02209nas a2200193 4500008004100000022001400041245011400055210006900169260001600238520157000254100002001824700002101844700002001865700002901885700002201914700002001936700002301956856003601979 2017 eng d a1464-368500aComparing methods to address bias in observational data: statin use and cardiovascular events in a US cohort.0 aComparing methods to address bias in observational data statin u c2017 Sep 083 a

Background: The theoretical conditions under which causal estimates can be derived from observational data are challenging to achieve in the real world. Applied examples can help elucidate the practical limitations of methods to estimate randomized-controlled trial effects from observational data.

Methods: We used six methods with varying design and analytic features to compare the 5-year risk of incident myocardial infarction among statin users and non-users, and used non-cardiovascular mortality as a negative control outcome. Design features included restriction to a statin-eligible population and new users only; analytic features included multivariable adjustment and propensity score matching.

Results: We used data from 5294 participants in the Cardiovascular Health Study from 1989 to 2004. For non-cardiovascular mortality, most methods produced protective estimates with confidence intervals that crossed the null. The hazard ratio (HR) was 0.92, 95% confidence interval: 0.58, 1.46 using propensity score matching among eligible new users. For myocardial infarction, all estimates were strongly protective; the propensity score-matched analysis among eligible new users resulted in a HR of 0.55 (0.29, 1.05)-a much stronger association than observed in randomized controlled trials.

Conclusions: In designs that compare active treatment with non-treated participants to evaluate effectiveness, methods to address bias in observational data may be limited in real-world settings by residual bias.

1 aKaiser, Paulina1 aArnold, Alice, M1 aBenkeser, David1 aHazzouri, Adina, Zeki Al1 aHirsch, Calvin, H1 aPsaty, Bruce, M1 aOdden, Michelle, C uhttps://chs-nhlbi.org/node/7502