Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology
Identifieur interne : 000258 ( Main/Exploration ); précédent : 000257; suivant : 000259Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology
Auteurs : Maya H. Buch [Royaume-Uni] ; Lucia Silva-Fernandez [Espagne] ; Loreto Carmona [Espagne] ; Daniel Aletaha [Autriche] ; Robin Christensen [Danemark] ; Bernard Combe [France] ; Paul Emery [Royaume-Uni] ; Gianfranco Ferraccioli [Italie] ; Francis Guillemin [France] ; Tore K. Kvien [Norvège] ; Robert Landewe [Pays-Bas] ; Karel Pavelka [République tchèque] ; Kenneth Saag [États-Unis] ; Josef S. Smolen [Autriche] ; Deborah Symmons [Royaume-Uni] ; Désirée Van Der Heijde [Pays-Bas] ; Joep Welling [Pays-Bas] ; George Wells [Canada] ; Rene Westhovens [Belgique] ; Angela Zink [Allemagne] ; Maarten Boers [Pays-Bas]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2014.
Abstract
Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.
We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance.
Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations.
This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.
Url:
DOI: 10.1136/annrheumdis-2013-204948
PubMed: 24827533
PubMed Central: 4431343
Affiliations:
- Allemagne, Autriche, Belgique, Canada, Danemark, Espagne, France, Italie, Norvège, Pays-Bas, Royaume-Uni, République tchèque, États-Unis
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Le document en format XML
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<author><name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name>
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<author><name sortKey="Symmons, Deborah" sort="Symmons, Deborah" uniqKey="Symmons D" first="Deborah" last="Symmons">Deborah Symmons</name>
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<author><name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
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<author><name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
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</nlm:aff>
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<author><name sortKey="Silva Fernandez, Lucia" sort="Silva Fernandez, Lucia" uniqKey="Silva Fernandez L" first="Lucia" last="Silva-Fernandez">Lucia Silva-Fernandez</name>
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<author><name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name>
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<author><name sortKey="Christensen, Robin" sort="Christensen, Robin" uniqKey="Christensen R" first="Robin" last="Christensen">Robin Christensen</name>
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<author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
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<author><name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name>
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,<institution>University of Leeds</institution>
,<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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,<institution>Leeds Teaching Hospitals NHS Trust</institution>
,<addr-line>Leeds</addr-line>
,<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Ferraccioli, Gianfranco" sort="Ferraccioli, Gianfranco" uniqKey="Ferraccioli G" first="Gianfranco" last="Ferraccioli">Gianfranco Ferraccioli</name>
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,<institution>Catholic University of the Sacred Heart</institution>
,<addr-line>Rome</addr-line>
,<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Guillemin, Francis" sort="Guillemin, Francis" uniqKey="Guillemin F" first="Francis" last="Guillemin">Francis Guillemin</name>
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,<addr-line>Nancy</addr-line>
,<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kvien, Tore K" sort="Kvien, Tore K" uniqKey="Kvien T" first="Tore K" last="Kvien">Tore K. Kvien</name>
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,<addr-line>Oslo</addr-line>
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</nlm:aff>
<country xml:lang="fr">Norvège</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name>
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,<addr-line>Amsterdam</addr-line>
,<country>The Netherlands</country>
</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Pavelka, Karel" sort="Pavelka, Karel" uniqKey="Pavelka K" first="Karel" last="Pavelka">Karel Pavelka</name>
<affiliation wicri:level="1"><nlm:aff id="af12"><institution>Institute of Rheumatology and Clinic of Rheumatology, Charles University</institution>
,<addr-line>Prague</addr-line>
,<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Saag, Kenneth" sort="Saag, Kenneth" uniqKey="Saag K" first="Kenneth" last="Saag">Kenneth Saag</name>
<affiliation wicri:level="1"><nlm:aff id="af13"><addr-line>Division of Clinical Immunology and Rheumatology</addr-line>
,<institution>University of Alabama at Birmingham School of Medicine</institution>
,<addr-line>Birmingham, Alabama</addr-line>
,<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
<affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Department of Internal Medicine 3, Division of Rheumatology</addr-line>
,<institution>Medical University of Vienna</institution>
,<addr-line>Vienna</addr-line>
,<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="af14"><addr-line>2nd Department of Medicine</addr-line>
,<institution>Center for Rheumatic Diseases, Hietzing Hospital</institution>
,<addr-line>Vienna</addr-line>
,<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Symmons, Deborah" sort="Symmons, Deborah" uniqKey="Symmons D" first="Deborah" last="Symmons">Deborah Symmons</name>
<affiliation wicri:level="1"><nlm:aff id="af15"><institution>Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester Academic Health Science Centre</institution>
,<addr-line>Manchester</addr-line>
,<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="af16"><addr-line>NIHR Manchester Musculoskeletal Biomedical Research Unit</addr-line>
,<institution>Central Manchester University Hospitals NHS Trust</institution>
,<addr-line>Manchester</addr-line>
,<country>UK</country>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Désirée" last="Van Der Heijde">Désirée Van Der Heijde</name>
<affiliation wicri:level="1"><nlm:aff id="af17"><addr-line>Leiden University Medical Center, Department of Rheumatology, Leiden</addr-line>
,<country>The Netherlands</country>
</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Welling, Joep" sort="Welling, Joep" uniqKey="Welling J" first="Joep" last="Welling">Joep Welling</name>
<affiliation wicri:level="1"><nlm:aff id="af18"><institution>EULAR Patient Research Partner</institution>
,<addr-line>Ede</addr-line>
,<country>The Netherlands</country>
</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name>
<affiliation wicri:level="1"><nlm:aff id="af19"><addr-line>Department of Epidemiology and Community Medicine</addr-line>
,<institution>University of Ottawa</institution>
, Ottawa,<country>Canada</country>
</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Westhovens, Rene" sort="Westhovens, Rene" uniqKey="Westhovens R" first="Rene" last="Westhovens">Rene Westhovens</name>
<affiliation wicri:level="1"><nlm:aff id="af20"><addr-line>Department of Development and Regeneration, KU Leuven</addr-line>
,<institution>Skeletal Biology and Engineering Research Center</institution>
,<addr-line>Leuven</addr-line>
,<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="af21"><addr-line>Department of</addr-line>
<institution>Rheumatology</institution>
,<institution>University Hospitals Leuven</institution>
,<addr-line>Leuven</addr-line>
,<country>Belgium</country>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
<affiliation wicri:level="1"><nlm:aff id="af22"><institution>German Rheumatism Research Centre</institution>
,<addr-line>Berlin</addr-line>
,<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
<affiliation wicri:level="1"><nlm:aff id="af23"><addr-line>Department of Epidemiology and Biostatistics</addr-line>
,<institution>VU University Medical Center</institution>
,<addr-line>Amsterdam</addr-line>
,<country>The Netherlands</country>
</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Annals of the Rheumatic Diseases</title>
<idno type="ISSN">0003-4967</idno>
<idno type="eISSN">1468-2060</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Objectives</title>
<p>Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.</p>
</sec>
<sec><title>Methods</title>
<p>We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance.</p>
</sec>
<sec><title>Results</title>
<p>Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations.</p>
</sec>
<sec><title>Conclusions</title>
<p>This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.</p>
</sec>
</div>
</front>
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</div1>
</back>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Canada</li>
<li>Danemark</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Norvège</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>République tchèque</li>
<li>États-Unis</li>
</country>
</list>
<tree><country name="Royaume-Uni"><noRegion><name sortKey="Buch, Maya H" sort="Buch, Maya H" uniqKey="Buch M" first="Maya H" last="Buch">Maya H. Buch</name>
</noRegion>
<name sortKey="Buch, Maya H" sort="Buch, Maya H" uniqKey="Buch M" first="Maya H" last="Buch">Maya H. Buch</name>
<name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name>
<name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name>
<name sortKey="Symmons, Deborah" sort="Symmons, Deborah" uniqKey="Symmons D" first="Deborah" last="Symmons">Deborah Symmons</name>
<name sortKey="Symmons, Deborah" sort="Symmons, Deborah" uniqKey="Symmons D" first="Deborah" last="Symmons">Deborah Symmons</name>
</country>
<country name="Espagne"><noRegion><name sortKey="Silva Fernandez, Lucia" sort="Silva Fernandez, Lucia" uniqKey="Silva Fernandez L" first="Lucia" last="Silva-Fernandez">Lucia Silva-Fernandez</name>
</noRegion>
<name sortKey="Carmona, Loreto" sort="Carmona, Loreto" uniqKey="Carmona L" first="Loreto" last="Carmona">Loreto Carmona</name>
</country>
<country name="Autriche"><noRegion><name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</name>
</noRegion>
<name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
<name sortKey="Smolen, Josef S" sort="Smolen, Josef S" uniqKey="Smolen J" first="Josef S" last="Smolen">Josef S. Smolen</name>
</country>
<country name="Danemark"><noRegion><name sortKey="Christensen, Robin" sort="Christensen, Robin" uniqKey="Christensen R" first="Robin" last="Christensen">Robin Christensen</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name>
</noRegion>
<name sortKey="Guillemin, Francis" sort="Guillemin, Francis" uniqKey="Guillemin F" first="Francis" last="Guillemin">Francis Guillemin</name>
</country>
<country name="Italie"><noRegion><name sortKey="Ferraccioli, Gianfranco" sort="Ferraccioli, Gianfranco" uniqKey="Ferraccioli G" first="Gianfranco" last="Ferraccioli">Gianfranco Ferraccioli</name>
</noRegion>
</country>
<country name="Norvège"><noRegion><name sortKey="Kvien, Tore K" sort="Kvien, Tore K" uniqKey="Kvien T" first="Tore K" last="Kvien">Tore K. Kvien</name>
</noRegion>
</country>
<country name="Pays-Bas"><noRegion><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name>
</noRegion>
<name sortKey="Boers, Maarten" sort="Boers, Maarten" uniqKey="Boers M" first="Maarten" last="Boers">Maarten Boers</name>
<name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Désirée" last="Van Der Heijde">Désirée Van Der Heijde</name>
<name sortKey="Welling, Joep" sort="Welling, Joep" uniqKey="Welling J" first="Joep" last="Welling">Joep Welling</name>
</country>
<country name="République tchèque"><noRegion><name sortKey="Pavelka, Karel" sort="Pavelka, Karel" uniqKey="Pavelka K" first="Karel" last="Pavelka">Karel Pavelka</name>
</noRegion>
</country>
<country name="États-Unis"><noRegion><name sortKey="Saag, Kenneth" sort="Saag, Kenneth" uniqKey="Saag K" first="Kenneth" last="Saag">Kenneth Saag</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Wells, George" sort="Wells, George" uniqKey="Wells G" first="George" last="Wells">George Wells</name>
</noRegion>
</country>
<country name="Belgique"><noRegion><name sortKey="Westhovens, Rene" sort="Westhovens, Rene" uniqKey="Westhovens R" first="Rene" last="Westhovens">Rene Westhovens</name>
</noRegion>
<name sortKey="Westhovens, Rene" sort="Westhovens, Rene" uniqKey="Westhovens R" first="Rene" last="Westhovens">Rene Westhovens</name>
</country>
<country name="Allemagne"><noRegion><name sortKey="Zink, Angela" sort="Zink, Angela" uniqKey="Zink A" first="Angela" last="Zink">Angela Zink</name>
</noRegion>
</country>
</tree>
</affiliations>
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