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
Artigo
em Inglês
| LILACS
| ID: lil-303312
Biblioteca responsável:
BR1.1
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
Texto completo:
Disponível
Coleções:
Bases de dados internacionais
Base de dados:
LILACS
Assunto principal:
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Publicação Periódica
Tipo de estudo:
Ensaio clínico controlado
/
Guia de prática clínica
Idioma:
Inglês
Revista:
Braz. j. med. biol. res
Assunto da revista:
Biologia
/
Medicina
Ano de publicação:
2001
Tipo de documento:
Artigo
País de afiliação:
Brasil
/
Estados Unidos
Instituição/País de afiliação:
Columbia University/US
/
Fundaçäo Oswaldo Cruz/BR