Objectives:
This workshop will be focused on patient-reported outcomes, and will be structured in two parts:
- A brief discussion of methods for interpreting PRO outcomes in clinical trials presented in lecture and case-materials provided for discussion
- Participants will then use the information provided during the first part to review and comment on 2 published articles. A checklist to evaluate health-related quality-of-life assessments in clinical trials will be provided to the participants.
The term, Patient-Reported Outcomes (PRO), addresses the source of the report rather than the content. PROs are a useful terminology as an organizing tool for the many concepts and applications of self-reports in treatment evaluations. Lumping all the different concepts of PROs under an umbrella term such as Quality of Life or Health-Related Quality of Life confuses many persons and studies, because such disparate concepts are included in the label. PRO terminology permits primary identification that this information comes directly from the patient and avoids confusion in using one or more concepts as an over-arching term with little specification.
PROs are important for measuring the impact of disease, treatment, health and social policies, and the progress of economic and social development. Reviewers conducting meta-analyses should specify and label the content and type of measure for every application of a PRO. Just like other outcomes, a major challenge faces reviewers in evaluating the clinical significance of PRO outcomes in studies.