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 |
{
"resourceType" : "Evidence",
"id" : "55",
"meta" : {
"versionId" : "24",
"lastUpdated" : "2023-12-06T00:45:56.090Z"
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Evidence</b><a name=\"55\"> </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\">Resource Evidence "55" Version "24" Updated "2023-12-06 00:45:56+0000" </p></div><p><b>StructureDefinition Work Group</b>: cds</p><p><b>url</b>: <code>https://fevir.net/resources/Evidence/55</code></p><p><b>identifier</b>: FEvIR Object Identifier:\u00a055, id:\u00a0143</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) [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.</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)\nRisk ratio 0.85 (95% CI 0.74 to 0.96) in fixed-effect analysis\nRisk 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/5.3.0/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 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (EvidenceDirectness[0.1.0]#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/5.3.0/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/5.3.0/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/5.3.0/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\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-statistic-type.html\">StatisticStatisticType[0.1.0]</a>#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/5.3.0/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/5.3.0/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/5.3.0/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/5.3.0/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/5.3.0/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\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-statistic-type.html\">StatisticStatisticType[0.1.0]</a>#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/5.3.0/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/5.3.0/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/5.3.0/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/5.3.0/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/5.3.0/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/5.3.0/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>"
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"title" : "14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY)",
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"display" : "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."
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"citation" : "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)\nRisk ratio 0.85 (95% CI 0.74 to 0.96) in fixed-effect analysis\nRisk 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" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "population"
}
],
"description" : "Adults with COVID-19 pneumonia admitted to hospital",
"note" : [
{
"text" : "population"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "population",
"display" : "population"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "Group/179799",
"type" : "Group",
"display" : "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" : {
🔗 "reference" : "Group/12714",
"type" : "Group",
"display" : "COVID-19PneumoniaHospitalizedAdult"
},
"directnessMatch" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/directness",
"version" : "0.1.0",
"code" : "high",
"display" : "High quality match",
"userSelected" : true
}
]
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "exposure"
}
],
"description" : "Remdesivir IV 200 mg once then 100 mg once daily for 9 days",
"note" : [
{
"text" : "exposure"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "exposure",
"display" : "exposure"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "Group/179783",
"type" : "Group",
"display" : "Remdesivir IV 200 mg once then 100 mg once daily for 9 days"
},
"intended" : {
🔗 "reference" : "EvidenceVariable/12717",
"type" : "EvidenceVariable",
"display" : "Remdesivir"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "exposure"
}
],
"description" : "Placebo",
"note" : [
{
"text" : "SOLIDARITY trial did not use placebo in control group"
},
{
"text" : "exposure"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "exposure",
"display" : "exposure"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "EvidenceVariable/12718",
"type" : "EvidenceVariable",
"display" : "Placebo"
},
"intended" : {
🔗 "reference" : "EvidenceVariable/12718",
"type" : "EvidenceVariable",
"display" : "Placebo"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code",
"valueCode" : "outcome"
}
],
"description" : "Mortality at 14 days",
"note" : [
{
"text" : "outcome"
}
],
"variableRole" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/variable-role",
"code" : "measuredVariable",
"display" : "measured variable"
}
],
"text" : "Use extension:variableRoleCode instead."
