Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals

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

HTLV-I associated myelopathy in Salvador (Northeastern Brazil)

Recentes estudos têm mostrado a presença de mielopatia associada a infecçäo por HTLV-I em muitas áreas tropicais do mundo. Com o objetivo de determinar o papel do HTLV-I como agente etiológico de mielopatias em Salvador, realizamos estudo clínico e sorológico em 43 pacientes com mielopatia de etiologia näo traumática e näo tumoral. Encontramos 9 pacientes com mielopatia associada a HTLV-I (HAM) o que sugere nova área endêmica de HAM