Department of Biostatistics Seminar/Workshop Series

The use of patient-reported outcomes in clinical trials: methodological and biostatistical considerations

Jeff A. Sloan, Ph.D.

Professor of Oncology, Professor of Biostatistics
Department of Health Sciences Research, Mayo Clinic

Wednesday, May 7, 1:30-2:30pm, MRBIII Conference Room 1220

Intended Audience: Persons interested in applied statistics, statistical theory, epidemiology, health services research, clinical trials methodology, statistical computing, statistical graphics, R users or potential users

This presentation will review issues, challenges, and solutions regarding doing clinical trials involving patient-reported outcomes (PROs). A number of example clinical trials will discuss issues surrounding measurement issues, analytical techniques, and approaches to interpretation and communication of results for PROs. The trials are drawn from studies carried out within the North Central Cancer Treatment Group and Mayo Clinic Cancer Center. PRO endpoints have included pain, fatigue, stomatitis, anorexia, hot flashes and quality of life (QOL) domains. Methods related to the assessment of clinical significance for symptoms and other patient-reported outcomes will be articulated. The need for the identification of clinical meaningfulness in studies involving PROs and solutions to date will be presented. The evolution of the standard deviation guideline for definition of a clinically meaningful effect size across a wide variety of PRO endpoints will be highlighted. The talk is aimed at providing the audience with practical solutions for successfully undertaking and interpreting clinical research involving patient-reported outcomes.

Presenter Information
Topic revision: r1 - 30 Apr 2008, DianeKolb

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