期刊
AMERICAN JOURNAL OF EPIDEMIOLOGY
卷 190, 期 10, 页码 2181-2187出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/aje/kwab110
关键词
active comparators; case-only designs; confounding-by-indication
资金
- International Society of Pharmacoepidemiology's strategic manuscript initiative
In a study investigating the association between penicillin and venous thromboembolism (VTE) using roxithromycin as a comparator, it was found that upper respiratory infections serve as a transient risk factor for VTE, indicating time-dependent confounding by indication. Results from different analytical methods varied in their conclusions, with case-crossover analysis showing a strong association, while other methods suggested a weak protective effect of penicillin, highlighting the importance of using active comparators to mitigate confounding bias in medication-related studies.
For self-controlled studies of medication-related effects, time-varying confounding by indication can occur if the indication varies over time. We describe how active comparators might mitigate such bias, using an empirical example. Approaches to using active comparators are described for case-crossover design, case-time-control design, self-controlled case-series, and sequence symmetry analyses. In the empirical example, we used Danish data from 1996-2018 to study the association between penicillin and venous thromboembolism (VTE), using roxithromycin, a macrolide antibiotic, as comparator. Upper respiratory infection is a transient risk factor for VTE, thus representing time-dependent confounding by indication. Odds ratios for case-crossover analysis were 3.35 (95% confidence interval: 3.23, 3.49) for penicillin and 3.56 (95% confidence interval: 3.30, 3.83) for roxithromycin. We used a Wald-based method or an interaction term to estimate the odds ratio for penicillin with roxithromycin as comparator. These 2 estimates were 0.94 (95% confidence interval: 0.87, 1.03) and 1.03 (95% confidence interval: 0.95, 1.13). Results were similar for the case-time-control analysis, but both the self-controlled case-series and sequence symmetry analysis suggested a weak protective effect of penicillin, seemingly explained by VTE affecting future exposure exclusively for penicillin. The strong association of antibiotics with VTE suggests presence of confounding by indication. Such confounding can be mitigated by using an active comparator.
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