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ID
23877
Beschreibung
Type of information collected in the ICN2 Database for the scientific infrastructure "ImproveCareNow" (http://www.improvecarenow.org/) to improve health outcome of chrildren and adolescents with IBD.
Link
http://www.improvecarenow.org/
Stichworte
Versionen (3)
- 16.07.17 16.07.17 -
- 16.07.17 16.07.17 -
- 29.07.17 29.07.17 -
Hochgeladen am
16. Juli 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0 Legacy
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Visit data CRF ImproveCareNow
Visit data CRF ImproveCareNow
- StudyEvent: ODM
Ähnliche Modelle
Visit data CRF ImproveCareNow
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
s_assessdt
Item
Date of assessment
date
Item
Since the last visit documented in the database were there any visits that were not captured?
integer
Code List
Since the last visit documented in the database were there any visits that were not captured?
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
s_visitnotcap
Item
Number of visits not captured
integer
s_entry
Item
Current visit data entered by
text
s_primprov
Item
Primary Attending Gastroenterologist
text
s_secprov
Item
Secondary provider
text
Item
Has the patient had a colectomy? (If Yes, and the patient's diagnosis is UC, the patient should be inactivated)
integer
Code List
Has the patient had a colectomy? (If Yes, and the patient's diagnosis is UC, the patient should be inactivated)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
s_colectomydt
Item
Date of colectomy
date
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Crohn's Disease (1)
CL Item
Ulcerative Colitis (2)
CL Item
Indeterminate Colitis (3)
Item Group
In the following set of questions, describe the symptoms on the worst day in the last 7 days
CL Item
Well/Normal (7)
CL Item
Fair (8)
CL Item
Poor (3)
CL Item
Don't Know/Not Assessed (6)
CL Item
None (1)
CL Item
Occasional (2)
CL Item
Frequent (3)
CL Item
Don't Know/Not Assessed (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate to Severe (6)
CL Item
Don't Know/Not Assessed (5)
Item Group
In the following set of questions, describe the patient's stools on the worst day in the last 7 days
s_totstool
Item
Total number of stools per day (enter 0 if none)
integer
s_totstool not assessed
Item
Not Assessed
boolean
CL Item
Formed (1)
CL Item
Partially Formed (2)
CL Item
Liquid (3)
CL Item
Don't Know/Not Assessed (4)
s_liquidstool
Item
Number of liquid/watery stools per day (enter 0 if none)
integer
s_liquidstool not assessed
Item
Not Assessed
boolean
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Small amount in less than 50% of stools (5)
CL Item
Small amount in greater than 50% of stools (6)
CL Item
Large amount (2)
CL Item
Not available/assessed (4)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Not available/assessed (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Not available/assessed (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Not available/assessed (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Not available/assessed (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Not available/assessed (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Not available/assessed (2)
CL Item
No tenderness, no mass (1)
CL Item
Mild tenderness or questionable mass without tenderness (2)
CL Item
Moderate to severe tenderness, involuntary guarding, definite mass (3)
CL Item
Don't Know (4)
CL Item
Not Assessed (5)
CL Item
Normal or asymptomatic tag, non-draining fistula without tenderness, no deep fissuring or abscess (1)
CL Item
Mildly inflamed skin tag(s), 1 to 2 indolent fistulas with scant drainage (NO tenderness, deep fissures or abscess (2)
CL Item
Severely inflamed tag(s), active fistula with drainage, tenderness, abscess, or deep fissure (3)
CL Item
Don't Know (4)
CL Item
Not Assessed (5)
CL Item
cm (cm)
CL Item
in (in)
s_ht
Item
Current Height
integer
s_ht not assessed
Item
Not Assessed
boolean
CL Item
kg (kg)
CL Item
lb (lb)
s_wt
Item
Current Weight
float
s_wt not assessed
Item
Not Assessed
boolean
s_bmi
Item
Current BMI
float
Item
For patients less than 18 years old, has height, weight and BMI been plotted on a growth chart?
integer
Code List
For patients less than 18 years old, has height, weight and BMI been plotted on a growth chart?
