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Wednesday, June 29 • 2:00pm - 3:15pm
#348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-572-L01-P; CME 1.25; IACET 1.25; RN 1.25

Methods to interpret the meaning of change in patient-reported outcome (PRO) scores often do not directly include perspectives of potential stakeholders. In this session, we will discuss how common and novel methods to define meaningful change can enhance insight into treatment benefit.

Learning Objectives

Distinguish when to use different methods to identify meaningful individual-level change and group-level differences on a patient-reported outcome; Recognize issues related to assessment frequency and missing data that impact the ability to assess treatment benefit.


Marian M Strazzeri, MS


Scott Komo, DrPH

Cheryl D. Coon, PhD

avatar for Marian Strazzeri

Marian Strazzeri

Mathematical Statistician, OB, OTS, CDER, FDA
Marian Strazzeri currently works on clinical outcome assessments (COAs) and data standards within the Office of Biostatistics (OB) at FDA/CDER. Before joining FDA in her current capacity, she worked as a survey statistician at the National Center for Health Statistics (NCHS) in the... Read More →

avatar for Cheryl Coon

Cheryl Coon

Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument... Read More →

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Forum