FHIR IG analytics| Package | hl7.fhir.uv.ebm |
| Resource Type | Evidence |
| Id | Evidence-55.json |
| FHIR Version | R6 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
[No data.]
{
"resourceType": "Evidence",
"id": "55",
"meta": {
"versionId": "41",
"lastUpdated": "2025-11-04T15:33:09.522Z"
},
"language": "en",
"text": {
"status": "empty",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
"valueCodeableConcept": {
"coding": [
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"code": "active",
"display": "Active"
}
]
}
}
],
"url": "https://fevir.net/resources/Evidence/55",
"identifier": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "ACSN",
"display": "Accession ID"
}
],
"text": "FEvIR Object Identifier"
},
"system": "https://fevir.net/FOI",
"value": "55",
"assigner": {
"display": "Computable Publishing LLC"
}
}
],
"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)",
"citeAs": "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.",
"status": "active",
"date": "2021-08-23T12:33:29.572Z",
"approvalDate": "2020-12-17",
"lastReviewDate": "2020-12-21",
"author": [
{
"name": "Brian S. Alper"
},
{
"name": "Joanne Dehnbostel"
},
{
"name": "Khalid Shahin"
}
],
"publisher": "Computable Publishing LLC",
"contact": [
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"telecom": [
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"system": "email",
"value": "support@computablepublishing.com"
}
]
}
],
"copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"relatesTo": [
{
"type": "derived-from",
"targetMarkdown": "Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial"
},
{
"type": "derived-from",
"targetMarkdown": "Remdesivir for the Treatment of Covid-19 - Final Report"
},
{
"type": "derived-from",
"targetMarkdown": "Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results"
}
],
"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)"
},
"intended": {
"reference": "Group/12714",
"type": "Group",
"display": "COVID-19PneumoniaHospitalizedAdult"
},
"directnessMatch": {
"coding": [
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"system": "http://terminology.hl7.org/CodeSystem/directness",
"code": "high",
"display": "High quality match between observed and intended variable"
}
]
}
},
{
"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",
"roleSubtype": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/variable-role",
"code": "referenceExposure",
"display": "reference exposure"
}
]
},
"observed": {
"reference": "EvidenceVariable/12718",
"type": "EvidenceVariable",
"display": "Placebo"
},
"intended": {
"reference": "EvidenceVariable/12718",
"type": "EvidenceVariable",
"display": "Placebo"
}
},
{
"description": "Mortality at 14 days",
"variableRole": "outcome",
"observed": {
"reference": "EvidenceVariable/12719",
"type": "EvidenceVariable",
"display": "Mortality at 14 days"
},
"intended": {
"reference": "EvidenceVariable/12719",
"type": "EvidenceVariable",
"display": "Mortality at 14 days"
}
}
],
"studyDesign": [
{
"coding": [
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"system": "https://fevir.net/sevco",
"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": "https://fevir.net/sevco",
"code": "STATO:0000245",
"display": "risk ratio"
}
]
},
"quantity": {
"value": 0.85
},
"numberOfEvents": 779,
"numberAffected": 779,
"sampleSize": {
"numberOfStudies": 3,
"numberOfParticipants": 6774,
"knownDataCount": 6744
},
"attributeEstimate": [
{
"type": {
"coding": [
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"system": "https://fevir.net/sevco",
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"display": "confidence interval"
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]
},
"level": 0.95,
"range": {
"low": {
"value": 0.74
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"high": {
"value": 0.96
}
}
},
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"display": "z-score"
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"quantity": {
"value": 2.52
}
},
{
"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000700",
"display": "p-value"
}
]
},
"quantity": {
"value": 0.01
}
},
{
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "STATO:0000420",
"display": "I-squared"
}
]
},
"quantity": {
"value": 0.73
}
},
{
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "STATO:0000419",
"display": "Cochran's Q"
}
]
},
"quantity": {
"value": 7.33
},
"attributeEstimate": [
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"type": {
"coding": [
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"system": "https://fevir.net/sevco",
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"display": "degrees of freedom"
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]
},
"quantity": {
"value": 2
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},
{
"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000700",
"display": "p-value"
}
]
},
"quantity": {
"value": 0.03
}
}
]
}
],
"modelCharacteristic": [
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"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/statistic-model-code",
"code": "effectsFixed",
"display": "Fixed-effects"
}
]
},
"applied": true
},
{
"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/statistic-model-code",
"code": "metaAnalysis",
"display": "Meta-analysis"
}
]
},
"applied": 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": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000245",
"display": "risk ratio"
}
]
},
"quantity": {
"value": 0.81
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"numberOfEvents": 779,
"numberAffected": 779,
"sampleSize": {
"numberOfStudies": 3,
"numberOfParticipants": 6774,
"knownDataCount": 6744
},
"attributeEstimate": [
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"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000196",
"display": "confidence interval"
}
]
},
"level": 0.95,
"range": {
"low": {
"value": 0.6
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"high": {
"value": 1.08
}
}
},
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"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000104",
"display": "z-score"
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]
},
"quantity": {
"value": 1.44
}
},
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"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000700",
"display": "p-value"
}
]
},
"quantity": {
"value": 0.15
}
},
{
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "STATO:0000421",
"display": "tau squared"
}
]
},
"quantity": {
"value": 0.04
}
},
{
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "STATO:0000420",
"display": "I-squared"
}
]
},
"quantity": {
"value": 0.73
}
},
{
"type": {
"coding": [
{
"system": "https://fevir.net/sevco",
"code": "STATO:0000419",
"display": "Cochran's Q"
}
]
},
"quantity": {
"value": 7.33
},
"attributeEstimate": [
{
"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000069",
"display": "degrees of freedom"
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]
},
"quantity": {
"value": 2
}
},
{
"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "STATO:0000700",
"display": "p-value"
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]
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"quantity": {
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}
}
]
}
],
"modelCharacteristic": [
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"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/statistic-model-code",
"code": "effectsRandom",
"display": "Random-effects"
}
]
},
"applied": true
},
{
"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/statistic-model-code",
"code": "metaAnalysis",
"display": "Meta-analysis"
}
]
},
"applied": true
},
{
"code": {
"coding": [
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"system": "http://terminology.hl7.org/CodeSystem/statistic-model-code",
"code": "tauDersimonianLaird",
"display": "Dersimonian-Laird method"
}
]
},
"applied": 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": [
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"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": [
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"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": {
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"system": "http://hl7.org/fhir/certainty-type",
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"display": "Indirectness"
}
]
},
"rating": {
"coding": [
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"system": "http://hl7.org/fhir/certainty-rating",
"code": "no-concern",
"display": "no serious concern"
}
]
}
},
{
"type": {
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{
"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": [
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"note": [
{
"text": "No blinding (no placebo control) in the largest trial"
}
],
"type": {
"coding": [
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"system": "https://fevir.net/sevco",
"code": "SEVCO:00035",
"display": "Inadequate blinding of participants"
}
],
"text": "Lack of blinding"
},
"rating": {
"coding": [
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"system": "http://hl7.org/fhir/certainty-rating",
"code": "present",
"display": "present"
}
]
}
}
]
}
]
}
]
}