See the reply [Response to "Comment on Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study"].
See the article "Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study" on page 537.
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Comment on “Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study”
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Raghuraman M Sethuraman
, Pranjali Kurhekar
- Received October 1, 2024 Accepted October 24, 2024
Dear Editor,
We read with great interest the article “Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study” [1] and wish to reflect our views on the design of the study.
Kim et al. [1] reported their study as a “propensity score-matched, non-inferiority study.” Notably, a non-inferiority study is conducted to prove that a new or reference treatment is not inferior to the existing one [2] and thus is a prospective interventional study. However, the study conducted by Kim et al. [1] was a retrospective, observational study. Furthermore, before commencing a non-inferiority study, the non-inferiority margin should be calculated, and the sample size should be determined based on a previously published superiority study (preferably one that compares the existing treatment with a placebo) [2]. Importantly, all these details should be stated during trial registration. Hence, unfortunately, the current study cannot be considered a “non-inferiority study.”
In this regard, we would like to highlight a statement made by Hong and Lee [3] in their recently published article describing the key points and challenges of this type of study: “As the sample size in a study is determined by the noninferiority margin, it should be predetermined based on strict criteria and cannot be modified based on the results after the study is completed.”
- References
- 1. Kim JH, Nam JS, Seo WW, Joung KW, Chin JH, Kim WJ, et al. Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study. Korean J Anesthesiol 2024; 77: 537-45.
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