Preparing for Multinational Clinical Trials: Translation and Cultural Adaptations of PRO Measures
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Distance Learning
- 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
Benjamin Arnold, MA, Helena Correia
Course Description
Translation and cultural adaptation of patient reported outcomes measures is an important component of research methodology in preparation for multinational studies. In order to improve cross-cultural equivalence it is essential to consider the process by which an instrument is translated/adapted and validated. This module will cover: 1) types of cross-cultural equivalence in the context of data poolability and potential threats to validity if equivalence is not achieved; 2) translation methodologies which adhere to industry standards including examples and case studies related to specific steps and challenges; 3) use of qualitative research methods such as cognitive interviewing techniques to assess linguistic validity and cross-cultural equivalence of translated measures, including case studies and examples. The module will conclude with recommendations toward ensuring appropriateness and therefore comparability of data when dealing with research in multiple cultural contexts.