Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-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 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
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Evidence ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "55"] ; # fhir:meta [ fhir:versionId [ fhir:v "28" ] ; fhir:lastUpdated [ fhir:v "2024-06-24T19:15:18.127Z"^^xsd:dateTime ] ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 55</b></p><a name=\"55\"> </a><a name=\"hc55\"> </a><a name=\"55-en-US\"> </a><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\">version: 28; Last updated: 2024-06-24 19:15:18+0000</p></div><p><b>url</b>: <a href=\"https://fevir.net/resources/Evidence/55\">https://fevir.net/resources/Evidence/55</a></p><p><b>identifier</b>: FEvIR Object Identifier/55, <code>https://gps.health/coka</code>/143</p><p><b>version</b>: 4</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\">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>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>author</b>: Brian S. Alper: , Joanne Dehnbostel: , Khalid Shahin: </p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><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><code>http://computablepublishing.us/fevir/resources/Citation/4932</code></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><div><p>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.</p>\n</div></td><td> </td></tr></table><p><b>description</b>: </p><div><p>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>\n</div><p><b>assertion</b>: </p><div><p>Remdesivir might reduce 14-day mortality, but this finding has not been repeated in a second trial (Low certainty)</p>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Adults with COVID-19 pneumonia admitted to hospital</p>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"Group-179799.html\">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></p><p><b>intended</b>: <a href=\"Group-12714.html\">COVID-19PneumoniaHospitalizedAdult</a></p><p><b>directnessMatch</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/directness high}\">High quality match between observed and intended variable</span></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Remdesivir IV 200 mg once then 100 mg once daily for 9 days</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>observed</b>: <a href=\"Group-179783.html\">Remdesivir IV 200 mg once then 100 mg once daily for 9 days</a></p><p><b>intended</b>: <a href=\"EvidenceVariable-12717.html\">Remdesivir</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Placebo</p>\n</div><p><b>note</b>: SOLIDARITY trial did not use placebo in control group</p><p><b>variableRole</b>: Exposure</p><p><b>observed</b>: <a href=\"EvidenceVariable-12718.html\">Placebo</a></p><p><b>intended</b>: <a href=\"EvidenceVariable-12718.html\">Placebo</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Mortality at 14 days</p>\n</div><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-12719.html\">Mortality at 14 days</a></p><p><b>intended</b>: <a href=\"EvidenceVariable-12719.html\">Mortality at 14 days</a></p></blockquote><p><b>studyDesign</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/181513 SEVCO:01003}\">randomized assignment</span></p><blockquote><p><b>statistic</b></p><p><b>description</b>: </p><div><p>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>\n</div><p><b>statisticType</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/statistic-type C93152}\">Relative Risk</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>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</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>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/181513 TBD:0000077}\">Z-score</span></p><p><b>quantity</b>: 2.52</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></p><p><b>quantity</b>: 0.01</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type 0000420}\">I-squared</span></p><p><b>quantity</b>: 0.73</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type 0000419}\">Cochran's Q statistic</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><span title=\"Codes:{https://fevir.net/resources/CodeSystem/181513 STATO:0000069}\">degrees of freedom</span></td><td>2</td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></td><td>0.03</td></tr></table></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/statistic-model-code