AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review
Identifieur interne : 000726 ( Istex/Corpus ); précédent : 000725; suivant : 000727AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review
Auteurs : W. Bautista-Molano ; V. Navarro-Compán ; R. Landewé ; D. Van Der HeijdeSource :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-06.
English descriptors
- KwdEn :
- Acute phase reactants, Ankylosing, Ankylosing spondylitis, Basfi, Clinical attachment loss, Clinical trials, Control trials, Core sets, Implementation trials, Periodontal, Periodontal condition, Periodontitis, Physical function, Plaque index, Pocket depth, Rcts, Rheum, Rheumatoid arthritis, Rheumatology, Rheumatology department, Spine radiograph, Spondylitis, Systematic literature review, Systemic lupus erythematosus, Tuberculin skin test.
- Teeft :
- Acute phase reactants, Ankylosing, Ankylosing spondylitis, Basfi, Clinical attachment loss, Clinical trials, Control trials, Core sets, Implementation trials, Periodontal, Periodontal condition, Periodontitis, Physical function, Plaque index, Pocket depth, Rcts, Rheum, Rheumatoid arthritis, Rheumatology, Rheumatology department, Spine radiograph, Spondylitis, Systematic literature review, Systemic lupus erythematosus, Tuberculin skin test.
Abstract
Background The Assessment of SpondyloArthritis international Society (ASAS) has selected a core set of variables to include as standardized endpoints in clinical trials and clinical practice. These core sets received endorsement by OMERACT and specific measurement instruments to assess each of these domains have been chosen. The implementation of the ASAS/OMERACT core sets, though, has so far not been evaluated. The purpose of this systematic literature review, therefore, was to compare the usage of domains and instruments of the core-sets before and after the original publication. Objectives To investigate how well the ASAS/OMERACT core sets for the outcome of ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions Methods A systematic literature search was performed in electronic databases up to January 2012 looking for RCTs in patients with AS. Domains of outcome, and instruments belonging to them, for disease controlling antirheumatic therapy (DC-ART) and symptom modifying antirheumatic drugs (SMARD) were extracted. Results are reported for clinical trials published before (control trials) in comparison to those published 2 years after the publication of the core set (1 April 2001, implementation trials). Results One hundred eight articles reporting results from 91 RCTs, and together including 11.174 patients, fulfilled the selection criteria for this project. Forty-seven RCTs were considered ‘control trials’ and 44 were considered ‘implementation trials’. NSAID and conventional non-biological DMARD therapies were more often tested in the ‘control’ - than in the ‘implementation trials’. Biological DMARDs and physical therapy were more often tested in the ‘implementation trials’. The domains ‘physical function’, ‘pain’, ‘stiffness’, ‘peripheral joint/entheses’, ‘acute phase reactants’ and ‘fatigue’, as well as the instruments ‘BASFI’, ‘BASMI’, ‘CRP’ and ‘spine radiograph’ were more frequently addressed in the ‘implementation trials’. Conclusions This systematic literature review suggests that the definition and dissemination of the core set measures for clinical trials in AS has indeed resulted in an improved usage of the endorsed domains and instruments. References van der Heijde D. J Rheumatol 1999;26:951-4, Sieper J. Ann Rheum Dis 2009;68:ii1-44 Disclosure of Interest None Declared
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DOI: 10.1136/annrheumdis-2013-eular.2890
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ISTEX:C0BF867E3E70D159D4DA86918274DCA3568F9D92Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review</title><author><name sortKey="Bautista Molano, W" sort="Bautista Molano, W" uniqKey="Bautista Molano W" first="W." last="Bautista-Molano">W. Bautista-Molano</name><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation></author><author><name sortKey="Navarro Compan, V" sort="Navarro Compan, V" uniqKey="Navarro Compan V" first="V." last="Navarro-Compán">V. Navarro-Compán</name><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation></author><author><name sortKey="Landewe, R" sort="Landewe, R" uniqKey="Landewe R" first="R." last="Landewé">R. Landewé</name><affiliation><mods:affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</mods:affiliation></affiliation><affiliation><mods:affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Van Der Heijde, D" sort="Van Der Heijde, D" uniqKey="Van Der Heijde D" first="D." last="Van Der Heijde">D. 