Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.
Identifieur interne : 003677 ( PubMed/Corpus ); précédent : 003676; suivant : 003678Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.
Auteurs : Maarten Boers ; John R. Kirwan ; George Wells ; Dorcas Beaton ; Laure Gossec ; Maria-Antonietta D'Agostino ; Philip G. Conaghan ; Clifton O. Bingham ; Peter Brooks ; Robert Landewé ; Lyn March ; Lee S. Simon ; Jasvinder A. Singh ; Vibeke Strand ; Peter TugwellSource :
- Journal of clinical epidemiology [ 1878-5921 ] ; 2014.
English descriptors
- KwdEn :
- Consensus, Controlled Clinical Trials as Topic (methods), Controlled Clinical Trials as Topic (standards), Health Personnel, Humans, Outcome Assessment (Health Care) (methods), Outcome Assessment (Health Care) (standards), Rheumatic Diseases (therapy), Rheumatology (methods), Rheumatology (standards), Severity of Illness Index, Treatment Outcome.
- MESH :
- methods : Controlled Clinical Trials as Topic, Outcome Assessment (Health Care), Rheumatology.
- standards : Controlled Clinical Trials as Topic, Outcome Assessment (Health Care), Rheumatology.
- therapy : Rheumatic Diseases.
- Consensus, Health Personnel, Humans, Severity of Illness Index, Treatment Outcome.
Abstract
Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process.
DOI: 10.1016/j.jclinepi.2013.11.013
PubMed: 24582946
Links to Exploration step
pubmed:24582946Le document en format XML
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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 S" sort="Simon, Lee S" uniqKey="Simon L" first="Lee S" last="Simon">Lee S. Simon</name>
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<author><name sortKey="Singh, Jasvinder A" sort="Singh, Jasvinder A" uniqKey="Singh J" first="Jasvinder A" last="Singh">Jasvinder A. Singh</name>
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<author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name>
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<author><name sortKey="Gossec, Laure" sort="Gossec, Laure" uniqKey="Gossec L" first="Laure" last="Gossec">Laure Gossec</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" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O" last="Bingham">Clifton O. Bingham</name>
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</affiliation>
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<author><name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name>
<affiliation><nlm:affiliation>School of Population and Global Health, University of Melbourne, Melbourne, Australia.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewé">Robert Landewé</name>
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</affiliation>
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<author><name sortKey="March, Lyn" sort="March, Lyn" uniqKey="March L" first="Lyn" last="March">Lyn March</name>
<affiliation><nlm:affiliation>Institute of Bone and Joint Research, Kolling Institute of Medical Research, University of Sydney, Sydney, Australia; Department of Rheumatology, Royal North Shore Hospital, St. Leonards, New South Wales, Australia.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Simon, Lee S" sort="Simon, Lee S" uniqKey="Simon L" first="Lee S" last="Simon">Lee S. Simon</name>
<affiliation><nlm:affiliation>SDG LLC, Cambridge, MA 02138, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Singh, Jasvinder A" sort="Singh, Jasvinder A" uniqKey="Singh J" first="Jasvinder A" last="Singh">Jasvinder A. Singh</name>
<affiliation><nlm:affiliation>Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL 35294, USA; Veterans Affairs Medical Center, Birmingham, AL 35294, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name>
<affiliation><nlm:affiliation>Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA 94028, USA.</nlm:affiliation>
</affiliation>
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<affiliation><nlm:affiliation>Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.</nlm:affiliation>
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<front><div type="abstract" xml:lang="en">Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process.</div>
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<Title>Journal of clinical epidemiology</Title>
<ISOAbbreviation>J Clin Epidemiol</ISOAbbreviation>
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<ArticleTitle>Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.</ArticleTitle>
<Pagination><MedlinePgn>745-53</MedlinePgn>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n=125) at the OMERACT 11 consensus conference endorsed this model and process.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.</AbstractText>
<CopyrightInformation>Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
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<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Boers</LastName>
<ForeName>Maarten</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 165, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: eb@vumc.nl.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kirwan</LastName>
<ForeName>John R</ForeName>
<Initials>JR</Initials>
<AffiliationInfo><Affiliation>University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wells</LastName>
<ForeName>George</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Conaghan</LastName>
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</AffiliationInfo>
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<ForeName>Clifton O</ForeName>
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<AffiliationInfo><Affiliation>Division of Rheumatology, Johns Hopkins University, Baltimore, MD 21224, USA.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Brooks</LastName>
<ForeName>Peter</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>School of Population and Global Health, University of Melbourne, Melbourne, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Landewé</LastName>
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<Initials>R</Initials>
<AffiliationInfo><Affiliation>Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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<ForeName>Vibeke</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA 94028, USA.</Affiliation>
</AffiliationInfo>
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<AffiliationInfo><Affiliation>Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.</Affiliation>
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