effectsFixed}\">Fixed-effects</span></p><p><b>applied</b>: true</p></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/statistic-model-code metaAnalysis}\">Meta-analysis</span></p><p><b>applied</b>: true</p></blockquote></blockquote><blockquote><p><b>statistic</b></p><p><b>description</b>: </p><div><p>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>\n</div><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>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/statistic-type C93152}\">Relative Risk</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>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</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>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/181513 TBD:0000077}\">Z-score</span></p><p><b>quantity</b>: 1.44</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></p><p><b>quantity</b>: 0.15</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type 0000421}\">Tau squared</span></p><p><b>quantity</b>: 0.04</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type 0000420}\">I-squared</span></p><p><b>quantity</b>: 0.73</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type 0000419}\">Cochran's Q statistic</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><span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 defined-in-text}\">degrees of freedom</span></td><td>2</td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></td><td>0.03</td></tr></table></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/statistic-model-code effectsRandom}\">Random-effects</span></p><p><b>applied</b>: true</p></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/statistic-model-code metaAnalysis}\">Meta-analysis</span></p><p><b>applied</b>: true</p></blockquote><blockquote><p><b>modelCharacteristic</b></p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/statistic-model-code tauDersimonianLaird}\">Dersimonian-Laird method</span></p><p><b>applied</b>: true</p></blockquote></blockquote><blockquote><p><b>certainty</b></p><p><b>description</b>: </p><div><p>Low certainty due to inconsistency and risk of bias</p>\n</div><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-type Overall}\">Overall certainty</span></p><p><b>rating</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-rating low}\">Low quality</span></p><blockquote><p><b>subcomponent</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-type PublicationBias}\">Publication bias</span></p><p><b>rating</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-rating no-concern}\">no serious 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>: <span title=\"Codes:{http://hl7.org/fhir/certainty-type Inconsistency}\">Inconsistency</span></p><p><b>rating</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-rating serious-concern}\">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>: <span title=\"Codes:{http://hl7.org/fhir/certainty-type Imprecision}\">Imprecision</span></p><p><b>rating</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-rating no-concern}\">no serious concern</span></p></blockquote><blockquote><p><b>subcomponent</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-type Indirectness}\">Indirectness</span></p><p><b>rating</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-rating no-concern}\">no serious concern</span></p></blockquote><blockquote><p><b>subcomponent</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-type RiskOfBias}\">Risk of bias</span></p><p><b>rating</b>: <span title=\"Codes:{http://hl7.org/fhir/certainty-rating serious-concern}\">serious concern</span></p><h3>Subcomponents</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Note</b></td><td><b>Type</b></td><td><b>Rating</b></td></tr><tr><td style=\"display: none\">*</td><td>No blinding (no placebo control) in the largest trial</td><td><span title=\"Codes:{https://fevir.net/resources/CodeSystem/181513 SEVCO:00035}\">Lack of blinding</span></td><td><span title=\"Codes:{http://hl7.org/fhir/certainty-rating present}\">present</span></td></tr></table></blockquote></blockquote></div>" ] ; # fhir:url [ fhir:v "https://fevir.net/resources/Evidence/55"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ; fhir:code [ fhir:v "ACSN" ] ; fhir:display [ fhir:v "Accession ID" ] ] ) ; fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ; fhir:system [ fhir:v "https://fevir.net"^^xsd:anyURI ] ; fhir:value [ fhir:v "55" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] [ fhir:system [ fhir:v "https://gps.health/coka"^^xsd:anyURI ] ; fhir:value [ fhir:v "143" ] ; fhir:assigner [ fhir:display [ fhir:v "COVID-19 Knowledge Accelerator" ] ] ] ) ; # fhir:version [ fhir:v "4"] ; # fhir:name [ fhir:v "Fourteen_day_mortality_remdesivir_vs_placebo_meta_analysis_ACTT_1_Wang_et_al_WHO_SOLIDARITY"] ; # fhir:title [ fhir:v "14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY)"] ; # fhir:citeAs [ a fhir:Reference ; fhir:reference [ fhir:v "Citation/58" ] ; fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ; fhir:display [ fhir:v "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." ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:date [ fhir:v "2021-08-23T12:33:29.572Z"^^xsd:dateTime] ; # fhir:approvalDate [ fhir:v "2020-12-17"^^xsd:date] ; # fhir:lastReviewDate [ fhir:v "2020-12-21"^^xsd:date] ; # fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # fhir:contact ( [ ( fhir:telecom [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "support@computablepublishing.com" ] ] ) ] ) ; # fhir:author ( [ fhir:name [ fhir:v "Brian S. Alper" ] ] [ fhir:name [ fhir:v "Joanne Dehnbostel" ] ] [ fhir:name [ fhir:v "Khalid Shahin" ] ] ) ; # fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # fhir:relatedArtifact ( [ fhir:type [ fhir:v "citation" ] ; fhir:display [ fhir:v "Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial" ] ; fhir:resource [ fhir:v "http://computablepublishing.us/fevir/resources/Citation/4932"^^xsd:anyURI ; fhir:link <http://computablepublishing.us/fevir/resources/Citation/4932> ] ] [ fhir:type [ fhir:v "citation" ] ; fhir:display [ fhir:v "Remdesivir for the Treatment of Covid-19 - Final Report" ] ] [ fhir:type [ fhir:v "citation" ] ; fhir:display [ fhir:v "Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results" ] ] [ fhir:type [ fhir:v "cite-as" ] ; fhir:citation [ fhir:v "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." ] ] ) ; # fhir:description [ fhir:v "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"] ; # fhir:assertion [ fhir:v "Remdesivir might reduce 14-day mortality, but this finding has not been repeated in a second trial (Low certainty)"] ; # fhir:variableDefinition ( [ fhir:description [ fhir:v "Adults with COVID-19 pneumonia admitted to hospital" ] ; fhir:variableRole [ fhir:v "population" ] ; fhir:observed [ fhir:reference [ fhir:v "Group/179799" ] ; fhir:type [ fhir:v "Group"^^xsd:anyURI ] ; fhir:display [ fhir:v "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)" ] ] ; fhir:intended [ fhir:reference [ fhir:v "Group/12714" ] ; fhir:type [ fhir:v "Group"^^xsd:anyURI ] ; fhir:display [ fhir:v "COVID-19PneumoniaHospitalizedAdult" ] ] ; fhir:directnessMatch [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/directness"^^xsd:anyURI ] ; fhir:version [ fhir:v "1.0.0" ] ; fhir:code [ fhir:v "high" ] ; fhir:display [ fhir:v "High quality match between observed and intended variable" ] ] ) ] ] [ fhir:description [ fhir:v "Remdesivir IV 200 mg once then 100 mg once daily for 9 days" ] ; fhir:variableRole [ fhir:v "exposure" ] ; fhir:observed [ fhir:reference [ fhir:v "Group/179783" ] ; fhir:type [ fhir:v "Group"^^xsd:anyURI ] ; fhir:display [ fhir:v "Remdesivir IV 200 mg once then 100 mg once daily for 9 days" ] ] ; fhir:intended [ fhir:reference [ fhir:v "EvidenceVariable/12717" ] ; fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ; fhir:display [ fhir:v "Remdesivir" ] ] ] [ fhir:description [ fhir:v "Placebo" ] ; ( fhir:note [ fhir:text [ fhir:v "SOLIDARITY trial did not use placebo in control group" ] ] ) ; fhir:variableRole [ fhir:v "exposure" ] ; fhir:observed [ fhir:reference [ fhir:v "EvidenceVariable/12718" ] ; fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ; fhir:display [ fhir:v "Placebo" ] ] ; fhir:intended [ fhir:reference [ fhir:v "EvidenceVariable/12718" ] ; fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ; fhir:display [ fhir:v "Placebo" ] ] ] [ fhir:description [ fhir:v "Mortality at 14 days" ] ; fhir:variableRole [ fhir:v "outcome" ] ; fhir:observed [ fhir:reference [ fhir:v "EvidenceVariable/12719" ] ; fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ; fhir:display [ fhir:v "Mortality at 14 days" ] ] ; fhir:intended [ fhir:reference [ fhir:v "EvidenceVariable/12719" ] ; fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ; fhir:display [ fhir:v "Mortality at 14 days" ] ] ] ) ; # fhir:studyDesign ( [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:01003" ] ; fhir:display [ fhir:v "randomized assignment" ] ] ) ] ) ; # fhir:statistic ( [ fhir:description [ fhir:v "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%" ] ; fhir:statisticType [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/statistic-type"^^xsd:anyURI ] ; fhir:version [ fhir:v "0.1.0" ] ; fhir:code [ fhir:v "C93152" ] ; fhir:display [ fhir:v "Relative Risk" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.85"^^xsd:decimal ] ] ; fhir:numberOfEvents [ fhir:v "779"^^xsd:nonNegativeInteger ] ; fhir:numberAffected [ fhir:v "779"^^xsd:nonNegativeInteger ] ; fhir:sampleSize [ fhir:numberOfStudies [ fhir:v "3"^^xsd:nonNegativeInteger ] ; fhir:numberOfParticipants [ fhir:v "6774"^^xsd:nonNegativeInteger ] ; fhir:knownDataCount [ fhir:v "6744"^^xsd:nonNegativeInteger ] ] ; ( fhir:attributeEstimate [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "C53324" ] ; fhir:display [ fhir:v "Confidence interval" ] ] ) ] ; fhir:level [ fhir:v "0.95"^^xsd:decimal ] ; fhir:range [ fhir:low [ fhir:value [ fhir:v "0.74"^^xsd:decimal ] ] ; fhir:high [ fhir:value [ fhir:v "0.96"^^xsd:decimal ] ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ; fhir:code [ fhir:v "TBD:0000077" ] ; fhir:display [ fhir:v "Z-score" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "2.52"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "C44185" ] ; fhir:display [ fhir:v "P-value" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.01"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "0000420" ] ; fhir:display [ fhir:v "I-squared" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.73"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "0000419" ] ; fhir:display [ fhir:v "Cochran's Q statistic" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "7.33"^^xsd:decimal ] ] ; ( fhir:attributeEstimate [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ; fhir:code [ fhir:v "STATO:0000069" ] ; fhir:display [ fhir:v "Degrees of Freedom" ] ] ) ; fhir:text [ fhir:v "degrees of freedom" ] ] ; fhir:quantity [ fhir:value [ fhir:v "2"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "C44185" ] ; fhir:display [ fhir:v "P-value" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.03"^^xsd:decimal ] ] ] ) ] ) ; ( fhir:modelCharacteristic [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/statistic-model-code"^^xsd:anyURI ] ; fhir:code [ fhir:v "effectsFixed" ] ; fhir:display [ fhir:v "Fixed-effects" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:applied [ fhir:v "true"^^xsd:boolean ] ] [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/statistic-model-code"^^xsd:anyURI ] ; fhir:code [ fhir:v "metaAnalysis" ] ; fhir:display [ fhir:v "Meta-analysis" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:applied [ fhir:v "true"^^xsd:boolean ] ] ) ] [ fhir:description [ fhir:v "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" ] ; ( fhir:note [ fhir:text [ fhir:v "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." ] ] ) ; fhir:statisticType [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/statistic-type"^^xsd:anyURI ] ; fhir:version [ fhir:v "0.1.0" ] ; fhir:code [ fhir:v "C93152" ] ; fhir:display [ fhir:v "Relative Risk" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.81"^^xsd:decimal ] ] ; fhir:numberOfEvents [ fhir:v "779"^^xsd:nonNegativeInteger ] ; fhir:numberAffected [ fhir:v "779"^^xsd:nonNegativeInteger ] ; fhir:sampleSize [ fhir:numberOfStudies [ fhir:v "3"^^xsd:nonNegativeInteger ] ; fhir:numberOfParticipants [ fhir:v "6774"^^xsd:nonNegativeInteger ] ; fhir:knownDataCount [ fhir:v "6744"^^xsd:nonNegativeInteger ] ] ; ( fhir:attributeEstimate [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "C53324" ] ; fhir:display [ fhir:v "Confidence interval" ] ] ) ] ; fhir:level [ fhir:v "0.95"^^xsd:decimal ] ; fhir:range [ fhir:low [ fhir:value [ fhir:v "0.6"^^xsd:decimal ] ] ; fhir:high [ fhir:value [ fhir:v "1.08"^^xsd:decimal ] ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ; fhir:code [ fhir:v "TBD:0000077" ] ; fhir:display [ fhir:v "Z-score" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "1.44"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "C44185" ] ; fhir:display [ fhir:v "P-value" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.15"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "0000421" ] ; fhir:display [ fhir:v "Tau squared" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.04"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "0000420" ] ; fhir:display [ fhir:v "I-squared" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.73"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "0000419" ] ; fhir:display [ fhir:v "Cochran's Q statistic" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "7.33"^^xsd:decimal ] ] ; ( fhir:attributeEstimate [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ] ; fhir:code [ fhir:v "defined-in-text" ] ; fhir:display [ fhir:v "Defined in text" ] ] ) ; fhir:text [ fhir:v "degrees of freedom" ] ] ; fhir:quantity [ fhir:value [ fhir:v "2"^^xsd:decimal ] ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "C44185" ] ; fhir:display [ fhir:v "P-value" ] ] ) ] ; fhir:quantity [ fhir:value [ fhir:v "0.03"^^xsd:decimal ] ] ] ) ] ) ; ( fhir:modelCharacteristic [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/statistic-model-code"^^xsd:anyURI ] ; fhir:code [ fhir:v "effectsRandom" ] ; fhir:display [ fhir:v "Random-effects" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:applied [ fhir:v "true"^^xsd:boolean ] ] [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/statistic-model-code"^^xsd:anyURI ] ; fhir:code [ fhir:v "metaAnalysis" ] ; fhir:display [ fhir:v "Meta-analysis" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:applied [ fhir:v "true"^^xsd:boolean ] ] [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/statistic-model-code"^^xsd:anyURI ] ; fhir:code [ fhir:v "tauDersimonianLaird" ] ; fhir:display [ fhir:v "Dersimonian-Laird method" ] ; fhir:userSelected [ fhir:v "true"^^xsd:boolean ] ] ) ] ; fhir:applied [ fhir:v "true"^^xsd:boolean ] ] ) ] ) ; # fhir:certainty ( [ fhir:description [ fhir:v "Low certainty due to inconsistency and risk of bias" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Overall" ] ; fhir:display [ fhir:v "Overall certainty" ] ] ) ] ; fhir:rating [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ; fhir:code [ fhir:v "low" ] ; fhir:display [ fhir:v "Low quality" ] ] ) ] ; ( fhir:subcomponent [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "PublicationBias" ] ; fhir:display [ fhir:v "Publication bias" ] ] ) ] ; fhir:rating [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ; fhir:code [ fhir:v "no-concern" ] ; fhir:display [ fhir:v "no serious concern" ] ] ) ] ] [ ( fhir:note [ fhir:text [ fhir:v "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." ] ] ) ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Inconsistency" ] ; fhir:display [ fhir:v "Inconsistency" ] ] ) ] ; fhir:rating [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ; fhir:code [ fhir:v "serious-concern" ] ; fhir:display [ fhir:v "serious concern" ] ] ) ] ] [ ( fhir:note [ fhir:text [ fhir:v "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." ] ] ) ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Imprecision" ] ; fhir:display [ fhir:v "Imprecision" ] ] ) ] ; fhir:rating [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ; fhir:code [ fhir:v "no-concern" ] ; fhir:display [ fhir:v "no serious concern" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Indirectness" ] ; fhir:display [ fhir:v "Indirectness" ] ] ) ] ; fhir:rating [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ; fhir:code [ fhir:v "no-concern" ] ; fhir:display [ fhir:v "no serious concern" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "RiskOfBias" ] ; fhir:display [ fhir:v "Risk of bias" ] ] ) ] ; fhir:rating [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ; fhir:code [ fhir:v "serious-concern" ] ; fhir:display [ fhir:v "serious concern" ] ] ) ] ; ( fhir:subcomponent [ ( fhir:note [ fhir:text [ fhir:v "No blinding (no placebo control) in the largest trial" ] ] ) ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/181513"^^xsd:anyURI ] ; fhir:code [ fhir:v "SEVCO:00035" ] ; fhir:display [ fhir:v "Inadequate blinding of participants" ] ] ) ; fhir:text [ fhir:v "Lack of blinding" ] ] ; fhir:rating [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/certainty-rating"^^xsd:anyURI ] ; fhir:code [ fhir:v "present" ] ; fhir:display [ fhir:v "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
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