English

Baseline and Annual Clinical Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical TYPE: Numerical RESPONSE OPTIONS: According to institution

Data type

integer

Alias
UMLS CUI [1]
C1269815
Time Relative to Baseline (e.g. 3 months follow-up, 6 months follow-up, 1 year follow-up, ...)
Description

This Item does not exist in the original standard set, instead it is asked to do the following: Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. In this case 6 months, 1, and 2 years should be done, 3 months and 5 years follow-up are recommended, but not essential.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1442488
Baseline Condition Factors
Description

Baseline Condition Factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1442488
Indicate whether the patient has hypertension and/or uses antihypertensive medication
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinician TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0003364
Indicate whether the patient has had a myocardial infarction
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinician TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0027051
Indicate whether the patient has had a stroke (excluding transient ischemic attacks)
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0007787
Indicate whether the patient has any other heart disease
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205394
Indicate whether the patient has chronic lung disease
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0746102
Indicate whether the patient has diabetes mellitus
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0011849
Indicate whether the patient has any malignancies
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0006826
Indicate whether the patient has depression
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0011581
Indicate whether the patient has a fracture
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0016658
Indicate whether the patient has stomach ulcers
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0038358
Indicate whether the patient has stomach problems
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0577027
Indicate whether the patient is obese
Description

Obesity is defined as a BMI ≥30 INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0028754
Indicate the current diagnosis/diagnoses of inflammatory arthritis 1 = Rheumatoid arthritis
Description

INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1]
C0003873
Indicate the current diagnosis/diagnoses of inflammatory arthritis 2 = Spondyloarthritis
Description

INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1]
C0949690
Indicate the current diagnosis/diagnoses of inflammatory arthritis 3 = Psoriatic arthritis
Description

INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1]
C0003872
Indicate the current diagnosis/diagnoses of inflammatory arthritis 4 = Juvenile idiopathic arthritis
Description

INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1]
C3495559
Indicate the year of inflammatory arthritis diagnosis
Description

INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Date by YYYY

Data type

partialDate

Measurement units
  • YYYY
Alias
UMLS CUI [1]
C0872146
UMLS CUI [2,1]
C0439234
UMLS CUI [2,2]
C0011900
YYYY
Indicate the presence of rheumatoid factor
Description

INCLUSION CRITERIA: If "1 = Rheumatoid arthritis" or "4 = Juvenile idiopathic arthritis" to IA_DIAG TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer RESPONSE OPTIONS:

Data type

integer

Alias
UMLS CUI [1]
C0201660
Indicate the presence of anti-citrullinated protein antibodies (ACPA)
Description

INCLUSION CRITERIA: If "1 = Rheumatoid arthritis" or "4 = Juvenile idiopathic arthritis" to IA_DIAG TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C4505301
Treatment-Specific
Description

Treatment-Specific

Alias
UMLS CUI-1
C0087111
Has the patient suffered from any serious adverse events in the past 12 months?
Description

According to the FDA, a serious adverse event is an undesirable experience associated with the use of a medical product in a patient. The event is serious when the patient outcome is: death; life-threatening; hospitalisation; disability or permanent damage; congenital anomaly/birth defect; required intervention to prevent permanent impairment or damage; other serious (important medical events). INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4086728
Which serious adverse event(s) has the patient suffered from in the past 12 months? 1 = Death
Description

INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C1519255
Which serious adverse event(s) has the patient suffered from in the past 12 months? 2 = Life-threatening
Description

INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1517874
Which serious adverse event(s) has the patient suffered from in the past 12 months? 3 = Hospitalization
Description

INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826664
Which serious adverse event(s) has the patient suffered from in the past 12 months? 4 = Disability or permanent damage
Description

INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3640792
Which serious adverse event(s) has the patient suffered from in the past 12 months? 5 = Congenital anomaly/birth defect
Description

INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826727
Which serious adverse event(s) has the patient suffered from in the past 12 months? 6 = Required intervention to prevent permanent impairment or damage
Description

INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1546955
Which serious adverse event(s) has the patient suffered from in the past 12 months? 7 = Other serious (important medical events)
Description

INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826256
What was the disease activity target?
Description

INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0544450
UMLS CUI [1,2]
C1521840
Was the disease activity target reached?
Description

INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0544450
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C1550543
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Similar models

