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Use of composite outcomes facilitate core outcome set uptake in rheumatoid arthritis trials
  1. Jamie Kirkham1,
  2. Robin Christensen2,3,
  3. Maarten Boers4
  1. 1 Centre for Biostatistics, The University of Manchester, Manchester, UK
  2. 2 Department of Rheumatology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
  3. 3 Department of Clinical Research, Odense University Hospital, Odense, Denmark
  4. 4 Epidemiology and Biostatistics, Vrije Universiteit, Amsterdam, The Netherlands
  1. Correspondence to Professor Jamie Kirkham, Centre for Biostatistics, The University of Manchester, Manchester M13 9PL, UK; jamie.kirkham{at}manchester.ac.uk

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The WHO and the International League of Associations for Rheumatology set of core outcomes for rheumatoid arthritis (hereafter RA-COS) was adopted in 1993; it comprises eight individual outcomes which aim to assess disease activity, patient-reported outcome and damage.1 2 In addition, several validated composite outcome measures are available for use in clinical trials to measure both disease activity and state. The two key indices used in RA, the American College of Rheumatology (ACR) 20% and the Disease Activity Score (DAS) 28, represent combined subsets of the core outcome set (COS); they have been widely adopted as primary endpoints, and reporting of one of these, as well as the RA-COS, is recommended in regulatory guidance.3 4 Non-reporting of the individual core outcomes restricts meta-analyses, might lead to relevant information being missed, to exaggerated perceptions on how well an intervention works, and could lead to suspicion of intentional …

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Footnotes

  • Handling editor Josef S Smolen

  • Contributors JK conceived the idea for the study and is the guarantor for the project. The study methods were designed and the analysis was carried out by JK, RC and MB. JK prepared the initial manuscript. All the authors were involved in the revision of this manuscript. All the authors read and approved the final manuscript and are accountable for all aspects of the work, including accuracy and integrity.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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