Determinants of mortality in oncology patients colonized or infected with Staphylococcus aureus

Oxacillin-resistant Staphylococcus aureus (ORSA) infection is an important cause of hospital morbidity and mortality. The objective of this study was to identify the main factors associated with death in patients colonized or infected with Staphylococcus aureus in a cancer center. A matched-pair case-control study enrolled all patients infected or colonized with ORSA (cases) admitted to the Hospital do Câncer in Rio de Janeiro from 01/01/1992 to 12/31/1994. A control was defined as a patient hospitalized during the same period as the case-patients and colonized or infected with oxacillin-susceptible Staphylococcus aureus (OSSA). The study enrolled 95 cases and 95 controls. Patient distribution was similar for the two groups (p > or = 0.05) with respect to gender, underlying diseases, hospital transfer, prior infection, age, temperature, heart and respiratory rates, neutrophil count, and duration of hospitalization. Univariate analysis of putative risk factors associated with mortality showed the following significant variables: admission to the intensive care unit (ICU), presence of bacteremia, use of central venous catheter (CVC), ORSA colonization or infection, pneumonia, use of urinary catheter, primary lung infection, prior use of antibiotics, mucositis, and absence of cutaneous abscesses. Multivariate analysis showed a strong association between mortality and the following independent variables: admission to ICU (OR [odds ratio]=7.2), presence of Staphylococcus bacteremia (OR=6.8), presence of CVC (OR=5.3), and isolation of ORSA (OR=2.7). The study suggests a higher virulence of ORSA in comparison to OSSA in cancer patients.

Guidelines on how to assess the validity of results presented in subgroup analysis of clinical trials

In observational studies, identification of associations within particular subgroups is the usual method of investigation. As an exploratory method, it is the bread and butter of epidemiological research. Nearly everything that has been learned in epidemiology has been derived from the analysis of subgroups. In a randomized clinical trial, the entire purpose is the comparison of the test subjects and the controls, and when there is particular interest in the results of treatment in a certain section of trial participants, a subgroup analysis is performed. These subgroups are examined to see if they are liable to a greater benefit or risk from treatment. Thus, analyzing patient subsets is a natural part of the process of improving therapeutic knowledge through clinical trials. Nevertheless, the reliability of subgroup analysis can often be poor because of problems of multiplicity and limitations in the numbers of patients studied. The naive interpretation of the results of such examinations is a cause of great confusion in the therapeutic literature. We emphasize the need for readers to be aware that inferences based on comparisons between subgroups in randomized clinical trials should be approached more cautiously than those based on the main comparison. That is, subgroup analysis results derived from a sound clinical trial are not necessarily valid; one must not jump to conclusions and accept the validity of subgroup analysis results without an appropriate judgment.