Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set

Joanna Tieu, Jonathan T. L. Cheah, Rachel J. Black, Robin Christensen, Nilasha Ghosh, Pamela Richards, Joanna Robson, Beverley Shea, Lee S. Simon, Jasvinder A. Singhi, Peter Tugwell, Maarten Boers, Marco A. Alba Garibay, Corrado Campochiaro, Simon Decary, Maarten de Witt, Anthony P. Fernandez, Helen I. Keen, Lauren King, Andrea Hinojosa-AzaolaCathie Hofstetter, Inna Gaydukova, Michael D. George, Latika Gupta, Suellen Lyne, Ashima Makol, Chetan Mukhtyar, Win Min Oo, Michelle Petri, Huai Leng Pisaniello, Sebastian E. Sattui, Oscar Russell, Vitor Teixeira, Karine Toupin-April, Courage Uhunmwangho, Margaret Whitstock, Kevin Yip, Sarah L. Mackie, Susan M. Goodman, Catherine L. Hill

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

Objective: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions. Methods: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set. Results: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as “mandatory in specific circumstances”. The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders. Conclusion: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.

Original languageEnglish
Pages (from-to)1139-1145
Number of pages7
JournalSeminars in Arthritis and Rheumatism
Volume51
Issue number5
Early online date25 Jun 2021
DOIs
Publication statusPublished - 1 Oct 2021
Externally publishedYes

Keywords

  • Adverse effects
  • Glucocorticoid
  • OMERACT
  • Patient perspective
  • Prednisolone/prednisone/steroid

Cite this