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Activity Number: 204
Type: Topic Contributed
Date/Time: Monday, August 3, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304015
Title: Analysis of Repeated-Measures Score Data Obtained from Patient Questionnaires in Medical Device Studies
Author(s): Chang S. Lao*+
Companies: FDA
Address: 1350 Piccard Drive, Rockville, MD, 20850,
Keywords: Patient reported outcomes ; Sample size ; Least square means
Abstract:

Abstract Repeated-measures design is frequently seen in medical device clinical trials, such as in orthopedic, neurological, surgical, cardiovascular, and general-use medical devices. Subjects are followed-up at baseline and at various post-treatment time intervals. Repeated measures analysis summarizes the information obtained on subjects over many follow-up times. Medical device repeated-measures data are obtained from patient-reported outcome (PRO) measures, which range from symptomatic, such as VAS (visual analogue scale) pain score or joint stiffness score, to more complex measures, such as quality of life, which generally include physical, biological, physiological, and social factors. In this paper, we discuss general statistical methodologies, their assumptions, and applications for analysis of medical device repeated-measures clinical trial data obtained from PRO measures.

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