Quantitative bias analysis for outcome phenotype error correction in comparative effect estimation: an empirical evaluation and simulation study (QBA evaluation)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105663
• EU PAS number:
  EUPAS104459
• Study ID:
  105663
• Official title and acronym:
  Quantitative bias analysis for outcome phenotype error correction in comparative effect estimation: an empirical evaluation and simulation study (QBA evaluation)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Outcome phenotype error is acknowledged but rarely corrected for in causal effect estimation studies using observational data. Quantitative bias analysis (QBA) is a method for phenotype error correction, but the extent to which it minimizes bias in effect estimates is unclear. We will empirically evaluate the impact of QBA for outcome phenotype error correction in several pharmacoepidemiologic comparative effect estimation scenarios. Further, we will simulate an analytic space defined by outcome incidence, observed effect estimates, and phenotype measurement errors to determine which QBA input combinations produce valid results.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 10/06/2021

Actual: 10/06/2021

Study start date

Planned: 03/01/2022

Actual: 03/01/2022

Date of final study report

Planned: 29/12/2023

Sources of funding

Other

More details on funding

Clarendon Fund, University of Oxford

Study protocol

Initial protocol

EUPAS104459_protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable