Journal Club: June 2021

JPAG Article, June 2019:Dowlut-McElroy T, et al. Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial.

  1. This study is a randomized control trial. Do you think this was a well-designed study? What are the study design types of randomized controlled trials?   

  2. The authors report that the relatively small sample size likely contributed to the lack of statistical significance between the 2 treatment groups (estrogen vs emollient).  What 4 components are necessary to calculate sample size for trials with dichotomous outcomes (i.e. complete resolution of labial adhesion or not)?  Did the authors provide all the necessary assumptions for readers to replicate their sample size calculation? Go to (or another sample size calculator). Based on the info they provided did they have enough patients in each group?  

  3. Although the results were not statistically significant, the estrogen intervention group was 2X as successful as the Cetaphil group (36% vs. 19%) with respect to complete resolution.  Though not statistically significant likely due to low sample size, would you consider the results to be clinically significant?  How, if at all, would you incorporate these findings into your clinical practice?  How would you use their results in a future study?

  4. The authors created a composite score to determine adhesion severity. What do you think about the variables included in this score? How do you interpret the significance of this score?  

  5. The authors identify a significant limitation in their study, ie: adherence to treatment was collected only by patient report and treatment was not observed.  The authors state that the overall lower complete resolution rates of labial adhesions in this study might be a function of lack of adherence.  Do you agree?  Would there any way to mitigate this limitation as consistent observed therapy would be challenging to achieve?

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