The OMERACT Handbook

The OMERACT Handbook is currently undergoing a revision once published (ETA May 2024) the latest version of the handbook will be available here

The OMERACT Handbook offers guidance on the OMERACT Way for Developing Core Outcome Sets. The handbook captures decades of collaborative expertise, encompassing conceptual frameworks and patient research partner engagement strategies.

How to cite this version of the Handbook

Beaton D, Maxwell L ,Grosskleg S, Shea B, Tugwell P (editors). The OMERACT Handbook Version 2.1 [updated April 2021]. OMERACT. Available from

To cite a specific chapter please put the chapter number and name before the list of the editors. Eg. Beaton D, Maxwell L ,Grosskleg S, Shea B, Tugwell B (editors). The OMERACT Handbook Version 2.1 [updated April 2021]. OMERACT. Available from

Reproduction and translation

Permission from the editors is required to reproduce or translate the OMERACT Handbook.

The OMERACT Handbook © 2021 by OMERACT is licensed under CC BY-ND 4.0

This handbook is a freely accessible resource open to anyone – patient research partners, clinicians, researchers, regulators, industry trial developers, trial funder, technology implementation decision-makers, or others interested in how best to develop a Core Outcome Set (COS).

General OM

Chapter 1: Purpose, Structure, and Evolution of OMERACT

Chapter 1 of the OMERACT Handbook introduces the essence of OMERACT as a leading force in core outcome set methodology, its historical emergence and evolution. It delves into the organization's structure, inclusive consensus-building approaches, and global impact, emphasizing the ongoing development of methodologies and core outcome sets, underscoring its legacy and promising future.

Chapter 2: Spirit of OMERACT

Chapter 2 delves into the foundational principles of OMERACT. The chapter offers a deep understanding of how OMERACT's ethos shapes its mission and operations.

Spirit of OMERACT - 2
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Chapter 3: Pioneering Patient Research Partner Engagement and the Journey of Continual Evolution

Chapter 3 unfolds how OMERACT was the first to embrace patient research partners and continues to lead the way in this collaborative approach. This chapter delves into the ongoing evolution of patient involvement, showcasing how OMERACT's pioneering efforts have set the stage for continuous growth and improvement.

Chapter 4: Developing Core Domain Sets

Chapter 4 outlines a rigorous and transparent process for generating, agreeing and voting core domains that should be measured in clinical trials for specific health conditions across the OMERACT Core Areas.

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Chapter 5: Instrument selection for Core Outcome Sets

Chapter 5 delves into the process of selecting instruments for Core Outcome Sets. This process, guided by the "OMERACT Filter," assesses instruments based on the pillars of Truth, Discrimination, and Feasibility, ensuring their suitability for inclusion in Core Outcome Sets for clinical trials.

Chapter 6 – Developing OMERACT Methodology

This chapter focuses on the OMERACT Way for Developing OMERACT Methodology. It outlines a process for either pioneering new methodologies within the OMERACT framework or refining existing ones.

OMERACT Way - Domains, Instruments, Composites
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