A user's guide to the disease management literature: recommendations for reporting and assessing program outcomes

Recently there has been tremendous growth in the number of lay-press articles and peer-reviewed journal articles reporting extraordinary improvements in health status and financial outcomes due to disease management (DM) interventions. However, closer scrutiny of these reports reveals serious flaws in research design and/or analysis, leaving many to question the veracity of the claims. In recent years, there have been numerous contributions to the literature on how to assess the quality of medical research papers. However, these guidelines focus primarily on randomized controlled trials, with little attention given to the observational study designs typically used in DM outcome studies. As such, general guides to evaluating the medical literature are inadequate in their utility to assist authors and readers of DM outcomes research. The purpose of this paper is to provide authors with a clear and comprehensive guide to the reporting of DM outcomes, as well as to educate readers of the DM literature (both lay and peer reviewed) in how to assess the quality of the findings presented.