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J.Jpn. Surg. Soc.. 125(2): 113-119, 2024


Feature topic

CURRENT TRENDS IN RANDOMIZED, CONTROLLED TRIALS IN CARDIOVASCULAR SURGERY IN JAPAN

Division of Cardiovascular Surgery, Japanese Red Cross Kobe Hospital and Hyogo Emergency Medical Center, Kobe, Japan

Takuro Tsukube

The relatively few randomized, controlled trials (RCTs) in cardiovascular surgery (CVS), especially in Japan, could be explained by special issues compared with those in general cardiology. These issues may be intrinsic to the nature of the field (issues with blinding, learning curves, and surgeons’ experience, and difficulties in defining the appropriate timing for comparative trials). Other issues could be related to the surgical culture, the attitude of surgeons toward randomized trials, difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community. Over the course of the last 20 years, the number of RCTs in CVS in Japan was very small. In this review, important challenges faced by RCTs in CVS are discussed and suggestions for the successful design and completion of RCTs in CVS in Japan are provided.


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