Core Outcome Measures in Effectiveness Trials

The OMERACT-OARSI core set of outcome domains to measure in clinical trials for people with hip and/or knee osteoarthritis

General Information

Summary:
In 1997 OMERACT reported the core outcome set (COS) for people involved in trials of hip and knee osteoarthritis (Bellamy et al, 1997). In this, the group reported that four domains should be evaluated in future clinical trials. These were: pain; physical function; patient global assessment; and for studies with a follow-up period of a year or longer, joint imaging (such as x-rays or MRI scans).

Since 1997, there have been developments in how the OMERACT COS are developed, with greater emphasis on patient involvement, involving both developed and developing nations, and people from other organisations such as industry (e.g. pharmaceutical), research and social care. Furthermore, there have been developments in how domains are identified through the recent adoption of the OMERACT Filter 2.1 which establishes that all COS should consider the ‘Core Areas’ of Death, Life Impact, Resource Use/Economic Impact and Pathophysiological Manifestations, in addition to monitoring for adverse events and factors which may influence the outcomes of a trial (known as contextual factors).

The purpose of this Working Group was to update this COS based on current OMERACT methodology. The work has been divided into three phases:

Phase 1 (March 2017 to November 2017): All musculoskeletal (orthopaedic and rheumatology, bone, joint, muscle) core outcome sets from the COMET (Core Outcome Measures in Effectiveness Trials) organisation repository of core outcome sets were reviewed to identify potential candidate domains published from 1997 to 2017. This identified 29 potential domains from the literature. These were then reviewed by patient and clinician advisory groups in UK, Canada and Australia who were asked to identify any additional domains and comment on the terminology of their description.

Phase 2 (November 2017 to March 2018): A three-round Delphi survey was undertaken to assess agreement on 49 candidate domains in Round 1. The Delphi survey was translated in English and Italian. In addition to dissemination across social media accounts, the Delphi survey was emailed across arthritis-related networks in UK, Australia, Canada, USA, Spain and Italy, with target responders representing patients, clinicians, researchers and industry. We are currently undertaking the Delphi survey phase (correct to 11th January 2018).

Phase 3 (May 2018): The results of Phases 1 and 2 will be presented at OMERACT 2018 for consensus on Core Outcome Domains based on the OMERACT Filter 2.1.

Following this project, once the COS Domains have been identified, it is the intention of the working group to investigate the COS Instruments/Tools to complete the COS (estimated work period: 2018 to 2020).

Contributors:
Principal Investigator:
Professor Philip Conaghan - University of Leeds, UK

OMERACT Working Group Fellow:
Dr Toby Smith – University of Oxford, UK

OMERACT Working Group Co-Chairs:
Professor Philip Conaghan - University of Leeds, UK
Professor David Hunter – University of Sydney, Australia
Professor Gillian Hawker – University of Toronto, Canada

OMERACT Embedded Mentor:
Professor Lyn March - University of Sydney, Australia

OMERACT Working Group Members
Professor Robin Christensen (University of Southern Denmark)
Professor Paula Williamson (Liverpool University, UK)
Professor Tuhina Neogi (Boston University, USA)
Dr Christoph Ladel (Merck, Germany)
Dr Gurdyal Kalsi (TissueGene, USA)
Professor Nigel Arden (University of Oxford, UK)
Professor Margreet Kloppenburg (Leiden University Medical Centre, Netherlands)
Professor Thomas Schnitzer (Northwestern Memorial Hospital, USA)
Professor Ewa Roos (University of Southern Denmark, Denmark)
Dr Caroline Terwee (VU Medical Centre Amsterdam, Netherlands)
Dr Ulrike Kaiser (University of Dresden, Germany)
Professor Francis Guillemin (University of Lorraine, France)
Professor Marc Hochberg (university of Maryland, USA)
Professor Ali Mobasheri (University of Surrey, UK)
Professor Alan Tennant (Swiss Paraplegic Research, Switzerland)

Further Study Information

Current Stage:
Ongoing
Date:
March 2017 - May 2018
Funding source(s):
The OMERACT FEllow (Dr Toby Smith) has been partly funded by Action Arthritis (Norfolk, UK)

Health Area

Disease Category
Rheumatology

Disease Name
Osteoarthritis

Target Population

Age Range
40 - 100

Sex
Either


Nature / type of Intervention
Drug
Nonpharmacological
Non-surgical

Method(s)

Consensus conference
Delphi process
Focus group(s)
Literature review
Survey
Systematic review

Phase 1 (March 2017 to November 2017): All musculoskeletal (orthopaedic and rheumatology, bone, joint, muscle) core outcome sets from the COMET (Core Outcome Measures in Effectiveness Trials) organisation repository of core outcome sets were reviewed to identify potential candidate domains published from 1997 to 2017. This identified 29 potential domains from the literature. These were then reviewed by patient and clinician advisory groups in UK, Canada and Australia who were asked to identify any additional domains and comment on the terminology of their description.

Phase 2 (November 2017 to March 2018): A three-round Delphi survey was undertaken to assess agreement on 49 candidate domains in Round 1. The Delphi survey was translated in English and Italian. In addition to dissemination across social media accounts, the Delphi survey was emailed across arthritis-related networks in UK, Australia, Canada, USA, Spain and Italy, with target responders representing patients, clinicians, researchers and industry.

Phase 3 (May 2018): The results of Phases 1 and 2 will be presented at OMERACT 2018 for consensus on Core Outcome Domains based on the OMERACT Filter 2.1.


Stakeholders Involved

Charities
Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Device manufacturers
Epidemiologists
Methodologists
Patient/ support group representatives
Pharmaceutical industry representatives
Researchers
Service users
Statisticians

Study Type

COS for clinical trials or clinical research

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