Commentary on "Health economics and the value of therapy in Alzheimer's disease." Report from the Alzheimer's Association Research Roundtable on patient-reported outcomes and dementia research.

The release of the Food and Drug Administration's draft guidance on the patient-reported outcomes (PROs) measurement in February 2006 has specific implication for outcomes research in dementia. Advances in treatments for probable Alzheimer's disease present unique challenges to the measurement of clinical outcomes. Standards adapted for PROs measurement can be applied to provide an alternative perspective on efficacy, and to access a more comprehensive range of outcomes than is currently assessed in dementia trials. The draft guidance provides only limited direction with regard to proxy measurements, but the principles of PROs assessment should be applied to proxy respondent measures. Taking a broad view of outcome measurements can offset limitations related to utility assessment and the use of data in pharmacoeconomic evaluations of dementia treatments. Measurements that formally encompass patients and caregivers can enhance our understanding of the disorder, and improve conclusions about treatment effectiveness.