Generated Narrative: Evidence

StructureDefinition Work Group: cds

url: https://fevir.net/resources/Evidence/32144

identifier: FEvIR Object Identifier: 32144

version: 1.0.0-ballot

name: ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study

title: ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)

status: active

date: 2022-05-28 11:56:53+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

author: Brian S. Alper:

copyright: Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International

relatedArtifact

type: derived-from

label: data source

display: Diabetes Surgery Study

citation: Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study [Journal Article]. Contributors: Sayeed Ikramuddin, Judith Korner, Wei-Jei Lee, Avis J Thomas, John E Connett, John P Bantle, Daniel B Leslie, Qi Wang, William B Inabnet, Robert W Jeffery, Keong Chong, Lee-Ming Chuang, Michael D Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Charles J Billington. In: JAMA, PMID 29340678. Published January 16, 2018. Available at: https://pubmed.ncbi.nlm.nih.gov/29340678/.

document

relatedArtifact

type: cite-as

citation: ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study) [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 32144. Revised 2022-05-28. Available at: https://fevir.net/resources/Evidence/32144. Computable resource at: https://fevir.net/resources/Evidence/32144.

description: Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01).

assertion: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.

variableDefinition

VariableDefinitionVariableRoleCode: population

description: Bariatric Surgery Trial Enrollment Group

note: population

variableRole: Use extension:variableRoleCode instead. (EvidenceVariableRole#population "population")

observed: Group/32145: 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) "StudyGroup_Bariatric_Surgery_Trial_Enrollment_Group"

variableDefinition

VariableDefinitionVariableRoleCode: exposure

VariableDefinitionComparatorCategory: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years

description: Group assignment

note: exposure

variableRole: Use extension:variableRoleCode instead. (EvidenceVariableRole#exposure "exposure")

observed: EvidenceVariable/172481: GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone "GroupAssignment_Roux_en_Y_gastric_bypass_surgery_vs_Lifestyle_intensive_medical_management_intervention_alone"

variableDefinition

VariableDefinitionVariableRoleCode: outcome

description: American Diabetes Association composite triple end point for metabolic control at 5 years *NOTE: note.text is used artificially to support the EBMonFHIR Implementation Guide and the following content would more properly be found in a note.text element:* The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years

note: outcome

variableRole: Use extension:variableRoleCode instead. (EvidenceVariableRole#measuredVariable "measured variable")

observed: EvidenceVariable/32143: OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years "OutcomeVariable_American_Diabetes_Association_composite_triple_end_point_for_metabolic_control_at_5_years"

synthesisType: not applicable (StatisticSynthesisType#NotApplicable)

studyDesign: randomized assignment (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:01003)

statistic

description: Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01).

statisticType: Risk Difference (StatisticStatisticType[4.4.0]#0000424)

quantity: 0.19

numberAffected: 15

SampleSizes

-	NumberOfStudies	NumberOfParticipants	KnownDataCount
*	1	120	98

AttributeEstimates

-	Type	Level	Range
*	Confidence interval (StatisticAttribute Estimate Type#C53324)	0.95	0.04-0.34