Analysis and interpretation of results based on patient-reported outcomes.
This article is part of a series of manuscripts dealing with the incorporation of patient-reported outcomes (PROs) into clinical trials. The issues dealt with in this manuscript concern the common pitfalls to avoid in statistical analysis and interpretation of PROs. Specifically, the questions addressed by this manuscript involve the analysis pitfalls with PRO data in clinical trials and how can they be avoided (e.g.,missing data, multiplicity, null results etc.). The manuscript provides key literature for existing resources and proposes new guidelines.
Sloan
Jeff A
JA
Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA. jsloan@mayo.edu
Dueck
Amylou C
AC
Erickson
Pennifer A
PA
Guess
Harry
H
Revicki
Dennis A
DA
Santanello
Nancy C
NC
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D004348:Drug Labeling / Q000592:standards* / Q000706:statistics & numerical data; D023381:Endpoint Determination; D006801:Humans; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D012680:Sensitivity and Specificity; D016896:Treatment Outcome