Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology
Identifieur interne : 000031 ( Pmc/Curation ); précédent : 000030; suivant : 000032Development 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.
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DOI: 10.1136/annrheumdis-2013-204948
PubMed: 24827533
PubMed Central: 4431343
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Buch</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Leeds Institute of Rheumatic and Musculoskeletal Medicine</addr-line>,<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><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>NIHR Leeds Musculoskeletal Biomedical Research Unit</addr-line>,<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></affiliation></author><author><name sortKey="Silva Fernandez, Lucia" sort="Silva Fernandez, Lucia" uniqKey="Silva Fernandez L" first="Lucia" last="Silva-Fernandez">Lucia Silva-Fernandez</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Rheumatology 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Descartes</institution>,<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><affiliation wicri:level="1"><nlm:aff id="af10"><addr-line>Department of Rheumatology</addr-line>,<institution>Diakonhjemmet Hospital</institution>,<addr-line>Oslo</addr-line>,<country>Norway</country></nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>Academic Medical Centre, University of Amsterdam</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><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></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24827533</idno><idno type="pmc">4431343</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4431343</idno><idno type="RBID">PMC:4431343</idno><idno type="doi">10.1136/annrheumdis-2013-204948</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000031</idno><idno type="wicri:Area/Pmc/Curation">000031</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology</title><author><name sortKey="Buch, Maya H" sort="Buch, Maya H" uniqKey="Buch M" first="Maya H" last="Buch">Maya H. Buch</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Leeds Institute of Rheumatic and Musculoskeletal Medicine</addr-line>,<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><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>NIHR Leeds Musculoskeletal Biomedical Research Unit</addr-line>,<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></affiliation></author><author><name sortKey="Silva Fernandez, Lucia" sort="Silva Fernandez, Lucia" uniqKey="Silva Fernandez L" first="Lucia" last="Silva-Fernandez">Lucia Silva-Fernandez</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Rheumatology Department</addr-line>,<institution>Hospital Universitario de Guadalajara</institution>,<addr-line>Guadalajara</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Carmona, Loreto" sort="Carmona, Loreto" uniqKey="Carmona L" first="Loreto" last="Carmona">Loreto Carmona</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>Institute for Musculoskeletal Health</institution>,<addr-line>Madrid</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Aletaha, Daniel" sort="Aletaha, Daniel" uniqKey="Aletaha D" first="Daniel" last="Aletaha">Daniel Aletaha</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></author><author><name sortKey="Christensen, Robin" sort="Christensen, Robin" uniqKey="Christensen R" first="Robin" last="Christensen">Robin Christensen</name><affiliation wicri:level="1"><nlm:aff id="af6"><addr-line>Department of Rheumatology</addr-line>,<institution>Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg</institution>,<addr-line>Copenhagen</addr-line>,<country>Denmark</country></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name><affiliation wicri:level="1"><nlm:aff id="af7"><addr-line>Department of Rheumatology</addr-line>,<institution>Lapeyronie Hospital, Montpellier I University of Montpellier</institution>,<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="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Leeds Institute of Rheumatic and Musculoskeletal Medicine</addr-line>,<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><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>NIHR Leeds Musculoskeletal Biomedical Research Unit</addr-line>,<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></affiliation></author><author><name sortKey="Ferraccioli, Gianfranco" sort="Ferraccioli, Gianfranco" uniqKey="Ferraccioli G" first="Gianfranco" last="Ferraccioli">Gianfranco Ferraccioli</name><affiliation wicri:level="1"><nlm:aff id="af8"><addr-line>Division of Rheumatology</addr-line>,<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></affiliation></author><author><name sortKey="Guillemin, Francis" sort="Guillemin, Francis" uniqKey="Guillemin F" first="Francis" last="Guillemin">Francis Guillemin</name><affiliation wicri:level="1"><nlm:aff id="af9"><institution>Université de Lorraine, Université Paris Descartes</institution>,<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><affiliation wicri:level="1"><nlm:aff id="af10"><addr-line>Department of Rheumatology</addr-line>,<institution>Diakonhjemmet Hospital</institution>,<addr-line>Oslo</addr-line>,<country>Norway</country></nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Landewe, Robert" sort="Landewe, Robert" uniqKey="Landewe R" first="Robert" last="Landewe">Robert Landewe</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>Academic Medical Centre, University of Amsterdam</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><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. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="iso-abbrev">Ann. Rheum. Dis</journal-id><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title-group><journal-title>Annals of the Rheumatic Diseases</journal-title></journal-title-group><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group</publisher-name><publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24827533</article-id><article-id pub-id-type="pmc">4431343</article-id><article-id pub-id-type="publisher-id">annrheumdis-2013-204948</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2013-204948</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject></subj-group><subj-group subj-group-type="heading"><subject>Recommendation</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Buch</surname><given-names>Maya H</given-names></name><xref ref-type="aff" rid="af1">1</xref><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Silva-Fernandez</surname><given-names>Lucia</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Carmona</surname><given-names>Loreto</given-names></name><xref ref-type="aff" rid="af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Aletaha</surname><given-names>Daniel</given-names></name><xref ref-type="aff" rid="af5">5</xref></contrib><contrib contrib-type="author"><name><surname>Christensen</surname><given-names>Robin</given-names></name><xref ref-type="aff" rid="af6">6</xref></contrib><contrib contrib-type="author"><name><surname>Combe</surname><given-names>Bernard</given-names></name><xref ref-type="aff" rid="af7">7</xref></contrib><contrib contrib-type="author"><name><surname>Emery</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="af1">1</xref><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Ferraccioli</surname><given-names>Gianfranco</given-names></name><xref ref-type="aff" rid="af8">8</xref></contrib><contrib contrib-type="author"><name><surname>Guillemin</surname><given-names>Francis</given-names></name><xref ref-type="aff" rid="af9">9</xref></contrib><contrib contrib-type="author"><name><surname>Kvien</surname><given-names>Tore K</given-names></name><xref ref-type="aff" rid="af10">10</xref></contrib><contrib contrib-type="author"><name><surname>Landewe</surname><given-names>Robert</given-names></name><xref ref-type="aff" rid="af11">11</xref></contrib><contrib contrib-type="author"><name><surname>Pavelka</surname><given-names>Karel</given-names></name><xref ref-type="aff" rid="af12">12</xref></contrib><contrib contrib-type="author"><name><surname>Saag</surname><given-names>Kenneth</given-names></name><xref ref-type="aff" rid="af13">13</xref></contrib><contrib contrib-type="author"><name><surname>Smolen</surname><given-names>Josef S</given-names></name><xref ref-type="aff" rid="af5">5</xref><xref ref-type="aff" rid="af14">14</xref></contrib><contrib contrib-type="author"><name><surname>Symmons</surname><given-names>Deborah</given-names></name><xref ref-type="aff" rid="af15">15</xref><xref ref-type="aff" rid="af16">16</xref></contrib><contrib contrib-type="author"><name><surname>van der Heijde</surname><given-names>Désirée</given-names></name><xref ref-type="aff" rid="af17">17</xref></contrib><contrib contrib-type="author"><name><surname>Welling</surname><given-names>Joep</given-names></name><xref ref-type="aff" rid="af18">18</xref></contrib><contrib contrib-type="author"><name><surname>Wells</surname><given-names>George</given-names></name><xref ref-type="aff" rid="af19">19</xref></contrib><contrib contrib-type="author"><name><surname>Westhovens</surname><given-names>Rene</given-names></name><xref ref-type="aff" rid="af20">20</xref><xref ref-type="aff" rid="af21">21</xref></contrib><contrib contrib-type="author"><name><surname>Zink</surname><given-names>Angela</given-names></name><xref ref-type="aff" rid="af22">22</xref></contrib><contrib contrib-type="author"><name><surname>Boers</surname><given-names>Maarten</given-names></name><xref ref-type="aff" rid="af23">23</xref></contrib></contrib-group><aff id="af1"><label>1</label><addr-line>Leeds Institute of Rheumatic and Musculoskeletal Medicine</addr-line>,<institution>University of Leeds</institution>,<country>UK</country></aff><aff id="af2"><label>2</label><addr-line>NIHR Leeds Musculoskeletal Biomedical Research Unit</addr-line>,<institution>Leeds Teaching Hospitals NHS Trust</institution>,<addr-line>Leeds</addr-line>,<country>UK</country></aff><aff