0 Ratings
ID

42324

Description

Statin Discontinuation in Advanced Illness; ODM derived from: https://clinicaltrials.gov/show/NCT01415934

Link

https://clinicaltrials.gov/show/NCT01415934

Keywords

Versions (2)
  1. 5/28/21 5/28/21 -
  2. 6/11/21 6/11/21 -
Copyright Holder

University of Colorado, Denver

Uploaded on

June 11, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Palliative Medicine NCT01415934

    English

    Eligibility Palliative Medicine NCT01415934

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    at least 18 years old
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    have an advanced life-limiting illness
    Description

    Advanced life-limiting illness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205179
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [1,4]
    C0023671
    have a life expectancy of >1 month, and patient exhibits declining functional status, defined as a reduction in australia-modified karnofsky performance status (akps)22 score to <80 % in the previous 3 months
    Description

    Life expectancy | functional status worsening pattern recent | Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    UMLS CUI [2,1]
    C0598463
    UMLS CUI [2,2]
    C0332271
    UMLS CUI [2,3]
    C0332185
    UMLS CUI [3]
    C0206065
    statin medication for primary or secondary prevention of cardiovascular disease for ≥3 months;
    Description

    Statin prophylaxis cardiovascular disease duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0360714
    UMLS CUI [1,2]
    C0199176
    UMLS CUI [1,3]
    C0007222
    UMLS CUI [1,4]
    C0449238
    have adequately intact cognitive status to provide informed consent and complete the baseline assessment, as evidenced by a short portable mental status questionnaire (spmsq)23 score of ≥6;
    Description

    Cognitive functions informed consent | baseline assessment | mental status questionnaire

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392335
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [2,1]
    C0392335
    UMLS CUI [2,2]
    C1442488
    UMLS CUI [2,3]
    C1516048
    UMLS CUI [3]
    C0451291
    provide informed consent
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    speak and read english at or above a grade 5 level (per patient or caregiver report)
    Description

    English literacy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0564215
    UMLS CUI [1,2]
    C0376245
    UMLS CUI [2,1]
    C0586740
    UMLS CUI [2,2]
    C0376245
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    primary treating physician/care provider estimates patient's life expectancy as <1 month
    Description

    Estimated life expectancy by clinician

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023671
    UMLS CUI [1,2]
    C0022423
    UMLS CUI [1,3]
    C1710470
    under the care of a primary treating physician/primary care provider who is unwilling to have the patient enrolled;
    Description

    Primary clinician unwilling to enroll patient

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0871685
    UMLS CUI [1,3]
    C0034866
    UMLS CUI [1,4]
    C1136454
    not consenting
    Description

    Not consenting

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0332197
    having known active cardiovascular disease or sufficient risk of active cardiovascular disease to require ongoing therapy with statin drugs, in the opinion of the treating physician
    Description

    Cardiovascular disease | heart disease risk factors | requirement statin drugs judgment treating physician

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007222
    UMLS CUI [2]
    C0850624
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C0360714
    UMLS CUI [3,3]
    C0022423
    UMLS CUI [3,4]
    C1710470
    exhibiting obvious symptoms of myositis, known liver function test (lft) abnormalities of >2.5x the upper limit of normal (uln), known creatine kinase (ck) abnormalities of >2.5x uln, or other contraindications to continuing statins, in the opinion of the treating physician
    Description

    Myositis | liver function abnormal | ck measurement abnormal | Medical contraindications to statin treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027121
    UMLS CUI [2,1]
    C0232741
    UMLS CUI [2,2]
    C0205161
    UMLS CUI [3,1]
    C0201973
    UMLS CUI [3,2]
    C0205161
    UMLS CUI [4,1]
    C1301624
    UMLS CUI [4,2]
    C0360714
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    Similar models

    Eligibility Palliative Medicine NCT01415934

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    at least 18 years old
    boolean
    C0001779 (UMLS CUI [1])
    Advanced life-limiting illness
    Item
    have an advanced life-limiting illness
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C0023671 (UMLS CUI [1,4])
    Life expectancy | functional status worsening pattern recent | Karnofsky Performance Status
    Item
    have a life expectancy of >1 month, and patient exhibits declining functional status, defined as a reduction in australia-modified karnofsky performance status (akps)22 score to <80 % in the previous 3 months
    boolean
    C0023671 (UMLS CUI [1])
    C0598463 (UMLS CUI [2,1])
    C0332271 (UMLS CUI [2,2])
    C0332185 (UMLS CUI [2,3])
    C0206065 (UMLS CUI [3])
    Statin prophylaxis cardiovascular disease duration
    Item
    statin medication for primary or secondary prevention of cardiovascular disease for ≥3 months;
    boolean
    C0360714 (UMLS CUI [1,1])
    C0199176 (UMLS CUI [1,2])
    C0007222 (UMLS CUI [1,3])
    C0449238 (UMLS CUI [1,4])
    Cognitive functions informed consent | baseline assessment | mental status questionnaire
    Item
    have adequately intact cognitive status to provide informed consent and complete the baseline assessment, as evidenced by a short portable mental status questionnaire (spmsq)23 score of ≥6;
    boolean
    C0392335 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392335 (UMLS CUI [2,1])
    C1442488 (UMLS CUI [2,2])
    C1516048 (UMLS CUI [2,3])
    C0451291 (UMLS CUI [3])
    Informed consent
    Item
    provide informed consent
    boolean
    C0021430 (UMLS CUI [1])
    English literacy
    Item
    speak and read english at or above a grade 5 level (per patient or caregiver report)
    boolean
    C0564215 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    C0586740 (UMLS CUI [2,1])
    C0376245 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Estimated life expectancy by clinician
    Item
    primary treating physician/care provider estimates patient's life expectancy as <1 month
    boolean
    C0023671 (UMLS CUI [1,1])
    C0022423 (UMLS CUI [1,2])
    C1710470 (UMLS CUI [1,3])
    Primary clinician unwilling to enroll patient
    Item
    under the care of a primary treating physician/primary care provider who is unwilling to have the patient enrolled;
    boolean
    C2348568 (UMLS CUI [1,1])
    C0871685 (UMLS CUI [1,2])
    C0034866 (UMLS CUI [1,3])
    C1136454 (UMLS CUI [1,4])
    Not consenting
    Item
    not consenting
    boolean
    C0021430 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Cardiovascular disease | heart disease risk factors | requirement statin drugs judgment treating physician
    Item
    having known active cardiovascular disease or sufficient risk of active cardiovascular disease to require ongoing therapy with statin drugs, in the opinion of the treating physician
    boolean
    C0007222 (UMLS CUI [1])
    C0850624 (UMLS CUI [2])
    C1514873 (UMLS CUI [3,1])
    C0360714 (UMLS CUI [3,2])
    C0022423 (UMLS CUI [3,3])
    C1710470 (UMLS CUI [3,4])
    Myositis | liver function abnormal | ck measurement abnormal | Medical contraindications to statin treatment
    Item
    exhibiting obvious symptoms of myositis, known liver function test (lft) abnormalities of >2.5x the upper limit of normal (uln), known creatine kinase (ck) abnormalities of >2.5x uln, or other contraindications to continuing statins, in the opinion of the treating physician
    boolean
    C0027121 (UMLS CUI [1])
    C0232741 (UMLS CUI [2,1])
    C0205161 (UMLS CUI [2,2])
    C0201973 (UMLS CUI [3,1])
    C0205161 (UMLS CUI [3,2])
    C1301624 (UMLS CUI [4,1])
    C0360714 (UMLS CUI [4,2])
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