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Extended report
Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology
  1. Maya H Buch1,2,
  2. Lucia Silva-Fernandez3,
  3. Loreto Carmona4,
  4. Daniel Aletaha5,
  5. Robin Christensen6,
  6. Bernard Combe7,
  7. Paul Emery1,2,
  8. Gianfranco Ferraccioli8,
  9. Francis Guillemin9,
  10. Tore K Kvien10,
  11. Robert Landewe11,
  12. Karel Pavelka12,
  13. Kenneth Saag13,
  14. Josef S Smolen5,14,
  15. Deborah Symmons15,16,
  16. Désirée van der Heijde17,
  17. Joep Welling18,
  18. George Wells19,
  19. Rene Westhovens20,21,
  20. Angela Zink22,
  21. Maarten Boers23
  1. 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK
  2. 2NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  3. 3Rheumatology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain
  4. 4Institute for Musculoskeletal Health, Madrid, Spain
  5. 5Department of Internal Medicine 3, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
  6. 6Department of Rheumatology, Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark
  7. 7Department of Rheumatology, Lapeyronie Hospital, Montpellier I University of Montpellier, France
  8. 8Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy
  9. 9Université de Lorraine, Université Paris Descartes, Nancy, France
  10. 10Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  11. 11Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
  12. 12Institute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic
  13. 13Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA
  14. 142nd Department of Medicine, Center for Rheumatic Diseases, Hietzing Hospital, Vienna, Austria
  15. 15Arthritis 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
  16. 16NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Trust, Manchester, UK
  17. 17Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
  18. 18EULAR Patient Research Partner, Ede, The Netherlands
  19. 19Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  20. 20Department of Development and Regeneration, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium
  21. 21Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium
  22. 22German Rheumatism Research Centre, Berlin, Germany
  23. 23Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
  1. Correspondence to 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; m.buch{at}leeds.ac.uk

Abstract

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.

  • Rheumatoid Arthritis
  • DMARDs (biologic)
  • Epidemiology

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: http://creativecommons.org/licenses/by-nc/3.0/

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