Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
version: 20; Last updated: 2023-12-06 17:46:14+0000
Profiles: ComparativeEvidence, SingleStudyEvidence
ArtifactPublicationStatus: Active
url: https://fevir.net/resources/Evidence/32144
identifier: FEvIR Object Identifier/32144
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
author: Brian S. Alper:
publisher: Computable Publishing LLC
contact: support@computablepublishing.com
copyright:
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International
relatesTo
type: Derived From
relatesTo
type: Cite As
target:
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%; Pā=ā.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
description:
Bariatric Surgery Trial Enrollment Group
variableRole: Population
variableDefinition
description:
Group assignment
variableRole: Exposure
comparatorCategory: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years
variableDefinition
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
variableRole: Outcome
synthesisType: not applicable
studyDesign: randomized assignment
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%; Pā=ā.01).
statisticType: Risk Difference
quantity: 0.19
numberAffected: 15
SampleSizes
NumberOfStudies NumberOfParticipants KnownDataCount 1 120 98 AttributeEstimates
Type Level Range Confidence interval 0.95 0.04-0.34