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40654

Description

ICHOM Atrial Fibrillation data collection Version 1.0.0 Published: 3rd April 2019 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. The following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Atrial Fibrillation Population: An adult (≥ 18 years) diagnosed with atrial fibrillation (including symptomatic patients) Treatment approaches: Management of cardiovascular risk factors and institution of preventive therapy | Pharmacological management| Non-Pharmacological management Excluded populations: Children and Young persons below 18 years Excluded conditions: Patients diagnosed with cardiotoxic acute atrial fibrillation This document contains the Ongoing – Clinical Form. It has to be filled in ongoing after 6 months and annually. Collecting Patient-Reported Outcome Measure: PROMIS Global Health. As there is an official distribution site, the questions of this questionnaire will not be included in this version of the standard set. For more information see: https://bit.ly/29aOZu9 Alternatively Optum SF-12, AFEQT, AFSS or WPAI:GH may be used. Montreal Cognitive Assessment Test. For more information see: https://www.mocatest.org/ The Standard set of ICHOM was supported by the BigData@Heart organization. Publication: Seligman WH, Das-Gupta Z, Jobi-Odeneye AO, Arbelo E, Banerjee A, Bollmann A, et al. Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group. Eur Heart J. 2020 Jan 29; 10.1093/eurheartj/ehz871 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Link

http://www.ichom.org/

Keywords

Versions (3)
  1. 8/22/19 8/22/19 -
  2. 8/26/19 8/26/19 - Sarah Riepenhausen
  3. 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder

ICHOM

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April 30, 2020

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Creative Commons BY-NC 4.0
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    ICHOM Atrial Fibrillation

    English

    Ongoing - 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 RESPONSE OPTIONS: According to institution

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1269815
    Time Relative to Baseline
    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_AT (After treatment); VARIABLEID_AS (After surgery); VARIABLEID_UPDATE (Update at least annually), etc.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C1442488
    Long-term consequences of disease
    Description

    Long-term consequences of disease

    Alias
    UMLS CUI-1
    C0443252
    UMLS CUI-2
    C0686907
    UMLS CUI-3
    C0012634
    Indicate if the patient has died
    Description

    Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0011065
    Indicate the date of death
    Description

    Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative date Type: Date by DD/MM/YYYY Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1]
    C1148348
    DD/MM/YYYY
    Tick if Date of death unknown
    Description

    Note: This item does not exist in the original version of the standard set. Please tick if you do not know the date of death. Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1148348
    UMLS CUI [1,2]
    C0439673
    Indicate cause of cardiovascular death
    Description

    Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative data Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0007465
    Indicate whether there was a cardiovascular event
    Description

    Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320716
    Indicate the type of cardiovascular event that occurred
    Description

    Inclusion Criteria: If ‘1 = Yes’ to CARDIOVASCULAREVENT Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0038454
    UMLS CUI [1,2]
    C0332307
    Provide the date of which the Cardiovascular event occurred
    Description

    Inclusion Criteria: If ‘1, 2, or 3’ to EVENTTYPE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C1320716
    UMLS CUI [1,2]
    C0011008
    DD/MM/YYYY
    Indicate if a new clinical diagnosis of heart failure has been made in this patient
    Description

    Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0205314
    UMLS CUI [1,3]
    C0332140
    Provide the date of Heart failure diagnosis
    Description

    Inclusion Criteria: If ‘1 = Yes’ to HF Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0018801
    UMLS CUI [1,3]
    C0205314
    UMLS CUI [1,4]
    C0332140
    DD/MM/YYYY
    Indicate if left ventricular ejection fraction (LVEF) was measured
    Description

    Inclusion Criteria: If ‘1 = Yes’ to HF Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0428772
    Provide date of LVEF measurement
    Description

    Inclusion Criteria: If ‘1 = Yes’ to LVEF Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0428772
    DD/MM/YYYY
    Provide a value of LVEF measurement
    Description

    Inclusion Criteria: If ‘1 = Yes’ to LVEF Timing: Ongoing Data Source: Clinical Type: Numerical value Response Options: LVEF measurement value

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0428772
    UMLS CUI [1,2]
    C0242485
    Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
    Description

    Supporting Definition: * admission = at least one overnight stay at a hospital or acute care facility from first atrial fibrillation diagnosis **Cardiovascular causes for admission are ones in which the principal admitting diagnosis relates to the cardiovascular system: myocardial infarction / ischaemic heart disease, heart failure, stroke/TIA, peripheral arterial disease, AF, venous thromboembolism/PE, etc. Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0184666
    UMLS CUI [1,2]
    C0038454
    Indicate type of cardiovascular cause
    Description

