Preprint Data Play a Large Role in COVID-19 Treatment

Prior to release of data from the RECOVERY trial, only 29.5% of hospitalized patients with COVID-19 were receiving corticosteroids. Following the preprint release of information, that percentage increased by an absolute difference of 62.5%.

As researchers aim to better understand COVID-19 in order to aid in treatment, prevention, and recovery, new data is being published daily. The COVID-19 pandemic has caused a significant increase in the release of preprint information prior to formal publication of study findings.

The Short Period Incidence Study of Severe Acute Respiratory Infection (SPRINT-SARI), a multicenter, prospective, observational database trial in Australia, analyzed the effect of preprint services on clinical practice. The study included a 78 practice sites, the majority of which were tertiary or metropolitan public hospitals. In total, 52 of the sites contributed to the SPRINT-SARI study, 15 of which had more than 20 intensive care unit (ICU) beds.

The researchers for the RECOVERY trial, which demonstrated the efficacy of corticosteroid use in adult patients with COVID-19, released their results on June 20, 2020, and published their final paper on July 17, 2020. The SPRINT-SARI trial compared corticosteroid use before, after preprint, and after publication.

Between February 27, 2020, and November 11, 2020, there were 461 COVID-19 cases documented at the 15 sites. The researchers found that, prior to release of information of the RECOVERY trial, 29.5% of patients had received corticosteroids. Following the preprint release, 92% (absolute difference of 62.5%) of patients had received corticosteroids. Once the RECOVERY trial was formally published, the use of corticosteroids increased further to 95% (absolute difference of 3.8%).

After the preprint release, based on the level of respiratory support at ICU admission, corticosteroid use increased from 4.0% to 66.7% among those requiring no support, 7.7% to 100% among those requiring low-flow oxygen, 35.9% to 100% among those requiring high-flow nasal cannula or noninvasive ventilation, and 48.6% to 93.1% among those requiring mechanical ventilation.

The preprint release of data should not be considered the only contributing factor to the widespread use of corticosteroids among patients with COVID-19. Drug availability, clinical familiarity, cost, and extensive safety data in the critically ill may have been additional factors that contributed to the widespread use of this treatment.

Limitations of the study included the lack of specification regarding the corticosteroids (type, dose, and duration were not documented), use in other locations besides the ICU was not documented, and the indication for corticosteroid use was not documented.

“In conclusion, preprint release of the RECOVERY trial findings led to an almost immediate, dramatic change in corticosteroid use in critically ill COVID-19 patients across Australia,” the researchers concluded. “Although the rapid translation of medical evidence is beneficial in cases where the intervention is of proven benefit, preprint release of trial findings prior to peer review, creates a risk of inappropriate global translation.”

—Audrey Amos, Pharm D

Reference:

Burrell AJC, Neto AS, Trapani T, Broadley T, French C, Udy AA; SPRINT-SARI Australia Investigators. Rapid translation of COVID-19 preprint data into critical care practice. Am J Respir Crit Care Med. Published online: December 3, 2020. doi:10.1164/rccm.202009-3661LE