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한국에서 시행된 심혈관계질환 Clinical Trial의 방법론적 분석91971-1993)

Other Titles
 Methodological Review on cardiovascular Disease Clinical Trials in Korea 
 서일  ;  지선하  ;  백희정 
 Korean Circulation Journal (순환기), Vol.25(6) : 1077-1083, 1995-06 
Journal Title
Issue Date
Cardiovascular disease ; Clinical trails ; Methodology
Background: Cardiovascular disease is the major cause of death in industrialized countries including Korea.

Methods: The methodology of cardiovascular disease clinical trials, published in 'The Korean Circulation Journal(KCJ)' and in 'The Korean Journal of Internal Medicine (KJIM)' from 1971 to 1993 were reviewed. For the study period, a total of 169 research papers in this field, includion 155 papers in the KCJ and 14 in the KJIM, were reviewed. To review the methodology behind the cardiovascular disease clinical trials, presence of a control group, set up a primary end point, determined sample size and the statistical method to be used, report on the side effects, and consent of patients were checked. In cases involving clinical trials using control groups, rendomization and blinding were also analysed.

Results: Among clinical trials reviewed only 6 (4.0%) of the 169 papers were used a control group, and 46.7% were set up with a primary end point. There was no clinical trial which used statitical methods to estimate the sample size. Clinical trials which reported results with statistical methods were 107 to 169 papers;most of these used the student's paired t-test. The number reporting the side effects of intervention was 143(88.7%) and papers reporting with the consent of patients was 15(8.8%).

Conclusion: Most of clinical trials reviewed did not use appropriate method for clinical trials. Methodologically well-designed clinical trials in cardiovascular disease should be performed to guarantee the validity of study result.
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Preventive Medicine (예방의학교실) > 1. Journal Papers
Yonsei Authors
Suh, Il(서일) ORCID logo https://orcid.org/0000-0002-9689-7849
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