FHIR © HL7.org  |  FHIRsmith 4.0.1  |  Server Home  |  XIG Home  |  XIG Stats  | 

FHIR IG analytics

Packagehl7.fhir.uv.ebm
Resource TypeEvidence
IdEvidence-55.json
FHIR VersionR6

Resources that use this resource

No resources found


Resources that this resource uses

No resources found


Narrative

Note: links and images are rebased to the (stated) source

[No data.]


Source1

{
  "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": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "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": [
    {
      "telecom": [
        {
          "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": [
          {
            "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": [
        {
          "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": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000196",
                "display": "confidence interval"
              }
            ]
          },
          "level": 0.95,
          "range": {
            "low": {
              "value": 0.74
            },
            "high": {
              "value": 0.96
            }
          }
        },
        {
          "type": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000104",
                "display": "z-score"
              }
            ]
          },
          "quantity": {
            "value": 2.52
          }
        },
        {
          "type": {
            "coding": [
              {
                "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": [
            {
              "type": {
                "coding": [
                  {
                    "system": "https://fevir.net/sevco",
                    "code": "STATO:0000069",
                    "display": "degrees of freedom"
                  }
                ]
              },
              "quantity": {
                "value": 2
              }
            },
            {
              "type": {
                "coding": [
                  {
                    "system": "https://fevir.net/sevco",
                    "code": "STATO:0000700",
                    "display": "p-value"
                  }
                ]
              },
              "quantity": {
                "value": 0.03
              }
            }
          ]
        }
      ],
      "modelCharacteristic": [
        {
          "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": [
          {
            "system": "https://fevir.net/sevco",
            "code": "STATO:0000245",
            "display": "risk ratio"
          }
        ]
      },
      "quantity": {
        "value": 0.81
      },
      "numberOfEvents": 779,
      "numberAffected": 779,
      "sampleSize": {
        "numberOfStudies": 3,
        "numberOfParticipants": 6774,
        "knownDataCount": 6744
      },
      "attributeEstimate": [
        {
          "type": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000196",
                "display": "confidence interval"
              }
            ]
          },
          "level": 0.95,
          "range": {
            "low": {
              "value": 0.6
            },
            "high": {
              "value": 1.08
            }
          }
        },
        {
          "type": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000104",
                "display": "z-score"
              }
            ]
          },
          "quantity": {
            "value": 1.44
          }
        },
        {
          "type": {
            "coding": [
              {
                "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": [
                  {
                    "system": "https://fevir.net/sevco",
                    "code": "STATO:0000069",
                    "display": "degrees of freedom"
                  }
                ]
              },
              "quantity": {
                "value": 2
              }
            },
            {
              "type": {
                "coding": [
                  {
                    "system": "https://fevir.net/sevco",
                    "code": "STATO:0000700",
                    "display": "p-value"
                  }
                ]
              },
              "quantity": {
                "value": 0.03
              }
            }
          ]
        }
      ],
      "modelCharacteristic": [
        {
          "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": [
              {
                "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": [
              {
                "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/sevco",
                    "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"
                  }
                ]
              }
            }
          ]
        }
      ]
    }
  ]
}