Generated Narrative: Evidence

StructureDefinition Work Group: cds

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

identifier: FEvIR Object Identifier: 33244

version: 1.0.0-ballot

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: HL7 International / Clinical Decision Support

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

author: Brian S. Alper:

UseContexts

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/.

document

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: Citation/33089: 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

VariableDefinitionVariableRoleCode: population

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).

note: population

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

observed: Group/33395: MetaanalysisStudyGroup: Study results included in Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis

intended: Group/175766: MetaanalysisEligibilityCriteria: Mean difference in HbA1c effect of bariatric surgery in type 2 diabetes and elevated BMI in 2016 meta-analysis "MetaanalysisEligibilityCriteria_Mean_difference_in_HbA1c_effect_of_bariatric_surgery_in_type_2_diabetes_and_elevated_BMI_in_2016_meta_analysis"

variableDefinition

VariableDefinitionVariableRoleCode: exposure

VariableDefinitionComparatorCategory: no bariatric surgery

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).

note: exposure

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

intended: EvidenceVariable/172427: GroupAssignment: Bariatric Surgery vs. no bariatric surgery "GroupAssignment_Bariatric_Surgery_vs_no_bariatric_surgery"

variableDefinition

VariableDefinitionVariableRoleCode: outcome

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

note: outcome

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

observed: EvidenceVariable/46025: OutcomeVariable: Mean difference in HbA1c between Surgery and Medical/Lifestyle groups at end of follow-up for HbA1c end point "OutcomeVariable_Mean_difference_in_HbA1c_between_Surgery_and_Medical_Lifestyle_groups_at_end_of_follow_up"

synthesisType: summary data meta-analysis (StatisticSynthesisType[3.1.0]#std-MA)

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

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. (StatisticStatisticType#0000457 "Mean Difference")

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

SampleSizes

-	Description	NumberOfStudies	NumberOfParticipants	KnownDataCount
*	15 studies with 1067 participants contributing to analysis	15	0	1067

attributeEstimate

description: 95% CI -1.57% to -0.71%

type: Confidence interval (StatisticAttribute Estimate Type#C53324)

level: 0.95

range: -1.57--0.71 %

attributeEstimate

description: z = 5.20

type: Z-score (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")

quantity: 5.2

attributeEstimate

description: p < 0.00001

type: P-value (StatisticAttribute Estimate Type#C44185)

quantity: <0.00001

attributeEstimate

description: Tau squared = 0.63

type: Tau squared (StatisticAttribute Estimate Type#0000421)

quantity: 0.63

attributeEstimate

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

type: Chi square for homogeneity (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")

quantity: 200.88

AttributeEstimates

-	Description	Type	Quantity
*	degrees of freedom (df) = 14	Degrees of Freedom (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")	14
*	p < 0.00001	P-value (StatisticAttribute Estimate Type#C44185)	<0.00001

attributeEstimate

description: I-squared = 93%

type: I-squared (StatisticAttribute Estimate Type#0000420)

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

modelCharacteristic

code: Meta-analysis (Statistic Model Code#metaAnalysis)

modelCharacteristic

code: Random-effects (Statistic Model Code#effectsRandom)