ID

27351

Beschreibung

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

Stichworte

Versionen (1)
  1. 08.11.17 08.11.17 -
Rechteinhaber

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

Hochgeladen am

8. November 2017

DOI

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Lizenz

Creative Commons BY-NC-ND 3.0
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REGATTA NCT03151603

Deutsch Englisch

Patient Diary

1 Formulare  
  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.
Beschreibung

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)
Beschreibung

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.

Datentyp

date

Maßeinheiten
  • tt.mm.jjjj
Alias
UMLS CUI [1]
C0011008
tt.mm.jjjj
Day - since study entry
Beschreibung

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.

Datentyp

text

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

Weekday

Datentyp

text

Alias
UMLS CUI [1]
C0680189
Report Completed?
Beschreibung

Report Completed

Datentyp

boolean

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

1. How strong are your symptoms today?

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

Urgency of micturition

Datentyp

integer

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

Dysuria

Datentyp

integer

Alias
UMLS CUI [1]
C0013428
Frequency of Urination
Beschreibung

Frequency of Urination

Datentyp

integer

Alias
UMLS CUI [1]
C2584336
Lower Abdominal Pain
Beschreibung

Lower Abdominal Pain

Datentyp

integer

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

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

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

Affected by Urgency of micturition

Datentyp

integer

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

Affected by Dysuria

Datentyp

integer

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

Affected by Urination Frequency

Datentyp

integer

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

Affected by Lower Abdominal Pain

Datentyp

integer

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

Intake of Analgesics and Antibiotics

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

If YES, please fill in section Antibiotics.

Datentyp

boolean

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

If YES, please fill in section Analgesics.

Datentyp

boolean

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

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)
Beschreibung

Name of Antibiotics

Datentyp

text

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

Dosage of Antibiotics

Datentyp

text

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

Medication Frequency of Antibiotics

Datentyp

text

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

Start Date of Antibiotics

Datentyp

date

Maßeinheiten
  • tt.mm.jjjj
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0003232
tt.mm.jjjj
End Date of Antibiotics
Beschreibung

End Date of Antibiotics

Datentyp

date

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

Antibiotics for Urinary Tract Infection

Datentyp

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:
Beschreibung

Reason for Antibiotics

Datentyp

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.
Beschreibung

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)
Beschreibung

Name of Analgesics

Datentyp

text

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

Dosage of Analgesics

Datentyp

text

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

Medication Frequency of Analgesics

Datentyp

text

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

Date of Analgesics

Datentyp

date

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

Analgesics for Urinary Tract Infection

Datentyp

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:
Beschreibung

Reason for Analgesics

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0002771
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Ähnliche Modelle

Patient Diary

1 Formulare
  1. StudyEvent: ODM
    1. Patient Diary
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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