},
"observed" : {
🔗 "reference" : "EvidenceVariable/12719",
"type" : "EvidenceVariable",
"display" : "Mortality at 14 days"
},
"intended" : {
🔗 "reference" : "EvidenceVariable/12719",
"type" : "EvidenceVariable",
"display" : "Mortality at 14 days"
}
}
],
"studyDesign" : [
{
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "SEVCO:01003",
"display" : "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" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/statistic-type",
"version" : "0.1.0",
"code" : "C93152",
"display" : "Relative Risk",
"userSelected" : true
}
]
},
"quantity" : {
"value" : 0.85
},
"numberOfEvents" : 779,
"numberAffected" : 779,
"sampleSize" : {
"numberOfStudies" : 3,
"numberOfParticipants" : 6774,
"knownDataCount" : 6744
},
"attributeEstimate" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C53324",
"display" : "Confidence interval"
}
]
},
"level" : 0.95,
"range" : {
"low" : {
"value" : 0.74
},
"high" : {
"value" : 0.96
}
}
},
{
"type" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "TBD:0000077",
"display" : "P-value"
}
],
"text" : "Z-score"
},
"quantity" : {
"value" : 2.52
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C44185",
"display" : "P-value"
}
]
},
"quantity" : {
"value" : 0.01
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "0000420",
"display" : "I-squared"
}
]
},
"quantity" : {
"value" : 0.73
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "0000419",
"display" : "Cochran's Q statistic"
}
]
},
"quantity" : {
"value" : 7.33
},
"attributeEstimate" : [
{
"type" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "STATO:0000069",
"display" : "Degrees of Freedom"
}
],
"text" : "degrees of freedom"
},
"quantity" : {
"value" : 2
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C44185",
"display" : "P-value"
}
]
},
"quantity" : {
"value" : 0.03
}
}
]
}
],
"modelCharacteristic" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/statistic-model-code",
"code" : "effectsFixed",
"display" : "Fixed-effects",
"userSelected" : true
}
]
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/statistic-model-code",
"code" : "metaAnalysis",
"display" : "Meta-analysis",
"userSelected" : true
}
]
}
}
]
},
{
"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" : [
{
"text" : "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" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/statistic-type",
"version" : "0.1.0",
"code" : "C93152",
"display" : "Relative Risk",
"userSelected" : true
}
]
},
"quantity" : {
"value" : 0.81
},
"numberOfEvents" : 779,
"numberAffected" : 779,
"sampleSize" : {
"numberOfStudies" : 3,
"numberOfParticipants" : 6774,
"knownDataCount" : 6744
},
"attributeEstimate" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C53324",
"display" : "Confidence interval"
}
]
},
"level" : 0.95,
"range" : {
"low" : {
"value" : 0.6
},
"high" : {
"value" : 1.08
}
}
},
{
"type" : {
"text" : "Z-score"
},
"quantity" : {
"value" : 1.44
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C44185",
"display" : "P-value"
}
]
},
"quantity" : {
"value" : 0.15
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "0000421",
"display" : "Tau squared"
}
]
},
"quantity" : {
"value" : 0.04
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "0000420",
"display" : "I-squared"
}
]
},
"quantity" : {
"value" : 0.73
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "0000419",
"display" : "Cochran's Q statistic"
}
]
},
"quantity" : {
"value" : 7.33
},
"attributeEstimate" : [
{
"type" : {
"text" : "degrees of freedom"
},
"quantity" : {
"value" : 2
}
},
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/attribute-estimate-type",
"code" : "C44185",
"display" : "P-value"
}
]
},
"quantity" : {
"value" : 0.03
}
}
]
}
],
"modelCharacteristic" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/statistic-model-code",
"code" : "effectsRandom",
"display" : "Random-effects",
"userSelected" : true
}
]
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/statistic-model-code",
"code" : "metaAnalysis",
"display" : "Meta-analysis",
"userSelected" : true
}
]
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/statistic-model-applied",
"valueBoolean" : true
}
],
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/statistic-model-code",
"code" : "tauDersimonianLaird",
"display" : "Dersimonian-Laird method",
"userSelected" : true
}
]
}
}
]
}
],
"certainty" : [
{
"description" : "Low certainty due to inconsistency and risk of bias",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "Overall",
"display" : "Overall certainty"
}
]
},
"rating" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "low",
"display" : "Low quality"
}
]
},
"subcomponent" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "PublicationBias",
"display" : "Publication bias"
}
]
},
"rating" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "no-concern",
"display" : "no serious concern"
}
]
}
},
{
"note" : [
{
"text" : "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" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "Inconsistency",
"display" : "Inconsistency"
}
]
},
"rating" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "serious-concern",
"display" : "serious concern"
}
]
}
},
{
"note" : [
{
"text" : "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" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "Imprecision",
"display" : "Imprecision"
}
]
},
"rating" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "no-concern",
"display" : "no serious concern"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "Indirectness",
"display" : "Indirectness"
}
]
},
"rating" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "no-concern",
"display" : "no serious concern"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "RiskOfBias",
"display" : "Risk of bias"
}
]
},
"rating" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "serious-concern",
"display" : "serious concern"
}
]
},
"subcomponent" : [
{
"note" : [
{
"text" : "No blinding (no placebo control) in the largest trial"
}
],
"type" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "SEVCO:00035",
"display" : "Inadequate blinding of participants"
}
],
"text" : "Lack of blinding"
},
"rating" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "present",
"display" : "present"
}
]
}
}
]
}
]
}
]
}
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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