Healthy Skepticism Library item: 12353

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Publication type: Journal Article

Sloan JA, Dueck AC, Erickson PA, Guess H, Revicki DA, Santanello NC; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group.
Analysis and interpretation of results based on patient-reported outcomes.
Value Health 2007 Nov-Dec; 10:
http://www.ncbi.nlm.nih.gov/pubmed/17995469

Abstract:

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.

Keywords:
Clinical Trials as Topic/statistics & numerical data* Data Interpretation, Statistical Drug Labeling/standards* Drug Labeling/statistics & numerical data Endpoint Determination Humans Patient Satisfaction/statistics & numerical data* Sensitivity and Specificity Treatment Outcome*