Perioperative investigators and professionals increasingly seek to evaluate whether implementing systematic practice changes improves outcomes compared to a previous routine. Cluster randomized trials are the optimal design to assess a systematic practice change but are often impractical; investigators, therefore, often select a before–after design. In this Statistical Grand Rounds, we first discuss biases inherent in a before–after design, including confounding due to periods being completely separated by time, regression to the mean, the Hawthorne effect, and others. Many of these biases can be at least partially addressed by using appropriate designs and analyses, which we discuss. Our focus is on segmented regression of an interrupted time series, which does not require a concurrent control group; we also present alternative designs including difference-in-difference, stepped wedge, and cluster randomization. Conducting segmented regression well requires a sufficient number of time points within each period, along with a robust set of potentially confounding variables. This method compares preintervention and postintervention changes over time, divergences in the outcome when an intervention begins, and trends observed with the intervention compared to trends projected without it. Difference-in-difference methods add a concurrent control, enabling yet stronger inference. When done well, the discussed methods permit robust inference on the effect of an intervention, albeit still requiring assumptions and having limitations. Methods are demonstrated using an interrupted time series study in which anesthesiologists took responsibility for an adult medical emergency team from internal medicine physicians in an attempt to improve outcomes.
From the Departments of *Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio
†Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.
Published ahead of print 25 February 2019.
Accepted for publication February 25, 2019.
The authors declare no conflicts of interest.
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Address correspondence to Edward J. Mascha, PhD, Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, P77-007, Cleveland, OH 44195. Address e-mail to firstname.lastname@example.org.