Patient reported outcomes as endpoints in medical research.
This review covers a number of the many design and analytic issues associated with clinical trials that incorporate patient reported outcomes as primary or secondary endpoints. We use a clinical trial designed to evaluate a new therapy for the prevention of migraines to illustrate how endpoints are defined by the objectives of the study, the methods for handling longitudinal assessments with multiple scales or outcomes, and the methods of analysis in the presence of missing data.
Fairclough
Diane L
DL
Colorado Health Outcomes Program, Department of Preventive Medicine, University of Colorado Health Sciences Center, Aurora, CO 80045-0508, USA. dianefairclough@earthlink.net
D035843:Biomedical Research; D004311:Double-Blind Method; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D006801:Humans; D008137:Longitudinal Studies; D008881:Migraine Disorders / Q000517:prevention & control; D012650:Self Disclosure; D016896:Treatment Outcome; D014481:United States