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 cutaneous T-cell lymphoma--report of a case with atypical clinical presentation.

A case of a 20-years-old black man from Salvador, Bahia with HTLV-I associated T cell lymphoma is presented. In spite of the absence of splenomegaly and leukemia, the patient had a marked cephalic tumoral infiltration associated with axillary tumors in a pattern not yet described in adult T cell lymphoma. Peripheral blood involvement was observed later on in the course of the disease. The patient underwent chemotherapy but died seven months after diagnosis.

Characteristics of the acquired immunodeficiency syndrome in Brazil.

The clinical and epidemiologic characteristics of the acquired immunodeficiency syndrome (AIDS) were studied in a tropical area of Brazil. During an 18-month period (July 1989-January 1991), 111 consecutive AIDS patients (102 men and nine women) were evaluated. Patients reported homosexual/bisexual activities (60%), intravenous drug use (19%), or both (6%), heterosexual activities (11%), blood transfusions (2%), and 2% belonged to an undetermined category. Weight loss, fever, oral thrush, and diarrhea were present in > or = 70% of the patients at presentation. An unexpected high frequency of hepatomegaly (49%) was detected, and found to be significantly associated with tuberculosis (P < 0.0001). Although the epidemiologic features of human immunodeficiency virus transmission were comparable to the United States/European pattern, the clinical spectrum of opportunistic infections more closely resembled that reported in Africa and Haiti, with a greater frequency of fungal and mycobacterial infections than Pneumocystis carinii pneumonia and viral infections.

HTLV-I associated myelopathy in Salvador (northeastern Brazil).

Recent studies of tropical spastic paraparesis have confirmed the existence of human T-cell leukemia virus type-1 (HTLV-I) in several tropical areas of the world. In order to determine the role of HTLV-I as an etiologic agent of myelopathies in Salvador, we conducted a clinical and serological study in 43 patients with non-traumatic and non-tumoral myelopathies. We found 9 patients with HTLV-I associated myelopathy (HAM) which points to a new endemic area of HAM.

PIP: Human T-lymphotropic virus type one (HTLV-I) exists in several tropical areas of the world and is associated with adult T-cell leukemia/lymphoma and tropical spastic paraparesis. HTLV-I associated myelopathy (HAM) has been described in southern Japan, the US, Colombia, and Central Africa. Several cases have also been identified and described in Brazil. The authors describe the first cases of HAM in Bahia based upon a clinical and serological study in 43 patients with non-traumatic and non-tumoral myelopathies. Sera and CSF of the 43 patients admitted to a general hospital in Salvador over the course of six months with chronic spastic paraparesis were tested for HTLV-I, of whom nine with progressive chronic spastic paraparesis had serum and CSF positive to HTLV-I. These patients were aged 18-56 years. Two were promiscuous and one of them had a blood transfusion eight months before symptoms. They had similar histories with progressive weakness, first in one leg and after in the other which was associated with paresthesias in varying degrees of intensity. None of the patients had sensory level, although all had vegetative disturbances which were characterized by bladder dysfunction, constipation, and impotence in men. These findings suggest the existence of a new area in which HAM is endemic.

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