Generated Narrative: Group

Artifact related artifact:

Artifact URL: https://fevir.net/resources/Group/170443

Artifact Date: 2022-09-09 10:30:50+0000

Artifact Publisher: Computable Publishing LLC

Artifact Copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/

Artifact Contact: support@computablepublishing.com

Artifact Author: Brian S. Alper:

CombinationMethod: all-of

modifierExtension[http://hl7.org/fhir/StructureDefinition/artifact-status]

identifier: FEvIR Object Identifier: 170443

type: animal

membership: definitional

name: StudyEligibilityCriteria_Eligibility_Criteria_for_Bariatric_Surgery_Randomized_Trial_Diabetes_Surgery_Study

description: Inclusion Criteria: Age 30 to 67 years at eligibility visit. Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0%. Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit. Willingness to accept random assignment to either treatment group. Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial. Willingness to comply with the follow-up protocol and successful completion of the run-in. Written informed consent. ///// Exclusion Criteria: Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months. Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. Cardiac stress test indicating that surgery or IMM would not be safe. Pulmonary embolus or thrombophlebitis in the past six months. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years. Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. Serum creatinine ≥ 1.5 mg/dl. HbA1c > 14.0%.

characteristic

CharacteristicDescription: Age 30 to 67 years at eligibility visit.

CharacteristicTiming

url

contextCode

value: Assessment of eligibility for clinical trial (procedure) (SNOMED CT#450332002)

url

offset

value: 0

url

text

value: at eligibility visit

code: Age (SNOMED CT#397669002)

value: 30-67

exclude: false

characteristic

CharacteristicDescription: Diagnosed with T2DM at least 6 months prior to enrollment

CharacteristicDurationDuration: >=6 months (Details: UCUM code mo = 'mo')

code: Disease (disorder) (SNOMED CT#64572001; All FHIR Types#Condition "Condition")

value: Diabetes mellitus type 2 (disorder) (SNOMED CT#44054006)

exclude: false

characteristic

CharacteristicDescription: under the active care of a doctor for at least the six months prior to enrollment

CharacteristicTiming

url

contextCode

value: Assessment of eligibility for clinical trial (procedure) (SNOMED CT#450332002)

url

offset

value: -6-0

url

text

value: for at least the six months prior to enrollment (presence throughout the range is equivalent to 'for at least the six months prior to')

code: Defined by CodeableConcept ()

value: under the active care of a doctor (SNOMED CT#305450004 "Under care of doctor (finding)")

exclude: false

characteristic

CharacteristicDescription: HbA1c ≥ 8.0%

code: Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol (LOINC#59261-8)

value: >=8 % (Details: UCUM code % = '%')

exclude: false

characteristic

CharacteristicDescription: Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.

CharacteristicTiming

url

contextCode

value: Assessment of eligibility for clinical trial (procedure) (SNOMED CT#450332002)

url

offset

value: 0

url

text

value: at eligibility visit

code: Body mass index (BMI) [Ratio] (LOINC#39156-5)

value: 30-39.9

exclude: false

characteristic

CharacteristicDescription: Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.

CharacteristicTiming

url

contextCode

value: Assessment of eligibility for clinical trial (procedure) (SNOMED CT#450332002)

url

offset

value: -6-0 months

url

text

value: occurrence within the range is equivalent to 'in the past six months'

code: Defined by Reference ()

value: Group/170442: CohortDefinition: Cardiovascular event "CohortDefinition_Cardiovascular_event"

exclude: true

characteristic

CharacteristicDescription: Pulmonary embolus in the past six months.

CharacteristicTiming

url

contextCode

value: Assessment of eligibility for clinical trial (procedure) (SNOMED CT#450332002)

url

offset

value: -6-0 months

url

text

value: in the past six months

code: Disease (disorder) (SNOMED CT#64572001; All FHIR Types#Condition "Condition")

value: Pulmonary embolism (disorder) (SNOMED CT#59282003)

exclude: true

characteristic

CharacteristicDescription: Thrombophlebitis in the past six months.

CharacteristicTiming

url

contextCode

value: Assessment of eligibility for clinical trial (procedure) (SNOMED CT#450332002)

url

offset

value: -6-0 months

url

text

value: in the past six months

code: Disease (disorder) (SNOMED CT#64572001; All FHIR Types#Condition "Condition")

value: Thrombophlebitis (disorder) (SNOMED CT#64156001)

exclude: true

characteristic

CharacteristicDescription: Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.

code: Defined by Reference ()

value: Group/170441: CohortDefinition: Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years "CohortDefinition_Cancer_of_any_kind_except_basal_cell_skin_cancer_or_cancer_in_situ_unless_documented_to_be_disease_free_for_five_years"

exclude: true

characteristic

CharacteristicDescription: Significant anemia (hemoglobin 1.0 g or more below normal range)

CharacteristicOffset: Lower Normal Limit (Characteristic Offset#LNL)

code: Hemoglobin [Mass/volume] in Blood (LOINC#718-7)

value: <=-1 g/dL (Details: UCUM code g/dL = 'g/dL')

exclude: true

characteristic

CharacteristicDescription: Serum creatinine ≥ 1.5 mg/dl

code: Creatinine [Mass/volume] in Serum or Plasma (LOINC#2160-0)

value: >=1.5 mg/dl (Details: UCUM code mg/dL = 'mg/dL')

exclude: true

characteristic

CharacteristicDescription: HbA1c ≥ 14.0%

code: Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol (LOINC#59261-8)

value: >=14 % (Details: UCUM code % = '%')

exclude: true