Empirical performance of a self-controlled cohort method: lessons for developing a risk identification and analysis system

PB Ryan, MJ Schuemie, D Madigan - Drug safety, 2013 - Springer
Background Observational healthcare data offer the potential to enable identification of risks
of medical products, but appropriate methodology has not yet been defined. The self …

Empirical performance of a new user cohort method: lessons for developing a risk identification and analysis system

PB Ryan, MJ Schuemie, S Gruber, I Zorych, D Madigan - Drug safety, 2013 - Springer
Background Observational healthcare data offer the potential to enable identification of risks
of medical products, but appropriate methodology has not yet been defined. The new user …

A comparison of the empirical performance of methods for a risk identification system

PB Ryan, PE Stang, JM Overhage, MA Suchard… - Drug safety, 2013 - Springer
Background Observational healthcare data offer the potential to enable identification of risks
of medical products, and the medical literature is replete with analyses that aim to …

Empirical performance of the self-controlled case series design: lessons for developing a risk identification and analysis system

MA Suchard, I Zorych, SE Simpson, MJ Schuemie… - Drug safety, 2013 - Springer
Background The self-controlled case series (SCCS) offers potential as an statistical method
for risk identification involving medical products from large-scale observational healthcare …

Evaluating performance of risk identification methods through a large-scale simulation of observational data

PB Ryan, MJ Schuemie - Drug safety, 2013 - Springer
Background There has been only limited evaluation of statistical methods for identifying
safety risks of drug exposure in observational healthcare data. Simulations can support …

Detecting adverse drug reactions following long-term exposure in longitudinal observational data: The exposure-adjusted self-controlled case series

MJ Schuemie, G Trifiro, PM Coloma… - … methods in medical …, 2016 - journals.sagepub.com
Most approaches used in postmarketing drug safety monitoring, including spontaneous
reporting and statistical risk identification using electronic health care records, are primarily …

Empirical performance of the case–control method: lessons for developing a risk identification and analysis system

D Madigan, MJ Schuemie, PB Ryan - Drug Safety, 2013 - Springer
Background Considerable attention now focuses on the use of large-scale observational
healthcare data for understanding drug safety. In this context, analysts utilize a variety of …

A comparison of estimators from self-controlled case series, case-crossover design, and sequence symmetry analysis for pharmacoepidemiological studies

Y Takeuchi, T Shinozaki, Y Matsuyama - BMC medical research …, 2018 - Springer
Background Despite the frequent use of self-controlled methods in
pharmacoepidemiological studies, the factors that may bias the estimates from these …

A simulation study to compare three self‐controlled case series approaches: correction for violation of assumption and evaluation of bias

W Hua, G Sun, CN Dodd, SA Romio… - … and drug safety, 2013 - Wiley Online Library
Purpose The assumption that the occurrence of outcome event must not alter subsequent
exposure probability is critical for preserving the validity of the self‐controlled case series …

Multiple self-controlled case series for large-scale longitudinal observational databases

SE Simpson, D Madigan, I Zorych, MJ Schuemie… - …, 2013 - academic.oup.com
Characterization of relationships between time-varying drug exposures and adverse events
(AEs) related to health outcomes represents the primary objective in postmarketing drug …