Evidence Based Medicine on FHIR Implementation Guide
1.0.0-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 1.0.0-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: All-cause mortality effect of bariatric surgery in 2022 meta-analysis

Active as of 2022-09-19

Generated Narrative: Evidence

Resource Evidence "49328" Version "25" Updated "2023-12-08 16:33:14+0000"

Profiles: ComparativeEvidence, EvidenceSynthesisEvidence

url: https://fevir.net/resources/Evidence/49328

identifier: FEvIR Object Identifier/49328

version: 1.0.0-ballot

name: AllCauseMortality2022metaAnalysis

title: ComparativeEvidence: All-cause mortality effect of bariatric surgery in 2022 meta-analysis

status: active

date: 2022-09-19 21:27:50+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

-CodeValue[x]
*Evidence Communication (Details: https://fevir.net/resources/CodeSystem/179423 code evidence-communication = 'Evidence Communication', stated as 'Evidence Communication')ComparativeEvidence (Evidence Based Medicine on FHIR Implementation Guide Code System#ComparativeEvidence)
*Evidence Communication (Details: https://fevir.net/resources/CodeSystem/179423 code evidence-communication = 'Evidence Communication', stated as 'Evidence Communication')EvidenceSynthesisEvidence (Evidence Based Medicine on FHIR Implementation Guide Code System#EvidenceSynthesisEvidence)
*Evidence Communication (Details: https://fevir.net/resources/CodeSystem/179423 code evidence-communication = 'Evidence Communication', stated as 'Evidence Communication')OutcomeMeasureEvidence (Evidence Based Medicine on FHIR Implementation Guide Code System#OutcomeMeasureEvidence)

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

relatedArtifact

type: derived-from

label: data source

citation: Bariatric surgery and cardiovascular disease: a systematic review and meta-analysis [Journal Article]. Contributors: van Veldhuisen SL, Gorter TM, van Woerden G, de Boer RA, Rienstra M, Hazebroek EJ, van Veldhuisen DJ. In: European heart journal, PMID 35243488. Published March 04, 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/35243488/.

document

relatedArtifact

type: supported-with

classifier: Citation Resource for the original article ()

display: Citation Resource for 2022 Systematic Review of bariatric surgery mortality effect - PMID 35243488

resourceReference: Citation/33400: StudyCitation: 2022 Systematic Review of bariatric surgery mortality effect 35243488

relatedArtifact

type: cite-as

citation: ComparativeEvidence: All-cause mortality effect of bariatric surgery in 2022 meta-analysis [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 49328. Revised 2022-09-19. Available at: https://fevir.net/resources/Evidence/49328. Computable resource at: https://fevir.net/resources/Evidence/49328.

description: effect estimate for bariatric surgery on all-cause mortality pooled hazard ratio (HR) 0.55 (95% confidence interval 0.49 to 0.62; P < 0.001 vs. controls) in meta-analysis of 21 cohort studies with 133,524 patients after bariatric surgery and 263,478 obese controls

assertion: The present systematic review and meta-analysis suggests that bariatric surgery is associated with reduced all-cause and CV mortality.

variableDefinition

VariableDefinitionVariableRoleCode: population

description: obese, adult (age ≥18 years old) patients *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:* Studies were considered eligible if they were designed to study outcomes in obese patients who underwent a weight-loss surgical intervention in comparison with an age, sex, and BMI matched control group who did not undergo a weight-loss surgical intervention. We searched for randomized controlled trials, prospective or retrospective longitudinal cohort studies, and case–control studies. For the control group, all non-surgical treatment options for obesity (e.g. intensive lifestyle intervention, standard of care, or no specific therapy) were accepted. Studies were excluded if (i) patients were not matched for age, sex, and BMI; (ii) the presence of one or more outcome parameters of interest (e.g. HF, AF, coronary artery disease) was required for inclusion; or (iii) if study groups were not representative in relation to the general population of patients with obesity (e.g. patients could only be included in the presence of a specific comorbidity, for instance, end-stage renal disease). The third criterium did not apply to Type 2 diabetes, thus studies that only included patients with Type 2 diabetes could be eligible for inclusion.

note: population

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

intended: Group/171819: StudyEligibilityCriteria: Obese patients ≥ 18 years old "StudyEligibilityCriteria_Obese_patients_18_years_old"

variableDefinition

VariableDefinitionVariableRoleCode: exposure

VariableDefinitionComparatorCategory: no bariatric surgery

description: comparison groups of bariatric surgery vs. no bariatric surgery *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 study, 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: All-cause mortality *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 an EvidenceVariable Resource that defines the outcome measured through structured characteristics. For example, “Mean difference in HbA1c at 12 months” or “Mean difference in HbA1c at end of study”. The structured characteristics can be references to the Evidence instances for each of the included studies, in which case this is a direct link to the dataset used for analysis. The intended element can reference an EvidenceVariable Resource that expresses the outcome intended for evidence application through structured characteristics. The structured characteristics could be used to express the SR eligibility criteria for study outcomes (as a subset of eligibility criteria for studies).

note: outcome

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

observed: : We searched for randomized controlled trials, prospective or retrospective longitudinal cohort studies, and case–control studies. For the control group, all non-surgical treatment options for obesity (e.g. intensive lifestyle intervention, standard of care, or no specific therapy) were accepted. Studies were excluded if (i) patients were not matched for age, sex, and BMI; (ii) the presence of one or more outcome parameters of interest (e.g. HF, AF, coronary artery disease) was required for inclusion; or (iii) if study groups were not representative in relation to the general population of patients with obesity (e.g. patients could only be included in the presence of a specific comorbidity, for instance, end-stage renal disease). The third criterium did not apply to Type 2 diabetes, thus studies that only included patients with Type 2 diabetes could be eligible for inclusion.

intended: EvidenceVariable/49217: OutcomeVariable: All-cause mortality "OutcomeVariable_All_cause_mortality"

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

studyDesign: Observational research (Study Design[5.0.0-cibuild]#SEVCO:01002), Parallel cohort design (Study Design[5.0.0-cibuild]#SEVCO:01011), Matching for comparison (Study Design[5.0.0-cibuild]#SEVCO:01014)

statistic

description: pooled hazard ratio (HR) 0.55 (95% confidence interval 0.49 to 0.62; P < 0.001 vs. controls) in meta-analysis of 21 cohort studies with 133,524 patients after bariatric surgery and 263,478 obese controls

note: heterogeneity: Tau2 = 0.06; Chi2 = 105.14; df = 23 (P < 0.00001); I2 = 78%, test for overall effect z = 9.41 (p < 0.00001)

statisticType: Hazard Ratio (StatisticStatisticType#C93150)

quantity: 0.55

SampleSizes

-DescriptionNumberOfStudiesNumberOfParticipants
*21 cohort studies with 133,524 patients after bariatric surgery and 263,478 obese controls21397002

attributeEstimate

description: 95% confidence interval 0.49 to 0.62

type: Confidence interval (StatisticAttribute Estimate Type#C53324)

level: 0.95

range: 0.49-0.62

attributeEstimate

description: z = 9.41

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

quantity: 9.41

attributeEstimate

description: p < 0.00001

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

quantity: <0.00001

attributeEstimate

description: Tau squared = 0.06

type: Tau squared (StatisticAttribute Estimate Type#0000421)

quantity: 0.06

attributeEstimate

description: Chi square for homogeneity 105.14, df 23 (p < 0.00001)

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

quantity: 105.14

AttributeEstimates

-DescriptionTypeQuantity
*degrees of freedom (df) = 23Degrees of Freedom (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")23
*p < 0.00001P-value (StatisticAttribute Estimate Type#C44185)<0.00001

attributeEstimate

description: I-squared = 78%

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

quantity: 78 % (Details: UCUM code % = '%')

modelCharacteristic

code: Hazard ratios were log transformed, and the CI was converted to standard error = (upper limit − lower limit)/3.92 for 95% CI. In random effect models (DerSimonian and Laird), we analysed adjusted HR to generate pooled HRs for the association between bariatric surgery for outcome in comparison with controls. The pooled HRs were calculated using inverse-variance weighted averaging and were depicted in forest plots. (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")

modelCharacteristic

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

modelCharacteristic

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