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Research ArticleOMERACT 11

How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0

Maarten Boers, John R. Kirwan, Laure Gossec, Philip G. Conaghan, Maria-Antonietta D’Agostino, Clifton O. Bingham III, Peter M. Brooks, Robert Landewé, Lyn March, Lee Simon, Jasvinder A. Singh, Vibeke Strand, George A. Wells and Peter Tugwell
The Journal of Rheumatology May 2014, 41 (5) 1025-1030; DOI: https://doi.org/10.3899/jrheum.131314
Maarten Boers
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Université Pierre et Marie Curie (UPMC) — Paris 6, GRC-UMPC 08 (EEMOIS), Paris, France; APHP, Hôpital Pitié-Salpêtrière, Rhumatologie; University of Leeds and UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK; Department of Rheumatology, APHP, Ambroise Paré Hospital, UPRES EA 2506 Université Versailles-Saint Quentin En Yvelines, Boulogne-Billancourt, France; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; Australian Health Workforce Institute, School of Population Health, University of Melbourne, Melbourne, Australia; Academic Medical Center University of Amsterdam and Atrium Medical Center Heerlen, Heerlen, The Netherlands; Institute of Bone and Joint Research and Sydney Medical School and School of Public Health, University of Sydney, and Department of Rheumatology, Royal North Shore, St. Leonards, NSW, Australia; SDG LLC, Cambridge, Massachusetts; University of Alabama at Birmingham; Veterans Affairs Medical Center, Birmingham, Alabama; Mayo Clinic College of Medicine, Rochester, Minnesota; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Department of Epidemiology and Community Medicine, and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
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  • For correspondence: eb@vumc.nl
John R. Kirwan
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Laure Gossec
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Philip G. Conaghan
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Maria-Antonietta D’Agostino
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Clifton O. Bingham III
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Peter M. Brooks
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Robert Landewé
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Lyn March
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Lee Simon
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Jasvinder A. Singh
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Vibeke Strand
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George A. Wells
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Peter Tugwell
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    Figure 1.

    A conceptual framework of Core Areas for measurement of health conditions in the setting of a health intervention. The lighter shading of Resource Use indicates it is currently strongly recommended, but not mandatory for inclusion. The choice of specific domains within an Area depends on the context for which the core set is being developed. In all areas, domains can be generic or made more specific: e.g., disease-specific, time-specific (e.g., short or longterm), specific for patient preference, etc. ICF: International Classification of Functioning, Disability and Health. From Boers, et al. J Clin Epidemiol 2014:in press; with permission.

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    Figure 2.

    Development of a Core Domain Set from the Core Areas of measurement. A Core Domain Set is defined as the minimum set of Domains and Subdomains necessary to adequately cover all Core Areas, i.e., to fully measure all relevant concepts of a specific health condition within a specified setting. From Boers, et al. J Clin Epidemiol 2014:in press; with permission.

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    Figure 3.

    Development of a Core Outcome Measurement Set from a Core Domain Set. A Core Outcome Measurement Instrument Set is defined as the minimum set of outcome measurement instruments that must be administered in each intervention study of a certain health condition within a specified setting to adequately cover a corresponding Core Domain Set. As depicted, the development process allows core set developers to declare a Preliminary Core Outcome Measurement Set when not all domains are covered by at least 1 applicable measurement instrument. From Boers, et al. J Clin Epidemiol 2014:in press; with permission.

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The Journal of Rheumatology
Vol. 41, Issue 5
1 May 2014
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How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0
Maarten Boers, John R. Kirwan, Laure Gossec, Philip G. Conaghan, Maria-Antonietta D’Agostino, Clifton O. Bingham, Peter M. Brooks, Robert Landewé, Lyn March, Lee Simon, Jasvinder A. Singh, Vibeke Strand, George A. Wells, Peter Tugwell
The Journal of Rheumatology May 2014, 41 (5) 1025-1030; DOI: 10.3899/jrheum.131314

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How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0
Maarten Boers, John R. Kirwan, Laure Gossec, Philip G. Conaghan, Maria-Antonietta D’Agostino, Clifton O. Bingham, Peter M. Brooks, Robert Landewé, Lyn March, Lee Simon, Jasvinder A. Singh, Vibeke Strand, George A. Wells, Peter Tugwell
The Journal of Rheumatology May 2014, 41 (5) 1025-1030; DOI: 10.3899/jrheum.131314
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Keywords

OUTCOME AND PROCESS ASSESSMENT
CLINICAL TRIALS
OMERACT FILTER
CORE OUTCOME SETS

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More in this TOC Section

OMERACT 11

  • Updating the OMERACT Filter: Implications for Patient-reported Outcomes
  • Updating the OMERACT Filter: Discrimination and Feasibility
  • Can We Decide Which Outcomes Should Be Measured in Every Clinical Trial? A Scoping Review of the Existing Conceptual Frameworks and Processes to Develop Core Outcome Sets
Show more OMERACT 11

The OMERACT Filter 2.0

  • Can We Decide Which Outcomes Should Be Measured in Every Clinical Trial? A Scoping Review of the Existing Conceptual Frameworks and Processes to Develop Core Outcome Sets
  • Updating the OMERACT Filter at OMERACT 11
  • Updating the OMERACT Filter: Core Areas as a Basis for Defining Core Outcome Sets
Show more The OMERACT Filter 2.0

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Keywords

  • outcome and process assessment
  • clinical trials
  • OMERACT FILTER
  • CORE OUTCOME SETS

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