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Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0

Identifieur interne : 004208 ( Main/Exploration ); précédent : 004207; suivant : 004209

Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0

Auteurs : Maarten Boers [Pays-Bas] ; John R. Kirwan [Royaume-Uni] ; George Wells [Canada] ; Dorcas Beaton [Canada] ; Laure Gossec [France] ; Maria-Antonietta D'Agostino [France] ; Philip G. Conaghan [Royaume-Uni] ; Clifton O. Iii Bingham [États-Unis] ; Peter Brooks [Australie] ; Robert Landewe [Pays-Bas] ; Lyn March [Australie] ; Lee S. Simon [États-Unis] ; Jasvinder A. Singh [États-Unis] ; Vibeke Strand [États-Unis] ; Peter Tugwell [Canada]

Source :

RBID : Pascal:14-0220648

Descripteurs français

English descriptors

Abstract

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. Methods: Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. 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. Conclusion: 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.


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Le document en format XML

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<s1>Division of Immunology/Rheumatology, Stanford University School of Medicine</s1>
<s2>Palo Alto, CA 94028</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Palo Alto, CA 94028</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
<affiliation wicri:level="1">
<inist:fA14 i1="17">
<s1>Department of Medicine, University of Ottawa</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Ottawa, Ontario</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Journal of clinical epidemiology</title>
<title level="j" type="abbreviated">J. clin. epidemiol.</title>
<idno type="ISSN">0895-4356</idno>
<imprint>
<date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Journal of clinical epidemiology</title>
<title level="j" type="abbreviated">J. clin. epidemiol.</title>
<idno type="ISSN">0895-4356</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Biological marker</term>
<term>Clinical trial</term>
<term>Epidemiology</term>
<term>Evolution</term>
<term>Filter</term>
<term>Goal</term>
<term>Healthcare</term>
<term>Medicine</term>
<term>Prognosis</term>
<term>Public health</term>
<term>Reference</term>
<term>Rheumatology</term>
<term>Scientific research</term>
<term>Standards</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Pronostic</term>
<term>Evolution</term>
<term>Essai clinique</term>
<term>Filtre</term>
<term>Rhumatologie</term>
<term>Recherche scientifique</term>
<term>But</term>
<term>Marqueur biologique</term>
<term>Référence</term>
<term>Norme</term>
<term>Médecine</term>
<term>Santé publique</term>
<term>Epidémiologie</term>
<term>Soins de santé</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Recherche scientifique</term>
<term>Norme</term>
<term>Médecine</term>
<term>Santé publique</term>
<term>Soins de santé</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">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. Methods: Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. 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. Conclusion: 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.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Hollande-Septentrionale</li>
<li>Nouvelle-Galles du Sud</li>
<li>Ontario</li>
<li>Victoria (État)</li>
<li>Yorkshire-et-Humber</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Amsterdam</li>
<li>Boulogne-Billancourt</li>
<li>Leeds</li>
<li>Melbourne</li>
<li>Paris</li>
<li>Sydney</li>
<li>Toronto</li>
</settlement>
<orgName>
<li>Université Pierre-et-Marie-Curie</li>
<li>Université d'Amsterdam</li>
<li>Université de Leeds</li>
<li>Université de Melbourne</li>
<li>Université de Sydney</li>
<li>Université de Toronto</li>
</orgName>
</list>
<tree>
<country name="Pays-Bas">
<noRegion>
<name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
</noRegion>
<name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name>
</country>
<country name="Royaume-Uni">
<noRegion>
<name sortKey="Kirwan, John R" sort="Kirwan, John R" uniqKey="Kirwan J" first="John R." last="Kirwan">John R. Kirwan</name>
</noRegion>
<name sortKey="Conaghan, Philip G" sort="Conaghan, Philip G" uniqKey="Conaghan P" first="Philip G." last="Conaghan">Philip G. Conaghan</name>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name>
</noRegion>
<name sortKey="Beaton, Dorcas" sort="Beaton, Dorcas" uniqKey="Beaton D" first="Dorcas" last="Beaton">Dorcas Beaton</name>
<name sortKey="Tugwell, Peter" sort="Tugwell, Peter" uniqKey="Tugwell P" first="Peter" last="Tugwell">Peter Tugwell</name>
</country>
<country name="France">
<region name="Île-de-France">
<name sortKey="Gossec, Laure" sort="Gossec, Laure" uniqKey="Gossec L" first="Laure" last="Gossec">Laure Gossec</name>
</region>
<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>
</country>
<country name="États-Unis">
<noRegion>
<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>
</noRegion>
<name sortKey="Simon, Lee S" sort="Simon, Lee S" uniqKey="Simon L" first="Lee S." last="Simon">Lee S. Simon</name>
<name sortKey="Singh, Jasvinder A" sort="Singh, Jasvinder A" uniqKey="Singh J" first="Jasvinder A." last="Singh">Jasvinder A. Singh</name>
<name sortKey="Singh, Jasvinder A" sort="Singh, Jasvinder A" uniqKey="Singh J" first="Jasvinder A." last="Singh">Jasvinder A. Singh</name>
<name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name>
</country>
<country name="Australie">
<region name="Victoria (État)">
<name sortKey="Brooks, Peter" sort="Brooks, Peter" uniqKey="Brooks P" first="Peter" last="Brooks">Peter Brooks</name>
</region>
<name sortKey="March, Lyn" sort="March, Lyn" uniqKey="March L" first="Lyn" last="March">Lyn March</name>
<name sortKey="March, Lyn" sort="March, Lyn" uniqKey="March L" first="Lyn" last="March">Lyn March</name>
</country>
</tree>
</affiliations>
</record>

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