국내 의학 잡지에 게재된 무작위대조임상시험 논문들의 보고의 질 = The Quality of Reporting of Randomized Controlled Trials in Korean Medical Journals Indexed in KoreaMed: Survey of Items of the Revised CONSORT Statement

다국어 초록 (Multilingual 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)

국문 초록 (Abstract)

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.

참고문헌 (Reference)

1 김석원, "국내 학회지에 실린 무작위임상시험논문의 양적 분석 및 질 평가 - 5개 학회지를 대상으로" 대한가정의학회 25 (25): 118-125, 2004

2 Hollis S, "What is meant by intention to treat analysis? Survey of published randomised controlled trials" 319 : 670-74, 1999

3 Egger M, "Value of flow diagrams in reports of randomized controlled trials" 285 : 1996-1999, 2001

4 Moher D, "Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation" 285 : 1992-1995, 2001

5 Fergusson D, "Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials" 328 : 432-, 2004

6 Mills EJ, "The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement" 26 : 480-487, 2005

7 Scherer RW, "Reporting of randomized clinical trial descriptors and use of structured abstracts" 280 : 269-272, 1998

8 Piaggio G, "Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement" 295 : 1152-1160, 2006

9 Nuovo J, "Reporting number needed to treat and absolute risk reduction in randomized controlled trials" 287 : 2813-214, 2002

10 Devereaux PJ, "Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials" 285 : 2000-2003, 2001

11 Campbell MJ, "Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons" 311 : 1145-1148, 1995

12 Altman DG, "Endorsement of the CONSORT statement by high impact medical journals: survey of instructions for authors" 330 : 1056-1057, 2005

13 Chan AW, "Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles" 291 : 2457-2465, 2004

14 Schulz KF, "Emperical evidence of bias. Dimentions of methodological quality associated with estimates of treatment effects in controlled trials" 273 : 408-412, 1995

15 Godlee F, "Effect on the quality of peer review of blinding reviewers and asking them to sign their reports: a randomized controlled trial" 280 : 237-240, 1998

16 Berlin JA, "Does blinding of readers affect the results of meta-analyses? University of Pennsylvania. Meta-analysis Blinding Study Group" 350 : 185-186, 1997

17 Clarke M, "Discussion sections in reports of controlled trials published in general medical journals: islands in search of continents?" 280 : 280-282, 1998

18 Clarke M, "Discussion sections in reports of controlled trials published in general medical journals" 287 : 2799-2801, 2002

19 Ioannidis JP, "Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas" 285 : 437-443, 2001

20 Campbell MK, "CONSORT statement: extension to cluster randomised trials" 328 : 702-708, 2004

21 Altman DG, "CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration" 134 : 663-694, 2001

22 Moher D, "CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials" 285 : 1987-1991, 2001

23 Ioannidis JP, "CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement" 141 : 781-788, 2004

24 Schulz KF, "Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology" 312 : 742-744, 1996

25 Kim CB, "Assessment on quality improvement of the abstracts of the original research articles in the korean journal of preventive medicine" 36 : 179-186, 2003