ID
42852
Description
ODM form derived from 119pp EBMT SLE 16SLE please refer to: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx
Link
Keywords
Versions (3)
- 7/21/16 7/21/16 -
- 8/10/16 8/10/16 -
- 9/17/21 9/17/21 -
Uploaded on
September 17, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Systemic lupus erythematosus EBMT General Information Form
Systemic lupus erythematosus EBMT General Information Form
- StudyEvent: ODM
Description
Patient
Description
Unique Identification Code (UIC)
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
Hospital Unique Patient Number or Code
Data type
text
Alias
- UMLS CUI [1]
- C1827636
Description
Initials
Data type
text
Alias
- UMLS CUI [1]
- C2986440
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
ABO Group
Data type
integer
Alias
- UMLS CUI [1]
- C0000778
Description
Rh factor
Data type
integer
Alias
- UMLS CUI [1]
- C0035403
Description
Disease
Description
Date of diagnosis
Data type
date
Alias
- UMLS CUI [1]
- C2316983
Description
Primary Disease Diagnosis
Data type
integer
Alias
- UMLS CUI [1]
- C0277554
Description
SYSTEMIC LUPUS ERITHEMATOSUS (SLE)
Description
Name of Referring Physician
Data type
integer
Alias
- UMLS CUI [1]
- C1709880
Description
Address
Data type
integer
Alias
- UMLS CUI [1]
- C0421449
Description
Fax
Data type
integer
Alias
- UMLS CUI [1]
- C1549619
Description
Data type
integer
Alias
- UMLS CUI [1]
- C0013849
Description
INITIAL DIAGNOSIS
Description
DIAGNOSTIC CRITERIA FOR SYSTEMIC LUPUS ERYTHEMATOSUS
Description
Fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial folds
Data type
integer
Alias
- UMLS CUI [1]
- C3805720
Description
Erythematous raised patches with adherent keratotic scaling and follicular plugging; atrophic scarring may occur in older lesions
Data type
integer
Alias
- UMLS CUI [1]
- C3805721
Description
Skin rash as a result of unusual reaction to sunlight, by patient history or physician observation
Data type
integer
Alias
- UMLS CUI [1]
- C0349506
Description
Oral or nasopharyngeal ulceration, usually painless, observed by a physician
Data type
integer
Alias
- UMLS CUI [1]
- C0149745
Description
Non-erosive arthritis involving two or more peripheral joints, characterized by tenderness, swelling or effusion
Data type
integer
Alias
- UMLS CUI [1]
- C0003864
Description
a) Pleuritis – convincing history of pleuritic pain or rub heard by a physician or evidence of pleural effusion ~OR~ b) Pericarditis – documented by ECG or rub or evidence of pericardial effusion
Data type
integer
Alias
- UMLS CUI [1]
- C0036749
Description
a) Persistent proteinuria >0.5 grams per day or >3+ on urine dipsCheck if quantitation not performed ~OR~ b) Cellular casts – may be red cell, hemoglobulin, granular, tubular or mixed
Data type
integer
Alias
- UMLS CUI [1]
- C0022658
Description
a) Seizures – in the absence of offending drugs or known metabolic derangements; e.g., uremia, ketoacidosis or electrolyte imbalance ~OR~ b) Psychosis – in the absence of offending drugs or known metabolic derangements, e.g., uremia, ketoacidosis or electrolyte imbalance
Data type
integer
Alias
- UMLS CUI [1]
- C0027765
Description
a) Hemolytic anemia – with reticulocytosis ~OR~ b) Thrombocytopenia – <100,000/mm 3 platelets in the absence of offending drugs
Data type
integer
Alias
- UMLS CUI [1]
- C0018939
Description
a) Anti-DNA: antibody to native DNA in abnormal titer ~OR~ b) Anti-Sm: presence of antibody to Sm nuclear antigen ~OR~ c) Positive finding of antiphospholipid antibodies based on (1) an abnormal serum level of IgG or IgM anticardiolipin antibodies, (2) a positive test result for lupus anticoagulant using a standard method, or (3) a false positive serologic test for Syphilis known to be positive for at least 6 months and confirmed by Treponema pallidum immobilisation or fluorescent treponemal antibody absorption test ~OR d) False positive serologic test for syphilis known to be positive for at least 6 months and confirmed by Treponema pallidum immobilisation or fluorescent treponemal antibody absorption test
Data type
integer
Alias
- UMLS CUI [1]
- C0021053
Description
An abnormal titer of antinuclear antibody by immunofluorescence or an equivalent assay at any point in time and in the absence of drugs known to be associated with “drug-induced lupus” syndrome.
