Unethical conduct of underpowered clinical trials.
Year: 2013
Type: article
Abstract: I read with interest the article on the effect of antiseptics on the colonization rate of central venous catheters, published in the recent issue of your Journal.1 Although the topic is very important, the study suffers from many shortcomings, the most important of which is low study power. Assuming expected prevalence rates of 22% and 17% in the control and treatment groups (an effect size of 5%) and type I error of 0.05, the power of this study is merely 0.17, far less than the minimum acceptable value of 0.80 for clinical trials. Considering the study design, the authors should have recruited almost 2000 patients to detect any difference between the two treatment arms. Conduction of underpowered clinical trials is unethical and discouraged.
Conflicts of Interest: I have no conflicts of interest to be declared.
Reference
Yousefshahi F, Azimpour K, Boroumand MA, Najafi M, Barkhordari K, Vaezi M, Rouhipour N. Can a new antiseptic agent reduce the bacterial colonization rate of central venous lines in post-cardiac surgery patients? J Teh Univ Heart Ctr 2013;8:70-75.
Source: PubMed Central
Author: Farrokh Habibzadeh
Institution: National Iranian Oil Company (Iran)
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W2425695509