Evaluating disease management programme effectiveness: an introduction to the regression discontinuity design.

Although disease management (DM) has been in existence for over a decade, there is still much uncertainty as to its effectiveness in improving health status and reducing medical cost. The main reason is that most programme evaluations typically follow weak observational study designs that are subject to bias, most notably selection bias and regression to the mean. The regression discontinuity (RD) design may be the best alternative to randomized studies for evaluating DM programme effectiveness. The most crucial element of the RD design is its use of a 'cut-off' score on a pre-test measure to determine assignment to intervention or control. A valuable feature of this technique is that the pre-test measure does not have to be the same as the outcome measure, thus maximizing the programme's ability to use research-based practice guidelines, survey instruments and other tools to identify those individuals in greatest need of the programme intervention. Similarly, the cut-off score can be based on clinical understanding of the disease process, empirically derived, or resource-based. In the RD design, programme effectiveness is determined by a change in the pre-post relationship at the cut-off point. While the RD design is uniquely suitable for DM programme evaluation, its success will depend, in large part, on fundamental changes being made in the way DM programmes identify and assign individuals to the programme intervention.