id="af3"><label>3</label><addr-line>Rheumatology Department</addr-line>,<institution>Hospital Universitario de Guadalajara</institution>,<addr-line>Guadalajara</addr-line>,<country>Spain</country></aff><aff id="af4"><label>4</label><institution>Institute for Musculoskeletal Health</institution>,<addr-line>Madrid</addr-line>,<country>Spain</country></aff><aff id="af5"><label>5</label><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></aff><aff id="af6"><label>6</label><addr-line>Department of Rheumatology</addr-line>,<institution>Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg</institution>,<addr-line>Copenhagen</addr-line>,<country>Denmark</country></aff><aff id="af7"><label>7</label><addr-line>Department of Rheumatology</addr-line>,<institution>Lapeyronie Hospital, Montpellier I University of Montpellier</institution>,<country>France</country></aff><aff id="af8"><label>8</label><addr-line>Division of Rheumatology</addr-line>,<institution>Catholic University of the Sacred Heart</institution>,<addr-line>Rome</addr-line>,<country>Italy</country></aff><aff id="af9"><label>9</label><institution>Université de Lorraine, Université Paris Descartes</institution>,<addr-line>Nancy</addr-line>,<country>France</country></aff><aff id="af10"><label>10</label><addr-line>Department of Rheumatology</addr-line>,<institution>Diakonhjemmet Hospital</institution>,<addr-line>Oslo</addr-line>,<country>Norway</country></aff><aff id="af11"><label>11</label><institution>Academic Medical Centre, University of Amsterdam</institution>,<addr-line>Amsterdam</addr-line>,<country>The Netherlands</country></aff><aff id="af12"><label>12</label><institution>Institute of Rheumatology and Clinic of Rheumatology, Charles University</institution>,<addr-line>Prague</addr-line>,<country>Czech Republic</country></aff><aff id="af13"><label>13</label><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></aff><aff id="af14"><label>14</label><addr-line>2nd Department of Medicine</addr-line>,<institution>Center for Rheumatic Diseases, Hietzing Hospital</institution>,<addr-line>Vienna</addr-line>,<country>Austria</country></aff><aff id="af15"><label>15</label><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></aff><aff id="af16"><label>16</label><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></aff><aff id="af17"><label>17</label><addr-line>Leiden University Medical Center, Department of Rheumatology, Leiden</addr-line>,<country>The Netherlands</country></aff><aff id="af18"><label>18</label><institution>EULAR Patient Research Partner</institution>,<addr-line>Ede</addr-line>,<country>The Netherlands</country></aff><aff id="af19"><label>19</label><addr-line>Department of Epidemiology and Community Medicine</addr-line>,<institution>University of Ottawa</institution>, Ottawa,<country>Canada</country></aff><aff id="af20"><label>20</label><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></aff><aff id="af21"><label>21</label><addr-line>Department of</addr-line><institution>Rheumatology</institution>,<institution>University Hospitals Leuven</institution>,<addr-line>Leuven</addr-line>,<country>Belgium</country></aff><aff id="af22"><label>22</label><institution>German Rheumatism Research Centre</institution>,<addr-line>Berlin</addr-line>,<country>Germany</country></aff><aff id="af23"><label>23</label><addr-line>Department of Epidemiology and Biostatistics</addr-line>,<institution>VU University Medical Center</institution>,<addr-line>Amsterdam</addr-line>,<country>The Netherlands</country></aff><author-notes><fn><p><bold>Handling editor</bold> Hans WJ Bijlsma</p></fn><corresp><label>Correspondence to</label> Dr Maya H Buch, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK; <email>m.buch@leeds.ac.uk</email></corresp></author-notes><pub-date pub-type="ppub"><month>6</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>14</day><month>5</month><year>2014</year></pub-date><volume>74</volume><issue>6</issue><fpage>963</fpage><lpage>969</lpage><history><date date-type="received"><day>20</day><month>11</month><year>2013</year></date><date date-type="rev-recd"><day>10</day><month>4</month><year>2014</year></date><date date-type="accepted"><day>12</day><month>4</month><year>2014</year></date></history><permissions><copyright-statement>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>2015</copyright-year><license license-type="open-access"><license-p>This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link></license-p></license></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="annrheumdis-2013-204948.pdf"></self-uri><abstract><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></abstract><kwd-group><kwd>Rheumatoid Arthritis</kwd><kwd>DMARDs (biologic)</kwd><kwd>Epidemiology</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>special-feature</meta-name><meta-value>unlocked</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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