title: Statistical considerations in the design, analysis and interpretation of clinical studies that use patient-reported outcomes.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, MD 1, USA Lisa.Kammerman@AstraZeneca.com.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Kammerman
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, MD 1, USA.
authors.forename: Stella
authors.initials: S
authors.lastname: Grosser
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D063868:Patient Outcome Assessment; D012107:Research Design; D013223:Statistics as Topic