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Quiescent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
CL Item
Don't Know/Not Assessed (5)
Item Group
Extent of Disease: Crohn's Disease/Indeterminate Colitis patients only (select one for each category)
CL Item
None (0)
CL Item
Ileal only (1)
CL Item
Colonic only (2)
CL Item
Ileocolonic (3)
CL Item
Not Assessed (8)
CL Item
Don't Know (9)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (8)
CL Item
Don't Know (99)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (8)
CL Item
Don't Know (99)
CL Item
Inflammatory, non-penetrating, non-stricturing (1)
CL Item
Stricturing (2)
CL Item
Penetrating (3)
CL Item
Both Stricturing and Penetrating (4)
CL Item
Don't Know (5)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Ulcerative Proctitis (rectum only (1)
CL Item
Left sided Ulcerative Colitis (2)
CL Item
Extensive Ulcerative Colitis (3)
CL Item
Pancolitis (the entire colon (4)
CL Item
Not assessed completely (5)
CL Item
Don't Know (6)
Item
For UC patients only: Ulcerative Colitis Behavior: Has the patient ever had severe disease?
integer
Code List
For UC patients only: Ulcerative Colitis Behavior: Has the patient ever had severe disease?
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Satisfactory (1)
CL Item
At Risk (2)
CL Item
In failure (3)
CL Item
Not Assessed (5)
CL Item
Satisfactory (1)
CL Item
At Risk (2)
CL Item
In failure (3)
CL Item
Not Assessed (5)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
Item
Since the last visit, has the patient had a serious infection? (Note: A serious infection is one that requires hospitalization or IV therapy)
integer
Code List
Since the last visit, has the patient had a serious infection? (Note: A serious infection is one that requires hospitalization or IV therapy)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
s_infecy
Item
If yes, indicate infection
text
Item
Are there psychosocial risk factors that are felt to significantly impact the patient's medical care?
integer
Code List
Are there psychosocial risk factors that are felt to significantly impact the patient's medical care?
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
s_lbdt
Item
Date of lab sample
date
CL Item
Not Done (0)
CL Item
Done on same date as above (1)
CL Item
Done on different date than above (2)
s_crpdt
Item
Date of sample
date
s_crp
Item
Result
text
s_crpunkn
Item
Outside quantifiable range
boolean
CL Item
Below level of quantification (1)
CL Item
Above level of quantification (2)
CL Item
LabCorp (1)
CL Item
Quest (2)
CL Item
In-house (3)
CL Item
Other (4)
CL Item
Not Done (0)
CL Item
Done on same date as above (1)
CL Item
Done on different date than above (2)
s_hemdt
Item
Hematocrite Date of sample
date
s_hem
Item
Result
text
s_esrunkn
Item
Outside quantifiable range
boolean
CL Item
Below level of quantification (1)
CL Item
Above level of quantification (2)
CL Item
Not Done (0)
CL Item
Done on same date as above (1)
CL Item
Done on different date than above (2)
s_albdt
Item
Date of sample
date
s_alb
Item
Result
text
Item
Is the patient currently taking any non-biologic prescription medications for IBD?
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
sulfataking
Item
Sulfasalazine
boolean
s_azuldose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
penttaking
Item
Pentasa
boolean
s_pentdose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
asataking
Item
Asacol
boolean
s_asadose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
aprtaking
Item
Apriso
boolean
s_aprisodose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
liataking
Item
Lialda
boolean
s_lialdadose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
colataking
Item
Colazal
boolean
s_coladose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
delztaking
Item
Delzicol
boolean
s_delzdose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (0)
CL Item
No (1)
rwstaking
Item
Rowasa
boolean
s_rowasadose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
cantaking
Item
Canasa
boolean
s_canasadose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
hdrtaking
Item
Hydrocortisone enema/suppository
boolean
s_hydrocortdose
Item
Dose
text
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (2)
pdstaking
Item
Prednisone
boolean
s_preddose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
bdstaking
Item
Budesonide
boolean
s_budedose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
mpredtaking
Item
Methylprednisolone
boolean
s_mpreddose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (2)
6mptaking
Item
6MP
boolean
s_6mpdose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
azataking
Item
Azathioprine
boolean
s_azadose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
alptaking
Item
Allopurinol
boolean
s_allopdose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
mthtaking
Item
Methotrexate
boolean
s_methdose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Subcutaneous (1)
CL Item
PO (2)
CL Item
IM (5)
CL Item
Don't Know (4)
folictaking
Item
Folic Acid
boolean
s_folicdose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (2)
cyclotaking
Item
Cyclosporine
boolean
