Abstract:

Background: Outcome misclassification is acknowledged but rarely corrected for in drug safety causal inference studies using observational data. Quantitative bias analysis (QBA) is a method for outcome misclassification correction, but its performance characteristics have not been systematically evaluated in pharmacovigilance applications across distributed database networks.

Objective: To evaluate the performance associated with the use of 2 types of QBA for outcome misclassification correction across a distributed database network.

Methods: METHODS

Results: RESULTS

Discussion: DISCUSSION

Key points:

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• The full manuscript is available at: https://data.ohdsi.org/
• The study was registered at XXX: https://data.ohdsi.org/
• The full study protocol is available at: https://data.ohdsi.org/
• The full source code for the study is available at: https://data.ohdsi.org/