Clinical differences between children with asthma and rhinitis in rural and urban areas

Abstract

In their article, Sánchez, et al ¹ have reported about an interesting study on asthma and rhinitis symptoms among children in urban and rural Colombian areas, describing that the control of symptoms, over time, is more difficult among children in urban areas. Their article has the methodological advantage of having done a prospective follow-up of pediatric patients with asthma and rhinitis; nevertheless I have some questions:

1) The sample size calculation is not clear. The authors mentioned the prevalence of asthma and rhinitis in the urban areas and their corresponding error, but they did not use these parameters in the sample size calculation. On the other hand, the authors argued that the main outcome was comparing the treatment of asthma and rhinitis between urban and rural areas; thus readers could assume that the measure of effect was the difference of the Asthma Control Test (ACT) score between both areas; but the authors did not clearly explain it. Furthermore, it is not clear why the ratio of urban/rural subjects is 1.57; is the ratio observed in the study health centers? In this line, it seems that the appropriate sample size calculation must have been the difference of means between two independent populations, although the authors did not report any ACT effect size based on previous studies. Thus, I have estimated the means difference (as the effect size) given the power (80%) and the study sample size (urban= 201 and rural= 128) provided by the authors; using Stata® 14.2 (power twomeans command). In this manner, the detectable effect size would be 3.5; which is higher than the ACT effect size estimated in the Sánchez, Sánchez and Cardona’s article (i.e.: 3.0), leading to an underpowered study, at least for the cross-sectional estimates. In this manner, what was the appropriate sample size calculation?