ID

42324

Description

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

Lien

https://clinicaltrials.gov/show/NCT01415934

Mots-clés

Versions (2)
  1. 28/05/2021 28/05/2021 -
  2. 11/06/2021 11/06/2021 -
Détendeur de droits

University of Colorado, Denver

Téléchargé le

11 juin 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Palliative Medicine NCT01415934

Anglais

Eligibility Palliative Medicine NCT01415934

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years old
Description

Age

Type de données

boolean

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

Advanced life-limiting illness

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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