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Effective Health Care Program

Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide

Research Report

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About the User's Guide

Researchers from the Effective Health Care Program’s DEcIDE Network authored this 11-chapter guide that aims to serve as a resource for researchers when developing observational comparative effectiveness research (CER) studies. The user's guide identifies best practices for designing observational CER studies and standardizes the review of study protocols with checklists in each chapter. Topics in this user's guide include developing study objectives and questions, study design, data sources, and analysis.

The educator resources, 12 presentations in PowerPoint format, are aligned with each chapter to expand training in these best practices.

Download individual sections of the User's Guide (PDF only):

Introduction to Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide (PDF 123 kB)

Chapter 1: Study Objectives and Questions (PDF 217 kB)

Chapter 2: Study Design Considerations (PDF 160 kB)

Chapter 3: Estimation and Reporting of Heterogeneity of Treatment Effects (PDF 168 kB)

Chapter 4: Exposure Definition and Measurement (PDF 233 kB)

Chapter 5: Comparator Selection (PDF 160 kB)

Chapter 6: Outcome Definition and Measurement (PDF 279 kB)

Chapter 7: Covariate Selection (PDF 606 kB)

Chapter 8: Selection of Data Sources (PDF 557 kB)

Chapter 9: Study Size Planning (PDF 131 kB)

Chapter 10: Considerations for Statistical Analysis (PDF 180 kB)

Chapter 11: Sensitivity Analysis (PDF 295 kB)

Supplement 1: Improving Characterization of Study Populations: The Identification Problem (PDF 250 kB)

Supplement 2: Use of Directed Acyclic Graphs (PDF 438 kB)