Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology.
OBJECTIVE
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.
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Maya H
MH
Buch
Rheumatology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain.
Lucia
L
Silva-Fernandez
Institute for Musculoskeletal Health, Madrid, Spain.
Loreto
L
Carmona
Department of Internal Medicine 3, Division of Rheumatology, Medical University of Vienna, Vienna, Austria.
Daniel
D
Aletaha
Department of Rheumatology, Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.
Robin
R
Christensen
Department of Rheumatology, Lapeyronie Hospital, Montpellier I University of Montpellier, France.
Bernard
B
Combe
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Paul
P
Emery
Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy.
Gianfranco
G
Ferraccioli
Université de Lorraine, Université Paris Descartes, Nancy, France.
Francis
F
Guillemin
Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Tore K
TK
Kvien
Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Robert
R
Landewe
Institute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic.
Karel
K
Pavelka
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.
Kenneth
K
Saag
Department of Internal Medicine 3, Division of Rheumatology, Medical University of Vienna, Vienna, Austria 2nd Department of Medicine, Center for Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.
Josef S
JS
Smolen
Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Trust, Manchester, UK.
Deborah
D
Symmons
Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands.
Désirée
D
van der Heijde
EULAR Patient Research Partner, Ede, The Netherlands.
Joep
J
Welling
Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada.
George
G
Wells
Department of Development and Regeneration, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Rene
R
Westhovens
German Rheumatism Research Centre, Berlin, Germany.
Angela
A
Zink
Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
Maarten
M
Boers
D026683:Advisory Committees; D003697:Delphi Technique; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D058028:Research Report / Q000592:standards*; D012219:Rheumatology
DMARDs (biologic); Epidemiology; Rheumatoid Arthritis