Patient Reported Outcomes: Instrument Development
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- Introduction to Outcomes Research
- Introduction to Systematic Reviews & Meta-Analysis
- Systematic Review & Meta-Analysis: Applications
- Introduction to Pharmacoeconomics
- Cost-of-Illness/Cost-Estimation (COI/CE)
- Cost-Minimization/Cost-Consequence (CMA/CCA)
- Cost-Effectiveness Analysis (CEA) and Cost-Utility Analysis (CUA)
- Modeling Health Care Costs – Part I: Characteristics of Health Care Costs
- Modeling Health Care Costs – Part II: Methods and Guidelines for Estimating Health Care Costs
- Modeling Health Care Costs – Part III: Estimation from Censored Data
- Introduction to Budget Impact Analysis (BIA) - Part I
- Introduction to Budget Impact Analysis (BIA) - Part II
- Markov Model Toolkit: Concepts, Assumptions and Examples
- An Introduction to Choice-Based Conjoint Analysis (Discrete Choice Experiments)
- Health-Related Quality of Life (HRQOL) – Basics
- Patient Reported Outcomes: Analysis and Interpretation
- Patient Reported Outcomes: Instrument Development
- Item Response Theory: A Conceptual Introduction
- Preparing for Multinational Clinical Trials: Translation and Cultural Adaptations of PRO Measures
- Evidence Generation for Patient Reported Outcome (PRO) Label Claims (FDA Requirements)
- Intermediate Retrospective Observational Study - Propensity Scoring Methods
- Use of Public Survey Data in Health Outcomes Research
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Faculty
Elizabeth Unni, BPharm, MBA, PhD
Course Description
With patient reported outcomes (PROs) becoming more common in clinical trials and FDA accepting PROs to be included in the labeling claims of a new drug or medical device, it is essential that health care providers should have a basic knowledge in developing PRO instruments. This module will provide you with a brief overview on patient reported outcomes and will guide you through a step by step approach to develop a new PRO instrument. The module will also help you in understanding the significance of PRO instruments in health outcomes research.