Evidence/3

This Evidence resource describes the placebo comparator used in a study evaluating Topamax for Migraine.

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FHIR JSON

{
  "resourceType" : "Evidence",
  "extension" : [ {
    "url" : "https://treatments.telix.health/implementationguide/extensions/study-country",
    "valueCodeableConcept" : {
      "coding" : [ {
        "system" : "https://hl7.org/fhir/ValueSet/country",
        "code" : "IN",
        "display" : "India"
      } ]
    }
  } ],
  "identifier" : [ {
    "use" : "official",
    "system" : "https://interneb.org/global-computable-evidence-identifiers",
    "value" : "migraine-placebo-10-1177-03331024221082077"
  } ],
  "title" : "This Evidence resource describes the placebo comparator used in a study evaluating Topamax for Migraine.",
  "status" : "active",
  "date" : "2022-08",
  "publisher" : "Linca LTDA",
  "author" : [ {
    "name" : "Ana Júlia",
    "telecom" : [ {
      "system" : "email",
      "value" : "anajulia9091@gmail.com"
    } ]
  } ],
  "useContext" : [ {
    "code" : {
      "system" : "https://build.fhir.org/ig/HL7/ebm/en/ValueSet-179431.html",
      "code" : "population",
      "display" : "Population"
    },
    "valueCodeableConcept" : {
      "coding" : [ {
        "system" : "https://icd.who.int/ct/icd11_mms/en",
        "code" : "8A80.Z",
        "display" : "Migraine, unspecified",
        "version" : "2026-01"
      } ]
    }
  }, {
    "code" : {
      "system" : "https://build.fhir.org/ig/HL7/ebm/en/ValueSet-179431.html",
      "code" : "comparator",
      "display" : "Comparator"
    },
    "valueCodeableConcept" : {
      "coding" : [ {
        "system" : "https://atcddd.fhi.no/atc_ddd_index/",
        "code" : "V03AX10",
        "display" : "Placebo"
      } ]
    }
  }, {
    "code" : {
      "system" : "https://build.fhir.org/ig/HL7/ebm/en/ValueSet-179431.html",
      "code" : "outcome-measure",
      "display" : "Outcome Measure"
    },
    "valueCodeableConcept" : {
      "coding" : [ {
        "system" : "https://terminology.hl7.org/7.1.0/en/ValueSet-research-study-purpose-type.html",
        "code" : "efficacy",
        "display" : "Efficacy Study"
      } ]
    }
  } ],
  "relatedArtifact" : [ {
    "type" : "citation",
    "display" : "Debashish Chowdhury et al. Cephalalgia (SAGE Publications), 08 / 2022",
    "document" : {
      "url" : "https://doi.org/10.1177/03331024221082077",
      "title" : "Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial"
    }
  } ],
  "variableDefinition" : [ {
    "description" : "Efficacy is calculated as the number of people who had a specific benefit from the placebo comparator divided by the number of people who received the placebo comparator. The specific benefits are categorized as the code system below.",
    "variableRole" : {
      "coding" : [ {
        "system" : "https://www.hl7.org/fhir/valueset-variable-role.html",
        "code" : "measuredVariable",
        "display" : "Measured Variable"
      } ]
    }
  } ],
  "studyDesign" : [ {
    "coding" : [ {
      "system" : "https://hl7.org/fhir/codesystem-study-design.html",
      "code" : "SEVCO:01003",
      "display" : "Randomized Clinical Trial"
    } ]
  } ],
  "statistic" : [ {
    "description" : "Efficacy calculated based on participants who achieved a persistent reduction in the intensity, frequency, or variety of symptoms in the placebo comparator group.",
    "category" : {
      "coding" : [ {
        "system" : "https://treatments.telix.health/codesystem/categorized-efficacy-outcomes",
        "code" : "persistent-reduction",
        "display" : "Persistent reduction of symptoms/indicators"
      } ]
    },
    "numberOfEvents" : 41,
    "numberAffected" : 12,
    "sampleSize" : {
      "numberOfParticipants" : 125
    }
  } ],
  "id" : "3"
}