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Bautista-Molano</name><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation></author><author><name sortKey="Navarro Compan, V" sort="Navarro Compan, V" uniqKey="Navarro Compan V" first="V." last="Navarro-Compán">V. Navarro-Compán</name><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation></author><author><name sortKey="Landewe, R" sort="Landewe, R" uniqKey="Landewe R" first="R." last="Landewé">R. Landewé</name><affiliation><mods:affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</mods:affiliation></affiliation><affiliation><mods:affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Van Der Heijde, D" sort="Van Der Heijde, D" uniqKey="Van Der Heijde D" first="D." last="Van Der Heijde">D. Van Der Heijde</name><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation><affiliation><mods:affiliation>Rheumatology, Leiden University Medical Center, Leiden</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-06">2013-06</date><biblScope unit="volume">72</biblScope><biblScope unit="issue">Suppl 3</biblScope><biblScope unit="page" from="A963">A963</biblScope></imprint><idno type="ISSN">0003-4967</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute phase reactants</term><term>Ankylosing</term><term>Ankylosing spondylitis</term><term>Basfi</term><term>Clinical attachment loss</term><term>Clinical trials</term><term>Control trials</term><term>Core sets</term><term>Implementation trials</term><term>Periodontal</term><term>Periodontal condition</term><term>Periodontitis</term><term>Physical function</term><term>Plaque index</term><term>Pocket depth</term><term>Rcts</term><term>Rheum</term><term>Rheumatoid arthritis</term><term>Rheumatology</term><term>Rheumatology department</term><term>Spine radiograph</term><term>Spondylitis</term><term>Systematic literature review</term><term>Systemic lupus erythematosus</term><term>Tuberculin skin test</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Acute phase reactants</term><term>Ankylosing</term><term>Ankylosing spondylitis</term><term>Basfi</term><term>Clinical attachment loss</term><term>Clinical trials</term><term>Control trials</term><term>Core sets</term><term>Implementation trials</term><term>Periodontal</term><term>Periodontal condition</term><term>Periodontitis</term><term>Physical function</term><term>Plaque index</term><term>Pocket depth</term><term>Rcts</term><term>Rheum</term><term>Rheumatoid arthritis</term><term>Rheumatology</term><term>Rheumatology department</term><term>Spine radiograph</term><term>Spondylitis</term><term>Systematic literature review</term><term>Systemic lupus erythematosus</term><term>Tuberculin skin test</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background The Assessment of SpondyloArthritis international Society (ASAS) has selected a core set of variables to include as standardized endpoints in clinical trials and clinical practice. These core sets received endorsement by OMERACT and specific measurement instruments to assess each of these domains have been chosen. The implementation of the ASAS/OMERACT core sets, though, has so far not been evaluated. The purpose of this systematic literature review, therefore, was to compare the usage of domains and instruments of the core-sets before and after the original publication. Objectives To investigate how well the ASAS/OMERACT core sets for the outcome of ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions Methods A systematic literature search was performed in electronic databases up to January 2012 looking for RCTs in patients with AS. Domains of outcome, and instruments belonging to them, for disease controlling antirheumatic therapy (DC-ART) and symptom modifying antirheumatic drugs (SMARD) were extracted. Results are reported for clinical trials published before (control trials) in comparison to those published 2 years after the publication of the core set (1 April 2001, implementation trials). Results One hundred eight articles reporting results from 91 RCTs, and together including 11.174 patients, fulfilled the selection criteria for this project. Forty-seven RCTs were considered ‘control trials’ and 44 were considered ‘implementation trials’. NSAID and conventional non-biological DMARD therapies were more often tested in the ‘control’ - than in the ‘implementation trials’. Biological DMARDs and physical therapy were more often tested in the ‘implementation trials’. The domains ‘physical function’, ‘pain’, ‘stiffness’, ‘peripheral joint/entheses’, ‘acute phase reactants’ and ‘fatigue’, as well as the instruments ‘BASFI’, ‘BASMI’, ‘CRP’ and ‘spine radiograph’ were more frequently addressed in the ‘implementation trials’. Conclusions This systematic literature review suggests that the definition and dissemination of the core set measures for clinical trials in AS has indeed resulted in an improved usage of the endorsed domains and instruments. References van der Heijde D. J Rheumatol 1999;26:951-4, Sieper J. Ann Rheum Dis 2009;68:ii1-44 Disclosure of Interest None Declared</div></front></TEI><istex><corpusName>bmj</corpusName><keywords><teeft><json:string>implementation trials</json:string><json:string>rheumatology</json:string><json:string>spondylitis</json:string><json:string>periodontal</json:string><json:string>rcts</json:string><json:string>ankylosing spondylitis</json:string><json:string>ankylosing</json:string><json:string>basfi</json:string><json:string>periodontitis</json:string><json:string>systematic literature review</json:string><json:string>pocket depth</json:string><json:string>clinical trials</json:string><json:string>rheum</json:string><json:string>control trials</json:string><json:string>spine radiograph</json:string><json:string>core sets</json:string><json:string>periodontal condition</json:string><json:string>rheumatology department</json:string><json:string>physical function</json:string><json:string>plaque index</json:string><json:string>clinical attachment loss</json:string><json:string>rheumatoid arthritis</json:string><json:string>tuberculin skin test</json:string><json:string>systemic lupus erythematosus</json:string><json:string>acute phase reactants</json:string></teeft></keywords><author><json:item><name>W. Bautista-Molano</name><affiliations><json:string>Rheumatology, Leiden University Medical Center, Leiden</json:string><json:string>Rheumatology, Leiden University Medical Center, Leiden</json:string></affiliations></json:item><json:item><name>V. Navarro-Compán</name><affiliations><json:string>Rheumatology, Leiden University Medical Center, Leiden</json:string><json:string>Rheumatology, Leiden University Medical Center, Leiden</json:string></affiliations></json:item><json:item><name>R. Landewé</name><affiliations><json:string>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</json:string><json:string>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</json:string></affiliations></json:item><json:item><name>D. van der Heijde</name><affiliations><json:string>Rheumatology, Leiden University Medical Center, Leiden</json:string><json:string>Rheumatology, Leiden University Medical Center, Leiden</json:string></affiliations></json:item></author><articleId><json:string>annrheumdis-2013-eular.2890</json:string></articleId><arkIstex>ark:/67375/NVC-STT5083G-4</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>abstract</json:string></originalGenre><abstract>Background The Assessment of SpondyloArthritis international Society (ASAS) has selected a core set of variables to include as standardized endpoints in clinical trials and clinical practice. These core sets received endorsement by OMERACT and specific measurement instruments to assess each of these domains have been chosen. The implementation of the ASAS/OMERACT core sets, though, has so far not been evaluated. The purpose of this systematic literature review, therefore, was to compare the usage of domains and instruments of the core-sets before and after the original publication. Objectives To investigate how well the ASAS/OMERACT core sets for the outcome of ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions Methods A systematic literature search was performed in electronic databases up to January 2012 looking for RCTs in patients with AS. Domains of outcome, and instruments belonging to them, for disease controlling antirheumatic therapy (DC-ART) and symptom modifying antirheumatic drugs (SMARD) were extracted. Results are reported for clinical trials published before (control trials) in comparison to those published 2 years after the publication of the core set (1 April 2001, implementation trials). Results One hundred eight articles reporting results from 91 RCTs, and together including 11.174 patients, fulfilled the selection criteria for this project. Forty-seven RCTs were considered ‘control trials’ and 44 were considered ‘implementation trials’. NSAID and conventional non-biological DMARD therapies were more often tested in the ‘control’ - than in the ‘implementation trials’. Biological DMARDs and physical therapy were more often tested in the ‘implementation trials’. The domains ‘physical function’, ‘pain’, ‘stiffness’, ‘peripheral joint/entheses’, ‘acute phase reactants’ and ‘fatigue’, as well as the instruments ‘BASFI’, ‘BASMI’, ‘CRP’ and ‘spine radiograph’ were more frequently addressed in the ‘implementation trials’. Conclusions This systematic literature review suggests that the definition and dissemination of the core set measures for clinical trials in AS has indeed resulted in an improved usage of the endorsed domains and instruments. References van der Heijde D. J Rheumatol 1999;26:951-4, Sieper J. Ann Rheum Dis 2009;68:ii1-44 Disclosure of Interest None Declared</abstract><qualityIndicators><score>6.122</score><pdfWordCount>1122</pdfWordCount><pdfCharCount>8002</pdfCharCount><pdfVersion>1.4</pdfVersion><pdfPageCount>1</pdfPageCount><pdfPageSize>594.72 x 841.68 pts</pdfPageSize><refBibsNative>false</refBibsNative><abstractWordCount>338</abstractWordCount><abstractCharCount>2423</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review</title><genre><json:string>abstract</json:string></genre><host><title>Annals of the Rheumatic Diseases</title><language><json:string>unknown</json:string></language><issn><json:string>0003-4967</json:string></issn><eissn><json:string>1468-2060</json:string></eissn><publisherId><json:string>ard</json:string></publisherId><volume>72</volume><issue>Suppl 3</issue><pages><first>A963</first></pages><genre><json:string>journal</json:string></genre></host><namedEntities><unitex><date><json:string>2013</json:string></date><geogName></geogName><orgName></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName></persName><placeName></placeName><ref_url></ref_url><ref_bibl></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/NVC-STT5083G-4</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - rheumatology</json:string></wos><scienceMetrix><json:string>1 - health sciences</json:string><json:string>2 - clinical medicine</json:string><json:string>3 - arthritis & rheumatology</json:string></scienceMetrix><scopus><json:string>1 - Life Sciences</json:string><json:string>2 - Biochemistry, Genetics and Molecular Biology</json:string><json:string>3 - General Biochemistry, Genetics and Molecular Biology</json:string><json:string>1 - Life Sciences</json:string><json:string>2 - Immunology and Microbiology</json:string><json:string>3 - Immunology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Immunology and Allergy</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Rheumatology</json:string></scopus><inist><json:string>1 - sciences appliquees, technologies et medecines</json:string><json:string>2 - sciences biologiques et medicales</json:string><json:string>3 - sciences medicales</json:string><json:string>4 - pathologie osteoarticulaire</json:string></inist></categories><publicationDate>2013</publicationDate><copyrightDate>2013</copyrightDate><doi><json:string>10.1136/annrheumdis-2013-eular.2890</json:string></doi><id>C0BF867E3E70D159D4DA86918274DCA3568F9D92</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/C0BF867E3E70D159D4DA86918274DCA3568F9D92/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/C0BF867E3E70D159D4DA86918274DCA3568F9D92/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/C0BF867E3E70D159D4DA86918274DCA3568F9D92/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review</title><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher scheme="https://publisher-list.data.istex.fr">BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><availability><licence><p>© 2013, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</p></licence><p scheme="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-7M42M2QJ-2">bmj</p></availability><date>2013</date></publicationStmt><notesStmt><note type="abstract" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-HPN7T1Q2-R">abstract</note><note type="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review</title><author xml:id="author-0000"><persName><forename type="first">W.</forename><surname>Bautista-Molano</surname></persName><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation></author><author xml:id="author-0001"><persName><forename type="first">V.</forename><surname>Navarro-Compán</surname></persName><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation></author><author xml:id="author-0002"><persName><forename type="first">R.</forename><surname>Landewé</surname></persName><affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</affiliation><affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</affiliation></author><author xml:id="author-0003"><persName><forename type="first">D.</forename><surname>van der Heijde</surname></persName><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation></author><idno type="istex">C0BF867E3E70D159D4DA86918274DCA3568F9D92</idno><idno type="ark">ark:/67375/NVC-STT5083G-4</idno><idno type="DOI">10.1136/annrheumdis-2013-eular.2890</idno><idno type="href">annrheumdis-72-A963-1.pdf</idno><idno type="article-id">annrheumdis-2013-eular.2890</idno><idno type="local">annrheumdis;72/Suppl_3/A963-a</idno></analytic><monogr><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="pISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><idno type="publisher-id">ard</idno><idno type="PublisherID-hwp">annrheumdis</idno><idno type="PublisherID-nlm-ta">Ann Rheum Dis</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-06"></date><biblScope unit="volume">72</biblScope><biblScope unit="issue">Suppl 3</biblScope><biblScope unit="page" from="A963">A963</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Background The Assessment of SpondyloArthritis international Society (ASAS) has selected a core set of variables to include as standardized endpoints in clinical trials and clinical practice. These core sets received endorsement by OMERACT and specific measurement instruments to assess each of these domains have been chosen. The implementation of the ASAS/OMERACT core sets, though, has so far not been evaluated. The purpose of this systematic literature review, therefore, was to compare the usage of domains and instruments of the core-sets before and after the original publication. Objectives To investigate how well the ASAS/OMERACT core sets for the outcome of ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions Methods A systematic literature search was performed in electronic databases up to January 2012 looking for RCTs in patients with AS. Domains of outcome, and instruments belonging to them, for disease controlling antirheumatic therapy (DC-ART) and symptom modifying antirheumatic drugs (SMARD) were extracted. Results are reported for clinical trials published before (control trials) in comparison to those published 2 years after the publication of the core set (1 April 2001, implementation trials). Results One hundred eight articles reporting results from 91 RCTs, and together including 11.174 patients, fulfilled the selection criteria for this project. Forty-seven RCTs were considered ‘control trials’ and 44 were considered ‘implementation trials’. NSAID and conventional non-biological DMARD therapies were more often tested in the ‘control’ - than in the ‘implementation trials’. Biological DMARDs and physical therapy were more often tested in the ‘implementation trials’. The domains ‘physical function’, ‘pain’, ‘stiffness’, ‘peripheral joint/entheses’, ‘acute phase reactants’ and ‘fatigue’, as well as the instruments ‘BASFI’, ‘BASMI’, ‘CRP’ and ‘spine radiograph’ were more frequently addressed in the ‘implementation trials’. Conclusions This systematic literature review suggests that the definition and dissemination of the core set measures for clinical trials in AS has indeed resulted in an improved usage of the endorsed domains and instruments. References van der Heijde D. J Rheumatol 1999;26:951-4, Sieper J. Ann Rheum Dis 2009;68:ii1-44 Disclosure of Interest None Declared</p></abstract></profileDesc><revisionDesc><change when="2013-06">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2017-10-17">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/C0BF867E3E70D159D4DA86918274DCA3568F9D92/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="abstract" xml:lang="EN"><front><journal-meta><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title>Annals of the Rheumatic Diseases</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Rheum Dis</abbrev-journal-title><abbrev-journal-title>Ann Rheum Dis</abbrev-journal-title><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">annrheumdis-2013-eular.2890</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2013-eular.2890</article-id><article-id pub-id-type="other">annrheumdis;72/Suppl_3/A963-a</article-id><article-id pub-id-type="other">annrheumdis;annrheumdis-2013-eular.2890</article-id><article-id pub-id-type="other">A963.1</article-id><article-id pub-id-type="other">annrheumdis-2013-eular.2890</article-id><article-categories><subj-group subj-group-type="heading"><subject>Abstracts accepted for publication</subject><subj-group subj-group-type="heading"><subject>Spondyloarthritis - clinical aspects (other than treatment)</subject></subj-group></subj-group></article-categories><title-group><article-title>AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review</article-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Bautista-Molano</surname><given-names>W.</given-names></name><xref ref-type="aff" rid="AF00001"><sup>1</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Navarro-Compán</surname><given-names>V.</given-names></name><xref ref-type="aff" rid="AF00001"><sup>1</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Landewé</surname><given-names>R.</given-names></name><xref ref-type="aff" rid="AF00002"><sup>2</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>van der Heijde</surname><given-names>D.</given-names></name><xref ref-type="aff" rid="AF00001"><sup>1</sup></xref></contrib></contrib-group><aff id="AF00001"><sup>1</sup>Rheumatology, Leiden University Medical Center, Leiden</aff><aff id="AF00002"><sup>2</sup>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</aff><pub-date pub-type="ppub"><month>6</month><year>2013</year></pub-date><volume>72</volume><volume-id pub-id-type="other">72</volume-id><volume-id pub-id-type="other">72</volume-id><issue>Suppl 3</issue><issue-id pub-id-type="other">annrheumdis;72/Suppl_3</issue-id><issue-id pub-id-type="other" content-type="supplement">Suppl_3</issue-id><issue-id pub-id-type="other">72/Suppl_3</issue-id><issue-title>Annual European Congress of Rheumatology EULAR abstracts 2013, 12–15 June 2013, Spain</issue-title><fpage seq="1">A963</fpage><permissions><copyright-statement>© 2013, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</copyright-statement><copyright-year>2013</copyright-year></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="annrheumdis-72-A963-1.pdf"></self-uri><abstract><sec><title>Background</title><p>The Assessment of SpondyloArthritis international Society (ASAS) has selected a core set of variables to include as standardized endpoints in clinical trials and clinical practice. These core sets received endorsement by OMERACT and specific measurement instruments to assess each of these domains have been chosen. The implementation of the ASAS/OMERACT core sets, though, has so far not been evaluated. The purpose of this systematic literature review, therefore, was to compare the usage of domains and instruments of the core-sets before and after the original publication.</p></sec><sec><title>Objectives</title><p>To investigate how well the ASAS/OMERACT core sets for the outcome of ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions</p></sec><sec><title>Methods</title><p>A systematic literature search was performed in electronic databases up to January 2012 looking for RCTs in patients with AS. Domains of outcome, and instruments belonging to them, for disease controlling antirheumatic therapy (DC-ART) and symptom modifying antirheumatic drugs (SMARD) were extracted. Results are reported for clinical trials published before (control trials) in comparison to those published 2 years after the publication of the core set (1 April 2001, implementation trials).</p></sec><sec><title>Results</title><p>One hundred eight articles reporting results from 91 RCTs, and together including 11.174 patients, fulfilled the selection criteria for this project. Forty-seven RCTs were considered ‘control trials’ and 44 were considered ‘implementation trials’. NSAID and conventional non-biological DMARD therapies were more often tested in the ‘control’ - than in the ‘implementation trials’. Biological DMARDs and physical therapy were more often tested in the ‘implementation trials’. The domains ‘physical function’, ‘pain’, ‘stiffness’, ‘peripheral joint/entheses’, ‘acute phase reactants’ and ‘fatigue’, as well as the instruments ‘BASFI’, ‘BASMI’, ‘CRP’ and ‘spine radiograph’ were more frequently addressed in the ‘implementation trials’.</p><fig id="F1" position="float"><graphic xlink:href="annrheumdis-72-A963-1-F1.jpg" alt-version="no" position="float" xlink:type="simple"></graphic></fig></sec><sec><title>Conclusions</title><p>This systematic literature review suggests that the definition and dissemination of the core set measures for clinical trials in AS has indeed resulted in an improved usage of the endorsed domains and instruments.</p></sec><sec><title>References</title><p><list list-type="order"><list-item><p>van der Heijde D. J Rheumatol 1999;26:951-4,</p></list-item><list-item><p>Sieper J. Ann Rheum Dis 2009;68:ii1-44</p></list-item></list></p></sec><sec><title>Disclosure of Interest</title><p>None Declared</p></sec></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>AB0568 How well are the asas/omeract core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? a systematic literature review</title></titleInfo><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Bautista-Molano</namePart><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Navarro-Compán</namePart><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Landewé</namePart><affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</affiliation><affiliation>Rheumatology, Academic Medical Center, Amsterdam, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">van der Heijde</namePart><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><affiliation>Rheumatology, Leiden University Medical Center, Leiden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="abstract" displayLabel="abstract" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-HPN7T1Q2-R">abstract</genre><originInfo><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><dateIssued encoding="w3cdtf">2013-06</dateIssued><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract>Background The Assessment of SpondyloArthritis international Society (ASAS) has selected a core set of variables to include as standardized endpoints in clinical trials and clinical practice. These core sets received endorsement by OMERACT and specific measurement instruments to assess each of these domains have been chosen. The implementation of the ASAS/OMERACT core sets, though, has so far not been evaluated. The purpose of this systematic literature review, therefore, was to compare the usage of domains and instruments of the core-sets before and after the original publication. Objectives To investigate how well the ASAS/OMERACT core sets for the outcome of ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions Methods A systematic literature search was performed in electronic databases up to January 2012 looking for RCTs in patients with AS. Domains of outcome, and instruments belonging to them, for disease controlling antirheumatic therapy (DC-ART) and symptom modifying antirheumatic drugs (SMARD) were extracted. Results are reported for clinical trials published before (control trials) in comparison to those published 2 years after the publication of the core set (1 April 2001, implementation trials). Results One hundred eight articles reporting results from 91 RCTs, and together including 11.174 patients, fulfilled the selection criteria for this project. Forty-seven RCTs were considered ‘control trials’ and 44 were considered ‘implementation trials’. NSAID and conventional non-biological DMARD therapies were more often tested in the ‘control’ - than in the ‘implementation trials’. Biological DMARDs and physical therapy were more often tested in the ‘implementation trials’. The domains ‘physical function’, ‘pain’, ‘stiffness’, ‘peripheral joint/entheses’, ‘acute phase reactants’ and ‘fatigue’, as well as the instruments ‘BASFI’, ‘BASMI’, ‘CRP’ and ‘spine radiograph’ were more frequently addressed in the ‘implementation trials’. Conclusions This systematic literature review suggests that the definition and dissemination of the core set measures for clinical trials in AS has indeed resulted in an improved usage of the endorsed domains and instruments. References van der Heijde D. J Rheumatol 1999;26:951-4, Sieper J. Ann Rheum Dis 2009;68:ii1-44 Disclosure of Interest None Declared</abstract><relatedItem type="host"><titleInfo><title>Annals of the Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Ann Rheum Dis</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">0003-4967</identifier><identifier type="eISSN">1468-2060</identifier><identifier type="PublisherID">ard</identifier><identifier type="PublisherID-hwp">annrheumdis</identifier><identifier type="PublisherID-nlm-ta">Ann Rheum Dis</identifier><part><date>2013</date><detail type="title"><title>Annual European Congress of Rheumatology EULAR abstracts 2013, 12–15 June 2013, Spain</title></detail><detail type="volume"><caption>vol.</caption><number>72</number></detail><detail type="issue"><caption>no.</caption><number>Suppl 3</number></detail><extent unit="pages"><start>A963</start></extent></part></relatedItem><identifier type="istex">C0BF867E3E70D159D4DA86918274DCA3568F9D92</identifier><identifier type="ark">ark:/67375/NVC-STT5083G-4</identifier><identifier type="DOI">10.1136/annrheumdis-2013-eular.2890</identifier><identifier type="href">annrheumdis-72-A963-1.pdf</identifier><identifier type="ArticleID">annrheumdis-2013-eular.2890</identifier><identifier type="local">annrheumdis;72/Suppl_3/A963-a</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2013, Published by the BMJ Publishing Group Limited. 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