Sjögren's disease & overlap diseases
A Systematic Review of Clinical Trial Designs and Outcome Measures in Sjögren Disease Randomized Controlled Trials
Authors' conclusion
Our review highlighted the heterogeneity of SjD RCTs in both the study designs and outcomes.
Study context
- Population
- Randomized controlled trials (RCTs) in Sjögren disease (SjD), Medline (PubMed) and EMBASE, January 2002 to March 202360 RCTs
- Outcome
- SjD-related instruments used as primary or secondary outcomes in SjD clinical trials, and whether the study succeeded in improving the outcome
Methodological detailsmanual and artificial intelligence software (Bibliography BOT) search
- Manual and artificial intelligence software (Bibliography BOT) search
Pooled result
As reported in the abstract
- RCTs focused on overall disease manifestations
- 53%
- RCTs focused on dry eyes
- 17%
- RCTs focused on xerostomia
- 15%
- RCTs focused on fatigue
- 12%
- RCTs focused on pulmonary function
- 3%
- Studies with ESSDAI as primary outcome
- 11
- Studies with ESSDAI as primary outcome reaching significance
- 45%
- Studies with ESSDAI as secondary outcome reaching significance (of 16)
- 0
- Studies with patient-reported outcomes (PROs) as primary outcome
- 34
- Studies focused on biological activity
- 2
Original publication
A Systematic Review of Clinical Trial Designs and Outcome Measures in Sjögren Disease Randomized Controlled Trials. J Rheumatol. Published 1 April 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →