Evaluating a Key Instrumental Variable Assumption Using Randomization Tests

Instrumental variable (IV) analyses are becoming common in health services research and epidemiology. Most IV analyses use naturally occurring instruments, such as distance to a hospital. In these analyses, investigators must assume that the instrument is as-if randomly assigned. This assumption cannot be tested directly, but it can be falsified. Most IV falsification tests compare relative prevalence or bias in observed covariates between the instrument and exposure. These tests require investigators to make covariate-by-covariate judgments about the validity of the IV design. Often, only some covariates are well-balanced, making it unclear whether as-if randomization can be assumed for the instrument. We propose an alternative falsification test that compares IV balance or bias with the balance or bias that would have been produced under randomization. A key advantage of our test is that it allows for global balance measures as well as easily interpretable graphical comparisons. Furthermore, our test does not rely on parametric assumptions and can be used to validly assess whether the instrument is significantly closer to being as-if randomized than the exposure. We demonstrate our approach using data from (SPOT)light, a prospective cohort study carried out in 48 National Health Service hospitals in the United Kingdom between November 1,2010, and December 31,2011. This study used bed availability in the intensive care unit as an instrument for admission to the intensive care unit.