Strengthening the case for disease management effectiveness: un-hiding the hidden bias.

As is the case with most health care program evaluations, disease management (DM) programs typically follow an observational study design, indicating that randomization to treatment or control was not performed. The foremost limitation of observational studies, compared to randomized studies, is that the only biases that can be controlled for are those associated with observed variables. Hidden bias refers to all those unobserved covariates that may distort the conclusions of the study. This paper introduces a sensitivity analysis that is used to determine the magnitude of hidden bias necessary to alter the conclusion that a DM program intervention was indeed effective.