Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Other

If ‘other’, further details on the scope of the study

Observational research methods
Non-interventional study

Non-interventional study design

Cohort
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

6000000
Study design details

Main study objective

1) Empirically evaluate QBA for outcome phenotype error correction in several pharmacoepidemiologic comparative effect estimation scenarios 2) Simulate an analytic space defined by outcome incidence, observed effect estimates, and phenotype measurement errors to determine which QBA input combinations produce valid results

Data analysis plan

Quantitative bias analysis (QBA) provides algebraic adjustment of person counts in an exposure by outcome 2x2 contingency table based on the magnitude of outcome misclassification. We will evaluate the impact of QBA for outcome phenotype error correction in several empirical and simulated comparative effect estimation pharmacoepidemiologic scenarios. We will evaluate QBA performance with several bias correction metrics.