OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

S.M. Nielsen, M. Boers, M. de Wit, B. Shea, D.A. van der Windt, B.C. Reeves, D. Beaton, R. Alten, K.T. April, A. Boonen, R. Escorpizo, C. Flurey, D.E. Furst, F. Guillemin, A. Leong, C. Pohl, M.U. Rasmussen, J.A. Singh, J.S. Smolen, V. StrandS.M.M. Verstappen, M. Voshaar, T.G. Woodworth, T. Ellingsen, L. March, G.A. Wells, P. Tugwell, R. Christensen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Objectives: To develop an operational definition of contextual factors (CF) [1].Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying-, Outcome Influencing -and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consen-sus (>70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (
Original languageEnglish
Pages (from-to)601-606
Number of pages6
JournalSeminars in Arthritis and Rheumatism
Issue number3
Publication statusPublished - 1 Jun 2021


  • Contextual factors
  • Delphi survey
  • Effect modifying contextual factors
  • Outcome explaining contextual factors
  • Measurement affecting contextual factors

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