ID

27351

Description

Original CRFs from: K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor. Further details on: http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html https://clinicaltrials.gov/ct2/show/NCT03151603 Patient Diary

Link

http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html

Keywords

Versions (1)
  1. 11/8/17 11/8/17 -
Copyright Holder

K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor

Uploaded on

November 8, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC-ND 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

REGATTA NCT03151603

German English

Patient Diary

1 forms  
  1. StudyEvent: ODM
    1. Patient Diary
Patient Diary - already filled out today? - Note: Taking antibiotics or analgesics: please note date of intake, amount, dosage in the fitting lists.
Description

Patient Diary - already filled out today? - Note: Taking antibiotics or analgesics: please note date of intake, amount, dosage in the fitting lists.

Alias
UMLS CUI-1
C3890583
Date (Study Entry)
Description

Please note on 7 days for each day of the week your health by ticking the corresponding fields in the diary. Start one day after study entry.

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1]
C0011008
tt.mm.jjjj
Day - since study entry
Description

Please do not stop recording when you feel better (documentation at least until day 7). If your symptoms persist beyond day 7, continue to fill out the journal until you are symptom-free.

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
Weekday
Description

Weekday

Data type

text

Alias
UMLS CUI [1]
C0680189
Report Completed?
Description

Report Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0684224
1. How strong are your symptoms today?
Description

1. How strong are your symptoms today?

Alias
UMLS CUI-1
C0439792
UMLS CUI-2
C1457887
Urgency of micturition
Description

Urgency of micturition

Data type

integer

Alias
UMLS CUI [1]
C0085606
Painful/Burning while urinate
Description

Dysuria

Data type

integer

Alias
UMLS CUI [1]
C0013428
Frequency of Urination
Description

Frequency of Urination

Data type

integer

Alias
UMLS CUI [1]
C2584336
Lower Abdominal Pain
Description

Lower Abdominal Pain

Data type

integer

Alias
UMLS CUI [1]
C0232495
2. How strongly are you affected by your symptoms today?
Description

2. How strongly are you affected by your symptoms today?

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0392760
Affected by Urgency of micturition
Description

Affected by Urgency of micturition

Data type

integer

Alias
UMLS CUI [1,1]
C0085606
UMLS CUI [1,2]
C0392760
Affected by Painful/Burning while urinate
Description

Affected by Dysuria

Data type

integer

Alias
UMLS CUI [1,1]
C0013428
UMLS CUI [1,2]
C0392760
Affected by Urination Frequency
Description

Affected by Urination Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C2584336
UMLS CUI [1,2]
C0392760
Affected by Lower Abdominal Pain
Description

Affected by Lower Abdominal Pain

Data type

integer

Alias
UMLS CUI [1,1]
C0232495
UMLS CUI [1,2]
C0392760
Intake of Analgesics and Antibiotics
Description

Intake of Analgesics and Antibiotics

Alias
UMLS CUI-1
C0013216
3. Do you take any antibiotics next to study medication since study entry?
Description

If YES, please fill in section Antibiotics.

Data type

boolean

Alias
UMLS CUI [1]
C0003232
4. Have you taken any analgesics in the last 24 hours?
Description

If YES, please fill in section Analgesics.

Data type

boolean

Alias
UMLS CUI [1]
C0002771
Antibiotics-List: If you take any antibiotics next to study medication: please report name, dosage, amount.
Description

Antibiotics-List: If you take any antibiotics next to study medication: please report name, dosage, amount.

Alias
UMLS CUI-1
C0003232
Name of Antibiotics (e.g. Cefuroxim)
Description

Name of Antibiotics

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C2360065
Dosage of Antibiotics (e.g. 500 mg)
Description

Dosage of Antibiotics

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0003232
Medication Frequency of Antibiotics (e.g. 2x1 tablets)
Description

Medication Frequency of Antibiotics

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C0003232
Start Date of Antibiotics
Description

Start Date of Antibiotics

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0003232
tt.mm.jjjj
End Date of Antibiotics
Description

End Date of Antibiotics

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0003232
tt.mm.jjjj
Reason for Intake: Urinary Tract Infection?
Description

Antibiotics for Urinary Tract Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0003232
Reason for Antibiotics: If the antibiotics are not used for Urinary Tract Infection, please specify:
Description

Reason for Antibiotics

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0003232
Analgesics-List: Please report name, dosage and amount of analgesics you have taken on this specific day.
Description

Analgesics-List: Please report name, dosage and amount of analgesics you have taken on this specific day.