Data type
integer
Alias
- UMLS CUI [1]
- C0003243
Description
FIRST LINE THERAPIES
Description
Date started
Data type
date
Alias
- UMLS CUI [1]
- C3173309
Description
(including antibodies, GF, hormones, etc.)
Data type
text
Alias
- UMLS CUI [1]
- C0002844
Description
(including antibodies, GF, hormones, etc.)
Data type
integer
Alias
- UMLS CUI [1]
- C0003374
Description
Azathioprin
Data type
integer
Alias
- UMLS CUI [1]
- C0004482
Description
Corticosteroids
Data type
integer
Alias
- UMLS CUI [1]
- C0001617
Description
Cyclophosphamide
Data type
integer
Alias
- UMLS CUI [1]
- C0010583
Description
Cyclosporine
Data type
integer
Alias
- UMLS CUI [1]
- C0010592
Description
Mycophenolate mofetil
Data type
integer
Alias
- UMLS CUI [1]
- C0209368
Description
Intravenous immune globulin (IVIG)
Data type
integer
Alias
- UMLS CUI [1]
- C0085297
Description
Other drugs
Data type
integer
Alias
- UMLS CUI [1]
- C2729346
Description
Lymphocytopheresis
Data type
integer
Alias
- UMLS CUI [1]
- C0024226
Description
Plasmapheresis
Data type
integer
Alias
- UMLS CUI [1]
- C0032134
Description
Other drugs
Data type
boolean
Alias
- UMLS CUI [1]
- C2729346
Description
DATE OF HSCT
Description
STATUS OF DISEASE AT MOBILISATION
Description
Was lupus nephritis present at anytime prior to mobilisation?
Data type
integer
Alias
- UMLS CUI [1]
- C0024143
Description
Renal biopsy
Data type
integer
Alias
- UMLS CUI [1]
- C0194073
Description
date of most recent renal biopsy
Data type
date
Alias
- UMLS CUI [1,1]
- C0194073
- UMLS CUI [1,2]
- C2963433
Description
Grade Histology
Data type
integer
Alias
- UMLS CUI [1]
- C1317415
Description
Grade Histology
Data type
text
Alias
- UMLS CUI [1,1]
- C1317415
- UMLS CUI [1,2]
- C0205394
Description
SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score
Description
Recent onset (last 10 days). Exclude metabolic, infectious or drug cause, or seizure due to past irreversible CNS damage.
Data type
integer
Alias
- UMLS CUI [1]
- C0036572
Description
Altered ability to function in normal activity due to severe disturbance in the perception of reality. Include hallucinations, incoherence, marked loose associations, impoverished thought content, marked illogical thinking, bizarre, disorganized or catatonic behavior. Exclude uremia and drug causes.
Data type
integer
Alias
- UMLS CUI [1]
- C0033975
Description
Altered mental function with impaired orientation, memory or other intellectual function, with rapid onset and fluctuating clinical features. Include clouding of consciousness with reduced capacity to focus and inability to sustain attention to environment, plus at least 2 of the following: perceptual disturbance, incoherent speech, insomnia or daytime drowsiness or increased or decreased psychomotor activity. Exclude metabolic, infectious or drug causes.
