Current Practice in Evaluation of Treatment Interventions for Individuals with Chronic Diseases

What questions can we answer about new neurotechnology devices designed for treating patients with depression? What is the evidence needed to allow access to these new treatment methodologies to patients with no other treatment options - at a minimum the 33% of patients in the STAR*D trial that did not reach remission.

In her presentation to the National Task Force on Consumer Access to Emerging Neurotechnologies, Susan Horn, Ph.D., Senior Scientist, Institute for Clinical Outcomes Research & Vice President, Research, International Severity Information Systems, Inc., took a step back from treatment resistant depression and delved into these very important questions from a more general view - how to evaluate effectiveness for treatments of chronic diseases. Randomized controlled trials (RCT) have long been the gold standard evidence for approval by the Food and Drug Administration (FDA), but are there other methodologies that may be better suited to evaluate long term outcome for chronic diseases. Dr. Horn described the Practice-Based Evidence for Clinical Practice Improvement study design PBE-CPI, its approach to comparative effectiveness evaluation, how it differs from other study methodologies, and how it may be more useful for the evaluation of chronic diseases.