Healthy Skepticism Library item: 12285

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Revicki DA, Erickson PA, Sloan JA, Dueck A, Guess H, Santanello NC; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group.
Interpreting and reporting results based on patient-reported outcomes.
Value Health 2007 Nov-Dec; 10:
http://www.ncbi.nlm.nih.gov/pubmed/17995470?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Abstract:

This article deals with the incorporation of patient-reported outcomes (PROs) into clinical trials and focuses on issues associated with the interpretation and reporting of PRO data. The primary focus and context of this information relates to the evidentiary support and reporting for a labeling or advertising claim of a PRO benefit for a new or approved pharmaceutical product. This manuscript focuses on issues associated with assessing clinical significance and common pitfalls to avoid in presenting results related to PROs. Specifically, the questions addressed by this manuscript involve: What are the best methods to assess clinical significance for PROs? How should investigators present PRO data most effectively in a Food and Drug Administration (FDA) application? In labeling or in a scientific publication? Guidelines for interpreting clinical significance of PROs and for comprehensively reporting on the methods, measures and results of clinical trials that incorporate PROs are important for clinicians, regulatory agencies, and most of all to patients. Clear specifications for considering a finding on a PRO measure, as clinically meaningful, need to be determined by instrument developers and psychometricians; they need to be reported for all clinical trials involving PRO end points. Clinical trial reports need to be comprehensive, clear, and sufficient to enable any reader to understand the methods, PRO measures, statistical analysis, and results.

Keywords:
Clinical Trials as Topic/statistics & numerical data* Data Collection/methods* Data Collection/statistics & numerical data* Data Interpretation, Statistical Endpoint Determination Humans Patient Satisfaction/statistics & numerical data* Psychometrics/methods Treatment Outcome*