. Chronic rheumatic disease NO YES NA Specify:
32. Nervousness, anxiety, tension in
the last three months
NO YES NA
33. Other chronic diseases and/or
major surgeries
NO YES NA If YES, please specify which and the age
34.
35.
36.
37.
38.
LIFESTYLE HABITS
Do you smoke? (cross the right box)
Non smoker
Former smoker: How long have you stopped smoking?
Smoker (If smoker or former smoker for < 3 months, cross the subsequent boxes)
Cigarettes; n./day: Cigars; n./day: Pipe; packets/month:
Do you drink………? (Using the code at the end of the page)
Consumption^ Last time
(days)1
Frequency* N./day N./day
(weekend)3
Caffee
Decaffeinated
Tea
Green tea
Wine (glasses)
Beer2
Liquors
1Only for current drinker (consumption code 08);
2small size beer(33ml)= 1; medium size= 2; large size= 3
3 Fill in only if there are differences between the weekend and the other days
^ Consumption codes * Frequency codes
07 Never drunk 1 Every day
08 Current drinker (last consumption in the last three
months)
2 4-6 days/wee
10 Former drinker for less than 1 year 3 1-3 days/week
11 Former drinker for more than 1 year 4 One or more days/month
99 Unknown 5 Less than once at month
6 Only for the weekend
9 Unknown
Years ago
Months ago
Pharmacological anamnesis
fre
q1
23
45
67
fre
q1
23
45
67
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qfr
eq
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NN
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DD
WY
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YW
M
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NA
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NA
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e
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icat
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sub
stan
ce n
ame
trad
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nam
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dru
g
form
ula
tio
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last
use
do
seLa
st u
sed
ura
tio
n
mo
nth
s 2
- 3
(day
s 29
-90)
Fre
qw
ee
k 3
we
ek
4w
ee
k 2
DA
YD
AY
we
ek
1
Did you use herbal medicines, food supplements, or homeopathic products in the last months
(preceding the index date)?
NO YES NA
If YES, do you know the product name? (using also a picture of the product)
___________________________________________________________________________________
___________________________________________________________________________
Unknown
Have you ever taken a medicine that you would not take anymore because it has caused or could cause
liver damage?
NO YES NA
If YES, which drugs:
1. _____________________________________________ Starting date _____/____/____
2. _____________________________________________ Starting date _____/____/____
Unknown
Have you ever decreased the the dosage or the frequency of a medicine because it has caused or could
cause liver damage?
NO YES NA
If YES, for which drugs:
1. _____________________________________________ Starting date _____/____/____
2. _____________________________________________ Starting date _____/____/____
Unknown
Remarks related to any part of the interview:
_______________________________________________________________________________
________________________________________________________________________________
INTERVIEW INFORMATION
Peaple participating at the interview: interviewed family member caregiver
Main source: patient family member caregiver
Reliability: high medium low
Number of times that patient was contacted (even by telephone): __________
FURTHER INFORMATION FROM CLINICAL RECORDS
At the admission
Hematocrit: __________ Hemoglobin (specify the unit): ____________________
Blood pressure (min/max): _______ / ________ Pulse: __________ beat/min
Albuminemia: __________ Serum creatinine: ____________________
Ammoniemia: _______ Gamma Globulins: _______
Prothrombin time: _______ INR: _______
Examination procedures:
day month year
Report synthesis (as alternative enclose a copy): Date:
1. Abdominal echography
_______________________________________________________________________________
2. Abdominal CT with or without contrast medium
_______________________________________________________________________________
3. ERCP (Endoscopic Retrograde Cholangiopancreatography)
_______________________________________________________________________________
4. MRCP (Magnetic Resonance Cholangiopancreatography)
_______________________________________________________________________________
5. PET
_______________________________________________________________________________
INFORMATION FROM CLINICAL RECORD AFTER DISCHARGE
Discharge diagnoses:
1. ___________________________________________________________________________
2. ___________________________________________________________________________
3. ___________________________________________________________________________
4. ___________________________________________________________________________
Surgeries:
1. ___________________________________________________________________________
2. ___________________________________________________________________________
Hepatic biopsy: NO YES date: _____/______/______
Outcome of biopsy: _________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Discharge
Outcome of disease: date:
_____/______/______
Death
In case of death, autopsy: NO YES NA
Notes regarding discharge or death: ___________________________________________________
________________________________________________________________________________
________________________________________________________________________________
QUESTIONNAIRE FOR CONTROLS
To fill in by monitor
Sender Hospital Code: ___________ Monitor Code*: ______________
Associate Case Number: Control N.: 1 2 3 4
* If for some reason the interview was not performed by the monitor, indicate the name of the
interviewer:
_________________________________________________________________________
Index date: ________ / ________ / ________
For items with asterisk, the data must derive from the patient's clinical record
Patient initials* (name first): Nosographic n.*:
City of residence: _____________________________ Residence time:
Phone n. (only if necessary): _________________ Gender: M F
Year of birth*: 1 Age: Years of study:
Weight* (Kg): Height * (cm): BMI:
Day Month Year Day Month Year
Date of Inpatient admission*: Date of Interview:
Admission diagnoses*:
6. ___________________________________________________________________________
7. ___________________________________________________________________________
Presence of symptoms*: NO YES
If yes, please specify signs and symptoms *: ____________________________________________________
________________________________________________________________________________
Transferred from another Hospital *: NO YES NA
Years
Months
if YES, please indicate:
Hospital*: ______________________________ Date of inpatient admission
When was the last date of admission in an Hospital, Emergency Department or a Day Hospital?