Alias
UMLS CUI-1
C0002771
Name of Analgesics (e.g. Paracetamol)
Description

Name of Analgesics

Data type

text

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C2360065
Dosage of Analgesics (e.g. 500 mg)
Description

Dosage of Analgesics

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0002771
Medication Frequency of Analgesics (e.g. 2x1 tablets)
Description

Medication Frequency of Analgesics

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C0002771
Date of Analgesics
Description

Date of Analgesics

Data type

date

Measurement units
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0011008
tt.mm.jjjj
Reason for Intake: Urinary Tract Infection?
Description

Analgesics for Urinary Tract Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0002771
Reason for Analgesics: If the analgesics are not used for Urinary Tract Infection, please specify:
Description

Reason for Analgesics

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0002771
Back to the top of the page

Similar models

Patient Diary

1 forms
  1. StudyEvent: ODM
    1. Patient Diary
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Diary - already filled out today? - Note: Taking antibiotics or analgesics: please note date of intake, amount, dosage in the fitting lists.
C3890583 (UMLS CUI-1)
Date
Item
Date (Study Entry)
date
C0011008 (UMLS CUI [1])
Item
Day - since study entry
text
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Day
Code List
Day - since study entry
CL Item
 (Tag 01)
CL Item
 (Tag 02)
CL Item
 (Tag 03)
CL Item
 (Tag 04)
CL Item
 (Tag 05)
CL Item
 (Tag 06)
CL Item
 (Tag 07)
CL Item
 (Tag 08)
CL Item
 (Tag 09)
CL Item
 (Tag 10)
CL Item
 (Tag 11)
CL Item
 (Tag 12)
Item
Weekday
text
C0680189 (UMLS CUI [1])
Weekday
Code List
Weekday
CL Item
 (Mo)
CL Item
 (Di)
CL Item
 (Mi)
CL Item
 (Do)
CL Item
 (Fr)
CL Item
 (Sa)
CL Item
 (So)
Report Completed
Item
Report Completed?
boolean
C0449788 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Item Group
1. How strong are your symptoms today?
C0439792 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
Item
Urgency of micturition
integer
C0085606 (UMLS CUI [1])
undefined item
Code List
Urgency of micturition
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item
Painful/Burning while urinate
integer
C0013428 (UMLS CUI [1])
Dysuria
Code List
Painful/Burning while urinate
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item
Frequency of Urination
integer
C2584336 (UMLS CUI [1])
Frequency of Urination
Code List
Frequency of Urination
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item
Lower Abdominal Pain
integer
C0232495 (UMLS CUI [1])
Lower Abdominal Pain
Code List
Lower Abdominal Pain
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item Group
2. How strongly are you affected by your symptoms today?
C1457887 (UMLS CUI-1)
C0392760 (UMLS CUI-2)
Item
Affected by Urgency of micturition
integer
C0085606 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
Affected by Urgency of micturition
Code List
Affected by Urgency of micturition
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item
Affected by Painful/Burning while urinate
integer
C0013428 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
Affected by Dysuria
Code List
Affected by Painful/Burning while urinate
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item
Affected by Urination Frequency
integer
C2584336 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
Affected by Urination Frequency
Code List
Affected by Urination Frequency
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item
Affected by Lower Abdominal Pain
integer
C0232495 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
Affected by Lower Abdominal Pain
Code List
Affected by Lower Abdominal Pain
CL Item
not at all (0)
CL Item
a little (1)
CL Item
moderate (2)
CL Item
strong (3)
CL Item
very strong (4)
Item Group
Intake of Analgesics and Antibiotics
C0013216 (UMLS CUI-1)
Antibiotics
Item
3. Do you take any antibiotics next to study medication since study entry?
boolean
C0003232 (UMLS CUI [1])
Analgesics
Item
4. Have you taken any analgesics in the last 24 hours?
boolean
C0002771 (UMLS CUI [1])
Item Group
Antibiotics-List: If you take any antibiotics next to study medication: please report name, dosage, amount.
C0003232 (UMLS CUI-1)
Name of Antibiotics
Item
Name of Antibiotics (e.g. Cefuroxim)
text
C0003232 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Dosage of Antibiotics
Item
Dosage of Antibiotics (e.g. 500 mg)
text
C0178602 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Medication Frequency of Antibiotics
Item
Medication Frequency of Antibiotics (e.g. 2x1 tablets)
text
C3476109 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Start Date of Antibiotics
Item
Start Date of Antibiotics
date
C0808070 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
End Date of Antibiotics
Item
End Date of Antibiotics
date
C0806020 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Antibiotics for Urinary Tract Infection
Item
Reason for Intake: Urinary Tract Infection?
boolean
C0042029 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Reason for Antibiotics
Item
Reason for Antibiotics: If the antibiotics are not used for Urinary Tract Infection, please specify:
text
C0392360 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Item Group
Analgesics-List: Please report name, dosage and amount of analgesics you have taken on this specific day.
C0002771 (UMLS CUI-1)
Name of Analgesics
Item
Name of Analgesics (e.g. Paracetamol)
text
C0002771 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Dosage of Analgesics
Item
Dosage of Analgesics (e.g. 500 mg)
text
C0178602 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
Medication Frequency of Analgesics
Item
Medication Frequency of Analgesics (e.g. 2x1 tablets)
text
C3476109 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
Date of Analgesics
Item
Date of Analgesics
date
C0002771 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Analgesics for Urinary Tract Infection
Item
Reason for Intake: Urinary Tract Infection?
boolean
C0042029 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
Reason for Analgesics
Item
Reason for Analgesics: If the analgesics are not used for Urinary Tract Infection, please specify:
text
C0392360 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial