Statistical and methodological considerations for reporting RCTs in medical literature

다국어 초록 (Multilingual Abstract)

Randomized controlled trials (RCTs) are known to provide the most reliable evidence on intervention. However, RCTsare often conducted and reported incompletely and inadequately, making readers and reviewers unable to judge the validityand reliability of the trials. In this article, we consider the statistical and methodological issues involved in reportingon RCTs, particularly in relation to the objectives, designs, and commencements of trials. This paper deals with the variousissues that should be considered in presenting RCTs, and suggests checklists for reporting on them. We expect thatthese checklists will remind readers and reviewers to evaluate manuscripts systematically and comprehensively, makingthose manuscripts more transparent and reliable.

참고문헌 (Reference)

1 안원식, "연구용 표본 수 구하기" 대한마취통증의학회 52 (52): 740-740, 2007

2 Glasziou P, "What is missing from descriptions of treatment in trials and reviews?" 336 : 1472-1474, 2008

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

4 Guyatt GH, "Users’ guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group" 270 : 2598-2601, 1993

5 Marshall M, "Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia" 176 : 249-252, 2000

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

7 May GS, "The randomized clinical trial : bias in analysis" 64 : 669-673, 1981

8 강현, "The prevention and handling of the missing data" 대한마취통증의학회 64 (64): 402-406, 2013

9 Noseworthy JH, "The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial" 44 : 16-20, 1994

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

11 Jüni P, "Systematic reviews in health care : Assessing the quality of controlled clinical trials" 323 : 42-46, 2001

12 Dwan K, "Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review" 8 : 66844-, 2013

13 Lewis JA., "Statistical principles for clinical trials(ICH E9) : an introductory note on an international guideline" 18 : 1903-1942, 1999

14 Macura A, "Selective outcome reporting : telling and detecting true lies. The state of the science" 5 : 151-155, 2010

15 Beck RW., "Sample size for a clinical trial : why do some trials need only 100 patients and others 1000 patients or more?" 113 : 721-722, 2006

16 Pitrou I, "Reporting of safety results in published reports of randomized controlled trials" 169 : 1756-1761, 2009

17 Cheng K, "Randomized controlled trials in cystic fibrosis(1966-1997)categorized by time, design, and intervention" 29 : 1-7, 2000

18 Altman DG., "Randomisation" 302 : 1481-1482, 1991

19 Lee YS, "Post-hoc Survey for Power of 119 Negative Results in Korean Journal of Anesthesiology" 36 : 286-292, 1999

20 Stephenson JM, "Overview of study design in clinical epidemiology" 76 : 244-247, 2000

21 Rahimi K, "Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review" 341 : 5707-, 2010

22 Gøtzsche PC., "Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis" 10 : 31-56, 1989

23 Chalmers TC, "Meta-analysis of clinical trials as a scientific discipline. I : Control of bias and comparison with large co-operative trials" 6 : 315-328, 1987

24 Fields WS, "Joint study of extracranial arterial occlusion. V. Progress report of prognosis following surgery or nonsurgical treatment for transient cerebral ischemic attacks and cervical carotid artery lesions" 211 : 1993-2003, 1970

25 Montori VM, "In the dark : the reporting of blinding status in randomized controlled trials" 55 : 787-790, 2002

26 Chan AW, "Identifying outcome reporting bias in randomised trials on PubMed : review of publications and survey of authors" 330 : 753-, 2005

27 Campbell DT., "Factors relevant to the validity of experiments in social settings" 54 : 297-312, 1957

28 Dwan K, "Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials" 11 : 1001666-, 2014

29 Deeks JJ, "Evaluating non-randomised intervention studies" 7 (7): 1-173, 2003

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

31 Wood L, "Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes : meta-epidemiological study" 336 : 601-605, 2008

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

33 Sackett DL, "Controversy in counting and attributing events in clinical trials" 301 : 1410-1412, 1979

34 Higgins JP, "Cochrane Handbook for Systematic Reviews of Interventions" John Wiley & Sons, Ltd 2008

35 Moher D., "CONSORT : an evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials" 279 : 1489-1491, 1998

36 Gøtzsche PC., "Blinding during data analysis and writing of manuscripts" 17 : 285-290, 1996

37 Meinert CL., "Beyond CONSORT : need for improved reporting standards for clinical trials. Consolidated Standards of Reporting Trials" 279 : 1487-1489, 1998

38 Schulz KF, "Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals" 272 : 125-128, 1994

39 강현, "Appropriate design of research and statistical analyses: observational versus experimental studies" 대한마취통증의학회 65 (65): 105-107, 2013

40 The Standards of Reporting Trials Group., "A proposal for structured reporting of randomized controlled trials" 272 : 1926-1931, 1994