Drug Saf (2017) 40:789–798 DOI 10.1007/s40264-017-0540-3 OR IGINAL RESEARCH ARTIC L E Evaluation of the Case–Crossover (CCO) Study Design for Adverse Drug Event Detection 1 1 1 1 • • • • Zachary Burningham Tao He Chia-Chen Teng Xi Zhou 1 1 Jonathan Nebeker Brian C. Sauer Published online: 4 May 2017 Springer International Publishing Switzerland 2017 Abstract 360-day window length. The AUC for the accumulative Introduction The case–crossover (CCO) design was orig- outcomes increased with longer risk and control windows inally intended to study exposures characterized as inter- and stronger simulated RR. For example, the AUC for the mittent with acute effects. The performance of the CCO simulated RR of 4 was 0.85 for a 360-day window length design is not well characterized under alternative exposure and 0.23 for a 30-day window length. Risk and control and outcome relationships. window lengths did not appear to sufﬁciently alter the Objective The purpose of this study was to evaluate the AUC for insidious onset outcomes. ability of the CCO to identify simulated treatment effects Conclusions The CCO performed best for acute-onset under different drug exposures and outcomes relationships outcomes, but may be useful for exploring adverse out- while varying the
Drug Safety – Springer Journals
Published: May 4, 2017
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