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Screening failure in systemic sclerosis randomized trials: reporting, rates, causes and trends over time
Delphine Sophie Courvoisier1, Barbara Russo2,3, Iulia-Simona Chirică4,5
1Division of Rheumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
Rheumatology Advances in Practice
|April 15, 2026
Summary
Reporting of patient screening in scleroderma (SSc) randomized controlled trials (RCTs) has improved but is still incomplete. Most screening failures in SSc RCTs are due to patients not meeting eligibility criteria or refusing to participate.
Area of Science:
- Clinical Trials
- Rheumatology
- Scleroderma Research
Background:
- Scleroderma (SSc) is a chronic autoimmune disease.
- Randomized controlled trials (RCTs) are crucial for evaluating SSc treatments.
- Complete reporting of patient flow in RCTs is essential for transparency and reproducibility.
Purpose of the Study:
- To assess the completeness of reporting for pre-randomization patient flow in SSc RCTs.
- To determine the extent and reasons for screening failures in SSc RCTs.
Main Methods:
- Systematic search of SSc RCTs in PubMed (2000-2024).
- Extraction of trial features, pre-randomization patient flow data, and screening failure information.
- Analysis of reporting adequacy, screening failure rates, and reasons for failure.
Main Results:
- 52.9% of SSc RCTs reported pre-randomization patient flow, with improved reporting in later years.
- Over 10,000 patients were screened, with a 51% screening failure rate.
- Ineligibility (72.5%) and patient refusal (20.8%) were the primary reasons for screening failure.
Conclusions:
- Reporting of screening procedures in SSc RCTs has improved but remains suboptimal.
- Patient ineligibility and refusal are significant barriers to recruitment in SSc clinical trials.
- Enhanced reporting of patient flow is needed to improve trial transparency and efficiency.

