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Stat Methods Med Res. 2004 Apr;13(2):115-38.

Patient reported outcomes as endpoints in medical research.

Author information

1
Colorado Health Outcomes Program, Department of Preventive Medicine, University of Colorado Health Sciences Center, Aurora, CO 80045-0508, USA. dianefairclough@earthlink.net

Abstract

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.

PMID:
15068257
DOI:
10.1191/0962280204sm357ra
[Indexed for MEDLINE]
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