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

Research output: Contribution to journalJournal articleResearchpeer-review

  • Sabrina Mai Nielsen
  • Maarten Boers
  • Maarten de Wit
  • Beverly Shea
  • Danielle A van der Windt
  • Barnaby C Reeves
  • Dorcas Beaton
  • Rieke Alten
  • Karine Toupin April
  • Annelies Boonen
  • Reuben Escorpizo
  • Caroline Flurey
  • Daniel E Furst
  • Francis Guillemin
  • Amye Leong
  • Christoph Pohl
  • Marianne Uggen Rasmussen
  • Jasvinder A Singh
  • Josef S Smolen
  • Vibeke Strand
  • Suzanne M M Verstappen
  • Marieke Voshaar
  • Thasia G Woodworth
  • Torkell Ellingsen
  • Lyn March
  • George A Wells
  • Peter Tugwell
  • Robin Christensen
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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 consensus (≥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.

Original languageEnglish
JournalSeminars in Arthritis and Rheumatism
Issue number3
Pages (from-to)601-606
Number of pages6
Publication statusPublished - Jun 2021

    Research areas

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

ID: 67397040