How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0 : OMERACT 11: The OMERACT Filter 2.0
Identifieur interne : 005A79 ( PascalFrancis/Curation ); précédent : 005A78; suivant : 005A80How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0 : OMERACT 11: The OMERACT Filter 2.0
Auteurs : Maarten Boers [Pays-Bas, Royaume-Uni, France, États-Unis, Australie, Canada] ; John R. Kirwan ; Laure Gossec ; Philip G. Conaghan ; Maria-Antonietta D'Agostino ; Clifton O. Iii Bingham ; Peter M. Brooks ; Robert Landewe ; Lyn March ; Lee Simon ; Jasvinder A. Singh ; Vibeke Strand ; George A. Wells ; Peter TugwellSource :
- Journal of rheumatology [ 0315-162X ] ; 2014.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Objective. The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0." Methods. Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. Results. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook." Conclusion. Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.
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<s3>NLD</s3>
</inist:fA14>
<country>Pays-Bas</country>
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<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>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</s1>
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</inist:fA14>
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<author><name sortKey="Conaghan, Philip G" sort="Conaghan, Philip G" uniqKey="Conaghan P" first="Philip G." last="Conaghan">Philip G. Conaghan</name>
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<author><name sortKey="D Agostino, Maria Antonietta" sort="D Agostino, Maria Antonietta" uniqKey="D Agostino M" first="Maria-Antonietta" last="D'Agostino">Maria-Antonietta D'Agostino</name>
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<author><name sortKey="Bingham, Clifton O Iii" sort="Bingham, Clifton O Iii" uniqKey="Bingham C" first="Clifton O. Iii" last="Bingham">Clifton O. Iii Bingham</name>
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<author><name sortKey="Brooks, Peter M" sort="Brooks, Peter M" uniqKey="Brooks P" first="Peter M." last="Brooks">Peter M. Brooks</name>
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<author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name>
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<author><name sortKey="March, Lyn" sort="March, Lyn" uniqKey="March L" first="Lyn" last="March">Lyn March</name>
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<author><name sortKey="Simon, Lee" sort="Simon, Lee" uniqKey="Simon L" first="Lee" last="Simon">Lee Simon</name>
</author>
<author><name sortKey="Singh, Jasvinder A" sort="Singh, Jasvinder A" uniqKey="Singh J" first="Jasvinder A." last="Singh">Jasvinder A. Singh</name>
</author>
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<author><name sortKey="Wells, George A" sort="Wells, George A" uniqKey="Wells G" first="George A." last="Wells">George A. Wells</name>
</author>
<author><name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
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<series><title level="j" type="main">Journal of rheumatology</title>
<title level="j" type="abbreviated">J. rheumatol.</title>
<idno type="ISSN">0315-162X</idno>
<imprint><date when="2014">2014</date>
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<seriesStmt><title level="j" type="main">Journal of rheumatology</title>
<title level="j" type="abbreviated">J. rheumatol.</title>
<idno type="ISSN">0315-162X</idno>
</seriesStmt>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term>
<term>Filter</term>
<term>Prognosis</term>
<term>Rheumatology</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Pronostic</term>
<term>Essai clinique</term>
<term>Filtre</term>
<term>Rhumatologie</term>
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<front><div type="abstract" xml:lang="en">Objective. The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0." Methods. Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. Results. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook." Conclusion. Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.</div>
</front>
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<fA14 i1="01"><s1>Department of Epidemiology and Biostatistics, VU University Medical Center</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
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<fA14 i1="02"><s1>University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary</s1>
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<s3>GBR</s3>
</fA14>
<fA14 i1="03"><s1>Université Pierre et Marie Curie (UPMC) - Paris 6, GRC-UMPC 08 (EEMOIS)</s1>
<s2>Paris</s2>
<s3>FRA</s3>
</fA14>
<fA14 i1="04"><s1>APHP, Hôpital Pitié-Salpêtrière, Rhumatologie; University of Leeds and UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit</s1>
<s2>Leeds</s2>
<s3>GBR</s3>
</fA14>
<fA14 i1="05"><s1>Department of Rheumatology, APHP, Ambroise Paré Hospital, UPRES EA 2506 Université Versailles-Saint Quentin En Yvelines</s1>
<s2>Boulogne-Billancourt</s2>
<s3>FRA</s3>
</fA14>
<fA14 i1="06"><s1>Division of Rheumatology, Johns Hopkins University</s1>
<s2>Baltimore, Maryland</s2>
<s3>USA</s3>
</fA14>
<fA14 i1="07"><s1>Australian Health Workforce Institute, School of Population Health, University of Melbourne</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
</fA14>
<fA14 i1="08"><s1>Academic Medical Center University of Amsterdam and Atrium Medical Center Heerlen</s1>
<s2>Heerlen</s2>
<s3>NLD</s3>
</fA14>
<fA14 i1="09"><s1>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</s1>
<s2>St. Leonards, NSW</s2>
<s3>AUS</s3>
</fA14>
<fA14 i1="10"><s1>SDG LLC</s1>
<s2>Cambridge, Massachusetts</s2>
<s3>USA</s3>
</fA14>
<fA14 i1="11"><s1>University of Alabama at Birmingham</s1>
<s3>USA</s3>
</fA14>
<fA14 i1="12"><s1>Veterans Affairs Medical Center</s1>
<s2>Birmingham, Alabama</s2>
<s3>USA</s3>
</fA14>
<fA14 i1="13"><s1>Mayo Clinic College of Medicine</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
</fA14>
<fA14 i1="14"><s1>Division of Immunology/Rheumatology, Stanford University School of Medicine</s1>
<s2>Palo Alto, California</s2>
<s3>USA</s3>
</fA14>
<fA14 i1="15"><s1>Department of Epidemiology and Community Medicine, and Department of Medicine, University of Ottawa</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
</fA14>
<fA20><s1>1025-1030</s1>
</fA20>
<fA21><s1>2014</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>16024</s2>
<s5>354000502767410330</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2014 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>26 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>14-0157494</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Journal of rheumatology</s0>
</fA64>
<fA66 i1="01"><s0>CAN</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Objective. The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0." Methods. Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. Results. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook." Conclusion. Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B15</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Pronostic</s0>
<s5>07</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Prognosis</s0>
<s5>07</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Pronóstico</s0>
<s5>07</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Essai clinique</s0>
<s5>08</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Clinical trial</s0>
<s5>08</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Ensayo clínico</s0>
<s5>08</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Filtre</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Filter</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Filtro</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Rhumatologie</s0>
<s5>13</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Rheumatology</s0>
<s5>13</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Reumatología</s0>
<s5>13</s5>
</fC03>
<fN21><s1>195</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
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