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