Epidemiology of Guillain-Barré Syndrome and Risk Associated with Exposure to ABRYSVO Among Vaccinees 18-59 Years of Age in the United States

Data sources

• Data source(s), other:
  The GBS epidemiology and safety study will be conducted using health plan administrative claims data held by up to 3 national health plans (e.g., Carelon, Humana, and CVS Health). ; These Research Partners (RPs) participate in the US FDA’s Sentinel System. Other RPs may be included. ; These RPs participate in the US Food and Drug Administration's (FDA) Sentinel System. ; For this analysis, the most recently available data refreshed for the Sentinel System will be leveraged if possible, or sites will create a study-specific refresh as needed. ; ; The GBS etiology medical record review objective will be conducted using administrative billing data from approximately 3 regional integrated delivery systems, or other appropriate data sources, with geographic diversity. EHRs from within each RP will primarily be used for abstraction, review, and adjudication of the identified cases; if cases are seen at hospitals outside of the RP, charts may be requested.;
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  Sentinel
• CDM website:
  https://www.sentinelinitiative.org/methods-Data-tools/sentinel-common-Data-model

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No