Data type
integer
Alias
- UMLS CUI [1]
- C0029221
Description
Retinal and eye changes of SLE. Include cytoid bodies, retinal hemorrhages, serous exudate or hemorrhages in the choroid, optic neuritis, scleritis or episcleritis. Exclude hypertension, infection or drug causes.
Data type
integer
Alias
- UMLS CUI [1]
- C0547030
Description
New onset of sensory or motor neuropathy involving cranial nerves. Include vertigo due to lupus.
Data type
integer
Alias
- UMLS CUI [1]
- C0010266
Description
Severe, persistent headache: may be migrainous, but must be nonresponsive to narcotic analgesia.
Data type
integer
Alias
- UMLS CUI [1]
- C3898566
Description
New onset of cerebrovascular accident(s). Exclude arteriosclerosis or hypertensive causes.
Data type
integer
Alias
- UMLS CUI [1]
- C0038454
Description
Ulceration, gangrene, tender finger nodules, periungual infarction, splinter hemorrhages or biopsy or angiogram proof of vasculitis.
Data type
integer
Alias
- UMLS CUI [1]
- C0042384
Description
More than 2 joints with pain and signs of inflammation (i.e., tenderness, swelling or effusion).
Data type
integer
Alias
- UMLS CUI [1]
- C0003864
Description
Proximal muscle aching/weakness, associated with elevated creatine phosphokinase/aldolase or electromyogram changes or a biopsy showing myositis.
Data type
integer
Alias
- UMLS CUI [1]
- C0027121
Description
Heme-granular or red blood cell casts.
Data type
integer
Alias
- UMLS CUI [1]
- C4048266
Description
>5 red blood cells/high power field. Exclude stone, infection or other cause.
Data type
integer
Alias
- UMLS CUI [1]
- C0018965
Description
>0.5 gm/24 hours. New onset or recent increase of >0.5 gm/24 hours
Data type
integer
Alias
- UMLS CUI [1]
- C0033687
Description
>5 white blood cells/high power field. Exclude infection
Data type
integer
Alias
- UMLS CUI [1]
- C0034359
Description
Ongoing inflammatory lupus rash
Data type
integer
Alias
- UMLS CUI [1]
- C0015230
Description
Ongoing abnormal, patchy or diffuse loss of hair due to active lupus.
Data type
integer
Alias
- UMLS CUI [1]
- C0002171
Description
Ongoing oral or nasal ulcerations due to active lupus
Data type
integer
Alias
- UMLS CUI [1]
- C0236053
Description
Classic and severe pleuritic chest pain or pleural rub or effusion or new pleural thickening due to lupus.
Data type
integer
Alias
- UMLS CUI [1]
- C0032231
Description
Classic and severe pericardial pain or rub or effusion or electrocardiogram confirmation.
Data type
integer
Alias
- UMLS CUI [1]
- C1963211
Description
Low complement
Data type
integer
Alias
- UMLS CUI [1]
- C3897137
Description
>25% binding by Farr assay or above normal range for testing laboratory.
Data type
integer
Alias
- UMLS CUI [1]
- C1148673
Description
Fever
Data type
integer
Alias
- UMLS CUI [1]
- C1556366
Description
<100,000 platelets/mm 3 (x 10 9 /L).
Data type
integer
Alias
- UMLS CUI [1]
- C0040034
Description
<3,000 white blood cells/mm 3 (x 10 9 /L). Exclude drug causes.