    Inclusion Criteria: If ‘1 = Yes’ to CVHOSPADM Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C0184666
    UMLS CUI [1,3]
    C0038454
    UMLS CUI [1,4]
    C0085978
    Was a fast atrial arrhythmia detected?
    Description

    Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0085611
    UMLS CUI [1,2]
    C0456962
    Provide the date when fast atrial arrhythmia was detected
    Description

    Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0085611
    UMLS CUI [1,2]
    C0456962
    UMLS CUI [1,3]
    C0011008
    DD/MM/YYYY
    Indicate type of treatment
    Description

    Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0085611
    UMLS CUI [1,2]
    C0456962
    UMLS CUI [1,3]
    C0087111
    If the patient received the treatment, indicate the type of monitoring performed post-treatment
    Description

    Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0456962
    UMLS CUI [1,2]
    C0085611
    UMLS CUI [1,3]
    C0150496
    UMLS CUI [1,4]
    C2709088
    Provide the date when each treatment started to be monitored
    Description

    Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2709088
    UMLS CUI [1,3]
    C0030695
    UMLS CUI [1,4]
    C0456962
    UMLS CUI [1,5]
    C0004238
    DD/MM/YYYY
    Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
    Description

    Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0456962
    UMLS CUI [1,3]
    C0085611
    UMLS CUI [1,4]
    C2709088
    UMLS CUI [1,5]
    C0030695
    Complications of treatment
    Description

    Complications of treatment

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C0009566
    Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
    Description

    Inclusion Criteria: If ‘1 = Yes’ to CVEVENT Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0038454
    UMLS CUI [1,2]
    C0333275
    Please provide date of Haemorrhagic stroke
    Description

    Inclusion Criteria: If ‘1 = Yes’ to HSTROKE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0038454
    UMLS CUI [1,3]
    C0333275
    DD/MM/YYYY
    Indicate whether the patient had fatal bleeding
    Description

    Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1302234
    UMLS CUI [1,2]
    C0019080
    Provide date of fatal bleeding event
    Description

    Inclusion Criteria: If ‘1 = Yes’ to FBLEED Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1302234
    UMLS CUI [1,3]
    C0019080
    DD/MM/YYYY
    Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
    Description

    Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0231220
    UMLS CUI [1,2]
    C0019080
    UMLS CUI [1,3]
    C1511545
    UMLS CUI [1,4]
    C0205146
    UMLS CUI [2,1]
    C0231220
    UMLS CUI [2,2]
    C0019080
    UMLS CUI [2,3]
    C0178784
    Provide date of symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
    Description

    Inclusion Criteria: If ‘1 = Yes’ to CRITICALBLEED Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [1,3]
    C0019080
    UMLS CUI [1,4]
    C1511545
    UMLS CUI [1,5]
    C0205146
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [2,3]
    C0019080
    UMLS CUI [2,4]
    C0178784
    DD/MM/YYYY
    Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
    Description

    Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C0547047
    UMLS CUI [1,4]
    C0019046
    UMLS CUI [2,1]
    C0019080
    UMLS CUI [2,2]
    C0678227
    UMLS CUI [2,3]
    C0686904
    UMLS CUI [2,4]
    C1879316
    Provide date of when patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
    Description

    Inclusion Criteria: If ‘1 = Yes’ to BLEEDOUTCOME Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0019080
    UMLS CUI [1,3]
    C0678227
    UMLS CUI [1,4]
    C0547047
    UMLS CUI [1,5]
    C0019046
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0019080
    UMLS CUI [2,3]
    C0678227
    UMLS CUI [2,4]
    C0686904
    UMLS CUI [2,5]
    C1879316
    DD/MM/YYYY
    Procedure
    Description

    Procedure

    Alias
    UMLS CUI-1
    C0087111
    Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
    Description

    Additional comment (not in the original standard set): Please fill in this item repeatedly if more than one procedure and provide a date for each of these procedures in a new PROCEDUREDATE item. Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single or multiple answers

    Data type

    text

    Alias
    UMLS CUI [1]
    C0455713
    Provide date of the procedure
    Description

    Inclusion Criteria: If ‘1-8’ to PROCEDURE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

