Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals
Braz. j. med. biol. res
;
34(11): 1441-1446, Nov. 2001. tab
Article
in English
| LILACS
| ID: lil-303312
ABSTRACT
Results of subgroup analysis (SA) reported in randomized clinical trials (RCT) cannot be adequately interpreted without information about the methods used in the study design and the data analysis. Our aim was to show how often inaccurate or incomplete reports occur. First, we selected eight methodological aspects of SA on the basis of their importance to a reader in determining the confidence that should be placed in the author's conclusions regarding such analysis. Then, we reviewed the current practice of reporting these methodological aspects of SA in clinical trials in four leading journals, i.e., the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, and the American Journal of Public Health. Eight consecutive reports from each journal published after July 1, 1998 were included. Of the 32 trials surveyed, 17 (53 percent) had at least one SA. Overall, the proportion of RCT reporting a particular methodological aspect ranged from 23 to 94 percent. Information on whether the SA preceded/followed the analysis was reported in only 7 (41 percent) of the studies. Of the total possible number of items to be reported, NEJM, JAMA, Lancet and AJPH clearly mentioned 59, 67, 58 and 72 percent, respectively. We conclude that current reporting of SA in RCT is incomplete and inaccurate. The results of such SA may have harmful effects on treatment recommendations if accepted without judicious scrutiny. We recommend that editors improve the reporting of SA in RCT by giving authors a list of the important items to be reported
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Randomized Controlled Trials as Topic
/
Periodical
Type of study:
Controlled clinical trial
/
Practice guideline
Language:
English
Journal:
Braz. j. med. biol. res
Journal subject:
Biology
/
Medicine
Year:
2001
Type:
Article
Affiliation country:
Brazil
/
United States
Institution/Affiliation country:
Columbia University/US
/
Fundaçäo Oswaldo Cruz/BR
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