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Patient reported outcomes as endpoints in medical research

Colorado Health Outcomes Program and Department of Preventive Medicine, University of Colorado Health Sciences Center, Aurora, CO, USA, dianefairclough{at}earthlink.net

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.

Statistical Methods in Medical Research, Vol. 13, No. 2, 115-138 (2004)
DOI: 10.1191/0962280204sm357ra


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