Baseline and Annual Clinical Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Time Relative to Baseline
Item
Time Relative to Baseline (e.g. 3 months follow-up, 6 months follow-up, 1 year follow-up, ...)
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Baseline Condition Factors
C0262926 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Item
Indicate whether the patient has hypertension and/or uses antihypertensive medication
integer
C0020538 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
High blood pressure
Code List
Indicate whether the patient has hypertension and/or uses antihypertensive medication
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has had a myocardial infarction
integer
C0027051 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has had a myocardial infarction
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has had a stroke (excluding transient ischemic attacks)
integer
C0038454 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0007787 (UMLS CUI [1,3])
High blood pressure
Code List
Indicate whether the patient has had a stroke (excluding transient ischemic attacks)
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has any other heart disease
integer
C0018799 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
High blood pressure
Code List
Indicate whether the patient has any other heart disease
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has chronic lung disease
integer
C0746102 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has chronic lung disease
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has diabetes mellitus
integer
C0011849 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has diabetes mellitus
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has any malignancies
integer
C0006826 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has any malignancies
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has depression
integer
C0011581 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has depression
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has a fracture
integer
C0016658 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has a fracture
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has stomach ulcers
integer
C0038358 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has stomach ulcers
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient has stomach problems
integer
C0577027 (UMLS CUI [1])
High blood pressure
Code List
Indicate whether the patient has stomach problems
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient is obese
integer
C1305855 (UMLS CUI [1])
C0028754 (UMLS CUI [2])
High blood pressure
Code List
Indicate whether the patient is obese
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Inflammatory arthritis diagnosis: Rheumatoid arthritis
Item
Indicate the current diagnosis/diagnoses of inflammatory arthritis 1 = Rheumatoid arthritis
boolean
C0003873 (UMLS CUI [1])
Inflammatory arthritis diagnosis: Spondylarthritis
Item
Indicate the current diagnosis/diagnoses of inflammatory arthritis 2 = Spondyloarthritis
boolean
C0949690 (UMLS CUI [1])
Inflammatory arthritis diagnosis: Psoriatic Arthritis
Item
Indicate the current diagnosis/diagnoses of inflammatory arthritis 3 = Psoriatic arthritis
boolean
C0003872 (UMLS CUI [1])
Inflammatory arthritis diagnosis: Juvenile idiopathic arthritis
Item
Indicate the current diagnosis/diagnoses of inflammatory arthritis 4 = Juvenile idiopathic arthritis
boolean
C3495559 (UMLS CUI [1])
Disease duration
Item
Indicate the year of inflammatory arthritis diagnosis
partialDate
C0872146 (UMLS CUI [1])
C0439234 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
Item
Indicate the presence of rheumatoid factor
integer
C0201660 (UMLS CUI [1])
Rheumatoid factor
Code List
Indicate the presence of rheumatoid factor
CL Item
Negative (0)
C0205160 (UMLS CUI-1)
(Comment:en)
CL Item
Positive (1)
C1446409 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate the presence of anti-citrullinated protein antibodies (ACPA)
integer
C4505301 (UMLS CUI [1])
Rheumatoid factor
Code List
Indicate the presence of anti-citrullinated protein antibodies (ACPA)
CL Item
Negative (0)
C0205160 (UMLS CUI-1)
(Comment:en)
CL Item
Positive (1)
C1446409 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item Group
Treatment-Specific
C0087111 (UMLS CUI-1)
Item
Has the patient suffered from any serious adverse events in the past 12 months?
integer
C1519255 (UMLS CUI [1,1])
C4086728 (UMLS CUI [1,2])
Serious Adverse Events
Code List
Has the patient suffered from any serious adverse events in the past 12 months?
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Serious Adverse Events - Classification: Death
Item
Which serious adverse event(s) has the patient suffered from in the past 12 months? 1 = Death
boolean
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Events - Classification: Life-threatening
Item
Which serious adverse event(s) has the patient suffered from in the past 12 months? 2 = Life-threatening
boolean
C1519255 (UMLS CUI [1,1])
C1517874 (UMLS CUI [1,2])
Serious Adverse Events - Classification: Hospitalization
Item
Which serious adverse event(s) has the patient suffered from in the past 12 months? 3 = Hospitalization
boolean
C1519255 (UMLS CUI [1,1])
C2826664 (UMLS CUI [1,2])
Serious Adverse Events - Classification: Disability or permanent damage
Item
Which serious adverse event(s) has the patient suffered from in the past 12 months? 4 = Disability or permanent damage
boolean
C1519255 (UMLS CUI [1,1])
C3640792 (UMLS CUI [1,2])
Serious Adverse Events - Classification: Congenital anomaly/birth defect
Item
Which serious adverse event(s) has the patient suffered from in the past 12 months? 5 = Congenital anomaly/birth defect
boolean
C1519255 (UMLS CUI [1,1])
C2826727 (UMLS CUI [1,2])
Serious Adverse Events - Classification: Required intervention to prevent permanent impairment or damage
Item
Which serious adverse event(s) has the patient suffered from in the past 12 months? 6 = Required intervention to prevent permanent impairment or damage
boolean
C1519255 (UMLS CUI [1,1])
C1546955 (UMLS CUI [1,2])
Serious Adverse Events - Classification: Other serious (important medical events)
Item
Which serious adverse event(s) has the patient suffered from in the past 12 months? 7 = Other serious (important medical events)
boolean
C1519255 (UMLS CUI [1,1])
C2826256 (UMLS CUI [1,2])
Item
What was the disease activity target?
integer
C0544450 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
Disease activity target
Code List
What was the disease activity target?
CL Item
Clinical remission (1)
C0544452 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
(Comment:en)
CL Item
Low disease activity (2)
C0544450 (UMLS CUI-1)
C0205251 (UMLS CUI-2)
(Comment:en)
CL Item
Both (3)
C0544450 (UMLS CUI-1)
C0205251 (UMLS CUI-2)
C0544452 (UMLS CUI-3)
C0205210 (UMLS CUI-4)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
(Comment:en)
Item
Was the disease activity target reached?
integer
C0544450 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
High blood pressure
Code List
Was the disease activity target reached?
CL Item
No  (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
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