Day Month Year Day Month Year
Date of admission: Date of discharge:
Previous reason of hospital admission:________________________________________________
Description of the current disease, according to the patient: ________________________________
________________________________________________________________________________
Did you have any of the following symptoms before the hospital admission?
___________________________________________________________________________
In case of Pneumothorax/ Acute pneumonia
Intercostal pain NO YES NA Starting date: ____/____/____
Cough NO YES NA Starting date: ____/____/____
Dyspnea NO YES NA Starting date: ____/____/____
In case of injuries, bites or burns
Date of injury, bite or burn: ____/____/____
Pain NO YES NA Starting date: ____/____/____
Redness NO YES NA Starting date: ____/____/____
Suppuration NO YES NA Starting date: ____/____/____
In the case of a foreign body in the digestive tract
Date of the accident: ____/____/____
Dysphagia NO YES NA Starting date: ____/____/____
Dyspnea NO YES NA Starting date: ____/____/____
nel caso di Appendicitis/testicular torsion/renal colic……
Abdominal pain/scrotal pain NO YES NA Starting date: ____/____/____
nausea NO YES NA Starting date: ____/____/____
fever NO YES NA Starting date: ____/____/____
In case of trauma
Date of the accident: ____/____/____
Vertigo/dizziness before the fall NO YES NA Starting date: ____/____/____
(Control will be excluded if he/she answers yes or does not know)
Headshot with knowledge loss or dizziness (Control will be excluded if he/she answers yes or does not
know)
NO YES NA Starting date: ____/____/____
Pain NO YES NA Starting date: ____/____/____
Functional impotence NO YES NA Starting date: ____/____/____
In case of thyroid nodules
Date of first diagnosis: ____/____/____
Previous interventations NO YES NA
Date of the last interventation: ____/____/____
Does someone tell you to not take medicines before the operation or decided not to take any
pharmacotherapy for her initiative? NO YES NA
If YES, which medicines? NA
1. ____________________________________ Date of the last administration:____________
2. ____________________________________ Date of the last administration:____________
3. ____________________________________ Date of the last administration:____________
4. ____________________________________ Date of the last administration:____________
During your life you had:
Age at first
episode
Age at last
episode
N. episodes
1. Hepatic disorder NO YES NA
Do you remember the type of problem?
2. Hepatitis NO YES NA
3. Cholelithiasis NO YES NA
4. Hepatic cirrhosis NO YES NA
5. Nodule in liver NO YES NA
6. Other hepatic disease NO YES NA
If YES, please specify the other hepatic diseases:
___________________________________________________________
Did you have an hospital admission? NO YES (if YES specify date)
day month year day month year
Date of the last hospitalization: Date of discharge:
7. Do you know if your hepatic disease was drug-related?
NO YES NA
Date of onset: ________/________/________
8. If YES, which drug/drugs: _______________________________________________ NA
9. Have you ever suffered from cardiac diseases?
NO YES NA
Age at first
episode
Age at last
episode
N. episodes
10. Myocardial infarction NO YES NA
11. Angina pectoris NO YES NA
12. Heart failure NO YES NA
13. Cardiac arrhythmias NO YES NA
14.Have you ever had a cardiac
surgery?
