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REPORTING ON METHODS OF SUBGROUP ANALYSIS IN CLINICAL TRIALS: A SURVEY OF FOUR SCIENTIFIC JOURNALS.
Randomized clinical trials
Research design
Epidemiological methods
Effect modification
Ensaios Clínicos Controlados Aleatórios como Assunto/normas
Interpretação Estatística de Dados
Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
Projetos de Pesquisa/normas
Autor(es)
Afiliação
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Columbia University. Department of Psychiatry. New York, NY, United States of America
Columbia University. School of Public Health. Division of Epidemiology. New York, NY,United States of America
Columbia University. Department of Psychiatry. New York, NY, United States of America
Columbia University. School of Public Health. Division of Epidemiology. New York, NY,United States of America
Resumo em Inglês
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%) had at least
one SA. Overall, the proportion of RCT reporting a particular methodological
aspect ranged from 23 to 94%. Information on whether the
SA preceded/followed the analysis was reported in only 7 (41%) 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%,
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.
Palavras-chave em inglês
Subgroup analysesRandomized clinical trials
Research design
Epidemiological methods
Effect modification
DeCS
Publicações Periódicas como Assunto/normasEnsaios Clínicos Controlados Aleatórios como Assunto/normas
Interpretação Estatística de Dados
Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
Projetos de Pesquisa/normas
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