Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses

Many analyses of observational data are attempts to emulate a target trial. The emulation of the target trial may fail when researchers deviate from simple principles that guide the design and analysis of randomized experiments. We review a framework to describe and prevent biases, including immortal time bias, that result from a failure to align start of follow-up, specification of eligibility, and treatment assignment We review some analytic approaches to avoid these problems in comparative effectiveness or safety research. (C) 2016 Elsevier Inc. All rights reserved.