ID
31683
Beschreibung
INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 www.ichom.org Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Clinical Variables to be administered at baseline visit and (a large number of the variables) annually. 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. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset, Sheba Academic Medical Center Hospital
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Stichworte
Versionen (2)
- 21.09.18 21.09.18 - Sarah Riepenhausen
- 30.04.20 30.04.20 - Sarah Riepenhausen
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ICHOM
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21. September 2018
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Creative Commons BY-NC 3.0
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ICHOM Inflammatory Arthritis
Baseline and Annual Clinical Form
- StudyEvent: ODM
Beschreibung
Baseline Condition Factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1442488
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinician TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0020538
- UMLS CUI [2]
- C0003364
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinician TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0332300
- UMLS CUI [1,3]
- C0007787
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018799
- UMLS CUI [1,2]
- C0205394
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0746102
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0011849
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0006826
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0011581
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0016658
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0038358
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C0577027
Beschreibung
Obesity is defined as a BMI ≥30 INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C1305855
- UMLS CUI [2]
- C0028754
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003873
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0949690
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003872
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3495559
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Date by YYYY
Datentyp
partialDate
Maßeinheiten
- YYYY
Alias
- UMLS CUI [1]
- C0872146
- UMLS CUI [2,1]
- C0439234
- UMLS CUI [2,2]
- C0011900
Beschreibung
INCLUSION CRITERIA: If "1 = Rheumatoid arthritis" or "4 = Juvenile idiopathic arthritis" to IA_DIAG TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer RESPONSE OPTIONS:
Datentyp
integer
Alias
- UMLS CUI [1]
- C0201660
Beschreibung
INCLUSION CRITERIA: If "1 = Rheumatoid arthritis" or "4 = Juvenile idiopathic arthritis" to IA_DIAG TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1]
- C4505301
Beschreibung
Treatment-Specific
Alias
- UMLS CUI-1
- C0087111
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C4086728
Beschreibung
INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
Beschreibung
INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Beschreibung
INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826664
Beschreibung
INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3640792
Beschreibung
INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826727
Beschreibung
INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1546955
Beschreibung
INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826256
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0544450
- UMLS CUI [1,2]
- C1521840
Beschreibung
INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0544450
- UMLS CUI [1,2]
- C1521840
- UMLS CUI [1,3]
- C1550543
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- StudyEvent: ODM
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C1519255 (UMLS CUI [1,2])
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