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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 : 005A80

How 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 Tugwell

Source :

RBID : Pascal:14-0157494

Descripteurs français

English descriptors

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.
pA  
A01 01  1    @0 0315-162X
A02 01      @0 JRHUA9
A03   1    @0 J. rheumatol.
A05       @2 41
A06       @2 5
A08 01  1  ENG  @1 How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0 : OMERACT 11: The OMERACT Filter 2.0
A11 01  1    @1 BOERS (Maarten)
A11 02  1    @1 KIRWAN (John R.)
A11 03  1    @1 GOSSEC (Laure)
A11 04  1    @1 CONAGHAN (Philip G.)
A11 05  1    @1 D'AGOSTINO (Maria-Antonietta)
A11 06  1    @1 BINGHAM (Clifton O. III)
A11 07  1    @1 BROOKS (Peter M.)
A11 08  1    @1 LANDEWE (Robert)
A11 09  1    @1 MARCH (Lyn)
A11 10  1    @1 SIMON (Lee)
A11 11  1    @1 SINGH (Jasvinder A.)
A11 12  1    @1 STRAND (Vibeke)
A11 13  1    @1 WELLS (George A.)
A11 14  1    @1 TUGWELL (Peter)
A14 01      @1 Department of Epidemiology and Biostatistics, VU University Medical Center @2 Amsterdam @3 NLD
A14 02      @1 University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary @2 Bristol @3 GBR
A14 03      @1 Université Pierre et Marie Curie (UPMC) - Paris 6, GRC-UMPC 08 (EEMOIS) @2 Paris @3 FRA
A14 04      @1 APHP, Hôpital Pitié-Salpêtrière, Rhumatologie; University of Leeds and UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit @2 Leeds @3 GBR
A14 05      @1 Department of Rheumatology, APHP, Ambroise Paré Hospital, UPRES EA 2506 Université Versailles-Saint Quentin En Yvelines @2 Boulogne-Billancourt @3 FRA
A14 06      @1 Division of Rheumatology, Johns Hopkins University @2 Baltimore, Maryland @3 USA
A14 07      @1 Australian Health Workforce Institute, School of Population Health, University of Melbourne @2 Melbourne @3 AUS
A14 08      @1 Academic Medical Center University of Amsterdam and Atrium Medical Center Heerlen @2 Heerlen @3 NLD
A14 09      @1 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 @2 St. Leonards, NSW @3 AUS
A14 10      @1 SDG LLC @2 Cambridge, Massachusetts @3 USA
A14 11      @1 University of Alabama at Birmingham @3 USA
A14 12      @1 Veterans Affairs Medical Center @2 Birmingham, Alabama @3 USA
A14 13      @1 Mayo Clinic College of Medicine @2 Rochester, Minnesota @3 USA
A14 14      @1 Division of Immunology/Rheumatology, Stanford University School of Medicine @2 Palo Alto, California @3 USA
A14 15      @1 Department of Epidemiology and Community Medicine, and Department of Medicine, University of Ottawa @2 Ottawa, Ontario @3 CAN
A20       @1 1025-1030
A21       @1 2014
A23 01      @0 ENG
A43 01      @1 INIST @2 16024 @5 354000502767410330
A44       @0 0000 @1 © 2014 INIST-CNRS. All rights reserved.
A45       @0 26 ref.
A47 01  1    @0 14-0157494
A60       @1 P
A61       @0 A
A64 01  1    @0 Journal of rheumatology
A66 01      @0 CAN
C01 01    ENG  @0 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.
C02 01  X    @0 002B15
C03 01  X  FRE  @0 Pronostic @5 07
C03 01  X  ENG  @0 Prognosis @5 07
C03 01  X  SPA  @0 Pronóstico @5 07
C03 02  X  FRE  @0 Essai clinique @5 08
C03 02  X  ENG  @0 Clinical trial @5 08
C03 02  X  SPA  @0 Ensayo clínico @5 08
C03 03  X  FRE  @0 Filtre @5 09
C03 03  X  ENG  @0 Filter @5 09
C03 03  X  SPA  @0 Filtro @5 09
C03 04  X  FRE  @0 Rhumatologie @5 13
C03 04  X  ENG  @0 Rheumatology @5 13
C03 04  X  SPA  @0 Reumatología @5 13
N21       @1 195
N44 01      @1 OTO
N82       @1 OTO

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Pascal:14-0157494

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<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>
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