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
<Evidence xmlns="http://hl7.org/fhir">
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<lastUpdated value="2024-06-24T19:15:18.127Z"/>
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<text>
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<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>
</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>
</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)
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>
</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>
</div><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Adults with COVID-19 pneumonia admitted to hospital</p>
</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>
</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>
</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>
</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>
</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>
</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>
</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>
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</attributeEstimate>
</attributeEstimate>
<modelCharacteristic>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="effectsFixed"/>
<display value="Fixed-effects"/>
<userSelected value="true"/>
</coding>
</code>
<applied value="true"/>
</modelCharacteristic>
<modelCharacteristic>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="metaAnalysis"/>
<display value="Meta-analysis"/>
<userSelected value="true"/>
</coding>
</code>
<applied value="true"/>
</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>
<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="TBD:0000077"/>
<display value="Z-score"/>
</coding>
</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>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="defined-in-text"/>
<display value="Defined in text"/>
</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>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="effectsRandom"/>
<display value="Random-effects"/>
<userSelected value="true"/>
</coding>
</code>
<applied value="true"/>
</modelCharacteristic>
<modelCharacteristic>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="metaAnalysis"/>
<display value="Meta-analysis"/>
<userSelected value="true"/>
</coding>
</code>
<applied value="true"/>
</modelCharacteristic>
<modelCharacteristic>
<code>
<coding>
<system value="http://hl7.org/fhir/statistic-model-code"/>
<code value="tauDersimonianLaird"/>
<display value="Dersimonian-Laird method"/>
<userSelected value="true"/>
</coding>
</code>
<applied value="true"/>
</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 © 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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