Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot International flag

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 2.0.0-ballot 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

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

Active as of 2022-05-28

Generated Narrative: Evidence 32144

version: 20; Last updated: 2023-12-06 17:46:14+0000

Profiles: ComparativeEvidence, SingleStudyEvidence

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

identifier: FEvIR Object Identifier/32144, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.22.10

version: 2.0.0-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/.

Documents

-Url
*https://fevir.net/resources/Citation/32147

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

org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code: population

description:

Bariatric Surgery Trial Enrollment Group

note: population

observed: 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)

variableDefinition

org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code: exposure

org/fhir/uv/ebm/StructureDefinition/variable-definition-comparator-category: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years

description:

Group assignment

note: exposure

observed: GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone

variableDefinition

org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code: 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

observed: OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years

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%; P = .01).

statisticType: Risk Difference

quantity: 0.19

numberAffected: 15

SampleSizes

-NumberOfStudiesNumberOfParticipantsKnownDataCount
*112098

AttributeEstimates

-TypeLevelRange
*Confidence interval0.950.04-0.34