Evaluation of the “Early” Use of Albumin in Children With Extensive Burns: Were the Differences Significant?
In this study, the important difference between the intervention and the control group was the lesser crystalloid fluid infusion requirement in the early albumin group. The data were expressed as median (interquartile range [IQR]), 2.49 (1.68–2.44) in the early albumin group, which was less when compared with the control group (p = 0.025). However, in these data, the median seems to be higher than the 75th quantile value, which may be, either be due to an error in typing or calculation. Before interpreting the results, we would like to know whether the difference between the two groups was statistically significant after correcting the median, IQR.
The number of patients who had hypotensive shock at admission or during the course of treatment in each group was not mentioned in the study. Patients with hypotensive shock are more likely to receive more IV fluids during resuscitation. The number of hypotensive patients in each group and the type of bolus received could affect the requirement of further crystalloid infusion between the groups. Similarly, the volume of fluid or boluses received prior to reaching the hospital could affect the occurrence of fluid creep and further crystalloid infusion requirement between the groups. Were any data collected regarding the same?
The sample size calculation in this study included a one-sided type I error of 5% arriving at a sample size of 23 patients in each group. In an interventional study, one is generally interested in whether a treatment results in outcomes that are better than chance, thus suggesting a one-tailed test; but a worse outcome is also of interest. Therefore, use of a two-tailed test will be preferred especially if the benefit of experimental treatment is not known to be better than the comparator (2).
There was no mention regarding adverse events in each group during the study. It is unclear whether the effect of confounders like presence of acute kidney injury in the two groups, occurrence of healthcare associated infections, any other organ failure at admission or during the course of the study, baseline albumin level of patients before infusion, which can affect the length of hospital stay were taken into consideration during the analysis.