s_cyclodose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
tacrotaking
Item
Tacrolimus
boolean
s_tacrodose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (2)
ciprotaking
Item
Cipro
boolean
s_ciprodose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
flagltaking
Item
Flagyl
integer
s_flagldose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
rifaxtaking
Item
Rifaximin
boolean
s_rifaxdose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
fidt
Item
Date of first induction dose
date
CL Item
Cimzia (1)
CL Item
Entyvio (7)
CL Item
Humira (2)
CL Item
Remicade (3)
CL Item
Simponi (5)
CL Item
Stelera (6)
CL Item
Tysabri (4)
Item Group
Reasons for initiation of biologics (*Note: these questions will only appear for new biologic agents)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
othspecify
Item
Specify
text
infmabtaking
Item
Remicade
boolean
s_inflixcurrdose
Item
Dose
integer
CL Item
Maintenance (1)
CL Item
Induction (2)
s_inflixcurrenterval
Item
Dosing Interval (for maintenance medications only)
integer
cimztaking
Item
Cimzia
boolean
s_cimziacurrdose
Item
Dose
integer
CL Item
Maintenance (1)
CL Item
Induction (2)
s_cimziacurrinterval
Item
Dosing Interval (for maintenance medications only)
integer
humrtaking
Item
Humira
boolean
s_humiracurrdose
Item
Dose
boolean
CL Item
Maintenance (1)
CL Item
Induction (2)
s_humiracurrinterval
Item
Dosing Interval (for maintenance medications only)
integer
tysataking
Item
Tysabri
boolean
s_tysabricurrdose
Item
Dose
integer
CL Item
Maintenance (1)
CL Item
Induction (2)
s_tysabricurrinterval
Item
Dosing Interval (for maintenance medications only)
integer
simptaking
Item
Simponi
boolean
s_simpdose
Item
Dose
integer
CL Item
Maintenance (1)
CL Item
Induction (2)
s_simpdi
Item
Dosing Interval (for maintenance medications only)
integer
steltaking
Item
Stelera
boolean
s_steldose
Item
Dose
integer
CL Item
Maintenance (1)
CL Item
Induction (2)
s_steldi
Item
Dosing Interval (for maintenance medications only)
integer
entyvtaking
Item
Entyvio
boolean
s_entyvdose
Item
Dose
integer
CL Item
Maintenance (1)
CL Item
Induction (2)
s_entyvdi
Item
Dosing Interval (for maintenance medications only)
integer
Item Group
Other prescription medications for IBD (per site discretion)
othmedtaking
Item
Medication
text
othmeddose
Item
Dose
integer
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Less than 1 month ago (1)
CL Item
More than 1 month ago (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Normal (1)
CL Item
Heterozygous (2)
CL Item
Homozygous recessive (3)
CL Item
Not Done (4)
s_tpmtgenodt
Item
TPMT Genotype date
date
CL Item
Normal/High (5)
CL Item
Intermediate (1)
CL Item
Low (3)
CL Item
Not Done (4)
s_tpmtphenodt
Item
TPMT Phenotype date
date
Item
Has the patient had 6MP metabolites measured more recently than the test indicated above?
integer
Code List
Has the patient had 6MP metabolites measured more recently than the test indicated above?
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
s_thiometabdt
Item
If Yes, most recent measurement date
date
s_6tgn
Item
Most recent 6-TGN level
text
6tgunkn
Item
Outside quantifiable range
boolean
CL Item
Below level of quantification (1)
CL Item
Above level of quantification (2)
s_6mmpn
Item
Most recent 6-MMPN
text
6mpunkn
Item
Outside quantifiable range
boolean
CL Item
Below level of quantification (1)
CL Item
Above level of quantification (2)
Item
If a chest x-ray has been done more recently than the test indicated above, please provide the result
integer
Code List
If a chest x-ray has been done more recently than the test indicated above, please provide the result
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not Done (3)
s_cxrposneg
Item
Date of last CXR
date
Item
If a PPD has been placed more recently than the test indicated above, please provide the result
integer
Code List
If a PPD has been placed more recently than the test indicated above, please provide the result
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not Done (3)
s_ppdposneg
Item
Date of last PPD
date
CL Item
Positive (1)
CL Item
Negative (0)
CL Item
Indeterminate (2)
CL Item
Not Done (99)
goldtestdt
Item
Date of last Quantiferon Gold test
date
Item
Has the patient had Remicade trough level measured more recently than the test above?
integer
Code List
Has the patient had Remicade trough level measured more recently than the test above?
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
s_inflixtrough
Item
Remicade trough level
text
CL Item
Below level of quantification (0)
CL Item
Above level of quantification (1)
s_inflixtroughdt
Item
Date of Remicade trough level measurement
date
CL Item
LabCorp (Esoterix (1)
CL Item
Prometheus (2)
CL Item
MAYO (3)
CL Item
ARUP (4)
Item
Has the patient had Remicade antibody levels measured more recently than the test above?
integer
Code List
Has the patient had Remicade antibody levels measured more recently than the test above?
CL Item
Yes (1)
CL Item
No (0)
CL Item
Don't Know (2)
s_inflixantibody
Item
Remicade antibody level
text
CL Item
Below level of quantification (0)
CL Item
Above level of quantification (1)
s_inflixantibodydt
Item
Date of Remicade antibody level measurement
date