Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - 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 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
| Active as of 2021-08-23 |
<Evidence xmlns="http://hl7.org/fhir">
<id value="55"/>
<meta>
<versionId value="25"/>
<lastUpdated value="2024-04-12T17:05:38.816Z"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Evidence</b><a name="55"> </a><a name="hc55"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceEvidence "55" Version "25" Updated "2024-04-12 17:05:38+0000" </p></div><p><b>url</b>: <code>https://fevir.net/resources/Evidence/55</code></p><p><b>identifier</b>: FEvIR Object Identifier/55, <code>https://gps.health/coka</code>/143</p><p><b>version</b>: 1.0.0-ballot</p><p><b>name</b>: Fourteen_day_mortality_remdesivir_vs_placebo_meta_analysis_ACTT_1_Wang_et_al_WHO_SOLIDARITY</p><p><b>title</b>: 14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY)</p><p><b>citeAs</b>: <a href="Citation-58.html">Citation/58: 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.</a></p><p><b>status</b>: active</p><p><b>date</b>: 2021-08-23 12:33:29+0000</p><p><b>approvalDate</b>: 2020-12-17</p><p><b>lastReviewDate</b>: 2020-12-21</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>author</b>: Brian S. Alper: , Joanne Dehnbostel: , Khalid Shahin: </p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><h3>RelatedArtifacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Display</b></td><td><b>Citation</b></td><td><b>Resource</b></td></tr><tr><td style="display: none">*</td><td>citation</td><td>Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial</td><td> </td><td><a href="http://computablepublishing.us/fevir/resources/Citation/4932">http://computablepublishing.us/fevir/resources/Citation/4932</a></td></tr><tr><td style="display: none">*</td><td>citation</td><td>Remdesivir for the Treatment of Covid-19 - Final Report</td><td> </td><td> </td></tr><tr><td style="display: none">*</td><td>citation</td><td>Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results</td><td> </td><td> </td></tr><tr><td style="display: none">*</td><td>cite-as</td><td> </td><td>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.</td><td> </td></tr></table><p><b>description</b>: 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</p><p><b>assertion</b>: Remdesivir might reduce 14-day mortality, but this finding has not been repeated in a second trial (Low certainty)</p><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: Adults with COVID-19 pneumonia admitted to hospital</p><p><b>note</b>: population</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#population "population")</span></p><p><b>observed</b>: <a href="Group-179799.html">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)</a> "MetaanalysisStudyGroup_Effect_Estimates_for_Mortality_at_14_days_from_COVID19_Remdesivir_vs_Placebo_RCTs"</p><p><b>intended</b>: <a href="Group-12714.html">Group/12714: COVID-19PneumoniaHospitalizedAdult</a> "COVID_19PneumoniaHospitalizedAdult"</p><p><b>directnessMatch</b>: High quality match between observed and intended variable <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (EvidenceDirectness[1.0.0]#high)</span></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>description</b>: Remdesivir IV 200 mg once then 100 mg once daily for 9 days</p><p><b>note</b>: exposure</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#exposure "exposure")</span></p><p><b>observed</b>: <a href="Group-179783.html">Group/179783: Remdesivir IV 200 mg once then 100 mg once daily for 9 days</a> "Remdesivir_IV_200_mg_once_then_100_mg_once_daily_for_9_days"</p><p><b>intended</b>: <a href="EvidenceVariable-12717.html">EvidenceVariable/12717: Remdesivir</a> "Remdesivir"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>description</b>: Placebo</p><p><b>note</b>: SOLIDARITY trial did not use placebo in control group, exposure</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#exposure "exposure")</span></p><p><b>observed</b>: <a href="EvidenceVariable-12718.html">EvidenceVariable/12718: Placebo</a> "Placebo"</p><p><b>intended</b>: <a href="EvidenceVariable-12718.html">EvidenceVariable/12718: Placebo</a> "Placebo"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: outcome</p><p><b>description</b>: Mortality at 14 days</p><p><b>note</b>: outcome</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#measuredVariable "measured variable")</span></p><p><b>observed</b>: <a href="EvidenceVariable-12719.html">EvidenceVariable/12719: Mortality at 14 days</a> "Mortality14Day"</p><p><b>intended</b>: <a href="EvidenceVariable-12719.html">EvidenceVariable/12719: Mortality at 14 days</a> "Mortality14Day"</p></blockquote><p><b>studyDesign</b>: randomized assignment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:01003)</span></p><blockquote><p><b>statistic</b></p><p><b>description</b>: 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%</p><p><b>statisticType</b>: Relative Risk <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (StatisticStatisticType[0.1.0]#C93152)</span></p><p><b>quantity</b>: 0.85</p><p><b>numberOfEvents</b>: 779</p><p><b>numberAffected</b>: 779</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>NumberOfStudies</b></td><td><b>NumberOfParticipants</b></td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>3</td><td>6774</td><td>6744</td></tr></table><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: Confidence interval <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C53324)</span></p><p><b>level</b>: 0.95</p><p><b>range</b>: 0.74-0.96</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: Z-score <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#TBD:0000077 "P-value")</span></p><p><b>quantity</b>: 2.52</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: P-value <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C44185)</span></p><p><b>quantity</b>: 0.01</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: I-squared <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#0000420)</span></p><p><b>quantity</b>: 0.73</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: Cochran's Q statistic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#0000419)</span></p><p><b>quantity</b>: 7.33</p><h3>AttributeEstimates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td>degrees of freedom <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#STATO:0000069 "Degrees of Freedom")</span></td><td>2</td></tr><tr><td style="display: none">*</td><td>P-value <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C44185)</span></td><td>0.03</td></tr></table></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>StatisticModelApplied</b>: true</p><p><b>code</b>: Fixed-effects <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-statistic-model-code.html">Statistic Model Code</a>#effectsFixed)</span></p></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>StatisticModelApplied</b>: true</p><p><b>code</b>: Meta-analysis <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-statistic-model-code.html">Statistic Model Code</a>#metaAnalysis)</span></p></blockquote></blockquote><blockquote><p><b>statistic</b></p><p><b>description</b>: 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</p><p><b>note</b>: 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.</p><p><b>statisticType</b>: Relative Risk <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (StatisticStatisticType[0.1.0]#C93152)</span></p><p><b>quantity</b>: 0.81</p><p><b>numberOfEvents</b>: 779</p><p><b>numberAffected</b>: 779</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>NumberOfStudies</b></td><td><b>NumberOfParticipants</b></td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>3</td><td>6774</td><td>6744</td></tr></table><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: Confidence interval <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C53324)</span></p><p><b>level</b>: 0.95</p><p><b>range</b>: 0.6-1.08</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: Z-score <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>quantity</b>: 1.44</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: P-value <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C44185)</span></p><p><b>quantity</b>: 0.15</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: Tau squared <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#0000421)</span></p><p><b>quantity</b>: 0.04</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: I-squared <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#0000420)</span></p><p><b>quantity</b>: 0.73</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: Cochran's Q statistic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#0000419)</span></p><p><b>quantity</b>: 7.33</p><h3>AttributeEstimates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td>degrees of freedom <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>2</td></tr><tr><td style="display: none">*</td><td>P-value <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C44185)</span></td><td>0.03</td></tr></table></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>StatisticModelApplied</b>: true</p><p><b>code</b>: Random-effects <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-statistic-model-code.html">Statistic Model Code</a>#effectsRandom)</span></p></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>StatisticModelApplied</b>: true</p><p><b>code</b>: Meta-analysis <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-statistic-model-code.html">Statistic Model Code</a>#metaAnalysis)</span></p></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>StatisticModelApplied</b>: true</p><p><b>code</b>: Dersimonian-Laird method <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-statistic-model-code.html">Statistic Model Code</a>#tauDersimonianLaird)</span></p></blockquote></blockquote><blockquote><p><b>certainty</b></p><p><b>description</b>: Low certainty due to inconsistency and risk of bias</p><p><b>type</b>: Overall certainty <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-type.html">Evidence Certainty Type</a>#Overall)</span></p><p><b>rating</b>: Low quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-rating.html">Evidence Certainty Rating</a>#low)</span></p><blockquote><p><b>subcomponent</b></p><p><b>type</b>: Publication bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-type.html">Evidence Certainty Type</a>#PublicationBias)</span></p><p><b>rating</b>: no serious concern <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-rating.html">Evidence Certainty Rating</a>#no-concern)</span></p></blockquote><blockquote><p><b>subcomponent</b></p><p><b>note</b>: 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.</p><p><b>type</b>: Inconsistency <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-type.html">Evidence Certainty Type</a>#Inconsistency)</span></p><p><b>rating</b>: serious concern <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-rating.html">Evidence Certainty Rating</a>#serious-concern)</span></p></blockquote><blockquote><p><b>subcomponent</b></p><p><b>note</b>: 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.</p><p><b>type</b>: Imprecision <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-type.html">Evidence Certainty Type</a>#Imprecision)</span></p><p><b>rating</b>: no serious concern <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-rating.html">Evidence Certainty Rating</a>#no-concern)</span></p></blockquote><blockquote><p><b>subcomponent</b></p><p><b>type</b>: Indirectness <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-type.html">Evidence Certainty Type</a>#Indirectness)</span></p><p><b>rating</b>: no serious concern <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-rating.html">Evidence Certainty Rating</a>#no-concern)</span></p></blockquote><blockquote><p><b>subcomponent</b></p><p><b>type</b>: Risk of bias <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-type.html">Evidence Certainty Type</a>#RiskOfBias)</span></p><p><b>rating</b>: serious concern <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-certainty-rating.html">Evidence Certainty Rating</a>#serious-concern)</span></p><blockquote><p><b>subcomponent</b></p></blockquote></blockquote></blockquote></div>
