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GUIDELINES ON HOW TO ASSESS THE VALIDITY OF RESULTS PRESENTED IN SUBGROUP ANALYSIS OF CLINICAL TRIALS
Subgroup analysis
Epidemiological methods
Interaction
Effect modification
Ensaios Clínicos Controlados Aleatórios como Assunto/normas
Reprodutibilidade dos Testes
Humanos
Pesquisa/normas
Afiliación
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Associação Obras Sociais Irmã Dulce. Núcleo de Apoio à Pesquisa. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Escola Bahiana de Medicina e Saúde Pública. Salvador, BA, Brasil / Hospital São Rafael. Salvador, BA, Brasil.
Columbia University. School of Public Health. Division of Epidemiology. New York, NY, USA.
Columbia University. School of Public Health. Division of Epidemiology. New York, NY, USA.
Resumen en ingles
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.
Palabras clave en ingles
Randomized clinical trialSubgroup analysis
Epidemiological methods
Interaction
Effect modification
DeCS
Guias como AssuntoEnsaios Clínicos Controlados Aleatórios como Assunto/normas
Reprodutibilidade dos Testes
Humanos
Pesquisa/normas
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