Outcome reporting in randomized trials in gout: A systematic scoping review from the OMERACT gout working group assessing the uptake of the core outcome set
Authors' conclusion
In this study we found a low adherence with the intended endorsed (i.e., core) outcome domains for acute and chronic gout studies which represents a poor uptake of the global OMERACT efforts for the minimum of what should be measured in clinical trials. In addition, there is a significant variation in how the OMERACT endorsed outcome domains have been measured.
Study context
- Population
- Randomized controlled trials (RCTs) allocating people with gout to an active pharmacological gout treatment or a control comparator
- Participants
- 71 trials
- Comparison
- Reporting of OMERACT core outcome domains before vs after the 2009 endorsement; acute vs chronic trials
- Acute trialsn = 36
- Chronic trialsn = 35
- Primary endpoint
- Extent to which gout trials collect and report data in accordance with the 2009 OMERACT core outcome domains
Methodological detailsOMERACT gout working group, no date limitation, 8,522 records identified; 134 full text papers reviewed
- OMERACT gout working group
- No date limitation
- 8,522 records identified; 134 full text papers reviewed
Primary result
As reported in the abstract
Trials reporting all core domains (5 acute; 7 chronic)
Acute trials
8%
3 of 36
Chronic trials
0
events
Further findings
Unique measurement instruments across core domains
Domains reported in chronic trials
- Serum urate reported
- 100%
- Gout flares reported
- 80%
- Other core domains reported
- <30%
- Patient-important domains (HR-QOL, PGA, activity limitations) rarely reported
Change before vs after 2009 endorsement
- Acute trials: consistently low, no change detected before and after 2009
- Chronic trials: none reported all 7 core domains at any time
Use of OMERACT endorsed instruments
- Broad variety of instruments; a minority of trials used OMERACT endorsed instruments
Original publication
Outcome reporting in randomized trials in gout: A systematic scoping review from the OMERACT gout working group assessing the uptake of the core outcome set. Semin Arthritis Rheum. Published 15 March 2023. doi:10.
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