Outcome Measurement in Clinical Research

CRES 706 Subject & Catalog Number

Description

This course provides an evidence-based, patient-centered approach to outcome measurement in clinical research. Through focused lectures, critical appraisal of published studies, discussion, and applied small-group activities, students will learn how to identify meaningful outcomes; develop core outcome sets; and develop, evaluate, interpret, and select measurement instruments for clinical trials and observational studies. Students will also learn the foundations of qualitative and mixed methods research, including study design, sampling, integration strategies, and their application to outcome development and measurement science. The course further covers classical and modern measurement approaches, including classical test theory, item response theory, Rasch measurement, and PROMIS. Frameworks such as COMET, OMERACT, COSMIN, AND IDEOM, together with FDA perspectives on clinical outcome assessments, will guide students in critically appraising measurement evidence and developing fit-for-purpose outcome measurement strategies across clinical specialties.