Patient-important outcomes reported as primary outcomes in clinical studies of treatments for COVID-19: a meta-epidemiological study.

OBJECTIVES

The reporting of patient-important outcomes (PIOs) in randomized controlled trials (RCTs) for COVID-19 varies widely, limiting their application in clinical decision-making. We evaluated how often PIOs were reported as primary outcomes in RCTs of COVID-19 treatments and identified trial characteristics associated with their reporting.

STUDY DESIGN AND

SETTING

This meta-epidemiological study analyzed primary outcome data from 102 RCTs evaluating COVID-19 treatments.

RESULTS

Mortality outcomes were more frequently reported in trials with 15- to 28-day follow-up than in trials with ≤14-day follow-up (OR: 3.53, 95% CI: 1.10-11.38), and less frequently in trials enrolling participants with moderate-severity COVID-19 compared with trials not enrolling such participants (odds ratio [OR]: 0.22, 95% confidence interval [CI]: 0.07-0.64). Morbidity outcomes were less frequently reported in trials enrolling severe-COVID-19 participants compared with trials not enrolling them (OR: 0.19, 95% CI: 0.05-0.78), and more frequently reported in trials conducted in Europe (OR: 12.78, 95% CI: 1.01-161.76), Asia (OR: 11.03, 95% CI: 1.50-81.03) and the Americas (OR: 8.92, 95% CI: 1.08-73.89), each compared with multicontinental trials. Trials with more than 200 participants were also more likely to report morbidity outcomes than trials with ≤50 participants (OR: 11.43, 95% CI: 1.37-95.55). Quality of life and functional status outcomes were not associated with any of the predictors examined.

CONCLUSIONS

Reporting of PIOs as primary outcomes in COVID-19 RCTs is inconsistent and influenced by region, disease severity, and sample size. Quality of life and functional recovery remain overlooked. The implementation of core outcome sets) is required to ensure that PIOs are routinely and consistently incorporated into trial designs.

PLAIN LANGUAGE SUMMARY: Clinical trials should measure outcomes that matter most to patients, such as survival and quality of life. We investigated whether COVID-19 trials prioritized these outcomes as their main goals. We analyzed 102 COVID-19 trials and found that while survival and clinical complications were frequently measured, quality of life and long-term recovery were rarely used as primary goals. The choice of what to measure was often influenced by the trial's location or size rather than patient needs. The lack of focus on quality of life limits the ability of trials to inform decisions that reflect what patients truly value. Future research should use standardized "patient-important outcomes" to ensure clinical trials remain relevant to the people they intend to help.