Demonstration study 2.5.5 of the ConcePTION project; Validation of primary source pregnancy exposure and outcomes (pharmacovigilance data)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Data validation study

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Data validation study

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The main objective is to compare the completeness and accuracy of self-reported pregnancy pharmacovigilance data with corresponding data supplied by healthcare professionals (HCPs) in a variety of different contexts.
• Data analysis plan:
  Sub-study 1 (validation of SADR reports) - Descriptive statistics (absolute numbers, percentages) will be used to describe the total number of reports available, the stratified numbers per report source (e.g. SRS, literature), and the stratified numbers for self-reported and HCP-validated ICSRs. Comparative statistics such as Cohen’s Kappa can be calculated to show agreement between the reports. Sub-study 2 (validation of neurodevelopmental assessment tools) - Agreement between parental reports and clinical assessment results will be quantified using a range of statistical approaches, including (where appropriate) Cohen’s Kappa statistic, correlation coefficients, receiver operating characteristic (ROC) and area under the curve (AUC) plots, and calculations of sensitivity/specificity. Descriptive statistics and qualitative methods may also be utilised where required.