Patient-important outcomes reported as primary outcomes in clinical studies of treatments for COVID-19: a meta-epidemiological study.
Julia Bidonde, Laura Yuriko González-Teshima, Sergio Mauricio Moreno López et al.
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In 30 seconds
This meta-epidemiological study evaluated the reporting of patient-important outcomes (PIOs) as primary outcomes in 102 randomized controlled trials (RCTs) of COVID-19 treatments. It found that mortality outcomes were reported more frequently in trials with 15- to 28-day follow-up (OR: 3.53) and less frequently in trials enrolling moderate-severity COVID-19 participants (OR: 0.22).
Key findings
- Mortality outcomes were reported more often in trials with 15- to 28-day follow-up (OR: 3.53).
- Morbidity outcomes were less frequently reported in trials enrolling severe-COVID-19 participants (OR: 0.19).
- Trials conducted in Europe, Asia, and the Americas reported morbidity outcomes more frequently than multicontinental trials (ORs ranging from 8.92 to 12.78).
- Trials with more than 200 participants were more likely to report morbidity outcomes than those with ≤50 participants (OR: 11.43).
Why it matters
Understanding the reporting of patient-important outcomes in clinical trials is crucial for ensuring that research aligns with patient needs and preferences. This study highlights significant gaps in the focus on quality of life and functional recovery, which are essential for informed clinical decision-making.