Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2021-08-23 |
Resource Evidence "55" Version "24" Updated "2023-12-06 00:45:56+0000"
StructureDefinition Work Group: cds
url: https://fevir.net/resources/Evidence/55
identifier: FEvIR Object Identifier: 55, id: 143
version: 1.0.0-ballot
name: Fourteen_day_mortality_remdesivir_vs_placebo_meta_analysis_ACTT_1_Wang_et_al_WHO_SOLIDARITY
title: 14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY)
status: active
date: 2021-08-23 12:33:29+0000
approvalDate: 2020-12-17
lastReviewDate: 2020-12-21
publisher: HL7 International / Clinical Decision Support
contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss
author: Brian S. Alper: , Joanne Dehnbostel: , Khalid Shahin:
copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/
| Type | Display | Citation | Resource |
| citation | Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial | http://computablepublishing.us/fevir/resources/Citation/4932 | |
| citation | Remdesivir for the Treatment of Covid-19 - Final Report | ||
| citation | Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results | ||
| cite-as | 14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY) [Evidence]. Contributors: Brian S. Alper, Joanne Dehnbostel, Khalid Shahin [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 55. Published 2020-12-17. Revised 2021-08-23. Available at: https://fevir.net/resources/Evidence/55. Computable resource at: https://fevir.net/resources/Evidence/55. |
description: COVID-19 pneumonia remdesivir vs. placebo 14-day mortality (779 events among 6,744 participants, 3 randomized trials) Risk ratio 0.85 (95% CI 0.74 to 0.96) in fixed-effect analysis Risk ratio 0.81 (95% CI 0.60 to 1.08) in random-effects analysis
assertion: Remdesivir might reduce 14-day mortality, but this finding has not been repeated in a second trial (Low certainty)
variableDefinition
VariableDefinitionVariableRoleCode: population
description: Adults with COVID-19 pneumonia admitted to hospital
note: population
variableRole: Use extension:variableRoleCode instead. (EvidenceVariableRole#population "population")
observed: Group/179799: MetaanalysisStudyGroup: Effect Estimates for Mortality at 14 days from COVID19 Remdesivir vs. Placebo RCTs (Biegel 2020 data 35/541 vs. 61/521) (Wang 2020 data 15/153 vs. 7/78) (SOLIDARITY data 219/2743 vs. 219/2708) "MetaanalysisStudyGroup_Effect_Estimates_for_Mortality_at_14_days_from_COVID19_Remdesivir_vs_Placebo_RCTs"
intended: Group/12714: COVID-19PneumoniaHospitalizedAdult "COVID_19PneumoniaHospitalizedAdult"
directnessMatch: High quality match (EvidenceDirectness[0.1.0]#high)
variableDefinition
VariableDefinitionVariableRoleCode: exposure
description: Remdesivir IV 200 mg once then 100 mg once daily for 9 days
note: exposure
variableRole: Use extension:variableRoleCode instead. (EvidenceVariableRole#exposure "exposure")
observed: Group/179783: Remdesivir IV 200 mg once then 100 mg once daily for 9 days "Remdesivir_IV_200_mg_once_then_100_mg_once_daily_for_9_days"
intended: EvidenceVariable/12717: Remdesivir "Remdesivir"
variableDefinition
VariableDefinitionVariableRoleCode: exposure
description: Placebo
note: SOLIDARITY trial did not use placebo in control group, exposure
variableRole: Use extension:variableRoleCode instead. (EvidenceVariableRole#exposure "exposure")
observed: EvidenceVariable/12718: Placebo "Placebo"
intended: EvidenceVariable/12718: Placebo "Placebo"
variableDefinition
VariableDefinitionVariableRoleCode: outcome
description: Mortality at 14 days
note: outcome
variableRole: Use extension:variableRoleCode instead. (EvidenceVariableRole#measuredVariable "measured variable")
observed: EvidenceVariable/12719: Mortality at 14 days "Mortality14Day"
intended: EvidenceVariable/12719: Mortality at 14 days "Mortality14Day"
studyDesign: randomized assignment (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:01003)
statistic
description: risk ratio 0.85 (95% CI 0.74 to 0.96) in fixed-effect meta-analysis; Test for overall effect Z = 2.52 (p = 0.01); Heterogeneity Chi-squared = 7.33, df = 2 (p 0.03), I-squared = 73%
