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
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"id" : "55",
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"version" : "4",
"name" : "Fourteen_day_mortality_remdesivir_vs_placebo_meta_analysis_ACTT_1_Wang_et_al_WHO_SOLIDARITY",
"title" : "14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY)",
"citeAsReference" : {
🔗 "reference" : "Citation/58",
"type" : "Citation",
"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."
},
"status" : "active",
"date" : "2021-08-23T12:33:29.572Z",
"approvalDate" : "2020-12-17",
"lastReviewDate" : "2020-12-21",
"publisher" : "Computable Publishing LLC",
"contact" : [
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"author" : [
{
"name" : "Brian S. Alper"
},
{
"name" : "Joanne Dehnbostel"
},
{
"name" : "Khalid Shahin"
}
],
"copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"relatedArtifact" : [
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"type" : "citation",
"display" : "Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial",
"resource" : "http://computablepublishing.us/fevir/resources/Citation/4932"
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{
"type" : "citation",
"display" : "Remdesivir for the Treatment of Covid-19 - Final Report"
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"type" : "citation",
"display" : "Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results"
},
{
"type" : "cite-as",
"citation" : "14-day mortality remdesivir vs placebo meta-analysis (ACTT-1, Wang et al, WHO SOLIDARITY) [Database Entry: FHIR Evidence Resource]. Contributors: Brian S. Alper, Joanne Dehnbostel, Khalid Shahin [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 55. Published 2020-12-17. Revised 2021-08-23. Available at: https://fevir.net/resources/Evidence/55. Computable resource at: https://fevir.net/resources/Evidence/55#json."
}
],
"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" : [
{
"description" : "Adults with COVID-19 pneumonia admitted to hospital",
"variableRole" : "population",
"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)"
},
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🔗 "reference" : "Group/12714",
"type" : "Group",
"display" : "COVID-19PneumoniaHospitalizedAdult"
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}
},
{
"description" : "Remdesivir IV 200 mg once then 100 mg once daily for 9 days",
"variableRole" : "exposure",
"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"
}
},
{
"description" : "Placebo",
"note" : [
{
"text" : "SOLIDARITY trial did not use placebo in control group"
}
],
"variableRole" : "exposure",
"observed" : {
🔗 "reference" : "EvidenceVariable/12718",
"type" : "EvidenceVariable",
"display" : "Placebo"
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"intended" : {
🔗 "reference" : "EvidenceVariable/12718",
"type" : "EvidenceVariable",
"display" : "Placebo"
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},
{
"description" : "Mortality at 14 days",
"variableRole" : "outcome",
"observed" : {
🔗 "reference" : "EvidenceVariable/12719",
"type" : "EvidenceVariable",
"display" : "Mortality at 14 days"
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🔗 "reference" : "EvidenceVariable/12719",
"type" : "EvidenceVariable",
"display" : "Mortality at 14 days"
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"display" : "randomized assignment"
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"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%",
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},
"quantity" : {
"value" : 0.85
},
"numberOfEvents" : 779,
"numberAffected" : 779,
"sampleSize" : {
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"numberOfParticipants" : 6774,
"knownDataCount" : 6744
},
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"display" : "Confidence interval"
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"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" : [
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"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."
}
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"display" : "Meta-analysis",
"userSelected" : true
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"code" : "tauDersimonianLaird",
"display" : "Dersimonian-Laird method",
"userSelected" : true
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]
},
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]
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"description" : "Low certainty due to inconsistency and risk of bias",
"type" : {
"coding" : [
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"system" : "http://hl7.org/fhir/certainty-type",
"code" : "Overall",
"display" : "Overall certainty"
}
]
},
"rating" : {
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"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "low",
"display" : "Low quality"
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{
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"coding" : [
{
"system" : "http://hl7.org/fhir/certainty-type",
"code" : "PublicationBias",
"display" : "Publication bias"
}
]
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"system" : "http://hl7.org/fhir/certainty-rating",
"code" : "no-concern",
"display" : "no serious concern"
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{
"note" : [
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"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" : [
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"system" : "http://hl7.org/fhir/certainty-type",
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},
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"note" : [
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"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."
}
],
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"code" : "Imprecision",
"display" : "Imprecision"
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]
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},
{
"type" : {
"coding" : [
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"system" : "http://hl7.org/fhir/certainty-type",
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"display" : "Indirectness"
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]
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]
}
},
{
"type" : {
"coding" : [
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"system" : "http://hl7.org/fhir/certainty-type",
"code" : "RiskOfBias",
"display" : "Risk of bias"
}
]
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"rating" : {
"coding" : [
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"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" : {
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"system" : "https://fevir.net/resources/CodeSystem/181513",
"code" : "SEVCO:00035",
"display" : "Inadequate blinding of participants"
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],
"text" : "Lack of blinding"
},
"rating" : {
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"code" : "present",
"display" : "present"
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}
}
]
}
]
}
]
}
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
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