</text>
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<name value="Joanne Dehnbostel"/>
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<display value="Remdesivir for the Treatment of Covid-19 - Final Report"/>
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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."/>
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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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<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="population"/>
<display value="population"/>
</coding>
<text value="Use extension:variableRoleCode instead."/>
</variableRole>
<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"/>
</intended>
<directnessMatch>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/directness"/>
<version value="1.0.0"/>
<code value="high"/>
<display
value="High quality match between observed and intended variable"/>
</coding>
</directnessMatch>
</variableDefinition>
<variableDefinition>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
<valueCode value="exposure"/>
</extension>
<description
value="Remdesivir IV 200 mg once then 100 mg once daily for 9 days"/>
<note>
<text value="exposure"/>
</note>
<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="exposure"/>
<display value="exposure"/>
</coding>
<text value="Use extension:variableRoleCode instead."/>
</variableRole>
<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>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
<valueCode value="exposure"/>
</extension>
<description value="Placebo"/>
<note>
<text value="SOLIDARITY trial did not use placebo in control group"/>
</note>
<note>
<text value="exposure"/>
</note>
<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="exposure"/>
<display value="exposure"/>
</coding>
<text value="Use extension:variableRoleCode instead."/>
</variableRole>
<observed>🔗
<reference value="EvidenceVariable/12718"/>
<type value="EvidenceVariable"/>
<display value="Placebo"/>
</observed>
<intended>🔗
<reference value="EvidenceVariable/12718"/>
<type value="EvidenceVariable"/>
<display value="Placebo"/>
</intended>
</variableDefinition>
<variableDefinition>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
<valueCode value="outcome"/>
</extension>
<description value="Mortality at 14 days"/>
<note>
<text value="outcome"/>
</note>
<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="measuredVariable"/>
<display value="measured variable"/>
</coding>
<text value="Use extension:variableRoleCode instead."/>
</variableRole>
<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"/>
</intended>
</variableDefinition>
<studyDesign>
<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:01003"/>
<display value="randomized assignment"/>
</coding>
</studyDesign>
<statistic>
<description
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%"/>
<statisticType>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/statistic-type"/>
<version value="0.1.0"/>
<code value="C93152"/>
<display value="Relative Risk"/>
<userSelected value="true"/>
</coding>
</statisticType>
<quantity>
<value value="0.85"/>
</quantity>
<numberOfEvents value="779"/>
<numberAffected value="779"/>
<sampleSize>
<numberOfStudies value="3"/>
<numberOfParticipants value="6774"/>
<knownDataCount value="6744"/>
</sampleSize>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C53324"/>
<display value="Confidence interval"/>
</coding>
</type>
<level value="0.95"/>
<range>
<low>
<value value="0.74"/>
</low>
<high>
<value value="0.96"/>
</high>
</range>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="TBD:0000077"/>
<display value="P-value"/>
</coding>
<text value="Z-score"/>
</type>
<quantity>
<value value="2.52"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C44185"/>
<display value="P-value"/>
</coding>
</type>
<quantity>
<value value="0.01"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="0000420"/>
<display value="I-squared"/>
</coding>
</type>
<quantity>
<value value="0.73"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="0000419"/>
<display value="Cochran's Q statistic"/>
</coding>
</type>
<quantity>
<value value="7.33"/>
</quantity>
<attributeEstimate>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="STATO:0000069"/>
<display value="Degrees of Freedom"/>
</coding>
<text value="degrees of freedom"/>
</type>
<quantity>
<value value="2"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C44185"/>
<display value="P-value"/>
</coding>
</type>
<quantity>
<value value="0.03"/>
</quantity>
</attributeEstimate>
</attributeEstimate>
<modelCharacteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied">
<valueBoolean value="true"/>
</extension>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="effectsFixed"/>
<display value="Fixed-effects"/>
<userSelected value="true"/>
</coding>
</code>
</modelCharacteristic>
<modelCharacteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied">
<valueBoolean value="true"/>
</extension>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="metaAnalysis"/>
<display value="Meta-analysis"/>
<userSelected value="true"/>
</coding>
</code>
</modelCharacteristic>
</statistic>
<statistic>
<description
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."/>
</note>
<statisticType>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/statistic-type"/>
<version value="0.1.0"/>
<code value="C93152"/>
<display value="Relative Risk"/>
<userSelected value="true"/>
</coding>
</statisticType>
<quantity>
<value value="0.81"/>
</quantity>
<numberOfEvents value="779"/>
<numberAffected value="779"/>
<sampleSize>
<numberOfStudies value="3"/>
<numberOfParticipants value="6774"/>
<knownDataCount value="6744"/>
</sampleSize>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C53324"/>
<display value="Confidence interval"/>
</coding>
</type>
<level value="0.95"/>
<range>
<low>
<value value="0.6"/>
</low>
<high>
<value value="1.08"/>
</high>
</range>
</attributeEstimate>
<attributeEstimate>
<type>
<text value="Z-score"/>
</type>
<quantity>
<value value="1.44"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C44185"/>
<display value="P-value"/>
</coding>
</type>
<quantity>
<value value="0.15"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="0000421"/>
<display value="Tau squared"/>
</coding>
</type>
<quantity>
<value value="0.04"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="0000420"/>
<display value="I-squared"/>
</coding>
</type>
<quantity>
<value value="0.73"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="0000419"/>
<display value="Cochran's Q statistic"/>
</coding>
</type>
<quantity>
<value value="7.33"/>
</quantity>
<attributeEstimate>
<type>
<text value="degrees of freedom"/>
</type>
<quantity>
<value value="2"/>
</quantity>
</attributeEstimate>
<attributeEstimate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
<code value="C44185"/>
<display value="P-value"/>
</coding>
</type>
<quantity>
<value value="0.03"/>
</quantity>
</attributeEstimate>
</attributeEstimate>
<modelCharacteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied">
<valueBoolean value="true"/>
</extension>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="effectsRandom"/>
<display value="Random-effects"/>
<userSelected value="true"/>
</coding>
</code>
</modelCharacteristic>
<modelCharacteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied">
<valueBoolean value="true"/>
</extension>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="metaAnalysis"/>
<display value="Meta-analysis"/>
<userSelected value="true"/>
</coding>
</code>
</modelCharacteristic>
<modelCharacteristic>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied">
<valueBoolean value="true"/>
</extension>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="tauDersimonianLaird"/>
<display value="Dersimonian-Laird method"/>
<userSelected value="true"/>
</coding>
</code>
</modelCharacteristic>
</statistic>
<certainty>
<description value="Low certainty due to inconsistency and risk of bias"/>
<type>
<coding>
<system value="http://hl7.org/fhir/certainty-type"/>
<code value="Overall"/>
<display value="Overall certainty"/>
</coding>
</type>
<rating>
<coding>
<system value="http://hl7.org/fhir/certainty-rating"/>
<code value="low"/>
<display value="Low quality"/>
</coding>
</rating>
<subcomponent>
<type>
<coding>
<system value="http://hl7.org/fhir/certainty-type"/>
<code value="PublicationBias"/>
<display value="Publication bias"/>
</coding>
</type>
<rating>
<coding>
<system value="http://hl7.org/fhir/certainty-rating"/>
<code value="no-concern"/>
<display value="no serious concern"/>
</coding>
</rating>
</subcomponent>
<subcomponent>
<note>
<text
value="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."/>
</note>
<type>
<coding>
<system value="http://hl7.org/fhir/certainty-type"/>
<code value="Inconsistency"/>
<display value="Inconsistency"/>
</coding>
</type>
<rating>
<coding>
<system value="http://hl7.org/fhir/certainty-rating"/>
<code value="serious-concern"/>
<display value="serious concern"/>
</coding>
</rating>
</subcomponent>
<subcomponent>
<note>
<text
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"/>
<code value="Imprecision"/>
<display value="Imprecision"/>
</coding>
</type>
<rating>
<coding>
<system value="http://hl7.org/fhir/certainty-rating"/>
<code value="no-concern"/>
<display value="no serious concern"/>
</coding>
</rating>
</subcomponent>
<subcomponent>
<type>
<coding>
<system value="http://hl7.org/fhir/certainty-type"/>
<code value="Indirectness"/>
<display value="Indirectness"/>
</coding>
</type>
<rating>
<coding>
<system value="http://hl7.org/fhir/certainty-rating"/>
<code value="no-concern"/>
<display value="no serious concern"/>
</coding>
</rating>
</subcomponent>
<subcomponent>
<type>
<coding>
<system value="http://hl7.org/fhir/certainty-type"/>
<code value="RiskOfBias"/>
<display value="Risk of bias"/>
</coding>
</type>
<rating>
<coding>
<system value="http://hl7.org/fhir/certainty-rating"/>
<code value="serious-concern"/>
<display value="serious concern"/>
</coding>
</rating>
<subcomponent>
<note>
<text
value="No blinding (no placebo control) in the largest trial"/>
</note>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:00035"/>
<display value="Inadequate blinding of participants"/>
</coding>
<text value="Lack of blinding"/>
</type>
<rating>
<coding>
<system value="http://hl7.org/fhir/certainty-rating"/>
<code value="present"/>
<display value="present"/>
</coding>
</rating>
</subcomponent>
</subcomponent>
</certainty>
</Evidence>
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-05-16
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