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Autor
Aletaha, Daniel 1 Boers, Maarten 1 Buch, Maya H 1 Carmona, Loreto 1 Christensen, Robin 1 Combe, Bernard 1 Emery, Paul 1 Ferraccioli, Gianfranco 1 Guillemin, Francis 1 Kvien, Tore K 1 Landewe, Robert 1 Pavelka, Karel 1 Saag, Kenneth 1 Silva-Fernandez, Lucia 1 Smolen, Josef S 1 Symmons, Deborah 1 Welling, Joep 1 Wells, George 1 Westhovens, Rene 1 Zink, Angela 1
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Pracoviště
Academic Medical Centre University of... 1 Arthritis Research UK Centre for Epid... 1 Department of Development and Regener... 1 Department of Epidemiology and Biosta... 1 Department of Epidemiology and Commun... 1 Department of Internal Medicine 3 Div... 1 Department of Internal Medicine 3 Div... 1 Department of Rheumatology Diakonhjem... 1 Department of Rheumatology Lapeyronie... 1 Department of Rheumatology Musculoske... 1 Division of Clinical Immunology and R... 1 Division of Rheumatology Catholic Uni... 1 EULAR Patient Research Partner Ede Th... 1 German Rheumatism Research Centre Ber... 1 Institute for Musculoskeletal Health ... 1 Institute of Rheumatology and Clinic ... 1 Leeds Institute of Rheumatic and Musc... 1 Leiden University Medical Center Depa... 1 Rheumatology Department Hospital Univ... 1 Université de Lorraine Université Par... 1
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Autor
Aletaha, Daniel 1 Boers, Maarten 1 Buch, Maya H 1 Carmona, Loreto 1 Christensen, Robin 1 Combe, Bernard 1 Emery, Paul 1 Ferraccioli, Gianfranco 1 Guillemin, Francis 1 Kvien, Tore K 1 Landewe, Robert 1 Pavelka, Karel 1 Saag, Kenneth 1 Silva-Fernandez, Lucia 1 Smolen, Josef S 1 Symmons, Deborah 1 Welling, Joep 1 Wells, George 1 Westhovens, Rene 1 Zink, Angela 1
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Pracoviště
Academic Medical Centre University of... 1 Arthritis Research UK Centre for Epid... 1 Department of Development and Regener... 1 Department of Epidemiology and Biosta... 1 Department of Epidemiology and Commun... 1 Department of Internal Medicine 3 Div... 1 Department of Internal Medicine 3 Div... 1 Department of Rheumatology Diakonhjem... 1 Department of Rheumatology Lapeyronie... 1 Department of Rheumatology Musculoske... 1 Division of Clinical Immunology and R... 1 Division of Rheumatology Catholic Uni... 1 EULAR Patient Research Partner Ede Th... 1 German Rheumatism Research Centre Ber... 1 Institute for Musculoskeletal Health ... 1 Institute of Rheumatology and Clinic ... 1 Leeds Institute of Rheumatic and Musc... 1 Leiden University Medical Center Depa... 1 Rheumatology Department Hospital Univ... 1 Université de Lorraine Université Par... 1
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NLK
ProQuest Central
od 1939-01-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 1939-01-01 do Před 6 měsíci
Family Health Database (ProQuest)
od 1939-01-01 do Před 6 měsíci
PubMed
24827533
DOI
10.1136/annrheumdis-2013-204948
Knihovny.cz E-zdroje
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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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