The Quality of Reporting of Randomized Controlled Trials in Korean Medical Journals Indexed in KoreaMed: Survey of Items of the Revised CONSORT Statement.

Hwang, Ye Won; Lee, Kyung Woo; Hwang, In Hong; Kim, Soo Young

Original Article

Journal of the Korean Academy of Family Medicine 2008;29(4):276-282.
Published online April 10, 2008.

The Quality of Reporting of Randomized Controlled Trials in Korean Medical Journals Indexed in KoreaMed: Survey of Items of the Revised CONSORT Statement.

Ye Won Hwang, Kyung Woo Lee, In Hong Hwang, Soo Young Kim

¹Department of Family Medicine, Korea University College of Medicine, Ansan, Korea.
²Department of Family Medicine, Das Jin Medical Center, Bundang, Korea.
³Department of Family Medicine, Hallym University College of Medicine, Seoul, Korea. hallymfm@gmail.com

국내 의학 잡지에 게재된 무작위대조임상시험 논문들의 보고의 질

황예원,이경우,황인홍,김수영

^¹
^²
^³

Abstract

Background
The revised Consolidated Standards for Reporting of Trials (CONSORT) were developed to improve the reporting of Randomized Controlled Trials. We studied to survey the extent to which RCTs report items included in the revised CONSORT recommendations. Methods: A descriptive survey of RCTs enrolled in 2005 at KoreaMed, which is a representative database in Korea was done. The main outcome measures were the proportion of RCTs that reported each of 22 checklist items of CONSORT. Results: We identified 125 RCTs from 26 journals. Random sequence implementation (0%), estimated effect size and its precision (0%), sample size determination (8.9%), method of random sequence generation (7.3%), allocation concealment (3.2%), participant flow (4.8%) and any other analysis (7.3%), generalizability of the trial findings (0.8%) were pooly reported. Conclusion: The proportions of following the CONSORT recommendations in Korean medical journals were very low. An effort to improve the reporting of RCTs by application and recommendation of CONSORT statement is required. (J Korean Acad Fam Med 2008;29:276-282)

Key Words: randomized controlled trial, double-blind method, random allocation

초록

연구배경: Consolidated Standards for Reporting of Trials (CONSORT) 개정안은 무작위대조임상시험의 보고의 질을 향상시키기 위해 개발되었다. 국내 의학 잡지에 게재된 무작위대조임상시험 논문들이 개정된 CONOSRT 권고안의 항목들을 어느 정도 보고하고 있는지를 확인하였다. 방법: 한국의 대표적인 데이터베이스인 Korea Med에 2005년 색인자료 중 무작위대조임상시험을 검색하였다. 검색된 논문에서 CONSORT 체크리스트의 22가지 항목을 얼마나 보고하고 있는지를 조사하였다. 결과: 26개의 의학 잡지에서 124개의 무작위대조임상시험을 추출하였다. CONSORT 체크 리스트 중 필요한 대상자 수를 결정하는 방법(8.9%), 무작위 배정의 순서를 결정하는 구체적인 방법(7.3%), 배정 은닉(3.2%), 무작위 배정의 실행(0%), 참가자 흐름도(4.8%), 결과의 추정치의 정밀도(0%), 부차적 분석결론(7.3%), 연구결과의 일반화 가능성(0.8%) 등의 보고의 질이 낮았다. 결론: 우리나라 의학 학술지에 실린 무작위 대조 연구들의 CONOSRT 권고안을 따르는 비율은 매우 낮았다. CONSORT 양식의 채택과 권고를 통해 무작위 대조 연구의 보고의 질을 향상시키려는 노력이 필요하다.

중심 단어: 무작위 대조군 연구, 이중맹검, 무작위 배정