Generated Narrative: EvidenceVariable

identifier: FEvIR Object Identifier: 32120

name: StudyEligibilityCriteriaEligibilityCriteriaForBariatricSurgeryRandomizedTrialDiabetesSurgeryStudy

title: StudyEligibilityCriteria: Eligibility Criteria for Bariatric Surgery Randomized Trial (Diabetes Surgery Study)

status: active

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

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%.

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

effectivePeriod: 2008-02 --> 2016-12

author: Brian S. Alper:

actual: true

characteristic

description: Age 30 to 67 years at eligibility visit.

exclude: false

DefinitionByTypeAndValues

-	Type	Value[x]
*	Age (SNOMED CT#397669002)	30-67 years

TimeFromEvents

-	Description	Event[x]	Quantity
*	at eligibility visit	EligibilityVisit	0

characteristic

description: 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%.

exclude: false

definitionByCombination

code: all-of

characteristic

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

exclude: false

definitionByTypeAndValue

timeFromEvent

characteristic

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

note: assumption that active care means active care of type 2 diabetes mellitus

exclude: false

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

timeFromEvent

characteristic

description: HbA1c ≥ 8.0%

note: assumption that this is the last recorded HbA1c before the enrollment visit, but not explicitly stated in the short-phrase Eligibility Criteria

exclude: false

definitionByTypeAndValue

characteristic

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

exclude: false

DefinitionByTypeAndValues

-	Type	Value[x]
*	Body mass index (BMI) [Ratio] (LOINC#39156-5)	30-39.9 kg/m2

TimeFromEvents

-	Description	Event[x]	Quantity
*	at eligibility visit	EligibilityVisit	0

characteristic

description: Willingness to accept random assignment to either treatment group.

exclude: false

characteristic

description: Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.

exclude: false

characteristic

description: Willingness to comply with the follow-up protocol and successful completion of the run-in.

exclude: false

characteristic

linkId: EligibilityVisit

description: Written informed consent.

note: The example used here acknowledges attainment of the written informed consent at the eligibility visit (which is also the time of enrollment) so is referencing this characteristic with the linkId EligibilityVisit to be used as a reference point from timeFromEvent in the specification of other characteristics.

exclude: false

TimeFromEvents

-	Event[x]
*	Assessment of eligibility for clinical trial (procedure) (SNOMED CT#450332002)

characteristic

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

exclude: true

definitionByCombination

code: any-of

characteristic

description: myocardial infarction

definitionByTypeAndValue

characteristic

description: acute coronary syndrome

definitionByTypeAndValue

characteristic

description: coronary artery angioplasty or bypass

definitionByTypeAndValue

characteristic

description: stroke

definitionByTypeAndValue

TimeFromEvents

-	Description	Note	Event[x]	Range
*	in the past six months	occurrence within the range is equivalent to 'in the past six months'	EligibilityVisit	-6-0 months

characteristic

description: Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.

note: This may be possible to encode as presence of Disease(disorder) without 'in remission'

exclude: true

characteristic

description: Cardiac stress test indicating that surgery or IMM would not be safe.

exclude: true

characteristic

description: Pulmonary embolus in the past six months.

exclude: true

DefinitionByTypeAndValues

-	Type	Value[x]
*	Disease (disorder) (SNOMED CT#64572001; resource-types#Condition "Condition")	Pulmonary embolism (disorder) (SNOMED CT#59282003)

TimeFromEvents

-	Description	Note	Event[x]	Range
*	in the past six months	occurrence within the range is equivalent to 'in the past six months'	EligibilityVisit	-6-0 months

characteristic

description: Thrombophlebitis in the past six months.

exclude: true

DefinitionByTypeAndValues

-	Type	Value[x]
*	Disease (disorder) (SNOMED CT#64572001; resource-types#Condition "Condition")	Thrombophlebitis (disorder) (SNOMED CT#64156001)

TimeFromEvents

-	Description	Note	Event[x]	Range
*	in the past six months	occurrence within the range is equivalent to 'in the past six months'	EligibilityVisit	-6-0 months

characteristic

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

exclude: true

definitionByCombination

code: all-of

characteristic

description: Cancer of any kind

exclude: false

definitionByTypeAndValue

characteristic

description: (except basal cell skin cancer)

exclude: true

definitionByTypeAndValue

characteristic

description: (except cancer in situ)

exclude: true

definitionByTypeAndValue

characteristic

description: unless documented to be disease-free for five years

exclude: true

definitionCodeableConcept: No evidence of cancer found (situation) (SNOMED CT#395100000)

timeFromEvent

characteristic

description: History of coagulopathy

exclude: true

characteristic

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

exclude: true

DefinitionByTypeAndValues

-	Type	Value[x]	Offset
*	Hemoglobin [Mass/volume] in Blood (LOINC#718-7)	<=-1 g/dL (Details: UCUM code g/dL = 'g/dL')	Lower Normal Limit (Characteristic Offset#LNL)

characteristic

description: Serum creatinine ≥ 1.5 mg/dl

exclude: true

DefinitionByTypeAndValues

-	Type	Value[x]
*	Creatinine [Mass/volume] in Serum or Plasma (LOINC#2160-0)	>=1.5 mg/dl (Details: UCUM code mg/dL = 'mg/dL')

characteristic

description: HbA1c ≥ 14.0%

exclude: true

DefinitionByTypeAndValues

-	Type	Value[x]
*	Hemoglobin A1c/Hemoglobin.total in Blood (LOINC#59261-8)	>=14 % (Details: UCUM code % = '%')