    Data type

    date

    Measurement units
    • DD/MM/YYYY
    Alias
    UMLS CUI [1]
    C2584899
    DD/MM/YYYY
    SAE
    Description

    SAE

    Alias
    UMLS CUI-1
    C1519255
    Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
    Description

    Inclusion Criteria: If ‘1-8’ to PROCEDURE Timing: Ongoing Data Source: Clinical Type: Single answer

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0184661
    Please specify serious adverse event(s)
    Description

    Additional comment (not in the original standard set): Please fill in this item repeatedly if more than one serious adverse event due to procedure and provide a date for each event in a new SAEDATE item. Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Single/multiple answers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0087111
    Other SAE due to procedure, specification
    Description

    Note: This item does not exist in the original standard set. It can be filled in for specification if you ticked the item "SAE_10". Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Free text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C0332282
    UMLS CUI [1,4]
    C0184661
    UMLS CUI [1,5]
    C2348235
    Provide date(s) of serious adverse events due to procedure
    Description

    Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Date(s) Response Options: DD/MM/YYYY(s)

    Data type

    date

    Measurement units
    • DD/MM/YYYY(s)
    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C0332282
    UMLS CUI [1,4]
    C0184661
    DD/MM/YYYY(s)
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    Similar models

    Ongoing - 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
    text
    C0439564 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Item Group
    Long-term consequences of disease
    C0443252 (UMLS CUI-1)
    C0686907 (UMLS CUI-2)
    C0012634 (UMLS CUI-3)
    Item
    Indicate if the patient has died
    integer
    C0011065 (UMLS CUI [1])
    Anticoagulation therapy
    Code List
    Indicate if the patient has died
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of death
    Item
    Indicate the date of death
    date
    C1148348 (UMLS CUI [1])
    Date of death unknown
    Item
    Tick if Date of death unknown
    boolean
    C1148348 (UMLS CUI [1,1])
    C0439673 (UMLS CUI [1,2])
    Item
    Indicate cause of cardiovascular death
    integer
    C0007465 (UMLS CUI [1])
    Cause of death
    Code List
    Indicate cause of cardiovascular death
    CL Item
    an acute myocardial infarction (1)
    C0155626 (UMLS CUI-1)
    (Comment:en)
    CL Item
    sudden cardiac death (2)
    C0085298 (UMLS CUI-1)
    (Comment:en)
    CL Item
    heart failure (3)
    C0018801 (UMLS CUI-1)
    (Comment:en)
    CL Item
    stroke (4)
    C0038454 (UMLS CUI-1)
    (Comment:en)
    CL Item
    cardiovascular procedure (5)
    C0189573 (UMLS CUI-1)
    (Comment:en)
    CL Item
    cardiovascular haemorrhage (6)
    C0007222 (UMLS CUI-1)
    C0019080 (UMLS CUI-2)
    (Comment:en)
    CL Item
    other cardiovascular causes e.g. peripheral arterial disease (7)
    C0007465 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    C0007222 (UMLS CUI-3)
    C1704436 (UMLS CUI-4)
    (Comment:en)
    CL Item
    Non-cardiovascular death (8)
    C0007465 (UMLS CUI-1)
    C1298908 (UMLS CUI-2)
    C0007222 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether there was a cardiovascular event
    integer
    C1320716 (UMLS CUI [1])
    Anticoagulation therapy
    Code List
    Indicate whether there was a cardiovascular event
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate the type of cardiovascular event that occurred
    integer
    C0038454 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Ischaemic stroke
    Code List
    Indicate the type of cardiovascular event that occurred
    CL Item
    an ischaemic stroke (1)
    C0948008 (UMLS CUI-1)
    (Comment:en)
    CL Item
    a systemic embolism (2)
    C0013922 (UMLS CUI-1)
    C0205373 (UMLS CUI-2)
    (Comment:en)
    CL Item
    an unclassified stroke (3)
    C0038454 (UMLS CUI-1)
    C1298908 (UMLS CUI-2)
    C0008902 (UMLS CUI-3)
    (Comment:en)
    CL Item
    none of above (4)
    C0151453 (UMLS CUI-1)
    (Comment:en)
    Date of Cardiovascular event
    Item
    Provide the date of which the Cardiovascular event occurred
    date
