14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY) - Evidence Based Medicine on FHIR Implementation Guide v2.0.0-ballot

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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: 14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY)

Generated Narrative: Evidence 55

version: 28; Last updated: 2024-06-24 19:15:18+0000

url: https://fevir.net/resources/Evidence/55

identifier: FEvIR Object Identifier/55, https://gps.health/coka/143

version: 4

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)

citeAs: Alper BS, Dehnbostel J, Shahin K. 14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY). Fast Evidence Interoperability Resources (FEvIR) Platform, entry 55, version 4. Created 2020 Dec 17. Revised 2020 Dec 21. Accessed 2021 Mar 13. Computable resource at: https://fevir.net/resources/Evidence/55.

status: Active

date: 2021-08-23 12:33:29+0000

approvalDate: 2020-12-17

lastReviewDate: 2020-12-21

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

author: Brian S. Alper: , Joanne Dehnbostel: , Khalid Shahin:

copyright:

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

RelatedArtifacts

- 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) [Database Entry: FHIR Evidence Resource]. 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
description:
Adults with COVID-19 pneumonia admitted to hospital

variableRole: Population
observed: 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)
intended: COVID-19PneumoniaHospitalizedAdult
directnessMatch: High quality match between observed and intended variable

variableDefinition
description:
Remdesivir IV 200 mg once then 100 mg once daily for 9 days

variableRole: Exposure
observed: Remdesivir IV 200 mg once then 100 mg once daily for 9 days
intended: Remdesivir

variableDefinition
description:
Placebo

note: SOLIDARITY trial did not use placebo in control group
variableRole: Exposure
observed: Placebo
intended: Placebo

variableDefinition
description:
Mortality at 14 days

variableRole: Outcome
observed: Mortality at 14 days
intended: Mortality at 14 days

studyDesign: randomized assignment

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
quantity: 0.85
numberOfEvents: 779
numberAffected: 779
SampleSizes
- NumberOfStudies NumberOfParticipants KnownDataCount
* 3 6774 6744
attributeEstimate
type: Confidence interval
level: 0.95
range: 0.74-0.96
attributeEstimate
type: Z-score
quantity: 2.52
attributeEstimate
type: P-value
quantity: 0.01
attributeEstimate
type: I-squared
quantity: 0.73
attributeEstimate
type: Cochran's Q statistic
quantity: 7.33
AttributeEstimates
- Type Quantity
* degrees of freedom 2
* P-value 0.03
modelCharacteristic
code: Fixed-effects
applied: true
modelCharacteristic
code: Meta-analysis
applied: true

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
quantity: 0.81
numberOfEvents: 779
numberAffected: 779
SampleSizes
- NumberOfStudies NumberOfParticipants KnownDataCount
* 3 6774 6744
attributeEstimate
type: Confidence interval
level: 0.95
range: 0.6-1.08
attributeEstimate
type: Z-score
quantity: 1.44
attributeEstimate
type: P-value
quantity: 0.15
attributeEstimate
type: Tau squared
quantity: 0.04
attributeEstimate
type: I-squared
quantity: 0.73
attributeEstimate
type: Cochran's Q statistic
quantity: 7.33
AttributeEstimates
- Type Quantity
* degrees of freedom 2
* P-value 0.03
modelCharacteristic
code: Random-effects
applied: true
modelCharacteristic
code: Meta-analysis
applied: true
modelCharacteristic
code: Dersimonian-Laird method
applied: true

certainty
description:
Low certainty due to inconsistency and risk of bias

type: Overall certainty
rating: Low quality
subcomponent
type: Publication bias
rating: no serious 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
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
rating: no serious concern
subcomponent
type: Indirectness
rating: no serious concern
subcomponent
type: Risk of bias
rating: serious concern
Subcomponents
- Note Type Rating
* No blinding (no placebo control) in the largest trial Lack of blinding present

IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-21
Links: Table of Contents | QA Report | Version History | | Propose a change

-	NumberOfStudies	NumberOfParticipants	KnownDataCount
*	3	6774	6744