statisticType: Relative Risk (StatisticStatisticType[0.1.0]#C93152)
quantity: 0.85
numberOfEvents: 779
numberAffected: 779
SampleSizes
NumberOfStudies NumberOfParticipants KnownDataCount 3 6774 6744 attributeEstimate
type: Confidence interval (StatisticAttribute Estimate Type#C53324)
level: 0.95
range: 0.74-0.96
attributeEstimate
type: Z-score (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#TBD:0000077 "P-value")
quantity: 2.52
attributeEstimate
type: P-value (StatisticAttribute Estimate Type#C44185)
quantity: 0.01
attributeEstimate
type: I-squared (StatisticAttribute Estimate Type#0000420)
quantity: 0.73
attributeEstimate
type: Cochran's Q statistic (StatisticAttribute Estimate Type#0000419)
quantity: 7.33
AttributeEstimates
Type Quantity degrees of freedom (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#STATO:0000069 "Degrees of Freedom") 2 P-value (StatisticAttribute Estimate Type#C44185) 0.03 modelCharacteristic
StatisticModelApplied: true
code: Fixed-effects (Statistic Model Code#effectsFixed)
modelCharacteristic
StatisticModelApplied: true
code: Meta-analysis (Statistic Model Code#metaAnalysis)
statistic
description: risk ratio 0.81 (95% CI 0.60 to 1.08) in random-effects meta-analysis; Test for overall effect Z = 1.44 (p = 0.15); Heterogeneity Chi-squared = 7.33, df = 2 (p 0.03), I-squared = 73%; Tau-squared = 0.04
note: We consider the random-effects model more appropriate for interpretation as the true effect of remdesivir is likely different across the different populations represented in each trial.
statisticType: Relative Risk (StatisticStatisticType[0.1.0]#C93152)
quantity: 0.81
numberOfEvents: 779
numberAffected: 779
SampleSizes
NumberOfStudies NumberOfParticipants KnownDataCount 3 6774 6744 attributeEstimate
type: Confidence interval (StatisticAttribute Estimate Type#C53324)
level: 0.95
range: 0.6-1.08
attributeEstimate
type: Z-score ()
quantity: 1.44
attributeEstimate
type: P-value (StatisticAttribute Estimate Type#C44185)
quantity: 0.15
attributeEstimate
type: Tau squared (StatisticAttribute Estimate Type#0000421)
quantity: 0.04
attributeEstimate
type: I-squared (StatisticAttribute Estimate Type#0000420)
quantity: 0.73
attributeEstimate
type: Cochran's Q statistic (StatisticAttribute Estimate Type#0000419)
quantity: 7.33
AttributeEstimates
Type Quantity degrees of freedom () 2 P-value (StatisticAttribute Estimate Type#C44185) 0.03 modelCharacteristic
StatisticModelApplied: true
code: Random-effects (Statistic Model Code#effectsRandom)
modelCharacteristic
StatisticModelApplied: true
code: Meta-analysis (Statistic Model Code#metaAnalysis)
modelCharacteristic
StatisticModelApplied: true
code: Dersimonian-Laird method (Statistic Model Code#tauDersimonianLaird)
certainty
description: Low certainty due to inconsistency and risk of bias
type: Overall certainty (Evidence Certainty Type#Overall)
rating: Low quality (Evidence Certainty Rating#low)
subcomponent
type: Publication bias (Evidence Certainty Type#PublicationBias)
rating: no serious concern (Evidence Certainty Rating#no-concern)
subcomponent
note: There is a high degree of heterogeneity (I-squared = 73%). There is also inconsistency in findings between the fixed-effect and random-effects statistical models.
type: Inconsistency (Evidence Certainty Type#Inconsistency)
rating: serious concern (Evidence Certainty Rating#serious-concern)
subcomponent
note: Although the random-effects analysis finds an estimate without statistical significance, this imprecision is explained by the inconsistency (heterogeneity) and thus not further downrated in certainty assessment.
type: Imprecision (Evidence Certainty Type#Imprecision)
rating: no serious concern (Evidence Certainty Rating#no-concern)
subcomponent
type: Indirectness (Evidence Certainty Type#Indirectness)
rating: no serious concern (Evidence Certainty Rating#no-concern)
subcomponent
type: Risk of bias (Evidence Certainty Type#RiskOfBias)
rating: serious concern (Evidence Certainty Rating#serious-concern)
subcomponent
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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