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• W2016404915 abstract "Sir: We read with interest the article published by Dr. Nipshagen and colleagues.1 Although the authors are to be commended for their aim of conducting a prospective, randomized, controlled study on the use of two different techniques of skin closure after reduction mammaplasty, there are some issues with both the design of the study and the statistical analysis used. As for study design, the major issue is that this study does not seem to be adequately powered. Actually, the authors do not state the endpoint at which an anticipated difference could be observed. This is mandatory in a prospective study and whenever statistical tests are used to detect differences after a particular type of treatment. In this particular case, the authors do not state anything about the expected change in values of, for example, Hollander Wound Evaluation Scale score at 6 weeks postoperatively or Patient and Observer Scar Assessment Scale score at 6 months postoperatively, and therefore it is almost impossible to perform a prestudy sample size calculation. However, it is possible to perform a post hoc sample size calculation or power analysis on the statistical tests they have used from their data. For example, considering a mean Hollander Wound Evaluation Scale value of 1.94 ± 0.54 in the suture group and a difference of 0.18 in the “adhesive” group (Table 7), more than 140 patients per group would have been necessary to provide the results with real significance (e.g., considering the “standard” α error of 0.05 and a power of 0.8). Similarly, considering the values of Table 8, more than 175 patients per group would have been necessary to achieve the same level of statistical significance. In addition, we feel that part of the data analysis and statistics is not clear. Why do the authors always use parametric tests except for scar erythema, for which the Wilcoxon rank sum test was used? Is not this variable normally distributed? Then why not report it as mean and SD, usually used in normal distributions? In addition, why did they use the McNemar test (usually used with categorical variables) for preference and the Hollander Wound Evaluation Scale, which does not seem to be categorical? Another critical point is the type of statistical analysis used. Despite its existence for many years, the importance of nonlinear mixed-effects modeling has been recently reasserted.2 Most of the variables analyzed (e.g., visual analogue scale score for scar comfort) in this study are continuous and measured in a “subjective” way. In particular, for how they are defined, these variables cannot be assessed objectively. Nowhere is the importance of a method that accounts for both interindividual variability (e.g., unique perception of comfort), able to characterize the time-course of comfort in different patients, and intraindividual variability (various sources of “noise”) as critical as in this type of study. This important trial may probably benefit from such analysis. We hope our suggestions will be useful to other authors who will be involved in similar studies in the future. Alberto Mangano Vita-Salute San Raffaele University School of Medicine IRCCS San Raffaele Andrea Albertin Department of Anesthesiology IRCCS Multimedica Sesto San Giovanni Luca LaColla Department of Anesthesiology Vita-Salute San Raffaele University School of Medicine IRCCS San Raffaele Milan, Italy DISCLOSURE None of the authors has any conflict or financial interest with regard to the issue discussed in this communication." @default.
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• W2016404915 title "Use of 2-Octyl-Cyanoacrylate Skin Adhesive (Dermabond) for Wound Closure following Reduction Mammaplasty: A Prospective, Randomized Intervention Study. “Tips and Tricks” to Improve Statistical Analysis and Significance of Results" @default.
• W2016404915 cites W2010118186 @default.
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• W2016404915 doi "https://doi.org/10.1097/prs.0b013e3181adde55" @default.
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