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.

Academic Medical Centre University of Amsterdam Amsterdam The Netherlands

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

Department of Development and Regeneration KU Leuven Skeletal Biology and Engineering Research Center Leuven Belgium Department of Rheumatology University Hospitals Leuven Leuven Belgium

Department of Epidemiology and Biostatistics VU University Medical Center Amsterdam The Netherlands

Department of Epidemiology and Community Medicine University of Ottawa Ottawa Canada

Department of Internal Medicine 3 Division of Rheumatology Medical University of Vienna Vienna Austria

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

Department of Rheumatology Diakonhjemmet Hospital Oslo Norway

Department of Rheumatology Lapeyronie Hospital Montpellier 1 University of Montpellier France

Department of Rheumatology Musculoskeletal Statistics Unit The Parker Institute Copenhagen University Hospital Bispebjerg and Frederiksberg Copenhagen Denmark

Division of Clinical Immunology and Rheumatology University of Alabama at Birmingham School of Medicine Birmingham Alabama USA

Division of Rheumatology Catholic University of the Sacred Heart Rome Italy

EULAR Patient Research Partner Ede The Netherlands

German Rheumatism Research Centre Berlin Germany

Institute for Musculoskeletal Health Madrid Spain

Institute of Rheumatology and Clinic of Rheumatology Charles University Prague Czech Republic

Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds UK NIHR Leeds Musculoskeletal Biomedical Research Unit Leeds Teaching Hospitals NHS Trust Leeds UK

Leiden University Medical Center Department of Rheumatology Leiden The Netherlands

Rheumatology Department Hospital Universitario de Guadalajara Guadalajara Spain

Université de Lorraine Université Paris Descartes Nancy France

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