How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0.
Identifieur interne : 003787 ( PubMed/Corpus ); précédent : 003786; suivant : 003788How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0.
Auteurs : 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 TugwellSource :
- The Journal of rheumatology [ 0315-162X ] ; 2014.
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Abstract
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."
DOI: 10.3899/jrheum.131314
PubMed: 24584913
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Kirwan</name></author><author><name sortKey="Gossec, Laure" sort="Gossec, Laure" uniqKey="Gossec L" first="Laure" last="Gossec">Laure Gossec</name></author><author><name sortKey="Conaghan, Philip G" sort="Conaghan, Philip G" uniqKey="Conaghan P" first="Philip G" last="Conaghan">Philip G. Conaghan</name></author><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></author><author><name sortKey="Bingham, Clifton O" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O" last="Bingham">Clifton O. Bingham</name></author><author><name sortKey="Brooks, Peter M" sort="Brooks, Peter M" uniqKey="Brooks P" first="Peter M" last="Brooks">Peter M. Brooks</name></author><author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewé">Robert Landewé</name></author><author><name sortKey="March, Lyn" sort="March, Lyn" uniqKey="March L" first="Lyn" last="March">Lyn March</name></author><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><author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name></author><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></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24584913</idno><idno type="pmid">24584913</idno><idno type="doi">10.3899/jrheum.131314</idno><idno type="wicri:Area/PubMed/Corpus">003787</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003787</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0.</title><author><name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name><affiliation><nlm:affiliation>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.</nlm:affiliation></affiliation></author><author><name sortKey="Kirwan, John R" sort="Kirwan, John R" uniqKey="Kirwan J" first="John R" last="Kirwan">John R. Kirwan</name></author><author><name sortKey="Gossec, Laure" sort="Gossec, Laure" uniqKey="Gossec L" first="Laure" last="Gossec">Laure Gossec</name></author><author><name sortKey="Conaghan, Philip G" sort="Conaghan, Philip G" uniqKey="Conaghan P" first="Philip G" last="Conaghan">Philip G. Conaghan</name></author><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></author><author><name sortKey="Bingham, Clifton O" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O" last="Bingham">Clifton O. Bingham</name></author><author><name sortKey="Brooks, Peter M" sort="Brooks, Peter M" uniqKey="Brooks P" first="Peter M" last="Brooks">Peter M. Brooks</name></author><author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewé">Robert Landewé</name></author><author><name sortKey="March, Lyn" sort="March, Lyn" uniqKey="March L" first="Lyn" last="March">Lyn March</name></author><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><author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name></author><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></author></analytic><series><title level="j">The Journal of rheumatology</title><idno type="ISSN">0315-162X</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials as Topic (standards)</term><term>Humans</term><term>Observational Studies as Topic (standards)</term><term>Outcome and Process Assessment (Health Care) (standards)</term><term>Rheumatic Diseases (therapy)</term><term>Rheumatology (standards)</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Clinical Trials as Topic</term><term>Observational Studies as Topic</term><term>Outcome and Process Assessment (Health Care)</term><term>Rheumatology</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Rheumatic Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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."</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24584913</PMID><DateCreated><Year>2014</Year><Month>05</Month><Day>05</Day></DateCreated><DateCompleted><Year>2015</Year><Month>02</Month><Day>04</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">0315-162X</ISSN><JournalIssue CitedMedium="Internet"><Volume>41</Volume><Issue>5</Issue><PubDate><Year>2014</Year><Month>May</Month></PubDate></JournalIssue><Title>The Journal of rheumatology</Title><ISOAbbreviation>J. Rheumatol.</ISOAbbreviation></Journal><ArticleTitle>How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0.</ArticleTitle><Pagination><MedlinePgn>1025-30</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3899/jrheum.131314</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="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."</AbstractText><AbstractText Label="METHODS" NlmCategory="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.</AbstractText><AbstractText Label="RESULTS" NlmCategory="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."</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Boers</LastName><ForeName>Maarten</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kirwan</LastName><ForeName>John R</ForeName><Initials>JR</Initials></Author><Author ValidYN="Y"><LastName>Gossec</LastName><ForeName>Laure</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Conaghan</LastName><ForeName>Philip G</ForeName><Initials>PG</Initials></Author><Author ValidYN="Y"><LastName>D'Agostino</LastName><ForeName>Maria-Antonietta</ForeName><Initials>MA</Initials></Author><Author ValidYN="Y"><LastName>Bingham</LastName><ForeName>Clifton O</ForeName><Initials>CO</Initials><Suffix>3rd</Suffix></Author><Author ValidYN="Y"><LastName>Brooks</LastName><ForeName>Peter M</ForeName><Initials>PM</Initials></Author><Author ValidYN="Y"><LastName>Landewé</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>March</LastName><ForeName>Lyn</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Simon</LastName><ForeName>Lee</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Singh</LastName><ForeName>Jasvinder A</ForeName><Initials>JA</Initials></Author><Author ValidYN="Y"><LastName>Strand</LastName><ForeName>Vibeke</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Wells</LastName><ForeName>George A</ForeName><Initials>GA</Initials></Author><Author ValidYN="Y"><LastName>Tugwell</LastName><ForeName>Peter</ForeName><Initials>P</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016446">Consensus Development Conference</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>03</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>Canada</Country><MedlineTA>J Rheumatol</MedlineTA><NlmUniqueID>7501984</NlmUniqueID><ISSNLinking>0315-162X</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D002986" MajorTopicYN="N">Clinical Trials as Topic</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064887" MajorTopicYN="N">Observational Studies as Topic</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010043" MajorTopicYN="N">Outcome and Process Assessment (Health Care)</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012216" MajorTopicYN="N">Rheumatic Diseases</DescriptorName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012219" MajorTopicYN="N">Rheumatology</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">CLINICAL TRIALS</Keyword><Keyword MajorTopicYN="N">CORE OUTCOME SETS</Keyword><Keyword MajorTopicYN="N">OMERACT FILTER</Keyword><Keyword MajorTopicYN="N">OUTCOME AND PROCESS ASSESSMENT</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>3</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>3</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>2</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24584913</ArticleId><ArticleId IdType="pii">jrheum.131314</ArticleId><ArticleId IdType="doi">10.3899/jrheum.131314</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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