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Guidelines on how to assess the validity of results presented in subgroup analysis of clinical trials
Moreira, Edson Duarte; Susser, Ezra.
  • Moreira, Edson Duarte; Fundaçäo Oswaldo Cruz. Centro de Pesquisas Gonçalo. Epidemiology and Statistic Nuclei. BR
  • Susser, Ezra; Columbia University. School of Public Health. Division of Epidemiology. New York. US
Rev. Hosp. Clin. Fac. Med. Univ. Säo Paulo ; 57(2): 83-88, mar.-apr. 2002. tab
Article in English | LILACS | ID: lil-307994
RESUMO
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
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Full text: Available Index: LILACS (Americas) Main subject: Research / Randomized Controlled Trials as Topic / Reproducibility of Results Type of study: Controlled clinical trial / Practice guideline / Observational study / Prognostic study Limits: Humans Language: English Journal: Rev. Hosp. Clin. Fac. Med. Univ. Säo Paulo Journal subject: Medicine Year: 2002 Type: Article Affiliation country: Brazil / United States Institution/Affiliation country: Columbia University/US / Fundaçäo Oswaldo Cruz/BR

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Full text: Available Index: LILACS (Americas) Main subject: Research / Randomized Controlled Trials as Topic / Reproducibility of Results Type of study: Controlled clinical trial / Practice guideline / Observational study / Prognostic study Limits: Humans Language: English Journal: Rev. Hosp. Clin. Fac. Med. Univ. Säo Paulo Journal subject: Medicine Year: 2002 Type: Article Affiliation country: Brazil / United States Institution/Affiliation country: Columbia University/US / Fundaçäo Oswaldo Cruz/BR