    C1320716 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Indicate if a new clinical diagnosis of heart failure has been made in this patient
    integer
    C0018801 (UMLS CUI [1,1])
    C0205314 (UMLS CUI [1,2])
    C0332140 (UMLS CUI [1,3])
    Anticoagulation therapy
    Code List
    Indicate if a new clinical diagnosis of heart failure has been made in this patient
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of a new heart failure diagnosis
    Item
    Provide the date of Heart failure diagnosis
    date
    C0011008 (UMLS CUI [1,1])
    C0018801 (UMLS CUI [1,2])
    C0205314 (UMLS CUI [1,3])
    C0332140 (UMLS CUI [1,4])
    Item
    Indicate if left ventricular ejection fraction (LVEF) was measured
    integer
    C0428772 (UMLS CUI [1])
    Anticoagulation therapy
    Code List
    Indicate if left ventricular ejection fraction (LVEF) was measured
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of Left ventricular ejection fraction
    Item
    Provide date of LVEF measurement
    date
    C0011008 (UMLS CUI [1,1])
    C0428772 (UMLS CUI [1,2])
    Value of LVEF measurement
    Item
    Provide a value of LVEF measurement
    integer
    C0428772 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item
    Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
    integer
    C0184666 (UMLS CUI [1,1])
    C0038454 (UMLS CUI [1,2])
    Anticoagulation therapy
    Code List
    Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate type of cardiovascular cause
    integer
    C0332307 (UMLS CUI [1,1])
    C0184666 (UMLS CUI [1,2])
    C0038454 (UMLS CUI [1,3])
    C0085978 (UMLS CUI [1,4])
    Type of cardiovascular cause hospital admission
    Code List
    Indicate type of cardiovascular cause
    CL Item
    myocardial infarction / ischaemic heart disease (1)
    C0027051 (UMLS CUI-1)
    C1869045 (UMLS CUI-2)
    (Comment:en)
    CL Item
    heart failure (2)
    C0018801 (UMLS CUI-1)
    (Comment:en)
    CL Item
    stroke/TIA (3)
    C3844446 (UMLS CUI-1)
    (Comment:en)
    CL Item
    peripheral arterial disease (4)
    C1704436 (UMLS CUI-1)
    (Comment:en)
    CL Item
    venous thromboembolism/PE (5)
    C1861172 (UMLS CUI-1)
    (Comment:en)
    CL Item
    atrial fibrillation (6)
    C0004238 (UMLS CUI-1)
    (Comment:en)
    CL Item
    other cardiovascular cause (7)
    C0205394 (UMLS CUI-1)
    C0007226 (UMLS CUI-2)
    C0085978 (UMLS CUI-3)
    (Comment:en)
    Item
    Was a fast atrial arrhythmia detected?
    integer
    C0085611 (UMLS CUI [1,1])
    C0456962 (UMLS CUI [1,2])
    Anticoagulation therapy
    Code List
    Was a fast atrial arrhythmia detected?
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of fast atrial arrhythmia detection
    Item
    Provide the date when fast atrial arrhythmia was detected
    date
    C0085611 (UMLS CUI [1,1])
    C0456962 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Indicate type of treatment
    integer
    C0085611 (UMLS CUI [1,1])
    C0456962 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    Type of treatment
    Code List
    Indicate type of treatment
    CL Item
    Rate control drugs (1)
    C0489879 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Pharmacological cardioversion (2)
    C1963873 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Electrical cardioversion (3)
    C0013778 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Atrial ablation (4)
    C2825182 (UMLS CUI-1)
    (Comment:en)
    CL Item
    AVN/His bundle ablation (5)
    C3275044 (UMLS CUI-1)
    C2007105 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Surgical atrial ablation (6)
    C0547070 (UMLS CUI-1)
    C0543467 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Pacemaker (7)
    C0030163 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other (8)
    C0205394 (UMLS CUI-1)
    (Comment:en)
    Item
    If the patient received the treatment, indicate the type of monitoring performed post-treatment
    integer
    C0456962 (UMLS CUI [1,1])
    C0085611 (UMLS CUI [1,2])
    C0150496 (UMLS CUI [1,3])
    C2709088 (UMLS CUI [1,4])
    Fast atrial arrhythmia post treatment monitoring
    Code List
    If the patient received the treatment, indicate the type of monitoring performed post-treatment
    CL Item
    12-lead ECG (1)
    C0430456 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ambulatory monitoring (2)
    C0439841 (UMLS CUI-1)
    C0030695 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Implantable devices (3)
