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: Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis

Generated Narrative: Evidence 33244

version: 36; Last updated: 2023-12-08 16:30:32+0000

Profiles: ComparativeEvidence, EvidenceSynthesisEvidence

url: https://fevir.net/resources/Evidence/33244

identifier: FEvIR Object Identifier/33244

name: MeanDiffA1c2016metaAnalysis

title: ComparativeEvidence: Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis

status: Active

date: 2022-05-28 12:01:55+0000

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

author: Brian S. Alper:

UseContexts

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationComparativeEvidence
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationEvidenceSynthesisEvidence

copyright:

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

relatedArtifact

type: Derived From

label: data source

display: Figure 2C

citation:

Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations [Journal Article]. Contributors: Francesco Rubino, David M Nathan, Robert H Eckel, Philip R Schauer, K George M M Alberti, Paul Z Zimmet, Stefano Del Prato, Linong Ji, Shaukat M Sadikot, William H Herman, Stephanie A Amiel, Lee M Kaplan, Gaspar Taroncher-Oldenburg, David E Cummings, Delegates of the 2nd Diabetes Surgery Summit. In: Diabetes care, PMID 27222544. Published June 2016. Available at: https://pubmed.ncbi.nlm.nih.gov/27222544/.

Documents

-Url
*https://diabetesjournals.org/care/article/39/6/861/29305/Metabolic-Surgery-in-the-Treatment-Algorithm-for

relatedArtifact

type: Supported With

classifier: Citation Resource for the original article

display: Citation Resource for Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations - PMID 27222544

resourceReference: Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations-Citation

relatedArtifact

type: Cite As

citation:

ComparativeEvidence: Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 33244. Revised 2022-05-28. Available at: https://fevir.net/resources/Evidence/33244. Computable resource at: https://fevir.net/resources/Evidence/33244.

description:

effect estimate for differences in mean HbA1c at study end point between Surgery and Medical/Lifestyle groups -1.14% (95% CI -1.57% to -0.71%) in meta-analysis of 15 trials with 1,067 participants

note: summary derived from Figure 2C as data not reported in the text

variableDefinition

description:

Patients with type 2 diabetes 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 observed element can reference a Group Resource that represents an actual group of studies included and has a quantity. The quantity would be the number of members (number of studies), and the characteristic can be code 'Member of' and valueReference EvidenceList with an EvidenceList that can reference the Evidence Resources representing the individual study results. This meta-analysis included 15 studies. The intended element (if desired) can reference a Group Resource that expresses the population of studies intended for evidence application through structured characteristics. The structured characteristics could be used to express the SR eligibility criteria for participants (i.e. included studies). The included trials included patients with T2D, including mainly individuals with BMI ≥35 kg/m2 (the most commonly used threshold for traditional bariatric surgery) as well as some patients with BMI <35 kg/m2 (range 25–35 kg/m2).

variableRole: Population

observed: MetaanalysisStudyGroup: Study results included in Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis

intended: MetaanalysisEligibilityCriteria: Mean difference in HbA1c effect of bariatric surgery in type 2 diabetes and elevated BMI in 2016 meta-analysis

variableDefinition

description:

Any of 4 bariatric surgery procedures (Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy, Laparoscopic Adjustable Gastric banding, Biliopancreatic Diversion) vs. Medical/lifestyle interventions 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: As the control group (observed reference exposure) was defined differently in each trial, the intended reference exposure is described as the absence of the intended exposure (Bariatric Surgery).

variableRole: Exposure

comparatorCategory: no bariatric surgery

intended: GroupAssignment: Bariatric Surgery vs. no bariatric surgery

variableDefinition

description:

Mean difference in HbA1c between Surgery and Medical/Lifestyle groups at end of follow-up for HbA1c end point

variableRole: Outcome

observed: OutcomeVariable: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups at end of follow-up for HbA1c end point

synthesisType: summary data meta-analysis

studyDesign: randomized assignment

statistic

description:

mean difference in HbA1c -1.14% (95% CI -1.57% to -0.71%)

note: random-effects model, heterogeneity tau-squared 0.63; chi-squared 200.88, df 14 (p < 0.00001), I-squared 93%, test for overall effect z = 5.20 (p < 0.00001)

statisticType: A mean of values in which each value is the subtraction of one quantity from another.

quantity: -1.14 % (Details: UCUM code% = '%')

SampleSizes

-DescriptionNumberOfStudiesNumberOfParticipantsKnownDataCount
*

15 studies with 1067 participants contributing to analysis

1501067

attributeEstimate

description:

95% CI -1.57% to -0.71%

type: Confidence interval

level: 0.95

range: -1.57--0.71 %

attributeEstimate

description:

z = 5.20

type: Z-score

quantity: 5.2

attributeEstimate

description:

p < 0.00001

type: P-value

quantity: <0.00001

attributeEstimate

description:

Tau squared = 0.63

type: Tau squared

quantity: 0.63

attributeEstimate

description:

Chi square for homogeneity 200.88, df 14 (p < 0.00001)

type: Chi square for homogeneity

quantity: 200.88

AttributeEstimates

-DescriptionTypeQuantity
*

degrees of freedom (df) = 14

Degrees of Freedom14
*

p < 0.00001

P-value<0.00001

attributeEstimate

description:

I-squared = 93%

type: I-squared

quantity: 93 % (Details: UCUM code% = '%')

modelCharacteristic

code: Meta-analysis

modelCharacteristic

code: Random-effects