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

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

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<Evidence xmlns="http://hl7.org/fhir">
  <id value="55"/>
  <meta>
    <versionId value="29"/>
    <lastUpdated value="2024-12-13T21:17:32.934Z"/>
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  <version value="4"/>
  <name
        value="Fourteen_day_mortality_remdesivir_vs_placebo_meta_analysis_ACTT_1_Wang_et_al_WHO_SOLIDARITY"/>
  <title
         value="14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY)"/>
  <citeAsReference>🔗 
    <reference value="Citation/58"/>
    <type value="Citation"/>
    <display
             value="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."/>
  </citeAsReference>
  <status value="active"/>
  <date value="2021-08-23T12:33:29.572Z"/>
  <approvalDate value="2020-12-17"/>
  <lastReviewDate value="2020-12-21"/>
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  <contact>
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  <author>
    <name value="Brian S. Alper"/>
  </author>
  <author>
    <name value="Joanne Dehnbostel"/>
  </author>
  <author>
    <name value="Khalid Shahin"/>
  </author>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <relatedArtifact>
    <type value="citation"/>
    <display
             value="Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial"/>
    <resource
              value="http://computablepublishing.us/fevir/resources/Citation/4932"/>
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  <relatedArtifact>
    <type value="citation"/>
    <display value="Remdesivir for the Treatment of Covid-19 - Final Report"/>
  </relatedArtifact>
  <relatedArtifact>
    <type value="citation"/>
    <display
             value="Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results"/>
  </relatedArtifact>
  <relatedArtifact>
    <type value="cite-as"/>
    <citation
              value="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#json."/>
  </relatedArtifact>
  <description
               value="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
             value="Remdesivir might reduce 14-day mortality, but this finding has not been repeated in a second trial (Low certainty)"/>
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    <description value="Adults with COVID-19 pneumonia admitted to hospital"/>
    <variableRole value="population"/>
    <observed>🔗 
      <reference value="Group/179799"/>
      <type value="Group"/>
      <display
               value="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)"/>
    </observed>
    <intended>🔗 
      <reference value="Group/12714"/>
      <type value="Group"/>
      <display value="COVID-19PneumoniaHospitalizedAdult"/>
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        <display
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      </coding>
    </directnessMatch>
  </variableDefinition>
  <variableDefinition>
    <description
                 value="Remdesivir IV 200 mg once then 100 mg once daily for 9 days"/>
    <variableRole value="exposure"/>
    <observed>🔗 
      <reference value="Group/179783"/>
      <type value="Group"/>
      <display
               value="Remdesivir IV 200 mg once then 100 mg once daily for 9 days"/>
    </observed>
    <intended>🔗 
      <reference value="EvidenceVariable/12717"/>
      <type value="EvidenceVariable"/>
      <display value="Remdesivir"/>
    </intended>
  </variableDefinition>
  <variableDefinition>
    <description value="Placebo"/>
    <note>
      <text value="SOLIDARITY trial did not use placebo in control group"/>
    </note>
    <variableRole value="exposure"/>
    <observed>🔗 
      <reference value="EvidenceVariable/12718"/>
      <type value="EvidenceVariable"/>
      <display value="Placebo"/>
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    <intended>🔗 
      <reference value="EvidenceVariable/12718"/>
      <type value="EvidenceVariable"/>
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  </variableDefinition>
  <variableDefinition>
    <description value="Mortality at 14 days"/>
    <variableRole value="outcome"/>
    <observed>🔗 
      <reference value="EvidenceVariable/12719"/>
      <type value="EvidenceVariable"/>
      <display value="Mortality at 14 days"/>
    </observed>
    <intended>🔗 
      <reference value="EvidenceVariable/12719"/>
      <type value="EvidenceVariable"/>
      <display value="Mortality at 14 days"/>
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                 value="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%"/>
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            <display value="Degrees of Freedom"/>
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                 value="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>
      <text
            value="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."/>
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          <userSelected value="true"/>
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    <subcomponent>
      <note>
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      </note>
      <type>
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    <subcomponent>
      <note>
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              value="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."/>
      </note>
      <type>
        <coding>
          <system value="http://hl7.org/fhir/certainty-type"/>
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