    C0687659 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Wearable devices/smartphones (4)
    C4505348 (UMLS CUI-1)
    (Comment:en)
    Date when each treatment started to be monitored
    Item
    Provide the date when each treatment started to be monitored
    date
    C0808070 (UMLS CUI [1,1])
    C2709088 (UMLS CUI [1,2])
    C0030695 (UMLS CUI [1,3])
    C0456962 (UMLS CUI [1,4])
    C0004238 (UMLS CUI [1,5])
    Item
    Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
    integer
    C1298908 (UMLS CUI [1,1])
    C0456962 (UMLS CUI [1,2])
    C0085611 (UMLS CUI [1,3])
    C2709088 (UMLS CUI [1,4])
    C0030695 (UMLS CUI [1,5])
    Anticoagulation therapy
    Code List
    Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Item Group
    Complications of treatment
    C0087111 (UMLS CUI-1)
    C0009566 (UMLS CUI-2)
    Item
    Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
    integer
    C0038454 (UMLS CUI [1,1])
    C0333275 (UMLS CUI [1,2])
    Anticoagulation therapy
    Code List
    Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of haemorrhagic stroke
    Item
    Please provide date of Haemorrhagic stroke
    date
    C0011008 (UMLS CUI [1,1])
    C0038454 (UMLS CUI [1,2])
    C0333275 (UMLS CUI [1,3])
    Item
    Indicate whether the patient had fatal bleeding
    integer
    C1302234 (UMLS CUI [1,1])
    C0019080 (UMLS CUI [1,2])
    Anticoagulation therapy
    Code List
    Indicate whether the patient had fatal bleeding
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of fatal bleeding
    Item
    Provide date of fatal bleeding event
    date
    C0011008 (UMLS CUI [1,1])
    C1302234 (UMLS CUI [1,2])
    C0019080 (UMLS CUI [1,3])
    Item
    Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
    integer
    C0231220 (UMLS CUI [1,1])
    C0019080 (UMLS CUI [1,2])
    C1511545 (UMLS CUI [1,3])
    C0205146 (UMLS CUI [1,4])
    C0231220 (UMLS CUI [2,1])
    C0019080 (UMLS CUI [2,2])
    C0178784 (UMLS CUI [2,3])
    Anticoagulation therapy
    Code List
    Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of symptomatic bleeding in a critical area or organ
    Item
    Provide date of symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
    date
    C0011008 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0019080 (UMLS CUI [1,3])
    C1511545 (UMLS CUI [1,4])
    C0205146 (UMLS CUI [1,5])
    C0011008 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C0019080 (UMLS CUI [2,3])
    C0178784 (UMLS CUI [2,4])
    Item
    Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
    integer
    C0019080 (UMLS CUI [1,1])
    C0678227 (UMLS CUI [1,2])
    C0547047 (UMLS CUI [1,3])
    C0019046 (UMLS CUI [1,4])
    C0019080 (UMLS CUI [2,1])
    C0678227 (UMLS CUI [2,2])
    C0686904 (UMLS CUI [2,3])
    C1879316 (UMLS CUI [2,4])
    Anticoagulation therapy
    Code List
    Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Date of when bleeding caused a fall in haemoglobin or transfusion
    Item
    Provide date of when patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
    date
    C0011008 (UMLS CUI [1,1])
    C0019080 (UMLS CUI [1,2])
    C0678227 (UMLS CUI [1,3])
    C0547047 (UMLS CUI [1,4])
    C0019046 (UMLS CUI [1,5])
    C0011008 (UMLS CUI [2,1])
    C0019080 (UMLS CUI [2,2])
    C0678227 (UMLS CUI [2,3])
    C0686904 (UMLS CUI [2,4])
    C1879316 (UMLS CUI [2,5])
    Item Group
    Procedure
    C0087111 (UMLS CUI-1)
    Item
    Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
    text
    C0455713 (UMLS CUI [1])
    Procedures
    Code List
    Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
    CL Item
    Catheter-based ablation (1)
    C2702800 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Pulmonary vein isolation (1a)
    C3544330 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Complex left atrial catheter ablation (1b)
    C2702800 (UMLS CUI-1)
    C0443246 (UMLS CUI-2)
    (Comment:en)
    CL Item
    AV node ablation (1c)
    C3275044 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Atrial flutter ablation (1d)
    C2702801 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Surgical ablation procedure (including all types of maze procedures) (2)
    C0547070 (UMLS CUI-1)
    C0543467 (UMLS CUI-2)
    C0397414 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Hybrid surgical-catheter ablation (3)
    C0004238 (UMLS CUI-1)
    C0009429 (UMLS CUI-2)
    C0547070 (UMLS CUI-3)
    C0543467 (UMLS CUI-4)
    C0397414 (UMLS CUI-5)
    C2702800 (UMLS CUI-6)
    (Comment:en)
    CL Item
    Left atrial appendage closure/occlusion (device) (4)
    C0004238 (UMLS CUI-1)
    C0205091 (UMLS CUI-2)
    C4523927 (UMLS CUI-3)
    C0004238 (UMLS CUI-5)
    C0205091 (UMLS CUI-6)
    C0441597 (UMLS CUI-7)
    (Comment:en)
    CL Item
    Left atrial appendage ligation/excision (surgical) (5)
    C0004238 (UMLS CUI-1)
    C0225860 (UMLS CUI-2)
    C0598782 (UMLS CUI-3)
    C0023690 (UMLS CUI-4)
    C0004238 (UMLS CUI-5)
    C0225860 (UMLS CUI-6)
    C0598782 (UMLS CUI-7)
    C0543467 (UMLS CUI-8)
    C0728940 (UMLS CUI-9)
    (Comment:en)
    CL Item
    Electrical cardioversion (6)
    C0004238 (UMLS CUI-1)
    C0013778 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Pacemaker implantation (7)
    C0189842 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Pharmacological cardioversion (8)
    C0004238 (UMLS CUI-1)
    C1963873 (UMLS CUI-2)
    (Comment:en)
    CL Item
    No, patient didn’t receive any of listed procedures (9)
    C0087111 (UMLS CUI-1)
    C4489286 (UMLS CUI-2)
    (Comment:en)
    Date of the procedure
    Item
    Provide date of the procedure
    date
    C2584899 (UMLS CUI [1])
    Item Group
    SAE
    C1519255 (UMLS CUI-1)
    Item
    Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
    integer
    C1519255 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [1,3])
    Anticoagulation therapy
    Code List
    Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    Item
    Please specify serious adverse event(s)
    text
    C1519255 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    Serious adverse event due to procedure
    Code List
    Please specify serious adverse event(s)
    CL Item
    In hospital death (1)
    C0277608 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Vascular complications (2)
    C1393529 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Postoperative haemorrhage (2a)
    C0032788 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Postoperative haemorrhage requiring transfusion (2b)
    C0032788 (UMLS CUI-1)
    C1514873 (UMLS CUI-2)
    C1879316 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Vascular complications (2c)
    C1393529 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Pericardial tamponade (2d)
    C0007177 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Requiring open heart surgery (3)
    C1514873 (UMLS CUI-1)
    C0189745 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Requiring repeat ablation procedure (4)
    C1514873 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    C0162563 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Ventricular arrhythmias (5)
    C0085612 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Respiratory complications (6)
    C0035237 (UMLS CUI-1)
    C0009566 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Pneumothorax (6a)
    C0032326 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Phrenic nerve palsy (6b)
    C0238371 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Pulmonary vein stenosis (6c)
    C0340756 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other iatrogenic respiratory complications (6d)
    C0205394 (UMLS CUI-1)
    C0439669 (UMLS CUI-2)
    C0035237 (UMLS CUI-3)
    C0009566 (UMLS CUI-4)
    (Comment:en)
    CL Item
    Trauma embolic complications, stroke, TIA, systemic or pulmonary embolism (7)
    C3714660 (UMLS CUI-1)
    C0013922 (UMLS CUI-2)
    C0009566 (UMLS CUI-3)
    C0038454 (UMLS CUI-5)
    C0007787 (UMLS CUI-7)
    C0205373 (UMLS CUI-9)
    C0013922 (UMLS CUI-10)
    C0034065 (UMLS CUI-12)
    (Comment:en)
    CL Item
    Postprocedure infections (8)
    C3714514 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Atrio-esophageal fistula (9)
    C3854460 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other (specify) (10)
    C0205394 (UMLS CUI-1)
    (Comment:en)
    Other SAE due to procedure, specification
    Item
    Other SAE due to procedure, specification
    text
    C0205394 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0332282 (UMLS CUI [1,3])
    C0184661 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Date(s) of Serious adverse events due to procedure
    Item
    Provide date(s) of serious adverse events due to procedure
    date
    C0011008 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0332282 (UMLS CUI [1,3])
    C0184661 (UMLS CUI [1,4])
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