Data type
integer
Alias
- UMLS CUI [1]
- C0023530
Description
LABORATORY VALUES
Description
Haemoglobin
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0019046
Description
ESR
Data type
integer
Measurement units
- mm/hr
Alias
- UMLS CUI [1]
- C1176468
Description
Erythrocyte sedimentation rate
Data type
integer
Alias
- UMLS CUI [1]
- C1176468
Description
platelets
Data type
integer
Measurement units
- x10^9 /l
Alias
- UMLS CUI [1]
- C0005821
Description
WBC
Data type
float
Measurement units
- x10^9/l
Alias
- UMLS CUI [1]
- C0023508
Description
Serumcreatinine
Data type
float
Alias
- UMLS CUI [1]
- C0201976
Description
Creatinine Clearance
Data type
float
Measurement units
- mL/min
Alias
- UMLS CUI [1]
- C0373595
Description
Total urinary protein excretion (mg/24 h)
Data type
float
Alias
- UMLS CUI [1]
- C3897352
Description
CH50 Complement reduced
Data type
integer
Alias
- UMLS CUI [1]
- C0369025
Description
Complement component reduced
Data type
integer
Alias
- UMLS CUI [1]
- C0009506
Description
Antibodies studied
Data type
integer
Alias
- UMLS CUI [1]
- C0003241
Description
anti-dsDNA
Data type
integer
Alias
- UMLS CUI [1]
- C2746079
Description
anti-cardiolipin IgG
Data type
integer
Alias
- UMLS CUI [1]
- C0368842
Description
anti-cardiolipin IgM
Data type
integer
Alias
- UMLS CUI [1]
- C0368843
Description
antinuclear antibody (ANA) test
Data type
integer
Alias
- UMLS CUI [1]
- C0003243
Description
anti-Sm
Data type
integer
Alias
- UMLS CUI [1]
- C0241910
Description
anti-SSA (anti-Ro)
Data type
integer
Alias
- UMLS CUI [1]
- C0075128
Description
anti-SSB (anti-La)
Data type
integer
Alias
- UMLS CUI [1]
- C1168480
Description
lupus-anticoagulant
Data type
integer
Alias
- UMLS CUI [1]
- C1142517
Description
PATIENT’S SELF ASSESSMENT PRIOR TO MOBILISATION
Description
SF-36 Health Survey
Data type
integer
Alias
- UMLS CUI [1]
- C3640521
Description
Physical Functioning
Data type
float
Alias
- UMLS CUI [1]
- C0516981
Description
Role Functioning-Physical
Data type
float
Alias
- UMLS CUI [1]
- C0516981
Description
Role Functioning-Emotional
Data type
float
Alias
- UMLS CUI [1]
- C0013987
Description
Social Functioning
Data type
float
Alias
- UMLS CUI [1]
- C2585826
Description
Bodily Pain
Data type
float
Alias
- UMLS CUI [1]
- C3890602
Description
Mental Health
Data type
float
Alias
- UMLS CUI [1]
- C0025353
Description
Vitality
Data type
float
Alias
- UMLS CUI [1]
- C0424589
Description
General Health
Data type
float
Alias
- UMLS CUI [1]
- C0516984
Description
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)
Description
Health Assessment Questionnaire
Data type
integer
Alias
- UMLS CUI [1]
- C0451208
Description
health score
Data type
float
Alias
- UMLS CUI [1]
- C2960025
Description
Worst possible score
Data type
float
Alias
- UMLS CUI [1,1]
- C0449820
- UMLS CUI [1,2]
- C1522166
Description
Best possible score
Data type
float
Alias
- UMLS CUI [1,1]
- C0449820
- UMLS CUI [1,2]
- C1299381
Description
STATUS OF DISEASE AT HSCT
Description
Was lupus nephritis present at anytime prior to HSCT?
Data type
integer
Alias
- UMLS CUI [1]
- C0024143
Description
Was lupus nephritis present at anytime prior to HSCT?
Data type
date
Alias
- UMLS CUI [1]
- C0194073
Description
Grade Histology
Data type
integer
Alias
- UMLS CUI [1]
- C1317415
Description
Renal biopsy done?
Data type
text
Alias
- UMLS CUI [1]
- C0194073
Description
ADDITIONAL TREATMENT POST-HSCT
Description
FORMS TO BE FILLED IN
Similar models
Systemic lupus erythematosus EBMT General Information Form
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C2963433 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1522166 (UMLS CUI [1,2])
C1299381 (UMLS CUI [1,2])
C0040739 (UMLS CUI [1,2])