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Response to Malla et al.

Journal of Perinatology volume 38, page 293 (2018)Cite this article

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Malla et al [1] published a randomized placebo-controlled trial on the use of erythropoietin (Epo) as monotherapy (i.e., without adjunct therapeutic hypothermia) in neonates with moderate to severe encephalopathy secondary to perinatal asphyxia. The authors report both a clinically and statistically significant primary outcome of combined death or moderate/severe disability at a mean age of 19 months with a 30% absolute risk reduction (40% in the Epo group compared to 70% in the placebo group, risk ratio = 0.57 (95% confidence interval (CI) of 0.38, 0.85; p = 0.003). This effect size is driven primarily by reduction in disability as the rate of death in both groups was 16%. These findings are modest in effect size and particularly important for resource limited settings where therapeutic hypothermia is not a feasible option, yet perinatal asphyxia is even a larger burden as compared to the developed world [2].

As the authors dissect the primary outcome into the subcomponents and explore the secondary outcomes, we have questions to how some of the findings are presented in the abstract, the text and Tables 2 and 3 of the publication. In particular, there are three reported findings that we have further inquiries on, as well as one finding that is likely a typo with the upper confidence level is less than the lower (Table 1).

Table 1 Secondary outcomes, risk ratio, confidence intervals and p value
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References

  1. Malla RR, Asimi R, Teli MA, Shaheen F, Bhat MA. Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial. J Perinatol. 2017;37:596–601.

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  2. Gunn AJ, Laptook AR, Robertson NJ, Barks JD, Thoresen M, Wassink G, et al. Therapeutic hypothermia translates from ancient history in to practice. Pediatr Res. 2017;81:202–9.

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  3. Chavalarias D, Wallach JD, Li AH, Ioannidis JP. Evolution of reporting P values in the biomedical literature, 1990-2015. JAMA. 2016;315:1141–8.

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  4. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2:e124.

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Authors and Affiliations

  1. Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA

    Joseph Samuel Bircher & Dmitry Dukhovny

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  1. Joseph Samuel Bircher
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  2. Dmitry Dukhovny
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Correspondence to Dmitry Dukhovny.

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Bircher, J.S., Dukhovny, D. Response to Malla et al.. J Perinatol 38, 293 (2018). https://doi.org/10.1038/s41372-017-0021-7

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