Abstract
A clinical interpretation of the Randomized Evaluation of COVID-19 Therapy (RECOVERY) study was performed to provide a useful tool to understand whether, when, and to whom dexamethasone should be administered during hospitalization for COVID-19. A post hoc analysis of data published in the preliminary report of the RECOVERY study was performed to calculate the person-based number needed to treat (NNT) and number needed to harm (NNH) of 6 mg dexamethasone once daily for up to 10 days vs. usual care with respect to mortality. At day 28, the NNT of dexamethasone vs. usual care was 36.0 (95%CI 24.9–65.1, p < 0.05) in all patients, 8.3 (95%CI 6.0–13.1, p < 0.05) in patients receiving invasive mechanical ventilation, and 34.6 (95%CI 22.1–79.0, p < 0.05) in patients receiving oxygen only (with or without noninvasive ventilation). Dexamethasone increased mortality compared with usual care in patients not requiring oxygen supplementation, leading to a NNH value of 26.7 (95%CI 18.1–50.9, p < 0.05). NNT of dexamethasone vs. usual care was 17.3 (95%CI 14.9–20.6) in subjects <70 years, 27.0 (95%CI 18.5–49.8) in men, and 16.2 (95%CI 13.2–20.8) in patients in which the onset of symptoms was >7 days. Dexamethasone is effective in male subjects < 70 years that require invasive mechanical ventilation experiencing symptoms from >7 days and those patients receiving oxygen without invasive mechanical ventilation; it should be avoided in patients not requiring respiratory support.
Highlights
The updated guidance of the American Thoracic Society (ATS) and European Respiratory Society (ERS) International Task Force for the management of coronavirus disease 2019(COVID-19) has recently suggested to use dexamethasone in hospitalized patients who require supplemental oxygen or are mechanically ventilated [1]
A careful interpretation of data reported in the supplementary appendix and preliminary report of RECOVERY study [2] via the analysis of number needed to treat (NNT) and number needed to harm (NNH) may provide a useful tool for clinical decision making to understand whether, when, and to whom dexamethasone should be administered during hospitalization for COVID-19
∞: infinity; infinity; CI: CI: confidence confidence interval; interval; NNH: NNH: number number needed needed to to harm; harm;NNT: NNT: number numberneed needto totreat. The results of this analysis provide the evidence that only ≈8 patients receiving invasive mechanical ventilation had to be treated with dexamethasone to prevent one death compared to usual care over 4 weeks, whereas in patients receiving oxygen only, one death was prevented for every 35 patients
Summary
The updated guidance of the American Thoracic Society (ATS) and European Respiratory Society (ERS) International Task Force for the management of coronavirus disease 2019(COVID-19) has recently suggested to use dexamethasone in hospitalized patients who require supplemental oxygen or are mechanically ventilated [1]. Despite the robustness of data provided by the RECOVERY study [2], results expressed as Kaplan–Meier survival curves and mortality rate ratios remain difficult to interpret, from a strictly clinical viewpoint, for those clinicians that are not accustomed to statistics. In this respect, the analysis of the number needed to treat (NNT) and number needed to harm (NNH) represents another way to assess the benefit and harm of a given therapeutic option, a validated approach to evaluate the clinical impact of corticosteroids in respiratory disorders [3,4]. A careful interpretation of data reported in the supplementary appendix and preliminary report of RECOVERY study [2] via the analysis of NNT and NNH may provide a useful tool for clinical decision making to understand whether, when, and to whom dexamethasone should be administered during hospitalization for COVID-19
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