NO YES NA
15. Stent NO YES NA
16. Angioplasty NO YES NA
17. By-pass NO YES NA
18. Other cardiac diseases or
cardiac surgery
NO YES NA Specify:
Confirm the surgery by checking the clinical record; If it does not coincide, specify below the
information in the folder:
day month year
Date of surgery:
19. Indication for surgery: ____________________________________________
Have you ever suffered of: Age at first
episode
Age at last
episode
N. episodes
20. Cerebrovascular damage
(cerebral embolism)
NO YES NA
21. Transient ischemic damage NO YES NA
22. Gout NO YES NA
23. Anemia NO YES NA
24. Claudicatio intermittens NO YES NA
25. Cerebrovascular failure NO YES NA
26. Hypertension NO YES NA
27. Dyslipidemia NO YES NA
28. Diabetes mellitus NO YES NA
29. Other endocrine diseases NO YES NA Specify:
30. Kidney disease NO YES NA Specify:
31. Chronic rheumatic disease NO YES NA Specify:
32. Nervousness, anxiety, tension in
the last three months
NO YES NA
33. Other chronic diseases and/or
major surgeries
NO YES NA If YES, please specify which and age
34.
35.
36.
37.
38.
LIFESTYLE HABITS
Do you smoke? (cross the right box)
Non smoker
Former smoker: How long have you stopped smoking?
Smoker (If smoker or former smoker for < 3 months, cross the subsequent boxes)
Cigarettes; n./day: Cigars; n./ day: Pipe; packets/month:
Do you drink………? (Using the code below)
Consumption^ Last time
(in days)1
Frequency* N./day N./day
(weekend)3
Coffee
decaffeinated coffee
The
Green the
Wine (glasses)
Beer2
Liquors
1 Only for current drinkers (consumption code 08);
2small size beer (33ml) = 1; medium size = 2; large size = 3
Years ago
Month ago
3 Fill in only if there are differences between the weekend and the other days
^ Consumption Codes * Frequency Codes
07 Never drunk 1 Every day
08 Current drinker (last consumption in the last 3 months) 2 4-6 days/week
10 Former drinker for less than 1 year 3 1-3 days/week
11 Former drinker for more than 1 year 4 One or more days/month
99 Unknown 5 Less than once at month
6 Only for the weekend
9 Unknown
PHARMACOLOGICAL ANAMNESIS
freq
12
34
56
7fr
eq1
23
45
67
freq
freq
DD
NN
NN
DD
WY
YY
YW
M
MW
NA
NA
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NA
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NA
NA
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MY
DD
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YY
YW
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MW
NA
NA
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DD
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DD
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YW
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NA
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NA
NA
MY
DD
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DD
WY
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YW
M
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NA
NA
NA
NA
MY
DD
NN
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WY
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YW
M
MW
NA
NA
NA
NA
MY
DD
NN
NN
DD
WY
YY
YW
M
MW
NA
NA
NA
NA
MY
DD
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DD
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YY
YW
M
MW
NA
NA
NA
NA
MY
DD
NN
NN
DD
WY
YY
YW
M
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NA
NA
NA
NA
MY
Dat
e
Indi
cati
onsu
bsta
nce
nam
etr
ade
nam
e
drug
form
ulat
ion
last
use
dose
Last
use
dura
tion
mon
ths
2 - 3
(day
s 29
-90)
Freq
wee
k 3
wee
k 4
wee
k 2
DA
YD
AY
wee
k 1
Did you use herbal, food supplements or homeopathic products for the past three months?
NO YES NA
If YES, do you know the product name? (using also of the product)
___________________________________________________________________________________
_____________________________________________________________________________
Unknown
Have you ever taken a medicine that you would not take anymore because it has caused or could cause
liver damage?
NO YES NA
If YES, which drugs:
1. _____________________________________________ Starting date _____/____/____
2. _____________________________________________ Starting date _____/____/____
Unknown
Have you ever decreased the the dosage or the frequency of a medicine because it has caused or could
cause liver damage?
NO YES NA
If YES, which drugs:
1. _____________________________________________ Starting date _____/____/____
2. _____________________________________________ Starting date _____/____/____
Unknown
Remarks regarding any part of the interview except discharge (see last page):____________
_______________________________________________________________________________
INTERVIEW INFORMATION
People present at the interview: interviewed family member caregiver
Main source: patient family member caregiver
Reliability: high medium low
Number of times that patient was contacted (even by telephone): ____________
INFORMATION FROM THE CLINICAL RECORD AFTER DISCHARGE
Discharge diagnoses:
1. ___________________________________________________________________________
2. ___________________________________________________________________________
3. ___________________________________________________________________________
4. ___________________________________________________________________________
Surgeries:
1. ___________________________________________________________________________
2. ___________________________________________________________________________
